The development of New Chemical and Biological Entities is becoming more and more challenging. Most people agree that the lower hanging fruit has been picked. However, there are steps that companies can take to maximize their chances of success. Drug development 101 requires that companies develop a Target Product Profile (TPP) and a Regulatory Strategy, and yet many companies are failing in these endeavors, or are leaving them out of their development programs altogether.

In this webinar targeted to scientists and project leaders in research and development, Dr. Lorna Speid will discuss and present examples of how to develop the Regulatory Strategy. Dr. John Burke will parallel these examples with case studies on how Model-Aided Drug Invention can support and guide such a regulatory strategy.

Featured Speakers

John M. Burke, PhD 

Co-Founder, President, and CEO
Applied BioMath

Dr. Burke received his Ph.D. in Applied Mathematics from Arizona State University, and his B.S. and M.S. in Applied Mathematics from University of Massachusetts, Lowell. Prior to co-founding Applied BioMath, Dr. Burke was at Boehringer Ingelheim as Associate Director, Head of Systems Biology and promoted to Senior Principal Scientist. Dr. Burke has also held positions at Merrimack Pharmaceuticals, the Systems Biology Department at Harvard Medical School, and in Douglas A. Lauffenburger’s lab at MIT.

Lorna Speid, B.Pharm.(Hons)., M.R.Pharm.S., Ph.D., RAC

Founder and President
Speid & Associates, Inc.

Lorna Speid, B.Pharm.(Hons)., M.R.Pharm.S., Ph.D., RAC works in the area of global and strategic regulatory affairs. Dr. Speid has experience with many therapeutic areas, including oncology, diabetes, obesity, anti-infectives, pulmonary, influenza, women’s health, bone, lupus, arthritis, transplantation, autoimmune diseases, anti-malarials, and CNS. She has worked for a number of international pharmaceutical companies and has a pharmacy degree with honors from London University (King's College) and a Ph.D. from the University of Wales, College Cardiff.


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