Drug Development Briefing

When Tuesday, November 12, 2013
9:00 a.m. - 4:30 p.m.
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RSVP by Sunday, November 10, 2013 11:45 p.m.
Where Biocom Boardroom
4510 Executive Drive, Plaza 7
San Diego, California 92121




A one-day class delivering an overview of the discovery, development, and regulatory processes for bringing a new drug to market. Participants will learn about the business and scientific decisions involved in moving a product forward from basic research into preclinical and clinical trials, as well as a detailed consideration of the regulatory requirements of clinical development. Post-approval commercial considerations and risk management will also be discussed.

Agenda

DRUG DEVELOPMENT OVERVIEW 9:00-10:00

•  Success Metrics & Chances of Success
•  Timelines & Costs
•  Commercial Considerations
•  Integrated & Global Development
•  Hope for the Future

ORIGIN OF DRUGS 10:00-10:50

•  Drug Defined
•  Types of Drugs
•  Drug Discovery Methods
•  Drug Development Organization

BREAK 10:50-11:00

SELECTING DRUG CANDIDATES 11:00-11:45
•  Drug Target
•  Types of Targets
•  Identifying the Target
•  Druggability

DEVELOPMENT: GENERAL CONSIDERATIONS 11:45-12:15
•  Draft Label
•  Commercial Evaluation
•  Exclusivity and Patent

LUNCH 12:15-1:00

THE REGULATORY PROCESS 1:00-1:45
•  History of Regulation
•  FDA
•  PDUFA
•  Special Protocol Assessment (SPA)
•  Regulatory Interactions & Tools
•  Regulatory Compliance
•  Generics & Biosimilars
•  Orphan Drug

THE INVESTIGATIONAL NEW DRUG & CLINICAL TRIALS APPLICATION 1:45-2:30
•  Investigational New Drug (IND)
•  Clinical Trials Application (CTA)
•  Preclinical Development (Pre-IND)
•  Preclinical Trials
•  IND Application & Safety
•  Preclinical Development (Post-IND)
•  NDA & BLA
•  Approval Proce

BREAK 2:30-2:45

CLINICAL DEVELOPMENT 2:45-4:15
•  Ethical Considerations
•  Regulatory Issues
•  Parallel vs. Crossover Studies
•  Phase 0 Clinical Trials
•  Pharmacokinetics & Pharmacodynamics
•  Phase I
•  Phase II
•  Phase III
•  Phase IV
•  Safety
•  Pharmacogenomics
•  Life Cycle Management

Q&A/REVIEW 4:15-4:30

Deliverables: A reference manual containing all of the slides used in the class, additional scientific
information and glossary of biotech terms. Lunch will be served.

Refund Policy: We do not refund purchases. However, if you cannot attend, you may send someone from your organization in your place.

Questions? Contact Heather Bergan at bergan@biotechprimerinc.com

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Planner Wendela Heering