Drug Development Lunch & Learn
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Washington, Washington
Drug Development Through a Regulatory Lens: From Basic Research to Clinical TrialsPresented by Scendea, an international Product Development, Regulatory, and Compliance Consulting Group The GW Technology Commercialization Office (TCO) invites you to join us for an upcoming Lunch & Learn presented by Scendea, an international Product Development, Regulatory, and Compliance Consulting Group. Space is limited. The first dozen GW inventors to register will receive a calendar invitation confirming with the room number. A boxed lunch will be provided. This seminar will feature a practical overview of the drug development process presented by leading Scendea experts. Whether you’re actively developing a new drug or plan to in the future, this session will give you a clear understanding of the process from early discovery to clinical trials and regulatory interactions with the FDA. The agenda includes:An overview of the stages of drug development from discovery to clinical evaluation Regulatory strategy and the pathway to IND submission and human studies Target Product Profile (TPP) development Chemistry, Manufacturing, and Controls (CMC) Nonclinical Mechanism of Action (MOA); pharmacology and proof-of-concept Nonclinical Toxicology Clinical study planning FDA interactions and expedited designation programs New FDA initiatives and emerging regulatory programs Interactive Q&A and discussion of real-world development challenges Scendea presenters include:Susan McCune, MD, executive principal medical consultant, former chief pediatrician at the FDA, and former vice president at PPD/Thermo Fisher Scientific Diana Noah, PhD, head of project management and executive principal consultant with more than 25 years of experience in biologics and infectious diseases WhereRoss Hall 2300 I ST NW Washington, DC 20052