News and Events

The clinical development of advanced therapies development often proceeds without a robust understanding of the rapidly changing regulatory and commercial environment.
As more cell and gene therapies come to market and indications for the recently approved therapies are likely to expand, reimbursement challenges will also increase.
This panel discussion focuses on regulatory and access strategies to ensure that your clinical development plans are aligned with your commercial goals and the regulatory and market realities.

Monday, June 5, 2:15–3:15PM EST, Session Room: 254A

See here for session details.

Read more.

This award would not be possible without our people – who bring passion, integrity, and talent to the work we do to help our clients make a profound impact on healthcare globally.
Read here.

As a recognized expert in a range of musculoskeletal technologies and a trusted advisor to clients in a range of industries, Masha is a valued leader with a long career at Health Advances. Masha co-leads the MSK practice area and has supported over 100+ client engagements as a strategy leader. She is also a member of the MedTech senior leadership team and an expert in the burgeoning Women’s Digital Health space.
Masha has deep expertise across all aspects of the MSK care continuum and with MSK products and markets, including pain management, regenerative medicine, traditional implants for joint, extremity, trauma, and spine applications, robotics, AR and VR, digital tools, and instruments.
Masha will continue to support clients with commercialization strategies, buy/sell-side due diligence, reimbursement and market access strategies, business model assessments, competitive and opportunity assessments, growth strategies, and more.
Prior to joining Health Advances in 2011, Masha worked at Adnexus Therapeutics (a BMS R&D company) in the Protein Sciences Group. Masha earned a Bachelors in Human Evolutionary Biology from Harvard College; she has also completed additional business coursework through Harvard Business School Online.

The partnership will help map market pathways, with a particular focus on reimbursement models to pave the way for DTx commercialization on a wider scale.

Read more here.

Kristen Garner Amanti, PhD joined the Health Advances team in 2010 and is a leader in the Precision Medicine and Diagnostics practice. She has deep experience in commercialization strategy, business development opportunity assessment, deal diligence, international and domestic market assessment, corporate strategy, and is a seasoned workshop facilitator. Prior to joining Health Advances, Kristen received her PhD in Cancer Pharmacology from Dartmouth College where her research focused on the development of novel targeted cancer therapeutics. She received her Masters degree in Cell and Molecular Biology and Bachelors degree in Biology from the University of Vermont.

Carrie Jones joined Health Advances in 2007 and leads the firm’s Biopharma Orphan Disease Practice. At Health Advances, Carrie works towards the advancement of novel therapeutics, drawing from experience across commercialization and development strategies and benchmarking, new product planning, and market assessment & forecasting. Prior to joining Health Advances, Carrie received her MS degree in organic chemistry from Massachusetts Institute of Technology, and she worked for several years as a medicinal chemist at Merck & Co., Inc. where she developed her interests in drug discovery and development. Carrie received a BA in chemistry from Williams College.

Balazs Felcsuti nearly 20 years of healthcare experience in corporate development, strategy, finance and operational positions. He co-leads the firm’s Biopharma Autoimmune and Metabolic Diseases Practice. Balazs joined Health Advances after a successful career with biopharma companies ranging from industry leading biotechnology firms to small start-up operations. Prior to Health Advances, Balazs held senior leadership roles at Lyndra Therapeutics, an early-stage platform technology company; led business development strategy for Ironwood Pharmaceuticals; and helped build the Patient Support Services organization at Biogen. Balazs holds a Master of Science in Economics from Corvinus University in Budapest, Hungary as well as an MBA in Finance from the Wharton of School of Business at the University of Pennsylvania.

Health Advances Partner and Managing Director Sheela Hegde celebrated these important promotions, saying “Balazs and Carrie are valued leaders in our Biopharma Sector Practice who have developed deep expertise in critical areas for our clients worldwide. Their strategic, scientific, and commercial insights have supported critical decisions for our biopharma clients through an enormously complex period in our industry. We look forward to their continued leadership in the years to come.”

Gary Gustavsen, Partner and Managing Director, said “Kristen has played a central role in building Health Advances into one of the world’s leading Precision Medicine consulting practices. Her dedication to the success of her clients and the well-being of her teams is emblematic of the balanced approach we hold dear at Health Advances. We are thrilled to have Kristen joining the Partner team!”

Chris joins practice leaders Donna Hochberg, Gary Gustavsen, Peter Origenes, Arushi Agarwal, Kristen Amanti, and Daniela Hristova-Neeley in providing strategic advisory services for diagnostic and investor clients around the globe.

Sangeeta has over 15 years of health care strategy and operational experience spanning disruptive innovation, product commercialization, growth planning, marketing, business development, and mergers and acquisitions. Sangeeta’s extensive device sector experience from early-stage start-up and large cap multinational companies crosses multiple therapeutic areas, including Peripheral Vascular, Cardiology, Dialysis, Interventional Oncology, and Otolaryngology.

Immediately prior to joining Health Advances, Sangeeta held senior executive roles at Becton Dickinson and C.R. Bard as the business development/M&A leader of the Peripheral, Renal, Venous and Interventional Oncology businesses. Prior to her time at BD/Bard, Sangeeta served in marketing leadership roles at Spirox (now Stryker ENT), Outset Medical, Entellus Medical (now Stryker ENT) and Boston Scientific. Sangeeta began her career in management consulting at Deloitte and earned her BS in Economics, with a concentration in Marketing, from The Wharton School at the University of Pennsylvania.

Sangeeta joins practice leaders Susan Posner, Tracy Walters, and Darcy Krzynowek in providing strategic advisory services for Medtech and investor clients.

Health Advances’ Susan Posner moderates a panel discussion with seasoned executives about lessons learned while navigating through early-stage challenges.
Watch here.

Her presentation was part of the session AI Driven Traditional Research and Diagnostics and focused on the application of AI, specifically machine learning, in training diagnostic algorithms or improving the performance of diagnostics overtime. Additionally the presentation looked at some of the challenges associated with the use of AI in diagnostic development.

See the presentation here.

• Even with continued deployment of the COVID vaccines, testing will need to continue to increase in capacity (both in consumables and infrastructure) to meet the increasing demand as we work to get to a ‘steady state’ similar to what we see with flu:
  - Outstanding questions on vaccine compliance, novel variants of the SARS-CoV-2 strains, and immunity status long-term all require continued focus on COVID testing for the next several years.
  - Testing capacity will continue to scale-up, with the continued ramp up from big molecular and antigen players as well as the entrances of several smaller players (with new POC instrumentation, novel technologies such as CRISPR, and increased focus on the OTC and patient self-test segments).
• The COVID vaccine is an exciting trial of a novel modality (mRNA) with implications for future manufacturing and immunity testing:
  - The mRNA modality has the potential to significantly reduce manufacturing costs long-term, but questions on its durability and logistic requirements (e.g., cold storage) mean there is room for the traditional modalities, particularly in the developing world.
  - Novel testing approaches (e.g., T-cell technologies) could play an important role in assessing and/or predicting response to vaccines as they roll out to the general population, though may have challenges with scaling up these complex assays in already overburdened labs.
• The pandemic has served as a catalyst for accelerated adoption of novel diagnostics within personalized medicine (particularly liquid biopsy and digital biomarkers), with Pharma continuing to be very actively involved:
  - Wrap-around solutions to enable increased patient engagement in testing (via home collection kits, telehealth visits and counseling services, and overall remote monitoring of patients) have seen increased adoption for COVID as well as other disease areas within oncology and rare diseases.
  - However, reimbursement for these solutions, and diagnostic testing as a whole, remains an open question. While the FDA has recently allowed for alternate modalities (e.g., for digital pathology) and has backed away from LDT regulation, it remains to be seen if these changes will be part of a growing trend or an exception to the norm.

Defeating COVID-19, our 2020 Virtual Roundtable Series returns! Join us Monday November 23, 2020 from 8 to 9 AM for an executive-level update on the state of COVID-19, advances in testing capabilities and capacity, and implications for important decisions employers and policy makers face during the current resurgence of infections world-wide.

This one-hour roundtable features Steve Pagliuca, co-owner Boston Celtics and co-chair Bain Capital; Marc Casper; President & CEO Thermo Fisher Scientific; Donna Hochberg, Partner, Health Advances; David Walt, HHMI Professor, Core Faculty Member Wyss Institute for Biologically Inspired Engineering, Brigham and Women’s Hospital; and David Weiss, SVP Player Matters, National Basketball Association.

Register here.

• How COVID 19 changed medical services delivery model?
• How healthcare & travel insurance business adapted to new reality?
• How #telemedicine & #AI is affecting the #insurance and medical services industry?
• Will telemedicine & AI stay with us in the post-COVID 19 reality?
• What #innovations will be driving the medical & health insurance sector in the coming months?
• Telemedicine implementation – how to do it in an agile way.

Time: 15.00 CEST / 9:00AM EST
Date: October 6, 2020

Participation in this event is free.

REGISTER HERE

“Since our founding nearly 30 years ago, Health Advances has appreciated the value of bringing people of all ethnicities, cultures, genders, and experiences together to achieve greater, more impactful results, for our clients, the healthcare industry, and the patients that it serves. BSCP has been an enlightened force in helping society make this a reality and we are proud to have been a sponsor of Evening of Hope for the last 23 years,” noted Vivek Mittal, Partner and Managing Director, of Health Advances, and leader of the firm’s Diversity, Equity and Inclusion (DEI) committee.

BSCP continues to widen the window of opportunity for disadvantaged students through critical mentoring and financial aid, and we are thrilled to continue supporting BSCP.

Join us on October 5 at 7:00pm ET for BSCP’s Evening of Hope Virtual Event .

Greg joined Health Advances in 2017, bringing fifteen years of experience in strategy, management consulting, marketing, operations, and technology leadership. A software engineer and manager by training, Greg’s career has included technical software development and product management; strategic growth consulting to the Fortune 500; product management; B2B marketing and communications; and senior operations leadership.

“I am honored and excited to begin this next chapter with Health Advances,” said Greg “especially given the unique opportunity to work with such a broad range of clients across healthcare technology sectors and at different stages of maturity — from startups to the largest companies in the world. We are often asked to help our clients address their most difficult questions, and in the quickly growing areas of digital and connected health, there are no shortage of those.”

Health Advances Co-Founder, Paula Ness Speers, announced and celebrated Greg’s promotion, saying “Greg has truly earned this promotion as he is widely respected in the industry externally and a great leader, collaborator and developer of our talented people internally. Health IT is an enormous growth area for the industry and for our firm and Greg and his colleagues are pioneering growth strategies for the sector with our clients”.

Prior to joining Health Advances, Greg held multiple senior executive roles at Arcadia.io, a leader in population health analytics and EHR data integrations serving health systems, accountable care organizations, and health plans nationwide. Greg built a Strategic Marketing team after an initial round of growth equity and drove company-wide business planning, performance improvement and measurement programs as the Strategic Sales Operations leader. Earlier in his tenure, he was the product director for the core analytics platform and a principal consultant in Arcadia’s legacy consulting business. While at Arcadia, Greg served as a subject matter expert to the Office of the National Coordinator for HIT on health information exchange (HIE) under the federal HIE, Regional Extension Center, and Beacon Community grant programs. Greg began his career as a project team leader and technical project manager at Monitor Group (now part of Deloitte), serving clients in the biopharma, high tech, and government sectors.

Greg holds a Masters of Engineering Management degree from the Thayer School of Engineering at Dartmouth College, a collaborative program with the Tuck School of Business. He holds BE and BA degrees in Engineering and Computer Science, also from Dartmouth College.

Arushi’s varied expertise in point of care testing, specialty lab testing, companion diagnostics and digital health make her a trusted and knowledge advisor to her clients. Arushi will continue to leverage these skills with a focus on helping clients navigate launch of less and minimally invasive testing technologies in liquid biopsy, digital biomarkers and beyond.
Prior to joining Health Advances, Arushi received her Masters in Biomedical Engineering from Columbia University where her research focused on the use of microfluidic technologies for regenerative medicine applications. She received a Bachelors in Biology from the Massachusetts Institute of Technology.

With over 15 years of healthcare experience, both as a line manager and a consultant, Holger has earned a reputation as a skilled strategist and innovative manager. Immediately prior to joining Health Advances, Holger served as Chief Commercial Officer for Biognosys AG, a contract-research organization focused on decoding the cellular proteome for improved drug target identification. In this role, he was responsible for sales and marketing of Biognosys’ broad product and service portfolio through a global salesforce. Prior to Biognosys, Holger held the position as Senior Vice President Commercial Operations at Cell Medica, a cell therapy pioneer. Holger launched Cell Medica’s lead product into several European markets including market access negotiation, health economic modelling and medical affairs planning, while also directing the positioning of Cell Medica’s pipeline assets.

Earlier in his career, Holger held various senior commercial roles at Novartis Pharma over a 10-year period, both at a local and global level, his latest position being the Global Head of Brand Vigilance, where he oversaw the commercial tactics for several end-of-exclusivity blockbuster brands. He was equally responsible for guiding the commercialization of pipeline assets from pre-clinical status to phase 3. In his local role, Holger launched an orphan drug into the markets of France and Benelux. Holger started his career at Bain & Company, where he served mainly Healthcare and Private Equity clients.

Holger joins a team of seasoned practice leaders in biopharma providing strategic advisory services for pharmaceutical and biotech clients. He will be located in the Zug, Switzerland office. Health Advances is recognized as a trusted advisor to many international biopharmaceutical companies on the commercialization strategies for assets, portfolio prioritization, organization development and digital health. The experienced, multi-disciplinary team includes PhD researchers, MDs and pharmaceutical executives, working to provide innovative solutions for clients worldwide.

Health Advances’ Hong Kong-based, multilingual team will be led by Vice President, Gary Cheng, who joins Health Advances with more than 30 years’ experience in the pharma, biotech, and medtech industries, and long-time Partner, Vivek Mittal.

Click here to read the official press release.

Click here for additional industry news coverage on this announcement.

With over 15 years of healthcare experience, Kristine has earned an excellent reputation as a skilled strategist and market planning executive. Immediately prior to joining Health Advances, Kristine served as Vice President of Marketing and Planning for OncoCyte Corporation, a publically traded company focused on developing liquid biopsy-based diagnostics for early cancer detection. She was responsible for all aspects of commercial and market planning including product development requirements, market access, commercial operations, and business development initiatives. Kristine was also instrumental in supporting the company through its IPO in early 2016, assisting in various SEC filings and investor relations activities.

Earlier in her career, Kristine was a Director of Business Analytics for Abbott Diabetes Care where she led several market analytics and forecasting initiatives. Prior to that she was a Senior Market Planner at Genentech where she assumed several lifecycle management responsibilities. She has also held Director and VP roles in Business Development for the Zitter Group, Corra Life Sciences, and Invest East of England.

Kristine joins practice leaders Donna Hochberg, Gary Gustavsen, Kate McLaughlin, Kristen Amanti and Peter Origenes in providing strategic advisory services for diagnostics, life science tools and bioproduction clients. Health Advances has been successfully advising companies on the development and commercialization of diagnostic products from traditional core lab platforms, through high value novel diagnostics and precision medicine strategies. Our experienced multi-disciplinary team includes PhD researchers, MDs, and diagnostics industry leaders working to provide innovative strategies for both diagnostic and biopharma clients.

Health Advances proudly supports the mission of the Biomedical Science Careers Program (BSCP) to help minority and underrepresented student populations to successfully pursue biomedical science and other science-related careers.

“Since the inception of Health Advances nearly 27 years ago, we are fervent advocates for innovation through diversity, and we know the value of bringing people of all ethnicities, cultures, and experiences together to achieve greater, more impactful results,” noted Paula Ness Speers (Co-Founder and Managing Director of Health Advances) after attending BSCP’s Evening of Hope on April 25.

BSCP continues to widen the window of opportunity for underprivileged students through critical mentoring and financial aid, and we are thrilled to continue supporting BSCP.

Peter has earned an excellent reputation as a skilled business development and strategic planning executive throughout a thirty-year career spanning major healthcare technology sectors including diagnostics, medical devices and pharmaceuticals, in US and UK-based roles. Peter was most recently the Vice President of Business Development at Ortho Clinical Diagnostics. Previously, he held this role at GE Healthcare Life Sciences and Becton Dickinson where he led over $2B in deals and laid the groundwork for Becton Dickinson’s CareFusion and CR Bard deals. Peter received an AB, Genetics and AB, History from the University of California at Berkeley and an MSIA from the Tepper School at Carnegie Mellon University.

Earlier in his career, he was a Managing Partner with Radius Ventures, an early stage venture fund investing across biopharma, medtech, and diagnostics. He first consulted to the industry as a Senior Consultant at Bain & Company and subsequently with The Wilkerson Group. Peter, reflecting on his decision, explained “I have seen numerous consulting firms in action during my career but the Health Advances teams always stood out in terms of their passion, analytic rigor and deep understanding of healthcare technology and strategy. When I decided to immerse myself in a consulting firm, Health Advances was the only one I considered.” Mark Speers, Co-Founder of Health Advances, exclaimed, “We are fortunate to attract Peter as his industry perspective and wisdom will prove invaluable as we seek to provide pragmatic advice to our client executives.”

Peter joins practice leader Donna Hochberg, Gary Gustavsen, Kate McLaughlin and Kristen Amanti in providing strategic advisory services for diagnostics, life science tools and bioproduction clients. Health Advances has been successfully advising companies on the development and commercialization of diagnostic products from traditional core lab platforms, through high value emerging diagnostics and personalized medicine strategies. Our experienced multi-disciplinary team includes PhD researchers, clinical pathologists, and diagnostics industry leaders working to provide innovative strategies for clients.

Prior to joining Health Advances, Tracy worked at the Equinox Group where she advised pharmaceutical companies on the commercial outlook of developmental agents to support licensing and product development decisions. She also worked at Johnson & Johnson Health Care Systems on internal consulting projects for various Johnson & Johnson operating companies, including both medical device and pharmaceutical companies.

Tracy earned a BS in statistics from Lehigh University, and an MBA from the University of Michigan Ross School of Business with an emphasis in Corporate Strategy.

Top Places to Work recognizes the most admired workplaces in the state voted on by the people who know them the best—their employees. The survey measures employee opinions about their company’s direction, execution, connection, management, work, pay and benefits, and engagement.

Read the press release.

Read the Boston Globe article.

At the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Conference, Earl Gillespie, PhD, Engagement Manager at Health Advances, presented key findings from a recent study conducted by the firm on the financial implications of cost-based pricing revisions in Japan.

Read our latest blog, Health Advances Presentation at ISPOR: An Initial Analysis of the Cost-Based Pricing Revisions in Japan for more information.

Kelly Cockerill, Director at Health Advances, led a podium presentation at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) to share key findings from this recent study and provide guidance for drug manufacturers considering this HTA pathway.

Read our latest blog, Health Advances Presentation at ISPOR: Findings from the First Five Years of the NICE HST Program for Ultra Rare Conditions, for more information.

Discussion topics ranged from how and when to develop an exit strategy, engage with potential acquirers, and challenging decisions executives face as companies mature.

The seasoned executive panel included Martha Shadan, President and Chief Executive Officer, Rotation Medical (acquired by Smith & Nephew plc in December 2017); Christopher von Jako, Chief Executive Officer, Dynatronics, Board Director, NinePoint Medical and nView Medical; and Jeffrey H. Burbank, Founder and Chief Executive Officer, NxStage.

Health Advances Partner, Wyatt Gotbetter, joins Bhardwaj Desai (PAREXEL International, Vice President – Technical) to lead this discussion at JLABS @ Toronto

Scott Garrett, Senior Operating Partner, Water Street Healthcare Partners and AdvaMedDx Board Chair Emeritus, moderated the discussion and fired several provocative questions to a seasoned panel including Steve Beuchaw, Executive Director, Morgan Stanley; Eric Lev, Partner, Ampersand Capital Partners: Brian Miller, Managing Partner and Co-Founder, Linden Capital Partners; and Ipsita Smolinski, Managing Director, Capitol Street. Topics ranged from the near- and long-term impacts of the Protecting Access to Medicare Act (PAMA) and other Federal policy initiatives on the diagnostics industry to value-based pricing and investment considerations in light of the historic high EBITDA multiples.

This invitation-only event attracted over 50 senior medtech executives and was co-sponsored by Silicon Valley Bank and SunTrust Robinson Humphrey with support from Health Advances.

The panel featured three successful private equity general partners who have consummated dozens of medtech deals: (1) Joe Damico, Co-Founder of RoundTable Healthcare Partners; (2) Chris Sweeney, Partner of Water Street Healthcare Partners; and (3) John LeRosen, Partner of Vance Street Capital. The panel debated topics ranging from the characteristics that differentiate a PE target vs a strategic target to the prospects for EBITDA multiples continuing to rise.

“Each year, approximately one-third of Health Advances’ projects are performed for PE firms [LINK TO INVESTORS SCTOR PAGE], “ said Mark Speers. “It was great fun to hear these seasoned investors’ differing strategies for identifying targets and creating value in portfolio companies. There were even some counter-intuitive ideas such as buying high technology bolt-ons to change the trajectories of some companies.”

“Each year, approximately one-third of Health Advances’ projects are performed for PE firms, “ said Mark Speers. “It was great fun to hear these seasoned investors’ differing strategies for identifying targets and creating value in portfolio companies. There were even some counter-intuitive ideas such as buying high technology bolt-ons to change the trajectories of some companies.”

Please join us in downtown Chicago on Tuesday, July 31 at 5:30 pm CDT for our 10th annual cocktail reception to mingle with industry leaders, return to hot topics from prior Health Advances AACC receptions, and speculate on what the next decade may hold. Please email us to RSVP for our reception or schedule another time to connect.
We hope to see you there!

The results, published in the Journal of Medical Economics [link], show that increasing access to FLX yielded a favorable budget impact in every scenario modeled, over a 2-year timeframe. For LE patients with comorbid frequent infections, the three alternate scenarios resulted in cumulative 2-year budget impacts of –$192,729, –$259,339, and –$613,179, respectively.

Health Advances often works with clients to document the economic implications of utilizing their technologies so that they can maximize pricing while gaining rapid and attractive coverage decisions.

Read the article.

The study design was a longitudinal matched case-control analysis utilizing de-identified private insurance claims information from Blue Health Intelligence. Julia Gaebler will present the results of the study with Blue Health Intelligence CEO, Swati Abbott, at the 14th annual Medical Device and Reimbursement Conference in Chicago, IL on July 11, 2018.

The results, published in the Journal of Vascular Surgery, document that Tactile’s Flexitouch saves 85% of per year lymphedema- and sequelae-related costs vs. simple pneumatic compression devices and 53% vs. advanced pneumatic compression devices. This publication will bolster Tactile’s market access and support its future pricing. As Gerald Mattys, Tactile’s CEO, stated: “These data highlight the dramatic positive impact of our Flexitouch system on healthcare utilization and costs in a large and important patient population.”

Health Advances often works with clients to document the economic implications of utilizing their technologies so that they can maximize pricing while gaining rapid and attractive coverage decisions.

Read the article.

The panel focused on key trends and future opportunities in the medical device market that signify the inevitable evolution of medical packaging.

There are numerous healthcare trends with packaging implications such as:

1. Focus on reducing nosocomial infections within healthcare facilities leading to more unit dose packaging
2. Shifting care to lower cost settings, such as ambulatory surgery centers and physician offices without the ability
   to sterilize and disinfect reusable instruments, leading to more disposable instruments
3. Increased homecare leading to packaging that is more intuitive for self-care and family care providers
4. Increased globalization leading to longer transportation routes via less conventional transportation modes

To learn more about Health Advances’ Medical Device Practice, visit https://healthadvances.com/medtech/

We are proud of the fact that the Company has stayed true to its initial vision of helping clients commercialize meaningful new products and services that improve the quality and cost-effectiveness of healthcare. We are also proud of the talented employees and alumni/ae who have helped build the firm’s reputation for responsiveness, insight and integrity.

Our growth to nearly 150 professionals in 3 offices has enabled Health Advances to codify an extraordinary wealth of experience accumulated over 2,500 projects in virtually every clinical indication and across over 75 geographic markets. Most importantly, as the healthcare industry navigates the greatest customer scrutiny in its history, Health Advances – bolstered by the resources of our parent PAREXEL – is able to combine cross-segment expertise from our biopharma, medtech, health IT and/or diagnostics practices to help executives confidently make their highest stakes decisions.

As the firm looks out over the next 10 years, we are thrilled to continue helping clients with commercial strategy and product strategy in the most cutting edge areas of innovation in healthcare, bringing to bear the unmatched expertise that Health Advances has amassed over the firm’s 26+ year history.

The Digital Therapeutics Alliance (DTA) is a global non-profit trade association with the mission of broadening the understanding, adoption, and integration of clinically-validated digital therapeutics (DTx) into healthcare through education, advocacy, and research.

As a Strategic Advisor to DTA, Andrew will collaborate with leading digital health and biopharma companies to help blaze the trail for acceptance and adoption of digital therapeutics. This work will involve assessing the value and impact of DTx solutions in clinical practice, constructing industry and regulatory frameworks, and encouraging data-driven integration and utilization of DTx solutions across the healthcare industry.

As I reflect on the 2018 HIMSS conference and my many years of attending this event, I can vividly remember a conversation I had with a long-time industry veteran and analyst.

By Greg Chittim, Vice President

Recently, more drugs for rare diseases have become available in European markets. While offering treatment options to once untreatable patients, the high price points often commanded by orphan drugs (ODs) have sparked intense discussions about their value and how to determine a fair price.

By Claudia Graeve, Ph.D. (Vice President) and Kelly Cockerill (Director)
Health Advances GmbH

Leading oncologists convened for the Annual Immuno-Oncology (IO) Congress in Geneva, December 7-10th, to discuss the latest advances in the field.

By Tarek Plaza, Senior Analyst (Health Advances GmbH)

Extreme mountaineer and journalist Luke Timmerman recently organized the Seattle Cancer Summit, an intimate half-day meeting of the minds focusing on cancer research and investments. He is raising money for cancer research through various events, such as this one, and through his personal quest to summit Everest this summer.

By Divya Harjani (Health Advances LLC)

To support the Accelerated Access Pathway (AAP), the UK foresees new structures and capabilities which aim to speed up access for transformative technologies:

By Claudia Graeve, Ph.D.; Kelly E. Cockerill; and Maria Iglesias (Health Advances GmbH)

Many people involved in digital health and health IT were thrilled to see the news that Roche is acquiring Flatiron Health for a hefty $2.1B.

By Andrew Matzkin, Partner at Health Advances

Darcy Krzynowek has consulted to industry executives for 20 years, having advised medical device, biopharma, and diagnostic clients in the areas of new product development, market access and commercialization strategies. With expertise across multiple therapeutic areas, she has particular interest in wound care, vascular access, surgical devices and supplies, and other hospital-based equipment. At Health Advances, Darcy is already partnering with clients to create and capture the full value of their medical devices, supplies, and services in acute, ambulatory, and home settings globally.

Prior to Health Advances, Darcy was a Principal in GfK’s Market Access Practice, co-leading the Medical Device Center of Excellence. In this role, Darcy led projects related to coding, coverage, reimbursement, and pricing strategies as well as the development of tactical materials to convey value for medical devices and prophylactic vaccines. She has extensive experience in primary and secondary market research to support evidence planning, value story development, pricing and forecasting. She has also held consulting roles with increasing responsibility at Abt Associates, Arthur D. Little and Decision Resources Group (DRG) Consulting. Darcy earned a BA in psychology from Bates College.

Balazs Felcsuti is a seasoned biopharma executive with over 15 years of healthcare experience in corporate development, strategy, finance and operational positions. While he will oversee a wide range of biopharma projects, he will surely be very involved in supporting clients with their business development transactions, both in the US and internationally.

Immediately prior to joining Health Advances, Balazs was VP of Operations for Lyndra, a biotechnology start-up developing an ultra-long acting drug delivery technology. He was responsible for all aspects of business operations, helping build the company to a 25 person-strong operation, secure financing and jump-start critical manufacturing R&D projects.

Prior to that, Balazs served as Senior Director, Corporate Development at Ironwood Pharmaceuticals. He formulated the company’s emerging market strategy and executed a complex joint venture transaction with Astra Zeneca for the development and commercialization of Ironwood’s flagship product, LINZESS® in China, Hong Kong and Macau. Earlier in his career Balazs spent six years at Biogen where he helped build the company’s Patient Support Services organization. Balazs holds a Master of Science in Economics from Corvinus University in Budapest, Hungary as well as an MBA in Finance from the Wharton of School of Business at the University of Pennsylvania. He graduated with honors from both institutions.

Ruggero Rossi brings 15 years of life sciences experience to Health Advances’ biopharma practice. He focuses on corporate strategy, business development, growth strategy, portfolio rationalization, and marketing strategy. He has substantial expertise in specialty pharmaceuticals, with an emphasis on oncology and rare disease, both domestically and in Europe.

Prior to joining Health Advances, Ruggero worked at Takeda Oncology, where he focused on R&D strategy and business development. In this role, he was responsible for the identification and execution of strategic partnerships in the immuno-oncology space. Previously, Ruggero led corporate strategy initiatives at Vertex Pharmaceuticals, including corporate-level portfolio prioritization and geographic expansion strategy.

Before his industry career, Ruggero was a management consultant at Monitor Group. He earned his MBA at the Kellogg School of Management at Northwestern University, and he graduated magna cum laude from Bocconi University (Milan, Italy) with a degree in Business Administration.

In 2016, spend on so-called specialty drugs, a class that contains many biologics, grew by over 13 percent, while spend on traditional drugs actually declined by 1 percent. Five of the top 10 earning drug therapies in the U.S. in 2016 were biologics.

With an exciting and productive 2017 behind us, we turn towards what Health Advances’ Biopharma Practice is excited to see in 2018.

by Wyatt Gotbetter, Partner; Carrie Jones, Vice President; Laura Hatton, Consultant

Of the 60 applications received, over 25 clinical specialties (e.g., cardiology, critical care monitoring, neonatology, pulmonology) were identified as potential areas of opportunity for pediatric device development. Health Advances is proud to partner with Challenge co-sponsors, the Boston Pediatric Device Consortium and the Innovation and Digital Health Accelerator at Boston Children’s Hospital, to accelerate the development of technologies that can bridge gaps in pediatric treatment and care and improve the lives of children and adolescents.

“The multitude of promising technologies and concepts submitted to BPDC serves as an encouraging sign of progress in pediatric device development,” said Susan Posner, Partner and Co-Leader of the MedTech Practice at Health Advances. “While it was difficult for our Health Advances team to narrow the applicant pool to a select few, we are excited about the winning technologies and the potential to improve pediatric care.”

We congratulate all winners of the Challenge, and we are excited to announce David Hoganson, MD, Boston Children’s Hospital as the Health Advances select Challenge winner for a cardiac device that allows surgeons to quantifiably measure leaflet coaptation height and success of heart valve repairs. We look forward to collaborating with Dr. Hoganson and his team to provide strategy consulting support to assist the company in achieving commercial success.

For more information about the Challenge, please read the full press release.

In our first post we highlighted the many successes of 2017, including record approvals in the US spanning a wide variety of disease areas. In this post we want to address what we foresee as the biggest challenges our clients faced in 2017, and will face in 2018 – a turbulent regulatory environment and evolving models of care.

By Wyatt Gotbetter, Partner; Carrie Jones, Vice President; Laura Hatton, Consultant

Health Advances’ Biopharma Practice had a very busy 2017 supporting our clients as they advanced exciting new drug assets and technologies, expanded businesses and served more patients, all while navigating a turbulent and often uncertain political environment.

By Wyatt Gotbetter, Partner; Carrie Jones, Vice President; Laura Hatton, Consultant

Julia joined Health Advances in 2014 and has greatly expanded the range of Market Access projects the firm performs for clients. Most strikingly, Julia has overseen several Global Launch Sequence projects defining the evidence requirements for each market as well as several Claims-Based Retrospective Analyses for both biopharma and medtech clients. Several of the latter have been presented at key clinical and outcomes conferences and published in peer-reviewed journals.

Immediately prior to joining Health Advances, Julia worked at Biogen as Senior Director, Global Medical Outcomes Strategy where she ensured that product strategies and tactics anticipated the evolving demands of the global payer landscape. At Biogen she was also Director, Global Market Access where she led the global reimbursement and market access launches for TECFIDERA and FAMPYRA for Multiple Sclerosis. Julia has also held related payer-facing and policy positions at Amylin Pharmaceuticals, Hoffmann-La Roche, and the RAND Corporation.

Julia earned a Doctorate in Health Policy and Decision Analysis from Harvard University, a Masters in International Economics from Johns Hopkins University, and a BA from the University of Pennsylvania.

Carrie joined Health Advances in 2007 as a Senior Analyst and has been promoted to assume increasing responsibilities in rapid succession a total of 4 times. Her clients have ranged from small start-ups and university technology transfer offices to the largest biopharmaceutical companies and private equity firms. With experience across multiple therapeutic areas, she is particularly interested in specialty markets including orphan, autoimmune, and respiratory diseases.
Prior to joining Health Advances, she worked for several years as a medicinal chemist at Merck & Co., Inc. in Rahway, New Jersey where she developed her interests in drug discovery and development.

Carrie earned her MS degree in Organic Chemistry from Massachusetts Institute of Technology, and received a BA in Chemistry from Williams College.

Pear Therapeutics created enormous buzz a few weeks ago when the FDA cleared its reSET program for the treatment of patients with substance use disorder. Pear proclaimed that this was the first ever FDA clearance for a digital therapeutic for disease treatment. reSET combines patient-facing mobile assessments and interventions with clinician-facing analytics and dashboards.

By Nick Haluck, Director at Health Advances

Health Advances will be providing quarterly business planning strategy support to (a) selected winner(s).

“Pediatric care is an underserved area in medical devices with promising opportunities for current and emerging innovators seeking to improve pediatric healthcare worldwide,” said Susan Posner, Partner and Co-Leader of the MedTech Practice at Health Advances. “Our Health Advances team is excited to be a part of this.”

We look forward to meeting applicants at the “Meet the Challenge Partners” Event on Tuesday, September 19.

Dean Giovanniello, RPh, joins Health Advances with experience in Commercialization and Launch Excellence in the Emerging Biopharma and Medtech industries. He has expertise in developing go-to-market strategies along with operational plans to support launch decision making across a variety of large and orphan disease segments in the US and EU. Immediately prior to joining Health Advances, Dean was a principal at QuintilesIMS Consulting where he focused on commercialization of assets. He has extensive experience in data sources/analytics, primary and secondary market research to support forecasting as well as commercial strategy informed by P&Ls to drive better decision-making for acquisitions and licensing deals. Prior to this work, Dean was an independent commercial consultant working with start-up companies to optimize their launch planning and execution in a variety of therapeutic areas. He has extensive experience in anti-infectives, CNS, gastroenterology, immunology, metabolic, ophthalmology and oncology. During his twenty-year career on the client side of the business at GlaxoSmithKline and Sepracor/Sunovion, Dean held senior positions in sales and sales management, product management, market research and business development. Over the course of his career, Dean has directed the launch of over 10 NCEs, indications and line extensions in numerous therapeutic areas. His teams were the recipients of multiple CEO awards based on innovative launch programs and sales performance. Dean received a BS in Pharmacy from the Massachusetts College of Pharmacy and Allied Health Sciences and is a Registered Pharmacist in the State of New Jersey. He also received an MBA from Lubin School of Business at Pace University in New York City.
Greg Chittim joins Health Advances with fifteen years of experience in strategy, management consulting, marketing, operations, and technology leadership. A computer engineer and manager by training, Greg’s career has included technical software development and product management; strategic growth consulting to the Fortune 500; product management; B2B marketing and communications; and senior operations leadership. Prior to Health Advances, Greg held multiple senior executive roles at Arcadia Healthcare Solutions, a leader in population health analytics and EHR data integrations serving health systems, accountable care organizations, and health plans nationwide. Greg founded and ran a Strategic Marketing team after an initial round of growth equity and drove company-wide business planning, performance improvement and measurement programs as the Strategic Operations leader. Earlier in his tenure, he was the product director for the core analytics platform and a principal consultant in Arcadia’s legacy consulting business. While at Arcadia, Greg also served as a subject matter expert to the Office of the National Coordinator for HIT on health information exchange (HIE) under the federal HIE, Regional Extension Center, and Beacon Community grant programs. Greg began his career as a case team leader and technical project manager at Monitor Group (now part of Deloitte), serving clients in the biopharma, high tech, and government sectors. Greg holds a Masters of Engineering Management degree from the Thayer School of Engineering at Dartmouth College, a collaborative program with the Tuck School of Business. He holds a BE and BA in Engineering and Computer Science, also from Dartmouth College.

In the last decade, the healthcare industry has witnessed significant changes, some of which present important challenges to how pharmaceutical companies develop drugs. One such challenge is the shift in influence from the physician to the payer in the adoption of new interventions. This article discusses threats to the traditional model of drug development posed by the increasing influence of payers and considers ways for industry to embrace “value-focused development” to simultaneously adapt to the evolving market and de-risk drug development. To read the full article, please click the link above.

Wyatt Gotbetter joined a panel of executives from digital media, solution development and other industries as the Cornell Club of Boston hosted this event to explore the fast growing Internet of Things. The panel discussing new IoT technologies, their impact on business and consumers and future applications and adoption and Wyatt shared perspectives on how healthcare care sectors are embracing the IoT.

Wyatt Gotbetter joined other industry experts at the PAREXEL Greater China Forum event in Shanghai, held before the Drug Information Association (DIA) annual conference. Wyatt presented best practices and tips for product development and commercialization for global markets for regional biopharma companies seeking to launch globally.

Gary Gustavsen leads the Personalized Medicine Practice at Health Advances, where his work focuses on commercialization strategy, indication prioritization, pricing and reimbursement strategy, and business development opportunities for both diagnostic and therapeutic clients. Gary has been with Health Advances for nearly 12 years, rapidly advancing through the ranks from the entry level Analyst position. Prior to joining Health Advances, Gary worked at Brookhaven National Lab, Becton Dickinson, and OSI Pharmaceuticals. Gary received his BSE degree in Biomedical Engineering from Duke University and his MS degree in Biomedical Engineering from Stony Brook University.
Wyatt Gotbetter, with over 2 decades of experience in the life sciences industry, helps lead the Biopharma Practice and focuses on commercial growth and business development strategies for therapeutics companies. Wyatt joined Health Advances over 3 years ago after working at Boston Consulting Group (BCG), Biogen, and Boston Scientific in strategy, product and portfolio management and new product commercialization. He earned his BS degree in Economics & Policy Analysis and an MPA degree, including a certificate from the Sloan Graduate Program in Health Services Management, at Cornell University.

Andrew Matzkin has 15 years of experience as a strategy consultant in healthcare, including 8 years at Health Advances. He leads the Digital Health and Health IT Practice, working closely with companies and investors in digital health, health IT, and the life sciences to develop strategies for development and commercialization of digital solutions. His areas of emphasis include connected devices and diagnostics, patient monitoring, digital disease management, real world data, and big data analytics across a wide range of technologies and therapeutic areas. Prior to Health Advances, Andrew was a Consultant at Bain & Company and also worked at Novartis in the global cardiovascular-metabolic franchise. Andrew earned his BA degree, Phi Beta Kappa, from Yale University and an MBA from Harvard Business School, where he was honored as a Baker Scholar.

The Biomedical Science Careers Program (BSCP) held its annual Evening of Hope event to celebrate and perpetuate its mission of providing academically outstanding students with critical mentoring and financial aid. BSCP particularly seeks to assist students of color to ensure an ethnically diverse workforce in the life sciences and healthcare industries. Since its founding 20 years ago, the Massachusetts biotech community has nurtured this organization through contributions of funds and time. Health Advances is proud to have been a supporter throughout the organization’s history, this year recognized as a Hope Benefactor. Paula Ness Speers, Co-Founder and Managing Director, received an award from John Maraganore, PhD., CEO of Alnylam Pharmaceuticals and Co-Chair of the Evening of Hope event.

While orphan drugs offer novel treatments for patients who previously had no options, the high price points they often command have resulted in restricted access by many European Health Technology Assessment (HTA) systems and intense discussions about how to determine their value. Against this backdrop, manufacturers are eager to understand how to value their innovation and collect sufficient evidence to support a price that appropriately reflects the improvement in clinical outcomes versus the standard of care. Patient prevalence is highly correlated with orphan drug pricing in Europe, highlighting the importance of budget impact to payer decision-making. With European pricing so complex and interrelated between countries, early understanding of the target orphan disease epidemiology and the product value proposition and price potential are all critical to optimize launch sequence decisions. To read the white paper, click on the header above.

Ratings were provided by 1,100 business executives on 7,000 consulting firms. This “client survey” asked the executives which industries they worked in, and then prompted them to recommend the best consulting companies in those sectors.

For more information see our Forbes awards listing

Our growth to nearly 150 professionals in 3 offices has enabled Health Advances to build an extraordinary wealth of experience accumulated over 2,500 projects in virtually every clinical indication in approximately 75 countries. Most importantly, as the healthcare industry navigates the toughest market conditions in its history, Health Advances – bolstered by the resources of our parent PAREXEL – is able to combine cross-segment expertise from our biopharma, medtech, health IT and/or diagnostics practices to help clients maximize the value they deliver to their customers.

Outside of the rising aging population, another big public health concern is the increase in metabolic disorders such as obesity, diabetes, and non-alcoholic fatty liver disease (NAFLD). NAFLD represents a histopathological spectrum of liver diseases ranging from fat accumulation in liver (steatosis) to non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis, and liver failure or liver cancer (hepatocellular carcinoma or HCC). NAFLD is estimated to affect 30% of adults in US. Pathogenesis of NAFLD is closely associated with obesity and diabetes and its prevalence has been rising in parallel with these two disorders. While adopting a healthy lifestyle could reverse NAFLD at the early stages such as steatosis, there is still a major unmet need for effective therapeutics at later stages of disease. To read the full post, please visit the Health Advances Blog

Over the past 15 years, the FDA and Congress developed several accelerated pathways to provide incentives for manufacturers to develop innovative new drugs to treat conditions with substantial unmet need. In this white paper, Health Advances describes recent trends in the use of the FDA’s accelerated pathways and examines the market advantage associated with these pathways. Through in-depth analysis of the PD-1 class, Health Advances highlights how companies can accelerate time to market and achieve first-mover advantage through a carefully-crafted indication strategy. To read the white paper, click on the header above.

Historically, companies developing CDx have been regarded as vendors by therapeutics companies and incentives between the two partners have been misaligned. However, multiple factors are impacting the CDx deal landscape pointing towards the need for a true partnership between the diagnostics and therapeutics companies. There was a thorough discussion of the factors impacting the deal landscape, as well as case studies, and the potential for more progressive deal structures.

Atlas5D welcomed Julia Gaebler, Health Advances VP, to their Board of Directors this week. For more information on Atlas5d, please click here

BSCP was established in 1991 to increase the number of underrepresented minorities in the biomedical sciences and health professions. BSCP identifies academically outstanding minority students and trainees dreaming of a career in medicine, health care, science and biotechnology; and provides them with the information and support needed to achieve their goals through conferences, workshops, symposia, newsletters, scholarships and the BSCP Linkage Program.

The principal source of funds to support the critical mission of BSCP comes from sponsorships of Evening of Hope. As a result of the event, over 10,000 students and over 1,100 postdoctoral trainees and junior faculty have participated in BSCP programs. Several senior leaders of Health Advances will attend the event to celebrate BSCP’s accomplishments.

Boston, MA – April 20, 2016

According to Forbes Magazine’s 2016 ratings of management consulting firms, Health Advances is one of the 13 healthcare consulting firms that received 4 or 5 star ratings. Most noteworthy, it is one of the 6 firms in this list that received a disproportionately high number of client recommendations.

Proving the power of industry focus and providing senior level attention to all clients, Health Advances is the only boutique healthcare consulting firm in the top 13 list.

Health Advances also received accolades for functional expertise in several categories relative to all consulting firms in all industries. The firm ranks in the top 12 firms earning a 4 or 5 star rating for Marketing, Brand & Pricing expertise. In this category, Health Advances was one of the 6 firms in this list highlighted for receiving a disproportionately high number of client recommendations.

For a complete listing of the Forbes ratings, click here.

“We are thrilled to add someone of Sheldon’s caliber to our growing San Francisco office. Sheldon’s expertise in launch excellence and commercial strategy will be a perfect complement to the existing work we do for biopharma. He also has significant experience in companion diagnostics and market access, two areas that we continue to see healthy client interest,” commented Vivek Mittal, Partner.

Sheldon comes to Health Advances with over a decade of strong consulting experience. He most recently headed Promidian Consulting’s Bay Area consulting practice where he focused on strategic engagements for some of the Bay Area’s leading biopharma companies. Previously, Sheldon was a successful Engagement Manager at IMS Consulting in San Francisco where he helped build a strong APAC practice.

Prior to his roles in consulting, Sheldon spent over a decade in industry, where he held business development roles at both Hana Biosciences and Guava Technologies. Early in his career, he was a scientist at Exelixis.

He earned his BA in Biological Sciences at Cornell and his MBA from the Kellogg School at Northwestern.

In fact, AdvisoryHQ explained, “We selected Health Advances for our healthcare consulting firms list because it’s small enough to give truly personalized service. If you’re looking for healthcare consulting firms that focus a great deal of time and energy on your needs, this is an excellent option.” For more information, visit AdvisoryHQ.

Health Advances is sponsoring the forum and Mark Speers, Managing Director, and Andrew Matzkin, Vice President, will be participating in several forums to identify ways to improve the clinical outcomes and cost-effectiveness of the healthcare delivery system. Health Advances’ pioneering work in connected health with biopharma and medtech clients is particularly relevant to the Summit

Bruno’s presentation focused on the laying out a balanced approach to VBC that considers organizational strategy, immediate needs, and the business environment in which they exist. A lot is being invested on VBC planning and readiness, but not all organizations need advanced capabilities to manage contracts today. By planning for maturing capabilities as the market matures, organizations can optimize resources for their most pressing needs, while laying a foundation for success in the future. With the hype around VBC, all stakeholders in healthcare need to be mindful of the opportunity cost of investments because it is easy to overextend finances and talent on capabilities that will not be needed in the near term. For more about this event, click here

“Being part of the Library Services and Knowledge Management team means being part of the entire Health Advances team,” Tara said. “We don’t stop to think about how we might assist someone. Everyone has a core strength at HA which is recognized company-wide. Ours is information and knowledge.” The SLA conference in Orlando had over 90 different companies participating in the event including professional research staff, librarians, and information providers.

The panel consisted of three highly experienced information specialists within three different workplace settings detailing the various ways each operates as an embedded librarian. Professional librarians from a precision medical device manufacturer, a cutting-edge pharmaceutical company, and a strategic management consulting firm shared real life examples and situations in which they have contributed to knowledge engineering and growth within each setting.

The Company enlisted Health Advances to perform a rigorous and comprehensive study of the robot’s long-term economic impact to hospitals, payers and society when deployed to perform radical prostatectomies for prostate cancer patients. The resulting study, “A Multidimensional Analysis of Prostate Surgery Costs in the United States: Robotic-Assisted versus Retropubic Radical Prostatectomy,” was written in collaboration with leading researchers and clinicians at Mount Sinai Hospital in NYC and has been published in the well-respected Value in Health Journal. The study estimates that, when factoring in all the costs of a surgery, the robot usually saves hospitals money. In addition, payers and society benefit from treating fewer downstream complications and less lost days of employment. The Health Advances authors are Mike Davitian, Holly May, and Mark Speers.
Click here to read the article.

Paula Ness Speers, Managing Director, introduced the panel discussion with a landscape overview of how and where Health IT is already implemented or on the verge of entering the orthopedics ecosystem, from product design and manufacture to implant selection and tracking to outcomes monitoring. Dr. Claudia Graeve, Vice President, moderated the expert panel of seasoned orthopedic surgeons from leading institutions as they discussed some of the Health IT solutions they have developed and/or adopted. They also discussed areas in need of new solutions that can help better manage costs and improve clinical outcomes. Senior leaders of Health Advances’ Health IT Practice – Andrew Matzkin and Bruno Nardone – also provided up-to-the-minute reports on new technology solutions they saw in the ortho and spine space direct at the HIMSS conference, which was going on in parallel with AAOS this year. Please look for the upcoming piece on our Health Advances blog for more details on this event!

Health Advances focuses exclusively on the healthcare industry, working with medtech, diagnostics, biopharma, HIT, and healthcare services organizations, to help them gain market access, optimize growth strategies and achieve their full potential. The firm recently announced it has joined forces with PAREXEL, one of the leading global clinical research and commercialization services organizations, with 80 offices in 51 countries. This partnership further enhances Health Advances’ global reach and capabilities, including access to key experts and insights in clinical development, regulatory, compliance, marketing communications, and other services, which are critical to the full commercialization and strategy optimization services we provide to our clients.

Please contact the Ortho Team at (781) 647-3435 or email ortho@healthadvances.com for more information.

As more drug-companion diagnostics enter late phase clinical development, more emphasis than ever is being placed on building and executing a successful adoption and reimbursement strategy. With the fragmented European landscape presenting many challenges, appreciation and understanding of the major stakeholders is becoming paramount. Gary Gustavsen, Vice President at Health Advances, along with Martina Kaufmann, Managing Director, Martina Kaufmann Strategic Consulting, leads a discussion offering a comprehensive understanding of the reimbursement frameworks in the major European states. Learn more about Health Advances’ diagnostics practice

Leaders of Health Advances’ Global Spine & Orthopedics Practice will be in Orlando, FL for the Academy of Orthopaedic Surgeons (AAOS) 2016 Annual Meeting Tuesday, March 1st through Friday, March 4th.

They will be hosting a breakfast seminar on Thursday morning where leading orthopedic surgeons share their experiences with incorporating various health IT solutions into their orthopedics practices. They will discuss which solutions providers value from OEMs to help improve clinical outcomes and manage costs across the full spectrum of care. This event is invitation-only to senior executives in companies and investment firms focused on the orthopedic industry. To learn more, visit our orthopedics page

Paula Ness Speers, Health Advances co-founder and Managing Director co-leads Health Advances’ Global Orthopedics Practice with Dr. Claudia Graeve, Vice President. Paula is based in the US and Claudia is based in Europe. They regularly attends annual meetings for both AAOS and NASS. Together with a highly seasoned team of consultants with experience across the spectrum of ortho and spine products and with Health Advances’ HIT Practice specialists, they conduct research and develop forward-thinking strategies for orthopedics and spine companies around the world. They also conduct commercial diligence for investors making investments in these sectors.

Health Advances focuses exclusively on the healthcare industry, working with medtech, diagnostics, biopharma, HIT, and healthcare services organizations, to help them gain market access, optimize growth strategies and achieve their full potential. The firm recently announced it has joined forces with PAREXEL, one of the leading global clinical research and services organizations, with 80 offices in 51 countries. This partnership further enhances Health Advances’ global reach and capabilities, including access to key experts and insights in clinical development, regulatory, compliance, marketing communications, and other services, which are critical to the full commercialization and strategy optimization services we provide to our clients.

Please contact the Ortho Team at (781) 647-3435 or email ortho@healthadvances.com for more information.

With more and more innovative diagnostics hitting the market, scrutiny and evidentiary requirements from payers is at an all-time high. To meet these demands, developers must make large investments which in turn drive a need for premium pricing to capture a return. To justify this, system economic analyses have become a critical component of a diagnostic’s launch plan. This case study, “System Economic Justification: Tools for Success in the New Reimbursement Environment,” will review the process for such an analysis, the resulting outcomes, and highlight specific payer-facing tools for future use.

PAREXEL Press Release
Health Advances Press Release

Donna is widely respected in the industry for her technical and business acumen, having worked with dozens of seasoned executives across all sectors. Notably, many of her recent projects have navigated life sciences tools into the clinical domain successfully.

Prior to joining Health Advances, Donna worked as a scientist at One Cell Systems and Iquum developing diagnostics for oncology and infectious diseases. She earned her Bachelor’s degree in Biology from the University of Illinois at Urbana-Champaign and her PhD in Immunology from the Sackler School of Biomedical Sciences at Tufts University.

A lot of folks are committed to healthcare in a lot of ways. Some work directly with patients, others dedicate their lives to research, while others lean shoulder to the yolk of making the health system work more effectively in myriad ways. At Health Advances we touch all aspects of the industry, but generally from the top down; working with executive teams to optimize business strategies aimed at improving the complex ecosystem of healthcare and life sciences. Because of this orientation and the scale of the focus areas analyzed, these efforts can sometimes be abstract.

By Bruno Nardone

both companion and complementary – to optimize the success of therapeutics. Please join us November 5-6 in Boston! Click here for more information and to sign up to attend.

At a recent event sponsored by Health Advances, a panel of experts from the healthcare industry weighed in on drug pricing, a topic that is frequently a part of industry discussion but has also recently entered the national spotlight. Beyond the media hype around the recent Turing Pharmaceutical controversy, panelists pointed to potential reasons why drug costs and pricing reform are currently at the forefront of the American consumer consciousness.

by Maggie O’ Brien

On August 27th, the Health Resources and Services Administration released an omnibus guidance on the 340B Drug Pricing Program. The notice offers “proposed guidance” for hospitals and other organizations enrolled in the program, as well as for the drug manufacturers that are required to comply with its requirements. Interested parties have until October 27th to submit comments regarding the new guidelines, which will be considered before the guidance is finalized.

by Maggie O’Brien

The discussion will cover a wide range of issues impacting the medtech industry. Cooley Medical Technology Growth Conference focuses on the key drivers affecting the medtech industry and explores growth strategies for medical device, medical technology and digital health companies. Visit the conference website for more information and to sign up to attend.

Read more about EOS

Monday’s presentation focuses on preferences for colorectal cancer screening tests among a previously unscreened population and Tuesday’s presentation focuses on the impact of novel test choices on respondent intent-to-screen. The SMDM conference brings together experts from a broad range of health science disciplines to explore implementation and exchange ideas on how to improve the translation of research findings into better bedside care and health care utilization. Visit the conference website for more information.

The organizers of the Health 2.0 Conference have always done a great job of providing a platform to showcase the latest technologies to empower consumer driven health. Biometric and/or remote monitoring offerings are celebrated for their creative application of technology to connect people and measure their well-being.

By Bruno Nardone

The panel includes Dave Amerson, President and CEO, NeoTract, Inc. and Matthew Cantonis, Corporate Director, Orthopedics, Spine, Neuroscience and Rehabilitation Clinical Care Lines, Scripps Health, in a discussion about how to evaluate a product’s value proposition both clinically and economically and translate that to sales. The panel will also cover health economic and product positioning considerations, as well as the evolving buyers’ decision-making drivers in various settings.

Click here for more information.

Click here for more information or to register for the event.

The idea around bundled payments is that by combining all medical activities and expenses around a pre-defined “episode of care”, providers, not just payers, share in the risk and financial decision making around patient treatment.

By Masha Dumanis

Biopharma companies are in desperate need of technologies and strategies that can reduce the cost of their clinical trial programs, which now routinely exceed $1 billion for a new drug. At the same time, these companies face pressure to expand the endpoints measured in their trials in order to demonstrate clinical relevance, economics, and patient satisfaction, all of which are now seen as prerequisites for broad adoption.

By Andrew Matzkin

As Health Advances Partner and Chief Operating Officer, Karen oversees and directs all of the administrative functions and infrastructure necessary to deliver the highest quality product to our clients.

With a mix of investors, industry veterans, and entrepreneurs, WSGR’s Medical Device Conference in San Francisco underscored several forces shaping the future of the medical device industry, from evolving corporate investment strategies to innovative collaboration models and the growing influence of tech in medtech. The panel discussions reinforced several themes that have been redefining the industry.

By Nick Haluck

The recent deal activity in the CAR-T space has pushed valuations to breathtaking heights and already generated strong returns for early investors. At the same time, these valuations come with seemingly giddy optimism that CAR-T approaches will prove capable of conquering all cancer. With the limited data seen to-date, a little caution is due.

By Vivek Mittal, PhD

A new Harvard Medical School, Department of Healthcare Policy study published recently in the British Journal of Medicine tempers the enthusiasm over web-based symptom checkers.

By Bruno Nardone

The Celgene and Juno Therapeutics executive teams held a joint webcast on June 30th, 2015 to discuss their newly announced large-scale collaboration deal in T-cell technologies.

By Alison Munroe

On May 14, 2015, 60 senior physician executives from the Boston area biotech and pharmaceutical industry gathered at Alnylam Pharmaceuticals in Cambridge to hear Julia Gaebler, Ph.D., Vice President, Health Advances and Troyen Brennan, MD., M.P.H. EVP & CMO, CVS Caremark, discuss Drug Pricing & Reimbursement. The event was moderated by Akshay Vaishnaw, EVP R&D & CMO of Alnylam.

Wyatt Gotbetter discusses themes from this year’s BIO convention.

Nayna Aggarwal interviews Sheela Hedge on her experience moderating the DiabetesMine™ D-Data Exchange Industry Forum Panel at this year’s American Diabetes Association (ADA) conference.

Andrew Funderburk interviews Carrie Jones on her recent attendance at the World Orphan Drug Congress and Julia Gaebler and Martha Boylston on the International Society for Pharmaeconomics and Outcomes Research (ISPOR) annual meeting.

This annual event of the second largest US-based American College of Healthcare Executives chapter convenes over 400 participants associated with the College, most in executive and management roles at provider organizations in the NY metropolitan area. Bruno, a Fellow of the College, was honored as a Past President, along with annual awardees recognized for leadership in the industry.

Health Advances works closely with the Summit organizers to help prepare the annual report and to ensure that conference participants and the broader healthcare community can benefit from the thinking and discussion that happens at this special event.

This year’s Summit Report features insights across the wide range of transformative changes impacting healthcare and the opportunities that those changes are creating for healthcare innovators.

Participants from Health Advances at this year’s Summit included Partners Paula Ness Speers and Mark Speers, as well as Vice Presidents Bruno Nardone and Andrew Matzkin.

Click here to read the report.

Panelists from leading companies in the field, including Medtronic, Animas, Roche, Insulet, Tandem and Dexcom, will engage in a lively discussion on issues related to open data sharing and device interoperability.

The two workshops are titled “Connecting the Dots between Regulatory Approval to Reimbursement Outside the US” and “Strategies to Manage the Multiple Stakeholder Groups to Improve the Regulatory Approval Process.”

Sheela Hegde interviews Nayna Aggarwal on her experience at the recent T1D Exchange Annual Meeting.

Other speakers include Mya Thomae, Illumina, Vice President of Regulatory Affairs; Chandra Branham, Advamed; and Bruce Quinn, Foley Hoag LLP. The event will focus on Tackling the Tough Questions in Tools.

Andrew Funderburk interviews Alison Munroe, who attended this year’s American Association for Cancer Research (AACR) conference.

The distinguished panel includes two local Hospital CEOs, Bruce S. Auerbach, MD, FACEP, President & CEO of Sturdy Memorial Hospital and Trish Hannon, President & CEO, New England Baptist Hospital in a discussion about the changing dynamics in hospitals and the impact on medical device manufacturers.

MassMEDIC is teaming up with UBM Canon and holding its 19th Annual Conference in conjunction with the Boston BIOMEDevice Show, May 6-7 at the Boston Convention and Exhibition Center.

In the press release, the Trust highlights its white paper ‘Type 1 Diabetes Prevention Landscape: A Guide for Navigating Emerging Opportunities’, co-authored by Health Advances. Health Advances’ research supported The Helmsley Trust’s critical investment decisions in the field of prevention.
Read the white paper.
Read the announcement on Helmsley’s website.

The Summit convenes over 500 senior leaders, policy makers, and investors from across the healthcare industry, with a strong focus on Health IT innovation. Health Advances has partnered with Summit organizers for a number of years to coordinate sessions, facilitate dialog among attendees, and serve as a catalyst and contributor to the annual Summit report that distills key insights for the Health IT segment and health industry in general. Health IT topics at this year’s Summit included leveraging technology to improve patient engagement, coordinate high-cost complex patient care, effectively apply the ‘internet of things’, and explore evolving applications of cloud computing in healthcare.

The 2015 report of Summit findings was recently released with highlights that emerged during the event. Click here to read the report.

A preview of Health Advances latest white paper, authored by Bruno Nardone.

While there they met with many Health IT clients, as well as other companies and innovators across the HIT sector to maintain and expand Health Advances’ knowledge base and understanding of the rapidly growing and evolving array of HIT solutions for providers, payers, product companies, and patients. This years’ prevailing Conference themes of population health management and health analytics aligned well with solution investments Health Advances is making to support client needs.

The team is hosting a breakfast seminar on Thursday morning where leading orthopedic clinical and supply chain experts will discuss the growing focus on value-based healthcare and ideas for how orthopedic companies can work with providers and payers to survive and thrive in a cost-containment-driven world. This event is invitation-only to senior executives in companies and investment firms focused on the orthopedic industry. To learn more, visit our orthopedics page.

Paula Ness Speers, Health Advances co-founder and Managing Director leads Health Advances’ Global Orthopedics Practice and regularly attends annual meetings for both AAOS and NASS.

Dr. Claudia Graeve, Vice President responsible for the European Practice and the newest member of the Health Advances Management Team. Claudia brings more than 20 years of healthcare experience, including senior executive roles at orthopedics leaders DePuy and Stryker in EMEA, Africa, and Asia Pacific.

Kate Strayer-Benton, Manager and key member of the Orthopedics Practice Group with nearly a decade of consulting experience across the healthcare landscape regularly attends AAOS and NASS to stay abreast of industry trends in new products and services.

Hilary Imai, Business Development Analyst, works closely with senior management on the Orthopedics Team and was instrumental in the planning of this year’s Breakfast Panel event.

Please contact the Ortho Team at (781) 647-3435 or email ortho@healthadvances.com “ortho@healthadvances.com” for more information.

For more information see the press release on Implanet’s website where you may also read the white paper. Additionally, the white paper is also posted on the Becker Spine Review.

Health Advances’ Global Orthopedics Team is attending the annual meeting of the American Academy of Orthopaedic Surgeons In Las Vegas this week. Health Advances will be hosting a breakfast seminar for orthopedics executives with a panel of leading orthopedic clinical and supply chain experts on Thursday morning, March 26th, focusing on Healthcare’s Increasing Focus on “Value” and Implications for Orthopedic Companies.

Welcoming her to the firm, Mark Speers, Managing Director exclaimed “While we have been doing great work in Europe for over two decades, we are excited to expand our presence with the expertise that Claudia brings. She is a seasoned executive who is intimately familiar with all the nuances of the major European healthcare systems.” A true pan-European executive, Claudia has lived and worked in the UK, Switzerland, Italy and Germany. She speaks German, English, French, and Italian fluently, with proficiency in Spanish and Portuguese.

Claudia most recently led the Medical Affairs and Technology functions at Anteis SA, a biotechnology company with biopolymers for aesthetic, orthopedic, and ophthalmic applications. Previously, Claudia focused largely on international strategic planning and marketing with senior executive positions at Depuy and Stryker with responsibilities for the EMEA, Africa, and Asia Pacific.

Claudia started her career as a management consultant for Arthur D. Little AG and has run Graeve Consulting Sarl as an independent consultant across the biopharma and medtech sectors.

Claudia earned her Master of Science degree in Chemistry from the Westfälische Wilhelmsuniversität in Münster, Germany, graduating in the Top 5% of her class. She then received her PhD in Organic Chemistry from the same university, earning magna cum laude honors. She later earned her MBA at the Bocconi School of Management in Milan.

This year’s conference will focus on partnering for outcomes in modern healthcare during a time of incredible change in the public and private sectors across the US and the rest of the world.

Alan will be the moderator of the Devices/Diagnostics panel, while Gary will be a panelist on the Personalized Medicine panel.

February 7th
Panel Discussion: Devices/Diagnostics
2:00-3:00 PM
How Strategic Partnerships in Medical Devices Foster Innovation and Efficiency
The medical device market is facing unprecedented change with reforming healthcare policy, advancing technology, emerging global markets, and growing patient education. The concurrence of these trends are creating immense opportunities for new business models and innovation, but are also challenging current developmental practices. Players in the device industry are realizing they can achieve better clinical outcomes and mitigate risk by leveraging outside expertise and relationships at key points in the development process. Strategic alliances, licensing agreements, and other partnerships are proving to be a necessary way to navigate through this evolving landscape.

Alan Braly, Moderator
Mark Johanson, CEO, Audax Medical, Inc.
Patrick Freuler, CEO, Audicus
Sean Burke, Chief Marketing Officer, GE Healthcare
Stuart Blitz, Executive Director of Business Development and Strategy at AgaMatrix

Panel Discussion: Personalized Medicine
3:15-4:15 PM
Molecular Diagnostics and the Promise of Better Health: What’s the Prognosis?
We recently celebrated the 10th anniversary of the Human Genome. The price of human genome sequencing is rapidly decreasing thanks to next-gen sequencing technologies. What have we accomplished since then? Have we reached the era of true personalized medicine? This panel will feature perspectives from diagnostic companies, biotech firms, sequencing/tools companies, and healthcare payers to determine what progress we’ve made and how we continue making progress towards personalized medicine.

Mara Aspinall, Moderator
Todd Kruger, Head of Commercialization and Operations, Broad Institute
Theresa Tribble, VP of Commercial Strategy, SynapDX
Gary Gustavsen, VP, Health Advances
Michael Kolodziej, MD, Medical Director, Oncology Strategies, Aetna
Anne Morriss, Founder and CEO, GenePeeks

“The growth of the San Francisco office reflects Health Advances’ continued success in providing innovative, actionable, and strategic recommendations to companies operating in the healthcare and life sciences market. With a client roster that spans biopharma, devices, diagnostics, services, health IT, and investors, Health Advances has built a world-class reputation in providing strategic consulting services to the healthcare industry by leveraging its deep industry knowledge and extensive contacts,” remarked Vivek Mittal, PhD, Partner.

Health Advances’ new San Francisco office address is:
601 Montgomery Street
Suite 1850
San Francisco, CA 94111

Andrew joined the firm in 2009 and has established himself as a strong strategic thinker and excellent collaborative partner for his clients.

Andrew is based in Health Advances’ San Francisco office. He co-leads the Health Advances Health IT practice and regularly collaborates with health IT, medtech, and private equity clients. He has worked closely with dozens of senior executives to develop winning strategies for product development and commercialization. He frequently leads commercial due diligence projects, many of which have supported lucrative transactions for his clients.

Andrew has over a decade of experience as a strategy consultant, with prior experience at Bain & Company and Axia Limited. He also worked at Novartis in the Global Cardiovascular-Metabolic franchise.

Andrew holds a BA from Yale University, where he graduated magna cum laude and Phi Beta Kappa, and an MBA from Harvard Business School, where he was honored as a Baker Scholar.

A distinguished panel including a hospital procurement officer and experienced medtech executives will discuss medtech company size and scale and whether or not it is important for selling products.

Panelists:

• Bill Floyd, President & Chief Executive Officer, CSA Medical, Inc.
• Philip Spiegel, Global Sales and Marketing Executive, Cheetah Medical
• Rick Ulrich, Senior Sourcing Agent – Supply Chain Management, UPMC
• Mike Miller, Chief Operating Officer, Image Stream Medical

Several women from Health Advances attended the 16th Annual Women’s Breakfast—a powerful morning of compelling stories, inspiring presentations, and special guest speaker, poet Azure Antoinette—in honor of Horizons for Homeless Children’s 25th year.

As a long-time supporter of HHC, Paula Ness Speers, Managing Director of Health Advances, commented on the importance of the HHC mission, its success in truly making an impact, and its conscientious stewardship of the donations it receives, saying: “This organization addresses some of the most important issues facing homeless children and their parents. The entire HHC team is passionate about providing high quality childcare in its 3 centers, and through its Playspace Volunteers who visit children in more than 150 homeless shelters throughout Massachusetts, to ensure that the most fragile amongst us are given all the opportunities to achieve their hopes and dreams that so many of us can take for granted. I am a firm believer in helping children get off to the best start possible by providing a nurturing, safe and educational environment in which they can learn, play and grow. Health Advances and its entire staff have engaged in many important community and charitable causes since our founding and we are proud to continue this commitment through our sponsorship of Horizons for Homeless Children.”

HHC also provides important coaching and support services for the parents of these children, who often struggle to get out of the cycle of homelessness because they can’t afford quality childcare and pre-school for their children to enable them to have time to train for and seek job opportunities and find a safe and affordable place in which to live.

Julia has accumulated over 15 years of experience in pharmacoeconomics, market access, health policy, and health services research in both the biopharma industry and academic research. A mathematical modeler by training, she applies Health Advances’ Market Access and Health Economic functional expertise across biopharma, medtech, diagnostics, services, and HIT clients.

Paula Ness Speers, Managing Director, explained “We are thrilled that Julia has decided to join us as our clients’ products and services are under tremendous scrutiny for delivering economic value. Julia understands the demands of regulators and payers globally and will be able to further enrich our ability to help our clients plan ahead for and address this new reality.”

Immediately prior to joining Health Advances, Julia worked at Biogen Idec as Senior Director, Global Medical Outcomes Strategy where she provided strategic leadership and technical health outcomes expertise to ensure that medical product strategies and tactics anticipated the evolving demands of the global payer landscape. At Biogen she was also Director, Global Market Access where she built and managed a team of Health Economics and Outcomes Researchers (HEOR) responsible for payer value evidence development for the Company’s late stage development products. In that capacity Julia led the global reimbursement and market access launches for TECFIDERA and FAMPYRA for Multiple Sclerosis. Julia has also held related positions at Amylin Pharmaceuticals and Hoffmann-La Roche where she supported payer and ‘Real World Evidence’ development for Phase II/III products in Diabetes, Obesity, HIV/AIDs and Hepatitis. In addition to her leadership positions in industry, Julia was a Health Policy Researcher at the RAND Corporation, where she applied her decision analytic methods to international and domestic health policy issues.

Julia reflected on her decision to join Health Advances, stating “I have always only heard the greatest respect paid to the work of Health Advances’ teams. I am enjoying working with this passionate and seasoned group of professionals striving to help clients bring valuable new technologies and services to markets and patients around the world.”

Julia holds a Doctorate in Health Policy and Decision Analysis from Harvard University, a Masters in International Economics from Johns Hopkins University, and a BA from the University of Pennsylvania. She has held Adjunct Faculty positions at UCSD Division of Global Public Health and at the RAND Corporation and has published many articles on health technology assessment in journals such as Nature, Health Services Research, Diabetes Medicine, and Plos Medicine.

This unique event features stories from founders and investors of New England biotechs that used very different strategies to pull off some of the biggest recent life sciences IPOs.

This is critical to the continued success of our industry. Julia Gaebler, Vice President, will join a distinguished group in a panel presented by MassBio. The panel, titled “The Future of Biotech: Defining & Building Value in Healthcare” is the first in the series, “Value Creation: From Cradle to Commercialization.” For more information read the event flyer.

The panel will include three additional seasoned globe trotters:

• Dr. Trevor Gunn, Managing Director for International Relations, Medtronic
• Deputy Assistant Secretary Chandra Brown, International Trade Administration, US Commerce Dept.
• Scott Gucciardi, EVP and Chief Marketing Officer, Welch Allyn

Most US based medtech companies, until near $100 million in revenue, are reluctant to splinter management’s efforts by considering ex-US opportunities. However, the right combination of market factors can converge to accelerate uptake of a specific new product in particular countries. The panel will discuss these market factors and provide examples of how they can be identified and exploited.
AdvaMed 2014 is the largest medtech conference in North America, attracting over 1,000 companies.

Based on experiences from recent companion programs, it is clear that a “one size fits all” approach is insufficient when commercializing a companion diagnostic worldwide. This dynamic and burgeoning field fundamentally requires complete drug-companion diagnostic commercialization strategies and this workshop will provide you with the toolkit to maximize these.
World CDX Boston brings together the industry’s leaders and those pushing the boundaries with companion diagnostics to discussing the biggest opportunities and challenges in the precision medicine space.

The findings of this important study were the subject of a recent press release picked up by a number of news sites.

Come prepared to fire your toughest and most provocative questions at the panel.

For more information and to register for this event please contact Michaela Coyne at diagnostics@healthadvances.com

Moderator:

John Schoellerman, J.P. Morgan, , Executive Director, Healthcare Investment Banking
Health Advances Panelists:

Mark Speers, Managing Director
Donna Hochberg, Vice President
Gary Gustavsen, Vice President
Kristen Garner, Associate
Kate McLaughlin, Manager

In his nine years with Health Advances, Gary has risen through the ranks and now leads the Personalized Medicine Practice at Health Advances. A noted writer and workshop leader in the field of companion diagnostics and personalized medicine, his work focuses on commercialization strategy, indication prioritization, pricing and reimbursement strategy, and business development opportunities for both diagnostic and therapeutic clients.

Prior to joining Health Advances, Gary worked as a research assistant at Brookhaven National Lab evaluating a proprietary line of synthetic growth factors. Gary also worked in the Cell & Tissue Technologies group at Becton Dickinson, the Exploratory Cancer Research group at OSI Pharmaceuticals, and most recently the Corporate Strategy group at Millennium Pharmaceuticals. Gary received his Bachelor’s degree in Biomedical Engineering from Duke University and his Master’s degree in Biomedical Engineering from Stony Brook University.

Titled “Partnering for the Long Haul: Lessons in Alliance Management,” the session will be chaired by Vivek Mittal, Partner and head of the Health Advances San Francisco office. He will be joined by speakers Sujay Kango (Onyx Pharmaceuticals), Sandra Shpilberg (BioMarin Pharmaceuticals), and Curt Herberts (Sangamo Biosciences).

Based in the US, and drawing on nearly 30 years of experience in strategy development for global companies, Paula Ness Speers brings a wealth of specific expertise in the healthcare sector.

Current healthcare cost pressures are leading payer and hospital customers to increasingly demand compelling cost-effectiveness evidence for our clients’ new technologies to be adopted. To build upon its extensive experience in cost-effectiveness analyses, Health Advances will be attending ISPOR this year to ensure it stays on the leading edge of new pharmacoeconomic methodologies and outcomes research techniques including the best ways to quantify the value of downstream quality of life.

ISAR is involved in supporting registries to work collaboratively with each other and with industry to improve registry frameworks, data collection and analytics across arthroplasty procedures. Health Advances has a large orthopedics and spine industry commercial strategy consulting practice and engages leaders in the sector in in-depth discussions about their evolving practice patterns, product usage, clinical outcomes, and unmet needs. Specifically as relates to registry data, Health Advances maintains a keen awareness of data availability and robustness across various international orthopedic registries, as well as other data sources pertinent to this industry sector to facilitate detailed and timely analyses of industry trends and opportunities.

On May 29th, Paula will present two case studies in prioritizing disease targets for platform technologies to optimize commercial potential in oncology and CNS as part of BIO KOREA’s 3rd GPKOL International Symposium 2014. The US healthcare system is one of the most fragmented systems in the world. This translates into a wide range of customers that need to be convinced to purchase and/or use a new biotherapeutic. Cost-conscious customers are now scrutinizing new therapies more diligently than ever before and strong economic benefits can greatly catalyze uptake of new products. Paula will walk through case studies and lessons learned from multinational companies making the decision to invest in early-stage oncology and CNS drug development, with an emphasis on creating value and collecting data for all stakeholders from the earliest stages of development.

Paula hosted two widely respected CEO’s – Mike Mussallem of Edwards Life Sciences and Alex Lukianov of Nuvasive – with reputations for pioneering medical technologies in cardiac and spine medicine. In addition, the panel included Mark Bussard of Rock Springs Capital, a leading hedge fund, to candidly pressure test the attractiveness of medtech investments in this new world.

Speakers

• Paula Ness Speers (Moderator)
• Michael A. Mussallem- Chairman and Chief Executive Officer, Edwards Lifesciences
• Alexis V. Lukianov- Chairman and Chief Executive Officer, Nuvasive, Inc.
• Mark Bussard- Founding Partner and Managing Director, Rock Springs Capital

No longer can promised ROI in the sales process meet leaders need post implementation to demonstrate accountability to constituents for promised improvements to quality, efficiency, or satisfaction. Bruno Nardone led a discussion forum with industry leaders aimed at validating the market shift to FFV and illuminating critical success factors to organizations developing and offering HIT solutions in the current environment. Two special commentators were featured. Dr. David Blumenthal President of the Commonwealth Fund and former National Coordinator for HIT (2009 -2011) set the stage by sharing his views on the urgency of rigorous ROI analyses. Stephen Lieber, President and CEO of HIMSS, shared his organization’s priorities to help members prove clinical and financial value creation from HIT initiatives to their constituents. The active discussion allowed participants to explore how best support their own clients’ realization of value from their solutions.

Speakers

• Bruno Nardone, M.H.S.A., F.A.C.H.E. (Moderator)
• David Blumenthal, M.D., M.P.P – President, The Commonwealth Fund
• H. Stephen Lieber, C.A.E. – President and CEO HIMSS

Ambitious startups are sprouting up, sparked by science that is turning heads. New, nontraditional sources of cash are turning their attention to life sciences, creating unlikely options for fledgling biotechs that simply weren’t imagined a short time ago. But which ideas are generating the most buzz? What’s it going to take for the grandiose visions to become reality? And what does it all mean for drug discovery and health? Join Xconomy as we bring together some of the Boston biotech scene’s top innovators, venture capitalists, and executives, who are at the forefront of some of the biggest new ideas in life sciences.

Confirmed Speakers:

• Michael Bonney, CEO, Cubist Pharmaceuticals

• Douglas Williams, EVP, Research and Development, Biogen Idec

• John Maraganore, CEO, Alnylam Pharmaceuticals

• David Berry, CEO, Seres Health; Partner, Flagship Ventures

• Kevin Bitterman, Interim CEO, Editas Medicine; Principal, Polaris Partners

• Katrine Bosley, Entrepreneur-in-residence, Broad Institute

• Steven Holtzman, EVP, Corporate Development, Biogen Idec

• Nancy Simonian, CEO, Syros Pharmaceuticals

In the past, non-profit organizations dedicated to research in specific disease areas were typically unable to take advantage of the upside of any significant discoveries that were funded through the organization’s grants. The panel will focus on the recent emerging trend: non-profit organizations are now creating and being involved with investment in biotech startups in return for an equity stake, rather than simply giving a grant or donation-so when an exit event (such as a licensing deal, acquisition, or IPO) takes place, these new entities receive a piece of the upside and can re-invest their profits into future research. Panel:

• Eugene Williams, Founder, Virtua (Moderator)
• Skip Irving, Partner and Managing Director, Health Advances, LLC
• Dale Botting, COO, Prevent
• Maya Merrell, Director, Business and Partnership Development, FastForward
• Steve Perrin (CEO / CSO, ALS TDI)

In addition to reviewing new product and service offerings across the sector, and senior level discussions focused on evolving solutions for the manufacturers, providers and payers to collaborate for better outcomes at lower costs, the team met with top executives of the industry’s leading companies to assist a client seeking partnering opportunities. Orthopedics, including spine, O&P and other DME, and orthobiologics, is one of the core practice areas at Health Advances and AAOS is a great opportunity to meet with clients, industry executives, and the key decision makers in this field to continue to develop new insights and innovative strategies.

Health Advances works with its HIT clients to hone and quantify their value propositions and to identify innovative strategies that enable them to achieve leadership positions across the healthcare ecosystem.

Bruno Nardone, Vice President, recently joined Health Advances to lead our growing HIT practice. Bruno has a long career working in the HIT sector, including as the VP of Connected Health Solutions at Allscripts Healthcare Solutions, as well as consulting experience at SAIC and IBM, where he led their Healthcare Transformation and IT consulting efforts. We are very excited to have him on board and look forward to continuing to expand our HIT practice.

Over 80 executives attended and recognized Russ Carson for his lifetime contributions to the industry and society.

Mark Speers, Managing Director and Partner, provided the key note address which summarized 2010 investment activities and compared them to the previous decade. 2010 saw investment activity, in volume if not in deal size, return to historic highs and also witnessed 4 of the largest exits in the history of healthcare private equity: Talecris, Parkway Holdings, Multiplan, and US Oncology. Healthcare services have grown over time as a percentage of deal flow while medical equipment and supplies have fallen in their representation.

The new Partners, Andrew Funderburk, Sheela Hegde, Susan Posner, and Vivek Mittal – each with Health Advances for over eight years – have established themselves as thought leaders and trusted advisors in the healthcare industry. These new leaders represent a strengthened leadership team to ensure the firm maintains its strong record of growth as it enters its third decade.

Soren Peterson, Senior Analyst, will discuss the impact of reimbursement headwinds on emerging and established trends in IVD M&A, outlining how pressures on the industry are driving movements towards product innovation and the creation of value for laboratory customers.

The breakout session, “Comparing Cost, Time, and Complexity-Regulatory and Reimbursement Global Case Studies”, takes place on November 20th at LifeScience Alley’s 2013 Conference: Healthcare Transformation — Surviving the Shift.

how to attract potential buyers, prepare for due diligence and position a company to achieve the greatest value, as well as share perspectives as to what strategic acquirers and investors are seeking in medtech companies today.Susan’s panelists include:

• Mike Grippo – Vice President, Business Development, CR Bard
• Daniel Levangie – Co-Founder and Managing Partner, ATON Partners
• David Wong – Principal, Audax Private Equity

A dynamic panel consisting of the company leaders and their VC backers describe some of the radical approaches that are changing the game in cancer, vaccines, rare diseases, and more – and what they must continue to do to pursue their disruptive vision.

Kristin Pothier will speak at the summit on commercializing these new technologies, outlining challenges faced during initial phases and exploring how integrating the early voice of customer research at all stages is critical in ensuring a final product meets end user needs.

The panel focused on a critical issue in personalized medicine today, entitled Developing Effective Policy Strategies for Coverage and Reimbursement of Companion Diagnostics.

The ADA’s Scientific Sessions bring together world leaders in diabetes research and care. The yearly meeting features its sessions around the most significant advances in the prevention, diagnosis, and treatment of diabetes.

CALBIO is a California-based biotechnology conference that brings together top-level executives from life science companies, patient foundations, venture capital firms, and nationally recognized corporations around the world.This year’s conference is covering topics like the future of healthcare, capital case studies, and a unique life sciences “speed dating” track which gives entrepreneurs the opportunity to meet with executives one-on-one.

Patrick Kennedy, Kristin Pothier, and study leader Gary Gustavsen, along with the team from bioMérieux subsidiary bioTheranostics, were awarded an abstract at ASCO 2013 based on a recent health economic analysis of a novel breast cancer prognostic test developed by Health Advances.

The exchange consists of an integrated clinic network of 65+ clinics, a clinical registry of 26,000 well-characterized type 1 diabetes patients, a biorepository, and Glu, an online community with mobile capabilities for people touched by type 1 diabetes. The focus of the conference is to identify the challenges in advancing treatments for diabetes, from innovation to commercialization, by bringing together over 75 key stakeholders who are scientific, clinical and business leaders in the diabetes space. The goal of the meeting is to create an integrated view towards product development, commercialization, and delivery of healthcare in diabetes and identify key action items where the Exchange can help to improve and advance the development of innovative treatments for diabetes.

Biopharma executives and venture investors will share their criteria for investment and licensing of academic research while the National Brain Tumor Society-funded researchers will present brain tumor drug candidates ready for early stage investment and/or licensing.

Kristin Pothier, Partner, leads an illustrious group in two panels. Panelists delve into challenges in drug development and collaborations in personalized medicine.

4/22 10:15AM: Finding Your Niche

In embracing personalized medicine early in the R&D life cycle, niche drug companies hope to find both quicker paths to approval for their medicines and a greater acceptance with payers, all while retaining premium pricing. Is this possible? Consider the regulatory/reimbursement environment driving niche indications as industry experts evaluate the opportunities and failures associated with personalized medicine and niche drug development.

Speakers:

• Kristin Pothier, Partner, Health Advances (moderator)
• Mohammad Azab, Chief Medical Officer, Astex Pharmaceuticals
• Tom Davis, Senior Vice President and Chief Medical Officer, Celldex Therapeutics
• Christian Behrenbruch, Founder and CEO, ImaginAb

Tuesday 4/23 3:45PM: “Panacea or Pain: Collaboration in Personalized Medicine”

Key industry leaders who are successfully pioneering personalized medicine launches will review the state of collaboration in personalized medicine, highlighting successes and major challenges, and debating the potential of the most attractive pathways for the future. Kristin and her panel will introduce a framework to enable companies to maximize their collaborations and viability in personalized medicine. Is collaboration among companies a hindrance to the advancement of personalized medicine, or a panacea?

Speakers:

• Kristin Pothier, Partner, Health Advances (moderator)
• Jonathan Hirsch, Founder and President, Syapse
• James R. McCullough, CEO, Exosome Diagnostics
• Hakan Sakul, PhD, Executive Director and Head of Diagnostics, Pfizer Inc.
• Paul Billings MD, PhD, Chief Medical Officer, Life Technologies
• David Jackson, VP of Business Development, PrimeraDx

4/24: Korean Life Sciences Industry Executive Series Breakfast and Networking Event. (In association with the BIO annual meeting)

Relations between the United States and Korea are rapidly strengthening because of the U.S.-Korea Free Trade Agreement (KORUS FTA), which entered into force one year ago. Korean Life Sciences Companies with a U.S. presence, or who are seeking to expand into the US, can enhance their competitiveness with a solid understanding of the evolving U.S. healthcare environment. The panel moderators will offer an overview of US competitive reimbursement and clinical strategy and discuss their applicability to fueling emerging Korean Life Science Companies operating, partnering, or planning to expand in the United States.
Moderators: Paula Ness Speers, Partner and Managing Director, Health Advances and Tom Barker, Partner/Co-Chair of the Healthcare Practice, Foley Hoag LLP.

This summit brings together payers, patients, health care workers and industry representatives to discuss the challenges and potential solutions to advancing personalized medicine. Kristin will lead a discussion on evidentiary standards and data requirements for payer coverage, with Jerry Conway, Vice President of Reimbursement and Payer Strategy, Foundation Medicine, Jeff Allen, Executive Director, Friends of Cancer Research, and Matt Zubiller, Vice President for Decision Management Business, McKesson Corporation.

Health Advances works with device, diagnostic, therapeutic and service companies to identify opportunities to incorporate medical informatics into their business for further value-added services to their customers, as well as to gain more insight into patients they serve. The firm also assists technology and informatics companies navigate the healthcare sector to identify new applications for their products and services. Health Advances has also invested in the building and maintenance of its own robust knowledge management resource center for 20+ years, and attends regular summits to stay abreast of new resource and technology trends.

World CDx Frankfurt brings together the leading minds to discuss these rapid advances. Kristin Pothier, Partner, and Gary Gustavsen, Manager will be delivering an invited workshop on the commercialization of companion diagnostics during this conference.

Orthopaedics is one of Health Advances clinical focus areas, and our staff attends each year to stay abreast of latest changes in the industry, including orthopaedic implants, instruments, services and pain management biomaterials. This gathering of surgeons and company executives allows us to meet with clients and key decision makers to gather information and develop new insights that enable us to continue to evolve and refine innovative strategies for companies and investors in this industry.

The diagnostics business model remains a mystery, with price and clinical utility as oft-cited concerns. Hear a frank discussion from players across the industry on what’s now required for molecular diagnostic reimbursement and how best to capture the promise of personalized medicine. The panel, which is part of the symposium titled, The Future is Now: Disrupting Drug/Dx Reimbursement will take place at 3:45.

Panel

• Kristin Pothier, Partner, Health Advance
• Michael Kolodziej, MD, National Medical Director, Oncology Solutions, Office of the CMO, Aetna
• Douglas Moeller, MD, Medical Director, McKesson Health Solutions
• Annalisa Jenkins, EVP, Head of Global Development and Medical, Merck Serono
• Ted Snelgrove, Chief Commercial Officer, Crescendo Bioscience

ATTD brings together leading researchers and clinicians from around the world who are working in the treatment and prevention of diabetes and related illnesses.

Our expert panel will help the audience understand some of the key issues facing putative biosimilar manufacturers:

• What Are The Relevant Differences Between The Regulatory Guidelines in US/Europe?
• How does it impact the drug development and clinical strategies – one across the board or specific ones for each market?
• What other regulatory nuances and implications should biosimilar developers be aware/cognizant of?

Kristin Pothier, Partner, will be delivering the industry keynote at the conference.

Industry Keynote: Advancing Molecular Medicine

The American healthcare system operates on the precipice of a catastrophic economic burden. A rapidly aging population and widespread inability to eliminate trial-and-error medicine and manage costs comprise this burden’s alarming weight. High-value diagnostics can bridge the gap between the need and the solution, but we must first strengthen its foundation. This is the mission of the non-profit educational organization DxInsights. DxInsights is building operational leadership, scientific and commercial strategy, legal and regulatory grounding, and seasoned publicity and communications expertise in a world class resource center that assembles the best data, unbiased guidance, and sharing of information specifically devoted to diagnostics’ expanding role in the future of healthcare. Delivered by one of its founders, this keynote will address the changing face of diagnostics in the healthcare system today, the role DxInsights is playing to take these challenges head on, and how all stakeholders can participate.

Breakout Session: Changing the Face of Diagnostics in Healthcare

Moderator:
Kristin Ciriello Pothier, Partner, Health Advances, LLC

Skip was joined by a panel of industry executives in discussing the resulting impact within the biotech industry as countries are using comparative effectiveness systems to guide decisions about which new products to reimburse and the terms of reimbursement. Are comparative effectiveness systems making health systems more efficient and effective in delivering the best treatments, or are they impeding market access for promising new medicines? What are the regional and global trends? How will these government actions influence the price for a new product?

Panel:

• Joseph Damond, Senior VP, International Affairs, Biotechnology Industry Organization (BIO)
• Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
• Koen Torfs, VP, Health Economics, Reimbursement and Market Access, Europe, Middle East and Africa, Janssen

This is the first time this annual event was held outside of Washington, DC. The conference brings together senior Medtech executive leadership to engage in critical discussions ranging from regulatory affairs and reimbursement, to IP and business development.

Susan Posner, Vice President, moderated a panel discussion titled, “How to Attract Buyers and Maximize Valuation.” Tight financial markets have caused many companies that in prior years may have pursued a go-it-alone strategy to focus on an acquisition exit. At the same time, potential large acquirers are facing a new reality as revenue growth is slowing relative to a few years ago. Slow growth, large balance sheets, and previous R&D cost-cutting by large medtechs have hurt development and will likely drive an uptick in acquisitions. However, smaller companies are struggling with the best ways to demonstrate value and identify the time of key valuation inflection points. The panel fostered an open dialogue to provide critical advice on how (and when) to put their best foot forward to garner an attractive exit. Susan was joined by a distinguished panel including:

• Chad Cornell, Vice President, Corporate Development, Medtronic
• Mike Grippo, Vice President, Business Development, C.R. Bard
• David Milne, Managing Partner, SV Life Sciences
• Kevin Schimelfenig, Managing Partner, McGeever and SalesForce4Hire

Kristin Pothier, Partner, also delivered a presentation titled “Diagnostic Commercialization and Reimbursement Reform” at the AdvaMed Global Diagnostics Meeting. This meeting brings together delegates from global associations including the British In Vitro Diagnostics Association, European Diagnostic Manufacturers Association, Camara Brasileira De Diagnostico Laboratorial, IVD Australia, Japan Association of Clinical Reagents Industries, and Medical Devices Association Canada, to unify vision and discuss 2013 major initiatives within and between associations.

The AACC Annual Meeting is an excellent opportunity to participate in a variety of discussions and activities surrounding the clinical in vitro diagnostics industry including exploring novel biomarker development and innovative diagnostic technologies, networking with business executives, clinicians, laboratorians, and scientists, and attending the largest clinical expo in the world.

Kristin led two panels:
Companion Diagnostics: Maximizing the Potential of Your Partnerships

• George Maliekal, Senior Director of Business Development, Abbott Molecular Inc.
• Matt McManus, MD, PhD, CEO and President, PrimeraDx
• Francois Ferre, PhD, CEO, AltheaDx
• Judith Roesler, Esq., Former Chief Patent Counsel, bioMérieux
• Commercialization in International Markets: A Debate on Global Strategy Development

• Rob DeWitte, General Manager, Mass Spectrometry Diagnostics, ThermoFisher Scientific
• Jim Widergren, Senior Vice President of Global Customer Operations, Danaher
• Simon Shorter, Senior Director, Strategic Health Initiatives, Abbott Diagnostics
• Thomas Brinkmann, Group Chief Medical Officer, Unilabs

Join our leadership team and their expert panelists as they address your greatest industry challenges.

Personalizing Medicine through Health IT Solutions

A New Commercial Value Driver Looking at the evolution of Health IT and its importance in product commercialization strategies, you can determine whether; or how; your company might benefit from Health IT solutions. Consider the ability to personalize therapeutic solutions and the value of Health IT investments versus more traditional commercial approaches.

Speakers

• Marie Schiller, Partner, Health Advances (Moderator)
  h5. Speakers:
• Dennis Urbaniak, VP US Diabetes, Sanofi
  h5. Speakers:
• Chris Bergstrom, Chief Strategy and Commercial Officer, WellDoc
  h5. Speakers:
• Imran Nasrullah, Head of Strategic Alliances, T1D Exchange
  h5. Speakers:
• John Ridyard, Manager, Health Advances

Novel Securities to Leverage Company Assets

How can you more accurately value your biotech company’s complex assets? Leading bankers and pioneering executives will walk you through the reasons behind and ways to use novel securities when financing. We’ll look at case studies of Shaman, Genzyme, Sanofi and others.

Speakers

• Mark Speers, Managing Director, Health Advances (Moderator)
• Henri Termeer, Former Chairman, CEO and President, Genzyme Corporation
• Greg Brown, MD, Founding Managing Director, Cowen Healthcare Royalty Partners
• Ashwin Pai, MD, Executive Director, Healthcare Investment Banking

Commercialization of Personalized Medicine: Stakeholders’ Recipe for Success

The collaboration a successful PM program requires can be tricky to navigate. What is the best mix of collaborators? When is it time to nurture skills in-house versus ask for help? The panelists have experience making it work; and will share their strategies with you.

Speakers

• Kristin Pothier, Partner, Health Advances (Moderator)
• Mara Aspinall, President and CEO, Ventana Medical Systems
• Paul Beresford, Vice President, Business Development and Strategic Marketing, Biodesix
• Glenn Miller, Vice President / Head of Personalized Medicine, AstraZeneca
• Ronnie Andrews, President, Medical Sciences, Life Technologies

Is Big Pharma the Preferred Partner for Orphan Drug Biotechs?

Orphan drug commercialization often requires pharma’s broad international reach to capture the limited available patients but the processes and structure of pharma’s large companies are not very well suited to many other requirements of orphan markets. In light of this, what in-licensing or acquisition strategies are optimal? What should small companies who are considering partnering their orphan products be thinking about to ensure successful development and commercialization?

Speakers

• Andrew Funderburk, Vice President, Health Advances (Moderator)
• Bradley Campbell, Chief Business Officer, Amicus Therapeutics
• Daniel Curran, Vice President, Business and Corporate Development, Millennium
• Daniel Karp, Senior Director, Worldwide Business Development, Pfizer
• Andre Turenne, Vice President, Strategy and Business Development, Genzyme, a Sanofi Company
• Jeffrey Walsh, Chief Operating Officer, bluebird bio

Disease Foundation-Funded Drug Development Partnerships: Structuring for Success

Funding from disease foundations for US biomedical research has tripled over the past decade. As foundations join other contributors,pharma and biotech companies, government agencies and research institutions at the table, the potential for conflicts rises. What are the interests of each of these involved parties, and what strategies can partners employ to help balance those interests?

Speakers

• Beth Arnold, Partner, Foley Hoag LLP (Moderator)
• Skip Irving, Managing Director, Health Advances
• Linda Johnson, Senior Director, Partnerships and Alliance Management, JDRF
• Heather Lounsbury, Sr. Director, Portfolio Management & Business Planning, Avila Therapeutics (a subsidiary of Celgene Corporation)
• Rebecca Menapace, CLP Director, Research Ventures and Licensing, Partners Healthcare

About BIO (Biotechnology Industry Organization

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.

Panelists included:

• Jeff Burbank, Founder and CEO of NxStage Medical, Inc.
• Elijah White, Director, Marketing of Haemonetics Corporation
• Maria B. Stewart, Director, Health Economics and Reimbursement, Endoscopy Division, Boston Scientific Corporation

The cost of health care is dominating the political agenda and medtech purchase decisions. Learn how industry leaders in Massachusetts are approaching this new and evolving paradigm. Susan and the panelists will discuss product development and sales in the evolving medtech marketplace and thoughts about what the future might hold.

Founded in 1996, the Massachusetts Medical Device Industry Council (MassMEDIC) is an organization of medical device manufacturers, suppliers and associated non-profit groups in Massachusetts and the surrounding region. Over the past 15 years, the efforts of MassMEDIC and its members have driven MedTech industry success and growth in the region, establishing Massachusetts as the nation’s second largest medical technology community.

Considered the world’s largest industry-focused companion diagnostics meeting, this summit gathers together key stakeholders from across the industry to examine how to turn biomarker research into successful patient stratification and deliver better, safer drugs to market with drug-diagnostic co-development. This premier event focuses on commercialization, cooperation and technical/scientific advances in predictive biomarker identification and CDx development.

His talk provided a framework for those interested in entering the space to use in assessing opportunities and will use case studies from real client work to help illustrate the key themes.

… into the clinical markets from their original life science markets is occurring rapidly, but not without major commercialization challenges for life science companies as they develop their strategies for a very different clinical market.

Kristin Pothier, Partner, delivered a presentation and panel discussion titled, “Transforming Translational Tools: The Commercialization of Novel Diagnostics from Life Science Technologies” at the 2012 Molecular Medicine Tri-Conference. The conference is a premier event focused on innovations in molecular medicine, diagnostics, and life science tools.

Panelists:

• Kristin Ciriello Pothier, Partner, Health Advances, LLC (Moderator)
• Nancy Krunic, PhD, Vice President, Molecular Diagnostics, Luminex
• Austin Tanney, PhD, Scientific Liaison Manager, Almac
• Pamela Swatkowski, Director, Regulatory Affairs, Abbott Molecular

Paula leads the firm’s orthopedics and spine practice, working with a broad client base from start-ups to large public companies involved in all aspects of the orthopedics industry. With the increasing cost containment pressures facing all of healthcare, which are weighing heavily on the orthopedics industry in particular, Paula and the teams at Health Advances are helping product and service companies, as well as investors in this sector, to think out-of-the-box and identify business models and strategies to create new and sustainable success. This involves conducting comparative effectiveness studies to quantify economic and clinical benefits, exploring applications for HCIT in their product and service businesses that can help provide differentiation and generate valuable information to guide their business strategy, or evaluating the financial impact of new business model ideas. Health Advances is also active in evaluating ex-US market expansion opportunities, developing clinical trial strategies for market penetration, pricing/reimbursement and market access strategies for new products preparing to launch or repositioning of marketed products that aren’t achieving their full potential. To learn more about Health Advances’ expertise in orthopedics, contact Paula at 781-647-3435.

The new office in Zug will continue Health Advances’ mission of ensuring its clients are making the best decisions and investments by providing knowledge-driven insights and recommendations on a global basis.

… Mara Aspinall of Ventana/Roche, Terri Clevenger of Continuum Health, and Hathaway Russell of Foley Hoag have launched Diagnostic Insights, an independent organization designed to educate on the impact of diagnostics in improving health care outcomes to the nation’s healthcare communities.

The presentation entitled, “Economics of Life Science Innovation and Personalized Medicine,” highlighted the business strategy, financial investment and costs associated with the global expansion of Life Science and Personalized Medicine. This conference brings together leaders across therapeutics and diagnostics to discuss the challenges and solutions to successful global commercialization of personalized medicine.

… “Genetic Test Offerings to the American Population” at the Personalized Medicine Conference at Harvard Medical School in Boston.

Topics for discussion included CVS and Medco’s commitment to making personalized medicine an integral component to their business plan and reasons behind the decision to offer genetic testing services to their customers; other large organizations that may be contemplating incorporating genetics into their business plan, the reimbursement landscape and how payers are thinking about molecular diagnostics. The panel was moderated by Troyen Brennan, MD, MPH, Executive VP & CMO of CVS Caremark.

The meeting was an opportunity to find nontraditional allies who can help companies advance their medical research goals, and a platform for solutions needed to accelerate progress.

Convened by FasterCures, a Center of the Milken Institute, this effort brought together more than 800 leaders from all sectors of the medical research enterprise, across therapeutic areas, and across geographic boundaries.

Marie provided expert consultation in strategic planning, specifically addressing strategic and business model issues including establishing planning guidelines and timelines, conducting strategic analysis and organizational assessments, setting or changing strategic direction, refining goals and methods, approaching collaborations (with both partners and funders), and mapping/measuring success.

Insights into the molecular and genetic basis of disease are driving new product and therapeutic opportunities while changing the treatment paradigm for many cancers. The use of companion diagnostics in oncology may play a role in optimizing and expediting the development of targeted therapies for many cancers and other conditions among validated patient populations. Promising improved treatment outcomes tailored to genetic etiology and disease pathology, the field of companion diagnostics not only ignites the interest of clinicians and investors, but is also spurring potentially lucrative industry partnerships. Focusing on these new markets, industry executives and investors discussed some of the most compelling new technologies and applications for companion diagnostics in oncology.

Moderator: Scott Allocco, President and a Co-founder, BioMarker Strategies

Panelists:

• Steven M. Anderson, PhD, Chief Scientific Officer of Oncology and Genetics, LabCorp and Monogram Biosciences
• Rollie Carlson, PhD, President, Asuragen, Inc.
• Alan Wahl, Senior Director Oncology, Global Pharmaceutical Research & Development, Abbott
• Vivek Mittal, PhD, Manager, Health Advances

The yearly event provides medical device and diagnostics executives with an opportunity to engage in critical discussions ranging from regulatory affairs and reimbursement, to IP and business development.

Kristin Pothier, Partner, delivered a presentation and panel discussion on Tuesday, September 27th from 10:45am-12:00pm titled, “The Business of Personalized Medicine: An Evolving Paradigm.” The presentation focused on personalized medicine and the collaborative models in existence today, discussed the advantages and disadvantages of each option, and highlighted the most attractive models for the future. Kristin was joined by a distinguished panel including:

• Dr. John Beeler, Director, Theranostics and Business Development, bioMérieux
• Dr. Karen Long, Divisional VP, Medical, Regulatory and Clinical Affairs, Abbott Molecular
• Dr. Elizabeth Mansfield, Director, Personalized Medicine, Office of In Vitro Diagnostics, Center for Devices and Radiological Health, FDA

A medtech executive’s job is to champion the Company’s product and technology, but unrealistic market expectations and imprecise descriptions of compelling value propositions across stakeholders can lead investors to prematurely discredit a solid market opportunity and handicap the Company’s ultimate commercialization strategy.

A panel of seasoned investors and executives joined Susan to discuss accurately assessing a product’s value across decision-makers and sizing the market opportunity to both effectively position a product for market success and/or a rewarding exit.

Panel:

• Wende Hutton, General Partner, Canaan Partners
• Mike Kleine, President & CEO, EndoGastric Solutions
• David Stoffel, MD, Senior Director, New Business Development, Intuitive Surgical, Inc.
• Susan Posner, Vice President, Health Advances, LLC

The AACC Annual Meeting is an excellent opportunity to participate in a variety of discussions and activities surrounding the clinical in vitro diagnostics industry. Health Advances hosted a reception, The Evolution of Translational Tools: The Promise of Life Sciences in the Clinical World focusing on the transition of research tools into the clinical laboratory. The event included an exciting panel with Rahul Dhanda of T2 Biosystems, Scott Garrett of Water Street Healthcare Partners, and Kevin Hrusovsky of Caliper Life Sciences and was moderated by Kristin Pothier, Partner, Health Advances.

…in order to realize the dream and vision of personalized medicine, much work remains to ensure that diagnostic tests are fully partnered with these new and unique therapies.

The Commercializing Companion Diagnostics Conference seeks to highlight critical success factors in making personalized medicine a reality.

Vivek Mittal, Manager, and Gary Gustavsen, Manager, presented on two key hurdles to achieving this goal:

Companion Diagnostics: Necessary Evolution of Medicine

Advancement beyond the diagnosis and treatment of disease based on broad clinical symptoms to identification and treatment of discrete patient segments based on similar molecular characteristics requires increasingly complex diagnostics. These diagnostics must be seen as the enablers to providing patients with safer and more efficacious therapeutic options. Advancing patient care must align economic incentives and reward both drug & diagnostic innovators.

• Recognizing diagnostics as enablers of novel therapeutics
• Changing the economic view for paired drug-diagnostic combinations
• Overcoming competitive risks of diagnostic development

Regulatory Perspectives on Clearance Routes for Companion Tests

Navigating a companion test through the unclear FDA regulatory process can seem impossible without first considering the proper pathway and timeline allowing for additional information to be presented to the FDA in order to support approval. It is important to understand what is expected by the FDA on all aspects of developing a companion test and also to realize the low re-sources the FDA has to regulate appropriately which leaves much of the process misunderstood on what is expected.

• Review of recent changes in regulatory standards enforced by the FDA
• Focus on proper steps and timeline of a regulated companion test
• Discussing FDA’s plans of an open guideline of what is expected
• Case study of a successful companion test approval through CDER

In addition to Kristin, the panel included Scott Allocco, President, BioMarker Strategies, LLC; David Parker, Ph.D., Vice President, Boston Healthcare; and Steve Phillips, Director, Health Policy and Reimbursement, Johnson & Johnson. Kristin presented the findings from the detailed report developed with BIO called The Reimbursement Landscape for Novel Diagnostics: Current Limitations. Real-World Impact, and Proposed Solutions. Co-author Gary Gustavsen, Manager was also in attendance.

This interactive workshop provided participants with a detailed view of the reimbursement landscape today as it pertains to personalized medicine diagnostics. The real-world impact of current limitations were analyzed including coverage, coding, and payment. Successful reimbursement strategies were also discussed. Then, through a series of interactive, facilitated breakout sessions, participants were led through the most promising proposed solutions to the current reimbursement limitations and weighed the relative benefits and disadvantages from various stakeholders’ points of view. Finally, Health Advances shared its insights for capturing the true value of personalized medicine diagnostics today and amid potential reform environments in the future.

…as they discussed product commercialization options and their impact on private company valuation. The panel generally agreed that a swing in the M&A environment has occurred over the last two years and companies should think twice before scaling up large sales and marketing infrastructures.

MassMEDIC is the only organization in New England dedicated solely to promoting the unique interests of the medical device industry. Susan’s election by MassMEDIC’s more than 300 member organizations reflects her contributions and commitment to the medical device industry. Susan will serve a three-year term with the organization and anticipates active involvement in advocacy with State and Federal government and the enhancement of MassMEDIC’s educational forums.

As a key member of the senior leadership team, Karen is responsible for directing a wide range of functional resources necessary to deliver the highest quality consulting services to Health Advances’ clients.

Karen comes to Health Advances with over 25 years in managerial, operational and financial management in both the public and private sectors. For the last decade, Karen served as the Chief Operating Officer and Chief Financial Officer for the Commonwealth of Massachusetts’ $50 billion Pension Reserves Investment Management Board. Karen earned her BA in Business Administration from Merrimack College. “We are exceptionally pleased that Karen has chosen to join Health Advances. Our clients have come to expect extraordinary service which requires that our consulting staff can confidently access our information infrastructure and IT platforms globally. Karen has the experience and management talent to help Health Advances maintain this strong service orientation while continuing to grow,” says Marie Schiller, Partner.

This workshop gave attendees a broad overview of the reimbursement landscape for novel diagnostics and armed them with strategies for navigating the field in the future. Health Advances drew on its recently published report with BIO to set the stage for an interactive discussion. The current challenges in coverage, coding, and payment were explored. Participants shared perspectives on the real-world impact of these limitations and successful strategies for reimbursement. Finally, the group analyzed proposed reform solutions and discussion the implications for key stakeholders.

The BayBio2011 Annual Conference attracted more than 1,000 life science professionals from around the globe.

Health Advances sponsored the Regulatory and Commercialization track. Vivek Mittal, PhD, Manager moderated an exciting panel discussion, “Integrating Product Development and Corporate Strategies” exploring how companies assess tradeoffs such as time, cost, probability of regulatory success and commercial regulatory potential when making development decisions.

Gary moderated the panel “Applying Lessons Learned in Oncology to Other Treatment Areas” at 8:00am and Kristin moderated the panel “Business Models in Personalized Medicine: An Evolving Paradigm” at 11:00am.

Kristin was part of a panel titled, “Expert Reimbursement Panel: The Changing Landscape of Valuation and Reimbursement”. The conference is a premier event focused on innovations in molecular medicine, diagnostics, and life science tools.

Each year, the AAOS meeting highlights important clinical issues and trends in the orthopedic industry that drive the future demand for medical products and services. Senior members of the Health Advances team regularly attend the leading orthopedic conferences, such as AAOS and NASS, as part of our ongoing commitment to stay up to date on changes to products, policies and practices in the field.

The Cancer Research Challenge presents an opportunity to create visible connections between science, medicine and patient health and to accelerate the pace of progress against cancer. Speakers include Joan Brugge, PhD (Louise Foote Pfeiffer Professor and Chair of Cell Biology at Harvard Medical School) and Ed Harlow, PhD (CSO, Constellation Pharmaceuticals) and Ulrik Nielsen, PhD (SVP and CSO, Merrimack Pharmaceuticals).

Following up from MassBio’s Personalized Medicine Summit last September, MassBio continues to promote the education, awareness, and business challenges surrounding personalized medicine, kicking off the 2011 season with this State of the Industry Event.

This event was designed to familiarize MassBio’s membership with the issues facing our industry regarding PM. Health Advances walked through the complexities facing personalized medicine especially as it impacts commercialization strategies within biomarker research, drug discovery and development, clinical diagnostics, and companion approaches.

Health Advances recently released a report with BIO on diagnostics reimbursement reform, a necessary step in the successful realization of personalized medicine.

The focus was on launching a biotech/pharma/device company in the current regulatory environment. Skip was joined by an impressive group of panelists which should lead to an interesting discussion.

Entrepreneurship Panelists:

• David Berry, Partner at Flagship Ventures
• Amar Sawhney , CEO and President at Ocular Therapeutix
• Robert Kamen, Entrepreneur-in-Residence at Third Rock Ventures
• Terry McGuire, Co-Founder and General Partner at Polaris Ventures
• Micah Rosenbloom, Co-Founder at Brontes Medical

Despite the regulatory, financing and health reform changes confronting our industry, aggressive executives are pursuing new opportunities presented by these changes. In his speech, “The Device and Diagnostics Industry: Where We Stand Today”, Mark Speers, Partner and Managing Director, discussed five reasons to be bullish about our critical industry’s future.

Effectively positioning your product with the right decision makers in the optimal market segments can catalyze adoption and set the foundation for broader use. Who are all the potential decision-makers and influencers? Is convenience a greater value driver than clinical effectiveness? How important is the safety aspect? How does the hierarchy of attributes vary by decision-maker? When will comparative effectiveness data impact adoption?

Susan shared examples of how successful products have developed new markets by engaging new decision makers and highlighting less obvious value propositions. Susan described the mapping of value propositions to decision makers and developing a road map for targeting sequential decision makers and market segments over time. The session also discussed when comparative effectiveness data will be most valuable in the future.

The AACC Annual Meeting is an excellent opportunity to participate in a variety of discussions and activities surrounding the clinical in vitro diagnostics industry including exploring novel biomarker development and innovative diagnostic technologies, networking with business executives, clinicians, laboratorians, and scientists, and attending the largest clinical expo in the world.

.” Clinical laboratory tests account for less than 2% of Medicare spending, but influence 70% of healthcare decisions. This statistic becomes even stronger with emerging companion diagnostics. However, most diagnostic test reimbursement today does not reflect the value of these technologies or the evolution of healthcare towards a more personalized system.

These and other issues are magnified for companion diagnostics, where questions on overall commercialization strategy and the ultimate ROI for companion diagnostic developers are paramount and differ depending on the developer’s point-of-view.

This interactive workshop allowed participants to understand the pain points of the current system from both a diagnostics development and a therapeutics development perspective. Participants received a detailed view of the state of companion diagnostic development today, saw tangible examples of recent successes and failures, and discussed the most common pain points from several perspectives. Participants were then led through the essential questions and resulting analyses that must be developed within all personalized medicine programs for therapeutics and diagnostics companies. Finally, Health Advances shared its insights for capturing the true value of companion diagnostics for all stakeholders in the future.

Skip Irving, Partner at Health Advances moderated the discussion. Federico Pollano, CEO of Richter-Helm BioTec, Dr. Mark McCamish, Head Global Biopharmaceutical Development of Sandoz International, and Dr. Shyam Bishen, VP, Corporate Development at Ranbaxy Pharmaceuticals joined Kimberly Howland, PhD, Vice President at Health Advances to offer their take on opportunities in the market and which companies have the best chance of success in this complex and expensive arena. During this highly interactive event, the audience had the opportunity to weigh in on whether biologics can generate a positive return, what the model for success looks like, which products offer the greatest potential for follow-on biologic penetration, where and how branded biologic companies will defend their position, and many more key issues surrounding follow-on biologics.

The Forum was held on May 3, 2010 at the McCormick Place Lakeside Center in Chicago, immediately preceding the BIO International Convention.

On Tuesday, May 4, 2010, Health Advances, in conjunction with BVGH, unveiled a new report, “Diagnostics Innovation Map: Medical Diagnostics for the Unmet Needs of the Developing World.” Paula Ness Speers, Managing Director and leader of Health Advances’ Global Health Practice and Kristin Pothier, Vice President and leader of the Diagnostics and Discovery Tools Practice, participated in the presentation of summary findings.

The Diagnostics Innovation Map explores some of the most innovative current and emerging diagnostic technologies and provides insight into how these technologies might be applied to developing world settings. The report clarifies the diagnostic requirements for resource-poor settings and explores how recent and emerging technological advancements in the developed world might be used to improve patient care and save lives in the developing world. The report provides:

An understanding of unmet diagnostic needs for neglected diseases and the performance requirements for diagnostics used in resource-poor settings
An overview of the value that novel diagnostics can bring to health care in resource-poor settings
Examples of innovative lab-based and point-of-care (POC) technologies and analysis of how these recent advances could address unmet diagnostic needs in the developing world
Resources to aid in forging new partnerships to accelerate the development of diagnostics for neglected diseases.
In addition to their presentation of the Diagnostics Innovation Map, Paula Ness Speers and Kristin Pothier participated in BIO’s One-on-One Partnering meetings, part of the Business Forum at the 2010 BIO International Convention. One-on-One Partnering is the world’s largest biotech partnering event, allowing companies to connect with investors, senior scientific and business management professionals and create opportunities for collaboration and innovation.

Kristin Pothier, Vice President
Developing, commercializing, and generating return on personalized medicine has been a dilemma for many stakeholders to date, as the success of each program is highly dependent on a number of factors that are not always aligned among different stakeholders. Therapeutics companies, diagnostics companies, and service providers each have different approaches and goals in helping bring personalized medicine to market. Now, more than ever, they are realizing the need for and positive impact of carefully crafting an internal personalized medicine strategy and working together in successful, mutually beneficial partnerships.

h5.Keynote Panel

A lively discussion with executives from leading therapeutics, diagnostics, and life sciences companies who have spearheaded personalized medicine initiatives and have found ways to collaborate effectively for maximum return.

Panelists:

• Iain Miller, Ph.D., Executive Director, Theranostics Strategy and Business Development, bioMérieux
• Steve Bushnell, Ph.D., Sr. Director, Discovery Translational Medicine, Biogen Idec
• Lee Babiss, Ph.D., Executive Vice President of Global Laboratory Services, PPD (formerly of GSK and Roche)
• Gary Gustavsen, Associate, Health Advances (moderator)
  learn more about Health Advances’ expertise in diagnostics.

The meeting will feature leading hematology experts who will present analysis of the ASH annual meeting abstracts, evolving therapies, and the latest treatment options. In addition, daily panel discussions and programs such as “Breakfast with the Experts” will provide the opportunity to discuss real patient cases with leaders in the field, gain knowledge that can impact patient care strategies, and network with colleagues.

The panel, presented by the Healthcare Club at HBS, was entitled “Venture Capital & Entrepreneurship — Will Policy Changes Kill Innovation in Healthcare?” Joining Skip on the panel were:

• Bonnie Fendrock, President and CEO, Hepregen Corporation
• Jeffrey Levin-Scherz, Principal, Towers Perrin
• Tom McKinley, General Partner, Cardinal Partners

Kristin Pothier, Vice President, Health Advances, addressed this topic on December 10th at the 2009 BIOMEDevice Forum in San Jose, CA. She was joined by Amy DuRoss, Vice President of Policy and Business Affairs, Navigenics; Leah Sparks, Sr. Director, Business Development, DNA Direct; and Sandra Lee, Ph.D. Senior Research Scholar, Stanford University. The panelists discussed how each has navigated through the regulatory, ethical, and business issues surrounding direct-to-consumer diagnostics, what their greatest drivers and barriers are today, and how these controversial offerings may change in the future.

“Partnering for Cures” was a first-of-its-kind meeting that brought together philanthropy, medical research foundations, and the biopharmaceutical industry in an effort to forge strategic collaborations key to the timely development of new medical solutions. In addition to attending the conference, Marie Schiller participated in a panel discussion entitled “Stories from the Front Lines of Philanthropy.” Panel members shared their thoughts on philanthropic investment and collaboration in the battle to conquer deadly diseases.

Speakers

• Dana Ball, Program Director
• David Panzirer – Trustee
• Melissa Berman, CEO & President for Rockefeller Philanthropy Advisors
• Marie Schiller, Partner – Health Advances
• Doug Melton, Harvard Stem Cell Institute
• Alan Lewis, CEO – JDRF

Health Advances has extensive experience in orthopedics. We have worked with clients on a variety of projects such as new product design assessments, market sizing for new orthopedic products, and pricing and reimbursement strategies prior to market launch. The firm also supports major transactions for strategic and financial clients interested in orthopedics products or companies by conducting due diligence for licensing or acquisition activities.

The reception preceded the MIT Enterprise Forum’s program titled: Vaccines & Global Health: New Technologies Create Global Opportunities.

Paula Ness Speers, Partner and Managing Director at Health Advances, leads the firm’s Global Health practice area, which works with a range of clients, including non-profit global health organizations and for-profit companies developing products with potential applications in the developing world.

Led by Kimberly Howland, PhD, Vice President, our California-based team is adding new consultants to better serve our diverse and growing clientele. “Health Advances leverages the clinical expertise and deep industry insight of professionals in both our East and West Coast offices to provide innovative, actionable commercialization solutions for our clients worldwide,” said Ms. Howland. To accommodate its growth, our West Coast office has moved to a new location:

201 Mission Street, Suite 500
San Francisco, CA 94105

Will a more cost-conscious healthcare system catalyze or impede the adoption of more POC testing? Which POC innovations will move the needle? What is the future of POC testing in the US and ROW? Some of the industry’s pioneers joined us for a lively debate on this topic during the year’s AACC in Chicago, IL.

Panelists:

• Kristin Pothier, Vice President, Health Advances (Moderator and Presenter)
• Kent Lewandrowski, Editor-in-Chief, Point of Care Journal
• David Lewis, Executive Director, Morgan Stanley-Research
• Robert Kunkler, Divisional Vice President, Business Development, Abbott POC
• John McDonough, CEO, T2 Biosystems
• Douglas Michels, President and CEO, OraSure Technologies
• Clinton Severson, Chairman, President and CEO, Abaxis

This premier genetics show will gather companies and organizations involved in DTC genetic testing, genetic research, healthcare, and law to discuss issues facing the field: best practices, how to navigate the healthcare system, scientific and technological advances, legal and regulatory challenges, and more.

… Pharma Business Strategies for Biomarkers. The webinar provided thought-provoking analysis of the evolving concept of how a biomarker may ultimately become linked to a diagnostic product opportunity — as a predictive test to select patients more likely to respond to a drug or class of drugs, or as a way to monitor a response to one. But diagnostics development costs are soaring with greater demands for validation from prospective clinical trials, and pharma companies have been reluctant to support these efforts. Where are diagnostics companies turning for support and funding? Which high-value opportunities can sustain a business? Is collaboration the answer, and if so, in what form?

Joining Kristin were Mickey Urdea, CEO of Tethys Bioscience; Rosanne Welcher, PhD, MBA General Manager & VP, R&D of The Dako Group; Iain Miller, Senior Director, Oncology Strategy and Theranostics, BioMérieux; and Peter Collins, Senior Vice President of Business Development, DxS

This two-day event brought together key players involved in investing, partnering, licensing, and developing business opportunities in the rapidly growing market for innovative healthcare products.

Drug Delivery and Diagnostics: Kristin Pothier, Vice President, Health Advances (Moderator)

Kristin assembled and led senior executives from Allegro Diagnostics, Genzyme Corporation, Infinity Pharmaceuticals, SeraCare Life Sciences, and BG Medicine on a panel discussion of “Drug Delivery and Diagnostics,” exploring how different companies are harnessing the power of drug/diagnostic convergence to push both innovation in the space and corporate objectives forward.

Joining Kristin on the panel were:

• Dan Rippy, President & CEO of Allegro Diagnostics
• Joan Keutzer, Vice President, Scientific Affairs, Genzyme Corporation
• John Evans, Director of Product Development, Infinity Pharmaceuticals
• Michael Steele, Vice President- Business Development, SeraCare Life Sciences
• Gregg Mayer, Vice President, Diagnostic Strategy, BG Medicine

Convergent Technologies Present Unique Regulatory and Clinical Challenges

Susan, along with David Fox of Hogan & Hartson LLP and Tom Hutchinson of Davol (CR Bard), led a discussion on the unique challenges posed by combination products and convergent technologies in the clinical pathway and regulatory processes. Susan offered her wide-ranging expertise in the device sector and discussed specific strategies that can be used along the regulatory and clinical paths to avoid pitfalls and maximize revenues.

For the fifth year in a row, employees of Health Advances contributed their time and talent to “Daffodil Days,” a major fundraising event for the American Cancer Society.

Marie was joined by panelists from the pharmaceutical industry to discuss due diligence in the transaction process, including buyer and seller perspectives and best practices. Marie’s expertise in guiding corporations through business and scientific analyses on product development, market positioning, and corporate strategy as well as her M&A experience complemented insights from these industry panelists: Janice Olson, VP of Program Management, Genzyme; Young T. Kwon, Director, New Ventures and Business Development, Biogen Idec; Philip T. Chase, VP of Legal, Alnylam Pharmaceuticals, Inc.; and Clare Fisher, Senior Director, Oncology Business Development, Genzyme Corporation.

Now, more than ever, hungry people depend on the local food pantries, soup kitchens, homeless and residential shelters, youth programs, senior centers, and day-care centers to which the Food Bank provides food. Health Advances employees loaded food boxes onto conveyer belts, inspected and sorted grocery products, and checked and labeled boxes for shipment to agencies. Health Advances is committed to supporting charitable organizations in the Boston area through its community service activities.

Like the Greater Boston area, the San Francisco Bay Area is a focal point for innovative biotech, medical device, and diagnostic companies. For over 16 years, Health Advances has been an integral part of the life sciences industry. We look forward to expanding our involvement in the vibrant biomedical community in California.

For the fourth year in a row, employees of Health Advances contributed their time and talent to “Daffodil Days,” a major fundraising event for the American Cancer Society.

The abstract is as follows: Biomarker diagnostics are the linchpin of personalized medicine. But building a successful business around such tests is anything but straightforward, given the complexities associated with both their development and commercialization. Today’s molecular diagnostic companies need to think carefully before they choose a “go it alone” strategy when developing a particular test. It may make more sense to forge a partnership with another diagnostic company or a drug developer with the goal of sharing costs and relative risks.

In joining the Board, Skip will provide ongoing support for the further pursuit of this strategy. The Michael J. Fox Foundation for Parkinson’s Research is dedicated to finding a cure for Parkinson’s disease within the decade through an aggressively funded research agenda.