Navigation Links
AAPS and FDA announce appointment of research fellow

ARLINGTON, VA. (April 6, 2009) 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 "Ren 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.

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.


Contact: Tom Huddleston
American Association of Pharmaceutical Scientists

Related medicine news :

1. Intrinsic Therapeutics Announces CE Mark for Barricaid Anular Prosthesis
2. Nu Skin Enterprises to Announce First Quarter 2009 Results
3. Health Alliance Announces First Fracture Protection Program for Actonel(R) (risedronate sodium) Tablets
4. Rochester Medical Announces Second Quarter 2009 Earnings Conference Call April 30, 2009
5. Gene Network Sciences Announces Brain Cancer Collaboration With M.D. Anderson
6. HCA Announces Offering of $500 Million Senior Secured First Lien Notes
7. RESOLVE: The National Infertility Association Announces Partnership With CutisPharma
8. PolicyStat Announces John C. Render has Joined company's Board of Advisors
9. Align Technology Announces ClearCorrects Filing of Notice of Voluntary Dismissal of Complaint
10. Lionbridge Announces Partnership with Open Text to Streamline Regulatory Compliance Solutions for Pharmaceutical Companies
11. Dialysis Corporation of America Announces Share Repurchase Program
Post Your Comments:
(Date:6/27/2016)... Overland Park, KS (PRWEB) , ... June 27, 2016 , ... ... leader in retailers of Eyeglasses . , Millions of individuals in the United ... life, eyeglasses have become a way to both correct vision and make a fashion ...
(Date:6/26/2016)... ... 2016 , ... On June 10-11, 2016, A Forever Recovery, a holistic treatment ... Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. This ... of the world’s leading providers of cereal and other breakfast foods. Its residents often ...
(Date:6/26/2016)... ... 26, 2016 , ... PawPaws brand pet supplements owned by Whole ... enhance the health of felines. The formula is all-natural and is made from Chinese ... PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract and ...
(Date:6/26/2016)... Birmingham, Lake Orion, Clarkston, Michigan (PRWEB) , ... ... ... their direction with respect to fertility once they have been diagnosed with endometriosis. ... for tolerable intercourse but they also require a comprehensive approach that can help ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: ... 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) assay ... sepsis or septic shock. With this clearance, Roche is ... a fully integrated solution for sepsis risk assessment and ... with bacterial infection and PCT levels in blood can ...
(Date:6/23/2016)... June 23, 2016 Bracket , a leading ... next generation clinical outcomes platform, Bracket eCOA (SM) 6.0, ... June 26 – 30, 2016 in Philadelphia ... Clinical Outcome Assessment product of its kind to fully integrate ... Bracket eCOA 6.0 is a flexible platform for electronic ...
(Date:6/23/2016)... , June 23, 2016 ... Oticon , industry leaders in advanced ... launch of Oticon Opn ™, the world,s first ... of possibilities for IoT devices.      (Photo: ... Oticon introduces a number of ,world firsts,: ...
Breaking Medicine Technology: