The company’s scientific and business executives have extensive industry experience in developing advanced drug delivery technologies, making novel products, and creating high-value enterprises.
Chandramauli Rawal, M.D.
Chief Operating Officer and Head of Biosimilars
Chandra heads Quality Management, Operations, and Biosimilar Development at Kashiv BioSciences. Dr. Rawal has over 17 years of diversified manufacturing experience in various dosage forms, including oral solids, complex injectable, inhalation, and biologics. He has been instrumental in building infrastructures for cGMP manufacturing plants and building operational teams. Prior to his tenure with Kashiv, he 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. He 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, he 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).
John Pakulski, R.Ph.
Senior Vice President – Regulatory Affairs
John has over 30 years’ experience in regulatory affairs in the development and maintenance of novel drugs, biologics, 505(b)(2) products, and biosimilars. Over the past 10 years, 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. John is a pharmacist and graduate of Rutgers College of Pharmacy.