Mohammad Heidaran, Ph.D.

Mohammad Heidaran, Ph.D.

Mohammad Heidaran, Ph.D.

Vice President, Technical

Mo has worked previously as a Branch Chief (Acting) in Division of Cellular and Gene Therapy (DCGT) in the Office of Tissues and Advanced Therapies (OTAT) and as a CBER wide subject matter expert providing advice to ADRM in the Office of CBER Director on special subject matters related to CMC policies and regulatory review management processes. He also has close to 8 years prior experience as a Biologist and as a Master Reviewer in OTAT, and as a facility reviewer and inspector in the Division of Manufacturing and Product Quality (DMPQ). During his tenure at OTAT, in addition to his review responsibilities, he has served as a DCGT representative to several FDA and CBER wide working groups and outside organizations such as USP. He has also been involved in various standard development activities, cell-based product manufacturing initiatives and various compliance actions.

Work Experience

Mo has a multidisciplinary academic and industrial background in basic and applied cell biology and innovative cell therapy and tissue engineering product development. He also has hands-on industrial experience in manufacturing of cell therapy and tissue engineering products for about 15 years in small and large size Biotech companies. His long-lasting scientific interest is to understand the molecular control mechanisms that regulate growth and differentiation of stem cells in the threedimensional microenvironments. He is also founder and first chair of prestigious Gordon Research Conference in “Signal Transduction by Engineered ECMs”.

Education

Mo holds a Ph.D. in biochemistry from the University of South Carolina, and received his formal training at the National Cancer Institute. Prior to FDA, he served as R&D Director at both Celgene and Becton Dickinson. He has been an adhoc reviewer and member of editorial boards of several peer reviewed publications. He also holds 25 issued patents and 54 pending patents and his work has appeared in more than 50 scientific publications.

Connect With Me

We are always available for a conversation.

*