Clinical Trials in Emerging Regions - India a Case Study
Keynote & Endnote

Keynote addresses:

 

 

Dr. Andrew von Eschenbach, MD 

Former Commissioner, FDA

Senior Advisor, Greenleaf Health LLC

 

Dr. Andrew von Eschenbach has had a distinguished three-decade-long career as a physician, surgeon, oncologist, cancer researcher, medical educator, hospital executive and public servant. He is the only person to have held two of the nation’s top healthcare leadership roles -- Commissioner of the Food and Drug Administration (FDA) and Director of the National Cancer Institute (NCI).

 

As FDA Commissioner from 2005 to 2009, Dr. von Eschenbach’s leadership was marked by his efforts to modernize the FDA and enhance its ability to fulfill its mission of protecting and promoting public health.  During his tenure, he emphasized FDA’s role in working with external partners to assure quality throughout the entire life cycle of the products it regulates. Internally, he initiated process improvements to establish a regulatory pathway that was rigorous and science-led, yet transparent and efficient.  His administration was also marked by innovation in fostering creative projects, including FDA’s “Beyond Our Borders Initiative,” which created FDA permanent offices around the world, beginning with China in November 2008, and implementation of the “Critical Path Initiative,” which brought modern scientific tools to the product development process. Dr. von Eschenbach’s leadership team directed an intense focus on the needs of FDA staffers through initiatives that included the creation of an agency-wide Commissioner’s Fellowship program and the accelerated build-out of a new, integrated FDA campus in White Oak, MD. At a time when the volume of foreign imports entering the United States doubled, Dr. von Eschenbach substantially increased FDA collaboration with regulatory counterparts in other countries, provided technical assistance to foreign regulators and industries, and ramped up efforts to learn more about importers and their products.  His administration also fostered the integration of long-range strategic projects, such as the Drug Safety Plan and the Food Protection Plan, aimed at protecting the nation’s food supply from both unintentional contamination and deliberate attack.

 

As head of the NCI, he initiated programs and committed resources to ensure the application to oncology of nanotechnology, genomics, proteomics, bioinformatics, and other emerging technologies. Prior to that time, Dr. von Eschenbach spent more than 25 years in numerous leadership and academic roles at the University of Texas M.D. Anderson Cancer Center in Houston, an institution renowned for the magnitude and excellence of its clinical and research cancer programs. There he served as Professor and Chairman of the Department of Urologic Oncology, Executive Vice President and Chief Academic Officer, Consulting Professor of Cell Biology, and Director of the Laser Biology Program.

 

 An internationally renowned cancer specialist and author of more than 200 scientific articles, Dr. von Eschenbach was a founding member of the National Dialogue on Cancer. He has received many professional awards and honors during his career. In 2006, Dr. von Eschenbach was named one of Time magazine’s “100 most influential people to shape the world,” and in both 2007 and 2008 he was selected as one of the Modern Healthcare/Modern Physician’s “50 Most Powerful Physician Executives in Healthcare.”

Dr. von Eschenbach received a Bachelor of Science degree from St. Joseph’s University in his native Philadelphia and a medical degree from Georgetown University School of Medicine in Washington, D.C. 

 

 

 

 

Joseph E. Tomaszewski, PhD 

Deputy Director

Division of Cancer Treatment and Diagnosis

National Cancer Institute, NIH

 

 

Dr. Tomaszewski was appointed Deputy Director of the Division of Cancer Treatment and Diagnosis (DCTD), NCI in June 2005 and up until August 2008 was also the Chief of the Toxicology and Pharmacology Branch (TPB), DTP, DCTD, NCI for the past 20 years.  He received his B.S. in Chemistry from the University of Scranton in 1965 and a Ph.D. in Organic Chemistry from the University of New Hampshire in 1970.  His area of specialty is the development of new therapeutics to treat cancer.  In 2005, while he was the Acting Associate Director for DTP, he created the Laboratory of Human Toxicology and Pharmacology, which is responsible for developing human in vitro toxicology assays and the development of pharmacodynamic biomarker assays.  As a result, he was given the responsibility for developing a new pharmacodynamic initiative within NCI to support early (Phase 0) clinical trials under the FDAs Exploratory-IND Guidance as well as PK/PD driven Phase I clinical trials.  As a result, the NCI performed the first Phase 0 in oncology in 2006.  More recently, he has been designated as the lead in the division and the NCI for developing the new Chemical Biology Consortium (CBC) initiative to revitalize drug discovery at the NCI.  While Chief of TPB, he had responsibility for the preclinical toxicological and pharmacological evaluation of all new cancer drugs that are developed by the NCI and for non-oncology therapeutics under the NIDDK Type 1 Diabetes RAID and NIH RAID Pilot Programs.  During this period, he has been involved in the preclinical evaluation of more than 180 diverse clinical candidates that has led to the filing of more than 120 INDs/DMFs and the approval of 5 NDAs by the FDA.  He is the author/coauthor of over 300 publications / abstracts/ presentations at national and international meetings.