Personalized Medicine

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FountainBlue’s November 14 Life Science Entrepreneurs’ Forum was on the topic of Personalized Medicine, Biomarkers, Invitro Diagnostics: The Science Advances, The Business Opportunities, The Cultural Dilemmas. Below are notes from the conversation.
We were fortunate to have a wide range of perspectives and experiences on our panel, representing decades of expertise in personalized medicine, biopharma, oncology, infectious diseases, internal medicine, proteomics, and optics. They each spoke eloquently about the evolution of the personalized medicine industry and the opportunities and challenges ahead.
Our panelists are quite bullish about the opportunities in personalized medicine, remarking on the great progress made over the last decade or two, leveraging revolutionary technologies, research and other innovations and success stories from companies such as Cepheid, Genomic Health, Roche and Gilead. As we move from the first generation of non-specific diagnosis focused on treating symptoms (all typical of health care today), we gravitate toward solutions which require information correlation, providing organized therapies targeting those who would be most responsive to them, based on detailed analysis and research prior to treatment, known as translational medicine. Examples of such include digital imaging, genetic predisposition testing, and clinical genomics. The longer-term objectives for personalized medicine might include disease prevention and effective chronic disease management, and might leverage molecular medicine, CA diagnostics, pre-symptomatic treatment and lifetime treatment. (Source: Richard Bakalar, MD, IBM Healthcare and Life Sciences, November 3, 2004.)
Based on a Bernard Associates October 2003 report published in PharmExec.com, the opportunities in personalized medicine might include the following:
• Addressing patients with adverse event risk
• Serving treatment non-responders
• Serving treatment low-responders
• Introducing solutions to market with faster approvals
• Recruiting patients with less effective, more expensive drugs to new treatment
• Increasing use of drugs for diagnosed patients not treated
• Expanding treatments to new diseases and subgroups
• Diagnosing earlier and leveraging preventive treatments
• Enhancing patient compliance
• Securing better reimbursements for best-in-class drugs
Our panelists made the following comments and advice:
• Because of the nature of the industry, personalized medicine is not a sprint, it’s a marathon, with opportunities for success for only the most committed and resilient.
• Segmenting the patient base (high/low responders, high/low likelihood of recurrence for example) will provide better treatment for the patients, better data for the practitioners, better results for the payers and insurers alike.
• Making solutions easy for the physicians to use, for patients to take, will increase the overall effectiveness of the treatment.
o Getting quick test results will help doctors more quickly make diagnosis and recommend treatments, and also increase the likelihood that the patients will begin treatment. An example is TB testing which currently may take a week, but may eventually take an hour or two, while the patient is still in the office.
o Educate physicians about how to fold these easy-to-implement solutions into their day-to-day practice cost-effectively, and within reimbursement requirements and regulations.
• Focus on creating actionable testing to striate the patient base and recommend treatments based on patient-specific data.
• Create more cost-effective, more effective alternatives to current traditional treatments to 1) serve a more niche market, or a larger market, 2) save costs for patients and insurers, 3)
• Collaborate with clinicians to create value-based pricing and a more receptive regulatory environment conducive to more effective translational medicine.
• Leverage experts in databases and automated systems who can analyze data and recommend treatments, help research differences and similarities in patient and disease and further the research and effectiveness of personalized medicine overall.
• Research families/chapters of diseases as well as types of patients and their correlations with disease susceptibility, with an eye to prevention and treatment.
• There are huge opportunities around treatment resistance – whether it’s a low-responding patient or a patient which develops resistance to treatment over time.
o If it’s delayed resistance, make sure that lab data is current, rather than that taken at the onset of treatment.
o With that said, the difference between samples taken at the beginning of treatment and after the resistance has developed might give insights about the disease, the treatment and/or the patient and classes of each.
• Combination therapies might address the needs of low/non responders, or those who have developed resistance following initial treatment.
As the industry evolves, here are some critical questions to consider:
• Will patients be willing to pay higher prices for treatments more specific to their profile?
• Will diagnostics become more valued and more expensive as people begin to recognize the importance of detailed patient data prior to treatment?
• Will pharma continue to the most influential stakeholder?
• How can patient groups, advocacy groups, clinical collaboration groups, insurers, pharma and other stakeholders better collaborate?
• Will it be cost-effective enough to provide conclusive data which physicians would embrace?
• Will physicians have the time and inclination to embrace new diagnostics and personalized treatments? What are some practical financial incentives for them to do so?
• Will payers band together to insist on better diagnostics and more specialized treatment options based on more sophisticated diagnostics? How will payers work with insurers and physicians and others to make this so?
• What is the most efficient way to measure and communicate ROI and overall savings for diagnosis and treatments?
• Who will fund entrepreneurial innovations in this area, and if it’s not funded, how will the industry continue to evolve?
• How will global solutions and markets evolve?
Whatever the opportunities and questions ahead, we’re in agreement that personalized medicine is not to be swept aside: it is a business opportunity and there is a real need to deliver optimal treatments for patients, and benefit stakeholders across the value chain.
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We are grateful to our panelists for FountainBlue’s November 14 Life Science Entrepreneurs’ Forum was on the topic of Personalized Medicine, Biomarkers, Invitro Diagnostics: The Science Advances, The Business Opportunities, The Cultural Dilemmas:
Facilitator Audrey S. Erbes, Ph.D., Principal, Erbes & Associates
Panelist Michael Bates, M.D., Vice President, Oncology Research and Development at Cepheid
Panelist Dean Schorno, Chief Financial Officer, Genomic Health
Presenting Entrepreneur Giacomo Vacca, Ph.D., Founder & CEO, Kinetic River
Please join us in thanking our speakers for taking the time to share their advice and thoughts.

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