Sudeep Sen is an experienced upstream bioprocessing Subject Matter Expert for Single Use Technology and Manufacturing Process with hands on experience in both Single Use and Multi Use systems for End-End Bioprocessing of Biologics. Sudeep comes with over 18 years of experience in the Biopharmaceutical Industry and with a wholesome exposure on start-up plant commissioning FAT, SAT (IQ, OQ and PQ), scale-up, technology transfer, process validation and manufacturing under cGMP conditions for clinical and commercial batches. Currently, Sudeep leads the technical engagement strategy at Thermo Fisher Scientific in Asia Pacific & Japan upstream process of several projects including monoclonal antibodies, LV/AAV, mRNA, ADC, plasmid and vaccines along with end-to-end team.

Dr. Ranjan Chakrabarti has over 36 years of experience in Biopharma and Drug Discovery industries.

Dr. Ranjan Chakrabarti is now working as an advisor at Fortis Vita Nutraceuticals in drug discovery. He is a member of the Centre of Excellence monitoring Committee at NIPER-Mohali, advisory board member of Pharma Now magazine and also a member of the Executive Committee of Federation of Asian Biotech Association (FABA). He is advising several Conference organizers in the areas of Biosimilars, vaccines, peptides and oligonucleotides.

Ranjan was the Vice President – Global Biologics at United States Pharmacopeia for 11 years. He built the Biologics labs in India, China and Ghana, which were involved in characterization of Biotherapeutics and developing standards. Afterwards, he was overseeing USP’s scientific outreach activities in South, SE Asia and China working closely with regulators, biopharma cos and trade associations of those countries. Before joining USP, Ranjan was Head of Preclinical Biology at Dr. Reddy’s lab for 12 years. He played a key role in discovering and developing NCEs which have undergone global clinical trials (Phase 1-3) in collaboration with Novo Nordisk and Novartis. Ranjan was also heading the Biology SBU at GVK Biosciences, where he has worked with several National and International companies for discovery and development of both biological and chemical molecules. Before returning to India, Ranjan worked 7 years in Academics in the USA and successfully coordinated research projects in Cancer Cell Biology and Diabetes and guided several Ph. D. students.

Dr. Ranjan is the Co-Inventor of 32 US Patents; published 64 papers in peer reviewed International and National Journals and presented 96 lectures in International and National Conference

Dr. Tulip Nuwal is an accomplished biotech professional with extensive experience in cell and gene therapy. He has a strong background in leadership, strategy, and operations, demonstrated by his role in establishing one of India's first cGMP facilities for clinical and commercial manufacturing of cell and gene therapy products. Currently serving as Head of Business Excellence and CGT operations at Intas Pharmaceuticals, he oversees business strategy and operations for cell and gene therapy and biologics/biosimilars business units. His expertise includes setting up state-of-the-art operations, supply chains, structuring deals, and leading cross-functional teams to drive innovation. Dr. Nuwal holds a PhD in Neurobiology and Genetics, a business degree from Indian School of Business, and a B.tech in Industrial Biotechnology. His career includes significant roles and achievements in scientific research, business development and operations management.

Sankara Reddy Soma is a Head Quality assurance at Eugia Pharma specialities Limited. He joined Eugia Pharma specialities in 2022 following 22 years of experience in the pharmaceutical and Biopharmaceutical experience with Quality and compliance activities. He has previously worked for MNCs and Indian Pharma/vaccine Majors includes Sanofi, Mylan (Viatris) , Aurobindo Pharma and Biological E and held Senior Quality positions, His areas of particular interest in pharmaceutical Quality assurance includes sterility assurance, preparation of response to USFDA 483s, design and execution of audit remediation plans (including data integrity remediation),experience in handling the requirements and expectations of HA audits (for various large and small molecules) includes USFDA,EMA,WHO Geneva, MHRA, Health CANADA,ANVISA… .

Sankara Reddy has an educational background in Life science and received a M.Sc from the PSG college of arts and Science and Pursuing PhD from E Yogi vemana University Kadapa.

Dr Raj K. Shirumalla is currently working as Mission Director in National Biopharma Mission in Biotechnology Industry Research Assistance Council (BIRAC), New Delhi. He received his M Pharm from Jamia Hamdard, and PhD from BITS, Pilani. He has over 28 years’ experience as scientists, academician, administrator. He has worked with Indian and Japanese Pharmaceutical Companies (Daiichi Sankyo), focusing on drug discovery. He has worked on and led teams to identify eight clinical drug candidates – three of them reached Phase II clinical trials. Dr. Shirumalla’s primary research focus has been - respiratory diseases and Oncology. In addition, he has worked in Inflammatory diseases like - Rheumatoid arthritis, SLE, Multiple sclerosis, etc. He also worked with GlaxoSmithKline (GSK) in a collaborative project to identify one development candidate, reaching Phase II Trials for COPD. He has experience in translation research and worked on identifying novel biomarkers and QSP modelling for respiratory diseases. He has extensive experience in herbal research and was head of the operation of an herbal-based company. He has several publications in peer-reviewed journals and has 30 international patents to his credit.

Dr. Prathap Naidu is a Business Development Lead, Cell Biology & Synthetic Biology, South Asia at Thermo Fisher Scientific. A leader in the Cell & Gene Therapy space, Dr. Prathap has over 15 years of experience in Genomics, Cell, and Molecular Biology. He holds a Ph.D. in Biotechnology and has contributed to cross-disciplinary projects for advancing the understanding of complex biological systems at global institutes.

Over recent years, he has played a pivotal role in building and advancing India’s Cell & Gene Therapy ecosystem, partnering with research institutions, biopharma companies, and clinical centres to establish critical capabilities and end-to-end CGT solutions.

He joined Thermo Fisher Scientific in 2010 as a Field Application Scientist, and over the past fifteen years, he has been driving high-performing scientific teams and delivering differentiated solutions across the CGT value chain. Today, as Business Development Lead for Cell, Molecular Biology, and Cell Analysis across South Asia, he works closely with scientists, clinicians, and industry leaders to accelerate the translation of Cell, Gene and advanced therapies from concept to clinic. As a published researcher and respected industry voice, he blends deep scientific expertise with business insight to help bring life-changing innovations to patients.

Lalitha is a trained immunologist with over 25 years of pharmacology and integrated drug discovery experience in autoimmune disorders, inflammation and cancer. She is currently the VP and Head of Discovery Biology and Translational Sciences at PI Health Sciences. She has worked in organisations like Merck Res Labs(Rahway), Ranbaxy Research Laboratories Pvt Ltd, Daiichi Sankyo Research Laboratories and Syngene International Ltd. More recently , she worked at Eurofins Advinus as Senior Director and Head, Discovery Biology Services, where her group

Head Discovery Biology & Translational Sciences

provided regulatory services in the bioassay, batch release and immunogenicity evaluation for peptide generics in preclinical studies for ANDA submissions.

Lalitha has completed her Ph.D. in Immunology from the International Centre for Genetic Engineering and Biotechnology, New Delhi, post-doctoral from Harvard Medical School, Boston, USA, and an MBA from the Faculty of Management Studies (New Delhi, India).

Julian Poh is Senior Technical Sales Manager for Single Use Technologies at Thermo Fisher Scientific, across Asia Pacific & Japan region. In nearly a decade of experience at Thermo Fisher, he has undertaken diverse roles in technical sales, product management, and business development, spanning both laboratory consumables and bioproduction solutions. Prior to joining Thermo Fisher, he held multiple roles at Lonza Biologics in validation and development services. He holds a Bachelor’s (Honours) Degree in Chemical and Biomolecular Engineering from Nanyang Technological University (Singapore) and an Executive MBA from the Quantic School of Business & Technology.

Jayesh Ranjan currently serves as Special Chief Secretary & CEO of Telangana's Industry & Investment Cell and SPEED initiative in the Chief Minister's Office. Previously, he was Special Chief Secretary of Industries & Commerce and IT Departments for nearly a decade. His career includes roles as Commissioner of Industries, Tourism Secretary, and Vice-Chairman of Hyderabad Urban Development Authority, alongside 12 years in rural assignments covering tribal development and poverty alleviation. He's been a GHIAL board director since 2016 and supports numerous organizations including Save the Children and WWF Hyderabad.

Educationally, Ranjan holds a Psychology Masters from Delhi University, Business Management degree from IIM Calcutta, and Public Management Masters from Singapore's Lee Kuan Yew School. His specialized training includes courses at Harvard Kennedy School, London School of Economics, and Stockholm's Swedish Institute. An All-India topper of his 1992 IAS batch, he received Sweden's Royal Order of the Polar Star and a University of Bolton honorary doctorate.

Mr. Gopinadh Jakka completed his PhD from university of Zurich and postdoctoral fellowship from Ludwig Institute for Cancer Research, Lausanne. He is a scientifically seasoned immunologist with more than 15+ years of demonstrated experience in the field of Cell and gene therapy and has worked in world renowned companies including Beckman coulter life science center, Bangalore. He currently leads a scientific team comprising of PhDs and postdocs to develop allogeneic chimeric antigen receptor (CAR) redirected T cell therapy for solid tumors using in-vitro and preclinical models.

His scientific acumen in analytical method development and stringent process validations for cell and gene therapy products has rewarded him with an esteemed position of Head of Analytical Development at Immuneel and was instrumental in the commercial launch of approved CAR-T product (Qartemi®) for adult B-cell Non-Hodgkin Lymphoma (B-NHL).

Dr. Saravanan Kumar is a seasoned scientific leader with over 17 years of experience in advanced analytical sciences, specializing in mass spectrometry and allied technologies. As the head of PAN-India Omics & Biopharma Applications at Thermo Fisher Scientific, he drives scientific innovation, collaborates with leading academia and industry partners, and leads the development of cutting-edge analytical workflows for complex biologics.

His diverse expertise spans monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), peptide drugs, oligonucleotide therapeutics, proteomics, and regulatory-compliant QC solutions. Dr. Kumar has authored 25+ international publications, book chapters, and application notes, and has delivered numerous global training programs.

He earned his Ph.D. from the International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi, through a prestigious World Bank–funded project specializing in glycoproteomics. Recognized with multiple awards for scientific innovation and leadership, Dr. Kumar remains committed to empowering the Indian scientific community by democratizing access to advanced analytical technologies.

Dr. Melina Soares is seasoned Immunologist with more than two decades of experience in developing Cancer Immunotherapies in academia and industry. With a proven track record in research and development, she has successfully guided innovative research at companies including Biocon and Immuneel Therapeutics and has held research roles at the University of Texas Southwestern Medical Center and the University of Pittsburgh School of Medicine.

She currently serves as Head of Innovation at Immuneel Therapeutics, a pioneer in Cell and Gene Therapy in India. Melina is passionate about driving the pre-clinical development of innovative and affordable cell and gene products to treat patients in India and globally.

Vipul Saxena is a Subject Matter Expert at Lonza Bioscience with nine years of experience in biopharmaceutical process development. He specializes in upstream cell culture for monoclonal antibody production, with expertise in media optimization, scale-up, and regulatory readiness. Mr. Saxena brings a strong track record in client engagement, technical troubleshooting, and innovation across CDMO and product-based organizations.

In his current role as Managing Director of Thermo Fisher Scientific, Srinath Venkatesh is focused on continuing Thermo Fisher's legacy of excellence and industry leadership through its purpose-driven Mission- to enable our customers to make the world healthier, cleaner and safer.

A civil engineer with a business management degree, Srinath has previously served as President, Danaher India and Country Leader & CEO at GE, Bangladesh.

Kondal Reddy is the Director of the BioProduction Group for Thermo Fisher Scientific, India & South Asia, bringing with him over two decades of proven leadership across the life sciences, bioprocess, and healthcare sectors.

He holds a Master’s degree in Microbiology from Nagarjuna University and has further enhanced his strategic and business acumen through a General Management program at the prestigious Indian Institute of Management (IIM) Ahmedabad.

With over two decades of extensive leadership experience, Kondal has made significant contributions across the life sciences, bioprocessing, and healthcare sectors. He has demonstrated strategic vision and operational expertise in senior leadership roles across India and the Asia Pacific region.

Throughout his career, Kondal has successfully led business operations across diverse functional domains including P&L management, sales, marketing, service, application support, and supply chain management.

His depth of industry knowledge and cross-functional expertise position him as a key driver of innovation and growth in the bioproduction sector.

Tony Acciarito is the President of Asia Pacific, Middle East & Africa at Thermo Fisher Scientific, the world leader in serving science. A dynamic and accomplished senior executive with over three decades of global experience in the scientific and healthcare industries, Tony is widely recognized for his ability to accelerate strategic growth, lead transformative change, and drive operational excellence across highly diverse and complex markets.

Since joining Thermo Fisher Scientific in 2009 as Director and General Manager for Australia and New Zealand, Tony has consistently taken on roles of increasing scope and responsibility. In 2014, he was appointed Vice President and General Manager of South Korea, and in 2018, he relocated to China to serve as President of Thermo Fisher Scientific, China—one of the company’s most strategically important markets.

In 2021, Tony was named President of Asia Pacific & Japan, and in 2025, his leadership expanded to include the Middle East and Africa. Under his guidance, Thermo Fisher has significantly strengthened its market leadership, delivering sustained multi-billion-dollar growth, embedding customer-centric innovation, and building empowered, high-performance teams. He is a champion of operational rigor and is deeply committed to talent development and inclusion.

Tony holds a bachelor’s degree in chemistry from Victoria University and a diploma in Applied Science from NMIT. An Australian national, he is fluent in English and Italian and is currently based in Singapore

Dr. Arunkumar Thangaraju is a Principal Scientific Manager at Biocon Biologics, bringing over 13 years of industrial research experience in biologics drug discovery and development. His career includes impactful roles at Eli Lilly, Pfizer, and Biocon, where he has contributed extensively to pharmacokinetics, analytical and functional characterization of biologics. Dr. Arunkumar holds a Ph.D. in Biomedical Sciences (Molecular Pharmacology) from Oklahoma State University, USA. A passionate scientific leader, Dr. Arunkumar has spearheaded digital transformation initiatives in R&D. He is deeply committed to translating science into impactful therapies that improve patient outcomes

Dr. Fatima D’Souza serves as Chief Operating Officer at Zelle Biotechnology, bringing over 25 years of comprehensive experience spanning R&D, manufacturing, quality control, and intellectual property. She holds a PhD in Biochemistry from ICT Mumbai and has led key initiatives in downstream processing, assay development, and protein characterization. Her prior roles at Biocon and Goodwin Biotechnology focused on assay validation, process optimization, and setting up strategic operations in India. A published scientist and contributor to multiple patents, Dr. D’Souza is known for her leadership in technology transfer, cross-functional team development, and advancing innovation in biopharmaceuticals.

Dr. Stamm holds a doctoral degree in molecular parasitology and a master degree in drug regulatory affairs from the University of Bonn, Germany. He joined Charles River in 2003 and became responsible for the business development activities in Europe and Asia.

Prior to joining Charles River he worked for Eurofins Scientific running their microbiological GMP testing laboratories in Switzerland.

While being for many years the global subject matter specialist for impurity and contamination testing, most recently Dr. Stamm has focused his work on analytical/regulatory consulting for Charles River Biologics Services in Asia and Europe.

Dr. Muthumani is a seasoned pharmaceutical executive with extensive expertise in developing immunotherapies, including vaccines and monoclonal antibodies, for infectious diseases and cancer. He has led a translational research laboratory at the University of Pennsylvania and The Wistar Institute and holding prominent academic and industry positions, including Director of the Laboratory of Emerging Infectious Diseases.

He served as Chief Scientific Officer at GeneOne Life Science, Inc., specializing in vaccines and therapeutics, and later as Distinguished Scientist, Vaccine & Advanced Biotechnologies Process R&D at Merck, USA. Currently, he is the President of R&D at Bharat Biotech. Throughout his career, he has fostered impactful collaborations between academia and the pharmaceutical industry and secured major funding from organizations such as NIH-HVDDT, DARPA, WW Smith, and the Emerson Collective.

Dr. Muthumani’s expertise focuses on vaccine design and contributing to the development of immunogens for viruses such as HIV, CHIKV, MERS-CoV, Zika, Nipah, POWV, MAYV, and SARSCoV-2, several of which were among the first to reach human clinical trials. His work also includes pioneering novel vector-based delivery systems for immunomodulatory antibodies to combat viral pathogens and cancers.

Dr. Muthumani is a recognized leader in vaccinology and immunotherapy, with a strong record in biomedical innovation. He has authored 130+ peer-reviewed publications and holds 22 awarded patents. A recipient of multiple honors, including the Young Scientist Award at the Nobel Symposium on Global HIV Therapeutics, he also serves as associate editor for Frontiers in Virology and section editor for the Journal of Leukocyte Biology. With proven leadership and a commitment to public health, Dr. Muthumani is a driving force in the pharmaceutical and biotech industries

Dr.Amarnath is a Biophysicist with over two decades of experience in peptide and protein research. Following PhD studies in Biophysics, completed postdoctoral work at the prestigious Tata Institute of Fundamental Research in Mumbai and conducted research at the Scripps Research Institute in California alongside Nobel Laureate Prof. Kurt Wuthrich.

With 15+ years of industrial experience, Dr. Amarnath currently heads Biologics Analytical Development and Quality Control, providing expert guidance on analytical workflows for biologics/biosimilars characterization. Specializes in generating and analyzing physicochemical data for regulatory submissions, product release, and process development using advanced spectrometric and spectroscopic methodologies. Offers strategic troubleshooting support for quality control challenges across biopharmaceutical operations.

Dr. Manish Diwan is an accomplished leader with 30+ years in public sector and industry, recognized as a key enabler of India's startup ecosystem. For eight years, he served as Biotech sector lead for Startup India and Make in India national missions, advancing DBT-BIRAC's mandate for deep tech innovation across healthcare, medtech, agritech, and industrial biotech.

He contributes to policy advocacy promoting India's BioEconomy and R&D ecosystem through funding schemes, investments, incubation centers, and public-private partnerships. Dr. Diwan works toward developing technology clusters where industry, startups, and academia can evolve as global bio-innovation hubs.

Trained at prestigious institutions including ICGEB, NII, University of Alberta, and KAIST, Dr. Diwan contributed to global R&D pipelines at Daiichi Sankyo, Ranbaxy, and Dabur across multiple countries. He serves on national committees and advisory boards for various ministries, departments, and industry associations.

Dr. Murali Jayaraman, is currently working as Head, Formulation and Drug product process development at Biologics Unit, Dr. Reddy's Laboratories Ltd. Murali completed Ph.D., in Biochemistry in the area protein misfolding and aggregation at University of Madras. He did postdoctoral work at University of Tennessee and University of Pittsburgh in the area of mechanistic understanding and prevention of protein aggregation in Huntington’s disease. His pharmaceutical journey started during 2010 at Pfizer, St. Louis, USA in the area of formulation development for novel protein molecules using biophysical tools. Later, he worked as a chief research scientist at Hospira (A Pfizer company), Chennai, wherein he had built the formulation and DP process development capability for biosimilars. Murali has over 20 years of research experience, developed novel formulations for monoclonal antibodies, fusion proteins, pegylated proteins and bispecific antibodies. He has 23 publications in peer reviewed journals, 45 patents were filed and 15 patents were granted covering formulations, DP process and test methods. Murali is experienced in developing liquid and lyophilized formulations with protein concentrations up to 200mg/mL and combinations products with safety device and autoinjectors.

One of the founding members, Managing Director & CEO of CLONOVA BIO, a Biopharmaceutical company based in Genome Valley, Hyderabad and also one of the Key founding members of CLONZ BIO.

Molecular Biologist turned Entrepreneur has over 2 decades of experience in the field of Life Sciences Research including Cancer Biology, Proteomics, and Biologics.

One of the members of CII -National Biotech Committee.

One of the Mentors - CCMB-Atal Incubation centre, Hyderabad

Expert Member of Committee for Biological Sciences, of NIPER (National Institute of Pharmaceutical Education & Research), Mohali

Co-ordinator for India centre for the MetaSUB global Consortium project founded by Professor. Christopher Mason, Weill Cornell Medicine -USA

At CLONOVA BIO, along with the co-promoters coming from recognized leaders, driving the company to emerge as a significant Global Biosimilar player.

Ravishankar Kasturi is an accomplished operations leader with over 25 years of experience in biologics and sterile manufacturing, specialising in Drug Substance (DS), Drug Product (DP), and Drug-Device combinations. He serves as Senior Vice President & Head of India Operations at Enzene Biosciences Ltd. (since July 2020), driving its strategic and operational success. Enzene is a subsidiary of Alkem with PE investment.

Previously, at Reliance Life Sciences (2007–2020), Dr. Reddy’s Laboratories (2001–2007), and at Uni-Sankyo (1999–2001),

By training, has a Management degree from IIM Bangalore, M.Tech in Biotechnology from Andhra University and B.Pharm

Sandeep Majumdar is a highly accomplished professional with 29 years of experience in the biopharmaceutical industry. His expertise spans a broad range of critical areas, including project management, process development, and manufacturing. Sandeep's work has been particularly focused on driving digitization and integrating cutting-edge technologies such as Process Analytical Technology (PAT), Quality by Design (QbD), and process intensification, all aimed at improving operational performance.

Throughout his career, Sandeep has played an instrumental role in enhancing productivity and efficiency while reducing cost-of-goods-sold (COGS). By leveraging innovative strategies, he has significantly contributed to sustainability efforts within the biopharmaceutical sector. Sandeep has also been a key member of teams that have successfully delivered complex projects, particularly those involving biopharmaceuticals and advanced molecular development

Akhil leads the clinical development and regulatory departments at Aurigene. After completing his MBBS from AIIMS, New Delhi, in 1995, he completed his residency training in Internal Medicine and Clinical Fellowship in Hematology and Oncology from the Rutgers Cancer Institute of New Jersey. He has been in the industry for more than 20 years, with both big pharma as well as small biotech companies. He has been part of two successful New Drug Applications to the US FDA and has also led about 20 IND applications to US FDA and about 10 IND applications to DCGI, India. He established the clinical development department at Aurigene and works with cross-functional teams like pharmacology, pharmacokinetics and toxicology. In addition, while at Aurigene, he has also established the CGT (Cell and Gene Therapy) vertical, including a GMP facility for clinical trials. Currently, he is also part of teh Experts Committee of CDSCO for development of CGT regulatory guidelines in the country. Akhil has been with Aurigene since 2017

Dr. Lakshmikanth, a Damon Runyon Cancer Foundation Fellow with a Ph.D. and M.Sc. (Gold Medallist), has over twenty years of expertise in the biologics and cell and gene therapy industry. As Chief Scientific Officer at Immuneel Therapeutics, he led the development of India's first approved CD19-CAR-T product (Qartemi®) and created the patented SIM-CAR-T platform.

Previously, he served as CSO at InnovaVector SRL in Italy and as Senior Vice President at Intas Pharmaceuticals, where he established R&D facilities for gene and CAR-T cell therapies. His career also includes leadership positions at Biological Evans, Sanofi, and Dr. Reddy's Laboratories.

Dr. Lakshmikanth's expertise spans structural studies, process development, and biological assays, with specialized knowledge in AAV and Lentiviral vector-based therapies. He holds several patents and has contributed to successful US IND, BLA, and EU MAA approvals for biosimilars.

Dr. Nitin Damle is a biotechnology professional with four decades of experience in biotech and big pharma industries. He was trained in Immunology at then Tata Cancer Research Institute, Mumbai and Sloan-Kettering Cancer Center in New York, NY and Stanford University in Palo Alto, CA. He built his professional background and experience at Cetus Corporation, Bristol Myers Squibb, Wyeth/Pfizer and Endo Pharmaceuticals prior to joining Sun Pharma Advanced Research Company (SPARC) where he is EVP and Chief Innovation Officer. He has contributed to either discovery, development or both of six US FDA approved biological therapeutics primarily in the Oncology and Immunoinflammatory Diseases arena.

Rupa Vangala is a seasoned transformation leader with 24+ years of experience driving global digital initiatives across pharma, tech, and enterprise sectors. At Bristol Myers Squibb & JP Morgan Chase, she led global engineering and automation capabilities, enabling scalable innovation and business agility. Rupa specializes in GCC setup, Generative AI and enterprise automation, with a strong track record of stakeholder engagement and delivery excellence. Currently pursuing a PhD in AI/ML focused on chronic disease prediction, she combines academic rigor with real-world impact. Passionate about building high-performing teams and future-ready organizations, Rupa thrives at the intersection of strategy, technology, and global operations

Prof. Samir Kulkarni is a seasoned expert in biotherapeutics with more than two decades of experience spanning research, industry, and academia. In senior leadership roles he has contributed to biosimilars development at leading companies like Intas, Dr. Reddy's, and USV, and held research roles at Oak Ridge National Lab and University of Cincinnati.

He currently serves as Distinguished Professor at the Institute of Chemical Technology, Mumbai, leading the Department of Biological Sciences and Biotechnology, and the DBT-ICT Center for Energy Biosciences, where he focuses on Biotherapeutics, Biofuels and Circular bioeconomy.

A cross-functional leader, with core expertise in process and analytical development, he bridges R&D, manufacturing, regulatory, clinical and commercial functions, and actively consults for global biopharma organizations.

Dr. Tathagata Dutta holds a B.Pharm., M.Pharm, and PhD in Pharmaceutical Sciences from Dr. Hari Singh Gour University, Sagar. He further pursued postdoctoral studies at the School of Pharmacy & Diamantina Institute for Cancer, Immunology, and Metabolic Medicine, University of Queensland, Brisbane, Australia, focusing on the development of RNAi therapeutics for cancer management. Additionally, he is an alumnus of IIM Calcutta.

Over the span of more than two decades, Dr. Dutta has held various esteemed positions, including President, Chief Scientific Officer (CSO), Executive Director, Managing Director & CEO, within several reputable multinational pharmaceutical companies worldwide. His contributions to the field have been recognized with numerous National and International Awards and Honors. He has been featured in Cover Pages of few National and International Magazines and News Channels.

Dr. Dutta's research endeavors have led to the publication of several papers in renowned international journals, numerous patents, and authored book chapters. He serves as an editorial board member for several international journals focusing on drug discovery & delivery research.

His research interests span a wide array of topics, including novel drug delivery systems, dendrimers, liposomes, polymer bioconjugates, tissue-targeted drug delivery systems, nano drug delivery systems, gene therapy, vaccines, genetic immunization, depot injections, gene delivery, RNAi therapeutics, and Rare Diseases.

Dr. Vadiraja Bhat, is a seasoned Biopharma Business Development Manager at Agilent Technologies in India, bringing extensive expertise in biopharmaceutical research and development. With a Ph.D. in Chemical Biology from the JNCASR / IISc, and Post doc in Proteomics from MIT, USA., he has several years of experience in biopharmaceutical research and development. Dr. Bhat has held significant roles, including Senior LC/MS Applications Scientist at Agilent's Wilmington, DE, USA facility, and Associate Director-Proteomics Lab at Baylor Scott & White Memorial Hospital and Texas A&M Health Science Center. He has contributed to advancing LC-MS workflows for proteomics and biopharma applications and has been an adjunct faculty member at the Manipal Centre for Biotherapeutics Research (MCBR), Manipal Academy of Higher Education (MAHE) since 2023.

Dr. Chen is the Managing Director of Bio-Link Biotech Co., Limited (Hong Kong), with extensive experience across bioprocessing, CDMO operations, and commercial strategy. He previously held senior roles at CDMO and media supplier companies, leading business development, commercial operations, and M&A initiatives. Earlier in his career, Dr. Chen served at Sartorius, overseeing regional business for downstream bioprocessing technologies across the Asia-Pacific region. During his tenure, he successfully introduced new platform technologies to major biopharmaceutical companies and played a key role in establishing localization and production strategies across Asia. Dr. Chen began his industry career as a Lead Scientist at A-Bio Pharma Singapore, one of Asia’s pioneering CMOs, where he led and contributed to multiple biosimilar programs. His responsibilities spanned process development, scale-up, pilot-scale manufacturing campaigns, and technology transfer.

Rakesh Sinha serves as the Vice President & Head of Drug Product Manufacturing at Biological E. Limited (Vaccine Division), where he oversees large sterile operations producing more than 1 billion doses (> 300 million vials and ampoules/Annum). He collaborates with cross-functional teams to ensure regulatory compliance, optimize production schedules, and drive operational excellence using TQM Tools & automation.

With over three decades of extensive experience spanning Pharma, Biosimilar & Vaccine sectors, he has led transformative initiatives improving financial indicators, enhancing throughput, and fostering a positive quality culture. He is known for addressing complex challenges, prioritizing continuous improvement, talent development, and innovation to maintain a competitive edge while supporting sustainable practices.

Sinha has developed strategic leadership that combines Operational, Financial, Total Quality Management, Automation, and regulatory compliance expertise. He has led efforts to address FDA-OAI observations under the guidance of reputed consultants and improved quality & efficiency with focus on talent development, creating a positive quality/work culture while prioritizing environmental health and safety. He is recognized for his ability to troubleshoot complex issues and implement effective solutions swiftly.

Dr. Rakesh Mishra, Director, Tata Institute for Genetics and Society (TIGS), Bangalore J.C. Bose National Fellow at CCMB, Hyderabad

Dr. Rakesh Mishra did his university education at the University of Allahabad and received his Ph.D. (Organic Chemistry) in 1986. He started his career in biology at the Indian Institute of Science, Bangalore. He has several years of research experience at the University of Bordeaux (France), Saint Louise University (USA), and the University of Geneva (Switzerland). He then joined CCMB 2001 and became Director in 2016.

Under his leadership, the Atal Incubation Centre was established at CCMB, which provides life science entrepreneurs the infrastructure and mentorship needed to encourage innovation. CCMB has also played a key role in genomic surveillance of the SARS-CoV-2 virus in India during the COVID-19 pandemic and made major contributions in diagnostics, drug screening, environmental surveillance, and capacity building in various efforts against the pandemic.

His research interests are non-coding DNA and the role of epigenetic regulation in development. At TIGS since 2021, he is deeply involved in using cutting-edge science to solve societal problems in areas of healthcare (infectious diseases and rare genetic disorders) and nutritional security. TIGS, in particular is focussing on the new technologies like mRNA therapeutics, in vivo gene therapy, mAb/immuno-therapy, etc., to make them accessible and affordable.

Dr. Mishra has published about 200 articles. He is elected fellow of the Indian National Science Academy, Indian Academy of Science, and National Academy of Science, India.

Mannan Khambati is a competent and compassionate professional with 29 years of robust experience in the biotech industry. He holds an MBA in Operations from IGNOU (2012-2014) and an MSc in Microbiology from the Institute of Science, Mumbai (1994-1996). Since January 2006, Mannan has served as VP of Biotech Production at Bharat Serums and Vaccines Ltd, where he leads a highly motivated team in developing, scaling up, and manufacturing recombinant therapeutic biosimilar hormones and first-in-world novel antibodies. His responsibilities include overseeing scale-up and manufacturing processes using mammalian cell lines in fed batch and perfusion systems, managing area and process designing, and ensuring audit and compliance readiness. Previously, he worked as a Senior Scientist at USV Ltd (2003-2005), where he was in charge of the pilot facility and led technical transfer and scale-up of the company's first recombinant molecule derived from bacterial cell lines. His career began at Merind Ltd (1996-2003) as a Scientist, where he developed processes for Vitamin B12 derived from mutant bacterial culture and supervised technology transfer to manufacturing. Throughout his career, Mannan has demonstrated exceptional expertise in recombinant protein production, bioprocess scale-up, regulatory compliance, and team leadership.

An immunologist by training, I completed my PhD in Humoral Immunity from National Institute of Immunology, New Delhi in 2010, followed by post-doctoral research in autoimmunity at Harvard Medical School, Boston, USA. Coming back to the country in 2013, I was associated with academia briefly as assistant professor at Regional Centre for Biotechnology, working on neonatal immunity and autoimmunity. I was then at Syngene International for close to 7 years working on antibody discovery and characterization, immuno-oncology, and CAR-T cell R&D. I joined Aurigene in 2021 as head CAR-T Manufacturing and since February 2022 till December 2024, led efforts both in GMP and R&D in the Cell and Gene Therapy Division. I led Aurigene/Dr. Reddy’s first CAR-T program and India’s first BCMA CAR-T Trial, SWASTH, in relapse/refractory Multiple Myeloma. Since, January 2025 my focus has been primarily on development of novel therapeutics in Cell and Gene Therapy space, serving as Director CGT R&D and Process Development.

Dr. Abhishek Mathur is a seasoned healthcare executive with 18+ years of industry experience in Biologics R&D, Product Development, and Operations. With a proven track record of interdisciplinary leadership across various functions spanning early discovery research to product commercialization, his extensive experience reinforces commitment to innovation and patient-centricity. Prior to joining Enzene, he held prominent roles at pioneering biopharmaceutical firms like Amgen and Regeneron in the US, where he successfully guided numerous products from early development to commercialization. He is passionate about guiding innovation-focused strategies towards exponential and disruptive biotechnology advancements.

Dr. Mathur holds B.Tech. degree in Chemical Engineering from IIT Bombay, PhD in Biological Sciences from Northwestern University (USA) and MBA from Duke University (USA).

Dr. Abir Banerjee is a Ph.D in Biochemistry from North Dakota State University, USA and has over 19 years of experience in the field of Biotechnology. He is currently associated with BSV group as Vice President & Head of R&D Biotech Division. In the past, he has been associated with Wockhardt, Enzene, Pfizer & Lupin in various roles. He has published numerous articles in peer reviewed journals and has numerous patents filed and granted in US, EU etc. His research area focuses on novel recombinant proteins inclusive of complex hormones and monoclonal antibodies from clone to clinic.

Dr. Aridni Shah is the Co-founder and CEO at immunitoAI. She completed her Bachelor’s Degree in Biomedical Sciences from University of Delhi and went on to pursue an integrated PhD degree from National Center of Biological Sciences, TIFR. Her pioneering work during her PhD uncovered molecular mechanisms for time memory in honey bees, and has not only resulted in peer-reviewed publications but also fostered international research collaborations. After her PhD, she embarked on an entrepreneurial journey and co-founded immunitoAI Pvt. Ltd., which is dedicated towards tackling pressing challenges in the field of antibody therapeutics using Artificial Intelligence. Their proprietary AI-platform is capable of generating novel antibody therapeutics entirely from scratch for any desired target of interest, without any biological source.

Dr. Dinesh Kundu is the CEO & Co-founder of East Ocyon Bio, India’s pioneering biotech startup developing allogeneic CAR-NK and CAR-gamma delta T cell therapies for solid tumors, autoimmune, and rare diseases. A former Army physician with over 15 years in biopharma leadership across India and the US, he is driving innovation in affordable, off-the-shelf cell therapies for global health impact.

Dr. Chitra Gopinath earned her Ph.D. in Biomedical Sciences from Vellore Institute of Technology (VIT), where she focused on hematopoietic stem cell gene therapy using lentiviral vectors. As a Fulbright Fellow from 2016 to 2017, she trained in Dr. Inder Verma’s laboratory at the Salk Institute, USA. Since 2019, she has been associated with the GROW Research Laboratory, working extensively with adeno-associated virus (AAV) vectors and developing dual-vector strategies for ABCA4-associated inherited retinal diseases. She is actively involved in vector development, clinical-grade vector production, and preparation for upcoming gene therapy clinical trials under Dr. Arka’s supervision at the Narayana Nethralaya Foundation, Bangalore. Additionally, she serves as a genetic counsellor at the Gen Eye Clinic, led by Dr. Anuprita Ghosh at Narayana Nethralaya.

Sr. President, R&D, Bharat Serums and Vaccines Limited (A Mankind Group Company)

Dr. Jaby Jacob has worked at several large companies, including Kemwell Biopharma, Dr. Reddy’s and AMGEN before joining BSV.

He is an active participant in the development of several biopharmaceutical products, including monoclonal antibodies. He has over two decades of experience in developing biosimilar drug strategies for both regulated and emerging markets, including process characterization, analytical development and validation, and technology transfer management.

Dr. Taslimarif Saiyed is the CEO and Director of C-CAMP from 2009 till present. His initial training has been in neurosciences, where he received his PhD from Max-Planck Institute for Brain Research, Germany from 2002-2006 and followed it up by postdoctoral training at University of California San Francisco (UCSF) from 2006-2009. At the same time, he also underwent training in management for Biotech and Innovation from QB3 at UC Santa Cruz, UC Berkeley and UC San Francisco from 2007-2009. He has also completed a biotech management program for biotech executives at Wharton School of Management in the year 2012. In the Bay area, he served as a Management Consultant with QB3 New Biotech Venture Consulting and in an individual capacity, he also consulted for many biotech firms in the US.

Dr. Saiyed is an Adjunct Faculty at Indian Institute of Technology (IIT) Madras and also Amrita Institute - School of Biotechnology since 2015. He also heads the Discovery to Innovation Accelerator program at C-CAMP. He is actively involved in promoting innovation in lifescience / healthcare by supporting translation of discoveries to application, entrepreneurship and technology development.

Dr. Saiyed is also Co-chair of India AMR Innovation Hub (IAIH), a National Level Initiative anchored at the Office of Principal Scientific Adviser, Govt. of India

Dr. Dhananjay Patankar is an independent biopharmaceutical professional and freelance consultant, and is associated with several companies, startups and academic institutions in advisory roles. Previously he was the head of the biologics divisions of Syngene and Intas Pharmaceuticals and was senior scientist at Wockhardt.

He has been intimately involved in the growth of the Indian biopharmaceutical industry since its early days. Over his career, he led teams that developed India’s first biosimilar therapeutic product (EPO), India’s first biosimilar approved for marketing in Europe (Filgrastim), India’s first EU-GMP certified biologics manufacturing facility (Intas), and India’s first commercial contract manufacturing of a novel biologic for the US market (Syngene).

He has served in various national committees and biotechnology industry bodies in India, and was Biologics Expert Committee member at the US Pharmacopeia from 2011 till 2020.

By education he is a Chemical Engineer with bachelor’s degree from IIT Mumbai and Ph.D. from University of Utah in the US.

Dr. Maloy Ghosh is a founder member of Zumutor Biologics who designed and directed scientific, research, and technological operations to achieve the company's R&D missions. He built a resilient scientific team, implemented translational research, and empowered team members to reach their career potential.

As a visionary and seasoned professional with extensive scientific, regulatory, and clinical expertise in immuno-oncology biologic therapies, Dr. Ghosh drove corporate growth and innovation by translating goals into actionable strategies supporting Zumutor's mission.

Known for his proactive leadership in driving innovation and fostering collaborations, Dr. Ghosh effectively led the development of the company's IP portfolio, managed tech transfers, and oversaw CRO/CMO partnerships. He built and expanded company valuation, securing $32M USD through multiple venture capital funding rounds.

His work contributed to the successful progression of a Phase 1 clinical trial for a novel immuno-oncology biologic (mAb) product—the first of its kind from India—designed to treat advanced and metastatic cancers for patients with no existing alternatives.

Dr. Shandilya is a visionary leader and veteran in the global biosimilar development industry, bringing over 25 years of profound expertise in biologics, pharmaceutical innovation, and regulatory strategy. As the current Head of Torrent Biologics, he oversees the entire biosimilar product development lifecycle—from initial clone screening to global commercialization—with a clear mission: advancing innovation with affordability for patients and healthcare providers worldwide.

Throughout his illustrious career, Dr. Shandilya has been at the forefront of scientific and strategic breakthroughs in biologics. He possesses deep expertise in discovering and validating drug targets, crafting end-to-end product development roadmaps, and navigating evolving global regulatory landscapes—including India’s CDSCO, EMA and the US FDA

Dr. Shandilya’s career highlights include designing and executing preclinical and clinical development strategies for a wide array of therapeutic areas, tailored for both Indian and global markets. He has spearheaded the successful development and launch of numerous biosimilars, significantly expanding patient access to life-saving treatments. Notably, he led the pioneering team that secured regulatory approval for the first-ever biosimilar of filgrastim in the European Union.

Known for his visionary leadership and collaborative style, Dr. Shandilya is also an ardent advocate for affordable healthcare access that transform healthcare outcomes across the globe.

Mr. Mayank Garg, Head of MSAT (mAbs) at Biocon Biologics Limited, has over 24 years of experience in the biotech industry. He has worked on innovative biologics and biosimilars throughout the product lifecycle, holding significant roles at Sanofi, Dr. Reddy’s Laboratories (DRL), and Intas Pharmaceuticals. An alumnus of Jadavpur University, Kolkata, with a Master of Technology degree in Biotechnology, Mr. Garg also has a strong background in data science and artificial intelligence/machine learning (AIML), driving innovation and optimizing processes within the biotech industry.

Dr. Parthasarathy Sampathkumar heads the Group Center of Excellence at Biocon, a renowned, global biopharmaceutical company. In this capacity, he spearheads initiatives aimed at enhancing operational efficiency, cultural and digital transformation across the Group companies.

As a thought leader and strategic thinker, he actively contributes to the academic and professional circles through publications, presentations, and engaging panel discussions on advancements of the biopharmaceutical sector. His energetic participation in industry dialogues underscore his commitment to advancing Quality, excellence and innovation.

With an M.Phil and Ph.D. in Chemical Engineering, Dr. Sampathkumar has held multifaceted roles at California-based Genentech and Coherus BioSciences prior to joining Biocon.

Prasun Kumar Guha is the Vice President & Head of Regulatory Affairs, Biologics for Dr. Reddy’s Laboratories Ltd. In his current role, he takes care of the regulatory affairs for DRLs biosimilars; NBEs as well as CAR-T portfolio.

Prasun holds a master’s in biotechnology. He embarked on his professional journey in 2003 where he initially worked in the pilot fermentation lab at Solaris (formerly BILT) and on cell line development at RPG Life Sciences. His biosimilars regulatory stint started Wockhardt Ltd in 2006, where he played a pivotal role in regulatory submissions for their biosimilars in emerging markets. Subsequently, he joined SciGen BioPharma (now M.J. BioPharm) in Pune, leading their India regulatory team and contributing to IMPD submissions for their biosimilar portfolio.

He was also associated with Dr. Reddy’s from 2009-14 securing approvals for their biosimilars portfolio in India and across emerging markets. Subsequently, he moved to Mylan (now Viatris), where he actively worked on global regulatory submissions and approvals across US/EU/ANZ/CA/CH and emerging markets. He led the regulatory efforts for securing the first biosimilar trastuzumab; followed by pegfilgrastim BLA approvals in US and played a significant role in securing the biosimilar approvals across EU/ANZ/CA/CH/close to 100 emerging markets including the pre-qualification approval for biosimilar trastuzumab from WHO and further managing the life-cycle management activities for the biosimilar programs.

In his last stint at Intas, Prasun orchestrated the integration of the biosimilars regulatory team, leading efforts to submit multiple BLAs/MAAs to US FDA/EMA/Health Canada/TGA for the biosimilars portfolio and led the efforts in securing the latest trastuzumab by US FDA/Health Canada and Ustekinumab biosimilar BLA approval by US FDA/MAA approval by EMA.

Dr. Raches Ella serves as the Chief Development Officer at Bharat Biotech, where he leads a fully integrated research and development organization. His responsibilities span from discovery to registration and post-marketing commitments for vaccines including rotavirus, COVID-19, typhoid, flu, dengue, Zika, and Chikungunya.

A clinical researcher by training, Dr. Ella is an alumnus of Emory University, Johns Hopkins University, and Harvard Business School. He has made significant contributions to COVID-19 research as lead author on multiple peer-reviewed publications documenting the efficacy, safety, and immunogenicity of BBV152 (COVAXIN), an inactivated SARS-CoV-2 vaccine. His research has demonstrated the vaccine's effectiveness against multiple variants of concern.

Beyond COVID-19, Dr. Ella has published important research on rotavirus and Japanese encephalitis vaccines, establishing himself as a key figure in global vaccine development.

Dr. Rajendar Burki is a passionate scientific leader with extensive experience in the development of drugs, biologics, and vaccines. With a Ph.D. in Bioanalytical/Biological Chemistry from Tohoku University, he has held key roles in various organizations, culminating in his current position as Vice President of Research & Development at Biological E Limited, India.

Currently, Dr. Rajendar is heading highly responsible parts of vaccine research, process development (CMC) for Drug Substance, Drug Product, and Analytical development.

Prior to BioE, he was associated with Indian Immunologicals, Intas Biopharmaceuticals, and Dr. Reddy’s Laboratories, holding various levels of responsibilities.

He received Ph.D. degree in Bioanalytical/Biological Chemistry from Tohoku University (Japan), followed by postdoctoral training at the University of Alabama at Birmingham (USA).

Authored 10 patents, 25+ international publications, and delivered talks at National and international conferences.

Dr. Manda Venkata Sasidhar is a recognized Key Opinion Leader (KOL) in extracellular vesicle (EV) sciences, with expertise spanning EV biology, diagnostics, biologics, and vaccines. As the Founder of Urvogelbio, Dr. Sasidhar has spearheaded the development of innovative exosomal diagnostics and therapeutics, establishing the company as a leader in translating EV research into real-world clinical solutions. Under his leadership, Urvogelbio has driven several pioneering projects, resulting in new intellectual property and advancing the field of precision medicine.

Dr. Sasidhar currently serves as President of the Indian Extracellular Vesicle Society (IEVS) and Chief Scientific Officer at Apollo Hospitals Educational and Research Foundation (AHERF), where he fosters collaborative research and translational innovation. His academic affiliations include Andhra University, Heinrich Heine University, and UCLA, reflecting a strong foundation in scientific research and education.

Previously, Dr. Sasidhar held senior research and leadership positions at Gland Pharma, VINSBioproducts, and GVKBio, contributing to the development of biologics and vaccines. He is credited with multiple patents and has authored over 25 scientific publications.

In all his roles—especially as Founder of Urvogelbio—Dr. Sasidhar is dedicated to advancing the science and application of extracellular vesicles, promoting scientific integrity, diversity, and impactful innovation across the global biomedical community.

Dr. Sayan Basu is the Prof. D. Balasubramanian Chair of Eye Research and serves as the Director of both the Prof. Brien Holden Eye Research Centre (BHERC) and the Centre for Ocular Regeneration (CORE). He is also an Adjunct Associate Professor of Ophthalmology at the University of Rochester, NY, USA. A clinician-scientist and a key opinion leader in corneal and ocular surface disorders, he has significantly contributed to advancements in regenerative medicine and translational research. Clinically, he specializes in high-risk corneal and ocular surface cases, including those with prior surgical failures or complications. His research focuses on scarless corneal wound healing through innovations in stem cells, biomaterials, and 3D bioprinting. His clinical and research efforts are driven by the singular goal of helping all patients achieve their full visual potential, regardless of disease complexity.

Beyond his clinical and research roles, Dr. Basu is deeply committed to mentoring faculty, fellows, and PhD students, fostering the next generation of clinician-scientists. He is widely recognized for his ability to simplify complex concepts for students and colleagues, while also tackling intricate medical and scientific challenges with innovative solutions. Dr. Basu has published over 260 peer-reviewed articles in international scientific journals and serves on the editorial boards of several prestigious publications. He is a member-by-thesis of the Cornea Society and has received the Achievement Award from the American Academy of Ophthalmology.

Dr. Basu advocates for equitable and patient-centric care, personalized yet affordable medicine, and disruptive but controlled innovation to address global healthcare challenges, particularly in developing countries like India. He believes that nothing is impossible and that every problem has a solution, yet every solution comes with its own set of problems.

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.

Dr. Sushant Kumar is the Head of R&D at ImmunoACT, where he leads translational research in cell and gene therapy. He holds a MTech degree from IIT Guwahati, a PhD in Cancer Immunology from IIT Bombay, and completed his postdoctoral training at the University of Pennsylvania, USA. Dr. Kumar has contributed to the development of India’s first and most affordable CAR-T cell therapy, NexCAR19™, launched by the president of India in April 2024. He has authored over 18 peer-reviewed publications in leading international journals, including Nature Biomedical Engineering and The Journal of Clinical Investigation. He received several international awards including the Young Investigator Award, and multiple international research grants. Dr. Kumar also serves on the Scientific Advisory Council of Uplifting Athletes, USA, and has been a guest editor and reviewer for several international journals.

Sweety Mathew is a Senior Regulatory Affairs professional and a Global RA CMC Lead (Rare Diseases) working with Novo Nordisk. She has around 14 years of experience and has a broad expertise across biopharmaceutical drug development (Novel biologics, Biosimilars and peptides (synthetic & recombinant)) and providing regulatory strategies, signals and policies.

With a Cell and Molecular Biology background, the inspiration to join regulatory sciences was drawn from the fact that this function provided an insight on all stages of drug development to life cycle management and being that conduit between the company and the regulators, bridging science and business. Sweety has engaged in successful approvals of several biopharmaceutical drug candidates, from the early stages throughout the life cycle management across multiple therapeutic areas including metabolic disorders, oncology and rare diseases. Prior to joining Novo Nordisk, she was associated with companies such as Biocon Biologics, Biomarin etc. She has been an invited speaker in various international forums sharing the regulatory insights. She was an exchange student with Imperial University, London and pursued her postgraduation in Bioinformatics and Applied Biotechnology from the University of Westminster, London.

Arani Chatterjee, MBBS, MPhil, PGCPM completed his graduation from CMC, Vellore and post-graduation from NIMHANS, Bangalore. He has a Post Graduate Certificate in Management from IIM, Indore. Prior to joining Cadila Pharmaceuticals, he has held positions of Senior Vice President, Clinical Research at Aurobindo Pharma, Hyderabad for 5 years, Biological E, Hyderabad for 3 ½ years, Panacea Biotec, New Delhi for 9 years and Principal Research Physician at Dr. Reddy’s Laboratories (Discovery Research), Hyderabad for 6 years with a total experience of over 29 years. He was a visiting faculty at University of Pune and Institute of Clinical Research, member of Expert Committee for PG Diploma in Clinical Research at IGNOU, Academic Board of Studies, Institute of Clinical Research, Hindustan Institute of Medical Sciences & Research, Sharda University and National Committee on Biotechnology of CII. He has served as a WHO Adviser for the Global Polio Eradication Initiative. He is a member of several Brighton Collaboration groups for vaccine safety. His has participated in WHO SAGE and GVSI meetings, pre-IND meetings with USFDA, scientific advice meetings with BfArM (Germany), ANVISA (Brazil), Medsafe (New Zealand), ALIMS (Serbia), NORCB (Egypt), expert group meetings on Indian GCP guidelines and Schedule Y, National Technology Advisory Group on Immunisation, Asia Pacific Dengue Prevention Board Meeting under the Pediatric Dengue Vaccine Initiative of International Vaccine Institute and Pneumococcal Vaccines at UNICEF. He has authored 22 papers in peer-reviewed journals and 4 book chapters. He is a recipient of the 2012 Charles C. Shepard Award from CDC, Atlanta.

Summary of Activities:
I have been responsible for managing the internal operations of organizations, aligning product offerings with customer satisfaction, and identifying and resolving problems to increase efficiency. I have also led new business coordination and developed organizational policies and goals.

Skills & Consultancy:
My skills include molecular biology, upstream and downstream process development, and analytical method development for various techniques.

Professional Experience:
As Director of the Bioprocess Division at IMGENEX India Pvt Ltd (2012-present), he has developed in-house bioprocesses for off-patent biotherapeutics and implemented ISO9000 guidelines in the research reagent production arena. He has completed projects for the production of SARS CoV2/COVID-19 proteins and bioprocess development for biosimilar Trastuzumab. He has also filed a patent for an improved process for dyeing of textiles.

As Group Leader for R&D at Panacea Biotec Ltd (2008-2012), he was responsible for downstream process development following guidelines for the desired properties of biotherapeutics. He developed a novel purification method for influenza virus and filed a patent on the process of production of H1N1 influenza virus.

As Principal Scientist at Jubilant Discovery Centre (2006-2008), he established molecular biology, insect cell culture, and mammalian cell culture labs. he cloned and expressed recombinant mammalian proteins and developed downstream processes for high-quality protein production for biochemical assays and crystallography projects.

Presentations:
I have presented my research at various national and international conferences, including "Biosimilars: Process Driven Product Development" at the Biologics and Biosimilar Congress Asia in Singapore (2018) and "H1N1 Virus purification using membrane chromatography" at the 7th European Downstream Forum in Germany (2011).

Publications: 14 peer reviewed publications

Prof Ashutosh Kumar, is working as a Professor in the Department of Biosciences and Bioengineering, IIT Bombay, Mumbai. His work involves studying the structure and mechanism of action of protein complexes such SCF complex, specialized Nucleosome, and amyloid fibrils using state of the art solid- state and solution-state NMR spectroscopy alongwith other Biophysical tools. Ashutosh has made significant contribution in developing NMR methods and applying those on complex biological macromolecules to deduce structure and dynamics of these molecules. In recent time, he started working in the field of Biopharmaceuticals where he develop novel NMR methods to investigate HOS of Biosimilars and Biologics in their formulation states.

Prof. Kumar received his M.Sc. in Chemistry from IIT Delhi followed by his Ph. D. at the Tata Institute of Fundamental Research, Mumbai supervised by Prof. R. V. Hosur in 2007. He did his postdoctoral research work under the supervision ofProf. Marc Baldus, Prof. Adam Lange and Prof. C. Griesinger at MPI for Biophysical Chemistry Gottingen, Germany before coming back to IIT Bombay.

Dr. Tathagata Dutta holds a B.Pharm., M.Pharm, and PhD in Pharmaceutical Sciences from Dr. Hari Singh Gour University, Sagar. He further pursued postdoctoral studies at the School of Pharmacy & Diamantina Institute for Cancer, Immunology, and Metabolic Medicine, University of Queensland, Brisbane, Australia, focusing on the development of RNAi therapeutics for cancer management. Additionally, he is an alumnus of IIM Calcutta.

Over the span of more than two decades, Dr. Dutta has held various esteemed positions, including President, Chief Scientific Officer (CSO), Vice President (R&D), Executive Director, Managing Director & CEO, within several reputable multinational pharmaceutical companies worldwide. His contributions to the field have been recognized with numerous National and International Awards and Honors.

Dr. Dutta's research endeavors have led to the publication of several papers in renowned international journals, numerous patents, and authored book chapters. He serves as an editorial board member for several international journals focusing on drug discovery & delivery research.

His research interests span a wide array of topics, including novel drug delivery systems, dendrimers, liposomes, polymer bioconjugates, tissue-targeted drug delivery systems, nano drug delivery systems, gene therapy, vaccines, genetic immunization, depot injections, gene delivery, and the development of RNAi therapeutics.

Dr. Dinesh Kundu is passionate to bring allogeneic cell & gene therapy for the patients in India. He is a Medical Doctor and MBA from Indian School of Business & London Business School. He has 17 years of experience across CGT and Biotech. His company East Ocyon Bio Pvt. Ltd. is focusing on allogeneic CAR-NK and gamma delta research and commercialization. His belief is that India will emerge as a key hub for CGT in future specifically in the areas of clinical trials and low cost manufacturing. He actively welcomes allogeneic cell therapy companies to partner with East Ocyon Bio for India and ROW markets.

Dr. Swati Chitrangi is the Head of Production at the Advancells Group in India, with over 15 years of global experience in the development, manufacturing, and commercialization of cell and gene therapy and cell products for drug discovery. She holds a PhD and completed her postdoctoral studies at National Institute of Advanced Industrial Science and Technology (AIST）Japan and Indian Institute of Technology Bombay (IIT Bombay), where her research on the chemotherapeutic effects of exosomes derived from stem cells was supported by prestigious fellowships from DBT, ICMR, and JNMF.

During her doctoral studies, Dr. Swati pioneered the development of 3D liver models using scaffolds and Human Umbilical Cord-derived Mesenchymal Stem Cells. She evaluated drug metabolism through Mass Spectroscopy, resulting in publications in leading international journals. Her work in induced pluripotent stem cells (iPSCs) technology involved creating multiple well-characterized iPSC lines and differentiating them into various cell types, significantly advancing drug discovery and disease modeling.

Dr. Swati has also led groundbreaking projects on patient-derived organoids for cancer research, enhancing the efficiency of drug screening and improving clinical trial success rates. Her expertise in biobanking and stem cell research has earned her national and international recognition. At Advancells Group, she spearheads initiatives in regenerative medicine and the development of next-generation cellular models for drug discovery.

Dr. Swati's leadership, analytical skills, and effective communication are crucial in achieving research goals and driving innovation in cellular research and therapies.

A competent and companionate professional with 28 years of robust experience in biotech industry. Currently leading a highly motivated team of superheroes in developing, scaling up and manufacturing recombinant therapeutic biosimilars hormones and 1st in world novel antibodies at BSV Ltd.

He is currently working at Bharat Serums and Vaccines Ltd as AVP Biotech Production which includes Scale up and manufacturing of recombinant Hormones and 1st in world Novel Antibodies derived from mammalian cell line in fed batch and perfusion systems. He also has an experience in Area and process designing and Audit and compliance readiness.

Ravishankar Kasturi is Head of Manufacturing Operations at Enzene Biosciences Ltd., in Pune, India. He manages all aspects of manufacturing to produce biologics/biosimilars. The portfolio of products include proteins derived from microbial fermentation and mammalian cell culture.

Key responsibilities include

His prior assignments were at Reliance Life Sciences, Navi Mumbai as Head of Manufacturing and Process Development. Dr. Reddy’s Biologics, Hyderabad, and Uni-Sankyo ltd., Hyderabad. He received hisExecutive Management from Indian Institute of Management Bangalore (IIMB), Bangalore, India, M.Tech in Bio-Chemical Engineering from Andhra University, Vishakhapatnam, and his Bachelors in Pharmacy from Gulbarga University, India.

Mr. Ritwick Tandon is the Senior Director,Group Centre of Operational Excellence, Biocon. He comes with an experience of nearly 30 years in Project Management, Quality, lean six sigma, business, operations, manufacturing and process excellence, SMART manufacturing, and consulting.

He is a B.Tech in Electrical Engineering (NIT) with Dual Management Degrees in Marketing, IT & Systems.

He is a Certified LSSMBB with Certifications in TPM, 5S & Gemba Kaizen from JMA.

He is also a Certified Business and Manufacturing Excellence Assessor with about 1000+ Assessments and 1000+ Projects.

He has experience in building and rolling out of the Excellence model across Industry Verticals (Cement, Chemicals, Ferro-Alloys, Metals, Pharma, Telecom, Retail, IT, ITES, F&A, VFY, SF, APPARELS, ENU, etc.) across Functions and across Processes.

Sanchit Nanda is the Senior Director, Global Patient Solutions, Gilead Sciences with over 25 years’ Experience with Regional & Country leadership roles across South & Southeast Asia. He is passionate about unlocking value in Healthcare Ecosystem through establishing holistic value assessment and creating innovative solutions across patient journey. He has been developing new patient solutions, leveraging technology to improve/create new business models, creating Innovative partnerships with stakeholders across healthcare spectrum!. He has a proven record of accomplishment in creating new business models, well recognized for leading new initiatives that set Industry benchmarks. He hasled partnerships with various start-ups across various healthcare delivery value chain elements unlocking new value drivers. He has collaborated across stakeholders and pioneered the concept of Health Economics in India. He have been part of number of Industry forums/task forces such as OPPI, FICCI, CII on Healthcare Access, Health Insurance, and policy issues.

Shirish Arya is an MBA by education and has held various leadership roles at the AP-Moller-Maerskbased in Hong Kong and Copenhagen, Denmark - where he was heading the Corporate Strategy for Asia.

He left his corporate role to become a tech-entrepreneur. Since 2013 hehas been associated with tech start-up’s in the space of hospitality, digital educationand healthcare. He joined ImmunoACT as a co-founder in 2021 and leads various commercial roles including Investment strategy, finance, business development and international collaborations.

He believes that bio-tech as an industry is at an inflexion point in India and will drive the next wave of deep tech innovation and transform both preventive and curative healthcare landscape.

CDL (Calcutta) or more than 6 –years as Drug Analysis Assistant and had wide range of exposure to HPLC, GC, DSC, IR and chemical, Biological Assay / analysis of Drugs (both API and Formulations) .

Joined CDSCO (HQ) in April, 1995 and till date is working there. CDSCO is one of the technical wing of Directorate General of Health services (DGHS) under Min. of Health Govt. of India . CDSCO is the Nodal Regulatory body for “drugs” [ as defined at Section 3 (b) (i-iv) of Drugs Act] in India.

During Last 25 years worked as reviewer & assessor for Technical dossier of CMC, Pre-clinical (animal & lab.) & Human Clinical studies (incl. BA / BE / PK /PD studies), for Market Authorization (MA) of Pharmaceuticals products, Medical devices and Biological Drugs in the capacity of Bench level reviewer to the team leadership level.

worked in close collaboration with WHO in regulation of Human Vaccine and participated in number of NRA (National Regulatory Authority) assessment by international Team of experts endorsed by the WHO in 2007, 2009, 2012, 2017 and played instrumental role in achieving Level-4 in NRA assessment for India in regard to Vaccine vigilance as one of the mail parameter for NRA-Assessment.

Sudarshan has a strong passion for healthcare and the education sector. He is currently the Secretary General of the Indian Pharmaceutical Alliance (IPA), Senior Advisor with APAX Partners and the Chairman of the Indian Institute of Health Management and Research (IIHMR), Jaipur. He also serves as a Board Member of Abbott India, Healthium (APAX Portfolio), Sunshine Holdings PLC and various educational institutions. Sudarshan is on the Advisory Committee of the Biotechnology Ignition Grant, Government of India and a Visiting Faculty at the Indian Institute of Management Ahmedabad (IIM A). He is a Certified Executive Coach from the Coaching Foundation of India. Sudarshan has a rich healthcare business experience of over 45 years and has contributed to shaping healthcare policy and improving access to healthcare in India. He has held several leadership positions in Abbott, J&J, Boots and leading Indian companies and last served as the Managing Director at Abbott Healthcare Solutions. His experience spans across Pharmaceutical, OTC, Hospital, Diagnostic and Nutrition businesses. He has been associated with over 30 brands which are among the top 300 in the Indian pharmaceutical market. He also served as Chairman of the Life Sciences Skill Sector Development Council (LSSSDC) of India under the Ministry of Skill Development & Entrepreneurship. He is the first Indian recipient of the Global Chairman’s Award at Abbott. Sudarshan is an alumnus of St. Stephens College, Delhi and Indian Institute of Management, Ahmedabad (IIM A).

Vaishali is currently working at Syngene as a Senior General Manager in Biopharmaceutical Development. She brings over 15 years of experience in developing both novel biologics and biosimilars working for companies in the US, UK and India. After completion of her PhD at Univ of Illinois Chicago and postdoctoral fellowship at Northwestern University, Vaishali has worked for several global biopharmaceutical companies such as CSL Behring, AbbVie, Pfizer, and AstraZeneca before joining Syngene.

Vandana Iyer brings 14 years of experience in the life sciences, health, and wellness sectors, with a focus on global biotech, medical devices, biopharma, and microbiome industries. Her skills include competitive technology research, business analytics, and technology forecasting. She has experience across biopharma (microbiome, CAR-T cells, vaccines), healthcare (clinical trials, personalized medicines), and health & wellness (nutraceuticals, skincare technologies).

Her career highlights include roles at ZoomRx, Sigma Aldrich (now Merck KGaA), the Association of Biotech-Led Enterprises, and Thomson Reuters. Vandana holds an MSc in Biochemistry, a Post Graduate Diploma in Bioinformatics, and a Certificate in Drug Discovery and Development.

Sanjeev Gupta has obtained Ph.D. in Cell Line Engineering and M.Sc. in Applied Microbiology and Biotechnology. Also received Honorary Professorship award from Amity University, MH (Feb., 2024). At present working as Sr. Vice President and BU Head-Biosimilar Division (R&D, Mfg. and Business Dev.), Ipca Laboratories Ltd., Mumbai, India.

Dr. Gupta carries over 24 years of industrial experience and has been working since 2000 on the development of various "Biosimilars including monoclonal antibodies. His core expertise lies into Molecular Biology, Cell Line, Process Development, Regulatory, Tech Transfer and Scale-up in the GMP for Clinical and Commercial manufacturing. He is actively involved in dossier submission, approval and interaction with various regulatory agencies such as EMA, MHRA-UK, CDSCO and US-FDA for Biosimilar launch in the overseas markets. In addition, he is closely working with Indian regulatory bodies (RCGM/CDSCCO) and Govt. agencies (BIRAC) for Guidelines reforms and project selection/approvals, respectively.

Till date, he developed and contributed for over Fifteen (15) recombinant molecules, of which Nine (09) biosimilars are already launched in the various markets and the rest are under development or clinical phase, and are expected to be launched in near future.

He delivered talks on Biosimilars in various national and international conferences organized by IBC, Terrapin, BPI, BioTrain, IMAPAC, CphI, Biopharma, Informa and UBM. He also chaired/Moderated various sessions in the national and international forums for conducting the biological conferences.

He has published several Research articles (13), Book chapters (06), Magazines (06) and Patent (01) in lieu of the Biosimilar development.

During his professional tenure, he worked at various position in reputed Indian biopharmaceuticals industries such as Zydus-Ahmedabad, Wockhardt-Aurangabad, Panacea-New Delhi, Intas-Ahmedabad and at present with Ipca Laboratories, Mumbai.

Yogananth Rajendran, a distinguished Regulatory Affairs and Quality Assurance expert leads these critical functions at Immuneel Therapeutics. With over two decades of expertise in the biopharmaceutical industry, he has been instrumental in securing regulatory approvals and facilitating market entry for Biologics and cell and gene therapies. Yogananth’s career highlights include a key role in the global authorization of biologics and biosimilars, particularly in the EU and US markets. His professional journey includes impactful tenures at Biocon, Lupin, Intas, and Zydus, culminating in his current strategic position at Immuneel.

Dr. Lalit is currently serving as the regional therapeutic area market and pricing leader for Johnson & Johnson Innovative Medicine's oncology division in Southeast Asia and India. He holds a Master of Public Health from BITS Pilani and an executive education program in market access from the London School of Economics and Political Sciences in the UK.

He has 15 years of diverse experience working on worldwide projects for pharmaceutical MNCs, WHO collaboration centers, NIH USA-funded programs, the University of Waterloo, Ontario, Roswell Park Cancer Institutes, and the Harvard School of Public Health, among others.

Dr. Lalit's key experience and expertise include market access, reimbursement and pricing strategy, health economics outcomes research, real-world evidence, health technology assessment, business strategy, product launch, and project management. He served as a reviewer for ISPOR and a stakeholder in the government's HTA body. He has already been recognized as an access champion and garnered all-star awards for his contributions to the market access organization through exceptional access initiatives and inspiring leadership behaviors.

Dr. Lalit has published multiple research articles, given oral presentations at conferences, and led various trainings. Finally, he was state level badminton player during his university days.

Narendra Chirmule is a founder-director at SymphonyTech Biologics, a data analytics company focused on engineering solutions for biology. As former Head of R&D at Biocon (Bangalore), and in leadership positions at Amgen (Thousand Oaks, CA) and Merck Vaccines (West Point, PA), he has contributed to the clinical development of vaccines, biologics, and cell-and-gene therapies. During his academic career, he has worked on the development of a leprosy vaccine, the pathogenesis of AIDS, and gene therapy for several rare diseases. Dr. Chirmule is on the NIH advisory committee for HIV vaccines. He is a TEDx speaker and recently published a book “Good Genes Gone Bad” by Penguin Press, both of which describe lessons learned from colossal failures in drug development.

Akshaya S. Odak is currently Head – Regulatory ‐Biotechnology Division of Lupin limited based in Pune, Maharashtra. Prior to that, he was looking after the regulatory function for the registration of Biotechnology products of Wockhardt Limited, Aurangabad. During regulatory tenure, worked primarily on biosimilars and has a vast experience of regulatory dossier filing and product approval in US, EU, Japan, Australia, Canada, India and more than 70 countries. He has also faced regulatory audits from different agencies viz., US FDA, EU, PMDA, ANVISA, GCC and other countries. He has an industrial experience of around 31 years and has also worked for companies like Hoechst India Ltd., and Ranbaxy Laboratories Ltd. His prior experience included development and production of Biologics. He has done his Master’s, M.Phil., and Ph.D. from Jiwaji university, Gwalior.

Abir holds a Ph.D. in Biochemistry from North Dakota State University, USA, and has over 18 years of experience in the field of Biotechnology. He is currently associated with the BSV group as Vice President and Head of the R&D Biotech Division. In the past, he has been associated with Wockhardt, Enzene, Pfizer, and Lupin in various roles. Abir has published numerous articles in peer-reviewed journals and holds several patents. His current research focuses on challenging recombinant proteins, including complex hormones and monoclonal antibodies, from clone to clinic.

Started career in 1987. With Zydus Lifesciences Limited for last 24 years.

Currently leading BU Biologics as President for Zydus Lifesciences Limited covering Biologics, Vaccines, Diagnostics & specialty pharma with coverage of Hepatology, Oncology, Nephrology, Rheumatology, Gastroenterology and Orthopaedics.

Samir is an Executive Board member at Centre for Global Hepatitis Elimination & a member of various Pandemic Preparedness Initiatives. He is passionate about Patient Centricity and equitable access. Samir has published many papers in Peer Reviewed journals & is a TEDx speaker. Samir is also a frequent speaker at various Global forums. He is on the Editorial Board of several publications and has authored multiple books. Samir leads a charitable trust and has set up multiple public service projects.

Dr. Rahul Purwar is a distinguished academic professor of Biosciences and Bioengineering at IIT Bombay. He holds a Ph.D. in Molecular Medicine from Hannover Medical School, Germany and M.Sc. in Biochemistry from the University of Lucknow, India.

Dr. Rahul’s professional journey spans various prestigious institutions and roles. He started his post-doctoral career with a fellowship at Hannover Medical School, Germany, and then moved to Harvard Medical School, USA, as a Research Fellow. His industry experience includes a stint as a Research Scientist at ImmunoGen, Inc. (Waltham, MA).

Dr. Rahul’s diverse experience and deep fundamental and translational understanding of Biosciences & Bioengineering position him to uniquely convey complex scientific concepts to diverse audiences. Since 2022, he has also been serving as the Founder of ImmunoACT in Mumbai. In this role, he drives strategic initiatives through accelerated process & clinical development and manufacturing, which has not only led to the successful market authorization of the country’s first CAR-T cell therapy, but also one that is fully indigenous to India and distinguished by a superior safety profile. This is the first of many planned milestones in democratizing access to advanced cell & gene therapies in India, his fundamental vision and founding principle of ImmunoACT.

Dr. Rahul’s research work is well-recognized in the scientific community, with numerous publications to his credit in esteemed journals. His contributions to the field of Biosciences & Bioengineering are commendable and his work continues to inspire many in the scientific community.

Goutam Bhattacharya is a thorough Life Sciences professional with three decades plus of working experience in leading multinational pharmaceutical and medical device companies in India. Prior to joining Council, he has worked in senior leadership positions with companies in India like LG Life Sciences; Boston Scientific, Win-Medicare, having started his career as Medical Representative with Lupin Labs.

Goutam is a Bachelor of Science & MBA (Marketing). He has acquired deep domain knowledge in pharmaceuticals, biologics, medical devices, diagnostics, vaccines & agrochemicals sectors. He brings with him hands-on working experience in managing multi-disciplinary teams involved in business development & licensing of assets; CRAMS; co-marketing/ promotion; product sourcing; regulatory affairs; clinical trials and sales & marketing. He has been instrumental in successfully identifying & licensing-in of highly differentiated products from US, EU, Japan, Korea, Canada etc. in his past assignments.

Extremely passionate about adding value to Life Sciences sector skilling, capacity building and entrepreneurship, he has been collaborating with multiple stakeholders from across life sciences ecosystem like Government; Academia; Life Sciences Industry & associations and partners.

Manohar is the MD & CEO of Stempeutics – a leading stem cell research and product development Company based out of Bangalore, India. Manohar has transformed Stempeutics – a life science start-up from R&D to Commercialization stage with Global recognitions. Company's novel product “Stempeucel®” has been granted manufacturing and marketing approval for the treatment of Critical Limb Ischemia (CLI) and Knee Osteoarthritis (OA) by the Drug Controller General of India (DCGI). Stempeucel® becomes the first allogeneic cell therapy product to be approved for commercial use in India and the first stem cell product to be approved Globally for CLI indication. Twenty plus countries including US, UK, Japan & China has granted patent for the novelty and inventiveness of the drug. Europe has recognized this drug by granting Advanced Therapy Medicinal Product classification and Orphan Drug Designation. Stempeutics has put India on the “World map of Regenerative Medicine”. Under Manohar’s leadership Stempeutics has established marketing partnership with Pharma Companies Cipla and Alkem Labs. Stempeutics has been recognized as India’s hottest startups by Business Today in 2008 and Karnataka Government bestowed “Emerging Company of the Year award” in 2011 and 2013. In 2017 Manohar was awarded “Biotechnologist of the Year” award by Wockhardt Foundation, India. In 2018 Stempeutics received "Top 25 most innovative Company" award from CII. Manohar has raised more than US$ 25M by establishing strategic alliance with Cipla and with Kemwell Biopharma.

Pramod Wangikar is the Chair Professor for Green Chemistry and Industrial Biotechnology at IIT Bombay, India and an elected fellow of the Indian National Academy of Engineering. He has published over 120 journal articles on metabolomics, bioprocess development, and metabolic engineering. He has ongoing projects to identify predictive biomarkers as well as severity biomarkers for diabetes. He also has interests in 13C isotopic labeling and metabolic flux analysis (13C MFA). Dr. Wangikar has entrepreneurial interests and has co-founded a start-up company to develop metabolomics-based applications. The company provides R&D services in areas such as spent media analysis, AI and metabolic modeling in bioprocess engineering and other applications.

Pharmaceutical physician with 16+ years of experience in medical functions, including 13+ years in the industry and 3 years in academia

Currently Global Medical Director for Respiratory at GSK; previously held a leadership roleat Pfizer India.

Leadership roles in medical affairs across various therapeutic areas: Respiratory, Neuroscience, Women's Health, Cardiovascular, Ophthalmology, and Urology.​​

Expertise in medical affairs, evidence generation, pharmacovigilance, regulatory audit, and business development.

Conceptualized and led the Medical 'Centre of Excellence' and the 'Innovation in Healthcare' community.

More than 7 international publications and 30+ citations

Accomplishments:

• Global Medical Leadership One-GSK Award for best practices in ways of working.
• CEP-GPMO Global Gold Award for strategizing and mitigating risk amidst dynamic changes.
• Recognized as "Best Manager" in the APAC region.

Dr. Prasad Krishnamurthy is the co-founder and CTO of Biocognate Life Sciences Pvt. Ltd. from 2020 till present. His basic training is in molecular and cell biology and obtained his PhD from the Center for Cellular and Molecular Biology, Hyderabad (1999-2005). Further he went on to do his postdoctoral research at Columbia University Medical.​​

Center in New York, US (2005-2007). Subsequently, he has worked in various biotech industries including Dr. Reddy's, Biocon-BMS R&D Center, Intas Biopharma and CuraTeq Biologics (subsidiary of Aurobindo Pharma) handling different responsibilities at the senior management level..​​

Dr. Prasad has over 18 years of rich industry R&D experience in cell line engineering, drug discovery, process, and analytical development of biosimilar, cell and gene therapy products with 16 publications in peer-reviewed journals of high impact factor and 1 Indian granted patent to his credit. He is also working as a biopharma consultant supporting biotech startups and private equity fund organizations..​​

Narasimha is one of the founding members, Managing Director, and CEO of CLONZ Biotech, a Biosimilar Monoclonal Antibody company based in Genome Valley, Hyderabad, India. A Molecular Biologist turned Entrepreneur, Narasimha has over two decades of experience in Life Sciences Research, including Cancer Biology, Proteomics, and Molecular Diagnostics.​

He is a member of the CII - National Biotech Committee and serves as a mentor at the CCMB-Atal Incubation Centre in Hyderabad. Additionally, he is a member of the Advisory Committee of TSCOST (Telangana State Council of Science & Technology) and an Expert Member of the Committee for Biological Sciences at NIPER (National Institute of Pharmaceutical Education & Research), Mohali.

Narasimha also coordinates the India center for the MetaSUB Global Consortium project, founded by Dr. Christopher Mason, Professor at Weill Cornell Medicine, USA. At CLONZ, alongside co-promoters who are recognized leaders in launching complex Biosimilar MAbs, he is driving the company to emerge as a significant global Biosimilar MAb player.

Aruna Kumar Chelluboyina is an Assistant Professor at Mahindra University in Hyderabad. He earned his Ph.D. in Biotechnology from IIT Madras and completed postdoctoral training at Harvard Medical School, Cleveland Clinic, and Case Western Reserve University

His research is centered on developing gene editing and gene therapy techniques for various cancers. He has published in high-impact journals and is known for his work on molecular signalling in human cancers and advanced gene therapy methods. Currently, he is working on developing a CRISPR-based gene therapy approach to target pancreatic cancers and an AAV-based gene therapy for retinoblastoma. Additionally, he is extensively involved in creating hybrid AAVs with enhanced tropism for gene delivery.

Dr. Ashok Kumar completed his Ph.D. at CDRI, Lucknow under the supervision of Padmashree Dr. Nitya Nand. Subsequently, he pursued Post-Doctoral studies with Prof. Sir John Cornforth CBE, FRS, a Chemistry Nobel Laureate, at the University of Sussex, England from 1981-1984.

He commenced his professional journey at Alcheme Research Centre at ICI, Bombay in 1985 and later held positions at Lupin Laboratories before joining Ipca Laboratories Mumbai in 2000. Currently, Dr. Kumar serves as the President at the Centre for Research & Development of Ipca, actively engaged in Chemical & Biotechnological research and development.

Dr. Kumar has made significant contributions to the field of research and development, as evidenced by his publications record and more than 100 patent applications. Apart from co-authoring papers in peer-reviewed International Journals he has presented Scientific Papers and Keynotes at various National / International Conferences and delivered Invited Talks on topics such as R+D Management, Idea Management, Innovations and the Role of Common Sense and Philosophy in Discovery and Research.

Notably his recent keynote address centered on “Accelerated Regulatory Approvals of Biosimilars from Advanced Regulatory Bodies”, such as USFDA, MHRA and EMEA. Additionally, his latest article titled “AI: The Elephant in your Lab”, which sheds light on the advancements, Artificial Intelligence has made in Scientific Research and Development, was published in the May ‘2024 edition of Express Pharma.

Dr. Mukesh Kumar is a Pharma R&D leader, physician, and clinical pharmacologist (MD) with over 20 years of experience in drug development, both innovative and generic. His expertise lies in clinical development and navigating global regulatory frameworks across the US, EU, APAC, and other regions.

Dr. Kumar has nearly a decade of experience leading clinical development functions, including preclinical, clinical pharmacology, and biopharmaceutics, as Head of Clinical R&D at major Indian multinational companies like Cipla and Dr. Reddy's Laboratories. He was part of Integrated Product Development Leadership teams. Additionally, he has another decade of experience serving as Clinical Research Director and Clinical Pharmacology Director in the Global R&D divisions of prominent pharmaceutical companies, including Sanofi and Daiichi Sankyo.

During his career, Dr. Kumar has been involved in approximately 50 innovative drug programs and 200 complex generic programs. He is particularly passionate about supporting startups, transforming clinical R&D for small pharmaceutical companies, and designing cost-effective clinical development strategies for both innovative and complex generic products.

Collaborative R&D and Product Development leader in CART & Cell Therapy. Currently, working as an Assistant Professor and the Senior lead for R&D and CMC CAR T Cell & Therapy Centre (CTCTC) at Tata Memorial Centre, Mumbai, with demonstrated success in bringing products from early development through commercialization, including regulatory framework. In addition to her contributions to the 1st CAR T Cell Therapy developed by ImmunACT-IITB-TMC collaboration, her current research interests include Design & Development of Novel Vectors for CAR T in solid Tumorus, Oncolytic Virotherapy and CTL lymphocytes for Pediatric Solid tumours. Dr. Nisar is a DBT BioCare Early Career Fellow and an ISCT Early Stage Professional member. She has been recognized with the Early Career Scientist Award, (RGO) category by the Department of Biotechnology, India. Dr. Nisar has received training at several prestigious international cell therapy manufacturing centers, including NIH Bethesda, CCRM Toronto, and Miltenyi Singapore. She is an active member of the International Society of Cell Therapy, the European Hematological Society, the American Society for Transplantation and Cellular Therapy, and the Immuno-oncology Society of India.

Mr. Susheelendra Vaidya is a FAS- Technical expert, APAC based out of Bangalore and currently working at Sartorius India Pvt, Ltd. He has more than 16 years of experience both in industry and academia. He joined Fortebio division at Pall India Pvt Ltd in the year 2013 and later division acquired by Sartorius in May 2020. Experience professional having more than 11 years experience in label free interaction systems where handles instruments like BLI and SPR technologies and its applications. He supports pre-sale, post-sale and marketing of Octet and SPR products ranges across APAC and one of the hub leader for APAC technical support. Prior to Fortebio worked at Waters India Pvt Ltd as Application specialist for High Resolution Mass Spectrometry(HRMS) for product characterization and Worked at Biocon R&D as senior scientist on mass Spectrometry based product characterization in Analytical characterization division. He studied M. Pharm in Pharmaceutical Chemistry from Govt. college of Pharmacy, Bangalore. Executive General management Program from IIM-Raipur. His research interests into Proteomics and identification of novel plant-based compounds by activity guided BLI and Physico-chemical and Biophysical characterization

Dr. (Surg Cdr) Gaurav Narula is a Professor of Pediatric Oncology & Health Sciences at Tata Memorial Center, Homi Bhabha National Institute, Mumbai. He is the Project Lead for the CAR T & Cell Therapy Center and has previously served as the Convener of the Pediatric Hemato-lymphoid Group. Dr. Narula is also a member of the Clinical Advisory Committee for the WHO 2022 Classification of Hematolymphoid Tumors. Additionally, he is the Founding Editor-in-Chief of the Pediatric Hematology Oncology Journal and the Founder Treasurer of the Immuno-Oncology Society of India (I-OSI).

At 38, Satyen is a first-generation entrepreneur, Chief Scientific Officer, and Co-founder of Regrow Biosciences Pvt. Ltd., a leading Indian biotech company. Satyen’s journey over the past 12 years has been challenging, yet fulfilling, as would be the case with any groundbreaking innovator in a sunrise/new industry. He received his Masters in Stem Cell Technology from University of Nottingham (UK) and Bachelors in Biotechnology from Dr. D.Y. Patil University (India).

Satyen has setup a team of winners from varied backgrounds, ensured they received adequate training, and empanelled consultants to establish the first-of-its-kind GMP laboratory in Lonavala, Maharashtra.

The regulatory framework in India back in the year 2009 did not include guidelines on stem cell and cell therapy products; Satyen has made significant contributions to development of draft guidelines for this sector. With Regrow, Satyen has created a name for himself as an ‘Out-of-the-Box’ innovator; he has been developing the company’s intellectual property portfolio of >25 patents and spearheading commercialization efforts. Regrow is now Asia’s first company to have three products in the domestic cell therapy market space (worth 25000 crores)

After successful adoption of India’s First two cell based orthopedic products, treating > 4000 patients with excellent results, his research acumen has led the development of Regrow’s third cell therapy Product – UREGROW® (Urology Cell Therapy), supported and funded by BIRAC, DBT, Govt of India. This product is also awarded as Best Innovation in Healthcare Therapeutics, by Department of Biotechnology, Govt of India (2018).

In 2018, Satyen was handpicked to be part of ‘Champions of Change’, an event organized by NITI Aayog where select industry leaders presented strategic inputs on transformation of Indian healthcare sector to the current Prime Minister of India, Shri. Narendra Modi. Also, he is a key member of the Indian Ministry of Health and Family Welfare’s inter-ministerial working groups that formulate standards in regenerative medicine.

As an industry disruptor, Satyen has been invited to speak and represent India at international medical and biotech conferences such as Cord Blood World Europe Congress (2016), World Stem Cells & Regenerative Medicine Congress (2016), and BIO CEO & Investor Conference (2018). In addition to the above, Satyen has been featured as a ‘Young Turk’ on CNBC TV18’s entrepreneurship show. He has been an expert panel speaker on Cell Therapy at Global Bio India (2023).

Satyen continues his dream to make Regrow’s stem cell technology globally accessible in the fight against debilitating and life-threatening diseases through development of next-gen technology.

Soumya joined DFE Pharma in 2021 as Technical Manager for India. He has been working in pharmaceutical industry for more than 15 years. In his current role he is assisting the formulators in selecting right excipients as well as handling the technical challenges in OSD and biopharmaceutical formulations. He is responsible for the new product portfolio’s positioning , long-term business strategy, innovation pipeline and customized excipient development. Prior to Joining DFE, he was associated with Merck Life Sciences as Business Development Manager for Southeast Asia and handled specialty chemical business for drug delivery such as biopolymers, synthetic lipids etc. He co-founded a specialty excipient start-up named Pharmonix and worked as Managing Director from 2014 to 2018. Prior to his entrepreneurial journey, he was working at Glenmark Pharmaceuticals Ltd and Bharat Serums & Vaccines Ltd, as Formulation Scientist in parenteral drug delivery systems.

He is pharmacist from education with master’s and PhD in Pharmaceutical Technology from School of Pharmaceutical Sciences, SOA University, Bhubaneswar, India. His doctoral research focused polymeric and lipid-based drug delivery systems.

Sudarshan has a strong passion for healthcare and the education sector. He is currently the Secretary General of the Indian Pharmaceutical Alliance (IPA), Senior Advisor with APAX Partners and the Chairman of the Indian Institute of Health Management and Research (IIHMR), Jaipur. He also serves as a Board Member of Abbott India, Healthium (APAX Portfolio), Sunshine Holdings PLC and various educational institutions. Sudarshan is on the Advisory Committee of the Biotechnology Ignition Grant, Government of India and a Visiting Faculty at the Indian Institute of Management Ahmedabad (IIM A). He is a Certified Executive Coach from the Coaching Foundation of India. Sudarshan has a rich healthcare business experience of over 45 years and has contributed to shaping healthcare policy and improving access to healthcare in India. He has held several leadership positions in Abbott, J&J, Boots and leading Indian companies and last served as the Managing Director at Abbott Healthcare Solutions. His experience spans across Pharmaceutical, OTC, Hospital, Diagnostic and Nutrition businesses. He has been associated with over 30 brands which are among the top 300 in the Indian pharmaceutical market. He also served as Chairman of the Life Sciences Skill Sector Development Council (LSSSDC) of India under the Ministry of Skill Development & Entrepreneurship. He is the first Indian recipient of the Global Chairman’s Award at Abbott. Sudarshan is an alumnus of St. Stephens College, Delhi and Indian Institute of Management, Ahmedabad (IIM A).

Dr. Jezamine Lim is the CEO and Co-Founder of Cell Biopeutics Resources in Malaysia, where she leads with passion and dedication in the field of biotechnology. Her primary focus lies in the commercialisation of stem cell therapy and stem cells derived cosmetic products.

Dr. Lim achieved a significant milestone by becoming the first woman to earn a PhD in Stem Cells and Tissue Engineering from The National University of Malaysia (UKM). Her doctoral research centred on the study of human Wharton’s jelly stromal cells as a viable allogenic cell source for bone tissue engineering, contributing to pre-clinical proof of concept in this field. Prior to her doctoral studies, Dr. Lim completed her MBBS and gained clinical experience at Manipal University in India.

Dr. Lim's dedication to advancing stem cell research is recognised by her appointment as the stem cells board member of The Malaysia Medical Council under the Ministry of Health Malaysia and as a committee member of the Malaysia Society of Stem Cells Research and Therapy (MSCRT) council.

Dr. Lim is also appointed as an Exco member of the prestigious Young Scientist Network - Academy of Sciences Malaysia (YSN-ASM) and consultant research fellow at the Centre of Tissue Engineering & Regenerative Medicine National University of Malaysia. Dr Lim also serves as an advisory scientific and research board member for Wellous, a health supplement brand, and various other biotech companies.