Rheumatoid Arthritis – Clinical Development
Clinical Development: Working with the product planning and clinical development groups of a large pharmaceutical company, Health Advances identified and interviewed key opinion leaders in rheumatoid arthritis to advise the company on the prospects and clinical trial design of a new molecule in preclinical development and assembled a panel of thought leaders for a six-hour focus group held with representatives from the company. As a result of the project, the company significantly revised its clinical development program to generate more substantial preclinical data prior to proceeding into the clinic.
Rheumatoid Arthritis – Product Strategy
On behalf of a large biotechnology company, Health Advances designed a conjoint study and survey to assess rheumatologists’ anticipated use of novel treatments for rheumatoid arthritis. The study assessed rheumatologist trade-offs between multiple new therapies expected to enter the market in the near future, including new biologics, follow-on biologics, and novel small molecule treatments.
Multiple Sclerosis – Franchise Strategy
Health Advances completed a franchise strategy optimization for a company’s neuro-immunology division. Health Advances worked with senior management to define the vision, strategy, goals, and metrics for the franchise moving forward. As part of this process, Health Advances investigated and prioritized activities within five key strategic initiatives and proposed recommendations along with short and mid-term action plans.
Multiple Sclerosis – Biosimilar Commercialization
Health Advances worked with an emerging biosimilar manufacturer to develop a commercialization strategy for a biosimilar interferon-beta in the US and EU. Health Advances conducted interviews with physicians, payers, pharmacists, wholesalers, regulatory experts, and industry experts to understand the spectrum of issues that will accompany a new biosimilar launch. In particular, we sought to understand the relevant stakeholders in each country and how best to engage with each to ensure success. The end result was the identification and prioritization of market-specific success factors and action steps for our client to use when developing the launch plan for their product.
Psoriasis – Formulation
On behalf of a biotech company, Health Advances assessed the potential impact of delivery format on the roll-out and acceptance of an infused drug for psoriasis. In addition to the US market, hurdles and opportunities relating to the logistics of the product’s potential use in France and Germany were also identified. A detailed understanding of the approval and adoption practices within these countries was crucial to outlining the how the client could maximize adoption of its product in a market that historically had few or no infusion-based therapies.
Crohn’s Disease – Forecasting
Health Advances created a patient flow forecast model of Crohn’s disease in the US, 5EU, and Japan to support a large pharmaceutical company’s clinical development program. Model assumptions were based on market research reports, interviews with gastroenterologist and rheumatologist KOLs, and a detailed analysis of clinical literature, pipeline compounds, and clinical trials. A "lines of therapy" framework was used to define a patient transition matrix with numerous positions for a new therapy to penetrate to allow for a flexible, scenario-based model.
Systemic Lupus Erythematosus – International Market Assessment:
Health Advances worked a large pharmaceutical company to conduct a comprehensive evaluation of the market for systemic lupus erythematosus (SLE) and lupus nephritis therapies in the US, EU, Japan and China. Working with the company we developed a perspective on the opportunity and potential fit for SLE in the broader strategy. Over 75 interviews were conducted in the US, EU, Japan and China with both thought leaders and practicing rheumatologists. “Patient flow” interviews reviewing specific patient charts were utilized to accurately capture real treatment practice. A detailed forecast model was developed and future therapies and clinical development challenges were evaluated in depth.
CAD and PVD
Health Advances was asked to help a client identify key competitors in coronary artery and peripheral vascular diseases. Looking at the client's marketed products and those in development, we outlined clinical trial attributes necessary to position the client's products favorably from both a physician and payer prospective.
Market Sizing for a Novel Mechanical Thrombus Ablation Device
To create a development strategy for a client with a novel mechanical thrombus ablation device, Health Advances explored four target indications: DVT, peripheral arterial disease, hemodialysis clots, and coronary thrombi. Extensive secondary and primary research revealed the unmet needs, referral patterns, decision-making process and reimbursement environment in each clinical area. This allowed the Health Advances team to develop a detailed market segmentation and sizing which, along with clinical development considerations, formed the basis for the strategic plan.
Vascularization in Refractory Angina
Health Advances was asked to assess the unmet needs in induction of vascularization in refractory angina and to determine the relative enthusiasm among physicians toward procedures inducing mechanical injury compared to novel angiogenic therapies. Feedback from cardiologists, interventional cardiologists, and cardiac surgeons informed clinical trial criteria and directed a development plan incorporating both methodologies.
Reformulation of a Beta-Blocker
Health Advances was asked to evaluate the opportunity to enter the large but crowded beta-blocker market with a once-daily formulation of one of the market-leading compounds. A key issue in positioning our client's product was that the branded compound was also being launched in a daily formulation. While our client's product would have some modest advantages, understanding formulary and reimbursement issues was essential in determining the degree to which the proposed advantages would overcome an established brand presence in addition to competition from lower-priced generics.
Cellular Therapies in Cardiac Indications
A large public company sought to develop a clinical trial development plan for cellular therapies in cardiac indications. Health Advances used a thorough investigation of relevant cellular therapy literature to assist application prioritization and benchmarking trial parameters. Extensive interviews with cardiovascular and cell therapy experts were used to determine relevant patient segments for the high-priority indications.
P-Selectin Inhibitor for Vascular Diseases
A start-up company engaged Health Advances to analyze multiple vascular diseases including sickle cell anemia, deep vein thrombosis, ischemic reperfusion injury, and vascular restenosis for potential applicability of a P-selectin inhibitor. The Health Advances team examined market size, unmet need, competition, trial feasibility, and the role of P-selectin in disease etiology in order to determine the best development strategy for our client.
Development of a CNS Entry Strategy
Health Advances assisted a large pharmaceutical company interested in increasing its CNS presence through licensing and acquisition with a comprehensive review of the CNS space and the development of a CNS strategy. After reviewing the spectrum of CNS indications, Health Advances conducted interviews with top thought leaders and completed a scientific/clinical literature review in order to perform a deep and careful investigation into six high-priority areas: Alzheimer's, Parkinson's, schizophrenia, neuropathic pain, insomnia, and depression. This investigation evaluated targets, mechanisms, and pipelines for clinical utility and commercial potential. We also identified key unmet needs and the state of current clinical practice for each disease.
Health Advances assisted a large public company in preparing a commercial development plan for acute ischemic stroke. At the time of the project, the client's product was in late stage clinical development and was expected to receive FDA approval shortly thereafter. Health Advances interviewed numerous cardiologists and neurologists with experience as investigators in clinical trials for ischemic stroke. Integrating unmet needs, competitive positioning, development timing, and possible label claims, the Health Advances team refined the product development plan.
An esoteric reference lab asked Health Advances to investigate the utility of various esoteric lab tests marketed to neurologists to facilitate differential diagnosis of diseases exhibiting similar symptoms such as muscular dystrophy versus ataxia. The project forecasted the demand for the high-margin panels in light of changing referral patterns, managed care pressures, and pioneering therapeutics in development.
Neurotechnology for Brain Stimulation
An early-stage company was developing a neurotechnology device to detect neural signals and stimulate the brain. The primary application was spinal cord injury but the technology was applicable to many other disease areas. The client asked Health Advances to help determine the first group of applications upon which it should initially focus, the most interesting of which was Alzheimer's disease. All potential applications were screened and 10-12 indications were prioritized for initial development.
Health Advances worked with a client on the formation of a new company to complete the development of a novel compound that could potentially slow progression of Parkinson's disease. In addition to examining the market opportunity, we also explored issues around the predictability of preclinical disease models, the utility of disease scores for evaluating clinical performance, and other possible endpoints for clinical development.
Health Advances developed a detailed commercialization plan for a novel agent targeting psoriasis. The plan highlighted the market opportunity, product positioning strategies, clinical trial plans, and sales and marketing requirements for the novel agent. The company used the Health Advances analysis to support business development activities and maximize the value of the program.
Platelet Concentrators for Wound Healing
As part of an acquisition candidate search, Health Advances evaluated the market dynamics surrounding platelet concentration systems in plastics and musculoskeletal surgeries. The study considered use of Platelet Rich Plasma (PRP) as a wound healing sealant, soft-tissue growth factor, and as an agent to augment bone repair.
Laser-Based Acne Therapy
Health Advances investigated both the reimbursed path and the self-pay path for a novel laser-based therapy intended to displace some of the most expensive drug regimens. Although acne is a covered medical necessity, we discovered that it would be better for the company to rely on self-pay patients.
Laser-Based Therapy Onychomycosis
Health Advances evaluated the commercial potential for a novel laser-based treatment for onychomycosis. The project included in-depth physician interviews, rigorous competitor analysis, and market sizing.Health Advances evaluated the commercial potential for a novel laser-based treatment for onychomycosis. The project included in-depth physician interviews, rigorous competitor analysis, and market sizing.
Product for Treatment of Diabetic Foot Ulcers
Health Advances conducted due diligence on a product used in diabetic foot ulcers. Primary research with users focused on determining the decision-making process in choosing wound healing products and identifying current treatment paradigms.
Relationship with Juvenile Diabetes Research Foundation
Health Advances has an ongoing relationship with the Juvenile Diabetes Research Foundation (JDRF), working directly with the Board of Directors and research management team to ensure research investments are optimized and the funding portfolio is properly balanced to achieve JDRF's goals. Health Advances initially developed the long-term strategic plan for JDRF's research team in 2006.
DPP-IVs Inhibitors - Brand Strategy
A large pharmaceutical company asked Health Advances to help it understand how a novel DPP-4 inhibitor in Phase II should be positioned in the marketplace, depending on the outcome of the clinical studies that were still in progress. Health Advances developed a 3x3 matrix with nine different product profiles, reflecting different outcomes from the trial program. For each product profile, a positioning statement and key marketing messages were developed in the form of a "message ladder." This tool helped to illustrate how each one of the nine profiles could be positioned in a way that made the product look attractive and its profile clinically relevant.
Insulin - Lifecycle Strategy
Health Advances worked with a large pharmaceutical company to develop a 10-year perspective and portfolio strategy for its diabetes franchise. Health Advances developed a worldwide insulin market model based on data from 28 countries to understand key product share dynamics and to forecast market opportunities. Implications from this analysis were used to prioritize portfolio initiatives and secure funding for key programs.
Insulin Delivery and Continuous Glucose Monitoring - Growth Strategy
Leveraging its strong foundation in delivery systems and glucose monitoring, Health Advances assisted a major pharmaceutical company with an assessment of the influence of insulin pumps and continuous glucose monitoring (CGM) on the competitive dynamics of the insulin market. Health Advances quantitatively modeled the financial impact of a number of strategies, including potential partnerships with major insulin pump and CGM companies.
Obesity - Customer Analysis and Market Forecast
A clinical-stage biotechnology company developing a product to minimize a common side effect of many obesity drugs asked Health Advances to provide a comprehensive overview of the current and future obesity market. This analysis provided the foundation for developing the clinical trials, brand positioning, and a potential partnership strategy.
Surgical Approach to Obesity and Diabetes Management - Commercialization Strategy
Health Advances developed the commercialization strategy for a venture-backed company developing a less invasive surgical approach to treat obesity. A key finding shifted the strategy of the company towards the segment of obese patients with type 2 diabetes. The business plan has been used by the company to successfully raise $50MM from top-tier venture capital companies.
Diabetic Neuropathy - Development Strategy
A large biotechnology company developing a novel agent for peripheral neuropathy requested that Health Advances review its brand strategy for the diabetic neuropathy indication. This product was one of the first drugs in development with the potential to modify disease progression. Key focal points were a customer segmentation analysis and an assessment of the rational and emotional arguments that could be supported through pivotal and post-market clinical studies.
Tissue-Engineered Product for Bladder Reconstruction
The client asked Health Advances to investigate the market potential for its tissue-engineered product in bladder augmentation and bladder reconstruction. The main indications for these procedures were neurogenic bladder arising from spinal cord injury, multiple sclerosis or spina bifida, and bladder cancer. A pricing analysis was used to determine potential pricing, including current economics for these procedures and associated complications from both the hospital and the payer perspectives. The Health Advances team used several market examples to determine likely adoption rates for this type of product, including cadaveric fascia for pubovaginal sling and InterStim for urge incontinence.
Radiopharmaceutical Diagnostic for Prostate Cancer
Health Advances determined the US commercial potential for a public company's novel radiopharmaceutical used in the diagnosis and monitoring of prostate cancer. We used primary and secondary research to understand the current diagnostic standard of care for prostate cancer, provide details on relevant patient segments, and determine the greatest unmet needs for each segment. We also determined the potential penetration of the radiopharmaceutical into the diagnostic paradigm and developed detailed stacked incidence models of patient segments and preliminary revenue projections.
Health Advances studied the market for a currently marketed medical device to treat prostate cancer to determine how to achieve broader market penetration. Our team assessed product positioning as a first-line alternative treatment versus a second-line therapy for treatment failures. The study involved interviewing both current users and non-users to determine current perceptions of product positioning and use, and assessed the opportunity for growth and the likely requirements for penetration (clinical trials, etc.) in other indications not yet targeted by the client.
Novel Dialysis Product
Health Advances conducted a system economics analysis for a novel product intended to treat dialysis patients. This product would be used in conjunction with current continuous dialysis treatment to augment the performance of dialysis and more closely mimic the true functionality of kidneys. The analysis was built on a large dataset obtained from a major health system. This provided detailed charge and reimbursement information on the major cost drivers of managing dialysis patients and the costs when problems arise and they are hospitalized. Using inputs from physicians involved in the development of the novel product, expected benefits were outlined and modeled into a range of economically justifiable prices to consider for the future introduction. The specific price could be selected once trials were completed and the actual performance was documented.
Applications for an Antimicrobial Product
An early-stage client recognized that an antimicrobial industrial product may possess valuable healthcare capabilities. Health Advances evaluated thirteen applications ranging from oral mucositis to onychomycosis. The evaluation included understanding the role of pathogens, unmet needs, and developmental requirements. Using this analysis, Health Advances developed a blueprint for the client's healthcare enterprise, which led the client's Board to appropriate several hundreds of thousands of dollars for preclinical work.
Identification and Prioritization of Target Medical Devices for a Novel Antimicrobial Coating
A large public client was committed to developing an antimicrobial coating for a broad range of devices. Health Advances initially evaluated dozens of conceivable applications, from coatings on disposable diapers to heart valves. The analysis quickly focused on four applications and these were then further prioritized based upon manufacturability, clinicians' perceptions of the devices' roles in the infection process, and the value-based premiums that each could capture. The initially targeted product has been successfully commercialized and the organization is now working on expanding the core technology and base product into a wide range of related products for analogous indications.
Genomic-Based Infection Detection
With the goal of rapid diagnosis of infectious agents in the hospital setting, our client developed a novel DNA-based bacterial fingerprint system. Health Advances conducted an extensive interview program with hospitals and infectious disease experts to understand how they diagnose and treat many of the major infections seen in the hospital setting. We worked with the client to determine the value of a rapid test from a clinical and economic perspective.
Market Assessment for a Novel Antibiotic Therapy:
Health Advances worked with a private early-stage company focused on developing novel antibiotics using structure-based design. We help our client to identify potentially attractive market opportunities in the hospital and community setting based on unmet needs, market size, and segmentation of the current antibiotic market, antibiotics in the clinical pipeline, anticipated treatment trends, and hospital formulary decisions.
HIV Vaccine Development Planning
Health Advances was asked to take a top-level look at a client's HIV vaccine program as part of a company-wide portfolio reassessment initiated when a new president was appointed to the company. This review examined the client's technical progress versus that of competitors, funding sources, likely continued commitments from those sources, and synergy with the company's other products in development.
Business Unit Strategy
The team worked with the Bio-discovery division of a large life sciences company to help set the division's strategy for the next 3-7 years. In addition to extensive secondary research, the team interviewed academic, CRO and industry researchers in the US, EU, China, and India across a range of disciplines including mass spec, flow cytometry, genomics, biomarker discovery, HTS, and HCS. The team identified target acquisition candidates and developed an execution strategy for building a business that would address major unmet needs from basic research to translational medicine.
Health Advances worked with a large life sciences tools company to develop a total market potential for stem cell derived cells for drug discovery and screening applications. A detailed primary research program with top scientists at leading pharmaceutical and biotech companies was used to determine likely positions of stem cell derived products as well as cellular requirements for screening campaigns. Health Advances worked closely with the company's stem cell strategic initiative planning group to incorporate these findings into their overall strategy.
Facilitated a major strategic objective to identify synergistic product opportunities and subsequent product packaging for the senior management teams of two large life sciences companies in the process of merging. Through a series of facilitative meetings with both senior management teams, Health Advances identified, analyzed, and presented the most favorable synergy opportunities for various functional groups within both organizations. Deliverables included a qualitative interview program with customers, extensive secondary research, participation and facilitation of key team meetings, market models for select teams, detailed financial models for each synergy opportunity, and presentations prepared and presented for each meeting throughout the project.
Conducted commercial diligence on a clinical CRO for a group of private investors. The team participated in several management meetings with the target, conducted in-depth interviews with CRO customers and industry executives and extensive secondary research to understand the trends in clinical outsourcing and the relative positioning of the target to act against these trends. The team developed a robust demand forecast model to assess how the outsourced market would change over time by therapeutic area, phase, molecule and company type. The team combined these analyses to help inform the client's successful bid during the auction process.
Go-to Market Strategy
A large CRO client historically focused on GLP-level preclinical animal studies was interested in understanding the opportunity to offer non-GLP discovery services. Health Advances conducted an extensive internal research program to understand the company's strengths/weaknesses, the current approach to handling such requests, and general organizational opinion of the opportunity. We also conducted interviews with customers, KOLs, and competitors to understand the relative demand for discovery services and the types of models that would be relevant and possible for a CRO to offer. We worked closely with the client to develop a document outlining the key investments to make, services/model to offer, and potential acquisition targets to build the business.
Business Unit Strategy
Conducted a market assessment and evaluated market strategies within drug discovery and clinical biomarker services for a large life sciences company with a discovery services business. By targeting director-level customers and outsourcing decision-makers within pharma and large biotech, we provided the company with specific detail around the current use and demand for drug discovery and clinical biomarker services, the major unmet needs, and future trends. With this information, we developed a strategy to address the services space that matched the industry needs and leveraged the company's strengths.
Business Development Strategy
Health Advances reviewed the basic research portfolio of a medical school and associated academic medical center to evaluate and identify individual translational research programs that could be leveraged to increase the level of industry sponsorship for the institutions. The potential of grouping individual faculty's research programs into multi-faculty platform areas that could provide "bench-to-beside" translational science capabilities was also evaluated. In addition, recommendations were made about the internally and externally focused tactics the university/medical center could pursue to enhance industry funding.
Working with a non-for profit, independent academic research institute, Health Advances evaluated a number of different sustainability models for the organization to facilitate development of an approach that would facilitate moving research discoveries and inventions through the translation gap to the market to ensure patients have access to the best care and an approach that would allow sustained funding of future research programs. Programs for drug candidates, software packages, research tools and reagents, and education programs were evaluated.
Health Advances developed positioning strategies and pricing recommendations for product line extensions in trauma, spine, and degenerative disc disease populations. Qualitative interviews and a quantitative analysis including conjoint were used. The study considered competitive threats from all the existing competitors as well as likely new entrants.
Bioresorbable Bone Cement
A private early-stage company was seeking to better understand the market opportunity for its bioresorbable bone cement. Heath Advances outlined which indications would provide the best lead candidate versus the best overall market opportunity. The assessment covered market sizing in cranio-maxillofacial, dental, spinal, and general musculoskeletal markets.
Musculoskeletal Implant Components
Health Advances worked with a private equity firm to evaluate an acquisition in the musculoskeletal implant component market. The study assessed the evolution of materials and designs likely to grow and shrink in the next ten years. This assessment helped project the market demand for the subset of components made by the target company and provided insights into which OEM customers were best leveraged to target for increased sales and those that were likely to decrease orders due to design and material changes.
Corrective Procedures for Treatment of Damaged Knee Cartilage
Health Advances identified and analyzed a large research database developed by a leading musculoskeletal surgeon to assess the frequency of different corrective procedures for damaged knee cartilage and their outcomes. The Health Advances team captured quantitative and qualitative measures of outcomes, including timing to subsequent treatments. This information was combined with findings from musculoskeletal surgeon interviews to document current clinical pathways by patient segment. Subsequently, the economics of a novel therapeutic procedure were quantified, assuming a range of clinical success rates as documented in the database and published literature. This work was included in the BLA filed with the FDA, which was approved.
Diagnostic for Soft Tissue Musculoskeletal Injuries
Health Advances was asked to assess the annual market size of soft-tissue musculoskeletal injuries in terms of volume of tests, to examine the potential cost effectiveness of the device in different patient populations, and to test the concept of a MDSN strategy, whereby the client would establish provider networks to address patients with musculoskeletal injuries and to boost use of the client's device. This diagnostic was initially being used to evaluate the source of cervical and lumbar pain, both where the problem was and as a way to identify malingerers who really did not have a problem (a concern with prolonged workers' compensation cases).
Osteoporosis and Estrogen Replacement
Working closely with an investor group, Health Advances supported a market evaluation and planning effort for a new company to be formed around breakthrough technology targeting the estrogen receptor and its role in osteoporosis. In addition to addressing some of the technical questions underlying the opportunity, Health Advances also examined the role of estrogen replacement therapy in post-menopausal women, the potential impact of the Women's Health Initiative Study, and competitive product development efforts.
On behalf of a financial investor, Health Advances created a five-year risk-adjusted global revenue forecast for a blockbuster oncology drug. The team conducted in-depth interviews with opinion leaders in the US and Europe to understand the drug’s potential across multiple indications and treatment settings.
Health Advances worked with a major medical device company to conduct an in-depth analysis of the oncology ablation market to inform the client’s strategic options going forward. The project outputs included a market sizing analysis with detailed segmentation in both the US and EU, and an in-depth evaluation of current and emerging technologies.
As a novel cancer agent was completing Phase III studies targeted at three cancers: colon, lung and breast, Health Advances conducted a detailed analysis leading to the recommended launch price taking into consideration the potential product positioning in current and future indications.
Clinical Trial Planning
Health Advances worked with a non-profit disease foundation to identify ways to streamline and enhance the outcomes of clinical trials in multiple myeloma. The team analyzed over 100 ongoing and proposed multiple myeloma trials and spoke with leaders in industry, academia, and the FDA to identify best practices.
Health Advances worked with the business development team at a specialty pharmaceutical company to identify and analyze potential acquisition targets to supplement the company’s early-stage pipeline. The team developed a rigorous set of acquisition criteria and used them to identify attractive assets and prioritize therapeutic markets for entry.
Health Advances was asked to perform strategic due diligence for a large pharmaceutical company looking to grow its oncology franchise through the acquisition of a novel therapeutic cancer vaccine. Health Advances conducted a detailed analysis of the market to predict the competitive position of the therapy, understand the logistical issues surrounding commercialization, and conducted a study of pricing and reimbursement to inform the financial forecast.
The Competitive Intelligence group of a large biotech client asked Health Advances to analyze how three competitive programs in development for hormone refractory prostate cancer would impact the competitive positioning of the client’s molecule. The team developed detailed profiles on each drug, including current clinical trial status, previous results, likely positioning, and expected resources dedicated to further development and marketing.
Health Advances provided a full commercialization strategy for a device for intraoperative margin assessment in breast cancer lumpectomies. The team assessed the potential market by segment and the likely reimbursement for the technology, and recommended clinical, pricing, and sales strategies.
Device-Based Glaucoma Therapy
A client engaged Health Advances to determine the market size and segmentation for a novel device to treat glaucoma. Health Advances quantified the economics of the entire range of glaucoma diagnostics and treatments from the perspectives of payers, doctors, patients, and facilities.
Diagnostic for Diabetic Retinopathy
Health Advances worked for a venture-backed company to assess the state-by-state reimbursement potential for a novel diagnostic with a complex revenue generation model. The Health Advances team developed the investor road show characterizing the opportunity and estimating market potential.
Novel Therapy for Improving Night Vision
Health Advances tested product concepts for a novel therapy for night vision with thought leaders and practitioners, including ophthalmologists and optometrists. A detailed model projected the potential market size, considering likely penetration into different patient segments and pricing potential for the therapy in the US market.
Cataract and Refractive Surgery Devices
Health Advances conducted due diligence for a private equity investor on a manufacturer of equipment and disposables used in cataract and refractive procedures. The Health Advances team also investigated the competitive landscape and emerging technologies through secondary research and primary interviews with ophthalmologists in the US and Germany
Health Advances conducted consumer research with amblyopia patients to assess willingness to self pay for therapy. The market potential was determined considering patients' preferred treatment regimen and pricing threshold among various patient segments for a computer-based treatment for amblyopia.
Ear Infection (Otitis Media)
Many young children experience six or more ear infections per year, and these infections, commonly treated with inexpensive antibiotics, place these young patients at risk for hearing loss and the development of antibiotic resistance. Our client identified a novel, non-vaccine approach to the prevention of ear infections. Health Advances was asked to investigate the potential to change pediatricians' existing treatment paradigm, to determine whether physicians could select patients for treatment before patients entered a cycle of infections, and to project how that would translate into market potential. We went on to assist the client with a strategy for positioning the product and identifying potential commercialization partners.
Orphan Disease Forecasting
Health Advances developed a worldwide market forecast for a cell-based gene therapy targeting an ultra-orphan indication. Countries were classified into segments based on standard of care, reimbursement considerations, and regulatory processes. The team combined epidemiologic data from multiple sources with physician-level patient volumes from interviews to establish the number of eligible patients in each country segment. The resulting flexible model allowed the client to evaluate various commercialization and distribution strategies. In addition, the team advised the client on the unique manufacturing and distribution requirements for their therapy.
LSD Drug Global Market Opportunity
For a university technology transfer office considering the sale of its royalty stream for an orphan drug in development for a lysosomal storage disorder, the team forecasted the global revenue potential of the orphan asset. Assumptions for revenue projections were supported by interviews with key opinion leaders in multiple geographies.
Orphan Disease Launch Road Map
On behalf of a specialty pharmaceutical company, Health Advances developed a comprehensive launch strategy road map for commercialization of what would be the first drug approved for a specific lysosomal storage disease. This involved a detailed examination of how treatment patterns would shift, strategies for different patient segments, and expected adoption rates over time.
International Orphan Drug Pricing Strategy
Using in-depth interviews with KOLs, government agencies, disease foundations, patient groups and various payers across 19 ex-US markets, Health Advances prepared an analysis of key product adoption and market penetration issues that would frame the pricing and reimbursement strategy for this orphan drug. The information informed the clinical trial design strategy and the international pricing strategy.
Hereditary Angioedema Commercial Plan
To support the commercialization plan and options, Health Advances prepared a market forecast for this orphan indication reflecting our assessment of the patient segmentation, product positioning, competitive environment, pricing scenarios and go-to-market options.
Cellular Therapy Strategy
Health Advances worked with a biotechnology company to support the development and commercialization of the company’s cellular therapy for an ultra-orphan enzymatic deficiency. The project consisted of three primary modules: pricing and reimbursement, partnering support, and a US market commercialization roadmap. Health Advances helped the company to develop a framework and argument to support a price in the US market by evaluating the product’s clinical value and assessing orphan drug and cellular therapy price benchmarks. Health Advances also examined reimbursement trends and policies, as well as identified pharmaco-economic rationales that could be compelling to payers. We helped the company’s management team prepare for partnering discussions by identifying and evaluating potential partners, developing and refining a pitch presentation, and benchmarking relevant deal structures. Finally, Health Advances worked with the company’s management team to develop a high level roadmap that addresses the major commercialization activities, timing and investments that are required in order to build infrastructure and execute a launch in the US.
International Orphan Disease Drug Forecast
As part of a deal negotiation, Health Advances prepared a detailed sales forecast for a launched drug for an orphan indication in the US, EU and Japan. Secondary and primary resources were used to verify epidemiology, treatment patterns, market penetration, growth rates, pricing and the future outlook for reimbursement and drug utilization.
LSD Clinical Trial Design and System Economics
Anticipating the complex challenges of developing and pricing a novel, high-priced therapy, Health Advances was engaged to prepare a comprehensive development strategy and system economic analysis of a LSD therapy. The analysis integrated a complex disease management paradigm, actual patient treatment activities and cost data and extensive discussions with thought leaders in the field.
Orphan Disease Strategy
Health Advances completed a comprehensive analysis on behalf of a multinational pharmaceutical company in support of a strategic decision regarding how to pursue orphan drug opportunities. Our work involved extensive benchmarking of orphan drug products, company strategies (including other large pharmaceutical companies, mid-size specialty and orphan drug companies, and emerging venture-backed companies) and the strategies that enabled those companies to be successful.
Therapeutic for Ventilator-Associated Pneumonia (VAP)
A client with strong anti-infective science was considering developing a new agent for this indication. The Health Advances team focused on quantifying the potential size of the problem in the US and in three major European countries, since this market was not well documented in the literature and consisted of patients with a variety of underlying conditions. This study also provided insights into the current treatment for these patients and any other unmet needs, as well as competitive efforts focused on the same indication. The contributions of the Health Advances team helped the client understand the relative importance of this internal development initiative.
Pseudomonas in Cystic Fibrosis
Health Advances developed the marketing strategy for a new formulation of tobramycin for use in cystic fibrosis patients. Our work involved projecting market demand, looking at patient segmentation, analyzing pricing options, and determining the positioning for the product.
Valuation of Respiratory Indications
Health Advance assisted a large public company in the evaluation of potential lead indications for their respiratory program. Indications examined included ARDS, cystic fibrosis, COPD, nosocomial pneumonia, fungal pneumonia, ventilator acquired pneumonia, tuberculosis, and interstitial lung disease.
Hospital Respiratory Products
Health Advances assisted a major manufacturer of respiratory products in building a five-year revenue forecast for its hospital products division. The model encompassed revenue projections for the US and international markets for various hospital product lines: acute, subacute and transport invasive and non-invasive ventilation, cardiac output and vCO2 monitors, oximetry, capnography, multiparameter monitors, OEM manufacturing and disposables where relevant.
Due Diligence for a Respiratory Device Company
Health Advances performed due diligence on a company that manufactured respiratory devices used in critical care, emergency rooms, ambulances, long-term care facilities, and home care. Focus was on humidification products used in ventilation, but we also looked at ET tubes, spirometers, and nebulizers. Market growth trends in the US, UK, France and Germany were studied.
Portable Liquid Oxygen
A manufacturer of medical devices asked Health Advances to assess the US safety history of portable liquid oxygen and high-pressure tanks used for home oxygen therapy. Using secondary sources, we estimated the frequency of accidents relative to consumption. In addition, we summarized causes listed in the database and interviewed regulatory as well as home oxygen therapy experts.
HPV Market Assessment
Health Advances conducted a market assessment of the HPV diagnostic and treatment paradigm. Health Advances performed a comprehensive search of the clinical literature and conducted primary research with OB/GYNs, primary care physicians, and pediatricians to assess the impact of the HPV vaccine and co-testing on the treatment market. To identify the optimal product profile and positioning for a novel HPV therapeutic, Health Advances performed a quantitative survey and conjoint analysis. The analytic insights drive a dynamic financial model that estimates sales under various competitive scenarios, providing the client with the information necessary to pursue the optimal clinical strategy.
OB/GYN Practice and Economic Overview
On behalf of a client, Health Advances completed a study of OB/GYN physician offices to assess the relative economic benefits of procedures and various office visits. The study involved site visits to OB/GYN offices to understand a “typical day” and the time involved in each visit. The analysis outlined the contribution margin for the most frequently performed procedures and office visits to dissect the economics of an OB/GYN practice.
Oral Contraceptive Market
Health Advances forecasted the sales of the oral contraceptive (OC) market and the sales of a specific OC in development. Health Advances spoke with OB/GYNs to understand the decision-making process when prescribing OCs and considered the impact of other contraceptive delivery options, generic entrants and PBM tiering to forecast product sales.
Health Advances worked with an early stage company to develop a value based price for a non-invasive maternal blood test that replaces amniocentesis while providing complete and accurate prenatal diagnosis. Health Advances provided a fact-based compelling analysis quantifying the technology’s value proposition to lobby for a value-based price with payers. This analysis integrated both the current costs for prenatal testing and the costs of potential complications of invasive testing.
Breast Biopsy Devices
A client engaged Health Advances to analyze the breast biopsy market. The project involved extensive research with radiologists and breast surgeons to detail the current referral patterns and decision-making processes when selecting the type of biopsy to perform and the specific breast biopsy device. The project also involved understanding the types of procedures performed in each setting and the corresponding economics to physicians and facilities.