Q: What advantages will personalized medicine bring to patients, and what is its overall public health benefit?
A: Personalized medicine could trump the current one-size-fits-all approach to pharmaceutical interventions in certain cases. Some individuals fall on one side of the bell-shaped curve, and the rest will be okay with a general therapy. The closer to the top of the curve, and to the right (high responders), the greater chance the therapy will be successful. The outliers on the left will benefit the most from individualized therapy. For example, knowing specific tumor genotypes can focus chemotherapy on agents effective for such tumors. Understanding personal genetics will enable physicians to tailor therapy based on ability to respond to a specific chemotherapy and avoid treating individuals whose genetics make them poor responders. People metabolize drugs differently based on liver enzymes (Cyps), so understanding patient Cyp genotypes could help physicians tailor drug therapy to those with the ability to correctly metabolize prodrugs.
CAROL NACY, PH.D.
Dr. Nacy is CEO of Sequella, Inc., a private company that develops new antiinfective drugs. She was formerly CSO at Anergen and EVP/CSO at EntreMed. Prior to her business experience, she directed research in tropical infectious diseases at Walter Reed Army Institute of Research, Washington, D.C.
Q: Who would you be most interested in reading about in Life Science Leader?
A: Michael Jaharis has made three fortunes in pharmaceuticals. The first was when he and dermatologist Phillip Frost bought Key Pharmaceuticals in 1972. Jaharis was CEO until 1986 when it merged with Schering-Plough in an $836 million deal. Number two came when he founded Kos Pharmaceuticals in 1988 and sold it to Abbott Labs in 2006 for $4.2 billion. The third home run for Jaharis was when AstraZeneca purchased Pearl Therapeutics for $1.15 billion in 2013. At the time, Vatera Healthcare Partners, the VC firm cofounded by Jaharis, was the controlling investor in Pearl. As a biopharmaceutical entrepreneur, I think readers would be enlightened by his wisdom.
Leslie Williams is president, CEO, and founder of ImmusanT, Inc., an early-stage company focused on peptide treatments for autoimmune diseases. She has more than 20 years of industry experience.
Q: What macro trend have you noticed beginning to impact the way you do business?
A: A recent labor statistic noted 2015 as the year the millennial generation will become the majority in both the workforce and consumer space. I feel the shift. The things that motivated my staff 10 years ago do not resonate with current workers. Although I have no metrics to cite, I feel we are not training and developing enough clinical trialists. It takes me much longer to find a suitable hire. In a few instances, I have had positions open for months with only a trickle of applicants, and few of them qualified. It seems fewer and fewer have been adequately educated in the discipline of drug development. We need to ensure a steady stream of top talent is coming into our industry.
MARY ROSE KELLER
Mary Rose Keller, VP clinical operations at Tocagen, has 30+ years of industry experience in clinical development strategy and execution of global Phase 1 to 4 clinical trials for drug, biologic, and diagnostic products.