Drug Development Primer is an intensive one-day course concentrating on the FDA regulatory considerations required to successfully bring a drug to market in the US. Discussion points will focus on biologic products.

Drug Development Overview 9:00–9:45
Success Metrics & Chances of Success
Timelines & Costs
Commercial Considerations
Integrated & Global Development

Selecting Drug Candidates 9:45–11:00
Macro Commercial Input
Market Dynamics
Drug Target
Types of Targets
Identifying the Target
Druggability
Early Toxicology
Pharmacology
Absorption, Distribution, Metabolism, Excretion (ADME)

Break 11:00–11:15

Development: General Considerations 11:15–12:00
Therapeutic Target Profile
Draft Label
Commercial Evaluation

Lunch 12:00–1:00

Investigational New Drug 1:00–2:00
Investigational New Drug (IND)
Clinical Trials Application (CTA)
Preclinical Trials
IND Application & Safety
Preclinical Development (Post-IND)
NDA & BLA
Approval Process

Break 2:00–2:15

Clinical Development 2:15–4:15
Clinical Trial Considerations
Design, Endpoints & Statistics
Clinical Holds
Phase I
Phase IIA & IIB
Phase IIIA & IIIB
Phase IV
Safety

Q&A|Review 4:15-4:30