The Declining Pharmaceutical R&D Productivity: Role of Clinical
Pharmacology in a Changing Environment
 
Jean-Michel Gries, PharmD, PhD, MBA, FCP

Biography:

Dr Jean-Michel Gries is the US head of Clinical Pharmacology for Hoffmann-La Roche.

In his role, he has the responsibility for overseeing all aspects of early drug development across all therapeutic areas. Immediately prior to this position, Jean-Michel was a director in the clinical pharmacology department at Aventis Pharmaceutical in New Jersey. His research interests are related to PK/PD modeling and data analysis, population analyses, parametric and non-parametric modeling approaches, clinical trial design and simulation, decision tree analysis and risk assessment, and the impact on portfolio management.

Dr. Gries is the author of more than 30 papers and communications, and is a member of the American Society for Clinical Pharmacology and Therapeutics (ASPCT), and a fellow of the American College of Clinical Pharmacology. He served as the chairperson of the Pharmacometrics and Biostatistics section of the ASCPT, and is now serving on the Education Committee.

Dr. Gries graduated from Rene Descartes University in Paris with a PharmD degree and a PhD in pharmacokinetics. His training covers all aspects of clinical pharmacology with a master in Statistics and a doctoral degree in Analytical Chemistry. He is a former Clinical Pharmacology resident with numerous assignments both in adult and pediatric medicine and a post-doctoral fellowship from UC San Francisco. Dr. Gries has also completed a MBA with a major in finance and concentration in entrepreneurial leadership from the Wharton School.

Abstract:

The productivity of the pharmaceutical industry, in term of drug approved for a given level of investment, has stagnated. Most of the trends in cost, spending, public perception are not sustainable. Clinical Pharmacology by sitting at the interface of research and development is experiencing the pains of both aspects of drug development. Better understanding of disease models and human pathology will enable a more informative translational research. Biomarkers and Pharmacogenetics (and other 'omics) may increase the value of information gathered in early phase. Some increase in operational productivity can also be gained. New development at the level of regulatory agency (FDA) is putting pressure on providing a different level of information throughout the development of new drugs. Model based drug development is still far in the distance, but uptake of new in-silico and modeling techniques has been relatively steadily increasing across the industry.