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Meet Our Speakers and Panelists
3rd Global Biologics India,
Hotel Le Meridien, Hyderabad
22-23 April 2026
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Vishwas Kaveeshwar, Ph.D.
Incharge/Assitant Professor
Central Res. Lab, SDM Medical College, SDM University, India
Below is the list of speakers for April 2025 conference.
2nd Global Biologics India, 16-17 April 2025
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Below is the list of speakers for April 2024 conference
1st Global Biologics India, April 24-25, 2024
Vishwas Kaveeshwar
Incharge/Asst Professor
Central Research Lab, SDM Medical College
SDM University, India
Sanjeev Gupta, Ph.D.
Sanjeev Gupta has obtained Ph.D. in Molecular Biology/Cell Line Engineering and M.Sc. in Applied Microbiology and Biotechnology. At present working as Vice President and Head, Advanced Biotech Lab (Biosimilar Division-R&D and Mfg.), Ipca Laboratories Ltd., Mumbai, India.
Dr. Gupta carries over 23 years of industrial experience and has been working since 2000 on the development of “Biosimilars” including monoclonal antibodies and other therapeutic proteins. His core expertise lies into Molecular Biology, Cell Line, Cell culture, Upstream process, Bio-analytical, Regulatory as well as Tech Transfer to the GMP for Clinical and Commercial manufacturing. He is actively involved in dossier submission, approval and interaction with different regulatory agencies such as EMA, MHRA-UK, CDSCO and USFDA for Biosimilar launch in overseas markets.
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 in the developmental 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, BioTrain, IMAPAC, CphI, Biopharma, Informa and UBM. He also chaired/Moderated couple of sessions in international forums/platforms 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.
Shawn Smith
Shawn was one of the early members of the cell culture bioprocessing community, having led various functions with then-GIBCO/Invitrogen to focus exclusively on the industrial applications of cell culture technology as that market began expanding in the mid-1990s. His 30-year career working for such influential bioprocessing companies as GIBCO (Life Technologies/Invitrogen), Kerry, HyClone (then-Thermo), Pall (now Danaher), Irvine Scientific (now Fujifilm) and Millipore-Sigma focused on developing process solutions and providing customer support for biopharmaceutical end-users involved with cell line development, media selection and optimization, single-use bioreactor utilization, outsourced CDMO services, and overall facilities design.
After receiving a BS in Biochemical Pharmacology, he continued his education in graduate curricula in the sciences and in business. Shawn has spent his entire career in the Life Sciences market, transitioning from an analytical bench chemist to various roles within cGMP (medical device) manufacturing before ultimately spending the past 20+ years in commercial functions of increasing responsibility, culminating as President & CEO of ZeptoMetrix, a molecular diagnostics company that doubled in size and was sold to private equity under his leadership
Arun Singhal
Arun Singhal has worked at leading cell culture companies in various commercial positions, including Hyclone (now Cytiva), Gibco (now Thermo Fisher) and Irvine Scientific (now FujiFilm) to develop markets in different regions, including South East Asia, Australia and South America. He has spent a considerable amount of time with the Indian biotech industry, where his innovative customer-focused approach complemented by his scientific background yielded tremendous success in penetrating over 90% of potential companies with targeted products/services in just a matter of a few years.
He has a Ph.D. in Biotechnology and MBA. Dr Singhal is one of the pioneers in the field of Gene Therapy. He has published over a dozen scientific articles in leading journals along with chapters in books in Gene Therapy. He contributed to a book, “Gene Therapeutics”, which was published 30 years ago. Most of his work focused on liposome-based targeted gene therapy and control of gene expression using various types of promoters. He has also extensively worked on different cell lines (both primary and stable) and commonly used biotechniques for his research.
BN Manohar
Manohar has been associated with the Manipal Education & Medical Group (MEMG) for the last 14 years and has taken up the role of CEO at Stempeutics in August 2007. He is responsible for making Stempeutics a leading stem cell company in Asia. He is responsible for developing innovative stem cell products addressing major unmet medical needs with an India first global next approach. His responsibilities include implementing strategies which will shape future business delivery and contribute to the achievement of the Company’s objectives both strategic and financial. Under his leadership Stempeutics has crossed various milestones including successful conduct of Phase 2 clinical trials in India and Malaysia, obtaining ATMP & ODD classification in Europe, getting patents from USA, Japan, ANZ and China. Prior to this assignment, Manohar has handled multiple assignments in the MEMG – starting Manipal Infocom a BPO Organization and successfully migrating it to Manipal–Omega Healthcare BPO JV, taking over a startup Distance Education business and growing it to US$ 18M, establishing and propping up the new Education Services business. Prior to Joining Manipal Group, Manohar has had 12 years successful stints at Wipro GE Medical Systems. At GE Medical he has handled multiple senior assignments including Vice President – Customer Service and as Chief Operating Officer of IT Joint Venture – GE Medical Systems Information Technology, at Hyderabad. Manohar has done his B.E. from Regional Engineering College, Trichy and M.E. from Guindy Engineering College, Chennai.
Sudarshan Reddy
Founder and CEO of Oncosimis Biotech Private limited and an accomplished leader in drug discovery and innovation in the field of metabolic and neuromuscular diseases. Received post -doctoral training from Harvard Medical School, Boston, USA, where his research focused on the development of therapeutic strategies for major neurodegenerative diseases and oncology. He has secured certificate in Healthcare Innovation and Commercialization, Best Business Start-up Pitch award at Harvard University and also got nominated for the AAAS/Science Program for Excellence in Science.
Under the able leadership of Sudarshan Reddy, Oncosimis Biotech has achieved notable milestones includes more than 30 patents to-date, apart from being recognized by several honors, grants and awards, which include BIG, NBM grant, Bio-Asia Best startup award, X-PRIZE for Covid testing, Biocon Innovation Excellence (NBEC), StartupIndia Pharma Grand Challenge and Syngene Emerging Biopharma award to name a few.
Sanjay Shah
Sanjay Shah has three decades of experience with prominent multi-national biopharmaceutical and engineering consulting organizations. Sanjay is recognized SME in technical operations, strategic infrastructure planning, capital projects management, process engineering and automation, technology transfer, commissioning & qualification. His experience spans the entire life-cycle of biopharma operations: from facility inception, design, start-up, GMP commercial operations, tech transfers, and compliance.
Sanjay has spent 16+ years in the US, and is in India since 2010. As process engineering lead at Eli Lilly in New Jersey, Sanjay supported large scale biopharmaceutical projects and operations. He was lead engineer for Amgen’s Enbrel® BioNext project. In 2010 he relocated to India, joined Dr. Reddy’s Labs as Director, and was tasked with setting up a new Plant & Process Engineering Department. He later worked as Director & Head of Biologics operations at Syngene (Biocon group) where he led CDMO operations serving Syngene’s global clients. Subsequently, he joined Intas Biopharma as VP and Head of Manufacturing Operations & Site Engineering. Sanjay served as Vice President, Global Engineering at Pfizer, supporting the Asia-Pacific sterile injectables network, and oversaw remediation of legacy Hospira sites. He was recently with Hyde E+C, US-based engineering consulting organization, as a Principal Consultant and VP Global Engineering.
Sanjay holds MS in Chemical Engineering. He is an active member of ISPE and PDA.
Prashant Kumar
Prashant Kumar is the General Manager at Bharat Serums & Vaccines Ltd, Navi Mumbai, India, where he leads a team for Cell Line Development & Upstream Process development. He earned an MS degree in biotechnology and has over 23 years experience in the health care segment with 2 years international exposure in the subsidiary company BSV Biosciences Inc. USA. He has an industrial expertise on the development of “Biosimilars” including monoclonal antibodies, Biosimilar glycoproteins where his core expertise lies into Cell Line Development, Cell culture, Upstream process and Technology Transfer to the GMP for Clinical manufacturing
Ganesh Sangle
Dr Ganesh Sangle has an outstanding track record of 17+ years in leading the discovery and development of NCE’s, 505(b)2, and biosimilars/biobetter products. Core competencies include an excellent and broad scientific background with proven expertise in multiple therapeutic areas such as rare diseases, oncology, pain, and metabolic diseases. Dr Sangle earned a master’s in pharmacy degree with a specialization in pharmacology from the Dr MGR Medical University (Chennai, TN, India) and a Ph.D. degree in Physiology & Pathophysiology, with a focus on diabetes-associated cardiovascular complications, from the University of Manitoba (Winnipeg, Canada). In addition, he was a postdoctoral fellow in the Department of Physiology at the University of Toronto (Toronto, Canada).
Renu Kundu
Renu Kundu, Co-founder of East Ocyon Bio, India’s one of the first Allogeneic Cell & Gene Therapy Research Company focused on Solid Tumors & Rare Diseases. East Ocyon Bio vision is to develop and commercialize NK and gamma delta T based cell therapies for difficult to treat tumors and auto-immune disorders. Her core expertise is Regulatory and Clinical Strategy.
Yogananth Rajendran
Yogananth Rajendran is the Head of Regulatory Affairs and Quality Assurance- Cell and Gene Therapy at Immuneel Therapeutics Private Limited. With over 19 years of experience, he is a seasoned Biologics Regulatory professional specializing in the CMC development, clinical advancement, and lifecycle management of biologics, biosimilars, and Cell and GeneTherapy Products.
Throughout his career, Yogananth has played a pivotal role in formulating global regulatory strategies for the commercialization of biologics, biosimilars, orphan drugs, and cell and gene therapy products. His expertise has significantly contributed to numerous biologics approvals across major markets, including EU and the USA.
Harshit Shah
Name – Harshit Shah
Designation – MSAT Group Lead
Total Experience – 16.5 years
Core competency – Downstream Processing and Upstream processing for biologics (Process Development and MSAT)
Previous Organization – Intas, Zydus cadila, Cadila Pharma and Hetero Biopharma.
Kinchit Shah
Kinchit Shah is a seasoned biotechnology professional with over 17 years of experience in upstream bioprocess development, leading teams to advance biologic products from lab to commercialization. Currently serving as Assistant General Manager at Intas Biopharmaceuticals, he directs a team of scientists in process development, characterization, scale-up and technology transfer for biosimilars. He also served previously for companies like Zydus Cadila and Sun Pharmaceuticals.
Chandrashekhar KN
Chandrashekhar working at Biocon Biologics, is functional leader and responsible for Cell Culture Process Development.
He has a decade of rich experience in developing, scaling-up and characterization of upstream processes.
In his tenure at Biocon he has been part of successful development of molecules leading to approval of several biosimilars across globe.
Chandrashekhar holds a Bachelor’s degree in Computer Science (along with Life sciences) and Master’s degree in Biotechnology from University of Mysore.
Dipankar Das
Dr. Dipankar Das is presently designated as a Director and Head-Biologics at United States of Pharmacopeia, India. Dipankar holds a Bachelor’s degree in Chemistry, Master’s and PhD in Biochemistry, Post-Doctoral research experience from University of Alberta, Canada, Certificate in Bioinformatics from CGDN Canada and Certificate in Supervisory Leadership from University of Alberta, Canada. He is a skilled researcher with more than 25 years of hands-on experience in the research, product development and commercialization in the biopharmaceutical industries.
With more than 50 international publications in peer-reviewed journals (Nature, The Lancet, Mol. Pharmaceutics, etc) and 4 books chapters, he serves as a reviewer for several scientific journals. Before joining USP, Dipankar worked in University of Missouri-Columbia, USA, University of Alberta, Canada and in two vaccine manufacturing companies in India and was playing a leading role in CMC of several pipeline and commercial products. Dipankar participated in several collaborative studies with different national and international organization for establishment of biological reference standards.
Rohan Kamat
Rohan Kamat currently serves as the COO at Kodo Lifescience, a CDMO focused on catering to the Cell and Gene Therapy space globally. Prior to Kodo Lifescience, Rohan has worked with a Bangalore based organization and was involved in commercializing India’s second CAR-T therapy. His expertise lies in developing various aspects of CAR-T cell therapies, from critical raw materials to therapies.
Murali Addepalli
Dr. Murali K. Addepalli is an accomplished drug discovery and development professional with over 20 years of experience, specializing in novel immunetherapeutics for oncology and autoimmune diseases. His career features pivotal scientific and leadership roles, including his current position as Vice President and CSO at SANSHI Bio Solutions, where he leverages amplified intelligence for better health outcomes. He previously served as CoFounder and CSO at Lextro Bio Solutions and held leadership roles at major firms like Nektar Therapeutics and Biocon – Bristol Myers Squibb. Dr. Addepalli has successfully led over 15 discovery programs and was instrumental in securing multiple IND filings. An expert in translational research and mechanism of action (MoA) studies, he drives innovation, contributing to 9 patents and 25+ publications and conference abstracts. Holding a PhD and NIH post-doctoral experience, he combines rigorous scientific acumen with proven regulatory expertise, including securing AAALAC accreditation and managing IACUC/Biosafety committees.
Sanjeeva Metikala
Sanjeeva Metikala is currently leading the R&D functional analytics for biosimilars at CuraTeQ Biologics Pvt. Ltd., Hyderabad.
He has a Ph.D. in Medical Physiology and Pathophysiology from Martin-Luther University, Germany. He also has post-doctoral research experience from various renowned institutes in the USA like Marine Biological Laboratory, USA, Cincinnati Children’s Hospital, USA and University of South Florida, USA. He has nearly 15 years of experience in research and development in molecular biology, developmental biology, gene editing using CRISPR/Cas etc.
Sanjeeva’s team not only develops, qualifies and transfers cell-based and cell-free release methods from R&D to QC, but also develops and qualifies extensive repertoire of functional characterization assays for large proteins and monoclonal antibodies. He is an expert in developing assays to demonstrate in vitro functional and immunogenicity similarity of biosimilars in line with expectations to regulatory agencies such as FDA, EMA, MHRA, etc.
G.S. Sameer Kumar
Dr. Sameer Kumar G.S is currently working as a Senior Manager & leading the Analytical team – in Biologics division, USP India. Dr. Sameer Kumar holds a PhD in Biotechnology from Kuvempu University. He has over 19 years of Biopharmaceutical research & Industry work experience. In his research career he has published 20 peer-reviewed international research publications (Cancers, Genome Biology, Nucleic Acids Research, Food Chemistry, Frontiers in Molecular Neuroscience, Clinical Proteomics etc) and application note.
In his current role at USP, he majorly focused on develop/modernize documentary standards (monographs & chapters), Reference Standard development and characterization Material characterization studies, development of MAM work flow, Method development and validation and Proof of concept (PoC) testing of different Biologics modalities. Sameer has a vast experience in analytical method development for various Biologics molecules using Chromatography, Mass Spectrometries (Triple Quad, Q-TOF & Orbitrap), CD, & SEC-MALS, Capillary Electrophoresis, etc. Sameer is a member of the Proteomics Society –India (PSI), India, Indian Society for Mass Spectrometry (ISMAS), India & Chromatographic Society of India (CSI), India.
Kamala Bhavaraju, Ph.D.
Dr. Kamala Bhavaraju is currently leading Clinical Bioanalytics group in the division of Clinical Development at Biologics, Dr. Reddy’s Laboratories Ltd, Hyderabad. Her group develops new methods to understand Pharmacokinetics, Pharmacodynamics and Immunogenicity of large molecules and therapeutic proteins to support phase 1, 3 and 4 clinical studies. Dr. Kamala received her master’s degree from University of Hyderabad, where she bagged two gold medals for her academic excellence. She received her PhD degree in Molecular and Cellular Physiology from Temple University, Philadelphia USA in 2010. She has received several travel grants and awards during her PhD, including prestigious “Erwin Margulies” Award for excellence in Thrombosis research. She has authored and reviewed peer-review journal articles and is the inventor in many patents. She joined Dr. Reddy’s in 2011 as post-doctoral research fellow and has steadily risen ranks within the company and continues to build strong research and innovation focused group. In her position at Dr. Reddy’s she also mentors new technical trainees and interns from various academic institutes. Research work by her group has been accepted and presented at international conferences and a recent publication in Bioanalysis journal. She was also conferred with Anji Reddy Excellence Award in the category of “Innovation Excellence” in 2020. Apart from being an avid and seasoned researcher she is also a certified Master trainer and Woman Safety Ambassador at Dr. Reddy’s where she conducts women safety awareness sessions. Her interests include reading, gardening and travelling and she is a staunch advocate of Diversity, equity and inclusion (DEI).
Dinesh Khokal
Dr. Dinesh Khokal, as a Global Director of Regulatory GxP Intelligence & External Affairs in BeiGene, is responsible for supporting BeiGene’s compliance with regulations and industry trends and, for shaping external regulatory and GXP environment (Policy and Advocacy) in collaboration with industry peers and regulators.
He is an accomplished pharmaceutical professional with distinguished career of over 40 years of combined experience in regulatory agency, biopharmaceutical & diagnostic industries, and in academia.
Prior to BeiGene, Dinesh working in Amgen for 7 years as Director and Regional Lead of External Affairs covering Japan Asia Pacific and LATAM. Before this role, Dinesh was a regulator holding the position of Director of Therapeutic Products Branch at the Singapore Regulatory Agency, Health Sciences Authority (HSA). During his tenure in HSA, Dinesh held many different leadership positions including Senior GMP Inspector and Senior Regulatory Consultant. He has also played several key roles in multiagency consortiums and World Health Organization initiatives working towards capability building, regulatory harmonization, and mutual reliance.
Dinesh received his Ph.D. in Cell and Molecular Biology from the National University of Singapore. Dinesh is active in Scientific Organizations such as PDA, ISPE and In several Industry Associations. He is a recipient of 2020 PDA Distinguished Service Award.
Sweety Mathew
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. She believes in nurturing an inquisitive and explorative culture to create a more scientifically advanced tomorrow.
Sattva Neelapu, MD
Dr. Sattva S Neelapu is a tenured Professor and Deputy Chair in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, Houston, Texas. He completed medical school at JIPMER, Puducherry in India, Internal Medicine residency in New York, and clinical fellowship in Medical Oncology and postdoctoral fellowship in tumor immunology and immunotherapy at the National Cancer Institute, Bethesda, Maryland. As a physician-scientist at MD Anderson, his research is focused on clinical and translational development of novel immunotherapies for B-cell malignancies. His work on the pivotal clinical trial of axicabtagene ciloleucel CD19 CAR T-cell therapy in aggressive B-cell lymphomas led to its FDA approval as the first CAR T-cell therapy for lymphoma. His laboratory is focused on developing CAR T-cell therapies against novel targets, understanding mechanisms of resistance to CAR T-cell therapy, and developing allogeneic cell therapy approaches. He is nationally and internationally recognized for his expertise in CAR T-cell therapy in B-cell malignancies and management of toxicities associated with CAR T-cell therapy. He has authored or co-authored over 300 publications.
Sabyasachi Halder, Ph.D.
Dr. Sabyasachi Halder is an experienced Biopharmaceutical Professional in CMC Analytical for Biologics/Biosimilars Process Development and Product Development. Currently he has been working as Head of Analytical Research and Development (R$D), CDMO Biologics, Aurigene Pharmaceuticals Service Limited,Hyderabad, India. He is versatile and highly skilled with Ph.D from India with 6 years Postdoctoral Research at United States of America (USA) in Protein structure/function and 10 Years Biopharmaceuticals Industry in the area of analytical Development and Characterization with various techniques for Biologics/Biotherapeutics development. Developed, managed and maintained several research projects on therapeutic proteins, monoclonal antibody, bispecific antibody etc. and delivered within Timeline. He has published his research work on academic and industry in peer reviewed international journals and also presented his work in International and National Platforms.
Kishore Kunapuli, Ph.D.
Dr Kunapuli has a Ph.D. from the German Cancer Research Centre in Germany. He also holds a Biotechnology Post Graduate degree. He possess more than 15 years of hands-on experience in Cell Biology and Immunology systems.
His expertise lies in devising innovative solutions for life-threatening infections, cancer treatment procedures, and diagnostics, utilizing state-of-the-art biotechnologies. Prior to joining the Pulse team, he gained valuable experience working at reputable organizations, including the Singapore Immunology Network in Singapore. During this time, he successfully completed multiple research projects.
Amit Jogi
Amit Jogi heads the CDMO Biologics division at Aurigene Pharmaceutical Services Ltd., where he oversees the strategic planning, delivery, and execution of biologics projects within the CDMO framework.
With over two decades of comprehensive experience in the biologics sector, Amit has worked across CDMO and CMO environments, progressively advancing through roles of increasing responsibility. His expertise covers process development, manufacturing science and technology, as well as clinical and commercial manufacturing. Amit has made significant contributions to the development of monoclonal antibody (mAb) production techniques and has played a key role in scaling up these processes for large-scale commercial production. Over the course of his career, he has led more than 25 process development projects and contributed to the successful development of over 20 products for clinical and commercial manufacturing.
A trained bioprocess technologist, Amit holds a Ph.D. in microbiology, bringing both technical depth and practical experience to his leadership role. In addition to his professional accomplishments, Amit is an accomplished author and speaker. He has co-authored a book, published numerous research papers, and frequently presents at international conferences, sharing his expertise and innovations in biologics manufacturing.
Before Aurigene, Amit held prominent positions at leading organizations such as Syngene International Ltd, Xcelris Lab, Magene Life Sciences, and Cadila Healthcare (Zydus), where he further developed his expertise and laid the groundwork for his leadership in the CDMO biologics industry.
Manish Singh
Manish Singh is the Director of Agile Bioscience, bringing over 17 years of expertise in the Biopharmaceutical industry with a focus on Analytical Development and Protein Characterization.
He has held key roles at leading organizations, including Intas Biopharmaceuticals, Dr. Reddy’s Biologics, Kemwell Biopharma, Thermo Fisher Scientific, and Bio-Techne. His contributions have been instrumental in advancing LC-MS methodologies, peptide mapping, glycoprotein analysis, and Higher Order Structure characterization. His work has significantly enhanced N- and O-linked oligosaccharide analysis and large molecule structural assessments.
Manish holds a Master’s in Biotechnology from Dehradun and an MBA in Pharma Business Management, blending deep technical expertise with strategic leadership. His vision continues to drive Agile Bioscience toward innovation and excellence in biopharmaceutical characterization.
Rashmi Kanagal- Shamanna, MD
Dr. Rashmi Kanagal-Shamanna is a practicing triple board-certified Molecular Genetic Pathologist and Hematopathologist at The University of Texas MD Anderson Cancer Center. She is a tenured Professor and co-director of the clinical Bone Marrow Laboratory, and Molecular Diagnostic Laboratory (Innovative Diagnostics section). Dr. Kanagal-Shamanna received her MD from St. John’s Medical College, Bangalore, India followed by a residency in Anatomic and Clinical Pathology at Henry Ford Hospital, Detroit, Michigan. She completed her fellowships in Hematopathology, Advanced Hematopathology, and Molecular Genetic Pathology at M.D. Anderson Cancer Center. Dr. Kanagal-Shamanna’s clinical responsibilities include the development and validation of genomic assays and clinical reporting, signing out bone marrow and lymph node biopsies among others. Her primary research interest is the application of novel tools for molecular profiling of hematological malignancies for prognosis and guiding therapy. Dr. Kanagal has >250 highly cited peer-reviewed publications in her field. She is the recipient of the Leukemia SPORE career development award, Ladies Leukemia League grant, and RP Foundation award. Dr. Kanagal is an invited lead author for the 2022 World Health Organization (WHO) Classification of Hematolymphoid Tumors, and author of the WHO Genetic Tumor Syndromes. Her work on myeloid neoplasms with isochromosome (17q) has led to the recognition of this as a provisional entity in the latest International Consensus Classification (ICC) system. Dr. Kanagal-Shamanna is on the Board of Directors of the Cancer Genomics Consortium (CGC) where she also served as the President (2023-2024), and Annual meeting Program Chair (2022-2023). She co-leads the Clinical Genome (ClinGen) resource’s Somatic Hematologic Malignancy Taskforce. She served as the past chair of the Professional Association Collaboration Committee tasked with developing guidelines for the appropriate utilization of genomic assays in patient care. She serves as an editorial board member for the Cancer Genetics journal.
Fatima D’Souza
Dr. Fatima D’Souza is a seasoned biopharmaceutical expert with over 15 years of cross-functional experience spanning Research and Development, Production, Quality Control, and Patents. She holds a PhD in Biochemistry from the Institute of Chemical Technology, Mumbai, and an MS in Biotechnology and a BS in Life Sciences from the University of Mumbai.
Fatima is a distinguished biopharmaceutical professional with a robust record in downstream process development, assay development, and quality control. Currently serving as Chief Operating Officer at Zelle Biotechnology Pvt. Ltd., she leads strategic initiatives, oversees workflow, and drives research and development. Previously, as Head of Process Development and Bioservices at the same company, she spearheaded efforts in downstream processing and assay development, focusing on
protein characterization and cell culture-based potency assays. Her experience encompasses significant contributions to process improvements and quality management, demonstrating her deep expertise and leadership in advancing biopharmaceutical technologies. Her tenure at Biocon Ltd involved managing quality control for clinical monoclonal antibodies and therapeutic proteins, where she made impactful improvements in assay validation and cost reduction. At Goodwin Biotechnology, she advanced process development for novel antibodies and played a pivotal role in establishing the company’s Indian operations.
Dr. D’Souza’s career began in patent searching and product specialization, with notable scientificpublications and contributions to patent applications in protein purification and biosimilar comparability. She has also delivered seminars on biopharmaceutical drug development and maintains a strong track record in project and operations management, including successful technology transfers and method validations. Her extensive experience, combined with her ability to mentor cross-functional teams and meet critical deadlines, underscores her capability to drive innovation and quality in the biopharmaceutical industry.
Anurag Tulsyan
Anurag Tulsyan is a visionary leader with a strong foundation in scientific research and business management. He earned his Master of Science in Chemistry from the prestigious Georgia Institute of Technology, where he honed his analytical and problem-solving skills, laying the groundwork for his future endeavors in biotechnology and pharmaceuticals. Following his academic journey, Anurag gained valuable industry experience in cutting-edge biotechnology and pharmaceutical research.
He worked at Protein Design Labs in San Francisco, a company known for pioneering work in therapeutic antibody development. During his time there, he was involved in advanced research projects that contributed to breakthroughs in the field of proteinengineering. Subsequently, he contributed to Recombinant Cell Culture Development at Bharat Serums and Vaccines, a leading Indian biopharmaceutical company specializing in critical-care products. In this role, he played a key part in optimizing cell culture processes for the production of recombinant therapeutic proteins, further solidifying his expertise in the field. Anurag’s career has been defined by an unstinted pursuit of excellence—a commitment to continuous learning, innovation, and leadership in the pharmaceutical and biotechnology sectors. His ability to blend scientific acumen with strategic vision has positioned him as a dynamic leader dedicated to driving growth, fostering innovation, and delivering impactful solutions in the healthcare industry
Dhananjay Patankar
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.
Ranjan Chakrabarti
Dr. Ranjan Chakrabarti has over 38 years of experience in Biopharma and Drug Discovery industries.
Ranjan is now working as a consultant in biopharmaceutical analysis and 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, overseeing USP’s Biologics activities in South, SE Asia and China. Before joining USP. Ranjan was Head of Preclinical Biology at Dr. Reddy’s lab and played a key role in initiating drug discovery in India, discovering and developing NCEs in collaboration with Novo Nordisk and Novartis. Before returning to India, Ranjan worked 7 years in the USA and successfully coordinated research projects in Cancer Cell Biology and Diabetes.
Dr. Ranjan is the Co-Inventor of 32 US Patents; published 64 papers in peer reviewed International and National Journals and presented more than 100 lectures in International and National Conferences.
Deepika Arora
Dr. Deepika Arora serves as the Laboratory Director (Head, R&D and Operations) at the Regenerative Cell Research Institute, Genome Valley, Hyderabad, where she oversees the development of advanced stem cell therapeutics, exosome technologies, and next-generation bioprocessing platforms. With over 14 years of experience in biotechnology and regenerative medicine, she has a strong record across R&D, operations, and academia. She has authored 15+ peer-reviewed publications, co-edited academic books, and received several distinguished national and international awards.
She was awarded the prestigious Fulbright–Nehru Postdoctoral Fellowship, through which she carried out cutting-edge research at the National Institutes of Health (NIH) and the National Institute of Standards and Technology (NIST), USA, focusing on pluripotent stem cell–based tissue engineering. Dr. Arora has also held academic and research positions at the SIET, IIT Guwahati, and CSIR-IITR. Her multidisciplinary expertise spans toxicology, oncology, bioassay development, tissue-engineered organoids, drug screening, and the end-to-end development of stem cell and regenerative medicine products from early research to translational readiness.
Pankaj Gupta
Dr. Pankaj leverages 18 years of QA leadership across pharmaceuticals, biologics, medical devices, and plasmid DNA to build quality systems that enable speed, compliance, and scalability. At Kodo Lifescience, he leads QA for the GMP-grade plasmid DNA facility, driving GMP infrastructure creation, regulatory alignment, high-fidelity tech transfer, and implementation of a fully digital QMS ecosystem. He brings expertise in QbD and risk-based decision-making that enables QA to support fast, compliant, and scalable manufacturing for next-generation gene therapy and mRNA technologies.
Saravanan Desan
Saravanan Desan is the Senior Director at Biocon, where he leads biosimilar product development and regulatory support.
With over 21 years of experience in biologics, he has played a pivotal role in scaling up and transferring technologies for monoclonal antibody production.
He currently manages a team of more than 30 scientists, overseeing both drug substance and drug product development.
Saravanan has been instrumental in the successful development of biosimilar products like Ogivri, Jobevene and Fulphila, which have received approvals from the US FDA and EMA.
His expertise spans upstream processing, process development, and regulatory submissions for global markets and currently working as project group leader.
Saravanan is passionate about integrating science with practical solutions to accelerate product development timelines. Known for his strategic vision, he has successfully implemented process improvements that enhance quality an reduce costs. Beyond his technical contributions, he is committed to mentoring young scientists and fostering a culture of continuous learning.
Atin Tomar
Atin Tomar is Founder and CEO of Yapan Bio Private Limited (Associate Company of Piramal Pharma Limited), a company specializing in the process development and GMP manufacturing services for Vaccines and Biologics/Biotherapeutics. Atin brings with him comprehensive experience in the Biotechnology industry, globally. Atin’s experience and expertise spans from Process Development, Technology Transfer and Operations to Business Development, and Licensing. Before founding Yapan Bio, Atin was President & CEO of CPL Biologicals Pvt. Ltd. Prior to that he had worked with organizations like Human Genome Sciences, Amgen, Syngene International, Dr. Reddy’s Laboratories, MSD Wellcome Trust Hilleman Laboratories, and International Vaccine Institute (IVI). Atin holds a B.Tech (Hons) degree in Biotechnology and Biochemical Engineering from the Indian Institute of Technology (IIT) – Kharagpur, MS in Biological Engineering from the University of Georgia, USA and MBA from the Indian School of Business (ISB), Hyderabad.
Raghu Malapaka
Raghu Malapaka, Ph.D, Chief Business Officer, Nucelion, has an extensive commercial experience in the development and manufacturing of large molecules as well as advanced therapies. He served in leadership roles in global CDMOs including AGC Bio, Thermofisher and WuXi and played key role in bringing some of the earliest CGTs to the patients. Dr. Malapaka has a PhD in molecular biology and post-doctoral experience at Harvard Medical School.
Devesh Panwar
Devesh Panwar is an accomplished biopharmaceutical RA professional with over 15 years of experience in advancing Biologics, Biosimilars, and Cell & Gene Therapy across global markets, including the European Union, major ROW regions, and India. Currently working as Head, Regulatory Affairs with Immuneel Therapeutics Private Limited, Bengaluru, one of the pioneering organization in CGT space in India.
With deep expertise in end-to-end product development, I have successfully driven clinical strategy, regulatory submissions, and commercialization for complex biologics and next-generation therapies.
His work spans navigating through complex and evolving regulatory landscapes to bring transformative treatments to patients.
Played pivotal role in:
- Global biosimilar product development for some of the key therapeutic areas.
- Seeking regulatory approvals for some of the first of its kind Novel biologics, ADCs and advanced therapies in India.
- Strategic market access initiatives ensuring product sustainability and maintaining regulatory compliance.
- Cross-functional leadership fostering collaboration between R&D, regulatory, and commercial teams.
Mansi Jakhade
Ms. Mansi Jakhade is an Analytical Project Manager in the Clinical Bioanalytics department at Dr. Reddy’s Laboratories Ltd, Hyderabad. She designs and develops bioanalytical methods for pharmacokinetics, pharmacodynamics, and immunogenicity assessments of large molecules and therapeutic proteins for clinical studies.
Her experience includes research in cloning and designing vectors to produce high yields of protein, earning her patents. She was also actively involved in novel innovative biologic research of significant therapeutic promise to fulfill unmet medical needs in oncology. Ms. Mansi earned her master’s degree in Biotechnology from Nirma University, Ahmedabad, in 2007, with training and dissertation experience at CSIR institutes. With 18 years of industry experience at Zydus, Sun Pharma, and Dr. Reddy’s, she joined Dr. Reddy’s in 2021, contributing to bioanalytical activities for clinical studies.
Additionally, Ms. Mansi is a certified Master Trainer and Woman Safety Ambassador at Dr. Reddy’s, conducting women safety awareness sessions.
Shubrata Khedkar
Dr. Shubrata Khedkar brings over 18 years of expertise in bioassay development and validation for biotherapeutics. At USP, she leads initiatives in functional analysis for diverse modalities, including therapeutic proteins, vaccines, and monoclonal antibodies (mAbs). Her work extends to developing advanced impurity quantitation methods, including host cell DNA (HCD) and double-stranded RNA (dsRNA), supporting the quality and safety of biotherapeutics. In addition to her scientific contributions, Dr. Khedkar is an approved USP instructor who regularly conducts training on Bioassay Design, Development, and Validation. Through these programs, she shares practical insights and hands-on experience in applying USP bioassay guidelines, helping professionals strengthen their analytical capabilities. She has authored and contributed to several scientific publications reflecting her thought leadership in advancing bioassay science. Prior to USP, she gained extensive experience in bioassay development for small molecules.
Vaijayanti Gupta
Dr. Vaijayanti Gupta is a biotechnology leader with over 20 years of experience in genomics and translational research, and deep expertise in CRISPR-based diagnostics and gene-editing technologies. She has led the design and execution of CRISPR assay platforms from concept to clinical readiness, including development, validation, and scale-up of point-of-care diagnostic solutions. She has a strong track record of building and leading multidisciplinary R&D teams, shaping product roadmaps, and translating cutting-edge science into deployable healthcare products. She holds a PhD in Molecular and Cell Biology from the University of Maryland and completed her postdoctoral research at the National Institutes of Health (NIH), USA, where her work focused on functional genomics and regulatory pathways. She currently serves as the Chief Scientific Officer at CrisprBits private limited and is focused on building CRISPR led solutions and platforms in point of need diagnostics, gene editing and strain engineering.
Prashant Chawla
Mr. Prashant Chawla is a seasoned Bioprocess Manager with over 20 years of progressive experience in drug substance manufacturing, process engineering, validation, and regulatory compliance. His career spans prestigious Indian and multinational organizations, including Hyde Engineering & Consulting, Serum Institute of India, and currently, Biological E Ltd.
With a deep-rooted expertise in vaccine bulk antigen manufacturing, Mr. Chawla has led end-to-end operations encompassing scale-up, technology transfer, and cGMP compliance for critical vaccines such as Diphtheria, Hib Conjugate Vaccine, and Typhoid Vi Polysaccharide. He has played a pivotal role in the successful manufacturing of Typhoid O2 Polysaccharide, CRM197, and CORBEVAX (COVID-19 Vaccine), steering cross-functional teams to deliver operational excellence.
Mr. Chawla has overseen technology transfers for both bacterial and recombinant antigen production, consistently optimizing production timelines and resources while ensuring alignment with stringent global regulatory frameworks, including USFDA, EU, WHO, and ANVISA standards.
In addition to his technical acumen, Mr. Chawla holds certifications in Lean Six Sigma Green Belt (LSSGB), and has pursued professional development in Managerial Economics and Operations Management.
He holds a Master’s degree in Bioprocess Engineering from ICT and a Bachelor’s degree in Chemical Engineering, complemented by multiple cGMP certifications and regulatory training credentials.
Sankar Srinivasan
Dr. Srinivasan has a PhD from the University of Texas Health Science Center – Houston, USA and Post Doctoral experience from Baylor College of Medicine- Houston, USA. He has more than 15+ years academic and industrial experience at various organizations. He also has to his credit, 11 peer reviewed international publications, with more than 550 citations and 7 international PCT patent applications. His varied experience includes CMC support for commercialization of complex pharmaceutical products like biologics, synthetic peptides and vaccines in the US, EU, Health Canada and India.
Mahesh Bhadane
Mahesh has been working in the biopharmaceuticals industry for more than two decades and has been an important Cog in the wheel of manufacturing and Science development at Advy Chemical Pvt Ltd. By education, he has a master’s in science and an MBA in operations.
In his past life, he has contributed to the development of several biologic molecules at a small scale and scaled up the process for commercial manufacturing. In his journey he has been instrumental in writing dossier modules, submission, approval, and responding to regulatory queries, including EMA and USFDA.
He started his career with Shantha Biotech Ltd. in 2004 and a couple of other reputed biopharma industries in India, which include Wockhardt Biotech Ltd.,USV Pvt. Ltd. and One Source Speciality Pharma Ltd.
In his current role as Head – Production Bulk, Mahesh leads the bulk production department at Advy Chemical Pvt. Ltd. and is responsible for early- and late-stage manufacturing of both antigen and antibody programs across multiple modalities. His experience spans recombinant peptides, fusion proteins, enzymes, vaccines, monoclonal antibodies (mAbs), native antigens, native antibodies, and PEGylated proteins.
Akhil Kumar
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 the Experts Committee of CDSCO for development of CGT regulatory guidelines in the country. Akhil has been with Aurigene since 2017
Somasundaram
Somasundaram has more than 25 years of combined experience in the pharma & biopharmaceutical industry. He has a broad experience in the areas of Aseptic Processing, Down stream processing of Biologics, & Closed Processing.
Som, is currently Global Principal Consultant for Merck Life Sciences under the Process Solutions division based in Bangalore, India. He has spent close to 24 years within Millipore & Merck in roles of increasing responsibilities. His previous tenure includes head of South Asia technology management, Validation Services, Technical Services & Sales Management.
Som is also Secretary for the PDA India Chapter & was formerly a Board member & Secretary of PDA Singapore Chapter and ISPE India former Executive Committee member.
Som has Master’s degree in Microbiology & Business Management.