Scendea presents
Drug Development Through a Regulatory Lens:
From Basic Research to Clinical Trials
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
- Target Product Profile (TPP) development
- FDA interactions and expedited designation programs
- New FDA initiatives and emerging regulatory programs
Interactive Q&A and discussion of real-world development challenges
Presented by:
- 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
- Hannah Lewis, PhD, Team Lead (US) & Principal Consultant specializing in global regulatory strategy and clinical development
We hope you'll join us for this informative discussion on navigating the path from the laboratory to the clinic.
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.
