Translational Research Workshop

"Regulatory considerations in the translation of basic discoveries into human therapies "

Date and Time: March 30, 2012 - 11:30am - 1:30pm
Location: Joseph B. Martin Conference Center at Harvard Medical School, Pechet Room, First Floor, 77 Avenue Louis Pasteur, Boston, MA

Guest speakers:

"Translating discovery research into human therapeutics"
David Williams, MD

Chief of the Division of Hematology/Oncology
Director of Translational Research, Children's Hospital Boston
Associate Chairman, Department of Pediatric Oncology
Dana Farber Cancer Institute
Leland Fikes Professor of Pediatrics, Harvard Medical School

"Developing Stem Cell-Based Therapies:  FDA Preclinical Regulatory Considerations"
Patrick Au, PhD
Division of Clinical Evaluation and Pharmacology/Toxicology
Office of Cellular, Tissue, and Gene Therapy
Center for Biologics Evaluation and Research
Food and Drug Administration

"The importance of regulatory planning for your translational research project"
Matthew Wladkowski, MS
Regulatory Affairs Coordinator, Translational Research Program at Children's Hospital Boston

Light lunch will be provided.