From a Beaker to a Bottle: Overview of the Drug Discovery and Development Process for Small Molecule TherapeuticsProfessional Growth Channel
Ever wondered what it takes for a molecule in a laboratory to become an approved drug on the market? It has been estimated that it costs over $1Billion to bring a drug into the market. The drug discovery and development process is a high risk but exciting endeavor akin to finding a diamond in a coal mine. Join us as Ann Newman, of Seventh Street Development Group, shares her decades of experience and provides you with an overview of the process. Learn how chemistry is making a valuable impact in the drug discovery industry.
What You Will Learn
- The complex scientific and regulatory process needed to get a new drug on the market
- How long it takes, how much it costs, and the odds of getting one new drug approved
- The animal trials, clinical trials, and human volunteers needed to test a new drug
- How generic drugs are approved and the role of patents in the regulatory process
Date: Thursday, May 6, 2010
Time: 2:00-3:00 pm ET
Meet Your Expert
Dr. Ann Newman is a pharmaceutical consultant at Seventh Street Development Group, a consulting and training firm specializing in solid state chemistry and pharmaceutical development, who has over 20 years of large pharma and contract research experience. Dr. Newman received her PhD in chemistry from the Univ. of Connecticut and for the first ten years of her career performed characterization studies on a wide range of pharmaceutical systems at Bristol-Meyers Squibb, covering drug substance and product scale-up from late drug discovery to launch and manufacturing. From there she became VP of Materials Science at SSCI, Inc. where she was involved in characterization of API and drug product samples, crystallization and polymorph screen studies, salt and cocrystal selections, quantitative assays, amorphous and amorphous dispersion projects, and general problem solving for the pharmaceutical industry. As VP of R&D at Aptuit, she instituted a companywide R&D initiative over six global sites and covering areas such as API, preclinical (toxicology, safety, pharmacokinetics), formulation, solids, analytical, clinical packaging, and regulatory. She holds an adjunct faculty position in Industrial and Physical Pharmacy at Purdue Univ. and is an author/collaborator on over 100 articles, book chapters, and scientific presentations.
The Fine Print
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