Dr. Tushar Ranjana Moharana is a computational protein engineer focused on machine learning–driven design of proteins and vaccines. He earned his PhD from the CSIR-Centre for Cellular and Molecular Biology and has over a decade of experience in computational protein engineering, more recently integrating advanced AI models such as AlphaFold and ProteinMPNN with physics-based simulations, structural modeling, and sequence optimization. At PopVax, he leads immunogen design and bioinformatics, developing ML-driven workflows for protein engineering and vaccine design targeting infectious diseases. His work spans de novo protein design, including binders, scaffolds, and enzymes, using large-scale sequence–structure datasets for model training and validation. He has contributed to 100+ designed proteins and is an inventor on 8+ US patents (published, pending grant).

Dr. Gopalkrishna Lakkireddy is an accomplished biopharmaceutical leader with over 25 years of global experience across product development, CMC, technology transfer, manufacturing operations, quality systems, regulatory compliance, and commercialization of biologics. He currently serves as Senior Vice President & Head – Biologics at MSN Laboratories, where he is leading the establishment of end-to-end biologics capabilities including R&D, drug substance and drug product manufacturing, MSAT, quality, supply chain, and greenfield project execution.

Previously, during his long tenure at Dr. Reddy’s Laboratories, he held multiple senior leadership roles including Head – Technical Operations and Head – Quality, overseeing multi-plant biologics manufacturing, global regulatory inspections (USFDA, EMA, MHRA, PIC/S), and large-scale CMC programs. He has successfully led complex global technology transfers, commercial launches, and operational excellence initiatives delivering significant capacity expansion and business growth.

Dr. Lakkireddy holds a PhD in Biotechnology from the University of Westminster, UK, and is widely recognized for his expertise in biologics manufacturing, regulatory compliance, and building high-performance technical organizations.

Dr. Colina Dutta is a Senior Principal Scientist at Bharat Serums & Vaccines Limited (Mankind Group). With over 10 years of industry experience, she leads the functional characterization and cell biology group at BSV.

She is experienced in cell and molecular biology wherein she has worked on the development of multiple cellular assays of monoclonal antibodies that are both novel and biosimilars. She also has significant exposure in identifying targets from oncology pathway studies and determining proof of concept before project onboarding across multiple modalities.

Prof. Shubhini A. Saraf currently serves as the Director of the National Institute of Pharmaceutical Education and Research (NIPER), Raebareli. With 30 years of teaching and research experience and over 20 years of administrative experience, she has made significant contributions to the field. Her research interests include lipid nanoparticles, drug-targeting approaches, molecular pharmaceutics, and the regulation of cellular markers as indicators of health status, as well as technology policy interventions in healthcare, all of which have had a profound impact on the field.

Saranya Ganapathy heads the Cell Line Development function for Biosimilars at Ipca Laboratories Ltd., Mumbai, where she leads strategy and execution for developing commercially viable biologics. She holds a PhD in Molecular Biology from Texas Tech University, USA, and brings over 15 years of experience in molecular biology, mammalian/microbial clone engineering, and recombinant protein production.

Saranya has successfully delivered robust, high-yield production clones for more than 12 recombinant products, consistently meeting or exceeding industry benchmarks, and has led seamless technology transfer to manufacturing. Her expertise spans novel vector and platform development, cGMP cell banking, characterization, Bulk harvest testing, with a strong focus on de-risking and scalability.

She has also contributed to global regulatory submissions (EMEA, PMDA) and served as an SME during audits, engaging with agencies such as US Food and Drug Administration and MHRA. At this conference, she will share insights on building robust, de-risked clones for commercial manufacturing.

Dr. Nivedita Roy is a global regulatory science leader with over 20 years of experience in biologics and biosimilars development across major markets, including the FDA (US), EMA (EU), PMDA (Japan), Health Canada, and other international agencies. As Vice President and Global Head of Regulatory Science & Policy at Alvotech, she leads global regulatory strategy spanning CMC, clinical, non-clinical, labeling, and lifecycle management to enable worldwide approvals and commercialization of complex biologics.Dr. Roy has led more than 50 health authority interactions, including extensive engagements with the FDA and EMA, and has contributed to over 20 successful BLAs, MAAs, and JNDAs. She actively represents industry in international regulatory policy discussions, including contributions to ICH guidance development.

Dr. Dipankar Das is presently designated as a Senior Director and Head-Biologics at United States of Pharmacopeia, India. He leads development and maintenance of standards and tools to support quality of Biologics medicines and oversees the USP biologics laboratory in Hyderabad, India. Dipankar holds a Bachelor’s degree in Chemistry, Master’s and PhD in Biochemistry, Post-Doctoral research experience from University of Alberta, Canada, ranked 1st Class 1st in MSc, Certificate in Bioinformatics from CGDN Canada, Certificate in Supervisory Leadership from University of Alberta, Canada and CQI and IRCA certified ISO 9001:2015 lead auditor.Recently Dipankar inducted as an Affiliate Member, Royal Society of Chemistry, London. He is a skilled researcher with more than 27 years of hands-on experience in the research, product development and commercialization in the biopharmaceutical industries. Dipankar has more than 50 international publications in peer-reviewed journals (Nature, The Lancet, Mol. Pharmaceutics, etc) and 4 books chapters. 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.

Dr. Anand Jain is working as Vice President, Product and Portfolio Strategy (P&PS) with Novo Nordisk Global Business Services (GBS) based out of Bangalore, India.

Dr. Jain leads various global functions across the P&PS, like Global Medical Affairs, Strategic Marketing, Customer Insights, Access, Forecasting, across all the therapy areas and is working with the leadership teams in Denmark HQ cross-functionally.

He is also a member of the GBS management team.

He joined Novo Nordisk in 2008 and has worked in clinical, medical, regulatory, quality & pharmacovigilance functions across several Novo Nordisk affiliates, business areas, and regional offices.

He completed his medical degree and his doctoral degree from Pune University, Pune, and has industry experience of over 24 years.

He has experience in developing New Chemical Entities (NCEs) and New Biological Entities (NBEs), right from early phase clinical trials till post-registration approval studies. He has several publications, including oral presentations and posters in scientific international congresses, to his credit.

Dr. Raj K. Shirumalla currently serves as Mission Director of the National Biopharma Mission at the Biotechnology Industry Research Assistance Council (BIRAC), New Delhi. He brings over 29 years of experience as a scientist, academician, and administrator. Dr. Shirumalla has worked with leading Indian and Japanese pharmaceutical companies, including Daiichi Sankyo, with a focus on drug discovery research. He has contributed to or led teams in identification of eight clinical drug candidates, three of which advanced to Phase II clinical trials. His primary research areas include respiratory diseases and oncology, along with chronic inflammatory conditions such as rheumatoid arthritis, SLE, and multiple sclerosis. He has also worked on a collaboration project with GlaxoSmithKline (GSK) that led to the identification of a development candidate that progressed to Phase II trials for COPD. He has extensive expertise in translational research, including biomarker discovery and has worked on quantitative systems pharmacology (QSP) modelling for respiratory diseases. In addition, Dr. Shirumalla has significant experience in herbal research and previously led operations at an herbal-based company. He has published widely in peer-reviewed journals and holds 30 international patents.

Ajay Mahipal is the Co-Founder and General Partner at HealthKois, brings over two decades of experience in investment management, corporate finance, and healthcare transformation. Over the course of his career, he has worked across global organizations including EY, American Express, Pepsi, Patni Family Office, and Amazon–Patni JV, leading fund-raising, deal sourcing, execution, portfolio management, and exit strategies that have shaped some of India’s most innovative healthcare and consumer ventures. His leadership has consistently bridged strategic vision with operational excellence, making him one of the leading voices in healthcare investing in India.

Dr. Sanjay Tiwari, with about 3 decades of experience in biopharma industry, has worked in various capacities and on diverse subjects under the vast umbrella of biotechnology. An alumnus of IIT Delhi as well as IITM, Chennai, he has worked for some of the leading companies such as Cadila, Biocon, and Lupin. He has extensively worked on process and product development for biological products, scale up and technology transfer, manufacturing support, health agency interactions, product portfolio build up, capacity expansion, reduction in COGS. During his work experience, he has taken multiple products, such as enzymes, small molecules, recombinant proteins, mAbs, fusion proteins, etc. from scratch to the markets. He is currently heading and leading research efforts at Lupin Limited (Biotech Division), Pune.

Caitlin is the Manager of the High Peak Client Services Team. Caitlin holds a PhD in Gene Expression studies and has over 20 years experience working in pharmaceutical sales and has also spent 3 years managing breast cancer clinical trials. She joined Charles River in 2022, as a Senior Client Manager for the Retrogenix Platform. Recently Caitlin became the manager of the Team and is focussed on helping clients in their drug discovery pathway.

Vipul Saxena is a seasoned biopharma professional with over a decade of expertise in upstream cell culture media and process development. As Subject Matter Expert at Lonza Bioscience, he leads technical excellence and business strategy supporting media solutions for Protein Therapeutics, Vaccines, and Cell & Gene Therapy. Vipul brings end-to-end comprehension and proven expertise of upstream cell culture within CDMO and product based environments, serving as the key technical interface for clients, auditors and production teams. His experience spans process development, consistency, scale-up/scale-down, technology transfer, and biologics manufacturing. At Dr. Reddy’s Laboratories and Stelis Biopharma, he served as an R&D scientist, driving antibody, enzymes and vaccine based therapeutics development, contributing to scalable bioprocessing and regulatory success. He had transitioned R&D products to market, including regulatory approvals for human use. Outside of work, Vipul enjoys trekking, photography, traveling, and is an avid movie buff.

Dr Banerjee is currently serving as CEO and Director of LifeSenz Cancer Research Labs in Mumbai and is a translational cancer biologist with more than 20 years of experience across academia and industry, setting them up at various international and national levels. His work expertise includes therapy resistance and cancer stem cells, altered metabolism, immuno-oncology and tumour microenvironment. He has contributed to multiple peer-reviewed scientific publications, including senior author publications such as in Breast Cancer Research, PLOS One, Journal of Biological Chemistry, and Cancer Research, and has received accolades at various international scientific meetings. Dr. Banerjee is also an expert in advanced in vitro and ex vivo cell modelling-based platform development in the cancer therapeutics field. Moreover, he has extensive experience with scientific project management, academic tutoring, and international collaborations. Dr. Banerjee received his PhD in molecular medicine from the University of Auckland, New Zealand, and subsequently gained relevant work experience across various international locations, such as the UK, Singapore, New Zealand, and India.

I am a Senior Manager in Downstream Process Development at Alvotech, with over 15 years of experience in the development, scale-up, and commercialization of biopharmaceutical processes. My expertise lies in downstream process development for biosimilar monoclonal antibodies, where I lead programs from early-stage development through process characterization, scale-up, technology transfer, validation, and commercial manufacturing readiness.

I am passionate about designing robust, scalable, and cost-effective purification processes that consistently meet product quality, regulatory, and manufacturing requirements. Throughout my career, I have successfully addressed complex process and product quality challenges while driving process optimization and implementation strategies that improve efficiency and reliability. I thrive in collaborative, cross-functional environments and work closely with teams across upstream process development, downstream development, analytical sciences, manufacturing, quality, and regulatory functions. My goal is to bridge scientific innovation with practical manufacturing solutions, enabling the successful delivery of high-quality biosimilar medicines to patients worldwide.

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.

Mayank Singhal serves as the Senior Business Manager (India, SEA, ANZ, and LATAM) at FUJIFILM Biosciences, where he designs high-growth commercial frameworks and cross-functional go-to-market strategies aligned with global bioprocessing demands. Over an 11-year career spanning industry majors, Mayank has managed multi-million-dollar portfolios, optimizing local sales execution and bridging supply chain bottlenecks for advanced single-use and bioproduction technologies. His expertise in portfolio positioning and strategic account integration directly addresses critical challenges in commercial scale-up and market penetration. Mayank holds an MBA from IIM Kozhikode and a B.Tech in Biotechnology from VIT University.