Leading experts to evaluate the clinical and regulatory path to approval in the US market of COVAXIN™, a whole-virion inactivated COVID-19 vaccine
MALVERN, Pa., Dec. 23, 2020 (GLOBE NEWSWIRE) — Ocugen, Inc., (NASDAQ: OCGN), a leading biopharmaceutical company focused on discovering, developing and commercializing a pipeline of innovative therapies, today announced the appointment of a vaccine scientific advisory board comprised of leading academic and industry experts in the vaccine field to evaluate the clinical and regulatory path to approval in the US market of Bharat Biotech’s COVAXIN™, a whole-virion inactivated COVID-19 vaccine candidate to be co-developed by Ocugen and Bharat Biotech for the US market.
Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen remarked, “We are thrilled to welcome this group of esteemed thought leaders to the Ocugen team to assist in our co-development with Bharat Biotech of COVAXIN™. This unique yet traditional vaccine candidate is different from other options currently available in the US market with potentially broader coverage against multiple protein antigens of the virus.”
The vaccine scientific advisory board consists of:
- Satish Chandran, PhD, Wyeth Vaccines, Pfizer, Nucleonics, Somahlution
Dr. Chandran founded Somahlution and is currently the Somahlution’s Chief Executive Officer and a member of the Board of Directors since inception in 2010. Prior to Somahlution he was the Chief Technology Officer at Pfizer Biotherapeutics and prior to that was the COO and CSO of Nucleonics, Inc. Satish started his biotech career at Apollon, Inc., headed the DNA vaccines at Wyeth Vaccines. He is a biotechnology veteran with nearly 30 years of leadership positions. Over the last 30 years, his career in biological research and development has spanned across academia and industry; early start up and mid-stage biotech companies and in large pharmaceutical companies. Satish’s passion and strength are in building and assembling teams and taking novel concepts and therapeutic strategies into products through development, regulatory approval, and commercialization. He is currently on the Board of Directors and serves as scientific advisor and consultant to several biotechnology companies.
- David Fajgenbaum, MD, MBA, MSc, FCPP, Translational Medicine & Human Genetics, University of Pennsylvania, Founding Director of Center for Cytokine Storm Treatment & Laboratory
Dr. Fajgenbaum is an Assistant Professor of Medicine in Translational Medicine & Human Genetics at the University of Pennsylvania, Director of the Penn Center for Cytokine Storm Treatment & Laboratory, Executive Director of the Castleman Disease Collaborative Network, and Associate Director, Patient Impact for the Penn Orphan Disease Center. He is doing groundbreaking work to advance precision medicine for Castleman disease, a condition that he is battling as a physician, researcher, advocate, and patient. Combining omic technologies with machine learning and other bioinformatic tools, Dr. Fajgenbaum has discovered novel predictive biomarkers of treatment response and novel treatment approaches, including one that is saving his life and others. Now, he is spreading this approach to other diseases such as COVID19.
- Bruce Forrest, MB, BS, MD, MBA, Wyeth Vaccines, Pfizer
For over 25 years, Dr. Forrest worked as a pharmaceutical industry physician leading the global development of pharmaceuticals, vaccines, and biological drugs. As Senior Vice President at Wyeth Vaccines, Dr. Forrest was responsible for all late phase clinical and pharmaceutical science development activities for vaccines in the Wyeth pipeline, including Prevnar 13®; the meningococcal B vaccine (Trumemba®) and an early investigational Staphylococcus aureus vaccine. This role included managing a vaccines’ development organization situated in North Carolina and New York, responsible for all R&D CMC and Manufacturing activities. In addition, Dr. Forrest was responsible for management and oversight of all Vaccines Clinical Research clinical trial and development activities globally with a dedicated vaccines clinical staff. He led the clinical activities supporting the market authorization for RotaShield® (EU), Prevnar® (Global), and FluMist®. Dr. Forrest also served as the Corporate Officer and Member of the Board of Wyeth K.K. during his tenure in Japan. He joined United Biomedical, Inc. in 1993 leading the earliest international clinical development of HIV vaccines, initiating clinical trials in China, Australia, and Thailand. At Chiron Corporation he was the global clinical team leader for a meningococcal C conjugate vaccine (Menjugate®). Dr. Forrest is an investment banker with a Westchester, NY based investment bank (Young America Capital, LLC) where he co-heads Life Sciences Investment Banking. He also owns an independent FINRA-registered investment advisory firm that is regulated by the State of New York (Aeolian Advisors Corp.).
- Catherine Pachuk, PhD, Chief Scientific Officer, Marizyme, Wyeth Vaccines, Pfizer and Coronavirologist, Vaccinologist
Dr. Pachuk has over twenty-five years R&D leadership experience in the pharmaceutical and biotech sectors with expertise in both drug, device, and vaccine development with significant experience in nucleic-acid based therapeutic platforms including ASO, RNAi and nucleic-acid based vaccines. Her key areas of therapeutic focus are viral diseases including Hepatitis B, Hepatitis C, and Coronavirus, metabolic disease, HCC, and indications associated with Ischemia Reperfusion Injury. She was involved in advancing multiple product candidates into the clinic and market including several first-in-man compounds. She received her Ph.D. in molecular virology from the University of Pennsylvania where she studied the molecular biology of coronaviruses. She also has a dual Regulatory Affairs Certificate from RAPS (Regulatory Affairs Professional Society) in Medical Devices and Pharmaceuticals.
- Harvey Rubin, MD, PhD, Professor of Microbiology and Infectious Diseases, U Pennsylvania
Dr. Rubin is Professor of Medicine with secondary appointment as Professor of Computer Sciences at the University of Pennsylvania. The NIH, NSF, DARPA, the Global Alliance for TB Drug Discovery, and the Gates Foundation have funded his basic biochemical and genetic research in infectious diseases, resulting in more than 100 peer-reviewed papers. He served on national and international scientific review panels including the NIH, NSF, NASA Intelligent Systems Program, DARPA, and The Medical Research Council, South Africa. He was a member of the U.S. National Science Advisory Board for Biosecurity and the Dept. of Defense/National Academy of Sciences Biological Cooperative Threat Reduction Program. Dr. Rubin is the founder of Energize the Chain, a non-profit organization and GAVI INFUSE and funded partner that ensures the delivery of vaccines to people in the most remote regions of the world by utilizing power and connectivity in the private sector, such as that available at cell tower sites to power the refrigeration systems that are necessary to keep vaccines at the proper temperature.
- Susan Weiss, PhD, Professor of Microbiology, U Pennsylvania. Co-Director Coronavirus Research Center and Renowned Coronavirologist
Dr. Weiss obtained her PhD in Microbiology and Molecular Genetics from Harvard University working on paramyxoviruses and did postdoctoral training in retroviruses at University of California, San Francisco with Mike Bishop and Harold Varmus. She moved to the University of Pennsylvania in 1980, where she is currently Professor and Vice Chair, Department of Microbiology and Co-director of the Penn Center for Research on Coronaviruses and Other Emerging Pathogens at the Perelman School of Medicine. She has worked on many aspects of coronavirus replication and pathogenesis over the last forty years, making contributions to understanding the basic biology as well as organ tropism and virulence. She has worked with murine coronavirus (MHV), MERS-CoV and most recently SARS-CoV-2. Her work for the last ten years has focused on coronavirus interaction with the host innate immune response and viral innate antagonists of double-stranded RNA induced antiviral pathways. Her other research interests include activation and antagonism of the antiviral oligoadenylate-ribonuclease L (OAS-RNase L) pathway, flavivirus- primarily Zika- virus-host interactions and pathogenic effects of host endogenous dsRNA.
About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing transformative therapies to cure blindness diseases. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. For more information, please visit www.ocugen.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.
Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
Chief Financial Officer
ir@ocugen.com
Media Contact:
LaVoieHealthScience
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 978-395-5970