FountainBlue’s February 23 Life Science Entrepreneurs’ Forum was on the topic of Personalized Medicine: The Breakthroughs, the Opportunities, and the Challenges, featuring:
• Facilitator Steven Cui, Of Counsel, Jones Day
• Panelist Bonnie Anderson, CEO, Veracyte, Inc.
• Panelist Deborah Kilpatrick, Vice President, Market Development, CardioDx, Inc.
• Panelist Geetha Rao, Springborne and Molecular Image
• Panelist Mike Richey, Chief Business Officer, Tethys Bioscience
• Panelist David Rollo, President, Cell Point LLC
Below are notes from the conversation:
With advancements in technology and science, we have not only a greater understanding of people and their various diseases, but we are also better understanding the human genome, and are making progress in creating personalized medicines to customize treatment and even preventive care for people. The panel highlighted the Promise of Personalized Medicine:
• Here’s one way of thinking of molecular medicine. It is comprised of molecular diagnostics – identifying biomarkers for diseases, molecular imaging – targeting location and extent of a disease, molecular therapy – targeting treatment for the diseased cells/areas. Investing in personalized medicine will help providers better diagnose, identify and treat patients more effectively and with less expense.
• Personalized medicine helps people understand their genome and what they are pre-disposed to, based on genetics or environment. Knowing this information will help patients, providers and payers alike better understand, diagnose and treat health challenges, even in the early stages.
• Personalized medicine has the potential to positively impact the regulatory, clinical trials, reimbursement and other challenges which have historically been barriers to delivering medication to patients.
• Personalized medicine has the ability to identify a wider range of solutions for a larger percentage of the affected population. In general, broadly prescribed drugs tend to work effectively on a subset of patients, which could be as low as 15% for some treatments and possibly as high as 80 or 90% for others. The benefit of personalized approaches is to better ensure that patients gets the drug “matched” to their subtype, which saves the costs of unsuccessful treatments followed by later rounds and supports an improved quality of life for the patients. This is overall a more cost effective approach than is used today. This would impact payers, physicians, providers, patients and investors alike, creating a tremendous business opportunity while also better serving everyone. Indeed, there is a lot of interest from patients, physicians, providers, payers and investors alike. But there are also challenges in proving the efficacy of personalized medicine.
• This economic downturn makes it challenging for the funding of even the most promising technologies. Be conservative about cash management, keep developing a business worthy of funding (people, products, market, risk management), build relationships with key stakeholders, and manage your fundraising needs to fit the times.
• If stakeholders move from a philosophy of treating the symptoms to understanding pre-dispositions to disease and providing targeted treatments early on, it may increase the effectiveness of the treatment while lowering the risks and the costs.
• We must prove through clinical trials that personalized medicine can safely and effectively live up to that potential of providing customized medical solutions to patients while still supporting solid business practices and satisfying all stakeholders.
• We must enlist the support of providers and educate them on developing use cases and advocating for the adoption of personalized medical options.
• We must work with the FDA to create new standards for clinical trial approval which are more appropriate for personalized medicine solutions. Current standards are more effective for pharma and device solutions, so while we’re advocating for a new standard, we must find a way to work within the current standards.
• There are political and societal barriers we must overcome in order to develop critical mass for the adoption of personalized medicine. This takes time and must be done through passionate education and advocacy from engaged stakeholders.
• Later, we must empower patients to take charge of their own health.
Your comments are welcome. We look forward to connecting with you soon.
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