DRUG DEVELOPMENT BOOT CAMP
NOVEMBER 9-10, 2011
THE HARVARD CLUB • BOSTON, MA
The pharmaceutical industry has its fair share of Ph.D.s, and MDs, and yet qualifications do not translate into understanding of the drug development process. In fact, Nobel Laureate scientists find the drug development process bewildering.
As drug development costs increase, the process of drug development is becoming more and more complex. Those involved with the process of developing new therapeutics (drugs, devices, combination products and diagnostics) must understand the process and be able to navigate it with great skill. These skills are difficult to acquire.
The Drug Development Boot Camp was founded by Dr. Lorna Speid. The first Boot Camp was held at Cornell University in September (9 - 10), 2010, and was a great success. Dr. Alan Paau, Vice Provost for Technology Transfer & Economic Development, Cornell University, was the Co-chair of the firstDrug Development Boot Camp.
The Boot Camp at Harvard University will be Co-chaired by Dr. Michal Preminger, Executive Director, Harvard University Office of Technology Development. It will provide a unique opportunity for participants to obtain a hands-on insight into the drug development process from drug discovery (designation of a lead) to registration. The major aspects of development will be considered in detail. Because most people in the industry work in silos, even those with many years of drug development experience will benefit.
Who Should Attend?
- CEOs, CFOs, COOs of biotech companies
- Executives involved with the drug development process
- Small and virtual company executives
- Large pharma professionals involved with drug development
- Regulatory affairs professionals, clinical research professionals, senior research scientists, toxicologists
- Clinical investigators who would like to gain an understanding of drug development, or improve their understanding of the drug development process
- Harvard University Investigators
- Harvard investigators - contact Office of Technology
- Development for information on how to register for the Drug Development Boot Camp
- Patent pitfalls to avoid with hands-on case studies
- How to select the best product candidate to take into development
- The Target Product Profile, and how to define it
- Detailed introduction to global strategic regulatory affairs
- Preclinical efficacy: demonstrating proof of efficacy
- Preclinical toxicology: linking toxicology studies to different clinical phases
- Very detailed session on Chemistry Manufacturing Controls with current best practices
- The clinical phase (strategic and operational sessions)
- How large pharma decides which drugs to license-in