Santosh Jadhav is a seasoned quality leader in the biopharmaceutical industry, currently serving as Associate Vice President and Head of Quality Operations, India at Kashiv Biosciences LLC. With over 24 years of extensive experience in quality systems for biologics and sterile injectable products, he brings deep expertise in ensuring compliance, product safety, and regulatory excellence.
Throughout his career, Santosh has successfully led and managed multiple global regulatory inspections, including those by the U.S. Food and Drug Administration (USFDA), European Medicines Agency (EMA), Agência Nacional de Vigilância Sanitária (ANVISA), Pharmaceutical Inspection Co-operation Scheme (PIC/S), and Central Drugs Standard Control Organization (CDSCO).
He has held key leadership roles across reputed pharmaceutical organizations such as Lupin Limited, Intas Pharmaceuticals, Wockhardt, Strides Pharma Science Limited, Bharat Serums and Vaccines Limited, and Kemwell Biopharma.
Santosh is recognized for his strong leadership in building robust quality systems, driving inspection readiness, and fostering a culture of compliance in highly regulated environments. His expertise spans aseptic manufacturing, sterile injectables, biologics, and global regulatory expectations, making him a valued speaker and thought leader in the pharmaceutical quality domain.
I am a qualified Packaging Technologist with 12+ years of industry experience in injectable drug–device combination products. I have completed a Post Graduate Diploma in Packaging Technology from the Indian Institute of Packaging, Mumbai. My professional background includes end-to-end responsibility for packaging material selection, supplier qualification, regulatory filings and product lifecycle management, with a strong focus on compliance, quality and continuous improvement.
With over 15+ years of experience of research, formulation R&D and commercialisation of complex injectables, differentiated, NDDS products across US/EU markets in Baxter Pharmaceutical, Reliance Life Sciences, Sun Pharma Ind Ltd., FDC Ltd.
Developed different dosage forms from feasibility to commercials includes Peptide depots, Lyophilized product, drug-device platforms (PFS, Pen injectors, autoinjectors, dual-chamber systems), Microspheres depot.
Characterization for NDDS for Peptides, Microspheres, Liposomes, iron injections.
QbD/DoE optimization for microspheres, depots, Liposomes, and AIML-driven process evaluation for LAIs improvements.
Building high-performing teams, establishing cost-effective R&D labs, and engaging directly with regulatory agencies through Pre-IND/ANDA, Scientific advice strategies, ensuring innovation aligns with business and compliance goals.
I am M. Pharma qualified packaging development professional with more than 13 years of industry experience. I have worked extensively on complex pharmaceutical products, including sterile injectables, ophthalmic preparations, pressurized metered-dose inhalers (pMDIs), nasal systems, and other advanced drug delivery platforms, with a strong focus on regulatory compliance and lifecycle management.
Dr. Paras Vasanani is currently associated with Kashiv BioSciences LLC, a US based innovator pharmaceutical and biotechnology company, where he is a member of the Executive Leadership Team and leads five key functions, including Business Development & Licensing, Portfolio Strategy, Corporate Strategy, Alliance Management, and Project Management.
Kashiv BioSciences is actively engaged in the development of biosimilars, 505(b)(2) products, new chemical entities (NCEs), and complex generics. Dr. Vasanani began his professional journey with a humble start as an Intellectual Property professional at Alembic Pharmaceuticals. Driven by strong interest and expertise, he progressively expanded his scope beyond IP into strategic and commercial domains during his tenure at Zydus Pharmaceuticals, Amneal Pharmaceuticals, and Kashiv BioSciences.
With extensive global exposure and strong networks across international pharmaceutical and biopharmaceutical companies, Dr. Vasanani has been a frequent speaker at national and international conferences. His strong academic foundation has enabled him to evolve into a techno legal and commercial leader, capable of driving informed strategic decision making. He is an inventor on more than 15 granted and published patents.
I am a highly qualified scientist with extensive skills in formulation development of various pharmaceutical finished dosage forms. I have more than 27 years of experience and currently working as a Head of Research & Development – Injectables division at Amneal Pharmaceuticals. I am overseeing the development, execution and regulatory filing of products by aligning to the business needs. My experience includes development and regulatory filing of various complex and conventional dosage forms such as injectables, ophthalmic products, nasal sprays, inhalations, solid and liquid orals. Presently, the area of focus is more on complex dosage forms such as Microspheres, Liposomes, Nano emulsions & suspensions, pen devices, autoinjectors, Nasal sprays, Colloidal solutions etc. My previous industry experience was in Aurobindo Pharma, Viatris (Mylan), Teva UK, Reckitt Benckiser UK, Concept Pharmaceutical Ltd. I have done my graduation and post-graduation in Pharmaceutical Sciences from University College of Pharmaceutical Sciences, Kakatiya University and Birla Institute of Technology and Science (BITS), Pilani, India respectively and PhD from Glasgow Caledonian University, UK. I have publications in international journals and patents as part of my research and professional experience.
Mukesh is one of the founder directors of Ortiv-Q3 (A Sotax joint venture), a pioneering pharmaceutical research and testing organization well acknowledged globally for its specialized skill set in IVRT, Q2/Q3 characterization and complex parenterals formulation development. He is a pharmaceutical veteran with over 30 years of industrial experience. He earned his M Pharm (Pharmaceutics) from Jamia Hamdard, New Delhi in (1992) and Ph.D. (2021) from BAMU, Aurangabad. His expertise includes Niche steriles, Value added generics, Topicals and NCEs. He holds 18+ US/EU Patents/Application to his credit and is specially versed in nanotechnology-based platforms including Nanoemulsions, Nanosuspensions, Liposomes, Microspheres, Insitu forming depots and associated Q2/Q3 characterization. He has profound knowledge in formulation development, Quality & compliance, preclinical evaluation, process development, optimisation, and scale-up of formulations for regulated markets. In his past assignments he was associated with many reputed companies like Ranbaxy, Dabur Pharma, Fresenius Kabi, Emcure, Wockhardt and Claris in Sr positions like, Asst. Director, AVP & Technical head (R&D). He is co-inventor of the innovative microdialysis based IVRT technology developed by Ortiv-Q3 which has been successfully commercialized globally (patent applied). He is also the co-inventor of indigenously developed patented nanoparticle technology for Polymeric micellar delivery of Paclitaxel (NanoxelTM - Fresenius Kabi) that reached from bench scale to the market. He contributed in many products approvals for various markets including US, EU in his past career. He has also been ranked as the top 2% most-cited scientists in a list published by Stanford University (2021).
Abiram Vijayakumar is the Co-Founder and Managing Director of AltiusHub, a cloud-based, enterprise-grade platform built for pharmaceutical and life sciences supply chain traceability, serialization, and global regulatory compliance.
With over a decade of experience spanning business transformation, supply chain optimization, and enterprise technology, Abiram has advised some of the world's most recognized organizations including GSK, Sun Pharma, Godrej, Aditya Birla Group, Saudi Aramco, Walmart, and Maruti Suzuki as well as government institutions including the Ministry of Defence, Government of India, and the Ghana Revenue Authority.
Prior to founding AltiusHub, Abiram held strategic roles at KPMG and led enterprise solutioning for Darwinbox's APAC operations, working with large-scale organizations across regulated industries including financial services and legal. At AltiusHub, he oversees product strategy, customer success, and enterprise deployments, ensuring every client engagement translates into measurable operational outcomes. His work is focused on enabling pharmaceutical manufacturers to move from reactive compliance to intelligent supply chain operations, helping them confidently navigate the serialization and traceability requirements of global export markets including the US, EU, Middle East, CIS and Rest of the World (ROW). Under his leadership, customers have shifted from consultant-dependent compliance models to intelligent, self-sufficient supply chain traceability infrastructure, reducing operational costs, accelerating market access, and gaining the confidence to meet the traceability demands of the world's most stringent regulatory markets.
Abiram is an alumnus of Anna University and the Tata Institute of Social Sciences (TISS), and brings a rare combination of consulting depth, enterprise SaaS experience, and regulatory domain expertise to the pharmaceutical traceability space.
M.Pharm., with 20 years of experience for Phase specific Formulation Development for NCE and Formulation Development for Generic products spanning from Prototype Formulation Development, Process Development and in manufacturing Science and Technology.
Currently working with Piramal Pharma Solutions – Associate Director and Head Formulation CDMO Vertica Clinical Manufacturing Operations since Sept -22
Previously worked with
Presenting Mr. Nitin R. Khaladkar, Head of R&D at Bharat Rubber Works. a true industry veteran with 37 years of mastery in rubber stopper manufacturing and a driving force behind our technical excellence. A curious mind with an unwavering attitude to achieve perfection, he has been instrumental in elevating Bharat Rubber Works quality benchmarks from local standards to globally recognized excellence.
Pankaj is a chemical technologist with specialization in polymers. He has extensive experience in sales and business development of packaging and drug delivery systems. Pankaj leverages his in-depth understanding of the drug delivery systems to drive successful sales strategies and growth initiatives. His experience of leading cross-functional teams enables him to align business goals with technical requirements ensuring smooth project execution and client satisfaction.
Mr. Vipul Doshi has been in pharmaceutical Industry from more than four decades with diverse leadership and operational expertise across development, manufacturing, R&D, GXP quality assurance (QA) and manufacturing operations (parenterals, solid dosage forms, biotechnology, transdermal, biologics and vaccines).
He has been leading the Quality and Regulatory affairs function in the Pharmaceutical Companies of high credentials. Throughout his career he has been providing passionate global leadership and pioneered in guiding the companies to meet the Global Regulatory, Quality Standards and Compliance requirements.
He has been a Great Contributor in developing and implementing Quality attributes and Culture of Excellence based upon a set of core values and ethical practices, which integrate and improve business operations and enhance the compliance within the Organization.
He has been a leading advocate for Global Competitiveness and instrumental in due diligence for various acquisitions and mergers. He possesses great expertise in Projects and Engineering for developing Infrastructures for APIs and Drug Products (Sterile and Non Sterile). He has been actively involved with various professional associations like ISPE/PDA/AAM.
Associated with varied Roles and increasing responsibilities he is currently Chief Quality & Compliance Officer at Zydus Lifesciences Limited (Company has headquarters at Ahmedabad). He also Leads IRA, Research and Development functions for Active Pharmaceutical Ingredient, Environment Health & Safety and Pharmacovigilance.
Zydus Lifesciences Limited is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The group employees nearly 25000 people worldwide and is dedicated to creating healthier communities globally.
The Product portfolio ranges from Complex generics Sterile and Non Sterile, Biologics and Vaccines and various dosage forms catering to global market.
Anurag Chauhan is Head of Digitalization, Automation and Analytics in Amneal. He brings strong experience in driving digital transformation and AI adoption across operations, with a focus on improving cross‑functional collaboration, process efficiency, and data‑driven decision‑making. Anurag has worked closely on shaping AI and GenAI roadmaps, prioritizing high‑impact use cases, and enabling scalable, business‑led digital & robotic solutions.
Dr. Mahesh has vast experience of being in C-Suite Leadership roles in the Pharma-Biotech world. Prior to founding AAPM Solutions, an Innovation driven biotech, he was the Group CEO and MD of Veeda Lifesciences, a global CRO. Prior to that, Mahesh was the COO for Syngene International (Biocon Group Company), India’s largest and most diverse CRO & CDMO company. At Syngene, he was instrumental in its transformation from a CRO to a CDMO. Prior to Syngene, he was the COO and Executive Director for Sanofi in Hyderabad, where he was responsible for initiating the first-ever Indian manufacturing operation for injectable polio vaccine among many other accomplishments. Mahesh started his India career with Biological E Limited, which he joined after 20 years in North America pursuing his study and working with multi-national large and small biotechnology companies, including Amgen and Monsanto (now Bayer) and Thermofisher.
Mahesh has contributed to the industry through several affiliations such as United States Pharmacopeia, Telangana Scientific Advisory Board, Karnataka Drugs and Pharmaceutical Manufacturers Association, Karnataka Vision Group on Biotechnology, Biotech committee of CII to name a few. He is also a visiting faculty member at IIT – Mumbai and is keen engaged in skill development for the pharma-biotech industry.
Mahesh has a PhD in Medicinal Chemistry at the University of Utah, USA and a Bachelors in Pharmaceutical Sciences from the University of Mumbai.
I am Pradip Som, a Packaging Development professional with over 17 years of experience in the pharmaceutical industry. I am currently working as Head – Packaging Development at Aculife Healthcare Ltd. My expertise spans packaging development for multiple dosage forms including OSD, parenteral, ophthalmic, aerosol, derma, and IV bags, along with artwork management, technology transfer, and product launches. I am driven by a strong compliance mindset, collaborative leadership, and a passion for delivering efficient, quality-driven packaging solutions aligned with global regulatory standards.>
Biologics R&D leader and Marie Curie Fellow with 16+ years of experience in product development and technology implementation across global, multicultural environments. Currently serving Intas Biopharma in the capacity of Sr. GM – Drug Product Development. A key member of the Research Leadership Team, driving biosimilar development across the full value chain.
Recognized Subject Matter Expert in formulation, drug product, and device development for regulated markets (USFDA, EMA & MHRA). Extensive experience in advanced platforms, including mRNA vaccine development (pDNA to mRNA-LNP), ADCs, mAbs etc. Instrumental in the successful commercialization of diverse biologics, including highly concentrated mAbs, lyophilized and ocular formulations, drug-device combinations, and traditional vaccines. Have been associated in past with global MNCs like Sanofi, Novartis, GSK & BioE.
Dr. Savale is the CEO of AIC-LMCP Foundation, an Atal Incubation Centre focusing on Pharmaceutical and Healthcare Sector, hosted by L. M. College of Pharmacy (LMCP), Ahmedabad, and supported by AIM, NITI Aayog, GoI.
He is an acknowledged leader with over twenty-four years of professional experience in drug research, development and compliance, in pharmaceutical organization, CRO set-up, consulting, academia as well as innovation ecosystem. He has expertise in the areas of regulated bioanalysis, biopharmaceutics and early clinical development including bioequivalence for small molecules and biosimilars/biologicals, GxP (GLP, GCP, GMP) compliance including data integrity, gap analysis and resolution for electronic data workflow and IT systems in GxP environment, CRO/Vendor qualification, electronic solutions deployment for automation of bioanalytical/clinical laboratory workflows (LIMS, SDMS)/clinical workflow (Phase I/BA-BE) and has been supporting pharmaceutical organizations and CROs, both national and international, in these areas.
He received Ph.D. in Pharmaceutical Sciences from Gujarat University, Ahmedabad. He has been part of various startup and innovation related initiatives at LMCP such as Member of Committee and Mentor for SSIP and Incubation Centre Representative of IIC. He was also an Adjunct Professor - Quality Assurance (MPharm and PharmD Courses). He was associated with Torrent Pharmaceuticals Ltd. as General Manager–Bio-Evaluation; Clinigene International Ltd. (presently Syngene International Ltd.) as Head-Bioanalytical Research; and Torrent Research Center as Scientist-II at Medicinal Chemistry Division.
He is the President of Gujarat State Branch of Indian Pharmaceutical Association and has served as the Track Screening CHAIR, Novel Strategies to Advance Biotherapeutic Development, Abstract Screening Committee, AAPS National Biotechnology Conference, 2024; Member, Scientific Programming Committee, 2022 Land O’ Lakes Pharmaceutical Analysis; the Track Screening CHAIR, Bioanalytics - Chemical Entity, Abstract Screening Committee, AAPS PharmSci 360, AAPS, 2023, 2018; Member, Steering Committee and Member, Clinical PK-PD subcommittee, Biosimilars Focus Group (BSFG), AAPS; Abstract Screener – AAPS National Biotechnology Conference (2021 onwards) and AAPS Annual Meetings (2010 onwards); the Founding Chairperson, Regulated Bioanalysis–APA India; Member of Steering Committee for Global Bioanalysis Consortium (GBC) on harmonization of bioanalytical guidance (via APA-India) representing Asia-Pacific region and is an active member of the organizing committee for Regulated Bioanalysis-APA India (2010 onwards). He is the Chair- Gujarat Chapter at Society for Pharmaceutical Dissolution Science (SPDS), India. He is also the Member, Board of Advisors, QRL Bioscience Pvt. Ltd., Gandhinagar and Member, Advisory Board, Consortium on Innovation and Entrepreneurship in Healthcare, IPA-Kerala (2026 onwards)
His scientific and professional contributions have been acknowledged with various awards such as Biocontribute Award, Best Research Paper Award (IPA), Best Research Award (LAARS), DST Travel Support for presentation at British Pharmaceutical Conference (Manchester, UK), etc. He has been a Reviewer for various national and international scientific journals; invited speaker at various national and international conferences and has 28 publications including three book chapters and many scientific presentations to his credit.
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Dr. Tushar Nahata is currently working as Vice President at Zydus Lifesciences, Ahmedabad in the formulation development of Injectable products. He has done PhD in Industrial Pharmacy from Shri GS Institute of Technology and Sciences, Indore (MP) and done management program from IIM A. He is having more than 23 years of research experience. He has published multiple international publication/presentation and patents as well. He has filed more than 50 ANDA products to US FDA and other regulated countries. He is actively involved in complex Injectable formulation development inclusive of peptides, Liposome, Microsphere, Nanoparticles and well versed with new analytical tools , packaging system (inclusive of devices).
A senior Quality leader with extensive experience overseeing Quality Control for biosimilars and driving end‑to‑end Quality operations for Cell and Gene Therapy programs. As General Manager – Quality Control at Intas Pharmaceuticals, she leads cross-functional teams, establishes robust quality systems, and ensures global regulatory compliance across clinical and commercial pipelines. She is known for building high‑performing QA/QC teams and enabling seamless technology transfer from R&D to GMP manufacturing.
Dr. Alagumurugan brings 25 years of research experience in developing both innovative and generic formulations for global markets. He has strong expertise in developing complex and challenging parenteral and oral solid dosage formulations. His career began at Zydus and includes successful tenures with Dr. Reddy’s Laboratories, Hospira, Cipla, and Maiva. Currently at Alembic, he leads the development of complex injectable and ophthalmic products.
Naresh Gaur Executive Vice President Manufacturing Operations, Stallion Laboratories Pvt. Ltd,
I am M. Pharm. of 1983 batch from Dr. H.S. Gour Vishwavidyalaya, Sagar M.P. On this 3rd Jan, I celebrated my 40 years in Pharma industry.
I have been associated with Indian Organisations such as Ipca Labs, Micro Labs, Cadila Pharma, Sun Pharma, Torrent, Ranbaxy & Amneal Pharmaceuticals Pvt. Ltd and now Stallion Laboratories.
A hard-core Orals formulations mfg technocrat, with an eye for operational excellence, innovation, cost improvements, employee engagement, motivation, team building etc.
I am big on compliance and quality with impeccable track record in facing regulatory audits, be it USFDA, Europe, Brazil, or any other country.
Dr. Arani Chatterjee is currently President (CRO) at Cadila Pharmaceuticals, which is one of the oldest and the largest privately held pharmaceutical company of India. In this role, Dr. Chatterjee is responsible for Pre-Clinical and Clinical Research including BA/BE studies, bioanalytical assays and clinical trials. He also oversees Pharmacovigilance at Cadila Pharmaceuticals.
Prior to joining Cadila pharmaceuticals, he served at Aurobindo Pharma, Biological E, Panacea Biotec and Dr. Reddy’s Research Foundation since 1998. During his tenure he made significant contributions to the clinical development of New Chemical Entities, vaccines, novel drug delivery products, complex generics and biologics.
Dr. Arani Chatterjee earned his medical degree from Christian Medical College, Vellore and postgraduate degree from National Institute of Mental Health and Neuro Sciences, Bangalore, India. He is also an alumnus of Indian Institute of Management, Indore, India.
He has served as a WHO Adviser for the Global Polio Eradication Initiative and was a member of the drafting group for WHO Guidelines on clinical evaluation of vaccines: regulatory expectations. He was a member of several Brighton Collaboration groups for vaccine safety. He has participated in WHO Strategic Advisory Group of Experts on Immunization and Global Vaccine Safety Initiative meetings, Asia Pacific Dengue Prevention Board Meeting under the Pediatric Dengue Vaccine Initiative of International Vaccine Institute and Pneumococcal Vaccines meetings at UNICEF. He has also participated in in-person pre-IND meetings with USFDA, scientific advice meetings with BfArM (Germany), ANVISA (Brazil), Medsafe (New Zealand), ALIMS (Serbia) and NORCB (Egypt) as well as expert group meetings on Indian GCP guidelines and National Technology Advisory Group on Immunisation meetings.
Dr. Chatterjee serves as a reviewer for the journal ‘Vaccine’ and has 24 peer-reviewed international research publications and 4 book chapters to his credit. He was awarded the prestigious 2012 Charles C. Shepard Award from CDC, Atlanta in 2012 and the Outstanding Contributions to Public Health at the Biopharma Excellence Awards 2026.
With over 26 years of experience, including over 13 years with the Otsuka I have led diverse functions across finance, strategy, and enterprise management. I began my career with reputed cost and chartered accountant firms. I later spent a decade with ESSAR in the Finance & Accounts function, building strong expertise in financial governance, MIS, and strategic planning.
Otsuka Pharmaceutical India Private Limited (OPI) provided me great learning opportunities to lead and oversee variety of functions such as Finance & Accounts, Corporate Planning, International Business, SCM, HR, IT, Legal-Secretarial, Regulatory & Corporate affairs. I am now responsible to lead OPI, India's largest IV fluids manufacturer, with revenues exceeding ₹600 crore and exports to over 60 countries, and a team of nearly 1,000 professionals delivering high-quality healthcare solutions. OPI as we fondly say is a Japanese MNC with an Indian heart.
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