The Center for Responsible Science (CRS) is a group of scientific, medical, regulatory, business, and legal professionals who promote advances in regulatory science. Such advances include the use of modern, predictive preclinical test methods in an effort to streamline drug and device development and bring safer, more effective products to patients more quickly at less cost.
Through collaboration with scientific, educational, legal, health care, patient advocacy and biotech communities, CRS pushes for better results for patients.
CRS moves product development forward by bringing policy up to date with existing science, and paving the way for use of emerging technologies.
CRS works to modify preclinical regulations that require traditional test methods in order to broaden drug and device sponsors' testing options to include the most predictive scientifically recognized test methods.
CRS advocates for use of the most predictive tests available and aims to spark innovation of better test methods to predict human safety and efficacy.
Board of Directors
Gerry R. Boss, M.D.
Dr. Boss is a Professor of Medicine at the University of California, San Diego, School of Medicine. He is board-certified in Internal Medicine, having received his M.D. degree from the University of California, Irvine and his residency training at The Johns Hopkins Hospital. He received post-doctoral training in genetics at Harvard Medical School/The Massachusetts General Hospital. He has published over 140 peer-reviewed papers in prestigious scientific journals, with his work currently supported by several grants from The National Institutes of Health. Most of his research has been in basic biochemistry and molecular biology studying signal transduction pathways, but recently he has been translating his work into developing new drugs, so he is well familiar with the problems in drug development. He is the primary inventor on several patents, and is in currently licensing a patent to a private drug development company. He was elected to the Alpha Omega Alpha honorary medical society and to the American Society of Clinical Investigation.
Troy McCall, PhD
Dr. McCall has more than twenty years of experience in the pharmaceutical industry, having worked for more than a decade each in increasingly senior positions in specialty pharma and life sciences services companies. He has a proven track record of success in leading and growing start-up, small, and medium-sized organizations. He has been a managing partner and/or CEO at four companies. Dr. McCall has consistently been successful in building value through a disciplined business approach which includes, but is not limited to, cost rationalization and expense management resulting in industry- leading margins, hands-on and effective engagement with clients, FDA, and other stakeholders, active participation with the sales and marketing organizations to significantly improve top-line results, and top-grading talent at all levels. He has extensive experience with growing and transforming companies and developing entities into successful, sustainable organizations. Dr. McCall has significant expertise in acquiring, integrating, and selling companies, having been involved with more than ten such transactions.
Rod Summers is a First Vice President of Investment at Wells Fargo Advisors. He is active in his community having served on the advisory boards of Free arts for Abused Children and Doctors Without Borders. Over the years, he has worked with local charities in raising more than five million dollars towards their causes. He earned his advanced education in financial planning from UCLA, and is currently pursuing his MBA in financial planning.
Katya Tsaioun, PhD
The focus of Dr. Tsaioun’s career has been bringing innovation, objectivity and transparency in pharmacology, toxicology and regulatory sciences in order to improve the safety of consumer products, drugs, and cosmetics. She currently serves as a Director of the Evidence-based Toxicology Collaboration at Johns Hopkins School of Public Health (EBTC). Prior to joining EBTC, Dr. Tsaioun was a Scientific Director of Safer Medicines Trust, a UK patient safety charity with the mission of improving patients’ safety by bringing innovation and human biology-based tests into regulatory science. In this role, she has established SMT's presence in the US, formed collaborations with US EPA and FDA and has built a scientific advisory panel with cross-Atlantic stakeholder consortium consisting of technology companies, academic groups, regulatory authorities and other non-profit organizations with aligned interests. Prior to that, Dr. Tsaioun founded a Contract Research Organization, Apredica, which specializes in pharmacology and safety assessment of the pharmaceutical, agrochemical, and cosmetic products. She led the company into becoming a leader in early safety assessment via development of a portfolio of novel mechanism-based toxicity assays and licensing and acquisition of proprietary platforms. Prior to this Dr. Tsaioun managed pharmacology and de-risking programs for early stage pharmaceutical companies. Dr. Tsaioun serves on the scientific review boards and study sections of the National Institute of Health and the Alzheimer's Drug Discovery Foundation. Dr. Tsaioun is frequently invited to speak at conferences on the topics of risk, early safety assessment, building productive R&D teams, and entrepreneurship. She published numerous scientific papers and co-edited a book, ADMET for Medicinal Chemists, which was published in 2011 by Wiley & Sons. Dr. Tsaioun earned her B.S./M.S. engineering degree in solid-state chemistry from the Leningrad Institute of Technology, and her Ph.D. from Tufts University in Human Nutrition Science.
Neil L. Wilcox, D.V.M., M.P.H.
Dr. Wilcox is currently an independent consultant. Most recently, he was the Senior Vice President and Chief Compliance Officer for ITG Brands. His experience in the Consumer Product Industry also includes Senior Vice President and Chief Compliance Officer of Lorillard, Inc., Director of Global Regulatory Affairs at The Gillette Company and Vice President of Global Regulatory and Scientific Affairs at the Kimberly-Clark Corporation. In these positions, his role involved developing and implementing global infrastructures to ensure regulatory compliance for an array of products world-wide. He also served at the Food and Drug Administration (FDA) as a science and regulatory expert, including Veterinary Medical Officer, Center for Veterinary Medicine; Senior Science Policy Officer, Office of Science, Office of the Commissioner and Science Policy Analyst, Office of Colors and Cosmetics, Center for Food Safety and Applied Nutrition. Dr. Wilcox brings substantive international understanding of product safety, regulatory affairs, quality control and clinical study management as related to numerous product types including consumer products, cosmetics, over-the-counter drugs, medical devices and veterinary products. Dr. Wilcox is experienced in the review of new drug applications for regulatory approval and was actively involved in the development of science policy for FDA-regulated products. He represented FDA on all issues related to alternatives to animal testing and was responsible for developing FDA’s policies related to alternatives. Dr. Wilcox chaired the Interagency Regulatory Alternatives Group (IRAG) and was instrumental in developing the strategy and implementation for the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). Dr. Wilcox graduated Cum Laude from Michigan State University’s School of Veterinary Medicine with a Doctor of Veterinary Medicine (DVM). He also holds a Masters of Public Health (MPH) in Public Health Policy and Administration (PHPA) from the University of Michigan.
Gerry R. Boss, M.D.
See Dr. Boss' bio under Board of Directors.
Robert A. Coleman PhD, DSc
Robert Alexander Coleman, MIBiol, Ph.D., D.Sc., is a pharmacologist committed to advancing the use of human cells and tissues in the evaluation of the potential safety and efficacy of new medicines, particularly where existing methods are demonstrably unreliable. Dr. Coleman is recognized for scientific achievements and contributions to the promotion and use of donated human tissues in drug research.
Throughout his career, Dr. Coleman experienced extensive promising therapeutic and toxicity opportunities that subsequently proved to be species-specific, and not relevant to human subjects. These experiences increased Dr. Coleman’s awareness of the shortcomings of experimental animals as human surrogates in the R&D process.
Dr. Coleman has an in depth understanding of the drug discovery/development process that grew from working thirty years with the Glaxo companies. During this time, Dr. Coleman led the identification of the now universally accepted classifications of both prostanoid and leukotriene receptors, and had a key role in the discovery and development of the long-acting β2-adrenoceptor agonist bronchodilator, salmeterol (Serevent®). Dr. Coleman co-founded Pharmagene now Asterand Bioscience), a drug R&D company that works exclusively with human cells and tissues, to provide human-based information to the pharma industry and its own drug discovery programs.
For seven years, Dr. Coleman served as editor of British Journal of Pharmacology. He has authored more than 80 peer-reviewed papers and book chapters, and more than 80 published abstracts. He has spoken at numerous international conferences. Currently, Dr. Coleman is a UK Science Director, an independent consultant in both drug discovery and the use of human materials in pharma R&D, and a science advisor to Safer Medicines Trust.