Dr. George Kottayil has spent over 20 years at prominent life science companies, holding senior positions of increasing responsibility in product development, business operations and general management.
George co-founded Insys Therapeutics Inc. (NASDAQ: INSY) and is the principal inventor of the company’s lead product SUBSYS® – sublingual fentanyl spray approved by the FDA in 2012 for the treatment of breakthrough cancer pain. SUBSYS achieved peak annual revenues that exceeded $250M and is the only product in its class that has demonstrated statistically significant pain relief at 5 minutes. He served as Insys’ President and on its board of directors.
Prior to Insys, George directed business operations at Unimed Pharmaceuticals Inc., a division of Solvay Pharmaceuticals now Abbvie. He played a key role in development and obtaining FDA approval for the company’s NDA products most notably ANDROGEL®. ANDROGEL has been the market leader in male hormone replacement therapy for well over a decade with peak annual revenues that exceeded $1.5 billion. ANDROGEL when launched in 2000 redefined the male hormone replacement therapy market, which until then was well below $50 million and was primarily served by ANDRODERM® patch and deep intra-muscular injections.
George was instrumental in formulating and executing the strategy that resulted in the down-scheduling (CII to CIII) of the controlled prescription drug MARINOL® by the US DEA.
George was educated at Fergusson College (BSc), University of Poona (MSc), and University of Kentucky (Ph.D.).
Prashant Kohli has over 20 years of commercialization experience leading strategy, sales, marketing, and product management. He has expertise crafting go-to-market plans for products with unique value proposition that address critical unmet needs. He has built, deployed, and led sales and marketing from the ground-up with significant experience in organization design, recruiting, performance management, incentive compensation, and P&L accountability.
He has successfully implemented evidence-based, consultative-selling model that is rooted in deep understanding of the health ecosystem including patients, providers, health systems, government, and payers. He has also designed strategic marketing plans that generate leads and increase share-of-voice, augmenting the salesforce with digital tactics that increase reach and frequency. He has extensive commercial experience with specialty and small molecule drugs including in rare and orphan diseases.
Prashant has worked at Archi-Tech Systems, Cardinal Health, IMS Health, Rosenbluth, and Dun & Bradstreet. He has a BA in Computer Science and Math, and an MBA from The Wharton School.
Dr. Prasanna Sunthankar has over 20 years of experience in Research and Development with an emphasis on pharmaceutical method development and validation, especially in the areas of solid oral and parenteral drug delivery. He is a synthetic organic chemist with strong analytical experience. He has developed new analytical methods for various dosage forms including oral solid, ointments, creams, liquids and injectable products. He was involved in the team that developed the DPP4 enzyme inhibitor Nesina, now marketed by Takeda and IV Tramadol for the treatment of post- operative pain currently in phase 3 clinical studies. Prasanna has played key role on cross functional teams tasked with submission of abbreviated new drug applications (ANDA) and for various controlled release/sustained release products such as Opano ER and Kadian. He was a member of the PQRI working group that developed new analytical testing methodologies for extractables and leachables for inhalation and injectable products. Prasanna has extensive experience in product development from concept to regulatory approval. He has authored and co-authored several peer-reviewed publications. His work experience spans PPD, Sandoz and Revogenex.
Prasanna graduated with Bachelors and Masters degrees in Chemistry from the University of Bombay and a Ph.D. in Organic Chemistry from Oklahoma State University.
Amresh Kumar has over 15 years of experience leading pharmaceutical development and drug delivery. He has developed innovative immediate and modified release dosages, oral solution and suspension, topical, injectable, and polymer based drug delivery systems.
Prior to joining Grace in March 2015, he was Senior Manager (R&D and QbD) at Sun Pharmaceuticals INC. where he successfully implemented Quality by Design (QbD) at the drug product development stage and commercialized several products with the QbD concept.
Amresh served in various product development positions at Revogenex Inc, Colorcon and Alembic Limited and was part of the team that developed the first levetiracetam extended-release tablets once daily formulation subsequently licensed to UCB and commercialized worldwide as Keppra XR.
Amresh holds Bachelor and Master degrees in pharmaceutical sciences from Sardar Patel University Gujarat India. He is a listed inventor on several patents and has published scientific papers to his credit.
Florence Clark is the Director of Clinical Operations at Grace Therapeutics. Prior to joining Grace, Florence was the Consulting Director of Clinical Operations for Grace since 2015. Florence has over 20 years of experience in the health care arena and has managed and overseen the performance of contract research organizations and other study vendors as well as consultants. Florence has been instrumental in building several effective investigator and clinical staff relationships.
Prior to consulting, Florence worked as a Senior Clinical Project Manager at Revogenex, Project Manager at UCB and Atherogenics and Clinical Research Associate at Atherogenics. In this role she managed several global clinical trials, including Eastern Europe, Latin America, Canada, Mexico, India, Australia, England and the USA. Her trial experience includes Phase 1 through 3 and Phase 4 Open-Label clinical studies. Her management experience includes participating and contributing to FDA meetings, IND and NDA fillings, managing CRA’s, clinical assistants and CRO’s.
Florence has extensive experience in hospital based health care systems and has successfully led interdisciplinary Quality Improvement teams. She oversaw and managed all aspects of training and education for all staff members of clinical satellite sites.
Florence holds degrees from Central Michigan University (MSA), Brenau College (BSN) and Methodist Hospital School of Nursing (RN). Florence has been involved in both SOCRA and ACRP.
Dr. Kamalkishore Pati brings extensive academic and industrial experience in drug research and development to Grace. Kamal has worked with several midsize and large pharmaceutical companies (Neuland labs, Srini Pharma, Sai life sciences, GVK-Bio and TCG Life Sciences) for more than thirteen years as a scientist researcher and is credited with the successful development of several key products (Bis-indole malemide analogs, clopidogrel bisulphate, levitracetam and the design and synthesis of several new chemical entitity candidate compounds for oncology and inflammatory disease). He has authored and co-authored fifteen peer-reviewed publications and features as a co-inventor on two issued patents and several applications. He is a scientific reviewer for several lead scientific journals and holds a Ph.D. in Organic Chemistry from National Tsinghua University, Taiwan. He has served as a National Science Foundation postdoctoral Research Fellow at the Department of Chemistry and Biochemistry, Florida State University.