July 21, 2016 9:35am
To advance pre-clinical studies ...
Harout DerSimonian, Ph.D. has joined BSTG as Chief Scientific Officer (CSO), a new position at Biostage. Dr. DerSimonian will direct and manage the cell biology, materials science and other scientific research that forms the basis of Biostage's Cellframe™ technology platform.
Dr. DerSimonian has over 20 years of experience in developing immunotherapy and cell therapy programs and was instrumental in directing the science that enabled the first FDA-approved clinical trial using autologous human stem cells for cardiac repair. Throughout his career, he has played a critical, senior role in designing and implementing therapeutic programs at leading global institutions. Dr. DerSimonian is a former assistant professor and post-doctoral fellow at Harvard Medical School and completed his post-doctoral training at the Dana-Faber Cancer Institute and Brigham and Women's Hospital. Dr. DerSimonian holds a Ph.D. in immunology from Tufts University and a B.A. in biology from Hartwick College.
The Bottom Line: Cellspan implants are currently being advanced and tested in preclinical studies.
- This testing is intended to expand the base of pre-clinical data in support of Biostage's goal of filing an Investigational New Drug (IND) application with the U.S. FDA in late 2016.
- The IND will seek approval to initiate clinical trials for its esophageal implants in humans.
- An IND filing is NOT a “Holy Grail” …
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