Leadership

Board of Directors

Shankar Hariharan

Ph.D. (President and CEO)

Shankar Hariharan,

Ph.D. (President and CEO)

A senior Pharmaceutical R & D leader with over 33 years of experience in successfully leading branded, specialty and generic pharmaceutical businesses. Shankar had managed all aspects of the Global Scientific Affairs function - PR&D, Global RA, clinical (NDAs, ANDAs and biosimilars), PV/safety, Labelling, Project and Portfolio Mgmt across multiple R & D centers with over 900 staff. Shankar has been instrumental in getting over 250 products approved while 125 product filings await approval.

Sandeep Gupta

Ph.D.

Sandeep Gupta

Ph.D.

Founder and CEO of Asana Biosciences, a novel drug discovery and development company. He was previously the Senior Vice-President of Discovery and Early Development, Endo Pharmaceuticals. Prior to Endo, Dr. Gupta spent a decade at Forest Laboratories as Head of Drug Discovery and Pharmacology. He played a key role in the development of several block buster drugs during his tenure at Endo and Forest. Before Forest Laboratories, Dr. Gupta held academic positions at the University of Pennsylvania and Boston University Schools of Medicine.

Polireddy Dondeti

Ph.D.

Polireddy Dondeti

Ph.D.

President and CEO of Saptalis, a proven product development leader with thorough knowledge of pharmaceutical sciences and regulatory environment. He is responsible for bringing numerous complex prescription dosage forms to the market. Dr. Dondeti has over 22 years of pharmaceutical industry experience with brand and generic companies such as Pfizer, Barr Laboratories, Morton Grove Pharmaceuticals and Hi-Tech Pharmacal. Dr. Dondeti received his M.S. in Pharmaceutics and Ph.D. in Pharmaceutical Sciences from the University of Rhode Island.

Narasimhan Mani

Ph.D., MBA

Narasimhan Mani

Ph.D., MBA

A proven leader with over 22 years of experience in both the scientific and business areas of the pharmaceutical industry. His experience over the years includes multifunctional leadership roles, in branded and generic product segments, across product development, manufacturing operations, portfolio management, business development, M&A, and Sales & Marketing. He held leadership positions at Elan Pharmaceuticals, Forest Laboratories, Par Pharmaceuticals, Johnson & Johnson, and Amneal Pharmaceuticals. Dr. Mani received his PhD in Pharmaceutics, from the University of Georgia, Athens and MBA in Finance and Marketing, from Columbia Business School, New York, NY.

Arun Agarwal

Arun Agarwal is a former Wall Street healthcare investment banker whose clients included some of the largest healthcare entities in the country. Formed in 2002, White Lotus Group, a real estate development firm, continues to facilitate a variety of real estate and healthcare projects totaling over $1.5 billion. Arun is a 1998 graduate from the Wharton School of Finance at the University of Pennsylvania, where he was awarded the Wharton Award for Academic Achievement. He also serves on the Boards of TinkRworks, NanoThernastics, Greater Omaha YMCA, HELP Foundation and Bemis Contemporary Arts.

Suneel Gupta

Ph.D.

Suneel Gupta

Ph.D.

An executive and an entrepreneur with 30 years of experience in discovering, developing and registering several pharmaceutical products (Duragesic, Concerta, Ionsys, Invega, and Rytary).

Dr. Gupta is chief development officer at Protagonist Therapeutics. His prior professional roles include SVP of R & D (Alza/J&J), CSO of ImpaxLabs. His areas of expertise include: Clinical Pharmacology, Clin Research & Dev, Drug Delivery, 505b(2), Formulation, Drug Safety, Medical Affairs, Pharmaceutical product production

Wantanee Phuapradit

Ph.D.

Wantanee Phuapradit

Ph.D.

Twenty-eight years of experience in pharmaceutical product development of new chemical entities, specialty products, and complex generics.

Her professional experience includes senior roles at Hoffman La Roche, Barr/Teva and Kashiv Pharma with expertise in all areas of pharmaceutics and development including modified release technology and differentiated complex dosage form development. She is a co-inventor of 20 drug delivery patents.

Lawrence Olanoff

M.D., Ph.D.

Lawrence Olanoff

M.D., Ph.D.

Lawrence Olanoff is an adjunct Assistant Professor and Special Advisor to the President for Corporate Relations at the Medical University of South Carolina. From 2006-2010, he served as President and Chief Operating Officer for Forest Laboratories, Inc. From 2005 to 2006, Dr. Olanoff was CEO of Celsion Corporation. Prior to 2005, he served as Executive VP of Research and Development and Chief Scientific Officer of Forest, and held senior clinical research roles at Sandoz Pharmaceutical Corporation and the Upjohn Company. During his pharmaceutical development career, Dr. Olanoff made substantial contributions leading to thirty new drug approvals, either as new chemical entities or as supplemental indications, over a range of therapeutic areas. He is Chairman of the board of directors of Mitochondria in Motion, and serves as a member of the Board of Ironwood Pharmaceuticals and Ichnos Sciences, as well as several non-profit organizations. Dr. Olanoff also held past directorships on the boards of Forest Laboratories, Axovant Sciences Ltd. and the Celsion Corporation. He received his Ph.D. in biomedical engineering and M.D. degree from Case Western Reserve University, was an internal medicine resident and clinical pharmacology fellow at the Medical University of SC and is the author of some 40 scientific publications on topics including controlled drug delivery, pharmacokinetics, drug metabolism and clinical toxicology.

Shankar Hariharan

Ph.D. (President and CEO)

Shankar Hariharan,

Ph.D. (President and CEO)

Rahul Surana

Ph.D., MBA (SVP, Corporate Strategy & Business Development)

Rahul Surana

Ph.D., MBA (SVP, Corporate Strategy & Business Development)

A dynamic leader and team player with strong pharmaceutical development background and demonstrated project/resource management, problem solving, supervisory and leadership skills. Over 20 years of brand and generic industry experience working for small, medium and large pharmaceutical companies in various capacities. Rahul has led and managed project teams, interfaced and negotiated with partners for co-development of products and devices, and closely worked with customers, business development and scientific affairs teams. Conducted due-diligence activities in collaboration with business development and scientific assessment groups for more than 30 products in several different therapeutic areas and was involved in the decision making for in-licensing/acquisition and partnering based product opportunities.

Shreena Patel

Senior Director, Regulatory Affairs & Project Management

Shreena Patel

(Senior Director, Regulatory Affairs & Project Management)
Seasoned regulatory professional with over 14 years of experience in handling the submissions of new drug applications and abbreviated new drug applications to FDA. Shreena has led cross-functional teams to achieve several 505(j), 505(b)(2) and 505 (b)(1) applications for various drug product dosage forms (solid, liquid, topical, nasal, transdermal and injectable products) across a broad range of therapeutic categories. She has efficiently worked on several pre- and post-approval IND, NDA and ANDA eCTD submissions including First to File opportunities and worked with multiple Clinical Research Organizations (CROs) to ensure good quality US FDA submissions. Shreena has coordinated several product development meetings, pre-submission meetings and mid-cycle-review meetings with FDA. She has efficiently managed regulatory staff working in different time zones and worked successfully on defining key product submission strategies based on ICH and FDA guidelines.

Jigar Bhatt

Director, Product Development

Jigar Bhatt

(Director, Product Development)

Formulation expertise for generic and complex generic development in various regulated market viz North America, Europe, South Africa, Brazil and Australia.

Expertise in Technology selection based on drug properties and pharmacokinetic requirements, Product Development, Process Development, Process Optimization, Process Scale-up, Registration, Process Validation and Launch, Technology Transfer, Commercial troubleshooting, lab and manufacturing facility set up. Good understanding and knowledge of pharmacokinetics and in-vitro dissolution, especially with respect to Bioequivalence Studies, Data interpretation, Patent landscape and work around strategies, Stability studies, Drug product specifications and Justifications, Scientific and Quality risk assessments for NDMA and others, CMC Regulatory requirements and documentation, Quality-by-Design (QbD) concepts, Design of Experiments, Handling PAI and other regulatory inspections, cGMP, Change Controls, OOS/OOT, Deviations & CAPA, SOPs, Controlled correspondence for Bio studies, IIG and toxicological aspects and Q1/Q2 proposal with FDA.

Responsible for managing and providing scientific leadership in developing formulations to the team leading to successful regulatory filings for complex oral formulations like OROS tablets, MUPS tablets, poorly soluble drugs. Design and proposal for new opportunities of 505(b)2s (such as Bio improvement, food effect, dose reduction and better dose management etc.) by time based targeted drug delivery in close coordination with internal specialty and business development team. Discussion and finalization of bio strategies and data interpretation.

Led and managed Portfolio, Project and Strategy group (at each R&D site) by tightly integrating across each cross functional department. Involved in strategic expansion and selection of projects related to international expansion – effectively utilized my technical expertise to work with BD group in strategizing product selection and other expansion. Projects range from NDAs, 505(b)2 and Complex Generics.

Board of Directors

Shankar Hariharan

Sandeep Gupta

Polireddy Dondeti

Narasimhan Mani

Arun Agarwal

Scientific Advisory Board

Suneel Gupta

Wantanee Phuapradit

Lawrence Olanoff

Executive Management

Shankar Hariharan

Rahul Surana

Shreena Patel

Jigar Bhatt