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.

Dr. Kapil Maithal is currently working as President – Vaccines and Diagnostics at Zydus Lifesciences, India. He has over two decades of experience in the field of Vaccines, Biologicals and Diagnostics Research, Development and Manufacturing. He did his doctorate in biochemistry from University of Delhi, followed by post-doctoral research in structural biology from Indian Institute of Sciences, Bangalore. Subsequently, he joined as a faculty at University of Delhi in Biomedical research before moving to industry, where over the years he has led the development of numerous viral, bacterial, toxoid, polysaccharide, conjugate and protein subunit vaccines for human and veterinary use. Recently, he also led the research & development of World’s First Licensed human DNA Vaccine, ZyCoV-D® against COVID-19. He also has interest in global public health and has served as a member in Independent Review Committee of GAVI Alliance, Geneva and number of committees of Developing Countries Vaccine Manufacturers Network (DCVMN), Geneva. He has also been on the recruitment panel of NISCAIR, CSIR; Gujarat Biotechnology University and advisory board for BIRAC-GMP Project of CSIR-IMTECH and School of Biotechnology, Jawaharlal Nehru University, Delhi. He has number of patents and international publications in peer reviewed journals to his credit and is also a reviewer to number of peer reviewed journals including Vaccine, NPJ Vaccines, International Journal of Medicine and Medical sciences, PLOS ONE etc.

Senior biotech executive with expertise in viral vaccines with over 30yrs experience in vaccine development. Currently at PATH, leading and managing projects for viral vaccines and biologics for product development strategies and compliance with GMP and/or GLP practices as applicable for national and international regulatory framework compliance (WHO, FDA, EMA, DCGI, NMPA). Experience in national regulatory approvals and for achieving WHO pre-qualification for vaccine products. Currently leading projects for polio vaccines development and scaleup for OPV, IPV related hexavalent vaccine work. Current and past projects at PATH includes work related to measles-rubella, influenza, RSV, Yellow fever, live rotavirus, and SARS-CoV2 with technologies including whole virion, inactivated, vectored, live attenuated, VLPs and subunit vaccines. Holds national and international patents on VLP technology for influenza and RSV vaccines and include publications in peer-reviewed journals. Presently serves on several scientific panels advisory board for biotech companies in Europe, for national and international vaccine meetings, also serves as scientific reviewer for journals including Vaccine, Journal of Infectious Diseases, Emerging Infectious Diseases, and Human Vaccines & Therapeutics.

Dr. Nimesh Gupta, a distinguished viral immunologist, is at the forefront of ground breaking research in translational immunology, with a remarkable career spanning over 20 years. He earned his doctoral degree from Jiwaji University, focusing on unravelling host-pathogen interactions for flaviviruses such as Dengue and Japanese encephalitis virus. Driven by an insatiable thirst for knowledge, he pursued postdoctoral training in immunology at the prestigious Institute Pasteur and University Pierre and Maire Curie in Paris, France. As the head of the Vaccine Immunology Laboratory at India's esteemed National Institute of Immunology, Dr. Nimesh envisions a future where long-lasting protective immunity is understood at its core, providing the foundation for designing effective human vaccines. His seminal work has left an indelible mark on the field, profoundly shaping the current mechanistic framework and understanding of T-cell immunity to virus vaccines. Dr. Nimesh's impactful research (40+ publications) has been prominently featured in esteemed journals including Science Translational Medicine, Nature Microbiology, Lancet Infectious Diseases etc. His contributions have resulted in several patents on T-cell-based bioassays and the application of T cells in vaccine development.

Dr. Raj Shankar Ghosh is a physician with three decades of experience in policy, planning and delivery of public health programs. His primary interests are in primary health care, infectious diseases and vaccine delivery. Dr. Ghosh has worked in West Bengal State Health Services as a Medical Officer in a Primary Health Centre, as a Regional Coordinator in the National Polio Surveillance Project of World Health Organization and as Director, Immunization for South Asian Region at PATH India office. His most recent assignment was as Senior Advisor, Immunization at the India office of Bill & Melinda Gates Foundation. Dr. Ghosh currently provides technical support to national and international organizations on One Health, Disease Surveillance and Immunization. Dr Ghosh is a recipient of honorary Fellowship form Indian Public Health Association for his contribution to public health in the South Asian region.

Dr. Rajinder as CEO-DCVMN International is responsible for leadership, governance, strategic vision and overall operational excellence of DCVMN. Rajinder is appointed as member GAVI’s Vaccine Investment Strategy (VIS) Steering Committee 2024, a permanent member of CEPI’s Joint Coordination Group (JCG), 2023-24, PAVMs Talent Development WS and Regional Vaccine Manufacturing Collaborative (RVMC). To meet an un-precedented challenge posed by COVID-19, Rajinder has been actively involved in all global strategic initiatives along with COVAX partners-WHO, GAVI, CEPI, UNICEF and several other international organizations including industry associations to ensure equitable and timely access to vaccines. He has been member of several advisory expert groups including COVAX Manufacturing & Supply Chain Task Force Leadership Team, G-20 Health group and Market Design and Demand Intelligence pillar of PAVM. Rajinder has over 25 years of top management experience in the industry including at the Board of Directors of the Indian subsidiary of Sanofi Pasteur and as CEO-Panacea Biotec. Rajinder has served as Member-GAVI-PPC as well as Vice-President, DCVMN Executive Committee.

Vice President, CanSino Biologics

Professor Nikolai Petrovsky is a physician and vaccine researcher. He is the founder of Vaxine, an Australian biotechnology company applying novel approaches including artificial intelligence to vaccine and adjuvant development. His research has been awarded multi-million dollar contracts from the US National Institutes of Health and he has authored over 200 peer-reviewed research papers. He developed SpikoGen®, a vaccine against COVID-19 that received emergency use authorization in the Middle East in October 2021, making it the first recombinant protein vaccine against COVID-19 to achieve regulatory approval.

I have been working in the past 15 years in both academia and industry, in various areas including biosensors for live-cell analysis, cell bio-mechanics, and in-vitro diagnostics for cancer and other diseases. Five years ago, I joined Ajinomoto Genexine as Chief Scientist and head of the Customer Solution Center in South Korea. Our company develops and manufactures cell culture media for CHO and HEK cell lines, for our Biopharma customers across Asia, as well as in Europe and the US. We also provide dedicated support to our customers, and offer media customization and process optimization, enabling our customers to get the most out of their pipelines.

Dr. Sunit was trained as Developmental/Cardiovascular Biologists in Leuven, Belgium where he received his PhD. He worked in industry (Mermaid Pharmaceuticals, Hamburg Germany) for three years where he was involved in target identification using model system. He has spent time at Max Planck Institute, Germany where he was involved in the CNS development related project. After coming back to India in 2007, he joined Avesthagen where he headed the biosimilar group at the end. He was responsible for development of biologics including recombinant protein and monoclonal antibodies using mammalian expression system. Thereafter, he was associated with Zumutor Biologics since its inception and worked as Director of Product Development team. His team’s role at Zumutor was focused on developing process and scale-up for novel monoclonal antibody drug in the ImmuneOncology segment. Currently, he is working as Sr General Manager, Biopharmaceutical development at Syngene.

Vice President and Site Quality Head

Lupin Ltd., Biotech Div., Pune, India

Result oriented career spanning over three decades in Quality Assurance / GMP / Quality Control and 2 years in academic with focus on streamlining & managing operations with proactive planning, building quality culture. Introducing new concepts for Top-notch companies with consistent contribution to increased performance. He believes in success through faster decisions by considering techno-commercial risk factors.

SYNOPSIS:

He completed Ph.D. in Applied Chemistry from M.S. University, Baroda, M. Sc. in Organic Chemistry from Poona University and M. Ed. from Uttar Maharashtra Vidyapeeth, Jalgaon. He proved his domain expertise in Quality and GMP department at various renowned organizations. Currently, heading Quality Unit of Lupin Ltd. (Biotech Division), Pune. Prior to Lupin, he associated with organizations like Intas, Dishman, Cadila, Glenmark, Sun, Aarti and Govt. Polytechnic College. Major areas of expertise in Quality system, GMP activities, SAP-ERP system, Designing of quality system according to various country specific regulatory guidelines e.g. USFDA, EMA, GCC, MCC,ANVISA, MHRA, Schedule M and TGA etc.

He handled successfully more than 200 different types of inspection e.g. Regulatory, Customer, Business partners, various organization and inspected more than 200 inspection at various pharma industry / laboratory. He delivered talk on technical and GMP topics in various workshops and conferences.

Always providing strategic direction. Ability to get the best out of existing teams to win desired operational and strategic results. An excellent communicator coupled with exceptional interpersonal, managerial and documentation skills.

Dr. Pradeep Nagalkar is Former Head, Quality Control at Haffkine Bio-Pharmaceutical Corp. Ltd. since last 19 years. He is responsible for all Quality Control (Chemical and Biological) related to various Vaccines and Antiseras, Pharmaceutical products like tablets, oral liquids.

Dr. Pradeep Nagalkar has over 34 years’ experience in the biotechnology industry, 22 years of his experience is in vaccine industry.

He has completed his post-graduation from Seth G. S. Medical College & K.E.M. Hospital, Parel, Mumbai.He is Ph.D. in Microbiology from University department of Chemical Technology (UDCT), Mumbai. He has Extensive knowledge of Protein purification and Biological testing. He has worked previously with National Plasma Fractionation Centre, Parel, Mumbai and Biological E., Hyderabad.

Dr. Pradeep Nagalkar is also deputed for various workshops and attended many conferences, symposiums and delivered many lecturers in national and international conferences, written scientific articles and received many awards

Awards

Excellence in Biopharma Leadership Year 2022Excellence in Biopharma Leadership Year 2022

Issued by Blue Tech Media • Sep 2022

ICONIC LEADERSHIP AWARD - PHARMACEUTICAL"ICONIC LEADERSHIP AWARD - PHARMACEUTICAL

Issued by DYNERGIC Business Solutions- GOLDEN AIM AWARD • Sep 2022.

Quality Leadership Award at 8th Edition of World Quality CongressQuality Leadership Award at 8th Edition of World Quality Congress

Issued by World Quality Congress & Awards • Jul 2022

Most Talented QUALITY LEADERS (GLOBAL) at 9th Edition for Excellence in Quality Management & Leadership

Issued by World Quality Congress & Awards • Aug. 2023

E-Mail: nagalkarp@yahoo.co.in

Contact No. : +91 98203 89069

Senior Director, Global Patient Solutions, Gilead Sciences

Over 25 years’ Experience with Regional & Country leadership roles across South & Southeast Asia

Passionate about unlocking value in Healthcare Ecosystem through establishing holistic value assessment and creating innovative solutions across patient journey. Developing new patient solutions, leveraging technology to improve/create new business models, creating Innovative partnerships with stakeholders across healthcare spectrum!

Senior Principal Investigator, Biopharmaceuticals Development, Syngene International Limited. Bangalore, India.

Dr. Sabyasachi Halder, Ph.D is a biopharmaceutical Professionalandhas been working as Senior Principal Investigator in Syngene International Limited, Bangalore, India. He has Passed B.Sc and M.Sc in Chemistry from Calcutta University and did Ph.D from Bose Institute, Kolkata India on Protein Structure-function. He continued his Post-doctoral Research in United States of America (University of Pennsylvania Medical School, Michigan State University etc.) in the same area. He has been working as Analytical Lead in Biologics Development Industry(Pfizer Biologics Development Centre, Chennai and Stelis Biopharmaceuticals, Bangalore, India) since 2015 and majorly contributedinAnalytical Methodologies in CMC of Biologics Development. He has presented and published in internationalPeer reviewed Journals in the area of Protein Chemistry and Analytical Sciences.

E-Mail: Sabyasachi.halder@syngeneintl.com

Contact No. : +91 98868 27852

A senior clinical pharmacologist with over 23 years of experience in setting up, expanding and managing global operations in clinical trials, pharmacovigilance, medico-regulatory & medical affairs in pharmaceuticals and CROs, Dr.Shubhadeep Sinha, Sr. VP & Global Head - Clinical Developments & Medical Affairs, Hetero Group, managed end-to-end clinical development of multiple biosimilars including Darbepoetin, Rituximab, Bevacizumab, Adalimumab, Trastuzumab, Tenecteplase and during Pandemic, antivirals Remedesivir, Molnupiravir and Sputnik vaccine against SARS-CoV-2 and a few others at Hetero including domestic and international development & registration. In addition to book chapters on pharmacology and a book, he has produced more than 30 original articles in scholarly journals across the globe and has been an invited speaker in 100+ national and international conferences.Dr Sinha received the prestigious FRSPH degree in 2023, PhD in public health in 2022, Fellowship in General Practise from the IMA in 2019, and the Fellowship in Diabetes from the Royal Liverpool Academy & Apollo, Medvarsity in 2016.

Business Lead, Pfizer India

A seasoned professional with 23 years’ experience in achieving top line, bottom line and business growth objectives within start-up, turnaround and rapid-change environments in the Pharmaceutical Industry. Conceptualized and launched the FirstNational Cervical Cancer Registry (surveillance program) with FOGSI (Federation of Obstetric and Gynecological Societies of India) involving ~500 HCPs under the project Reaching the Unreached to establish Cervical Cancer Burden in India. Launched GARDproject with FOGSI & Onco-Gyn society (Guard Against HPV through Regular screening, vaccination &Discussion) to impact KAP (Knowledge, Attitude and Practice) change among ~800 Obstetric and Gynaecologists. Partnered with FOGSI adolescent chapter for school education program on Cervical Cancer Prevention; "Protecting Young Girls." Partnered with Public – Private partnership for Influenza prevention advocacy "Influenza Foundation of India. Collaborated with National Flu Surveillance Network (WHO) and network of sentinel doctors to establish robust epidemiology data which helped in building strong recommendation for Influenza Vaccines in India. Presented as speaker in several institutes and forums like Goa Institute of Management, World Vaccine Congress etc).

Dr. Ajay Singh accomplished his doctorate in biochemistry from South Campus Delhi University, New Delhi, India. Dr. Singh is a proficient molecular biologist and biochemist with a core specialization in mRNA technology, cell/gene therapy, and antibody engineering. Dr. Singh has been part of Gennova since 2013 and has widened his horizon by working on various domains. His heart of research at Gennova is mRNA vaccines, cell therapy, gene therapy, biotherapeutics, and antibody discovery. Dr. Singh is known for his notable contribution to the area of mRNA vaccine design, development, and production by creating keener genetic designs, and versatile and robust mRNA production process. From the first moments of the COVID-19 pandemic, he is working diligently for the development of the first fully indigenous mRNA vaccine in India - GEMCOVAC®-19 followed by an Omicron-specific heterologous booster - GEMCOVAC®-OM. Currently, he is establishing the proof of concept of editing human genes to cure various genetic disorders. He is also developing mRNA-based personalized cancer vaccines targeting neo-antigens and mRNA-based CAR-T therapy for the treatment of refractory and relapsed cancer. Dr. Singh has played a significant role in laying the foundation pillar for the mRNA vaccine platform in the country and is working optimistically and diligently for serving mankind in the future.

David Chau is a Global Bioprocess Application Specialist in 3M’s Separation and Purification Sciences Division. He has over fifteen years of experience in the biotechnology industry. Currently, he is responsible for developing product application strategies and driving collaborations with key industry leaders. He manages technology projects, collaborations, and alliances around the globe. David is an active member of multiple biotechnology chapters and associations including serving as the chair for the Bio-Process Systems Alliance Continuous Processing Committee. He earned his Ph.D at the University of Minnesota in Twin Cities under Professor Wei-Shou Hu and his B.S at the University of Texas.

David Chau is a Global Bioprocess Application Specialist in 3M’s Separation and Purification Sciences Division. He has over fifteen years of experience in the biotechnology industry. Currently, he is responsible for developing product application strategies and driving collaborations with key industry leaders. He manages technology projects, collaborations, and alliances around the globe. David is an active member of multiple biotechnology chapters and associations including serving as the chair for the Bio-Process Systems Alliance Continuous Processing Committee. He earned his Ph.D at the University of Minnesota in Twin Cities under Professor Wei-Shou Hu and his B.S at the University of Texas.

Director Medical Affairs, Vaccines & Digital, Pfizer Limited

Chair, Real-World Evidence Council, Indian Society for Clinical Research (ISCR)

Qualification

Key Experiences

Key Achievements

Dr. Phillip Nguyen is a physician and policy staffer at the US FDA’s India Office, having previously worked on FDA’s biomedical research monitoring program. Before FDA, Dr. Nguyen’s experience spanned working in the nonprofit sector on regulatory systems strengthening, supply chains, and pharmaceutical quality standards with multilateral organizations. A former Assistant Professor of the Georgetown University School of Medicine, Dr. Nguyen holds a medical doctorate from Tufts University, and a bachelor’s in Molecular & Cell Biology, cum laude, from Harvard University.

Rajni [An IIT Kanpur Scholar] , Ex Vice President Regulatory Affairs ,is a Senior Pharmaceutical Regulatory, Quality & Compliance professional with 30 plus years of Pharmaceutical industry experience across different Departments - with leading Indian pharmaceutical organizations in various Leadership roles in multi-disciplinary cross functions –as- Ranbaxy Research Laboratories, Morepen, Torrent Pharmaceuticals, Glenmark Pharma, Unimark Remedies, Nicholas Piramal ,Indswift Laboratories & Naari Pharma .

Her diverse areas of experience & expertise lie in API Research including Technology transfer/ Scale –up activities- using the Quality by design approach , International Regulatory Affairs, Compliance, Corporate Quality Assurance alongwith leading & successfully sailing through several global Regulatory and Customer Audits / Inspections.

Country Medical Director, Bayer Pharmaceuticals, India

Dr. Ashish Gawdeis working asCountry Medical Director at Bayer Indiasince 2012 and is responsible for the overall functioning of Medical Affairs, medical governance and Phase IV clinical trials. He is a board member for Bayer Foundation India (Bayer CSR). He also plays a key role in supportingthe Managing Director (CDH) in Public affairs and health policy related matters. He is part of the Bayer Leadership Team in India and Asia Pacific and is also an active member of Organization of Pharmaceutical Producers of India (OPPI) and Indian Society for Clinical Research (ISCR).

He comes with vast experience in the pharmaceutical and clinical research industry, joining BayerIndia as Senior Manager- Clinical Research, heading clinical operations for Bayer Schering Pharma in India. He soon took on the role of Local Head of Monitoring and Site Management- Asia Pacific (India, Taiwan, Philippines and Indonesia) and was also the acting local Head for China and Hong Kong for 6 months prior to his current role. Ashish has completed his MBBS and MD (Pharmacology) from Mumbai.

Director and Head – Clinical Study Unit, India and Southeast Asia, Sanofi R & D – Clinical Sciences and Operations

Dr. Vaibhav Salvi is a physician by training with specialization in Cardio-vascular science.

He has around two decades’ experience in Clinical Research and Medical Affairs.

His research work has been presented at national conferences (Cardiological society of India, Indian Society of Medical Statistics, The Chennai Paediatric Electrophysiology Symposium) and international conferences (Drug Information Association, Statisticians in Pharmaceutical Industry, International Congress on Electrocardiology).

He has more than a dozen publications to his credit published in journals like British Journal of Pharmacology, Journal of Pharmacology, Diabetes Medicine, Journal of Electrocardiology and Diabetes Care to name a few.

He is life member of Indian Society of Clinical Research and TransCelerate Inc.

Dr. Tathagata Dutta has earned his B.Pharm.,M.Pharm and PhD in Pharmaceutical Sciences from Dr. Hari Singh Gour University, Sagar and completed his postdoctoral studies from School of Pharmacy & Diamantina Institute for cancer, Immunology and Metabolic Medicine, University of Queensland, Brisbane, Australia and was engaged in development of RNAi therapeutics for effective management of cancer. He is an alumni of IIM Calcutta. He has served as President, Chief Scientific Officer (CSO), Vice President (R&D), Executive Director, and Managing Director & CEO of several reputed Multinational Pharmaceutical Companies across the globe for more than two decades. He has been conferred with several National and International Awards and Honors. He has published several international papers in reputed international journals, several patents and had authored several book chapters. He is the editorial board member of several international journals on drug discovery &delivery research. His research interests include 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 development of RNAi therapeutics.

E-Mail: duttatathababu@gmail.com

Contact No. : +91 96186 21283

Dr. Hima Challa is Founder Director of GenepoweRx and Pioneer in delivering Personalized Medicine. Dr Hima is CoInvestigator for Large scale Pharmacogenomics study from India.Dr. Hima is member of CPIC, PGRN, ClinVar and Clin Gen.Dr. Hima ABIM certified Internal Medicine Physician, Academician, previously Program Director for Residency Program at Cape Fear Valley Hospital NC before venturing into startup journey with vision of delivering personalized medicine to every Individual.Dr. Hima's passion in the field of Pharmacogenomics lead to start a study on 3000 individuals taking more than 4 prescription medications, measuring long term outcomes with mean followup of 2 years.Comparing the MAF of haplotypes between different ethnicities and making a comprehensive database.

Dr. Hima leads R&D team at GenepoweRx, which includes developing in silico predictions, protein structuring and works with Pharma sector in bringing innovation to develop new therapies.

Dr. Rajesh Kolli, Heads the Cell and Gene Therapy R and D at Reliance Life Sciences pvt ltd.

PHD in infection biology form Hannover Medical School, Germany and Post Doc from University of Wisconsin, Milwaukee, USA.

PHD and Post doc work is on Virology , antiviral drug discovery. Managed projects of small molecule drug discovery and biosimilar. Experienced in design, development and translation of cell and gene therapy products for haemophilia, metabolic, eye , neuromuscular disorders and cancers.

Dr. Sindhura B R, Manager- Sales and Applications at NanoTemper Technologies India with eight years of industry experience in various roles including associate scientist, application scientist and manager. I enjoy using my skills to contribute for bringing cutting edge solutions to help scientists to tackle their research challenges. I received my PhD in Biochemistry from Karnataka University Dharwad, worked on studies on Remusatia vivipara lectin and its application in medicine. Recently, I pursued MBA in Marketing to enhance my management & leadership skills.

Dr. Ratnesh Jain is currently an Associate Professor at the Department of Biological Sciences and Biotechnology, Institute of Chemical Technology (ICT), Mumbai. He is currently heading the Bioprocess Technology course of ICT, which is inclined towards industry applicability. Dr. Jain’s research group extensively works towards developing analytical methods for protein and peptide characterization, mammalian cell culture, media, and upstream process development. He has over 100 research publications, reviews, and book chapters. His group has presented more than 350 abstracts in various leading conferences and workshops. Dr. Jain also leads one of India's largest learning and skill development platforms “Biologics Workshop”, formerly known as Biosimilar Workshop. Additionally, he is a leading consultant to the biopharmaceutical industry specifically to characterize protein aggregation and is currently supporting and providing services towards biopharmaceutical product development at the R&D stage as well as regulatory approval. Dr. Jain is also mentoring and advising multiple start-ups in the domain and encouraging entrepreneurship amongst students and professionals under the Govt. promoted Innovation Ambassador program.

Vipul Jain has overall 27 years of work experience in FMCG & Pharma Sectors. Vipul Is from Engineering background & MBA from IIM Indore. Vipul also possesses multiple Supply Chain & Digital Technologies certifications. He worked with Multinationals like Colgate Palmolive, Mondelez, Cipla prior to Joining Intas Pharma. His experience & expertise are in designing efficient & effective supply chains using advanced technology.

He is expert in ERP implementations like SAP, Integrated Planning platforms (IBP), warehousing & Transportation solutions and Manufacturing execution systems.

EDUCATIONAL QUALIFICATIONS:

Premnath Shenoy is a senior quality and compliance consultant and has over 30 years of industry experience in leadership roles in the area ofPharmaceutical research, Regulatory Affairs and Quality Assurance, working for small, mid-sized, and large pharmaceutical organizations. Dr Shenoy has extensive experience in Drug Product and Drug substance manufacturing, non-sterile and sterile product production, laboratory management, and performing compliance audits. He is an experienced trainer and has developed and implemented customized developmental and remedial programs.

His lastindustry assignment was with AstraZeneca as Director QA,RA and Patient Safety. Dr Shenoy has published over 30 Research papers,over 100 technical articles and delivered lectures at industry meetings in India and abroad (Singapore, Hamburg, London, Zurich etc.,) on topics such as GMP, Risk Assessment, Quality Management Systemand Regulatory Affairs. He has published five books “Handbook of Pharmaceutical Quality Assurance” “Herbs N Health” Indian Pharmaceutical Regulations, Invest Early N Enjoy Fully and Dream, Strategize, Accomplish.

He was bestowed with IPA/IPC/EDQM recognition for the contribution made in the area of “Quality Assurance” in Pharmaceutical Industry, Indian Drug Manufacturers Association’s “Outstanding Pharmaceutical Analyst” Award and “IPA Fellowship”.

He is serving as President Indian Pharmaceutical Association Karnataka branch (2018-2024) and as Senior associate with Lachman Consultants NY USA.

Hari Prasad Raju P is currently working as General Manager – Process Development, Vaccines at Zydus Lifesciences Limited.

He has over 20 years of experience in the field of vaccine R&D and manufacturing.

He did his Masters in Microbiology from Andhra University. He worked in various vaccine organizations and led teams in process development & commercial production for both domestic and global markets.

He specializes in Process Development, Technology Transfers, Risk assessment and Mitigation at R&D and in commercial manufacturing.

Dr. Stamm holds a doctoral degree in molecular parasitology and a master degree in drug regulatory affairs from the University of Bonn, Germany.

He joined Charles River in 2003 and became responsible for the business development activities in Europe and Asia.

Prior to joining Charles River he worked for Eurofins Scientific running their microbiological GMP testing laboratories in Switzerland.

While being for many years the global subject matter specialist for impurity testing, most recently Dr. Stamm has focused his work on analytical/regulatory consulting for Charles River Biologics Services in Asia and Europe.

Manish has been associated with Thermo Fisher Scientific India for past 12 years, currently executing the role of business leader for their Life Science and Laboratory Product Group and was their Chief Financial Officer prior to this. As an instinctive leader, he reaps personal fulfilment by helping other tap into their inner – excellence, aligning their personal growth with the company’s short term and long-range business goals. His strong business skills led to the business growth amidst COVID living to the purpose and vision of the company making the world healthier, cleaner and safer. Manish was recognized as - CFO emerged as a successful Business Leader by CMO Asia in Fy’21 and was in CFO power list issued by Google and ET Now.

Manish Singh earned his post-graduate degree in Biotechnology from Garhwal University in Dehradun. He earned an MBA in Pharma Business Management from ICFAI University in Hyderabad. Manish has over 15 years of industry experience in Biopharmaceutical R&D with companies such as Intas, Dr. Reddys, Kemwell Biopharma, and Thermo Fisher Scientific. In his present capacity as Senior Application Manager at Bio-Techne, he is responsible for APAC region customer support of innovative techniques and technologies for protein analysis and characterization, as well as their application in R&D and bioprocess.