Dr Ing. Jérôme Keldenich is the founder of Pharma K Consulting SRL (Belgium), an independent consultancy in drug product development, pharma manufacturing processes (especially aseptic processes including lyophilisation) and technology transfer. A PhD chemist with some twenty years' experience on both the CDMO and sponsor sides, he was previously Chief Scientific Officer and MSAT Director of the Cenexi group and Head of CMC at Immunic Therapeutics, after roles at Lonza/Capsugel, Patheon, Takeda and Baxter. His work focuses on applying quality risk management and quality by design from early process development through equipment design and lifecycle management of complex injectables.

René Holm is Professor of Pharmaceutics at the University of Southern Denmark (SDU) at the Department of Physics, Chemistry and Pharmacy. He received his PhD from the University of Copenhagen in 2002. His research focuses on pharmaceutical formulation and physical pharmacy, particularly long-acting depot formulations and drug delivery for chronic diseases and long-term therapies. Before joining SDU in 2021, he held research and leadership roles in the pharmaceutical industry, including positions at Lundbeck and Janssen. He also serves on the board of Independent Research Fund Denmark. Professor Holm have authored more than 300 scientific papers and book chapters in the field of pharmaceutics as well as 19 patents.

Raja Paulraj is an accomplished pharmaceutical professional with an M.Pharm qualification and over 24 years of experience in pharmaceutical manufacturing, process technology, technology transfer, and product commercialization. He has extensive expertise in complex sterile injectable products, including microspheres, sterile emulsions and suspensions, liposomal formulations, sterile liquid injections, dry powder for injection, lyophilized products, prefilled syringes, Blow-Fill-Seal (BFS) technology, and ophthalmic formulations.Throughout his career, he has been involved across the complete product lifecycle, from product and process development through scale-up, exhibit batches, process validation, technology transfer, and commercial manufacturing. His experience includes process optimization, troubleshooting, validation strategy, regulatory responses, and implementation of robust process controls to ensure consistent product quality and reliable manufacturing performance.He has also worked extensively with cross-functional teams, external partners, contract research organizations, and manufacturing sites to develop and commercialize complex pharmaceutical technologies. His strong technical and operational expertise enables him to effectively bridge development, manufacturing, quality, and regulatory requirements, supporting successful product launches and lifecycle management.

Shrenik Kole brings over 27 years of vast experience in the pharmaceutical sectors, particularly in drug product development of both conventional and speciality dosage forms, including solid oral, ophthalmic, sterile semisolids and complex injectable products. He is currently serving as Vice President/Head- Sterile Product Development at Micro labs advance Research centre, Bengaluru. He possesses a comprehensive background spanning the entire product lifecycle, from initial concept to commercialization, with a proven track record in developing complex injectable Peptide, Iron complex and ophthalmic products. A significant strength lies in navigating the intricacies of global regulatory landscapes, having successfully managed and submitted
regulatory dossiers for major markets including the USA and EU, as well as other international territories. He has completed his bachelors from Kolhapur university and Master in pharmaceutical sciences from Rajiv Gandhi University of Health Sciences and undergone senior leadership programmes at IIM Ahmedabad and IIM- Nagpur. Prior to joining Micro Labs Ltd, he held key leadership position at Lupin Research Centre and also worked in companies like Novartis and NPI, Oman. Shrenik Kole has several achievements: He has inventorship in 9 patents and several applications on his credit and also developed and filed more than 50 ANDA’s for the US and other regulated market, achieving a high approval rate.

Dr. Nirav Khatri leads complex injectable development programs at Dr. Reddy’s Laboratories Ltd., India, spanning long-acting injectables, liposomes, peptides and complex API-based products. Through his involvement in the end-to-end development and lifecycle management of complex injectable products, he has developed deep expertise in formulation design, scale-up, and commercialization. His experience includes navigating challenges specific to complex injectables, including reverse engineering, advanced product characterization, in-vitro performance assessment, sterility assurance, bioequivalence strategy development, and support for global regulatory submissions. Dr. Khatri, holds a Ph.D. in Pharmaceutical Sciences and has contributed to interdisciplinary research in targeted drug-delivery systems, resulting in international publications, book chapters and patents. He serves as an Expert Advisor to the USP Microparticle Expert Panel under the Dosage Forms Expert Committee of the United States Pharmacopeia (USP).

Loganathan Shanmugam is the Associate Vice President (AVP) of Device & Packaging Development at OneSource Specialty Pharma, where he leads the development of drug delivery devices and packaging solutions across the company’s biosimilar, CDMO, and generics portfolios. With over 27 years of experience in the design and development of drug delivery systems and medical devices, he brings extensive expertise across ophthalmic delivery systems, inhalers, injectors, and delivery systems for regenerative therapies. His experience encompasses Class I, II, and III medical devices, as well as combination drug delivery systems, including single-dose and multidose injectors. His expertise spans the entire product development lifecycle, from initial design to industrialization. His key areas of specialization include risk management, design controls, test method development, tooling, assembly machine development, process validation, manufacturing, and quality systems for medical devices and pharmaceutical drug delivery packaging.

At OneSource Specialty Pharma, Loganathan plays a key role in advancing device and packaging development for complex drug delivery applications. His broad technical and operational experience enables him to address the challenges associated with device development, manufacturing processes, and the integration of drug delivery technologies. He holds an MBA in Operations Research and has an educational background in Plastics Engineering. Combining technical knowledge with operational leadership, he brings a comprehensive perspective to the development and industrialization of medical devices and drug delivery systems, supporting the delivery of innovative and effective solutions for pharmaceutical applications.