Day 1 :
PD Science LLC, USA
Keynote: Essential consensus and scientific definition for advancement in 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 June 01, 2013. He is the Founder of PD Science, LLC., USA. He published 273 articles that have been cited by 16,421 papers in 850 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. Confusion and controversy in at least three major areas in biomedical-research and pharmaceutical development exists that compromise research efficiency, developmental cost-effectiveness and rigorous regulatory policy and affairs, namely: (1) Lack of consensus on “synergy definition and its quantification” in drug combination and treatment, especially in cancer and AIDS. (2) The terms PK/PD referred as Pharmacokinetics and Pharmacodynamics are used casually where PD is poorly defined and neglected. (3) The “care and use” legislatures for laboratory animals are good policy and regulation. However, the basic means for conservation of laboratory animals “use”, for reducing waste and minimizing data points and experimental size is poorly developed. It is proposed that all the above three serious problems can be minimized by employing the unified theory of the ‘median-effect equation’ for single entity drugs, and the ‘combination index theorem’ of drug combinations, based on the physico-chemical principle of mass-action law. Its computer soft ware, “CompuSyn”, for automated simulation of pharmacodynamics for new drug evaluation and for synergy quantification, have already been adopted by >10,000 scientists worldwide and is growing at over 1,000 citation papers per year.
University of Central Florida, USA
Time : 10:30-11:00
James J Hickman is the Founding Director of the NanoScience Technology Center and a Professor of Nanoscience Technology, Chemistry, Biomolecular Science, Material Science and Electrical Engineering at the University of Central Florida. Previously, he held the position of the Hunter Endowed Chair in the Bioengineering Department at Clemson University. He completed his PhD from the Massachusetts Institute of Technology in Chemistry. For the past 25 years, he has been studying the interaction of biological species with modified surfaces, first in industry and in the latter years in academia. While in industry he established one of the first bioelectronics labs in the country that focused on cell-based sensors and their integration with electronic devices and MEMS devices. He is interested in creating hybrid systems for biosensor and biological computation applications and the creation of functional in vitro systems for human body-on-a-chip applications. He has worked at NSF and DARPA in the area of biological computation. He is also the Founder and current Chief Scientist of a biotechnology company, Hesperos, which is focusing on cell-based systems for drug discovery and toxicity. He has 111 publications and 18 book chapters, in addition to 26 patents.
It is well known that the cost of drug discovery and subsequent regulatory approval for each new candidate now exceeds $2B and in most cases requires 10-15 years of development time before general availability is granted by either the FDA or EMA. The industry would benefit greatly from better pre-clinical screening technologies to reduce the attrition rate during clinical trials as well as to begin to pre-select specific genetic sub-populations for optimal drug efficacy with limited distribution. A promising technology to help reduce the cost and time of this process are body-on-a-chip or human-on-a-chip systems either at the single organ level or more advanced systems where multiple organ mimics are integrated to allow organ to organ communication and interaction. There is currently a focus at the NIH, FDA and EMA to understand how one could validate these systems such that qualification could be granted for their use to augment and possibly replace animal studies. This talk will give examples of some of the more advanced body-on-a-chip systems being developed as well as the results of five workshops held at NIH as collaboration between the American Institute for Medical and Biological Engineering (AIMBE) and NIH to explore what is needed for validation and qualification of these new systems.
Vascular Sciences, USA
Time : 11:15-11:45
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 Device Regulatory 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.