SAN DIEGO, Jan. 03, 2017 (GLOBE NEWSWIRE) -- Poseida Therapeutics Inc., a San Diego-based company translating best-in-class gene editing technologies into lifesaving therapeutics, today announced that Debra Gessner has joined the company as vice president, regulatory affairs.
Ms. Gessner brings deep expertise in drug development, regulatory communications and strategy — including significant experience in gene therapy and immuno-oncology programs and in working with the FDA’s Office of Cellular, Tissue and Gene Therapies.
“Debra’s significant leadership in regulatory affairs across 40 IND and six NDA filings will immediately benefit our P-BCMA-101 program, Poseida’s autologous CAR-T therapy for multiple myeloma, which has shown unprecedented durability in preclinical studies and is expected to enter the clinic this year,” said Nishan de Silva, M.D., president and chief operating officer at Poseida. “Debra’s background and unique skill set strengthens our leadership team at a key point in the growth of our company, in which a number of CAR-T and gene therapy programs are emerging in our drug development pipeline.”
Ms. Gessner has more than 25 years of hands‐on experience in regulatory affairs and compliance. She has served as vice president of regulatory and quality assurance at Tocagen Inc., a biotechnology company developing novel gene therapies for glioblastomas and other brain cancers, and Sirion Therapeutics Inc., which successfully developed two ophthalmic drug products and gained U.S. approvals for them. She has also served as director of regulatory affairs and quality assurance at Bruin Pharma and Santarus Inc. Ms. Gessner is a member of the Regulatory Affairs Professional Society (RAPS), Parental Drug Association (PDA) and American Society for Gene Therapy, among others, and she plays an active role in the University of California, Los Angeles Technology Development Group Entrepreneurs-in-Residence Program. Ms. Gessner received a Master of Science degree in regulatory affairs from San Diego State University, and a Bachelor of Science degree in medical technology at the University of Texas Medical Branch in Galveston.
About Poseida Therapeutics Inc.
Poseida Therapeutics is translating best-in-class gene editing technologies into lifesaving treatments. The company is developing CAR T-cell immunotherapies for multiple myeloma and other cancer types, as well as gene therapies for orphan diseases. Poseida has assembled a suite of industry-leading gene editing technologies, including the piggyBac™ DNA Modification System, XTN™ TALEN and NextGEN™ CRISPR site-specific nucleases, and Footprint-Free™ Gene Editing (FFGE). For more information, visit www.poseida.com.