Day 2 :
PD Science LLC, USA
Keynote: Scientific definitions and computerized algorithms for advancement of medical and pharmaceutical regulatory affairs
Time : 10:00-10:30
Ting-Chao Chou received MS in Pharmacology from National Taiwan University, and PhD from Yale University, and Postdoctoral Fellowship at Johns Hopkins University, School of Medicine. He joined the Memorial Sloan-Kettering Cancer Center (MSKCC) and became a member in 1988, and was a Professor of Pharmacology at Cornell University, Graduate School of Medical Sciences during 1988-2000. He was the Director of Preclinical Pharmacology Core at MSKCC, where he retired on January 06, 2013. He is the Founder of PD Science, LLC., USA. He published 273 articles that have been cited by 16,421 papers in 620 biomedical journals worldwide including Thomson Reuters Web of Science and Google Scholar Citations with 22,336 citations, h-index 65 and 38 U.S. Patents. He introduced the “Unified Theory of the Median-Effect Equation of the Mass-Action Law” in 1976 for single drug, and with Prof. Paul Talalay (JHU) in 1984, created the “Combination Index Theorem” for multiple drug dynamics. His dynamics equations and software have been utilized to advance Econo-Green Bio-Research.
Disparity in basic scientific concept and theory lead to weakness in setting policy and regulatory affairs. At least three major areas in biomedical-research and pharmaceutical development exist confusion that need clarifications to improve research efficiency, developmental cost-effectiveness and rigorous regulatory affairs: (I) Loose in consensus on “synergy definition and its quantification” in drug combination synergy claims, especially in cancer and AIDS. (II) The terms PK/PD referred as Pharmacokinetics and Pharmacodynamics are used casually, where PD dose-effect dynamics for effi cacy and toxicity algorithm for simulation is not yet defined clearly and with insufficient emphasis on PD comparing with PK. (III) The care and use of laboratory animals are good policy and regulation. However, the mass-action law-based conservation of animals to increase efficiency/cost-eff ectiveness and to minimize experimental size and data points, remain to be implemented and utilized. All the above important improvements can be implemented by employing the unified theory of the median-effect equation and the combination index theorem, based on the physico-chemical principle of mass-action law, using CompuSyn computer soft ware for automatic simulation, that have, so far, been adopted by >10,000 scientists in over 5,000 papers worldwide as indicated by Thomson Reuters Web of Science core database.
Vascular Sciences, USA
Time : 10:30-11:15
Michael Drues, PhD, is the President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including (but not limited to): stimulating & innovative educational programming, brain-storming sessions, prototype design, product development, bench top & animal testing, regulatory strategy & clinical trial design, FDA presentation preparation & defense, reimbursement, clinical acceptance, business development & technology assessment. He received his BS, MS, and PhD degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start ups to Fortune 100 companies. He also works on a regular basis for the US Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world. He is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the US Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world. Finally, as an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology, he teaches graduate courses in Regulatory Affairs & Clinical Trials, Clinical Trial Design, Medical DeviceRegulatory Affairs & Product Development, Combination.
Most product development in medical technology is evolutionary, i.e. make a drug or medical device then modify it slightly to create a new drug or device. There are many advantages to this approach but there are disadvantages as well. For example, the light bulb did not evolve from the candle nor did the car evolve from the horse. You can tweak a horse as many times as you want but you will never end up with a car! The light bulb and the car are examples of revolutionary a.k.a. destructive technologies. Our current regulatory environment was designed for and indeed encourages evolutionary advancements. However, when it comes to bringing revolutionary or disruptive technologies to market, the regulatory challenges are immense. Using case studies from 3-D printing, pharmacogenomics, tissue engineering and nanotechnology, this presentation will discuss the regulatory challenges of commercializing revolutionary technologies in an evolutionary world and how manufacturers can successfully meet them.