New Date: Drug Development for the Non-Scientist
Tuesday, December 11 2012
9:00 am – 4:30 pm
Location: MassBio, 300 Tech Square, 8th Floor, Cambridge
Please note the new date for this course.
Drug Development Primer is a one-day class delivering an overview of the development and regulatory process for bringing a new drug, either a small or large molecule, to market. Participants learn about drug discovery/product development as well as preclinical research, regulated clinical trials and post-approval commercial considerations.
Topics Covered Include:
- Drug Development Overview
- Origin of New Drugs
- Selecting Drug Candidates
- Target Product Profile
- The Regulatory Process
- Drug Development Pre-IND
- Clinical Development
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.
Fees: $795 for MassBio Members; $845 for non-members.
Click here to register: https://secure.massbioed.org/courses/index.php?page_function=detail&course_id=70