Additions support Obsidian's active program development, operational build-out and ongoing regulatory discussions
Nov. 12, 2019, 08:00 AM Eastern Standard Time
CAMBRIDGE, Mass., Nov. 12, 2019 – Obsidian Therapeutics, a biotechnology company pioneering controllable cell and gene therapies, today announced the appointment of three key members of the Company's development team: Shyam Subramanian, Ph.D., Vice President and Head of Technical Operations; Parnian Zia-Amirhosseini, Ph.D., Vice President and Head of Regulatory Affairs and Quality Assurance; and Melanie Call, Vice President and Head of Program Development.
Dr. Subramanian will lead all aspects of CMC, including process development, analytical development and manufacturing for Obsidian's product portfolio. Dr. Zia-Amirhosseini will lead Obsidian's regulatory efforts and will oversee all product quality initiatives. Ms. Call will lead program management across all internal and external programs at the company, including shepherding Obsidian's lead candidate through IND-enabling studies in 2020.
"Obsidian is rapidly building our development team as we prepare our lead program for first-in-human studies," said Catherine Stehman-Breen, M.D., Obsidian's Chief Development Officer. "The appointments of Shyam, Parnian and Melanie, all exceptionally talented and experienced individuals, signal our focus on moving these important and novel therapeutics into patients. I am thrilled with our momentum and ability to attract leading talent in our industry."
Dr. Subramanian brings to Obsidian over 20 years of post-discovery through commercialization product development experience in biologics, including products in the cell and gene therapy space. Prior to joining Obsidian, Dr. Subramanian was the Head of Cell Therapy Development & Manufacturing at Casebia Therapeutics, leading the CMC development of several novel CRISPR-edited T-cell therapy product candidates for autoimmune diseases. Prior to Casebia, Dr. Subramanian spent 20 years in biopharma—Merck, Chiron, Teva and Johnson & Johnson—with responsibility for early- and late-stage process development, technology transfer and manufacturing support for viral and bacterial vaccines, antibodies, and gene therapy vectors. Dr. Subramanian holds a Ph.D. in Chemical and Biomolecular Engineering from the University of Pennsylvania.
Dr. Zia-Amirhosseini brings to Obsidian 25 years of experience in drug development. She has led regulatory activities for both early and late-stage development programs in multiple therapeutic areas including oncology. Prior to joining Obsidian, Dr. Zia-Amirhosseini was the Executive Director of Regulatory Affairs at Sarepta Therapeutics and the Executive Director of Regulatory Affairs and Quality Assurance at Ambrx. Prior to Ambrx, she worked at Amgen for 14 years, in roles of increasing responsibility, concluding her time as the Global Regulatory Leader for oncology, bone and inflammation projects. She started her career as a reviewer at the Office of Clinical Pharmacology and Biopharmaceutics at FDA. Dr. Zia-Amirhosseini holds a Ph.D. from the University of California, San Francisco, in Pharmaceutical Chemistry.
Ms. Call brings to Obsidian over 25 years of product development, program management and strategic planning experience across multiple therapeutic areas in cell therapy, protein and small molecule therapeutics, and drug delivery. Prior to joining Obsidian, Ms. Call led the Accelerating Center at the Cell and Gene Therapy Center at IQVIA. Prior to IQVIA, she was Vice President, Strategic Planning and Operations at ImmunoCellular Therapeutics, focused on the development of cell therapies in oncology. Previously, Ms. Call worked at Amgen for more than 20 years in product development and R&D project management. While at Amgen, she provided operational leadership for more than 20 cross-functional product development teams, creating and executing global strategic plans that included integrated project planning, product profile development and risk management. Ms. Call holds an M.B.A. from Washington State University and a B.A. in Zoology from the University of Idaho.
About Obsidian Therapeutics
Obsidian Therapeutics is a biotechnology company pioneering controllable cell and gene therapies to deliver transformative outcomes for patients with intractable diseases. Obsidian's proprietary cytoDRiVE™ technology provides a way to control protein degradation using FDA-approved small molecules, permitting precise control of the timing and level of protein expression. The cytoDRiVE™ platform can be applied to design controllable intracellular, membrane and secreted proteins for cell and gene therapies as well as other applications. The Company's initial applications focus on developing novel cell therapies for the treatment of cancer. Obsidian is headquartered in Cambridge, Mass. For more information, please visit www.obsidiantx.com.
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