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About Biotech Forums
The Biotech Forum is a bi-monthly event run in partnership with the NC Biotechnology Center. The purpose of the Biotech Forum is to provide a meeting place for entrepreneurs, executives, professionals and academicians actively involved in the biotechnology industry. Each forum consists of a 75 minute panel followed by a networking reception. Next Biotech Forum: How to Work with the FDA
Successfully navigating the FDA approval process is a vital component of any regulated company's business plan. This Biotech Forum will provide practical and timely insight on how to work with FDA from a panel of industry experts. The focus is on providing information that is useful to companies that are dealing with FDA. The speakers will share tips and strategies on whether you are evaluating the possible pathways to approval, charting a clinical study program, or preparing to meet with FDA to discuss a proposed project.
Joseph D’Ambrosio, Partner, Clarkston Consulting
Program Details: Wednesday, March 7, 2012 5:00 pm - 5:30 pm Registration
Location:
Registration
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Speaker Bios
Joseph D’Ambrosio has over 20 years of experience in business and technology consulting. He has worked as a trusted advisor for senior executives, across a variety of regulated industries, in many of the world’s most recognized, innovative, and prestigious companies. As a Partner at Clarkston Consulting, D’Ambrosio has been responsible for the execution and delivery of over 100 business transformation / enterprise systems projects, specifically within the Life Sciences and Consumer Products industries. Areas of focus have included global supply chain, manufacturing, quality, packaging / labeling, compliance, and remediation programs for companies regulated by the FDA as well as other global agencies.
Mark Baumgartner has worked in the pharmaceutical industry for over 29 years and is currently a Senior Director, Global Regulatory Affairs at GlaxoSmithKline (GSK) supporting development of drugs for the treatment of neurologic diseases. He has been a member of the Global Regulatory Affairs team at GSK since 1998 and has experience leading the regulatory activities for projects in all Phases of clinical research from discovery through NDA approval. He has been the Regulatory lead on international teams in multiple therapeutic disciplines. His experience includes a rotation as Senior Director for Regulatory Policy, Intelligence, and Education, during which time he was recognized for his expertise in the area of Risk Management. Prior to joining GSK, Mark was employed by Pharmacia & Upjohn where he held positions in World Wide Regulatory Affairs, Clinical Research, Pharmacovigilance, and Pharmaceutical Product Development and Manufacturing Technical Services. Mark is a graduate of the University of Michigan College of Pharmacy.
Brenda Fielding has more than 20 years experience in the pharmaceutical and biotechnology industry, primarily in the area of Regulatory Affairs and Quality. She joins Clinipace Worldwide through the acquisition of Regulus Pharmaceutical Consulting, where she served as President and Board Chair. She has held senior management positions in US pharmaceutical and biotechnology companies, including Cortech, Gilead Sciences, and Napro BioTherapeutics, Inc. (now Tapestry Pharmaceuticals, Inc.). She has been involved in the successful clinical development of novel drugs, biologics, and drug delivery systems, over a wide range of therapeutic areas including oncology, anti-infectives, immunotherapeutics and ophthalmology. She regularly represents clients at meetings with Regulatory Authorities, including the US Food and Drug Administration.
Andrew Finn, Pharm.D. has been Executive Vice President of Product Development at BioDelivery Sciences International since January 2007. He joined the company in August 2004, upon the acquisition of Arius Pharmaceuticals, of which he was co-founder and Executive Vice President Clinical Development and Regulatory Affairs. Dr. Finn has nearly 30 years of experience in pharmaceutical product development and has played a major role in the development and regulatory approval of 6 individual products over his career, He is responsible for the development of BioDelivery Sciences' portfolio of products (e.g. BEMA® Buprenorphine for chronic pain, BEMA Buprenorphine with Naloxone for opioid dependence, and BEMA Granistron for nausea and vomiting) including pharmaceutical development and manufacturing, nonclinical and clinical development, regulatory affairs and quality assurance. Prior to his involvement with Arius, Dr. Finn was the Executive Vice President of Product Development at POZEN, Inc., where he had similar responsibilities to those at BDSI, he was the co-founder and Chief Executive Officer of enVision Sciences, a regulatory and clinical service company, Vice President of U.S. Clinical Research for Solvay Pharmaceuticals, and held a number of positions with increasing responsibility during his 10 year tenure at Glaxo, Inc. Dr. Finn received his Bachelor of Science in Pharmacy from the University of North Carolina and his Doctorate from the University of Michigan.
Michael Hinckle practice focuses on counseling corporations and individuals on all aspets of FDA regulatory and corporate matters. His primary efforts are in the area of pharmaceutical, medical device, and tobacco product regulation as well as related corporate transactional activities. His experience includes serving as in-house General Counsel for an international pharmaceutical corporation with responsibilities for all legal activities, regulatory affairs, quality assurance, corporate compliance and litigation oversight. Mr. Hinckle’s experience also includes representing clients before the FDA, DEA, North Carolina Department of Agriculture and various State Boards of Pharmacy. He has supervised the filing of numerous ANDAs, 505(b)(2) NDAs, Citizen Petitions and other regulatory filings. His corporate transactional experience includes negotiation and drafting of licensing, supply, distribution, and asset purchase agreements related to FDA-regulated products. |
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