Drug Development Immersion is an intensive two-day course concentrating on the regulatory, commercial and scientific considerations required to successfully bring a drug to market. Discussion points will feature both small molecule and biologic products. Numerous personal accounts and war stories are used to illustrate the decision-making process companies use, giving participants a working knowledge of strategic development.

Day One
Drug Development Overview 9:00–10:00
Drug Development Process Map
Success Metrics & Chances of Success
Timelines & Costs
FDA & EMA Approvals

Types of Drugs 10:00–10:45
Drug Defined
Types of Drugs
Product & Data Exclusivity
Approval Process for Generics: FDA & EMA
Approval Process for Biosimilars: FDA & EMA
Novel Biologics

Break 10:45–11:00

Drug Discovery 11:00-12:00
Target Identification
Potential Targets: Pharmacology
Target Validation
Assay Development
Screening
Animal Models
Lead Optimization
Case Study: Multiple Sclerosis
Drug Development Organizations

Lunch provided 12:00–1:00

Integrated Development & Strategic Considerations 1:00-1:30
Draft Label
Therapeutic Target Profile
Integrated Development Process
Project Teams
Stage Gates

Break 2:15-2:30

The Regulatory Process 2:30-4:15
Regulatory Agencies
FDA & EMA Mission
FDA & EMA Organization
FDA User Fees & Review Times (PDUFA, GDUFA, BsUFA)
FDA Risk Evaluation & Mitigation Strategy (REMS)
FDA & EMA Formal Meetings With Sponsors
FDA & EMA Desirable Designations
FDA & EMA Orphan Drug Designation
EMA User Fees & Review Times
EMA Risk Management Plan (RMP)
US & EU Regulatory Compliance

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

Day Two
Product Design & Manufacturing 9:00-10:15
Chemical Manufacturing Controls
Product Design
Routes of Administration
Making Therapeutics in Cells
Cell Line & Cell Bank Development
Upstream & Downstream Bulk Processing
Large Molecule Formulation
Stability & Analytical Testing of Protein Products
Small Molecule Manufacturing Overview
Small Molecule Formulation

Break 10:15-10:30

Preclinical Development: The IND & CTA 10:30–12:00
Mutagenicity & Carcinogenicity Testing
Toxicology
Reproductive & Developmental Toxicology
Safety Pharmacology
Absorption, Distribution, Metabolism, Excretion (DMPK)
Preclinical Studies Overview
IND/CTA Types & Approval Times

Lunch provided 12:00–1:00

Clinical Development 1:00–3:00
Clinical Protocols
Investigator Sites
Study Design & Endpoints
Statistical Considerations
Adaptive Designs
Phase I
Pharmacokinetics & Pharmacodynamics
Phase IIA & IIB
Phase IIIA & IIIB
FDA & EMA Approval Process

Product Launch 3:00-4:15
Marketing Plans
Manufacturing & Supply Chain
Payer Strategy
Pricing
Sales Force Readiness
Patient Strategy
Medical Affairs Readiness
Phase IV
Pharmacovigilance

Q&A|Review 4:15–4:30


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