On May 20, Harvard Business School announced the winners of its recent Precision Trials Challenge. The Precision Trials Challenge is an online competition to generate ideas on how to bring precision diagnostics and therapies to market faster by reinventing the clinical trials process.
A submission by Christopher Cogle, M.D., an associate professor of medicine at the University of Florida and member of the UF Health Cancer Center, and his research team was selected as one of two runners-up in the challenge: Using Patient-Specific Cancer Mutanome and Pharmacogenomics Data to Create Personalized Avatars for Predicting Drug Efficacy and Safety: patient-specific avatars for predicting drug response, discovering new indications for older drugs, and forecasting new drugs.
The challenge was the first research pilot for the newly-created, HBS/Kraft Precision Medicine Accelerator, launched with a $20 million gift from the Kraft Family Foundation, under the leadership of foundation president, Robert K. Kraft. The Accelerator’s mission is to expedite solutions to key precision medicine issues and disseminate best practices and models to enable commercialization.
“It was exciting to read the depth and breadth of all the applications,” said Robert Huckman, professor and chair of HBS Health Care Initiative. “It was crystal clear that using precision medicine protocols can reinvent the clinical trials process. Important issues such as identifying the ‘right’ patients with specific mutations for enrollment, therapies and trials combinations, off-label uses of drugs and N-of-1 approvals were issues that applicants are trying to address. Big data and data sharing were also very prevalent issues.”
A panel of judges comprised of clinical trials experts, precision medicine leaders, and influencers in biopharma, medical, science and academic fields provided expertise throughout the selection process.
MatchMiner will received the $50,000 first prize and an opportunity to share their winning idea at the annual Personalized Medicine Conference (PMC) at Harvard Medical School, where the ideation challenge was first announced last year. The two runners-up, including Cogle’s team, were awarded $25,000 each for their innovative ideas.
Q&A with Dr. Christopher Cogle
Q: What was the inspiration behind your team’s idea submission for this challenge?
A: I go to work every day to cure people. Clinical trials are my tools in which I build new treatments to get rid of disease. After a decade of practicing oncology, I became fed up with old clinical trial designs and challenged my group to invent new clinical trial methods. We created a new clinical trial strategy that uses individual patient DNA and computer mapping to construct three-dimensional models of the disease that permit digital drug treatment simulations. We validated this new invention using previously published data and are currently testing the trial strategy in a prospective clinical trial. We were also fortunate to receive funding to conduct a randomized study of our new technique. If our new clinical trial strategy proves better than current-day medical practice, then we will be able to tailor treatments for individual patients and help drug companies for new applications for their drugs.
Q: The Precision Trials Challenge is a competition to “generate ideas on how to bring diagnostics and therapies to market faster by reinventing the clinical trials process” — how does your idea help fulfill this goal, and what’s the next step?
A: We have used our DNA and computer technology to create four clinical trial innovations: (1) We can predict drug response to standard of care drugs with 80-100 percent accuracy in blood cancer patients, which is much greater than the standard of care rate of 30 percent; (2) Our method can identify new drug combinations that may be tailored for each patient’s blood cancer; (3) We can identify proteins within a cancer cell that explain why a drug does or does not work; and (4) Our method can be used to create virtual clinical trials thus avoiding exposure to patients, shaving years off of the drug development process, and reducing costs greatly.
Q: You will presented your idea during a webinar on Clinical Trials Day (May 20). Why is this an important day to acknowledge?
A: At the core of clinical research are the precepts of asking the right question and measuring response with exactness. Without precise questions or measurements, we’re at the whim of all our human biases and blindspots. Every major advance in medicine was borne from curiosity and quantitation. Clinical trials demand accuracy, precision and fairness from our physicians and scientists, and likewise honor and respect the privilege of helping our neighbors in need. Clinical Trials Day is one moment when we pause to appreciate need, precision and trust involved in advancing medical practice.
