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Biography

Paul A. Frohna has a Ph.D. in Pharmacology from the University of Pennsylvania and an M.D. (Internal Medicine) from Georgetown University in Washington, DC. He has been conducting translational research in the biotech industry for more than 14 yrs having served in roles from Medical Director to Chief Medical Offi cer at companies like Genentech, CV Therapeutics, Fibrogen and ProFibrix. He is currently the CMO at ProFibrix, Inc. and an industry consultant providing services in translational medicine, clinical pharmacology, and clinical trial design. He has designed clinical programs in regenerative medicine, hematology, oncology, immunology, neurology and cardiology.

Abstract

Precision Medicine is a drug development paradigm that has evolved within oncology where cancer-causing genetic mutations have been known or suspected for some time, and where the toxicity and poor effi cacy of non-specifi c chemotherapeutics promoted the search for targeted, less toxic therapies against these mutations. While programs like trastuzumab for HER-2 over-expression in breast cancer, crizotinib for ALK fusion proteins in NSCLC, and vemurafi nib for BRAF V600E mutations in melanoma are shining success stories for Precision Medicine, there are surprisingly few others. It has become very apparent that despite the application of Precision Medicine the response rates in oncology clinical trials have not approached 100% or even come close. Th e leading hypothesis is that intra-tumor genetic diversity of distinct subpopulations of cells is the key driver for resistance and the disappointing results with targeted therapies. Th e recent tumor sequencing work to date suggests that how, when and where tumor samples are collected and analyzed need to be thoughtfully planned and implemented in clinical trials in order to maximize the utility of this genetic diversity information for patient selection criteria or for post-hoc subgroup analysis. While oncology has been the original playground for Precision Medicine, examples of other diseases/therapeutic areas where these patient selection criteria are likely to be very benefi cial in improving the successes of clinical trials will also be briefl y discussed. Th e future of Precision Medicine is promising, and if implemented carefully and consistently should improve clinical trial success rates and deliver more eff ective treatments for physicians and patients.

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