Healthcare Industry News: FluMist
News Release - January 20, 2016
Immunotherapy Company PDS Biotechnology Strengthens Senior Management Team, Adds Two Drug Development ExecutivesNORTH BRUNSWICK, N.J., Jan. 20, 2016 -- (Healthcare Sales & Marketing Network) -- PDS Biotechnology, a clinical-stage biotechnology company developing cancer immunotherapies, is pleased to announce the appointments of Dr. Robert Shepard, M.D., F.A.C.P. as Chief Medical Officer, and Dr. Panna L. Dutta, Ph.D. as Vice President of Drug Development and Manufacturing.
In his role as Chief Medical Officer, Dr. Shepard will oversee all clinical development programs for the Company's Versamune® platform. PDS is currently completing a Phase I clinical trial on its lead cancer immunotherapy (PDS0101), an innovative first-in-class immunotherapy under development to treat cancers and diseases caused by infection with the human papillomavirus (HPV) such as cervical cancer, head and neck cancer and cervical intraepithelial neoplasia. PDS expects to initiate multiple Phase II clinical trials over the next 18 months, including several to evaluate PDS0101 in HPV-related early- and late-stage cancers.
Dr. Shepard is a leading authority on clinical oncology and immunotherapy. He has led the clinical development of multiple notable oncology drugs and immunotherapies over the past 20 years. Most recently, Dr. Shepard served as the global lead for several ongoing cancer trials at AstraZeneca, including prostate and breast cancer trials. Dr. Shepard was previously Chief Medical Officer at Callisto Pharmaceuticals and Cornerstone Pharmaceuticals, where he led clinical development of cancer drugs. He was also Medical Director of Oncology Clinical Research & Development at AstraZeneca, and served as a Medical Officer at the FDA's CBER Division, Oncology Branch, where he was involved in the medical review of the ground-breaking cancer drugs Avastin® and Erbitux®.
Dr. Shepard holds an M.D. from Duke University, where he focused on oncology and immunology. He performed his fellowship training in hematology and oncology at the Tufts-New England Medical Center and at the Dana-Farber Cancer Center.
Dr. Dutta is one of the industry's leading experts in the development of sterile injectable drugs. In his role as Vice President of Drug Development and Manufacturing, Dr. Dutta will lead PDS's product development and manufacturing activities. Dr. Dutta brings extensive expertise in drug development, manufacturing and commercial launch of products in the USA, Europe, and emerging markets. Dr. Dutta joined PDS from The Medicines Company, where he led the successful approval and launch of Kengreal®, an injectable platelet inhibitor. Dr. Dutta was previously at Pfizer (formerly Wyeth Vaccines), where he led the development, approval and commercial launch of two of the industry's most successful multibillion dollar vaccines, Prevnar® and FluMist®. Dr. Dutta began his industrial career at Baxter Healthcare as a Senior Research Scientist developing therapeutic products and immunodiagnostics.
Dr. Dutta holds a Ph.D. from the Massachusetts College of Pharmacy, Boston.
Frank Bedu-Addo, PDS's Chief Executive Officer, said: "We are very pleased that Rob and Panna have joined PDS to complement our drug development and clinical leadership teams. Their extensive clinical and product development experience will be tremendous assets as we continue to expand our clinical program to include several upcoming Phase II clinical trials, starting later in 2016."
Versamune® is a clinical stage and synthetic lipid-based immunotherapy platform. Due to its unusual combination of high safety and CD4+/CD8+ T-cell induction in humans, Versamune® has demonstrated the potential to achieve the ultimate goal of cancer immunotherapy: to effectively prevent and treat cancer in its most treatable early stages. Versamune® is unique in its demonstrated potential to activate all three critical immunotherapy mechanisms upon simple sub-cutaneous injection. The Versamune® platform is now being applied to the development of multiple clinical-stage cancer products.
About PDS Biotechnology
PDS Biotechnology is a private biopharmaceutical company with a growing pipeline of simpler, safer, and more effective clinical-stage immunotherapies to treat multiple early-stage and late-stage cancers. PDS is in the final stages of completing its first oncology human clinical trial and expects to report these Phase I study results at ASCO in May 2016. PDS is also applying the versatile Versamune® platform to the prevention of selected pandemic diseases.
Source: PDS Biotechnology
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