Drug Development Through a Regulatory Lens:
From Basic Research to Clinical Trials
Presented 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
