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.
Navnit H. Shah, Ph.D.
President and Chief Scientific Officer
Dr. Shah is the President and CSO for Kashiv Specialty Pharmaceuticals. With almost 40 years of Formulation R&D experience in various novel drug delivery platforms, Dr. Shah has received numerous awards for his distinguished contributions to the pharmaceutical and biomedical industries. He was elected as an AAPS fellow in 1998 and has received several notable awards, such as the Thomas Alva Edison Award for excellence in Innovation, Creativity and Ingenuity (2005), the New Jersey Association for Biomedical Research Leadership Award (2010) and New Jersey Inventor of the Year (2011) by the New Jersey Inventor Hall of Fame (NJIHoF). Dr. Shah has been named as the inventor or co-inventor of 30 issued patents and 45 patent applications in progress, primarily in the area of drug delivery, and has published over 100 peer-reviewed publications. Prior to joining Kashiv, he was a Distinguished Scientist and Head of the Oral Dosage Form Development Group at Hoffmann-La Roche. Dr. Shah also served as an Adjunct Professor at the University of Rhode Island and has mentored many Ph.D. students and scientists throughout their careers.
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).
Pavan Handa, MBA
Senior Vice President – Business Development and Strategy
Pavan leads business development, product selection, and business strategy at Kashiv Specialty Pharmaceuticals. He has held senior management positions in business development and commercialization at some of the leading specialty pharmaceutical, drug delivery, and life sciences companies, where he was responsible for building and diversifying the product portfolio, revenue-mix, and strategic partnerships, resulting in significantly increased profitability and market valuation. Over the past 25 years, he has served as Senior Vice President of Business Development at Antares Pharma, Vice President of Business Development & Alliance Management at Noven Pharmaceuticals, Director of Business Development and Marketing at Enzon, and Manager of Biomedical Business Development at Union Carbide. He has completed over fifty deals that have generated billions of dollars in value creation through strategic partnering, licensing, M&A, and commercialization of new products and ventures. Pavan holds a B.A. Honors degree in Economics from the University of Delhi, and an M.B.A. with dual majors in Finance and Marketing from the University of Cincinnati. He has also completed advanced programs in drug delivery, intellectual property, and negotiations from MIT, Northwestern, and Harvard, respectively.
Kenneth M. Cappel, R.Ph., Esq.
Senior Vice President – Legal & Intellectual Property
Ken is responsible for leading Kashiv BioScience’s legal and intellectual property department. Prior to joining Kashiv, Ken served as Vice President of Global Intellectual Property for Amneal Pharmaceuticals for 10 years, leading the company’s patent litigation for over 50 high-grossing generic launches and helping to grow Amneal into the fifth largest generic pharmaceutical company in the United States. Prior to Amneal, Ken served as the Executive Vice President and General Counsel for Interpharm, a Long Island, New York-based generic pharmaceutical company. Ken has also held various positions at Dr. Reddy’s Labs, Budd Larner PC, and the Schering-Plough Research Institute. Ken received his J.D. from Seton Hall Law and his B.S. in Pharmacy from Rutgers University.
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.