Biopharma is a world of big rewards, and even bigger risks. Since 1992, biopharma companies have turned to Health Advances for business strategies that help maximize the former while minimizing the latter.
Because healthcare is our sole focus, Health Advances quickly integrates knowledge from a clinical, technical, and business perspective to create strategies that guide your most critical business decisions.
How We Help Your Business
Winning strategies. Real results.
Our Biopharma team of scientists, physicians, and industry experts has a deep working knowledge of the healthcare industry and its stakeholders. We tackle the challenges of drug development, market access, and commercialization. Our teams partner with clients to:
Translate emerging science into compelling products backed by actionable development and commercialization strategies.
Develop go-to-market roadmaps that anticipate the evolving healthcare market
Identify opportunities and implement strategies that maximize the value of franchises and companies
Examples
Here are some of the ways our Biopharma team is helping clients drive business value:
Vivek Mittal: “When an emerging biotechnology company with a promising tyrosine kinase inhibitor (TKI) suitable for multiple patient populations needed a strategy to maximize clinical development dollars, Health Advances was the firm of choice.”
Sheela Hegde: “Over the years, we have built an unparalleled wealth of insights and expertise in the diabetes space. When our client needed a global forecast for a Phase 3 diabetes asset in a very aggressive timeline, they came to us because they knew we could deliver a level of market analysis and insight that others could not.”
Gary Gustavsen: “We recently completed a large project for a major biopharma that further validated the need for a globally-orchestrated, but locally-tailored companion diagnostic strategy. The barriers to CDx adoption across markets are unique; every country needs its own set of tactics.”
Carrie Jones will Join a panel of experts from Parexel Biotech at BIO International in Boston.
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
Cell and gene therapies offer extraordinary hope to patients with advanced cancers and genetic diseases but pose unprecedented challenges for sponsors. In this report, Parexel experts share insights that can bring these complex treatments to market faster and more efficiently.
Where should healthcare companies list in Asia Pacific? What are the characteristics of healthcare listings on stock exchanges in Hong Kong, Shanghai, Shenzhen, Japan and Korea? Explore key insights and trends from the 5-year listing history in this whitepaper. Read here.
By Jim Anthony, Parexel and Mike Davitian, Health Advances
A key insight from our recent survey of biotech R&D execs: Integration of commercial and regulatory strategy needs to begin earlier in the development process. Read here.
Yajie Li, Vice President Technical, Parexel Regulatory and Access Consulting; Gary Cheng, Vice President, Health Advances; Eric Woo, Senior Analyst, Health Advances; Chao Wang, Scientific Data Strategy Leader, Parexel
As China has become the world’s second-largest economy and the largest developing country, its economy and market have assumed a prominent position in the Asia-Pacific region. The pharmaceutical industry is an important part of China’s national economy, with continuous strong demand, need, and capability for innovation. The industry continues to experience high levels of growth. With China’s increasing emphasis on the pharmaceutical industry, and the gradual improvement of healthcare policies, momentum supporting the development of China’s pharmaceutical market continues to accelerate. Read here.
Biotech companies are a significant driver of innovation in drug development today, with a pipeline growing sharply in recent years. This growth provides hope for patients across many therapeutic indications. It also provides an avenue for future investment by financial institutions, industry partners, and investors. For the last two years, the financial market has supported biotechs with record-shattering funding. Read here.
By Jeff Bessen, Yinzi Liu, Christie Hung, Ned Wydysh, and Vivek Mittal
CRISPR-based gene editing technology is differentiated from other modalities, even traditional gene therapies, unlocking potential cures for a range of indications but also presenting unique developmental challenges. Devising a portfolio strategy for CRISPR-based gene editing therapies requires considering the novel therapeutic potential but also the technical, clinical, and commercial complexities. In this white paper, Health Advances proposes a framework for indication selection and portfolio strategy for CRISPR-based gene editing companies based on a range of factors including unmet need, level of competition, and addressable market size. Read here.
The development and commercialization of novel biopharmaceutical products in recent years has continued to offer more safe and efficacious treatment options for patients across therapeutic areas. While a good proportion of the world’s transformative drug development and early commercial resources for novel therapies are focused in the United States, the level of drug innovation in the rest of the world has begun to shift. In the past decade, Japan and China have invested in regulatory reform and established policies to increase drug innovation within their respective countries. Read here.
Health Advances Vice President Holger Müller, along with other participants Julius Ueckermann, Svyatoslav Miroshnik and Pawel Sieczkiewicz, will speak about most actual problems in #healthcare and #digitalhealth.
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
Gary Gustavsen, Kelsey Taylor, Doria Cole, Laura Gullet and Nicolas Lewine
Prior studies have established that broader incorporation of active surveillance, guided by additional prognostic tools, may mitigate the growing economic burden of localized prostate cancer in the USA. This study sought to further explore the potential of a particular gene expression-based prognostic tool to address this unmet need. Materials & methods: A deterministic, decision-analytic model was developed to estimate the economic impact of the Prolaris® test on a US commercial health plan. Results & conclusion: When adopted in patients classified by the American Urological Association as low or intermediate risk, the assay was projected to reduce costs by $1894 and $2129 per patient over 3 and 10 years, respectively, largely through the increased use of active surveillance. Read the article here. Read an interview with Gary Gustavsen, Partner at Health Advances, about the article.
05.20: :Journal of Vascular Surgery: Venous and Lymphatic Disorders
Thomas F. O’Donnell, Jr., MD, Jessica Izhakoff (Health Advances), Julia A. Gaebler, PhD (Health Advances), Timothy Niecko, MS, Mark D. Iafrati, MD
The purpose of this study was to define the current forms of treatment in lymphedema patients with breast cancer (BCRL) and venous leg ulcers (PLEDU). Our analysis of a large administrative claims database showed clear differences in treatment between each group, suggesting lymphatic therapy may be undervalued for treatment of chronic venous swelling and prevention and treatment of PLEDU.
09.19: Journal of Vascular Surgery: Venous and Lymphatic Disorders
Andrew Son, MD, Thomas F. O’Donnell Jr, MD, Jessica Izhakoff, BS (Health Advances), Julia A. Gaebler, PhD (Health Advances), Timothy Niecko, MS,and Mark A. Iafrati, MD
Lymphedema (LE) has been called the forgotten vascular disease, given such scant knowledge about LE-associated comorbidities or causes. Such knowledge of the comorbidities and treatment of LE may assist in diagnostic decisions and health care planning.
Amanda Sani, Divya Harjani, Tara Breton, Ned Wydysh, and Vivek Mittal
To anyone watching, the story of rising healthcare costs in the US is not a new one. Prescription drug prices in particular have made headlines in recent years, from outrage over the 56-fold increase of anti-malarial drug daraprim, to controversy over the steady rise in price of EpiPen packs used to quell life-threatening allergic reactions.
Mike Davitian, Haley Fitzpatrick, Grace Perkins, Tara Breton, Remy Denzler, and Dean Giovanniello
Launch planning is critical for the long-term commercial success of a drug product. Health Advances distills launch planning best practices learned from prior experience and illustrates the importance of those best practices with cases studies.
Adam Cohen, Engagement Manager, Health Advances; Julia A. Gaebler, Partner, Health Advances; Jessica Izhakoff, Consultant, Health Advances; Laura Gullett, Senior Analyst, Health Advances; Timothy Niecko, MS, Niecko Health Economics, LLC and Thomas O’Donnell, MD, Tactile Medical
To assess the budget impact to a US commercial health plan of providing access to the Flexitouch (FLX) advanced pneumatic compression device (Tactile Medical) to lymphedema (LE) patients with either comorbid chronic venous insufficiency (CVI) or frequent infections.
Michelle Lerman, Engagement Manager, Health Advances; Julia A. Gaebler, PhD, Partner, Health Advances; Sunday Hoy, Esq, Tactile Medical; Jessica Izhakoff, Senior Analyst, Health Advances; Laura Gullett, Senior Analyst, Health Advances, Timothy Niecko, MS, Niecko Health Economics, LLC; Pinar Karaca-Mandic, PhD, University of Minnesota, Carlson School of Management; Thomas O’Donnell, MD, Tactile Medical; and Stanley G. Rockson, MD Falk Cardiovascular Research Center, Stanford.
Phlebolymphedema (chronic venous insufficiency-related lymphedema) is a common and costly condition. Nevertheless, there is a dearth of evidence comparing phlebolymphedema therapeutic interventions. This study sought to examine the medical resource utilization and phlebolymphedema-related cost associated with Flexitouch (FLX; Tactile Medical, Minneapolis, Minn) advanced pneumatic compression devices (APCDs) relative to conservative therapy (CONS) alone, simple pneumatic compression devices (SPCDs), and other APCDs in a representative U.S. population of phlebolymphedema patients.
By Brendan Loftus, Wyatt Gotbetter, and Julia A. Gaebler
In recent years, the growth in U.S. drug spending has become a hot-button issue. Data released in 2017 by the pharmacy benefit manager (PBM) Express Scripts illustrates which drugs account for the increased spending. 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.
Zach Donnell, Divya Harjani, Amanda Sani, Ned Wydysh, and Vivek Mittal
CAR-T cell therapy is currently one of the most exciting areas of clinical research. To create these living therapies, human T cells are genetically modified to express a CAR (chimeric antigen receptor) that has been programmed to target specific antigens found on the surface of cancer cells.
Kelly Cockerill, Andrew Funderburk, Sheela Hegde
and Julia Gaebler
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. The white paper indicates that patient prevalence is highly correlated with orphan drug pricing in Europe, highlighting the importance of budget impact to payer decision-making.
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. The objective of this white paper is to describe recent trends in the use of the FDA’s accelerated pathways and to examine the market advantage associated with these pathways, particularly in oncology.
“Health Advances delivered a comprehensive evaluation of our key assets and helped to drive the creation of a focused business development strategy to accelerate the achievement of our scientific and business objectives.”
Vivek Mittal, PhD
Sheela Hegde
Gary Gustavsen
Balazs Felcsuti
Carrie Jones
Gary Cheng
Michael Davitian
Ned Wydysh, PhD
Kelly Cockerill
Dr. Marcus Koch
Juan Camilo Roman
Mark Speers