Challenges in Drug Evaluation and Regulatory Science: Applications to Multiple Sclerosis

Course Director: David Golan

Lecturers include:

Dr. Michael Panzara

Dr. Bruce Roberts

Contact information: Dr. Catherine Dubreuil catherine_dubreuil@hms.harvard.edu

Course Description:

Please join the Therapeutics Graduate Program and the Program in Regulatory Science, parts of the new Harvard Program in Therapeutic Science (HITS) (http://hits.harvard.edu/the-program/laboratory-of-systems-pharmacology/about/) on June 19th 2014, from 1pm to 6pm for the following event titled: 

‘Challenges in Drug Evaluation and Regulatory Science: Applications to Multiple Sclerosis’
 
This event has been designed in collaboration with scientists and clinicians from local biotech companies and Harvard Medical School. This course will address regulatory challenges in drug development in Multiple Sclerosis (MS) and how they can be addressed. This will be done by using case studies of two such drugs: Lemtrada (Alemtuzumab) and Tysabri® (natalizumab). The interesting issues and challenges in each of the following areas will be discussed in this course:

•       The clinical course and pathogenesis of multiple sclerosis
•       Clinical trial design challenges
•       Pathogenesis of autoimmune disease in general and how this may relate to management of complications of the treatment of MS
•       Issues related to the development of  a risk evaluation and mitigation strategy (REMS) for such drugs.

This nano course comprises a series of in depth lectures followed by a group discussion.  It is intended to be both educational and to raise important (regulatory) research questions that may, in turn, foster future collaborations.  It is expected to be a very interactive presentation and discussion.

Location: Harvard Medical School, Building C, Cannon Room
240 Longwood Avenue, Boston, MA 02215
Directions to the Cannon Room: http://q2m.hms.harvard.edu/Directions.htm

***Session 2 for student discussion will follow the end of the presentations in the cannon room.