Developing Alzheimer's Disease Model: AAPS And FDA Announce Appointment Of Research Fellow

Main Category: Alzheimer's / Dementia
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry;  Clinical Trials / Drug Trials
Article Date: 16 Apr 2009 - 1:00 PDT

email to a friend   printer friendly   opinions  

The American Association of Pharmaceutical Scientists (AAPS) has announced the appointment of Demiana William Faltaos, Ph.D., to the position of Research Fellow at the Oak Ridge Institute for Science and Education (ORISE), where she will begin work this week to develop effective Alzheimer's disease-state models for a 2-year period. Dr. Faltaos' appointment comes at the end of a collaborative effort to recruit and screen scientific candidates for the position by AAPS and the U.S. Food and Drug Administration (FDA) as part of a Cooperative Research and Development Agreement (CRADA). The agreement was signed in December of 2007 by Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research at the FDA, and the Executive Director of AAPS, John Lisack Jr., CAE. The CRADA marks the first time that AAPS has contributed the funding for a specific research agreement.

"We are thrilled to have Dr. Faltaos become a part of this unique partnership between AAPS and the FDA," said Lisack. "Her research skills and experience will be put to great use on this project."

Dr. Faltaos received her Ph.D. in pharmacy from the "René Descartes" University of Paris V in May of 2006. Prior to accepting this appointment, she served as a Clinical Pharmacology and Clinical Pharmacokinetics researcher with Johnson & Johnson Pharmaceutical Research & Development in Belgium.

"Dr. Faltaos brings with her years of drug development experience and a strong background in modeling and simulation," said Joga Gobburu, Ph.D., Center for Drug Evaluation and Research, Office of Clinical Pharmacology, FDA. "The FDA is excited to embark on this important Critical Path project - with new drugs under development that may modify disease progression, this CRADA will allow us to explore the benefits and risks of competing trial designs and analysis in order to discern disease-modification effects."

Under the terms of the CRADA, entitled "Enhancing Investigational New Drug Application (IND)/New Drug Application (NDA) Review Quality via Quantifying Prior Knowledge," AAPS and the FDA will look to advance current research by supporting the development of Alzheimer's disease-state models. These disease-state models will be implemented by the FDA to review clinical trial data for clinical pharmacology, as well as statistical and clinical reviews. Another goal is to use modeling and simulation (M/S) technology to improve efficiency in the drug product development process. AAPS members have agreed to provide its expertise in quantitative modeling and simulation, while FDA staff will provide working experience of disease-state model use.

Notes:

The AAPS Executive Council voted to support funding of the initiative in May of 2006 and it has been in development since that point. AAPS has pledged to contribute $200,000 over the 2-year research period to ORISE to cover the research process and salary of Dr. Faltaos. One principal investigator from each organization will also be involved in the research, with Dr. Gobburu representing the FDA's Office of Clinical Pharmacology and Dr. Sandra Allerheiligen representing AAPS.

About AAPS

The American Association of Pharmaceutical Scientists (AAPS) is a professional, scientific organization of almost 13,000 members employed in academia, industry, government, and other research institutes worldwide. Founded in 1986, AAPS provides a dynamic international forum for the exchange of knowledge among scientists to serve the public and enhance their contributions to health. AAPS offers timely scientific programs, on-going education, information resources, opportunities for networking, and professional development.

About FDA

The FDA is responsible for protecting the public health by assuring the safety, and efficacy of human and veterinary drugs, biological products, and medical devices. FDA also is responsible for protecting the public health by assuring the safety of our nation's food supply, cosmetics, and products that emit radiation. The FDA also advances the public health by helping to speed innovations that make medicines more effective, and safer; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Source:
Tom Huddleston
American Association of Pharmaceutical Scientists

• Additional
• References
• Citations