Technical Advisory Team
Dr Shirish Kulkarni is the CSO of Pharmwell Global, where he heads the data science, machine
learning and AI-based development programs in San Francisco, California.
Previously he was at Sun Pharmaceutical Industries Ltd., India as a Senior Vice President of R&D and he was responsible for the development of generic as well as value-added generic products. Before joining Sun Pharma, he was heading Advanced Drug Delivery Systems at Lupin Research Park, Pune, India with a primary focus on developing innovative and novel dosage forms.
Just before returning to India, worked for nearly 16 years in North America., as an associate Director of Pharmaceutical Development with GPC Biotech Inc., Princeton, NJ, USA, Senior Scientist at UpsherSmith Laboratories and as a Formulation Scientist at Monsanto Co., which is now part of Pfizer Inc.
He has also worked in India as a Drug Inspector with Maharashtra FDA; as a Development Pharmacist with E. Merck (India) Ltd.; and as a Research Associate with Rallis India Ltd.
Dr Kulkarni’s academic credentials include
- B. Pharm. and M. Pharm. degrees from India,
- MS degree from Dalhousie University, Canada,
- PhD degree from Auburn University, USA.
During his graduate studies in Canada and USA, he received Parke-Davis Graduate Research Award, Outstanding Graduate Student Award, and Dean’s Award for Excellence in Graduate Studies.
He has been an honorary member of Sigma Xi and Phi Kappa Phi scientific organizations. During his career span of over 30 years, he has worked on formulations of novel medicines and many generic drugs including several first-to-file Para IV ANDAs. He has visited and/or audited several companies, which specialize in novel drug delivery, formulation development, manufacturing, packaging and clinical supply operations in the USA, Canada, Europe, South America and India. He has over 55 patents, 35 scientific publications and presentations in various international journals and conferences.
Dr Andy Anantha, President & CEO AVA Pharma Consultants, North Carolina. He has over 30 years of experience in successfully Conducting research and development in biopharmaceutical organizations and companies in the CMC space for both NCEs and Generics.
Before AVA Pharma Consultants, Dr Anantha was most recently the Vice President of Pharmaceutical Development & Quality at vTv Therapeutics, North Carolina. In this role, he was responsible for complete CMC development and regulatory filings. Several lead candidates were taken to IND, Phase 1, 2 and Phase 3 stages.
Dr Anantha has spent 30 years in the biopharmaceutical industry, and served as a Manager/Principal Scientist at Wyeth Research for 9 and 1/2 years. In this role, in addition to research and development in Analytical and Quality, he led an interdisciplinary team of scientists on projects from the CMC side. Other experience includes 7 years in the Generics research and development area at G & W labs.
Dr Anantha’s academic credentials include :
- B. Sc degree in Chemistry from University of Bombay
- M.Sc degree in Organic Chemistry from University of Bombay
- M.S degree in Chemistry from the University of South Florida, USA
- Ph. D. in chemistry/Bio-Chemistry from Seton Hall University, USA
Dr Anantha is an author of several peer-reviewed publications and was a secretary and a member of the API manufacturing division of the American Association of Pharmaceutical Sciences.
Over 25 years of experience in Market Intelligence, IP strategy for all markets for API and formulations, Drafting and prosecution of patent applications for API / NCE / formulations / 505(b)(2), Litigation and settlements, legal contracts/agreements relating to in-licensing and out-licensing, supply and distribution, review and framing of HR policies, agreement related to trademarks, Freedom to Operate (FTO) opinions, Oppositions and Revocations, Legal and technical searches, Citizen’s petition issues, compatibility & Conflict analysis of patent law vis-a-vis Regulatory guidelines, Review of technologies and in-licensing / out-licensing contracts, 505 (b)(2) filings, Paragraph IV identifications, Value-added formulations via sNDA route, Due diligence for mergers and acquisitions and analysis for acquired assets.
Dr Iyer’s academic credentials include:
- B. Pharm degree from Bombay College of Pharmacy
- M.Pharm degree in Pharmaceutical Chemistry from Bombay College of Pharmacy
- Ph. D(Tech) in Industrial Pharmacy from Bombay College of Pharmacy
He played an active role in pharmaceutical drug delivery and dosage form Research & development with an emphasis on process engineering, product development, aseptic manufacturing, and filling at Sun Pharma R&D, Vadodara for about 25 years. He has working knowledge of all phases from drug discovery to product commercial manufacturing with expertise in small and large molecule formulations.
His key skills are Formulation Development & Pharmaceutical Technology, Proof-of-Concept, Design of Experiments, intellectual Property Generation, Product requirement specification, Risk assessment & FMEA, Data review & reporting, Regulatory Compliance, CMC, Bioequivalence & Clinical study inputs, Product Labeling, Vendor selection, Product Due Diligence, ANDA & NDA development reports & Supplements. Technology Transfer, Project Management, Product Development Team Coaching & Mentoring, Development Proposals & Strategies, Contract Management, Drug Delivery System Development, Particle Forming Technologies – Spray Drying / Supercritical Fluid / Fluid Jet Milling, Product Life-cycle management strategy. Etc.,
Dr Ganesh’s academic credentials include:
- B. Pharm degree from MGR Medical University
- M. Pharm degree in Pharmaceutical Sciences from Birla Institute of Technology (BIT),
- Ph. D in Pharmaceutical Sciences from Maharaja Sayajirao University (MSU)
- MBA in Pharmaceutical Technology from Indian Management School and Research Centre (IMSRC)
He holds 3 patents on Inhalation Products and author of seven peer-reviewed international publications.