Drug Development is 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.
Register at http://goo.gl/yJc4a
Class Details:
Date: December 8, 2011
Time: 9:00am-4:30pm
Location: Latham & Watkins, 140 Scott Drive
Menlo Park, CA 94025
Fee: $600 BayBio Members
$695 Non-Members
Discount Code: DD1211 (No Refunds Given)
Deliverables: Handout of all the presentation slides. A light breakfast and lunch will be served.
Class Agenda:
Drug Development Overview 9:00-10:00
• Success Metrics and Chances of Success
• Timelines and Costs
• Milestones
• Go-No Go Decisions
• Integrated and Global Development
Origin of New Drugs 10:00-11:00
• Plants, Animals and Laboratories
• Rational Drug Design and Targets
• Combinatorial Chemistry
• Alliances
• Start-ups
Break 11:00-11:15
Selecting Drug Candidates 11:15-11:45
• Macro Commercial Input
• Market Dynamics
• Chemistry
• Drugability
• Early Toxicology
• Pharmacology
• ADME
Target Product Profile 11:45-12:15
• Draft Label
• Commercial Evaluation
• Exclusivity and Patents
• Waxman Hatch
Lunch 12:15-1:00
The Regulatory Process 1:00-1:45
• History of Regulation
• IND* and CTA*
• FDA, EMEA* and ICH*
• NDA*, MAA*and CTD*
• Clinical Holds
• Quality Assurance
• GMP*, GLP* and GCP* Drug Development Pre-IND 1:45-2:15
• CMC*
• Characterization, Purity and Stability
• Formulation
• Preclinical
Break 2:15-2:30
Clinical Development 2:30-3:30
• Clinical Trial Considerations
• Design, End Points and Statistics
• Phase 1
• Phase 2a and 2b
• Phase 3 and 3b
• Phase 4
• Safety
• Pharmacoeconomics
• Life Cycle Management
• Risk Management Plan
Commercial Considerations 3:30-4:15
• Pricing
• Market Entry
• Forecasts
• Marketing, Sales and Promotional Activities
Wrap-Up 4:15-4:30
• Review
• Evaluations
*IND: Initial New Drug Application; *CTA: Clinical Trial Application; *EMEA: European Medicines Evaluation Agency; *ICH: International Conference on Harmonization; *NDA: New Drug Application; *MAA: Marketing Authorization Application
Instructor: Simon J. Tulloch, MD
Dr. Tulloch has more than 20 years of pharmaceutical and biotech experience in clinical development, R&D management, and business roles, both in Europe and the USA. For the last three years he has been the Chief Medical Officer at InfaCare Inc, a privately funded biotech company in the Philadelphia area. Prior to InfaCare, Dr. Tulloch spent ten years at Shire Pharmaceuticals Inc. He moved to the USA to establish a U.S. research and development organization- Shire Pharmaceutical Development Inc. Dr. Tulloch built the organization to 70 people, from all areas of drug development, and successfully conducted the development and NDA approval of Adderall XR, now a billion dollar drug, for Shire. During that time his organization also developed and got NDA approvals for Fosrenol (Shire's first global NCE) and Equetro, as well as providing CMC, preclinical, and marketing medical support to all of Shire's U.S. products. Latterly, he assumed the role of head of the global CNS Business Unit as Shire underwent significant management change in its transition to a big pharmaceutical company.
Prior to his time at Shire, Dr. Tulloch spent eight years with Johnson and Johnson companies, including five years as clinical research director for R.W. Johnson PRI's European R&D facility in Zurich, Switzerland, working on multiple projects in various therapeutic areas and stages of development.
Who Will Benefit:
• Professionals from all sectors of the biotech, pharma and life sciences industries, including: sales, marketing, HR, legal, manufacturing, business development, finance, management, government relations, IT, safety, tech transfer
• Policy makers, lobbyists, attorneys
• Venture capitalists, angel investors, banks, analysts, financial managers
• Insurance brokers, real estate professionals
• Consultants, public relations specialists, journalists
• Bioscience association staff, economic development executives
• University administrators, research institute support staff
Past Class Participants Include:
Amgen, Amylin Pharmaceuticals, Alexandria Real Estate, AstraZeneca, Biogen Idec, BIO, California Healthcare Institute, Chubb Insurance, Deloitte & Touche, Ernst & Young, Genentech, GE Financial, IBM, Life Technologies, Johns Hopkins University, KPMG, RENO Construction, Marsh, MedImmune, Merrill Lynch, Miles & Stockbridge P.C., Millipore, Morrison & Foerster LLP, Novartis, SAS, Stratagene, UCSF
Questions?
Contact Kerri Muir at 410-377-4429 ext. 22 or muir@biotechprimerinc.com
