CT & BSDM: Using Quantitative Models as Tools to Improve Drug Development Strategy & Decision-Making
Friday, November 2 2012
8:00 am – 10:00 am
Location: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA
Small and mid-sized biopharmaceutical companies face a number of drug development challenges. Quantitative modeling and predictive simulations of drug attributes, disease processes, and trial designs helps integrate preclinical and clinical data into knowledge that can influence drug development, regulatory and therapeutic decisions. These models can be applied within the cross-disciplinary fields of translational science, and can facilitate the interaction between basic research and clinical medicine.
This seminar provides an introduction to the value of quantitative models to improve knowledge of a compound’s attributes early in development, and to achieve tangible benefits for a company’s clinical program:
- Getting the dose right
- Requiring fewer or smaller clinical trials
- Improving interactions with regulatory authorities
- Developing therapeutics with better benefit/risk profiles (e.g., versus competing treatments)
- Attracting investor funding, performing due diligence or securing a development partner
The benefits of quantitative drug-disease-trial modeling and simulation have been well demonstrated by FDA and industry sponsors. These analyses have provided time and cost savings by requiring fewer or smaller clinical trials, enabled improved interactions with regulatory authorities by minimizing review cycles, and ultimately resulted in improved therapeutics with better benefit/risk profiles (1).
- Joga Gobburu, PhD, FCP, MBA, Professor, Executive Director, Center for Translational Medicine, Schools of Pharmacy & Medicine, University of Maryland (formerly Director, Division of Pharmacometrics at FDA)
- Varun Garg, PhD, Senior Director, Clinical Pharmacology at Vertex Pharmaceuticals
- JF Marier, PhD, FCD, Vice President and Lead Scientist, Pharsight Consulting Services
Joga Gobburu, PhD, FCP, MBA, Professor, Executive Director, Center for Translational Medicine, Schools of Pharmacy & Medicine, University of Maryland (formerly Director, Division of Pharmacometrics at FDA)
Dr. Gobburu is Professor with School of Pharmacy and School of Medicine, University of Maryland, Baltimore, MD, USA. He held various positions at US FDA between 1999 and 2011. Under his leadership, a Division of Pharmacometrics was formed at the FDA and several policies were established. He is a world-recognized scientific leader in the area of quantitative disease models and their application to decisions. Dr. Gobburu is best known for transforming the field of Pharmacometrics across the world into a decision-supporting science. He also established a Pharmacometrics Fellowship program at the FDA. He received numerous FDA awards such as Outstanding Achievement Award. He also received Outstanding Leadership Award from the American Conference on Pharmacometrics (2008), Tanabe’s Young Investigator Award from American College of Clinical Pharmacology (2008). Dr. Gobburu is on the Editorial Boards of several journals. He published over 60 papers and book chapters.
JF Marier, PhD, FCD, Vice President and Lead Scientist, Pharsight Consulting Services
Dr. Marier has directed PK/PD analyses, reporting, and modeling and simulation projects for hundreds of studies in early and late clinical research. His drug development experience spans non-compartmental and population PK/PD modeling and simulation across all phases of development and in specific populations (pediatric/geriatric, renal/liver impaired). His expertise includes scientific and regulatory consultation on drug development programs for small and large molecules, particularly in the therapeutics areas of oncology, inflammation, immunosuppressants, cardiovascular, infection and metabolic diseases. Dr. Marier has authored or co-authored more than 100 abstracts/manuscripts and book chapters in the field of PK/PD, and has leveraged modeling and simulation to build and optimize drug development programs for dozens of industry sponsors. Dr. Marier earned his Ph.D. in Pharmaceutical Sciences from the University of Montreal, Faculty of Pharmacy and is a fellow of the American College of Clinical Pharmacology.
Varun Garg, Ph.D., Senior Director of Clinical Pharmacology at Vertex Pharmaceuticals, Inc.
Dr. Garg previously held positions at Wyeth, Otsuka America, and Aronex. For the last several years, he has been involved in the development of telaprevir as the lead clinical pharmacologist for Vertex. Dr Garg has published/presented more than 60 papers and written 2 book chapters. He is a founding member of the organizing committee for the Annual International Workshops on the Clinical Pharmacology of Hepatitis. Dr. Garg received his Ph.D. at the University at Buffalo under the supervision of Dr. William Jusko. His paper titled “Comparison of four basic models on indirect pharmacodynamic responses” published in the Journal of Pharmacokinetics and Pharmacodynamics in 1993 is one of the most widely cited papers on PK/PD modeling.
1. Goldberger MJ, Singh N, Allerheiligan S, Gobburu JVS, Lalonde R, et al. ASCPT Task Force for Advancing Pharmacometrics and Integration into Drug Development. Clin. Pharmacol. Ther. 2010;88 2:158–161.