Drug Development: SSF, CA

Stacey Franklin

Date: October 12, 2017
Time: 9:00 am  to  4:30 pm

Drug Development Immersion

DateOct 12-13, 2017
Time9:00 am – 4:30 pm
Fee$1390 | CLSA Member Discount $1290
LocationCLSA Offices, 250 East Grand Ave Suite 26, South San Francisco, CA 94080
ExtrasLunch and all course materials included
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.

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Location

250 East Grand Ave Suite 26, S. San Francisco, CA 94080

Agenda

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

Instructor

Claire Gelfman, PhD

Drug Development Expert | Instructor

Claire M. Gelfman, Ph.D., is the Senior Director of Scientific Services at Ora, Inc., an ophthalmic contract research organization (CRO) providing preclinical, regulatory, and clinical trial services for companies worldwide. Her responsibilities in this role include the design and implementation of preclinical translational strategies and their integration into the clinical development process for the advancement of therapeutics to treat major unmet medical needs. Prior to Ora, Dr. Gelfman spent 12 years at Lexicon Pharmaceuticals in the area of molecular genetics where she was involved in early drug target discovery using molecular, cellular, and biochemical approaches, and directed in vivo pharmacology efforts in the areas of ocular inflammation and retinal degeneration. Her experience covers 17+ years’ in drug discovery and development, spanning academia, biopharma, and the CRO industry. Dr. Gelfman holds a BA in Biology from Washington University in St. Louis, and a Ph.D. in Biochemistry from The University of Texas at Austin.

Refund Policy

All courses and products are final sale. No refunds, exchanges or transfers. If you can not 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.

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