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26+ years of expertise in research and driving drug product development programs, formulation development, analytical development, intellectual property development, clinical studies and regulatory approvals. Developed and directed R&D labs and teams of up to 130+ scientists, pioneering oral, respiratory, ophthalmic, injectable, vaccines, topical, and transdermal products for US, EU, ROW and Indian markets. Successes include 100+ products developed and commercialized (NDA and ANDA), including approved patents and in-licensed NDA products. Experienced in early IND enabling product development, multiple formulation types, complex delivery forms and technology driven dosage forms. Seasoned in technical operations and outsourcing to CDMOs and CMOs. Having eight research publications in peer reviewed journals and three research paper presentations in national and international conferences.

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Ashok Dewangan is the General Manager Research & Development at Encube Ethicals Pvt. Ltd., India, with over 18 years of experience in the development of transdermal, topicals, oral thin film, and other complex generics for regulated markets.

He is among the first group of professionals in India to work extensively on transdermal systems, with several of his developed products now successfully commercialized.

Ashok also serves as a USFDA-Stakeholder Expert Committee (SEC) member on adhesion testing of Transdermal Delivery Systems for the Centre for Research on Complex Generics (CRGC) a joint initiative between the USFDA and the Universities of Michigan and Maryland.

At Encube, he leads the end-to-end development of transdermal and complex generics products, covering formulation, scale-up, technology transfer and regulatory correspondence. In addition, he also heads R&D Project Management, overseeing a dedicated team. In past, he has successfully collaborated with CMOs on complex product manufacturing and has held key roles at Zydus Group and Alkem Labs.

His expertise spans excipient and adhesive selection, in vitro and in vivo performance evaluation, process optimization, and troubleshooting. Ashok has played a pivotal role in multiple FDA interactions, including meetings and query responses related to transdermal systems, oral films, and complex generics.

With a strong track record in complex product development and regulatory strategy, Ashok continues to drive innovation and excellence in advanced drug delivery systems.

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Doctorate in Pharmaceutical Technology (Drug Delivery Systems) from University of Sagar, MP.

33 years experience on pharma industry; out of which 19 years is at seniormost leadership level.

Started career as a formulation development scientist, then as CSO/Head R&D and then as COO.

Managing all operations – research and manufacturing operations, Clinical, Quality, Laboratory and Regulatory. Expertise in all dosage forms – sterile, non sterile oral and topical.

Currently working with Shilpa Medicare Ltd for more than five plus years and am responsible for the formulation’s business vertical of the company.

An invited speaker in various forums. Sole industry member of Academic Planning Committee of NIPER constituted per Gazette of GOI. Member of Board of Studies of Abdul Kalam University, Lucknow. University Gold Medallist in graduate and post graduate pharmacy. Authored many publications and patents. Commercialised many products in worldwide markets, including first to file, first to market, generics and NDA’s.

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Dr. Shubhadeep Sinha is a senior pharmaceutical physician and medical pharmacologist with over 25 years of experience in the pharmaceutical industry. He currently serves as Senior Vice-President & Medical Director at Hetero Group, where he heads global operations for Clinical Trials, Pharmacovigilance, and Medical Affairs since 2011.

Throughout his distinguished career, Dr. Sinha has held leadership positions at prominent pharmaceutical organizations including Dr. Reddy's Laboratories, Vimta Labs, and Accenture. His expertise spans product development across new chemical entities, biologics, and generics, with significant experience in managing over 500 clinical trials and 100+ phase-3 and post-authorization studies globally.

Dr. Sinha established and led global pharmacovigilance systems at multiple organizations and has successfully navigated more than 100 regulatory inspections from authorities worldwide. As an academic, he serves as adjunct faculty in Pharmacology at Kasturba Medical College and Indira Gandhi Institute of Medical Sciences.

His contributions to the field include 36 publications in peer-reviewed medical journals, two published books, and a chapter in a medical textbook. Dr. Sinha's excellence has been recognized with several prestigious awards, including the Bharat Gaurav Puraskar, Fellowship of the Indian Pharmacological Society, and recognition as one of India's 10 most influential healthcare leaders.

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Khalid Asnari is an experienced pharmaceutical leader with global experience in R&D, strategic planning, and technical operations. Currently at Rising Pharmaceuticals, he has successfully led complex portfolios across oral solids, injectables, and topicals for generics, NCEs, and NBEs.

His career spans leadership roles at Sandoz, Novartis, Cipla, and Dr. Reddy’s, with a proven track record of driving projects from development to regulatory submission (INDs, ANDAs, BLAs). He holds 12 publications, 4 patents, and served as Editor-in-Chief of the Journal of Applied Pharmaceutical Science (2010–2019).

Khalid earned his Ph.D. in Pharmaceutical Technology from UDCT, Mumbai, and completed an executive program in Innovation Management at the University of Rotterdam.

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Dr. Nandkishore Yadav is a seasoned R&D leader with 20 years of industrial experience, specializing in formulation development for regulated markets, including compliance with global regulatory agencies such as USFDA, EMA, and other international authorities. Known for his strategic vision and hands-on technical expertise, he has successfully led numerous formulation projects from concept to commercialization, ensuring product efficacy, stability, and regulatory alignment.

Dr. Yadav is passionate about fostering a culture of scientific excellence and continuous innovation. His core strengths include solid dispersion techniques to enhance bioavailability and powder layering technologies, with a strong focus on successful scale-up and technology transfer. He remains committed to advancing patient-centric solutions through cutting-edge formulation strategies and collaborative leadership.

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Seasoned Pharmaceutical Professional with over 26 years of experience in formulation development, specializing in Generic Product Development and Novel Drug Delivery Systems.

Expert in Product Commercialization with extensive experience in scaling up Solid Dosage, Suspension and Emulsion products, implementing Pellet Coating technology, and managing technology transfers.

Leadership and Team Management adept at designing product development strategies, managing a team of scientists, and coordinating cross-functional departments to ensure timely product delivery.

Academic and Industry Contributor with a PhD, active participation in conferences, and a role as an industrial guide and faculty member, fostering the next generation of pharmaceutical professionals.

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Dr.KEDARNATH.S.A.’s leadership and Strategic Planning aims to provide vision and guidance in preparing the overall R&D strategic plan Build strategic plans for business to drive Innovation, improve margin and focused on well-being & sustainability Lead teams of Formulation scientists , Project management team & Engineering Department

His product Portfolio includes Dosage forms - Tablets, Capsules, soft gelatin Caps, semi-solids, oral liquids,& injectables.

His Process Expertise includes Quality by Design, Risk Assessment, Improvised QMS Process, Root Cause Analysis and DoE.

Project Management & Cross-Functional Collaboration: Collaborated with multiple global stake holders and delivered projects as per timelines, that involved global sites.

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Dr Lingam. M. Pharm with Ph.D from prestigious University College of Pharmaceutical Sciences, Kakatiya University.

Having 22 yr of experience in formulation R&D

Previously associated with

• Dr Reddy’s Labs
• MSN Labs
• Apotex
• Lee Pharma and
• Currently with Graviti Pharma as Vice President-FR&D.

Handled various generic dosage forms (OSD, Parenteral, Oncology and Nutraceutical Products) and supported for ANDA/Dossier filing for major regulatory markets.

Experienced from bench scale formulation development activities to technology transfer, submission/commercial batches planning and execution, Leading the teams, project management, planning and team building.

Establishment of R&D centers

He published 10 research papers, 5 research presentations in national and international journals and filed 5 number of patents.

He received prestigious award from Indian Achievers Forum as “MAN OF EXCELLENCE AWARD-2022” in Pharmaceutical Sciences.

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