Dr. Carlos Bertoncini is a strategic and scientifically driven Clinical Development Leader with a PhD and over 15 years of international experience in drug discovery, pharmaceutical development, and early-phase clinical research. Based in Madrid, Spain, he has extensive expertise in clinical pharmacology, global clinical development, and regulatory strategy, with a particular focus on biosimilars and complex generics.

In his professional role at Chemo, Dr. Bertoncini leads clinical scientists and pharmacometricians, overseeing more than 30 global early-development programs spanning non-clinical research and Phase I–II clinical trials. His work covers multiple therapeutic areas, including central nervous system disorders, oncology, and biosimilars. His scientific expertise encompasses pharmacokinetics and pharmacodynamics (PK/PD), population pharmacokinetic (PopPK) modelling, in vitro–in vivo correlation (IVIVC), and bioanalytical sciences. He applies these capabilities to optimize clinical trial designs, strengthen evidence generation, and support efficient clinical decision-making throughout pharmaceutical development.

Dr. Bertoncini possesses extensive regulatory experience with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regional regulatory authorities. His contributions include the preparation of INDs, CTAs, NDAs, ANDAs, and biosimilarity and bioequivalence submissions. He also represents sponsors in scientific advice and pre-IND/ANDA meetings, integrating scientific evidence with regulatory requirements. With a strong foundation in protein chemistry and biophysical analytics, he has contributed to the development of biologics, RNA-based therapies, and complex generics from early development through clinical proof-of-concept. His scientific contributions include more than 40 peer-reviewed publications and an H-index of 31. He collaborates across clinical, regulatory, bioanalytical, and research and development teams internationally, translating complex scientific challenges into practical development strategies. His expertise supports the advancement of safe, effective, and accessible medicines for patients worldwide.

Dr. Devendra Ridhurkar is the Founder & CEO of RidNova Pharmaceuticals, Barcelona, Spain, and a pharmaceutical R&D and drug-delivery expert with over 20 years of experience in complex formulation development, product development strategy, and scientific leadership.

His expertise spans complex generics, 505(b)(2), EU Hybrid and value-added medicines, with extensive experience in formulation and CMC strategies for differentiated pharmaceutical products.

His technical expertise includes modified- and controlled-release oral dosage forms, long-acting injectables, liposomes, nanoparticles, hot-melt extrusion, spray drying, solid dispersions, microencapsulation, continuous manufacturing, lyophilization, and other advanced drug- delivery technologies. His experience covers small molecules as well as peptides, proteins, biologics and biosimilars.

Dr. Ridhurkar has contributed to the development and regulatory advancement of numerous pharmaceutical products for global markets and has extensive experience in translating complex formulation concepts into scalable and commercially viable products. He is also actively exploring the application of Artificial Intelligence in pharmaceutical R&D, including formulation optimization, predictive modeling, and data-driven development strategies.

He recently contributed a book chapter on AI-embedded systems for brain targeting published by Elsevier. Dr. Ridhurkar holds an M.Pharm and PhD in Pharmaceutics from the Indian Institute of Technology (BHU), Varanasi. He has authored more than ten peer-reviewed publications and is an inventor on nine patents in advanced drug delivery and pharmaceutical technologies.

Prabhakar has joined USP in January of 2020 and he is currently the Senior Director of Pharmaceutical Sciences, General Chapters, and works with Dosage Forms and Packaging & Distribution Expert Committee related activities. He is also the scientific lead for the Complex Generics initiatives at USP, including developing standards for Extractables & Leachables, as well as other complex products such as Complex Injectables, Ophthalmics, Topical & Transdermal, Nasal & Inhalation products. 

Prior to joining USP, Prabhakar worked in the pharmaceutical industry for more than 27 years at various small and large pharmaceutical companies in the field of analytical and bio-analytical chemistry. His expertise includes analytical and bioanalytical method development and validations, use of modern analytical technologies such as HPLC/UPLC and LC-MS/MS for characterization of both small and large molecules, use of automated instrumentation (TPW, and Sotax AT MD) for assay and dissolution testing, ICH stability testing, and preparation of regulatory documentation for IND/ANDA/NDA submissions. Prabhakar has BS and MS degrees in chemistry and PhD degree in bioanalytical chemistry.

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).

Dr. Prabhat Shrivastava, M. Pharm., PhD, is Associate Director & Vertical Head – Formulation & Packaging Development, Product Development at Piramal Pharma Solutions, Piramal Pharma Ltd., Ahmedabad, India. 

He is a technically skilled, strategic, and resilient pharmaceutical professional with 20 years of experience across Torrent, Wockhardt, Lupin, IIT-BHU, Novartis, and Piramal Pharma, with extensive expertise in the product development lifecycle and project management. His core competencies include complex and oncology oral solid dosage (OSD) product and analytical development, Quality by Design (QbD), biopharmaceutics, global regulatory affairs, GMP/GLP quality and compliance, clinical operations, stakeholder management, CDMO/CMO business, and people development. 

Since May 2022, he has been leading Formulation & Packaging Development at Piramal Pharma Solutions. Previously, he served as Senior Expert – Product Development at Novartis Healthcare, Manager and Group Lead – Product Development at Torrent Pharmaceuticals, Manager – Regulatory Affairs at Freyr Inc., Research Scientist at Wockhardt Research Centre, Senior Research Fellow at IIT-BHU, and Research Associate at Lupin Research Park. 

He holds a PhD in Pharmaceutical Engineering from IIT-BHU, a Master of Pharmacy from RGPV, Bhopal, and a Bachelor of Pharmacy from RGPV, Bhopal. His professional achievements include research awards, international travel grants, an AAPS Drug Design and Discovery travel award, a DBT international grant, and the D. S. Kothari Post-Doctoral Fellowship.

Strategic R&D executive with over 23 years of leadership in Pharmaceutical Product Development across global organizations like Dr. Reddy’s and Ranbaxy (currently Sun pharma). Proven expert in steering multidisciplinary teams to deliver complex portfolios including Differentiated Formulations,  Complex Generics and Oral Peptides. 

A strategic architect of drug development  from conceptualization to pre-clinical to commercialization, with a deep focus on Operations Excellence, Global CMC Strategy and Unbossed Leadership. Adept at navigating matrixed global alliances and managing multi-million dollar Projects and Budgets while fostering a culture of Innovation and Diversity and Inclusion.

Dr Raghupathi Kandarapu currently serves as Vice President and head of technology transfer and scientific aspects of new product launch and life-cycle management of generic products at Medreich Limited. Dr Kandarapu is an alumnus of National Institute of Pharmaceutical Education and Research (NIPER), Mohali (Punjab). After completing his MPharm and PhD programs from NIPER, Dr Kandarapu spent more than two decades with major Indian pharmaceutical companies at different capacities and mentored cross-functional teams involved in the development, registration, and commercialization of novel/innovative drug delivery systems as well as complex generics for highly regulated markets.  

Dr Kandarapu holds several certifications including advanced leadership program in business development from IIM-A Campus, Project Management (PM-BOK) from PM-Soft®, Clinical Research (ICRI, New Delhi), Intellecutual Property Rights, etc. 

He has published more than dozen research papers in international journals and presented research work in several conferences. He has more than 30 patent applications filed to his credit and member of academic counsel of several Indian universities, including NIPER- Guwahati.

Dr Kandarapu research focus includes identification and/or conceptualization of novel drug-delivery ideations based on “un-met” medical need life-cycle management of drugs/formulations. The core areas of specialization of his interest are Multiparticulate Drug Delivery Systems (MUPS), solid-state characterization, novel salt/polymorph screening for 505(b)(2) or exclusive marketing opportunities.

Graduated from ABCP College in 2001 and completed post-graduation from Goa College of Pharmacy in 2003, followed by a Ph.D. from SNDT Women's University, Mumbai. She began her career in Research and Development with Cosmo Group of Companies and subsequently worked with reputed pharmaceutical organizations including Macleods Pharmaceuticals, Aurobindo Pharma, Rubicon Research Ltd and Indoco remedies. She is currently serving as Vice President – Research & Development at Raay Neo Pharma.

With over 23 years of rich experience in formulation R&D for regulated markets such as the US, EU, UK, Canada, and Australia, she possesses extensive expertise in the development of complex sterile formulations, including ophthalmics and injectables, as well as challenging oral and inhalation dosage forms & nutraceuticals . Her experience spans immediate-release and extended-release tablets, multiparticulates, capsules, and semisolid formulations.

Throughout her career, she has successfully filed numerous ANDAs and First-to-File (FTF) products across global markets. Her expertise covers the complete product lifecycle—from lab-scale development to commercialization—effectively addressing technical and regulatory challenges to ensure successful market entry.

She has strong proficiency in Quality by Design (QbD), enabling robust product development and seamless technology transfer with minimal failure rates. She has also authored several research publications and holds multiple patents to her credit.

Dr. Saurabh Srivastava has earned his Ph.D. in Pharmaceutics from “Panjab University, Chandigarh”and pursued his Master's in Pharmaceutical Sciences from “Birla Institute of Technology and Science (BITS), Pilani, Rajasthan. He carries more than 17+ years of profound industrial and research experience working with several Pharmaceutical R&Ds, including IPCA labs, Mumbai, Wockhardt research centre, Aurangabad and his latest stint was with Dr. Reddy’s Laboratories, Hyderabad, as Tech Lead for development and commercialization of various Differentiated, NDA and ANDA based products for different regulated markets. 

Currently, he is working as a Professor & Head in the Department of Pharmaceutics, NIPER-Hyderabadandalsoacting as Associate Dean, of NIPER Hyderabad. His Research Laboratory,famed as Pharmaceutical Innovation and Translational Research Lab (PITRL) is predominantly working on the development and optimization of Industrially viable Differentiated formulations; (505(b)2, through the utilization of Micro/Nanostructured Targeted drug deliveries along with Novel platform technologies. His major therapeutic area of research is Cancer, Dermal Disorder, Diabetic Complications and Neurodegenerative disorders. 

He has mentored 55+ Masters Research scholars, and 08 PhD Thesis submissions; whereas,07 PhD Scholars are pursuing their Doctoral research under his supervision. His research team is actively involved in executing several Extra Mural Research (EMR) and Industrial Research Projects (~1.5 CR.) to establish novel differentiated products. He has been awarded several appreciation and recognitions from Dr. Reddy’s Laboratories for his outstanding contribution to research. He was further elected as a Fellow of the Prestigious “Telangana Academy of Sciences” (TAS) in May 2024. He had been instrumental in 03 “Commercial Products”,and carries 17+ “International and National Patents”, 04 Edited books, 50+ Book chapters along with 225+ Publications in Journals of International repute with h-Index of 44 and 8800+ citations further to his credit.

N. Ravikumar is the President of Formulations R&D at Granules India Limited and holds an M.Pharm in Pharmaceutics from BITS Pilani. With over 30 years of experience in pharmaceutical and biopharmaceutical development, he has extensive expertise in product and process development, process optimization, scale-up, and technology transfer. 

Throughout his career at leading organizations, including Ranbaxy, Apotex, Amneal, Jubilant, and MSN, he has established and led large R&D teams and contributed significantly to generic drug development across global markets. His achievements include leading the development of 186 US ANDAs, 40 European Marketing Authorizations, 30 Canadian ANDS, and 19 Australian dossiers. 

He has also played a key role in establishing R&D and commercial facilities, developing oncology-focused portfolios, and advancing modified-release dosage forms. His work spans solid oral formulations, liquid orals, sterile injectables, and peptide formulations. He has contributed to over 415 global submissions, more than 100 product approvals, and over 20 patents published globally, while leading teams of more than 665 scientists across organizations.

Dr. Pradeep Dabhi is a Co-Founder and Chief Scientific Officer of Cutyx Research, Ahmedabad, India, where he leads analytical development activities for complex drug delivery systems. His current work focuses on phase-appropriate analytical development and characterization of topical semi-solids, transdermal patches, oral thin strips/films, and microneedle array patches.

With more than 16 years of experience in pharmaceutical R&D, Dr. Dabhi has developed broad expertise spanning complex drug product development, analytical science, advanced product characterization, and regulatory CMC. His areas of expertise include analytical strategy and method development, qualification, validation and transfer; reverse engineering of complex formulations; in-vitro release and skin permeation testing (IVRT/IVPT); extractables and leachables (E&L); nitrosamine and elemental impurity assessment; and statistical evaluation of complex pharmaceutical data. He has contributed to development programs supporting ANDA and NDA 505(b)(2) pathways and has extensive experience addressing complex CMC requirements and regulatory deficiencies.

Dr. Dabhi is a Member of the CRCG–FDA Stakeholder Expert Committee on Adhesion Testing for Transdermal/Topical Delivery Systems, contributing to scientific efforts toward improved in-vitro approaches for evaluating adhesion performance of transdermal systems. He is also a Member of the USP Expert Committee on Excipient Chapters, contributing to the development and maintenance of pharmacopeial standards related to excipients.

In addition to his scientific and regulatory expertise, he has extensive experience in establishing analytical and quality-control capabilities for complex drug products, including greenfield laboratory development and implementation. Dr. Dabhi holds a Doctorate in Pharmaceutical Sciences and an M.S. (Pharm.) from NIPER- Ahmedabad, India.

Babasaheb Aware is a dynamic pharmaceutical R&D leader with over 20 years of experience in formulation development, advanced drug delivery systems, R&D infrastructure development, and strategic business growth. He has a proven track record of establishing and scaling state-of-the-art R&D facilities, driving innovation, and building strategic collaborations that accelerate product development and commercialization.

He has led the development of a broad spectrum of pharmaceutical products, including oral solid dosage forms, injectables, and advanced nasal drug delivery systems. He possesses specialized expertise in preservative-free unit-dose nasal formulations and nasal delivery devices, covering formulation design, primary packaging, device integration, fill-finish operations, stability assessment, and commercialization strategies. His contributions to intranasal drug delivery innovation have been recognized through granted patents for novel nasal delivery devices and associated pharmaceutical technologies, reflecting his commitment to developing patient-centric and differentiated healthcare solutions.

Throughout his career, he has successfully directed R&D plant setup projects from concept design through commissioning, ensuring GMP compliance, operational efficiency, and scalability. He has also established and nurtured strategic partnerships with CROs, CMOs, and academic institutions to expand development capabilities and accelerate innovation.

His expertise encompasses formulation development, technology transfer, scale-up, process validation, and global regulatory submissions, including IND, NDA, ANDA, 505(b)(2), and international dossier filings. A strong advocate of Quality by Design (QbD) and risk-based development, he has consistently delivered innovative and cost-effective solutions that enhance product performance and accelerate time-to-market.

In addition to his technical leadership, he has actively supported business development initiatives, licensing evaluations, and portfolio expansion strategies. His innovation-focused approach has resulted in multiple successful product launches, proprietary technologies, patents, and differentiated formulations in sustained-release, bioavailability enhancement, and nasal drug delivery platforms.

Passionate about advancing healthcare through science, innovation, and strategic partnerships, he continues to bridge pharmaceutical research with commercial success, delivering meaningful value to patients, healthcare providers, and stakeholders worldwide.

Deval Gupta serves as Associate Vice President, Innovation & R&D, at Alternicq/Pravesha, where he leads the development of advanced drug delivery devices and combination product programs for global regulated markets.

A Fellow of the Indian Institute of Technology (IIT), Kharagpur, Deval brings more than 24 years of experience spanning materials engineering, polymer science, quality systems, and pharmaceutical device development. His expertise lies in the successful integration of pharmaceutical products with complex drug delivery devices, bridging engineering, regulatory science, and manufacturing to deliver compliant, robust, and patient-centric healthcare solutions.

Throughout his career, he has led the development and commercialization of a broad range of parenteral and inhalation drug delivery systems, including pen injectors, autoinjectors, prefilled syringes, passive needle-safety devices, pressurized metered-dose inhalers (pMDIs), nasal spray systems, and airless pumps. His responsibilities encompass device engineering, design controls, regulatory CMC strategy, risk management, human factors engineering, biocompatibility assessments, manufacturing scale-up, process validation, and global regulatory submissions.

Deval has extensive experience in combination product regulations and quality systems, including FDA combination product requirements, Quality Management System Regulation (QMSR), EU Medical Device Regulation (EU MDR), ISO 13485, ISO 14971, and ISO 10993. His work also includes establishing device quality control and release testing strategies, supporting regulatory inspections and audits, and leading technical investigations, root cause analyses (RCA), and corrective and preventive action (CAPA) programs.

Through strategic collaboration with device component manufacturers, contract development and manufacturing organizations (CDMOs), device assembly partners, and fill-finish organizations, he has played a key role in advancing combination product programs from concept through commercialization, enabling successful market access across major global healthcare markets.

Dr. Santosh Kumar Narla is a distinguished leader in the global pharmaceutical landscape, currently serving as the General Manager and Head of Regulatory Affairs at Shilpa Medicare Limited. With over 22 years of experience, he is a renowned expert in navigating the complex regulatory landscapes of the US, EU, and emerging global markets.

He holds a Ph.D. in Pharmaceutical Sciences from JNTU, Hyderabad. Throughout his career, Dr. Narla has held senior leadership positions at premier organizations, including Dr. Reddy’s Laboratories, Novartis, and Laurus Labs.