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2nd Global Biologics India
16-17 April 2025



This page is being updated (10 March 2025)- Click here for a current pdf – we will be updating agenda for more details on a regular basis
General Biologics Talks and Discussion
Navigating Global Waves: Trends in Medicine Regulations and GMP/GDP Inspections Dinesh Khokal, Ph.D., Global Director, GxP Surveillance & Quality External Affairs BeiGene, Singapore | |||||
Early-Stage Biologics into IND-ready Drugs: A Strategic Development Path Amit Jogi, Ph.D., Head, CDMO Biologics Aurigene Pharm Services, India
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Cell and Gene Therapy Track
Panel Discussion:
Cell and Gene Therapy- Progress, Challenges, and Future Outlook
Moderator: Renu Kundu, Ph.D. (East Ocyon)
Panel: BN Manohar (Stempeutics), Vishwas Kaveeshwar (SDM Uni), Sattva Neelapu (MD Anderson, USA), Yogananth Rajendran (Immuneel)
Module 2-1: New Approaches- CAR T and NK Cell Therapies Convenor: …….. | |||||
Translating Cell and Gene Therapies: From Concept to Commercialization Renu Kundu, Ph.D., Director and Co Founder East Ocyon, India | |||||
Optimization of CAR-T therapy design: A focus on improving the persistence and affinity Bajarang Kumbhar, Ph.D., Ass Professor NMIMS University, India | |||||
New Horizons in CAR T Therapies Murali Addepalli,Ph.D.,Co Founder/CSO Lextro Bio Solutions, India | |||||
CARs, BiTEs, TriTEs, QuTEs……The Power of the T Cell Kishore Kunapuli, Ph.D., CSO Pulse Pharma, India
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Module 2-3: iPSCs Convenor: …………. | |||||||||||||||
Leap frogging to pole vaulting in Cell Therapy: An iPSC Approach Vishwas Kaveeshwar, Ph.D. Asst Professor, Inchage SDM University, India
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Biosimilar and Novel mAbs Track
Panel Discussion: mAbs/Biosimilars: Functional Assessment/Analytics/Reg Inspection Moderator: Dinesh Khokal, Ph.D. (BeiGene) Panel: Praveen Reddy Ph.D. (Lupin), Siva Sankar (Aragen), Satish Makkina (Procell), Dhananjay Patankar (Consultant), TBD (Sponsor-1), Ravish Patel, Ph.D. (Kodo)
Module 2-6: Upstream and Clone Development Convenor: Sanjay Shah | |
Clone Development: Unlocking potential, Lessons learnt and future directions Saranaya Ganapathy,Ph.D., Sr Manager IPCA, India | |
Strategizing the challenges during clone development/Upstream Processes for Accelerated, high quality and Affordable MAB Development Prashant Kumar, Gen. Manager Bharat Serums and Vaccines, India | |
Overview of Upstream and Downstream Process Development for Biosimilars with Perfusion/ Conc. Fed batch and scale up challenges Harshit Shah, Ph.D., Group Lead MSAT Dr Reddys Lab, India | |
Emerging modalities and Controlling complexities in Upstream: Vial to Vial story Chandrashekhar KN, Sr Sci Manager Biocon, India |
Module 2-7: Tools and Products Convenor: Sanjay Shah | |
Multiparameter Stability Characterization of Biologics with Prometheus Panta Saji Menon, Ph.D. Sr. Field Application Scientist NanoTemper Technologies, India MSP |
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Cell Culture- Applications Yaron Silberberg, Ph.D., Director Ajinomoto, Korea |
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Module 2-9: Biologics Development- Clinical and CMC issues Convenor: Dinesh Khokal, Ph.D. | |
Global Clinical Development strategies for Biosimilars Chirag Shah, Ph.D., Head Clinical Opr Raptim Research, India |
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Analytical Perspective of Chemistry, Manufacturing and Control (CMC) for Biologics development Sabyasachi Halder, Ph.D. Group Lead Analytical R&D Aurigene Pharm Services, India |
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Module 2-10: BioAnalytics- New waves Convenor: Dinesh Khokal, Ph.D. | |
Bioassay: Advancement in Functional Assessment of Biologics and Regulatory Requirements Sanjeeva Metikala, Ph.D. Prin Scientist CuraTeQ, India |
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Critical Quality Attributes of the Comparability and Similarity testing panel of Biosimilar mAbs against the Reference Product Jakub Knurek, Marketing Specialist Mabion, Poland |
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Challenges in Immunogenicity testing of biosimilars Kamala Bhavaraju, Ph.D., Head Clinical BioAnalytics Dr Reddys Lab, India |
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Performance Assessment of the Multi-Attribute Method vs. Conv QC methods GS Sameer Kumar, Ph.D. Manager and Team Lead USP, India |
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Module 2-11: Manufacturing Facilities for future Growth Convenor: Kamala Bhavaraju, Ph.D. | |
Biopharma manufacturing in India, current gaps and opportunities Sanjay Shah Founder and Consultant Xenpharm India |
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Some of the topics/ titles of talks that would be discussed….