A 33,000 Foot Overview of Drug Development: From Out of the Research Laboratories to NDA Filing
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Date: December 15, 2011
Time: 8:30 a.m. - 9:30 a.m.
Topic: A 33,000 Foot Overview of Drug Development
Speaker: Luana Pesco Koplowitz, MD, PhD, FCP, FFPM, President & Chief Medical Officer, DUCK FLATS Pharma, LLC
Location: WilmerHale Venture Group Office
Presentation Summary
Dr. Pesco Koplowitz will highlight the major scientific and medical areas involved in drug development and discuss key factors that can assure positive, cost-effective results during the detailed process, as well as common mistakes that can derail a program. The talk will highlight the major areas involved in the IND/NDA-CTD submission process including nonclinical sciences, chemistry and manufacturing, clinical pharmacology, clinical research and regulatory affairs. This talk is a whirlwind tour covering the progressive path of nonclinical development and clinical research.
About the Speaker
Luana R. C. Pesco Koplowitz, MD, PhD, FCP, FFPM is the President and Chief Medical Officer of DUCK FLATS Pharma, New York-based consulting and contract company she founded 10 years ago. DUCK FLATS Pharma specializes in pharmacology and pharmacokinetics--clinical and non-clinical. The group has a related focus on strategic drug development, translational medicine, PK and PK/PD analyses, POP PK, Modeling, and Phase I-IV trials.
Dr. Pesco Koplowitz received her MD from Rutgers Medical School and her PhD from Rutgers College of Pharmacy and Columbia Pacific University. She completed her training in Clinical Pharmacology at the University of Miami School of Medicine. Dr. Pesco Koplowitz served as Global Group Director of Clinical Pharmacology and US Nonclinical Development for the Janssen Research Foundation of Johnson & Johnson. In addition, she held positions at Knoll Pharmaceuticals, Fujisawa Pharmaceutical Company, the Squibb Institute for Medical Research (now Bristol-Myers Squibb), and Key Pharmaceuticals.
She has been a member of the Advisory Committee of the Cardiac Safety Research Consortium (CSRC) since 2007.
Dr. Pesco Koplowitz has been responsible for numerous successful INDs and NDAs during her extensive career covering many therapeutic areas and holds several use patents in the treatment of various diseases.
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