Our TeamInvestors and Industry Leaders
Dr. Nikunj Patel
Dr. Nikunj Patel is the President of Prolong Pharmaceuticals, a clinical-stage biopharmaceutical company with novel therapeutics. He also currently holds an Executive Vice President role at Kashiv Biosciences, where he oversees their clinical development for both their biosimilar and 5050(b)(2) portfolios. He brings over 18 years of leadership experience as a pharmacologist in all phases of clinical drug development, including global registration trials, drug development processes, and clinical trial design. Prior to joining Prolong, Dr. Patel built his technical expertise in numerous leadership roles, most notably as EVP and Head of Operations at Amneal Pharmaceuticals, where he played several key roles across the entire development of several blockbuster products. Dr. Patel also has a successful track record within major roles at clinical research organizations, designing and supervising a large variety of global clinical trials. Dr. Patel earned his MD degree from B.J Medical College India.
HEAD OF OPERATIONS
Dr. Chandra Rawal
Dr. Rawal is the Head of Operations of Prolong Pharmaceuticals. He also currently holds a Chief Operating Officer role at Kashiv Biosciences, where he oversees Quality Management, Operations, and Biosimilar Development. He has over 17 years of diversified manufacturing experience in various dosage forms, including oral solids, complex injectable, inhalation, and biologics. Dr. Rawal has been instrumental in building infrastructures for cGMP manufacturing plants and building operational teams. Prior to his tenure with Kashiv, Dr. Rawal headed global commercial manufacturing plants for Amneal Pharmaceuticals, and supported filing of applications for approval for multiple complex generic products in the US and EU markets. Dr. Rawal has interacted with diverse cultures and has led international teams throughout the world. He has led many successful FDA and EU inspections throughout his career. He has a wide variety of industry experience in disciplines such as Clinical, Manufacturing, Commercialization, Quality and Project Management. Prior to entering the pharmaceutical industry, Dr. Rawal was the Chief Medical Administrator for a chain of hospitals and was part of global quality accreditations, such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the National Accreditation Board for Hospitals & Healthcare Providers (NABH) in India. Dr. Rawal received his Doctor of Medicine (M.D.) from M.P. Shah Medical College in Jamnagar, Gujarat, India and his Masters in Healthcare Management from Central Michigan University (CMU).
VICE PRESIDENT – R&D
Dr. Ron Jubin
Dr. Jubin is Vice President of Research and Development at Prolong Pharmaceuticals and brings more than two decades of experience at the forefront of drug discovery. Dr. Jubin’s experience includes key roles at Schering-Plough Research Institute and PBL Biomedical labs. At Schering-Plough, Dr. Jubin served in major roles in the hepatitis C protease program, directed other HCV inhibitor programs, and managed internal committees evaluating licensing opportunities for a novel interferon candidate. At PBL Biomedical, his tenure leading the Research and Development department at PBL resulted in the development of numerous interferon proteins, reagents, and functional assay for evaluating immune and interferon functions. Dr. Jubin received his PhD in Microbiology and Molecular Genetics from the UMDNJ-NJMS Graduate School of Biomedical Sciences, Newark, NJ.
SENIOR VICE PRESIDENT – REGULATORY
John Pakulski is the Senior Vice President of Regulatory Affairs at Prolong Pharmaceuticals. He also holds the same role at Kashiv Biosciences. Mr. Pakulski has over 35 years’ experience in regulatory affairs in the development and maintenance of novel drugs, biologics, 505(b)(2) products, and biosimilars. He has been a leader in global regulatory affairs for biosimilars and helped shape the biosimilar pathway in the US. He has served as Vice Chairman of the Biosimilar Council, Chair of the Association of Accessible Medicines (AAM) Biosimilars Working Group prior to the establishment of the Council, Chair of the Biosimilar Forum Regulatory Committee, and represented AAM during both Biosimilar User Fee Negotiations with FDA. Under his leadership at Mylan, the first biosimilar (trastuzumab) was approved in the U.S., two Biologics License Applications (BLAs) and 505(b)(2) biologics New Drug Applications (NDAs) were submitted to the U.S. F.D.A., and three Market Authorization Applications (MAAs) were submitted to the European Medicines Agency (EMA). He headed U.S. Biopharmaceutical Regulatory Affairs at Sandoz Inc., where he was involved with the approval of the first biosimilar in the US and with the submission of two additional biosimilar BLAs. Prior to his involvement with biosimilars, he worked for over 20 years on novel drugs and biologics, and 505(b)(2) products in roles of increasing responsibility within global and U.S. regulatory affairs at Pfizer, Aventis, and Sanofi. He has broad experience on the regulatory aspects of the technical and clinical development for drugs and biologics in a variety of therapeutic areas. Mr. Pakulski is a pharmacist and graduate of Rutgers College of Pharmacy.
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Expanded Access Policy
Prolong Pharmaceuticals, LLC does not provide any drug in development to patients unless they have been accepted into one of our ongoing clinical trials. For more information on our ongoing clinical trials, please contact email@example.com