Dr. Jay Herson

Jay Herson, Ph.D. earned his Ph.D. in Biostatistics from Johns Hopkins in 1971. Jay’s first positions after graduation were at the National Center for Health Statistics in Rockville, MD and the Howard University College of Medicine in Washington, DC. In 1976 he moved to Houston to work as a biostatistician on cancer clinical trials at the University of Texas MD Anderson Cancer Center and the Southwest Oncology Group.
 
In 1983 Jay formed Applied Logic Associates, a contract research organization in Houston. ALA provided data management, biostatistical and regulatory services on clinical trials for pharmaceutical, biotechnology and medical device firms. About 60% of services were delivered to emerging biotech firms working in oncology. However firms working in internal medicine and ophthalmology benefited through ALA’s transfer of sophisticated statistical methods developed for in cancer research. At the time that ALA was sold to Westat, Inc. Rockville, MD in 2001 there were 50 ALA employees in Houston. Under his leadership ALA was able to participate in the approval of many critical care products in oncology, cardiovascular disease and ophthalmology.
 
Jay moved to Chevy Chase, MD in 2003 to work out of the corporate office of Westat. His relationship with that company ended at the end of 2005. During the past 30 years he has developed methods for design and analysis of clinical trials with planned interim analyses and sample size re-estimation. He organized and chaired the first data monitoring committee in the pharmaceutical industry and helped FDA draft a guidance document on data monitoring committees. He is a regular attendee at FDA Advisory Committee meetings and reports regularly on trends in FDA policy and pharmaceutical company presentations. He has numerous publications in the medical and statistical journals and has made numerous presentations at statistical meetings.
 
He now works as a consultant or data monitoring committee member for several pharmaceutical, biotech, and medical device firms. Serving as Senior Associate in Biostatistics at Johns Hopkins University, Baltimore he teaches in several graduate courses and works on various research projects. He volunteers weekly as a tutor in English as a Second Language and news reader for the blind.
 
Jay’s second career is that of a futurist. He has written articles on the future of the pharmaceutical industry and scenarios for the coming osteoporosis epidemic. He serves as Senior Associate at the Institute for Alternative Futures, Alexandria, VA where he works with staff on future scenarios in areas such as pharmaceutical R&D and education. He is also Managing Editor and frequent contributor to the newsletter Future Takes.
 
He authored Highlights from World Future 2007: Fostering Hope and Vision for the 21st Century, Futurist History Comes Out of the Closet, Downloading Education, Looking Forward … and Backward, and Thinking Outside the Box — A Practical Lesson, and coauthored Steroid-Free Immunosuppression in Cyclosporine-Treated Renal Transplant Recipients: A Meta-Analysis. Structure-based design of an osteoclast-selective, nonpeptide Src homology 2 inhibitor with in vivo antiresorptive activity, Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees, and Robust Estimation in Finite Populations I.