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.

Maloy Ghosh is the CSO and Founder member of Zumutor Biologics. He has designed and directed scientific, research, and technological operations to achieve overall R&D missions of Zumutor. His goal is to build a resilient scientific team at Zumutor, implementation of translational research and empower them to achieve height of their career. Visionary, seasoned, and dynamic professional, offering indepth scientific, regulatory, and clinical knowledge of developing biologic therapies in the field of Immunooncology. He is focused on driving corporate growth and innovation by translating goals/objectives into actionable of developing novel Immuno-oncology biotherapeutic pipeline. Gained reputation as a self-starting leader who consistently drive innovation, implementing collaborations and overall elevation of team performance. With big-picture vision of products and technology, he has efficiently carried out transfer; management of CRO/CMO with keen attention to detail. Worked to build and expand company valuation which led to multiple rounds of venture capital funding, $28M USD till date. Strategic decision making and implementation of business ideas for high company valuation, product and platform out-licensing and eventual M&A by strategic partners. His work led to initiation of Phase 1 clinical trial of a novel immuno-oncology biologic (mAb) product, a first-in-class drug from India. The drug aims to treat various advanced/metastatic cancers where patients have no therapeutic alternative.

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.

Dr. Rakesh Mishra earned his PhD from the University of Allahabad, India, in 1986. He pursued post-doctoral research at esteemed institutions including the Indian Institute of Science, the University of Bordeaux in France, Saint Louis University in the USA, and the University of Geneva in Switzerland. Subsequently, he joined the Centre for Cellular and Molecular Biology (CCMB) in Hyderabad, India, where he ascended to the position of Director in 2016.

Currently, Dr. Mishra serves as the Director of the Tata Institute for Genetics and Society in Bengaluru. He is deeply committed to science communication, endeavouring to bridge the gap between intricate scientific concepts and the broader public. Through a variety of channels including outreach programs, workshops, public lectures, and media engagements, he aims to inspire the next generation of scientists and instil a deeper appreciation for genetics and molecular biology. Additionally, he holds the distinguished positions of Distinguished Emeritus Professor at the Academy of Scientific and Innovative Research (AcSIR) and J.C. Bose National Fellow at CCMB, Hyderabad.

Under his leadership, the Atal Incubation Centre was established at CCMB, providing essential infrastructure and mentorship to life science entrepreneurs, fostering innovation. Notably, CCMB has played a pivotal role in genomic surveillance of the SARS-CoV-2 virus in India during the COVID-19 pandemic, making significant contributions to diagnostics, drug screening, environmental surveillance, and capacity building efforts against the outbreak.

Dr. Mishra's research interests encompass diverse areas, including comparative genomics of non-coding DNA in the context of evolutionary complexity, the genetic basis of anterior-posterior body axis formation in animals, and the role of epigenetic regulation in development. He also maintains a keen interest in environmental and genomic surveillance of infectious diseases, utilizing cutting-edge science and technology to address societal challenges.

With a portfolio of over 200 publications and several patents, Dr. Mishra is a recognized authority in his field. He serves as an expert member on several committees for eminent institutions and has been elected as a Fellow of the Indian National Academy of Sciences, the Indian Academy of Sciences, the National Academy of Sciences, as well as the AP Academy of Sciences and the Telangana Academy of Sciences.

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.

Sandeep is highly experienced in various facets of Biosimilars and Vaccines manufacturing, projects and development.

With about 30 years of experience in this field has acquired knowledge in all these facets.

He is very passionate about automation and new technologies catering to biopharma manufacturing.

Will be extremely enthused to participate in exchanging knowledge from the industry stalwarts and peers.

He profusely thanks Informa group for providing this plat form.

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.

A Senior pharmaceutical professional, Clinical pharmacologist and physician, with > 25 years’ experience in pharmaceutical and healthcare industries.Currently, at Hetero group of Pharmaceuticals (2011 onwards). Senior Vice - President Head - Global operations of clinical trials, Pharmacovigilance, medical writing, medico-regulatory & medical affairs (Discovery, Biologics, Generics) & Head of Product ideation and Development (Generics). Earlier worked in leading organizations (since 1997) including Dr. Reddy’s Laboratories, Vimta Labs,, Indigene Alquest LLC, , Accenture , Glenmark,, Organon, Khandelwal Laboratories and TN Med.College&BYLl Nair Hospital. Clinical Development Experience- DISCOVERY, BIOLOGICALS AND Generics-

Led global clinical development of

1. New Chemical Entities (HIV {Hetero}), ONCOLOGY {Dr.Reddy’s& Hetero}), .

2. Biological/biosimilars (Rituximab, Bevacizumab, Adalimumab, Trastuzumab, Trastuzumab Emtansine, Tocilizumab, Tenecteplase, Erythropoietin analogues (Darbepoetin alfa & Erythropoietin), Sputnik vaccine, Insulins.

3. Multiple branded generics- multiple therapeutic areas including COVID-19 drugs (Molnupiravir, Remdesivir, Paxlovid generic), Hepatitis- C(Sofosbuvir & combinations), Cardiology, Diabetology, oncology, gastroenterology, urology, haematology, orthopedics& rheumatology products.

Academic

a. Adjunct Professor (Pharmacology ) at Kasturba Medical College (KMC), Manipal and .

b. Adjunct Professor (Pharmacology & Clinical harmacology) at Indira Gandhi Institute of Medical Sciences ( IGIMS), Patna.

PUBLICATIONS - 36 publications (all original articles) in peer reviewed journals

2 books (AI in healthcare & Taste of Pharmacology )& 1 book chapter (Antihypertensives in Textbook of Pharmacology).

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.

Dr. Samir Kulkarni is a recognized leader in the area of Biopharmaceutical development. He holds a versatile qualification background in complementing faculties of pharmaceutical sciences, bioprocessing, chemical engineering, and business management. His total experience extends over two decades in the area of biological sciences, with tenures in reputed research institutions such as OakRidge National Laboratory and University of Cincinnati in the United States and in leading biologics organizations such as Intas Pharmaceuticals, Dr Reddy's Laboratories and USV Limited etc.

With core expertise in process development and molecular characterization of Biologics, he has successfully diversified into strategic planning for biosimilars product development and have successfully driven integration between different functions such as R&D, manufacturing, regulatory and clinical development to achieve commercial and strategic objectives.

He has held the offices of the Director for Innovation and Research and the Director of the National Center for Nanoscience and Nanotechnology with the University of Mumbai and is presently working as the 'Tata Chemicals Darbari Sheth Distinguished Professor' at the Institute of Chemical Technology Mumbai and is heading the Department of Biological Sciences and Biotechnology. He is also actively involved with the Biopharma industry as a consultant and service provider in Biologics process and analytical development for different Biopharmaceutical organizations in India and Overseas.

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.

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 Univerity 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.

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.

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 held senior leadership positions in the biologics divisions of Wockhardt, Intas Pharmaceuticals and Syngene.

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.

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).

Dr. Chen is the Managing Director of Bio-Link Biotech Co., Limited (Hong Kong). He had previously worked at startup CDMO and cell culture media companies, where he held responsibilities in business development, commercial operation, and M&A. Before that, Dr. Chen worked at Sartorius with a regional business responsibility for downstream bioprocessing technologies in Asia-Pacific area. He had successfully introduced Sartorius’ new technologies into key biopharmaceutical players across Asia-Pacific region and established localization production strategies in Asia. Dr. Chen also worked as Lead Scientist earlier at A-Bio Pharma Singapore, Asia's pioneering CMO. He has led and participated in several biosimilar projects, with responsibilities of bioprocess development, process scale-up, pilot-scale production campaigns, and technology transfer.

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.