About Us

Dr. Vijay Tammara, an experienced regulatory scientist with about 30 years of leadership experience in the field of regulatory science and strategic clinical drug development including CMC perspective. 

I have made significant contributions to the approval of 9 Marketing Authorizations (BLAs and NDAs), 2 Biosimilar MAs in emerging markets, 3 ANDAs, 12 Orphan Drug Designations, 7 Qualified Infectious Drug Product Designations, and over 55 INDs. In addition, I led > 50 PIND meetings with FDA, 16 Scientific advice meetings with EMA, 3 device meetings (FDA), 6 meeting with COFEPRIS (Mexico), 3 meetings with ISP (Chile), 4 meetings with ANVISA (Brazil), 2 meetings with DIGIMED (Columbia), 5 meetings with PMDA (Japan), 3 meetings with KFDA (South Korea), 2 meetings with GCC (SFDA, Saudi Arabia and MoH), and 6 meetings with NMPA (China).  

Developed 505(b)(2) strategy for an oral multiple sclerosis product (an IV formulation), successfully filed an IND, obtained orphan designation, and filed an NDA, which is currently under review. 

Developed a clinical strategy for InterferonBeta 1B and negotiated clinical development plan with FDA and EMA using MRI as primary endpoint rather than the traditional relapse rate and enabled initiating Global Phase 3 study. Subsequently EMA issued a guidance recommending MRI as the primary endpoint for interferon beta 1b biosimilars (https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-interferon-beta_en.pdf).  

His research interests include: Regulatory Science with special emphasis on Vaccines, Gene and Cell Therapy, BA/BE, In vitro In vivo correlations, PK/PD relationships, Drug-Drug Interactions, novel biologics, and Pediatric Drug Development.  He is an active member of American Association of Pharmaceutical Sciences (AAPS), since 1988, contributing to many of its educational programs, and Past Chair for the RS section and AAPS Fellows Committee. In addition, he served on the Strategic and Steering committees of AAPS. He has served on several other committees at AAPS.  He had organized and chaired several symposia, workshops, round tables, sunrise sessions, satellite sessions, open sessions for hot topics, open forums, poster-podium sessions, poster sessions, and short courses at national meetings.     

Dr. Tammara is an AAPS Fellow (2006).  Dr. Tammara was also recognized with the AAPS highest recognition in Regulatory Science “Regulatory Science Achievement Award” in 2012 based on his contribution to the field of regulatory sciences and developing several guidelines and FDA policies.  

Vijay previously served as a Senior Vice President, Global Regulatory Affairs and Quality at Ocugen Inc. (wherein I have established Regulatory Group and expanded it by recruiting talented team members), and as an Independent Consultant. I have worked extensively in Neurological, Cardiovascular, Endocrine, Oncology, Infectious diseases (including Vaccines), Devices, Ocular, Gene, and Cell therapy areas.  My experience as an Independent Consultant, VRT Pharma Consulting LLC., Vice President, Clinical Pharmacology and Regulatory Affairs at Frontage Laboratories, Vice President, Global Regulatory Affairs and Project Management, Nuron Biotech Inc., Director, Regulatory Affairs at Merck & Co., Inc., Senior Associate Director at Wyeth Pharmaceuticals and as an Assistant Director at Sanofi-Synthelabo in Worldwide Regulatory Affairs have enabled me to gain insights into drug development and resolve complex issues.  Prior to industrial positions, Dr. Tammara held increasingly responsible positions in the Office of Clinical Pharmacology and Biopharmaceutics at the FDA.  He was a lead Clinical Pharmacology Reviewer and Team Leader for several cardiovascular, anti-viral, ocular, and neurological including anti-migraine, anti-epileptic, Alzheimer, Parkinson’s, and Anti-depressant drugs at FDA and approval of several INDs and NDAs.   He received several FDA awards including the CDER Outstanding Reviewer Award, FDA Outstanding Achievement Award, Group Recognition Awards, Center Director’s Special Citation Awards, CDER Team Excellence Awards, Team Spirit Awards, and Awards of Excellence. He also received awards in the Pharmaceutical Industry including Nuron’s Award of Merit in 2012, Merck’s Awards of Excellence in 2004, 2005, 2007, 2009, and 2010 and Special Recognition Awards in 2007, 2008, 2009, and 2010. He also received several AAPS-RS Awards including RS Section Recognition Awards in 2004, 2006, 2007 and 2010.  

Dr. Tammara received his Ph.D. in Pharmaceutics from the University of Louisiana, Monroe, LA, and received School of Pharmacy Research Achievement Award, in 1993. He is a member of Rho Chi, Phi Delta Chi, and Phi Kappa Phi honor societies.  

Global regulatory leadership is my passion as companies grow to take innovative products to market that deeply impact people’s lives.