Kamala Rai

Vice-President Sr Global Program Head - Global Health Development Unit, Novartis India

Currently, Kamala serves Novartis as Global Program Head, where she leads a multi-disciplinary team of experts based at various development centers within Novartis, with overall responsibilities for Pain, Neuroscience and Ophthalmology Portfolio within the Global Health Development Unit of Global Drug Development

She is a member of Leadership Team and Integrated Scientific Review Committee for Global Health Development Unit in Novartis

Subsequent to her training as a physician she specialized in Pharmacology from the prestigious All India Institute of Medical Sciences, New Delhi,
Over the past 18 years, she has developed and launched many compounds across various therapeutic areas. She has until recently, served as a member of the editorial team at the Journal of Applied Clinical Trials, Clinical Research and Regulatory Affairs.

She also successfully led clinical development and medical teams in Southern African Group of Countries as Chief Scientific Officer

For strengthening the clinical research footprint, she received the Asia, Middle-east and African countries Productivity Award.
In 2007 she received recognition as a “AIIMSONIAN AMBASSADOR AWARD” for her contributions to the pharma industry conferred by, AIIMS, New Delhi

She also served as the Diversity and Inclusion Champion for Novartis India and received the Global HR Board Award for Life Work Integration initiatives in 2012.

Recently, she was awarded the DST-FICCI Women in R&D Award of Excellence at the Global R&D Summit

She is passionate about the subject of ‘inside-out -Leadership’ to ‘reimagine medicine’

Mohua Chakraborty Choudhury

Rare Disease Policy Researcher, DST STI Policy Fellow, Member WHO CGN4RD

Dr. Mohua Chakraborty Choudhury is a Health Policy Researcher at the DST Center for Policy Research Indian Institute of Science (IISc), Bengaluru and Honorary Associate at Institute of Public Health Bengaluru.

Her Ph.D is in Molecular Biology and Bioinformatics

Her research interest is in the field of Rare diseases with focus on understanding the Rare disease ecosystem of the country and identifying policy and public health interventions to strengthen the ecosystem.

She is a working member of the WHO Collaborative Global Network For Rare Diseases which is enabling the establishment of the WHO National hub for Rare diseases in India.

As a working member of the Department of Science and Technology, Government of India, STIP secretariat, she has been extensively engaged with the formulation of the upcoming Science Technology and Innovation Policy (STIP) of India.

She was invited by the European Parliament For European Union Visitors Program 2023, where she had the opportunity to interact with EU institutions and Directorate Generals on exploring bilateral oppurtunities in health and rare diseases between EU and India.

She has also served as Scientific Advisor to the Organization for Rare Disease India (ORDI)

She is presently going on a one year sabbatical for pursuing Masters of Public Health program at the prestigious Johns Hopkins University, Baltimore, USA.

Rahul Saikia

Head of Mergers and Acquisitions, Strategic Alliances, Rising Pharmaceuticals

Dr. Sridhar Yeshamaina

Head – Global Pharmacovigilance, Clinical Development & Medical Affairs, Hetero Pharmaceuticals

Dr. Arani Chatterjee

Joint President , Cadila Pharmaceuticals

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. Sanjit Singh Lamba

Managing Partner, Trillyum Consulting and Advisory

Achievement-Driven Professional with cross functional experience in diverse functions and equipped with over 33 years of proficiency in the pharmaceutical industry. Strength in leading large teams across the globe , planning, executing & spearheading all the functions right from research , manufacturing of APIs and Formulations, Quality , business development to Sales and marketing functions with a P & L responsibility. Served at operational and leadership positions at MSD, Pfizer Ranbaxy, Dabur , Gland , Lupin, Eisai e tc. He pursued MPharm , PhD from Punjab University Chandigarh. He is the Ex MD of Eisai a Japanese pharma company . Currently he is associated with Biocuris pharmaceuticals , as CEO and Managing Partner at Trillyum consulting based at Chandigarh Awarded thrice in the list of one of the “100 of the Most Inspiring People” in the life science industry by PharmaVOICE, USA. Associated with professional bodies like Indian Pharmaceutical Association, International Society for Pharmaceutical Engineers (ISPE) and serves as Past Chair – India Chapter for Parental Drug Association (PDA) and past Chairman - Technical & Supply Chain committee for Organization of Pharmaceutical Producers of India (OPPI) . With a patient-first mentality and a philosophy that quality is everyone’s responsibility, continue to lead to further advance operational excellence and quality culture across the industry.

Dr. Sanjeev Gupta

Vice President & Head-Advanced Biotech, Ipca Laboratories

Sanjeev Gupta has obtained Ph.D. in Molecular Biology/Cell Line Engineering and M.Sc. in Applied Microbiology and Biotechnology. At present working as Vice President and Head, Advanced Biotech Lab (Biosimilar Division), Ipca Laboratories Ltd., Mumbai, India.

Dr. Gupta carries around 23 years of industrial experience and has been working since 2000 on the development of “Biosimilars” including monoclonal antibodies. His core expertise lies into Molecular Biology, Cell Line, Upstream process development, Bio-analytical, Regulatory as well as Tech Transfer to the GMP for Clinical and Commercial manufacturing. He is also actively involved and contributing as a key Industry leader to re-form the new guideline in India.

Till date, he developed and contributed for over fourteen recombinant molecules, of which eight biosimilars are already launched in the various markets and the rest are in the developmental 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, BioTrain, IMAPAC, CphI, Biopharma, Informa and UBM.

He has published several Research articles (12), 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.

Avinash Kumar Talwar

Vice President - MRO & Pkg. Material Sourcing (Strategic & Plant) and Global Supply Chain Management, Dr. Reddy's Laboratories

Rich experience of over 3 decades in successfully planning, sourcing, managing, and executing supply chain operations with deep understanding of standard processes & technology. Proven leadership in establishing key supply chain processes in the most challenging environment that consistently achieves superior results both operationally and financially. Having comprehensive wisdom achieved through closely working with Top Management and Prestigious Consulting Firms. Robust believer of system driven processes and result driven individual. Strong interpersonal skills, excellent attention to details, and brilliant analytical skills. Post Graduate gold medallist from IIP & Executive Alumni of ISB.
To sum it up, Avinash has a diverse experience in a slew of areas which includes procurement, vendor management & development, vendor audits, inventory control, packaging development, process re-engineering, cost excellence, Innovation & Digitalisation.

Malini Subbarao

Function Lead, SME Bioassay development, mAbs Biosimilars portfolio, Data Science enthusiast, Biocon Biologics

Scientist with 15 years of experience on working with multiple research projects in biologics.
My work entails functional characterisation of biosimilar monoclonal antibody therapeutics from early stage to commercialization for multiple programs. I also support technical inputs for regulatory filings of biosimilars, for primary and secondary in vitro pharmacodynamics, to demonstrate overall safety & efficacy of the drug. Previously, my work involved functional characterisation of peptide hybrids, insulin & analogues.
I have also supported the audit requirements pertaining to functional assays assessment during multiple regulatory audits triggered by product filings for commercialisation in advanced as well as emerging markets and contributed towards their successful approval.

Prof Bejon Kumar Misra

Founder Director, Patient Safety and Access Initiative of India Foundation

Prof Misra was born in Jamshedpur, India in 1951. He acquired his academic degree from Senior Cambridge Board and Degree in Business Management with Marketing as major from Banaras Hindu University (BHU) in the year 1971. Awarded "Distinguished Alumni Award" 2012 by the Institute of Management, BHU. The World No-Tobacco Day 2013 Award Winner, South-East Asia Region (SEARO), World Health Organisation (WHO). Recognized by National Bank for Agriculture and Rural Development (NABARD); as a Rural Innovator; improving access to safe drinking water. Conferred with “BHAMASHAH AWARD” 2013; by the Confederation of All India Traders (CAIT), for service to the consumers.

45+ years of professional career starting from Kolkata as a Marketing Executive with TATA Steel in the year 1971, subsequently became an entrepreneur in Jamshedpur in the Travel & Leasing Business till 1994. At present a qualified Independent Director on the Board of a Listed Company, Sunil Healthcare Limited. Adviser and Consultant to several Industry Associations and Business Entities; Founder Director of HAMARA CONSUMER DOST Pvt. Ltd. Ombudsman to Amway India Limited & Advisory Board Member of Global Healer LLC, USA & Alliance for Safe Online Pharmacies (ASOP) Global USA.

35+ years in the consumer education and advocacy: as a volunteer in the Consumer movement since 1983 as Founder Trustee of Consumer Guidance Society of Jamshedpur; Consumer Online Foundation, Healthy You Foundation and Founder Director of Patient Safety and Access Initiative of India Foundation. These are all not-for-profit Charitable Organizations registered in India.

25+ years as an International Expert on User (Consumer) Focus; for developing strategies and capacity building programs in developing countries on Quality Management Systems for public and private organizations. Have work experience as short term consultant with UNDP, UNICEF, UNCTAD, World Health Organisation (WHO), World Bank, GIZ, British Council, DFID, GAIN, PSM, EPOS, OPPI & ASOP; working on consumer protection policies and building customer-centric culture in public/private organizations.

At present Adviser to the Government of Odisha, Department of Food Supplies and Consumer Welfare (FS&CW), Executive Committee (EC) Member of General Insurance Council nominated by IRDAI, Advisory Committee Member, in accordance with Rule 19 of the Insurance Ombudsman Rules, 2017. Consumer Guidance Society of Jamshedpur is a Member of the Zonal Railway Users’ Consultative Committee (ZRUCC), South Eastern Railway and also a Member of the Divisional Railway Users’ Consultative Committee (DRUCC) Chakradharpur Division (CKP), South Eastern Railways. Chairman, Food Safety & Consumer Protection Committee, North East Regional Council of the Indian Chamber of Commerce (ICC), Chair, Health Insurance Vision 2030 of the Federation of Telangana Chambers of Commerce and Industry (FTCCI) Hyderabad, Board Member, National Accreditation Board for Hospitals & Healthcare Providers (NABH-QCI). Former Visiting Professor to the Institute of Management (IM) BHU and Former Adviser/Consultant to Institute of Medical Sciences (IMS) BHU, Former Member of the Planning & Monitoring Board of JSS Academy of Higher Education & Research (JSSAHER), MYSURU. Former Governing Board Member; Quality Council of India (QCI), Member of the Ethics Committee of National Dope Testing Laboratory (NDTL), Ministry of Youth Affairs & Sports, Government of India. Expert Member of the Core Training Panel, National Coordination Center, Pharmacovigilance Program of India (NCC-PvPI), Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India.

Former Member of Food Safety and Standards Authority of India (FSSAI) from 2008-2013, the Central Advisory Committee (CAC) FSSAI and Senior Expert with FSSAI; Special Invitee on the Steering Committee of National Foundation of CSR (NFCSR), Ministry of Corporate Affairs, Government of India, Served as a member on Expert Groups on framing Government Policies like the Mashelkar Committee for Review of Drugs Regulatory System and Tandon Committee on the Scientific and Technological Measures to Counter Spurious and Sub-standard Drugs and Diagnostic Centres in India, Expert Committee Member to Address the Issue of Faulty ASR Hip Implants manufactured by M/s DePuy International Limited, UK, Member of several Government of India Committees like how to tackle the nexus between Diagnostics Centre-Pharmaceutical Companies and the Medical Practitioners-Hospitals, Inter-Ministerial Monitoring Committee on Misleading Advertisements, Expert Committee on Patient Safety Implementation Program, Expert Committee on the Implementation of the UN Guidelines on Consumer Protection in India, Member National Drug Survey Core Expert Committee. Former Member of the Consumer Complaint Council (CCC) of the Advertising Standards Council of India (ASCI); Printer, Publisher and Editor of THE AWARE CONSUMER, English Monthly Consumer Magazine published from Delhi and registered with RNI. An Associate Member and Former Board Member of the International Alliance of Patients’ Organisations (IAPO), which has an official relationship with World Health Organisation (WHO).

Since 1983 visited more than 35 countries, as member of delegations and missions. Attended all the six Intergovernmental Negotiations; on the Framework Convention on Tobacco Control (FCTC) at Geneva from 2000 to 2003. Represented Consumers International (CI) in various international negotiations as a member and head of CI delegations at various international committee meetings of Codex Alimentarius Commission, World Health Organisation (WHO), World Health Assembly (WHA), Framework Convention on Tobacco Control (FCTC) & International Conference on Renewable Energies. Represented India; as the member of the Indian delegation, as a consumer representative, at the Codex Alimentarius Commission (CAC) and the Codex Committee on Food Labeling (CCFL) and ISO meetings abroad. In November 2004 lead the Indian delegation at ISO, TC 126/WG 9 Meeting at Geneva.

Founder Signatory of the Consumer Coordination Council (CCC) and served as the Founder Governing Council Member and Former Chairman of CCC. As the Chairman of CCC received support from Government of India to develop and manage several innovative projects like the JAGO GRAHAK JAGO Multi-Media Campaign and the Consumer Online Resource and Empowerment Centre (core.nic.in) and represented CCC in various international negotiations.

Member of the First Constituted Central Consumer Protection Council (CCPC) by Government of India in 1987 and the First Bihar State Consumer Protection Council in the same year, as per the provisions of the Consumer Protection Act 1986. Since 1983 played an effective role in Drafting several Rules and regulations in the interest of the Indian Consumer like the Consumer Protection Act 1986, Electricity Act 2003, Food Safety and Standards Act 2006, the Real Estate Regulation and Development (RERA) Act, 2016, Consumer Protection Act 2019.

Published several research papers on consumer behavior, perspectives, complaint handling mechanisms, accessibility, affordability and quality of service related issues on Healthcare, Electricity, Portable Water, Banking, Insurance, Telecom and similar for the World Bank, WHO and National Pharmaceutical Pricing Authority (NPPA), Government of India. Authored and published several books on “Safety Issues Concerning Storage Water Purifiers”, “Direct Selling: Is It ethical?”, “Patient Safety and Access to Safe Internet Pharmacies”. Presently working on the subject of “How Technology can play a Role to Empower the Indian Consumer to recognize Safe and Quality Products and Services”; Also working on issues concerning GOOD GOVERNANCE by preparing an INDEX to Measure the MOST ConsumerFriendly State(s) in India & the Most Consumer Friendly Brands globally.

Dr. Ajay Singh

Head - mRNA Department, Gennova Biopharmaceuticals

Dr. 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 is 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. His group of astute scientists has also made advances addressing infection of Varicella Zoster Virus, Human papillomavirus infection, Monkey Pox virus infection, Malaria, and Dengue. 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.

Dr. Kiran Marthak

Director - Medical Affairs, Phase-1 and Regulatory Affairs, Veeda Clinical Research

In the Indian Clinical Research industry, Dr. Kiran Marthak is one of pioneering leaders with a fabulous list of accomplishments and a rich experience of more than four decades.

Dr. Kiran Marthak has conducted numerous Phase 1 studies including First in Human studies, and complex clinical trials and has held senior positions in several Indian and Global pharmaceutical companies such as Ciba – Geigy (Novartis), GSK, Pfizer and Ranbaxy. He has very rich experience in conducting clinical trials across several geographies including USA, UK, Europe, China, Japan and South Africa. Dr. Marthak is highly respected amongst regulatory authorities for his knowledge of international clinical research guidelines. He is one of the accredited members for GCP training by Clinical Development Services Agency (CDSA), India and contributed to the New Clinical Trial Rules implemented in March 2019.

Dr. Marthak is a qualified M.D. in Internal Medicine from Grant Medical College, one of the oldest premier and pioneer medical institution run having 175 years of existence in the country. Additionally, Dr. Marthak is a Fellow of American College of Clinical Pharmacology, Fellow of Royal Society of Medicine, U.K. and Fellow of Faculty of Pharmacology, University of London. He has been awarded with ‘Vishist Chikitsa Medal’ in 1994, by the Association of College of Chest Physicians, India, (“ACCP”) in recognition of his services and was accepted as the honorary life member of the ACCP.

Dr. Kunal Joshi

Cell & Gene Therapy, Commercial Launch Excellence, CAR-T Cell Therapy, Immuneel Therapeutics

Dr Kunal Joshi is the part of Immuneel Commercial & Market Access team. In his current role he is spearheading Marketing for the Immuno-Oncology CAR-T Therapy launch in India. Prior to this he has led Strategy and Business Development for Stempeutics where he was instrumental in commercializing a range of first ever CDSCO approved Cell Therapy products in Knee Osteoarthritis, CLI and Biocosmetics for which the company was recognised at the Bengaluru Tech Summit 2022 with the 'Innovator of the Year' Award by the Chief Minister of Karnataka.

Dr Kunal has 10+ years of work experience across Sales, Marketing, Consulting, International Business across Johnson & Johnson and AstraZeneca. He was awarded the Agile Leadership Award at AstraZeneca for Digital Transformation.

His core interests are Cell & Gene Therapy commercial launch, branding, growth strategy and digital marketing

Dhananjay Patankar

Consultant, Biopharmaceutical Industry Professional

Rajesh Pednekar

Head - Supply Chain, Operations and Strategy, Healthcare SF

Mr. Rajesh Pednekar is an award winning International Expert in Pharmaceutical Supply Chain & Cold Chain and Keynote speaker at various Global Supply Chain & Cold Chain conferences in Europe, Asia Pacific, China and Korea with more than 20+ years’ experience in Supply Chain, Logistics & Procurement with leading companies like Cipla, Novartis, Pfizer, Nicholas Piramal (now Abbott), Goldshield Pharmaceuticals, Nutricia ( now Danone), ICI Paints (now Akzo Nobel) and Balsara (now Dabur) in Pharmaceuticals, Nutraceuticals, Food and Consumer Goods, across various geographies from Domestic & Sub-Continent Operations to Global Supply Chains. In his recent stint as Senior Director at Cipla, he was responsible for Logistics and Distribution for all entities of Cipla in India and launched initiatives to optimise costs, improve service and make medicines more accessible. Adjudged among the Top 50 Influencers in Logistics and Supply Chain in Asia Pacific by Terrapin, Singapore, he has a passion for Supply Chain and has conducted Workshops for International Delegates on Supply Chain / Cold Chain Design for Asia Pacific and Europe Regions. Recognition & Awards: He is the recipient of Chief Distribution Officer of the Year Award for 2018 by CNBC TV18. For his tenure as Head Supply Chain for Novartis Pharma, Novartis - India achieved the Excellence in Supply Chain Award for Asia Pacific, Middle East, Africa and Greater China Region for two consecutive years of 2008 and 2009. As Head – Distribution for All Entities of Pfizer Group in India, he achieved 70 % reduction in Pfizer's Outbound Supply Chain costs and was awarded Rewards and Recognition Award by Pfizer.

Dr. Shubhadeep Sinha

Senior VP Medical Director & Head Clinical Development/Medical Affairs, Hetero Group

Senior Pharmaceutical physician, with >23 years’ work experience.

Currently Senior Vice – President & Head – Global operations of clinical trials, Pharmacovigilance, medical writing, medico-regulatory & medical affairs at Hetero group of Pharmaceuticals since 2011.

Earlier worked in leading pharmaceutical organizations including Dr. Reddy’s Laboratories, Vimta Labs,, Indigene, Alquest LLC, , Accenture , Glenmark,, Organon, Khandelwal Laboratories,, before Hetero since 2000.

Clinical Development- DISCOVERY, BIOLOGICALS GENERICS Led global clinical development of NCEs (HIV, Oncology, Diabetes), Biological/biosimilars (Oncology, RA, Renal disease- Rituximab, Bevacizumab, Adalimumab, Trastuzumab, Trastuzumab Emtansine, Tocilizumab, Tenecteplase, Erythropoietin analogues (Darbepoetin alfa & Erythropoietin), differentiated generics & branded generics in multiple therapeutic areas including Oncology, Cardiovascular medicine, Infectious Diseases, Diabetes and Endocrinology, Gynaecology, Orthopedics & Urology etc..

Global Pharmacovigilance- Established and led global pharmacovigilance at Hetero (since 2011), at Dr. Reddy’s (2005), Accenture (2008), Vimta Labs (2009). Successful regulatory inspections- USFDA (thrice), Canada, UK, ROW- Mexico, Columbia, Indonesia, Malaysiaa, Kazakhstan, South Africa etc.

Clinical Development- COVID19- Led the global clinical development of anti-COVID agents such as Remdesivir, Favipiravir, Tocilizumab, Sputnik vaccine and Molnupiravir.

PUBLICATIONS- Has 30 original articles in peer reviewed journals. 2 Books – AI in Healthcare, Pharmacology, 1 Book chapter in Textbook of Pharmacology, Thieme Publishers

Academic- Adjunct Teaching Faculty in Dept of Pharmacology at Kasturba Medical College (KMC), Manipal and at Department of Clinical Pharmacology at Indira Gandhi Institute of Medical Sciences ( IGIMS), Patna

Memberships- Indian Pharmacological Society{IPS} (Life Member), Indian Medical Association (IMA) (life member & fellowship holder), Association of Family Physicians of India (Life Member), Indian Society of Rational Pharmacotherapeutics (ISRPT; Executive body and Life Member), Society of Pharmacovigilance of India (SOPI, Life Member)

M.Gopi Reddy

Vice President and Head -Corporate Quality and Compliance, Sun Pharma

Having over all 27 years of experience in managing Quality Operations in Leading companies like Sun Pharma, GSK, Glenmark Pharma, Cipla, Aurobindo, Microlabs and Syngene international ltd . etc.

At Current role to lead as Head (VP) –Corporate Quality Compliance & CQA. Am responsible for design and implementation of corporate systems and compliance across Sun Pharma sites including contract manufacturing and vendor sites. Responsible to develop SME to ensure anytime audit readiness of all sites for successful regulatory inspections. Responsible to develop and implementation of global quality standards and SOP’s for key systems across all sites.

Am also lead and establish Quality systems for Biologics and small molecules Including solid dosage forms, Api and injectables from development to commercial manufacturing of various products.

During my tenure I have worked at various levels from Executive to Sr. Vice President Level and possess hands on experience in manufacturing of Solid Dosage forms, Sterile formulations. Biologics, API’s.

Instrumental in creating leadership team under my guidance to meet individual and organisational goals.

As quality head played an instrumental role in handling various green field projects from start up to commercialisation.

Also did MBA in human resource.

Worked with regulatory agency as like FDA and Consultant as a part of remediation activity to bring back sites from Import Alert.

Proven Track record of facing various regulatory audits like, US FDA, UK, MHRA, MCC, ANIVISA, successfully. Possess Good Leadership skills, Confident and believes in Team Work.

Dhaval Trivedi

Strategic Planning, Operational Excellence, Programme Technical Lead, Regulatory Affairs: Biologics, Syngene International Limited

Dhaval is currently working as the Associate General Manager and leading Strategic Planning and Operational Excellence for Biologics Unit of Syngene International Limited. Syngene is an integrated research, development, and manufacturing organization providing scientific services from early discovery to commercial supply.

His current role includes Strategic planning for new capability development and bring operational excellence using Lean and Six Sigma principles.

He is having professional experience of more than 19 years in biopharmaceutical industry including direct work experience in areas related to Regulatory Affairs, Biosimilars Development, R&D, Strategic Planning, Medical Device, Program Management and Operational Excellence functions.
Working in various managerial roles since 2009, experience comprises of partnership development program for biopharmaceutical molecule specifically biosimilars and combination products development strategies including CMC, clinical development plans, global clinical trial approvals and marketing authorization applications in EU, US and RoW regions.

Tathagata Dutta

Chief Technology Officer, JODAS EXPOIM Pharmaceuticals

Dr. Tathagata Dutta has earned his 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 has served as Chief Scientific Officer (CSO), Vice President (R&D), Executive Director, 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, genetic immunization, depot injections, gene delivery, and development of RNAi therapeutics. Presently, he is the Chief Technology Officer (CTO) of JODAS EXPOIM Pvt Ltd.

Dr Dilip Pawar

Head – Medical Affairs and Pharmacovigilance, Unichem Labs

Dr Dilip Pawar has completed MBBS from Grant Medical college, MD from LTM Medical College, Specialisation in Oncology MMSc, Ph.D in Medicine, FCP (Fellow in Clinical Pharmacology USA) and recently completed GCSRT course ( Global Clinical Scholar Research Training) from Harvard Medical School USA with distinction and MBA from NSHU, USA.

Dr Pawar 25 years of experience in industry, with more than 10 years of experience in working in Oncology therapy. My passion is to work on unmet medical needs in Oncology. Conducted early phase Clinical trials, many Phase III clinical studies and Real world data studies. Currently working on two NBEs ( New Biological entities ) and one NCE in oncology indications like solid tumors and Hematology. Involved in monitoring of Pre clinical studies in Rodents and nonrodents, finalization of protocols and reports. Evaluation of the CROs for early phase clinical trials in oncology, team member for protocol development and formation of Advisory Board.

Earlier had worked on chemotherapy drug Pegasperginase ( NCE) which is used for the treatment of Acute Lymphoblastic Leukemia Cancer, successfully conducted Phase II and Phase III studies in India, got approval from the CDSCO and product launched in India and marketed in few European countries. Successfully conducted PK study for oncology molecule Treosulphan in hemopoietic stem cell transplantation (HSCT) patients and got approval for marketing in India. For the first time conducted a large Phase III trail for Tenecteplase recombinant molecule in stroke patients and got the first approval globally for stroke indication.

Conducted different Phase II and Phase III clinical Trials in Head and Neck cancers, Glioma Cancer in Indian population with Nimotuzumab a monoclonal antibody. Many outcome studies for various Oncology indications and products like Nimotuzumab, Trastuzumb and Bevacizumab.

At Dr Reddys Lab Clinical Lead and Medical Monitor, supervising Clinical Operations for the Clinical trial of DFA02 in colorectal surgery including Oncology patients, conducted in 40 sites in USA. Involved in protocol development, CRF and other study related documents, CRO selection, site selection, Investigator meetings.

At Akela Pharma worked extensively on Breakthrough Cancer pain. Conducted Phase I, Phase II and Phase III clinical trials. Global Medical Director, In charge of Global Clinical Operations and successfully conducted trials in Poland, UK and Thailand. Developed Protocol and CRF development.

Experience in Organizing and conducting Investigators meeting, site selection, Supervising Site initiation, Investigators, Site personnel and CRA training. Certified trainer and Responsible for organizing several Advisory Board meetings for Oncology Clinical trails.

Dr. Vishal Gandhi

Founder and CEO, BIORX Venture Advisors

Agnideep Mukherjee

Director Of Public Policy-Life sciences (Medical Devices, Pharmaceuticals, Biotechnology) and F.A.R, U.S.-India Business Council

Dr. Birendra Singh

President & Global Quality Head, Mankind Pharma

Dr. Birendra Singh is having an inspirational approach to lead along with proven track record of excellence. Setting strategies of quality cultural transformations to achieve global compliance with sustained growth. Building and mentoring team to meet highest global standards and profitability.

Have vast experience of handling with regulatory bodies across the World. Sound knowledge of the entire chain from drug development to reaching customers including Formulation, API, Biologics, Vaccine, Plasma Fractionation, CRO and pharmacovigilance.

Has led / is leading global transformation programs and initiatives in Cipla, Torrent, Zydus, Intas and Mankind at enterprise level.

Love to mentor young generations and students in spare time. Was awarded as young leader in the Industry.

Has an uncompromising quality commitment to play vital role in support of improving lives. Firm believer on never giving up your dream, whatever the stage of life.

Learn, Build and Grow together is the mantra for successful journey.

Ravi Uday Bhaskar

Director General, Pharmexcil

Lanka Srinivas

Mentor - Pharmaceuticals, Health technologies & Digital transformations, ElixGlobal

He is a thought leader in the field of pharmaceuticals with experience spanning over 30 years holding CEO/ VC /Director on Board positions.

Passion for building most respected, research-driven global pharmaceutical companies from Indian soil resulted in making mega corporates

As a Vice Chairman of Ramky Group, leading environment & infrastructure engineering organization, built and made Jawaharlal Nehru pharma city Visakhapatnam as a role model park with most competitive infrastructure and compliance.

Mr Lanka has served as Executive Director of Sun Pharmaceuticals. He has contributed to taking Sun Pharma to 6th Rank in India and built a global presence.

He was Head of business units of Novartis India and has integrated Ciba Geigy and Sandoz creating a novel and successful business model in India.

Being Director on Board, he has transformed Aurobindo Pharma from domestic penicillin company into one of the most respected vertically integrated global generic pharmaceutical company.

He helped build Alkem Labs, and Biological E transforms into a global organization.

He is one of the contributor of India earning significant market share and respect in the world. He led over 100 mergers/acquisitions and bought over 25 entities globally and integrated them successfully into the mainstream of the organizations with zero failure.

Mr Lanka, as the Chief Mentor of Pradhan Mantri Bhartiya JanAushadhi Pariyojana (PMBJP), championed the cause of providing quality generic medicines at affordable price.

Mr Lanka advises Pharmexcil and is a Mentor of several scientific institutions like IICT Hyderabad, NIPER Guwahati, etc.

He has served as a member of several policy-making committees such as Katoch Committee, Deepak committee, Samuel Paul committee, PM Taskforce on pharmaceuticals, Etc

He is a member of the technical committee of the department of pharmaceuticals, govt of India, for the revival of the API industry

He has received the award for outstanding contribution to exports of India from GoI.

He mentors technocrats, industrialists & corporate boards in Health and Digital Transformation and advises equity funds in mergers and acquisitions.

His mission is to make India as the health capital of Globe integrating modern and traditional medicine systems

Sanjeev Mahajan

Vice President of Quality, Cadila Pharmaceuticals

Sanjeev Mahajan is a Dynamic and seasoned Pharma Professional with 30+ years’ of experience.

Worked in all good regulatory GMP compliant companies (USFDA approved) like Ranbaxy, Sun pharma, Symbiotec pharmalab and Aurobindo Pharma and currently working as Vice President Quality at Cadila Pharmaceuticals Limited.

Rich Experience of handling Regulatory audits include US-FDA, MHRA, TGA, WHO, PMDA etc.

Expertize on designing and establishment of new facility including facility qualification, equipment’s qualification and quality system implementation.

Successfully lead Remediation projects for regulatory Audits.

Narasimha Rao Nedunuri

Managing Director & CEO, Clonz Biotech

Narasimha Rao Nedunuri is one of the founding members of CLONZ Biotech, a Biosimilar Monoclonal Antibody company based in Genome Valley, Hyderabad, India. He is currently serving the company as the Managing Director & CEO. Nedunuri, a Molecular Biologist turned Entrepreneur has over 2 decades of experience in the field of Life Sciences Research including Cancer Biology, Proteomics, and Molecular diagnostics. Nedunuri is also one of the members of CII India Biotech Committee, and actively involved in Mentoring young Entrepreneurs at Incubation Centres like CCMB-Atal Incubation centre.

At CLONZ , along with the co-promoters coming from recognized leaders who launched complex Biosimilar MAbs, Nedunuri is driving the company to emerge as a significant Global Biosimilar MAb company.

Varahabhatla N S Sarma

Corporate Head - IT, Vasudha Pharma

Dr. S D Ravetkar

Executive Director, Serum Institute

Ramesh Matur

PhD, Senior Vice President and Head, Vaccines R&D Division Biological E Ltd., Hyderabad, Telangana, India

Ramesh Matur has been heading Vaccines R&D Division since 2013 at Biological E Ltd, Hyderabad. Vaccines R&D Division comprises all scientific functions for bacterial, viral and subunit recombinant vaccines development from ideation to proof of concept, manufacturing process development on different platforms, analytical development, and animal studies for vaccine immunogenicity, all the way to clinical Phase3 studies. Clinical Development function is part of R&D Division. A highly talented, vibrant, strong scientific team with cross functional expertise was established. The Pneumococcal Conjugate Vaccine PCV14 received regulatory and marketing approval in December 2022. The next gen version PCV24 was developed and completed the Phase1 safety study in adults. Other viral vaccines such as Hepatitis A, Measles, Human Papilloma Virus vaccine (HPV), and Human Polyoma Virus Vaccine (HPyV) are in development. BioE R&D Division also created a team to develop mRNA platform- based vaccines for selected infectious diseases. Prior to joining BioE, Dr. Matur worked for Wyeth at Pearl River, NY (now Pfizer) in the USA, DuPont India, and led vaccines R&D at Indian Immunologicals Ltd. He has 25 research publications, filed 20 patents of which 7 were globally granted and other applications are under review in multiple countries. Dr. Matur has a Ph.D. in Biochemistry & M.Sc. in Microbiology. He pursued his postdoctoral research at Michigan State University and at The Ohio State University Biotechnology Centre.

Manoj Karwa

Head - Clinical Trials and Pharmacovigilance, Auriga Research

Manoj Karwa is working as Head - Clinical Trials and Pharmacovigilance with Auriga Research Pvt Ltd. His total industry experience is more than 17 years and worked in different domains like Preclinical development, BA/BE Studies, Clinical Trials and Pharmacovigilance. He completed his Pharmacy Graduation (B.Pharma) from Lachoo College of Science & Technology. Jodhpur in 2002 and Post Graduation from NIPER, Mohali in Pharmacology specialization in 2005. He started his career with Nicholas Piramal India Limited, Mumbai as a research scientist in drug discovery & development. He worked on NO-NSAIDs there and his role was screening of NCEs for their pharmacological actions and toxicity. During his tenure with Auriga Research Private Limited around 250 BE studies were completed under his supervision. The Pharmacokinetic analysis of BE studies of different study designs was performed by him on Phoenix WinNoNLin. Currently Auriga Research is using multiple electronic platforms like CTMS, eTMF, EDC, QMS, TMS in clinical operation activities and Pharmacovigilance Database in PV activities were set up by him. There are more than 10 publications from his industry work in reputed journals and also papers presented in the international conference.

Naresh Vadala

Pharmacovigilance Operations/Management, IQVIA

Mannan Khambati

Assistant Vice President Biotech manufacturing, Bharat Serums and Vaccines

A competent and companionate professional with 26 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.

Shalini Tanwar

Team lead- In vitro Biology, Aurigene Pharmaceutical

Cellular immunologist with strong theoretical background and practical expertise in cellular crosstalk during inflammation, autoimmunity and immuno-oncology.

Education:
PhD. National Institute of Immunology, New Delhi, India
Post Doc. NIH, Bethesda, USA

Experience:
Syngene International, India; Senior research investigator-Immune assays
Aragen Life Sciences, India; Senior Scientific Manager- Assay Biology and screening
APSL, India; Team Lead Immuno Oncology, NBE services

Key accomplishments:
Designed and validated POC experiments for various CAR mediated and bispecific mediated human immune cell (T-cells/NK cells) redirection approaches against TAAs
Established protocol to expand GD T-cell population from PBMCs by 300 fold
Established the crosstalk between Treg cells and myeloid derived suppressor cells (MDSCs) in mouse model of multiple sclerosis

Dr Kishore J R Kunapuli

Chief Scientific Officer Cell Therapeutics, Pulse Pharmaceuticals Pvt Ltd

Supriya Kashikar

Founder, GeNext Genomics

Awards and Recognition

o Biopharma Honours award by CPHI and Informa Connect for emerging personality of the year 2022.
o Top 75 women Entrepreneur in Biotechnology by BIRAC in 2022.
o Top 10 CRO Industry award by Industry Outlook 2021
o WiNER- BIRAC-TiE Award for Women in Entrepeneur Research 2018. Grant Acquired
o BIRAC-BIG (2013) grant for establishing a novel target in MTB.
o Genext Genomics has been a recipient of DBT-BIRAC- PACE -2019
o Genext Genomics has been a recipient of DBT-BIRAC- National Biopharma Mission grant 2019 in aid for biosimilar clone development of Golimumab.
o RKVY-RAFTAR grant in 2021.

Manjunath Dudhanikar

Applications, M R Sanghavi & Co (JNC)

Manjunath Dudhanikar is managing applications at M R Sanghavi & Co (JNC). He has 12+ years of rich experience as process development & scale up professional for cost effective and continuous manufacturing process development & scale up. He has previously worked with Serum Institute of India, GE Healthcare (now Cytiva) and Wockhardt. A techno-commercial professional with experience in both process intensification and commercial aspects of manufacturing. In his career, he has developed, scaled up & troubleshooted various purification process for large number of biomolecules.

At M R Sanghavi & Co, he is responsible for bringing the chromatography purification technology, resins, columns & systems to the commercial markets to enable the manufacturers to purify vaccines & all other biomolecules at large scales with ultimate process efficiency, increased productivity and cost effectiveness.

Manjunath holds a Masters in Bioprocess Technology (ICT, Mumbai), and B. Pharmacy degree (Govt. College of Pharmacy Karad).

Praveen Kumar Baheti

VP – IT, Biological E Ltd

Rajni Jha

Pharma Consultant

Dr. Sandhya Kumaraswamy

Head Learning Services, CRAMbridge

Ashutosh Shelar

Assistant Manager - Bioanalytical Solutions Shimadzu Analytical (India) Pvt Ltd

Mr. Ashutosh Shelar holds a master’s degree in Bioanalytical Sciences from Mumbai University and has been associated with Shimadzu, India for the past 8 years. His work area includes catering pre and post-sales support to various bioanalytical labs across India. He is also responsible for enhancing the biopharma market in India by developing trending applications, discussing, and presenting various solutions offered by Shimadzu. He is also working as a visiting faculty in many colleges under Mumbai University delivering lectures on bioanalysis, regulations, and LC-MS.

Prior joining to Shimadzu, Ashutosh worked with BA/BE labs like Teva Pharma and Accutest Research Laboratories Pvt. Ltd. for almost 6 years as a senior research associate developing bioanalytical methods for various drug molecules, performing method validation and clinical study sample analysis following several regulatory guidelines. He has also worked in Reliance Life Science as a research associate in the plasma protein manufacturing unit.

Madhusudhan Rao

CEO, Atal Incubation Centre -CCMB, Hyderabad

NM Rao is CEO of Atal Incubation Centre at CCMB, Hyderabad. A career scientist in protein engineering at CCMB for three decades is interested in technology transfer from academic institutions. AIC-CCMB, a not-for-profit incubation centre has supported 90+ startups in deep life science ideas. Besides the incubation, Rao leads a few programs that engage with young entrepreneurs and seeks ways to enhance the impact of CCMB technology know-how.

Dr. Uday Saxena

Executive Secretary, FABA, & CEO ReaGene Biosciences

Dr. Uday Saxena is a pharma Executive who has held C level positions in large and small multinational companies. He is vastly experienced in preclinical drug discovery and development

He has a PhD from memorial University of Newfoundland, Canada and a Post-Doctoral Fellowship from Columbia University in New York. He has since then held positions of increasing responsibilities at Parke-Davis/Pfizer, Michigan, AtheroGenics Inc, a NASDAQ listed Company where he was Vice President of Research. He then became Chief Scientific Officer of Dr. Reddy’s Laboratories in USA and India, a Company listed on NYSE since 2000.

He is currently Cofounder and CEO of a start-up Company working on 3D Bioprinting platform for COVID, Inflammation and diabetes products. He is an inventor on 30 plus granted or filed patents and over 60 peer reviewed publications. He was elected Fellow of American Heart Association and Member of American Diabetes Association and Alzheimer’s Association. He is an invited speaker on several International Pharma forums.

Venkat Kamalakar Bundla

Business Leader, Board Member, Advisor, Angel Investor, Co-Founder - MD , Garphi Biosciences

Founder Managing Director of Garphi Biosciences & an active Angel Investor Mr. Venkat Kamalakar Bundla has 3 decades of extensive and diverse experience (consulting, operations & general management). He has demonstrated success in leadership roles and experience in working and supporting Business and R&D of Pharmaceutical and Biotechnology companies globally. After exceling in Leadership positions with increasingly progressive mandates, for several large pharmaceutical organizations, where he played a vital role across wide geographies - Americas, Asia, Europe and globally, he co-founded Garphi Biosciences -A multi-disciplinary firm for Pharma and Biotech Advisory Services in 2007.Venkat a Notable BITS Pilani Alumni is also the board member & adviser for several Life Science companies in India, Europe and USA. He is also invested in many a cutting-edge start-up’s in the Pharma & Technology space. Widely networked and travelled, Venkat brings to the table, a strong techno-commercial and operational expertise which is of immense value in deal-making and has had extensive experience from being on both sides of the negotiation table in several multimillion-dollar global deals. An avid golfer and travel enthusiast, he is affiliated to many Industry bodies and is a regular speaker at various events organized by Accademia & industry in India and abroad. Currently he serves on the Boards of ABLE ( Association of Biotechnology led Enterprises) India & TiE Hyderabad.

Arun Dubey

Managing Partner, Zenfold Ventures

Dr. B Venkata Murali

Senior Research Scientist, Sai Life Sciences

Mukund Joshi

Manager -Market Development, South Asia

Mukund leads market development group at Beckman coulter life sciences, South Asia. He has been actively supporting life sciences researchers, Biopharma, and Clinical scientists in life science/biotech workflows and Clinical Diagnostics flow cytometry workflows for the past 14 years. He is a postgraduate in biosciences and has an executive management certification from IIM Bangalore. He has extensive training experience in flow cytometry and has trained more than 1000 + researchers in India.

Lakshmi Narayana

Associate Director, SCM, Aragen Life Sciences

“Lakshmi Narayana Dommarajula is passionate about building successful & empowered teams, leading transformation, and delivering results with proven track record working in complex matrix organizations. He has been focussing on continuous improvement programs.

He has 19+ years of experience and is currently an Associate Director with Aragen Life Sciences. He has managed various roles in Supply Chain Management (SCM), Category Management, Strategic Sourcing, Global Procurement, Project Procurement with Global & Indian MNCs - Aragen Life Sciences, Syngene, GSK and Novartis.

He has experience in the sourcing and procurement of Raw materials, Chemicals, Solvents, Lab supplies, Lab services, Analytical testing services, Clinical research/CRO services, Capex - Process/Engineering and Lab equipment, CMOs (Contract Manufacturing Organizations), Pharma R&D including Pharma New Product Development (NPD), Biologics, REFS, Professional services and IT.

He has a Bachelor degree in Pharmacy and Master’s in management.

Dr. Ratnakar Palakodeti

Vice President- Healthcare & Life Sciences, Persistent Systems