Drug Development: West Windsor, NJ

gen herres

Date: 09/28/2017
Time: 9:00 am  to  4:30 pm

Drug Development Immersion

DateSept 28-29, 2017
Time9:00 am – 4:30 pm
LocationThe Conference Center at Mercer, 1200 Old Trenton Rd, West Windsor, NJ 08550
IncludedLunch and all course materials
Drug Development Immersion

Drug Development Immersion is a two-day, intensive course focused on the regulatory, commercial and scientific considerations required to bring a drug successfully to market. Discussion points feature both small molecule and biologic products. Post-approval commercial considerations and risk management are also discussed. Numerous personal accounts and war stories are used to illustrate the decision-making process companies use, giving participants a working knowledge of strategic development. Learn what it takes to get a molecule from the bench into the marketplace by an industry expert who has received drug approvals in both the US and Europe.

All course materials are handed out at the course. There is no pre-work required. Lunch will be provided.


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1200 Old Trenton Rd West Windsor, NJ 08550


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
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
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
FDA & EMA Approval Process

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

Q&A|Review 4:15–4:30


Joseph H. Quinn

Biopharmaceutical Regulatory Expert | Instructor

Joe Quinn is an independent Regulatory Affairs Consultant in the biopharmaceutical industry.  Joe has more than thirty years of experience in the field of biologics/vaccines, including assignments in Quality Control, Research, Product Development & Scale-Up, Bioanalytical Development & Validation, Project Management, and Regulatory Affairs.  Joe was employed by Sanofi Pasteur for twenty-eight years, most recently in the position of Senior Director, Head of North American Regulatory Affairs.  Joe teaches graduate-level courses in the Temple University Regulatory Affairs and Quality Assurance program.  Joe holds a Master of Science degree in Quality Assurance and Regulatory Affairs (Temple University School of Pharmacy), Master of Science degree in Chemistry (University of Scranton), Bachelor of Science degree in Biochemistry (The Pennsylvania State University), and Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society.

Refund Policy

All courses and products are final sale. No refunds, exchanges or transfers.  If you cannot attend your purchased event, you may send someone in your place by notifying Sheila Wagner, Wagner@BiotechPrimer.com, no later than one week before the start date of the class. With the purchase of this course, you will automatically be registered for our WEEKLY. You will receive this free educational newsletter, conveying the science behind the headlines, every Thursday. You may unsubscribe with one click at anytime.