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2nd Global Biologics India
16-17 April 2025

DNA
Image by mcmurryjulie from Pixabay
Picture drawn by Arun Singhal

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

Successful Commercialization of Cell Therapy products in India

Manohar BN, MD and CEO

 Stempeutics, India  

Allogeneic CAR-T: Insights from the clinic and the path forward

Sattva S Neelapu, MD, Professor and Deputy Chair

Uni of Texas MD Anderson Cancer Center, USA

Global Regulatory Landscape of Biological molecules

Sweety Mathew, Global RA CMC Lead

Novo Nordisk, India

AI-enabled New Approach Methodologies to support Biopharma Workflows- Decentralized Assessments- A Proven Strategy 

 Subhadra Dravida, Founder and CEO

Transcell Biologics, India

Management of IP & Privileged communication in R&D

Kaushal Joshi, Asso VP – IP and Legal

 Kashiv Biosciences, India 

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

 

Module 2-2: Regulatory Issues with CGT

Convenor:………..

 

Navigating CMC challenges for cell and gene therapy

Yogananth Rajendran, M Pharm

Head Regulatory Affairs

Immuneel, India

 

 

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

 

 

Module 2-4: Raw Materials and Product Development

Convenor:……..

 

Role of critical raw materials in Cell and Gene therapy

Rohan Kamat, Ph.D., COO

Kodo Life Sciences, India

 

USP approach to Standards for Cell and Gene Therapy Product Development

Dipankar Das, Ph.D.

Director and Head, Global Biologics

USP, India

 

CAR T cell Talk from US based speaker

Details to provided soon

 

Reserved

 (details to be provided soon)

Module2-5: QC/Quality Systems/Regulatory

Convenor:………

Pharmaceutical Quality System Development 

Vaibhav Patel

Director, QA and Reg Affairs

University of Minnesota, USA

 

 

 

 

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

 

Cell Culture- Applications

Yaron Silberberg, Ph.D., Director

Ajinomoto, Korea

 

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

 

Analytical Perspective of Chemistry, Manufacturing and Control (CMC) for Biologics development

 Sabyasachi Halder, Ph.D.

Group Lead Analytical R&D

Aurigene Pharm Services, India

 

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

 

Critical Quality Attributes of the Comparability and Similarity testing panel of Biosimilar mAbs against the Reference Product

Jakub Knurek, Marketing Specialist

Mabion, Poland

 

Challenges in Immunogenicity testing of biosimilars

Kamala Bhavaraju, Ph.D.,

Head Clinical BioAnalytics

Dr Reddys Lab, India

 

Performance Assessment of the Multi-Attribute Method vs. Conv QC methods

GS Sameer Kumar, Ph.D.

Manager and Team Lead

USP, India

 

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

 

Some of the topics/ titles of talks  that would be discussed…. 

Recent Advances in Process Development and Next Generation Manufacturing for Accelerated and Affordable Biosimilar Development

Successful Commercialization of Cell Therapy products in India

Overview of upstream process development for Biosimilars

Successful Cell Therapy Program: challenges associated with drug manufacturing and process and product characterization

Manufacturing of AAV and lentiviral vectors using HEK293 cells

Challenges in process development of CAR T cell therapy

Induced Pluripotent Stem Cells in Regenerative Medicine

NK and Gamma Delta T based Allogenic Cell Therapy

Decoding the future of Healthcare; A comprehensive survey of cell therapy outcomes

Product development: commercialization and market

Regulatory Inspection – Challenges and Opportunities for Biosimilar Products

Regenerative medicine drug development in India: Challenges and Opportunities

Novel Biologics Development- A case study

Strategizing the challenges during clone development

Current challenges of development and cGMP manufacturing of Cell and Gene Therapy products

Induced Pluripotent Stem Cells (iPSC) In Disease Modelling and Drug Discovery

Panel Discussion: Biosimilars: Recent Advances in Cell Engineering and Upstream Processes for Accelerated, high quality and Affordable MAb development

Moderator

Panel Discussion: Cell and Gene Therapy- Progress, Challenges, and future outlook

Moderator

Bioassay: Advancement in functional assessment of biologics and regulatory requirements

Beyond the Blueprint: AI-Powered Protein Engineering for a Brighter Future

Scalable & Efficient Production of Lentiviral vectors

Collaboration of IP and Biosimilar R&D for Early Market Access

Bringing best practices to India in Design of Biopharmaceutical Facilities

Translating Cell and Gene Therapies- From Concept to Commercialization

 

Details on past conference