13th Annual Conference

Beyond New Regulations- Increasing Participation and

Enhancing Patient Safety

January 24-25, 2020, Mumbai

INDIAN SOCIETY FOR CLINICAL RESEARCH

Track I – Clinical Operations Speakers Profile

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Dr. Chirag Trivedi Sr. Director and Head of Clinical Study Unit India and

South East Asia Cluster, Sanofi President, ISCR

Work Experience:

Am currently working in Sanofi as Sr. Director and Head of Clinical Study Unit India and South East Asia Cluster - overseeing clinical studies in India, Singapore, Malaysia, Thailand, Indonesia, Philippines, Bangladesh, Sri Lanka and Vietnam.

Have been with Sanofi since May 2006 and have handled various roles and responsibilities in these years.

Prior to Sanofi, have worked in a CRO and prior to that, in a Central Lab.

Since April 2017, am the President of Indian Society for Clinical Research (ISCR). As a Society, ISCR brings together all those who are engaged in clinical research activities in India and provides a forum for exchange of information and learning. ISCR aims to build awareness of clinical research as a specialty in India and to facilitate its growth in the country while helping to evolve the highest standards of quality and ethics.

Experienced in the fields of Clinical Research, Clinical Quality Assurance, Medical Excellence, Pharmacovigilance, Bioavailability & Bioequivalence Studies, and Business Development.

Educational Qualification: Ph.D. in Pharmacology

Additional information:

Have been nominated as an external examiner by the University of Mumbai for the Ph.D. (Tech.) and for Masters in Pharmaceutical Sciences Examination (speciality – Pharmacology) for evaluating research thesis.

Have been a Speaker at various national and International conferences

Dr. Sanish Davis, MD DM FCP, R&D Director, GCO, Janssen Pharmaceuticals, India

Hon. General Secretary, ISCR Dr. Sanish Davis has been with Janssen since Sept 2019. He has dual responsibilities in the

Janssen India organization. He is responsible for providing oversight to the Clinical studiesthat are being conducted in India either as part of the global clinical studies or Phase IVpost approval commitment studies. He also drives the Portfolio prioritization process forJanssen India for which he works closely with the commercial, Medical, Regulatory andR&D organizations across India and APAC (APSSO, APMS). In his previous assignment withCovance he was responsible for providing medical and scientific leadership and strategicguidance for clinical development programs and medical monitoring for ongoing clinicaltrials, as well as medical advice to the drug safety service and clinical operations teams. Inthat role, he has been involved in providing Medical & Scientific Affairs capabilities forrunning Phase I-III clinical trials in CV, Metabolic areas and other Therapeutic Areas e.g.Opthalamology, Rare Disease, Oncology, Immunology etc. Prior to joining Covance he wasDirector, Clinical Pharmacology for Merck/SUN JV where he drove Early clinicaldevelopment programs for innovative generics/FDCs in the dyslipidemia/hypertensiontherapeutic area. As a Cardiovascular Research Physician in Pfizer, before he joinedMerck, he provided leadership for both Clinical Research and Medical Affairs for anti-hypertensive and lipid metabolic products. He is a thought leader in the Clinical ResearchIndustry in India and is currently the General Secretary of Indian Society for ClinicalResearch (ISCR) – an organization of ~40 accredited R&D companies who are conductingregulated clinical trials in India. He is conversant and in sync with the regulatory andethical changes for conducting clinical trials in India. He also has good experience inpresenting and defending clinical trial project applications with ICMR and DCGI (MoH) inIndia as well as other emerging market regulatory agencies. Dr. Davis completed hismedical degree (MD) and Clinical Pharmacology training (DM) at Seth GS Medical College& KEM Hospital, Mumbai, India. He is a Fellow of the American College of ClinicalPharmacology.

Dr. Seema Pai, Director & Head - India for Global Site and Study Operations (GSSO) , Clinical Development & Operations, Global Product

Development, PfizerTreasurer, ISCR

She is responsible for clinical trial delivery for global and local clinical trials placed in India. She is on theleadership for AsiaAfME & on the global extended leadership team for GSSO.

Dr.Pai is an office bearer & treasurer for the Indian Society for Clinical Research from 2018 onwards. Sheis the Scientific Committee Chairperson for ISCR & is an active member of the DIA in India & worksclosely with the Clinical Development Services Agency for supporting several activities of the Departmentof Biotechnology in India.

Dr. Pai was responsible for India, Thailand, Vietnam and Philippines for clinical trial delivery in herprevious role at Pfizer. She was responsible as the asset director for oncology assets like Lorlatinib,Crizotinib, C366 as well as vaccines like Prevnar, RSV until end of 2018.

She has also served as an practicing oncopathologist at tertiary care hospitals, ethics committeemember, medical writer and editor for key publication houses at the start of her career and then workedin clinical development extensively holding the roles of medical monitor, safety physician, oncologyprotocol development expert for an Indian CRO & local pharmaceutical company (SiroClinpharm)following which she was the Senior Director & Head - Clinical Development Division of a JapanesePharmaceutical Company in India – Daiichi Sankyo for over 8 years where she was responsible for IndiaCluster & Australia.

She has been instrumental in overseeing the largest, longest cardiovascular program in VenousThromboembolism & Atrial Fibrillation - ‘Edoxaban’ which had 2 large phase 3 cardiovascular studiesenrolling over more than 1200 patients in India and has provided leadership for establishment of theoncology, and frontier areas portfolio development at Daiichi Sankyo India.

She has completed her MBBS from Grant Medical College, Sir J J Group of Hospitals, Mumbai followedby her MD (Path) from T.N.Medical College, Nair Hospital, University of Mumbai.

She has worked in clinical research and pharmaceutical industry for >16 years.

Thus, during her career, Dr. Pai has worked in all phases of clinical trials from IND to NDA for variouscompounds in the areas of oncology, cardiology and metabolic diseases.

She has several published papers in journals of national and international repute.

Dr. V G SomaniDrugs Controller General (India),

Directorate General of Health Services,Ministry of Health and Family Welfare,

Government of India He is Drugs Controller General (India), under Dte.GHS, MoH&FW,

Government of India. He has done M. Pharm, PhD in Pharmaceutical Sciences.

He is Chairman of WHO’s Member State Mechanism (MSM) of 194 countries on substandard and falsified medical products at Geneva, Switzerland vide World Health Assembly (WHA) resolution 65.19 which is very important platform to safeguard Global interest for making a quality affordable generic medicines acceptable in the world.

He is working in CDSCO in Drugs Regulation for last 22 years and having vast experience in the field of GMP, GCP, GRP, GDP, GLP, Dossier Review etc. and he has also worked on all the posts in the hierarchy of CDSCO.

He has been involved in training various national regulatory guidelines like guidelines on similar biologics and contributed to various WHO guidelines on Drugs, Devices &Vaccine related issues.

His focus areas are Simplification of regulation and access to quality medical products through Good Regulatory Practices & strengthening of Drug Regulatory system.

He is a well-known speaker and trainer of various national and international/ WHO scientific bodies and was awarded merit scholarship/fellowships by the Government since schooling days till completion of his P

Kedar NayakGlobal Study delivery lead

GSK

Am currently working in GSK as Global Clinical Development Manager/Study Delivery lead as a part of the global clinical matrix team for HIV studies.

Started with GSK India in 1996 as a medical representative for critical care, anti-infectives and Asthma care products including being part of asthma task force for a novel device.

Subsequently moved to Clinical Operations in 2004, since then have been holding a variety of clinical research roles of increasing seniority starting from CRA, Local study Manager, Clinical Research Manager, Head of Clinical Operations -Vietnam, India and then recently as Area Manager - Area Manager - In-Country Clinical Operations - India, Russia, Africa.

Handled different responsibilities across diverse therapy areas primarily Oncology, Respiratory, Infectious diseases.

As Area Manager for RMEA in addition to my role for Russia, South Africa, have been responsible for overseeing clinical studies being done in partnership with strategic partners (CRO) within AP countries namely India, Singapore, Malaysia, HK, Thailand, Taiwan, Turkey Philippines, Vietnam & NZ.

Have also worked with India Medtronic for a brief period between 2006-2009 as Manager -Clinical Studies and then re-joined GSK as a Clinical Research Manager (Oncology) in 2010.

Head of Clinical Operations -Vietnam between 2013-2015

Since April 2017, am the Chair of the Western Chapter of Indian Society for Clinical Research (ISCR). As a Chair for the West Chapter, my passion is to create a forum for fellow colleagues to step up , exchange information and thus learning between all of us who are active & passionate about CR within the region with a sole objective towards the ISCR goal to build awareness, capacity and capability of clinical research.

Experienced in the fields of Clinical Research, Clinical Quality, Risk Based Monitoring.

Educational Qualification: MSc. MBA

Additional information :

◦ Have been a Core member of the RBM Regional Board (Representing EMAP & J) & Led RBM Champion Network for EMAP & J region to ensure that LOC activities in the region are aligned with the overall Global/Regional RBM business plan and priorities.

◦ MBA with specialization in Human Resources Management from NMIMS.

Key Note Speaker Dr. Gagandeep Kang

Executive Director, Translational Health Science Technology Institute (THSTI)

Professor Kang is the Executive Director, Translational Health Science TechnologyInstitute (THSTI), an autonomous institute of the Department of Biotechnology(DBT). Prior to joining DBT, Prof. Kang was Professor and Head of the WellcomeTrust Research Laboratory, and the Division of Gastrointestinal Sciences at theChristian Medical College (CMC) in Vellore.

Professor Kang has built a strong inter-disciplinary research program that usescareful and detailed field epidemiology with molecular tools for characterization ofinfectious agents and host response to infection to understand and change factorsthat affect transmission, development and prevention of enteric infections andtheir sequelae. Observational, interventional and mechanistic studies on entericinfection and nutrition have demonstrated the complex relationships between gutfunction and physical and cognitive development. Based first at an outstandingmedical college and now at the THSTI, she has established a strong trainingprogram for students and young faculty in clinical translational medicine aiming tobuild a cadre of clinical researchers studying relevant problems in India.

She is a member of the WHO's Product Development Vaccine Advisory CommitteeGlobal Advisory Committee and chairs the Immunization Technical Advisory Groupfor the WHO’s South East Asian Region. She serves or has served on the scientificadvisory committee of several national and international institutions, including theWellcome Trust, UK, the DBT-Wellcome Trust India Alliance, the InternationalVaccine Institute and the International Center for Genetic Engineering andBiotechnology.

Dr. Urmila ThatteProfessor and Head at the Department of Clinical Pharmacology,

Seth GS Medical College and KEM Hospital, Mumbai

Dr. Urmila Thatte is Professor and Head at the Department of Clinical Pharmacology, Seth GSMedical College and KEM Hospital, Mumbai. She has an M.D. and Ph.D. in Pharmacology from theUniversity of Mumbai, a Diplomate of the National Board of Examinations, New Delhi, in ClinicalPharmacology and is a Fellow of National Academy of Medical Sciences, New Delhi.

Dr. Thatte is a Member of the Subject Expert Committees (Govt. of India) for review of new drugapplications and the Expert Committee set up by the Ministry of Health and Family Welfare fordeciding compensation for Research Related Injury. She also serves on Scientific Advisorycommittees as a Clinical Pharmacology expert of the ICMR. Dr. Thatte is the Member Secretary,Forum for Ethical Review Committees in the India (FERCI), Chair of the Signal Review Panel,Pharmacovigilance Programme of India, member of the WHO Expert Advisory Panel on DrugEvaluation and Asia-Pacific Consortium, International Society of Pharmacoeconomics andOutcomes Research (ISPOR).

Dr. Thatte serves on the National Ethics Committee of NACO and chairs the Ethics Committees ofthe Bombay Hospital. She also serves on the Institutional Ethics Committee of KEM Hospital aswell as on the Independent Ethics Committee, Mumbai.

Having won several prizes at the undergraduate level, her team’s research work has beenrecognised by the prizes they have won in scientific conferences. Dr. Thatte has been awardedthe prestigious Dr. KN Udupa Award for Excellence in research in Ayurveda by IASTAM. She wasconferred the “Excellence in Drug Research Award” (Traditional Medicine) by the Central DrugResearch Institute, the prestigious Dr. BN Ghosh Oration of the Indian Pharmacological Society onthe topic “Herbal Drug Development – Opportunities and Challenges” and the Dr. FaroqueAbdullah Oration of SMS Medical College, Jaipur on “Ethical Issues in Clinical Research”. She hasover 220 Publications in National and International Journals including 8 books and 20 chapters invarious books on clinical pharmacology to her credit. Dr. Thatte was the Clinical PharmacologySection Editor for Clinical Pharmacology for the API (Association of Physicians of India) Textbookof Medicine published in 2008. Dr. Thatte is in the core team that authored the 2017 edition ofthe ICMR Ethical Guidelines for Biomedical Research.

Dr. Sripad BanavaliDirector Academics

Tata Memorial Hospital, Dr. Shripad Banavali has completed his MD

Internal medicine in 1986 and underwent 3 years Adult Oncology training at TMH under able guidance of Dr S H Advani. Then He spent nearly 8 years in the U.S. doing research on various aspects of leukemia including work at St Jude Children Research Hospital which is considered the “Mecca” of pediatric oncology. Then came back and joined TMH.

At present, he is the head of Medical Oncology at TMH. Since accepting the responsibility of the medical oncology dept in India’s largest and most advanced cancer hospital, Dr Banavali has embraced a revolutionary approach to cancer treatment known as metronomic therapy. He has more than 200 scientific publications in various peer reviewed journals to his credit. Dr Banavali is Oncology SEC member for past few years as well.

Suneela ThatteVice President & Head,

R & D Solutions, IQVIA India Suneela is an industry leader with extensive experience in clinical research, operations,

business operations and account management with a more than 25 year stint in thebiopharma industry. Currently serving as Vice President and Head R & D Solutions, IQVIAIndia, Suneela is responsible for IQVIA’s Clinical Development business in India. She alsosupports IQVIAs’ Regulatory strategy and is responsible for engagements with industrybodies and associations.

Suneela joined IQVIA (formerly Quintiles) as Clinical Team Leader in 1998 and has, over thelast 19 years, worked in various leadership positions. Suneela began her career as AssistantManager, Medical Information Service at Unichem Laboratories and later moved to RhonePoulenc as Clinical Research Associate in the Medical Services Division before she joinedIQVIA in 1998.

Suneela holds a Master of Pharmaceutical Sciences degree from Mumbai University and aMaster of Business Administration from New Port University, California, Mumbai Chapter.She is the Past President (2013–17) of the Indian Society for Clinical Research (ISCR), thenodal professional body in India for clinical research professionals. It was during her tenurethat ISCR, as a body representing all the stakeholders in clinical research, got widerecognition within India – including that of Indian regulatory authorities – and abroad.

Suneela is an active member of the Clinical Trials Committees of several industryassociations such as Confederation of Indian Industries (CII), Organization of PharmaceuticalProducers of India (OPPI), Advisory Council for Developing Human Resources forPharmaceutical Industry where she is a Task Force member. She has also published papers inmedical journals. Suneela is the recipient of Healthcare Businesswoman’s AssociationLuminary Award for 2017. In February 2019, she has been honored by The Indian Societyfor Clinical Research with a Lifetime Achievement Award for Notable Contribution toClinical Research Fraternity – Industry.

Dr. Suresh Menon Chief Scientific Officer, Novartis India Limited

Dr. Suresh Menon is an alumni of the Grant Medical College & J.J.Group of Hospitals in Mumbai

Has been associated with the Indian Pharmaceutical Industry formore than 3 decades and has worked in a number of Indian as wellas multi-national companies (including USV, Piramal, ScheringPlough and Organon).

Currently with Novartis (for the last 15 years+), heading theMedical Function as Chief Scientific Officer (CSO).

Is well networked in the Pharma industry and, in addition to beingthe Chair of the Medical- Regulatory Committee of OPPI, is also anExecutive Committee Member of the Indian Society for ClinicalResearch (ISCR). Was also a past President of the ISCR.

Dr. Menon has more than 30 publications in peer reviewed journalsto his credit.

Dr.(Prof) Asita D’silvaUniversity of Kelaniya, Sri Lanka

Professor Asita de Silva has held many positions in academic medicine over the last 26 years. He is a Clinical Pharmacologist and is currently Senior Professor of Pharmacology at the Faculty of Medicine, University of Kelaniya, Sri Lanka. He is also Director of the Clinical Trials Unit in the same institution. Prof de Silva graduated MBBS in 1991 from the North Colombo Medical College, Sri Lanka, and had his postgraduate training in clinical pharmacology at the Radcliffe Infirmary in Oxford. He holds a doctorate in Clinical Pharmacology from the University of Oxford and is a Fellow of the Royal College of Physicians, London. Prof de Silva’s research interests have focused on clinical trials in neglected tropical diseases and major non-communicable diseases. He has published more than 60 papers in indexed scientific journals including the New England Journal of Medicine, Lancet, Journal of the American Medical Association, PLoS Medicine, Clinical Science, Lancet Global Health and Stroke, and has delivered many orations and invited lectures. He has received Presidential awards for medical research on numerous occasions and is a recipient of many prestigious research grants including project grants from the Wellcome Trust, Medical Research Council, UK, and the National Health & Medical Research Council in Australia. Prof de Silva recently received the National honour of VidyaJyothi for his contribution to medical science.

DR GERALD J. DAL PAN,MD, MHS, Director of the Office of Surveillance and

Epidemiology, FDA’s Center for Drug Evaluation and Research

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. In this capacity, he is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics, and in the implementation of the drug safety provisions of the Food and Drug Administration Amendments Act and other initiatives. He is a member of the World Health Organization Advisory Committee on the Safety of Medicinal Products, and has served on working groups of the Council of International Organization of Medical Sciences (CIOMS) and the International Council on Harmonisation (ICH). He received his MD from Columbia University College of Physicians and Surgeons and his Master of Health Science in Clinical Epidemiology from the Johns Hopkins University School of Hygiene and Public Health. He completed residency training in Internal Medicine at the Hospital of the University of Pennsylvania and in Neurology at the Johns Hopkins Hospital. He is board certified in both Internal Medicine and Neurology. He joined FDA in 2000 as a medical reviewer in the Center’s Office of New Drugs. Before working at FDA, he was a faculty member in the Department of Neurology at Johns Hopkins and worked in the pharmaceutical industry.

Mr. Anirban Roy Chowdhury Director & Principal Consultant,

ARC LifeScience Consulting Group Anirban Roy Chowdhury is a clinical research professional with

about 2 decades of experience in the pharmaceutical industry.He started his career as a CRA in AstraZeneca and mostrecently he was the Executive Director, Global Clinical TrialOperations at MSD (Merck & Co). He is the Founder Directorand Principal Consultant at ARC Life Science Consulting Group,a boutique clinical research consulting firm.

He is an Adjunct Visiting Professor at Dept. of Pharmacology,Manipal College of Pharmaceutical Sciences, Manipal.

Anirban serves in the Executive Committee of the IndianSociety for Clinical Research.

Dr. Deepa BhartiyaHead Stem Cell Biology Department,

ICMR- National Institute for Research in Reproductive Health

Scientist G and Head, Stem Cell Biology Department, ICMR-NIRRH, Mumbai

Did PhD from CDRI, Lucknow and Post-doc at NIH, Bethesda, USA

Published extensively on stem cells and oncofertility

Have more than 100 published articles on Pubmed

Is attached to Mumbai University and several students done PhD under her guidance

Major interest of research is on pluripotent stem cells

Dr. Savita Rangarajan MD, FRCP, FRCPathConsultant Haematologist

University Hospital Southampton NHS Foundation TrustUnited Kingdom Prerana Medical Sciences & KJ Somaiya Super Speciality

Hospital & Research Centre

Savita Rangarajan, MD, FRCP, FRCPath is a Consultant Haematologist at theUniversity Hospital Southampton NHS Foundation Trust and at K J Somaiya SuperSpeciality Hospital & Research Centre in Mumbai, India. She is the R&D Director ofthe Clinical Trials & Research Unit in Mumbai.

Dr Rangarajan obtained her Undergraduate & Post Graduation degree in Medicineat Lokmanya Tilak Municipal Medical College, Mumbai, India, and further specialtytraining in Haematology in the United Kingdom. She trained at various teachinghospitals in London as a registrar including the Roya Free Hospital, UCLH, and theHammersmith Hospital.

She was made a Consultant Haematologist at St Thomas’ Hospital in 2000, whichis one of the largest Comprehensive Care Centre for Haemostasis & Thrombosis.She developed the Southern Haemophilia Network in Wessex and established avey successful Clinical Trials Unit at Hampshire Hospitals and was PI/CI in morethan 20 Phase I-IV Clinical Trials including Gene Therapy for Haemophilia.

Dr Rangarajan is a Fellow of the Royal College of Physicians and the Royal Collegeof Pathologists and is a member of UKHCDO, American Society of Hematology andInternational Society of Thrombosis and Haemostasis (Co Chair of the Factor VIII,Factor IX and Rare Coagulation Disorders ISTH subcommittee) among others.

She has contributed a book chapter on haemophilia and has published widely,with papers appearing in The New England Journal of Medicine, Haemophilia,Journal of Thrombosis and Haemostasis, British Journal of Haematology, BloodCoagulation and Thrombolysis, and Blood, to name a few.

Dr Mahesh IyerCo-Founder, Sineflex Solutions LLP

Mahesh is a co-founder of Sineflex Solutions LLP, a consulting firm focused onenabling and accelerating innovation in the healthcare space. He is also thedomain mentor of the BIRAC funded med-tech accelerator located at the Centrefor Innovation and Entrepreneurship, IIIT Hyderabad. In this role, Mahesh isresponsible for mentoring startups in the medtech space, and helping them scaletheir products and solutions. Mahesh Iyer has over 20 years of experience inresearch and development in healthcare. He has been responsible for guidingmany products through the development life-cycle. Before co-founding SineflexSolutions, Mahesh was at Novartis in various roles, including Site Head,Biostatistics at Hyderabad, and Global head for Exploratory Safety and StatisticalAnalytics. Prior to Novartis, Mahesh worked with Bristol Myers Squibb andBoehringer Ingelheim.

Mahesh brings a strong analytical mind-set, deep insights into healthcaredevelopment and a proven record of implementing innovative solutions in thehealthcare domain. Mahesh is passionate about enhancing industry academiacollaboration; he set up one of the first part-time Ph.D. program in Statistics forNovartis associates, teaches at a number of Indian universities and has chairedmultiple conferences over the years. He is currently Secretary of the IndianAssociation for Statistics in Clinical Trials and President of the International IndianStatistical Association, India Chapter.

Apart from his functional activities, Mahesh has led various organizationaldevelopmental activities and trainings. He is a certified coach in the areas ofemotional intelligence, assessment centers, and psychometric evaluations.Mahesh has completed his Ph.D. in Statistics from Temple University, Philadelphia.

Shankar ArunVice President and Head, Parexel Informatics India

As Vice President, Shankar Arun heads Parexel India’s InformaticsBusiness Unit in India which specializes in the areas of Technology,Operations and Clinical Programming. With 24 years of workexperience largely devoted to the CRO/IT/KPO functional carve-outswithin the Life Sciences segment, Shankar brings in rich expertisedeveloping solutions around EDC, Biostats, and Safety Platforms.Before joining the Life Sciences Industry, he had worked as aconsultant in the US for some of the prestigious names like Microsoft(Seattle) and Apple (Cupertino).

A Technology Evangelist, Shankar specializes in designing solutionswithin the Clinical Research space around the framework of “SMAC”(Social Media, Mobility, Analytics and Cloud) and is an activeproponent of “Go Digital” models. He also leads Parexel Informatics’Innovation Initiative which conducts research on the application ofArtificial Intelligence and Robotic Process Automation in the field ofClinical Development.

Shankar is an active participant in external forums like Cypher AnalyticsSummit, India Analytics Summit, SCDM, DIA etc where he haspresented keynote speeches on topics related to Artificial Intelligence,Machine Learning and IOT. A strong believer in people power, Shankaris focused on mentoring and coaching his teams to maximize their fullpotential.

Dr. Arun Bhatt MD (Med), FICP (India), FICR (UK)

Consultant – Clinical Research and Development Dr Bhatt has extensive experience of over three decades in the Indian

pharmaceutical industry in clinical research, drug development, and regulatoryaffairs. He has managed clinical development of novel molecular entities indiverse therapeutic areas in all clinical development phases.

Dr Bhatt has worked as a consultant in pharmaceutical medicine and clinicalpharmacology. His past positions held include President, Clininvent ResearchPrivate Limited – a CRO, CEO of CMI (India) Private Limited and MedicalDirector of Novartis India Limited.

Dr Bhatt has been active in industry associations and was earlier the Presidentof Indian Society for Clinical Research (ISCR). He is Editor-in-Chief ofPerspectives in Clinical Research – the journal of ISCR.

In 2009, the Institute of Clinical Research UK nominated Dr Bhatt for theHonorary Fellowship of Institute of Clinical Research.

Dr Bhatt is the recipient of Drug Information Association Outstanding Serviceaward 2012 for his immense contributions in his field of specialization.

Dr Bhatt was awarded ISCR Special Award 2017 for Notable Contribution toClinical Research Fraternity in India

Dr Bhatt delivered the prestigious Prof U K Sheth Oration in 2013.

Dr Bhatt is a qualified assessor for NABH Accreditation for Clinical Trials – sites,investigators and Ethics Committees.

Dr Bhatt has more than 150 publications in national and international journals.He runs a regular monthly column on “Good Clinical Practice – QuestionAnswers” and has published a book “Clinical Trials and “Good Clinical Practicein India – Questions and Answers”.

Dr Girish ChinnaswamyAssociate Professor,

Department of Medical Oncology, Tata Memorial Hospital

Girish Chinnaswamy completed his medical school and post graduate training in paediatrics at Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Pondicherry. He further underwent subspeciality training in paediatric and adolescent oncology at the Royal London and Newcastle Upon Tyne Hospitals in the United Kingdom. He subsequently pursued research in paediatric cancer pharmacology at the Northern Institute of Cancer Research, Newcastle University studying the pharmacokinetics and pharmacogenomics of anticancer drugs in Children. He has previously worked as a faculty in paediatric oncology at Christian Medical college hospital Vellore and is presently working as a consultant at Tata Memorial Hospital. His special interests are paediatric neuro-oncology and bone tumors in children.

Dr Sameer Shah Head, Department of Hepatology Institute of Liver Diseases,

HPB Surgery and Transplant at the Global hospital

Dr. Samir Shah is the Head, Department of Hepatology Institute of LiverDiseases, HPB Surgery and Transplant at the Global hospital, Mumbai, andvisiting consultant to Breach Candy Hospital.

He has been awarded the Hargobind Foundation Scholarship and trained inHepatology and Liver transplant at the Institute of Hepa tology, UniversityCollege London.

He was the first elected Secretary of the Indian Association for Study of theLiver for the period 1995-1997 and has been a Council Member ofInternational Liaison Committee, Asian Pacific Association for the Study ofthe Liver (APASL).

He has been involved with several international clinical trials on new drugdevelopment with presentations in international meetings and publicationsin peer reviewed journals.

He has been the driving force to co-ordinate efforts to start a cadavericorgan transplant programme in the country and Mumbai in particular.

Member of the Editorial Board of Indian Journal of Gastroenterology,National Advisory Board of the Journal of the Association of Physician ofIndia (JAPI) Editorial Board Member, Journal of Clinical and ExperimentalHepatology.

Founder Trustee and the Hon.Gen. Secretary of the National LiverFoundation.

Founder Member, Coalition to Eradicate Viral Hepatitis in Asia Pacific(CEVHAP).

Expert, Core Advisory, Group on Viral Hepatitis, ICMR.

Ms Vandana Gupta Founder, V Care Foundation

Driven by the axiom “Together we can and we will conquer cancer”, Vandana was inspired to setup V Care Foundation in 1994 after she successfully conquered cancer. Based on her personaljourney of managing cancer, Vandana was determined to fill the gap cancer patients and theircaregivers feel as they battle the disease.

A strong advocate of patient care and caregiver support, Vandana leads from the forefront toensure V care Foundation helps them face cancer with hope, confidence and maintain a goodquality of life.

Vandana is passionate about bringing value to the lives of cancer patients and spends a significantamount of time serving and meeting patients and their families. She is driven by the motivation toease this difficult emotional and physical journey from diagnosis to treatment for patients.

Vandana acts as a strong advocate for cancer awareness and has presented at several national andinternational forums on ethical treatment and need of cancer care in India. She has receivedseveral accolades for her work and vision.

Vandana manages a team of 60 dedicated volunteers and 10 employees, to lead V CareFoundation’s national efforts towards providing emotional assistance, financial aid, nutritionalsupport, paediatric cancer care, palliative care and managing a compassionate medicine assistanceprogram for a multinational company. Today, V Care is associated with voluntary work at TataMemorial Cancer Hospital & Research Centre, Nanavati Hospital, Leelavati Hospital, Breach CandyNursing Home and Jaslok Hospital.

She has also played a key role in bring global exposure and expertise to V Care Foundation throughaffiliations with American Cancer Society, International Kidney Cancer Coalition and LymphomaCoalition.

Vandana has two papers published in the Perspective in Clinical Research in 2013 and 2016 , titled“What I wish every doctor knew: A patient perspective” and “Involvement of general public inbiomedical research”. Vandana was also part of the ASCO panel in development and publication of“Secondary prevention of cervical cancer; American society of clinical oncology resource-stratifiedclinical practical guide 2016”.

She has a Masters in English Literature, and a certification in child development. She has thehonour of being the first fellow of the International partner program by American Cancer Society.Currently, she is the chairperson of the ethics committee of Breach Candy hospital in Mumbai.

Dr Gouri Pantvaidya, MS,DNB,MRCS.Professor,

Department of Head & Neck Surgery, TMH Dr Gouri Pantvaidya, MS,DNB,MRCS.

Professor,

Department of Head & Neck Surgery,

Secretary, Data Safety Monitoring Unit

Tata Memorial Hospital,

Parel, Mumbai

Dr. Partha GokhaleHead Clinical Operations-

Boehringer Ingelheim India Dr. Partha Gokhale is the Head Clinical

Operations- Boehringer Ingelheim India. Partha isa medical doctor and has done his post-graduation in Pharmacology. He is a M.D, D.N.B(Pharmacology) and is also a certified lawyer(L.L.B). During the last 18 yrs, Partha has beeninvolved in increasing responsibilities in clinicalresearch from clinical protocol development,medical monitoring to increasing managerialpositions in clinical research. He was instrumentalin setting up the clinical research departments ofBoehringer Ingelheim India Pvt Ltd and assisted insetting up the clinical research department atWyeth Pharmaceuticals India. Dr Partha Gokhaleis the Chair of the Ethics council of Indian SocietyFor Clinical Research.

Dr.Durga GadgilResearch Consultant, Tata Memorial Centre

Durga Gadgil, an independent clinical research consultant, is currently working also as aconsultant with the Tata Memorial Administrative and Research Council (TRAC). She is thechief coordinator for the two-year MSc in Clinical Research course conducted by the TataMemorial Centre under the Homi Bhabha National Institute. She is also a GCP Trainer andconducts workshops and seminars for the same. Besides, she is instrumental in setting upthe National Cancer Grid Contract Research Organization (NCG CRO) at TMH in 2017,which monitors NCG funded, multicentric studies carried out in India. At present 4 CRAsand one Project Manager report to her in the NCG CRO, who monitor 9 NCG fundedMulticentre studies in India.

She has 31 years of experience in the pharmaceutical industry and retired in November2015 as Area Head, Asia Pacific, Regional Medical Monitoring Organization, Pfizer. In thisrole, she was the line manager for medical monitors based in Australia, India, Singapore,Hong Kong, China, Korea, Taiwan and Philippines. The team was responsible formonitoring all global studies from Phase 2 to 4 for medical aspects, ensuring patienteligibility, protocol adherence, data integrity and quality, in compliance with local andglobal ethical principles.

Durga is a certified NABH assessor for NABH Accreditation Standards for Clinical Trials(Ethics Committee, Investigator, and Clinical Trial Site)

During her career span of 30+ years, she has worked in many pharmaceutical companies,all MNCs and one India company. She has experience in all fields related to a medicaldoctor’s role in the industry, like medico-marketing support, regulatory activities,pharmacovigilance and safety reporting, clinical operations, medical monitoring, auditingand training.

Dr. Pooja Sharma Senior Scientist and Head,

Medanta institute of Education and Research A gynaecologist and clinical researcher with 18 years of research

expertise.

Has spearheaded the establishment of two clinical researchinstitutions at Society for Applied Studies and the MedantaInstitute of Education and Research, in addition to the MedantaPublic Health Initiatives Unit and recently the Medanta Foundation.

An investigator who has conducted vaccine trials for Rotavac, Chikvand Japanese Encephalitis.

Has special interest in bioethics and has served on several Ethicscommittees, like those at Medanta, Genebandhu, National Brainresearch center and the Indian Spinal Injuries center.

Works in the area of patient advocacy for research and is foundersecretary of PARTAKE (NGO for Patient Awareness of Research andTherapeutic Advancements for Knowledge and Empowerment) andworks with several patient support groups towards creatingresearch awareness in patients.

Dr. Manjunath KDeputy General Manager Clinical R&D,

Zydus Research Center Cadila Healthcare A pharmaceutical physician with more than 14 years of

experience in clinical research/clinical development. The leadrole in the medical and scientific affairs of various global clinicaldevelopment programs for new chemical entities, biosimilars,new drug delivery systems, translational research and genericsdevelopment.

An extensive experience in strategizing and developing theentire global clinical development pathway for drugs in manydifferent therapeutic areas with notable experience in oncology,hepatology and biosimilars development. The lead role ininteracting with the global regulatory agencies, specifically theUnited States food and drug administration, Europeanmedicines agency, Medicines and healthcare productsregulatory agency, United Kingdom, the Indian council ofmedical research and the Drug controller general of India.

Medical monitoring and safety monitoring experience acrossearly and late phase clinical trials in multiple therapeutic areas.

Dr. Sandhya KamatHead of Dept, Pharmacology, KEM Hospital

Dr. Sandhya Kamat is Professor and Head at the Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai. She has an M.D. in Pharmacology from the University of Mumbai.

Dr. Kamat is the Chairperson of the on the Institutional Animal Ethics Committee of the Institute. She also serves on the Institutional Ethics Committees of Nowrosjee Wadia Hospital and Bai Jerbai Wadia Hospital and on the Independent Ethics Committee, Mumbai. She was the member secretary of the Institutional Ethics Committee of Seth GS Medical College & KEM Hospital from 2002-2006 after which she continued to be member till 2011. Dr. Kamat is a founder Member and treasurer of the Forum for Ethical Review Committees in the India (FERCI)

Her main areas of research interest include cardiovascular and gastrointestinal pharmacology, herbal medicines and rational use of medicines. She and her team have won several prizes in scientific conferences. Dr. Kamat has undergone training in GCP and ethics and has been a faculty for several workshops on Research Methodology and Ethical Aspects of Research.

Dr. Nithya GogtayAdditional Professor in Clinical Pharmacology, KEM

Hospital, Mumbai Currently working as Additional Professor in the

Department of Clinical Pharmacology Seth GS Medical College & KEM Hospital, Mumbai (Bombay, India.

Have over 100 peer reviewed publications to my credit. Received special training in Pharmacovigilance at the Uppsala Monitoring Centre, Sweden in 1996 and Bioethics at the Thammasat University, Thailand in 2005. Also trained in biostatistics through training programs of the NIH USA and Christian Medical College, Vellore, India from 2000-2010.

Serves on the Editorial board of the Journal of Association of Physicians of India and has been the past Editor [2012-2016] of the Journal of Postgraduate Medicine.

Have done 25 GCP clinical studies and guided 10 Masters students and is guiding 3 PhD students.

Also serves on the boards of several IRBs in the city.

Dr. Sameer BakhshiDepartment of Medical Oncology

Dr. B. R. A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences• Professor, Department of Medical Oncology,

Dr. BRA Institute Rotary Cancer Hospital,

All India Institute of Medical Sciences, New Delhi

• Faculty since 2002 at AIIMS

• Ex-Member Secretary of AIIMS Ethics Committee

• SEC Member for CDSCO Oncology Related Drugs

• Areas of interest:

Leukemias, Sarcomas and Supportive Care in Cancer

• Published more than 350 peer review articles

Dr. Sujeet RajanConsultant Respiratory Physician, Interstitial Lung

Diseases/ILD Clinic, Bombay Hospital Institute of Medical Sciences and Bhatia Hospital

Sujeet Rajan is a respiratory Physician who graduated from the Grant Medical College in 1989 and Post-graduated in respiratory medicine from the Seth. GS Medical College and KEM Hospital in 1994.

He Joined the Bhatia Hospital in Mumbai in 1996 and subsequently also joined the Bombay Hospital Institute of Medical Sciences from August of 2000. He has been actively involved in teaching, research and clinical practice at these 2 Hospitals.

His areas of interest are interstitial lung disease, airway disease, sleep disorders and patient communication, and he is also in the process of setting up and ILD clinic to run twice a week.

He is currently the European Respiratory Society’s National Representative from india and also the Indian Editorial Adviser for the American Journal of Respiratory and Critical Care Medicine, and has 34 publications to his credit

Dr.Denis Xavier

St.John’s Medical College, Bangalore

Vice-Dean (PG), Professor of Pharmacology and Head, Div. of Clinical Research at St. John’s Medical College and

Research Institute, India.

Vice President of SOCHARA – an NGO for health; 2019 onwards.

Executive Committee member of Indian Society for Clinical Research (ISCR) and National Convener of its Academic Consortium for Clinical Research in India (ACCRI).

Under graduation and post graduation training at St. John’s and a Masters in Clinical Epidemiology at McMaster University, Canada.

Helped set up the Clinical Research Division at St. John’s in 1999 with collaborations in about 180 Centers across India and 2 other Asian countries; to date recruited over 95,000 subjects in over 30 large projects.

He has or is serving on about 25 international research steering committees.

Principal Investigator of the NIH (USA) Center of Excellence to counter chronic diseases (2009-14).

He runs courses in Research Methods, Biostatistics and Evidence Based Medicine since 2009, trained about 2000 from India and 7 other countries in 23 courses.

Received research grants from the NIH (USA), CIHR (Canada), NHMRC (Australia), UK- MRC, WellcomeTrust, ICMR etc.

He has over 120 papers in journals such as the Lancet, NEJM, JAMA, BMJ, Circulation, Eur Heart J, Heart, AHJ, Nature CV, IHJ etc., 6 book chapters and is Section Editor of a cardiology textbook.

Editorial Board of JACC, Nature Cardiology, RUHS and Preventive Cardiology.

Formerly Chairperson of the Narayana Health Academic Ethics Committee and Member of NIMHANS ethics committee.

Task force member of ICMR (4 projects), Advisory Board of BIRAC (DST, Govt. of India)

Delivered invited lectures at

◦ Oxford University, UK;

◦ McMaster University, and University of Toronto, Canada;

◦ Harvard, Stanford, Duke and North Western Universities, USA.

Xavier has also delivered invited lectures at the World Congress of Cardiology, Dubai 2012 (2 lectures), Melbourne Australia 2014 (2 lectures), American Heart Association’s International Stroke Conference, Los Angeles 2016, World Stroke Congress (2016) and American College of Cardiology, New Orleans, USA (2016).

Dr. Ramesh Jagannathan

MBBS, MD, MSc (Pharm)Clinical Research Consultant,

Bengaluru

Medical doctor (MBBS) with MD (Pharmacology) from B.J. Medical College and Sassoon Hospitals, Pune and

a Master's research degree in Experimental Pharmacology from a Public University Medical School in USA

Currently, he is a Clinical Research consultant and has 20 years’ experience in Pharmaceutical Industry, worked in different leadership and managerial roles:

• Head-Clinical Development at Biocon Research Ltd.;

• Medical Director at Novo Nordisk India Pvt. Ltd.;

• Director-Clinical Research, Associate Director-Medical affairs and others at AstraZeneca Pharma India Ltd.;

• Head-Clinical Development, Global Medical Affairs, Dr Reddy’s Labs Ltd.

Member, Indian Society for Clinical Research (ISCR) since 2009; currently EC member and past South Chapter Head (2014-2018)

Has organized and/or contributed as Speaker to over 60 meetings/programmes, including major Conferences (National/Regional) and workshops in Clinical Research

He has experience in areas of Commercial (Medical affairs, Medico-marketing) and R&D (Clinical Development, Clinical Trials and Medical Science) roles.

Dr. Yashashri Shetty Associate Professor, in the Department of Pharmacology &

Therapeutics, Seth GS Medical College & KEM Hospital

Dr Yashashri Shetty is currently working as Associate Professor, in the Departmentof Pharmacology & Therapeutics, Seth GS Medical College & KEM Hospital. She isbeing trained at international workshops in rational use of medicines incommunity, PK – PD modeling, Medical Statistics and Medical writing.

She has 16 years of experience of undergraduate and 10 years of post-graduatetraining. She has 12 years’ experience of being a part of Ethics committee and 5years as Member Secretary, and now currently working as Joint Member secretaryof Institutional Ethics committee II (IEC II), at Seth GS Medical College & KEMHospital, and member of Institutional Ethics committee II (IEC -II) of Tata memorialHospital.

She and her team had contributed in the Institutional Ethics CommitteeAccreditation (SIDCER-FERCAP) which was first of his kind in the country as well asin NABH accreditation. She is been a trained International surveyor for Ethicscommittee and had surveyed 9 Ethics Committees for International FERCAP SIDCERrecognition at national as well international level. She is also undergraduatePharmacology Quiz In-charge from last 10 years and her team has won nearby 9state level quizzes.

She is one of the authors of the chapter “Ethical review process” in ICMR 2017guidelines. She is author of 6 manuals the subjects ranging from StandardOperating Procedure of ethics committee, manuals on prescription writing, SLOs inPharmacology’ and “Neuropharmacology”

She is a recipient of 31 awards for her research in the field of pharmacology andresearch ethics including the prestigious Achari Award at national level and 2papers at international forum.

She has experience of working as Investigator in many animal studies and clinicalstudies in the area of Rational use of Medicines, Pharmacoeconomics, ResearchEthics and neuropharmacology. She has over 70 publications in peer reviewedjournals.

Ms Indu NambiarSenior Manager – Local Pharmacovigilance /

LPVM, Boehringer Ingelheim Ms. Indu Nambiar, is a Home Science Graduate with

Majors in Nutrition. She pursued her P. G Diploma in Dietetics, and is a registered Dietician.

Currently holds the position of Head - Pharmacovigilanceat Boehringer Ingelheim India Pvt. Ltd. She started her career in the Pharmacovigilance field in 2006, when she joined Novartis India Ltd. as Executive – Drug safety & Epidemiology (DS&E) and was associated with Novartis for the next 5 years.

She is a life time member of ISCR and was instrumental in the formation of the PV working Group within ISCR in 2014. She was the Co-Chair for the PV council from its inception for 4 years (2015 – 2019).

Has been awarded for her consistency in being compliant to the ever changing regulations and received accolades from her Global PV team for innovations within the function.

She has been a resource person in several National and International Pharmacovigilance conferences.

Sachin MangalvedhekarAssociate Director,

Novartis Sachin Mangalvedhekar is an Associate Director with Novartis based out of

Hyderabad. He has been with the QA department of Novartis since 2015. In thisrole Sachin is a Data Integrity Lead for GDD Hyderabad and drives qualitycapability development through several training programs and supports audits,self-inspections and anytime inspection readiness.

Sachin began his career as a clinical pharmacist, followed by CRA role where heworked with CROs and GlaxoSmithKline Mumbai for close to 5 years.

In a career spanning over 20 years, Sachin has performed various roles such asproject manager, senior project manager in SIRO ClinPharm and also head ofclinical operations group at Sun Pharma Advanced Research Company Limited(SPARC).

Sachin is a lifetime member of FERCI- Forum for Ethical Committee Review inIndia (FERCI) and RQA – Research Quality Association.

By qualification, Sachin is a pharmacist with B Pharm and M Tech in PharmaOperations and Management from BITS Pilani.

Given his passion for quality and training, Sachin has trained/ mentored morethan 150 associates, led 3 regulatory inspections, several audits and has 7publications in the field of pharmacovigilance.

In his free time, Sachin likes to spend time with his family that comprises his wifeChitra who is into clinical research training and daughter Saisha who is in grade 8.He also gives career guidance to new as well as experienced associates.

Suhail AliExec. Director – Project Management, Global

Oncology & Hematology, Syneos Health An experienced Clinical Research professional with more than 18 years

of experience in Clinical Project Management, Clinical Operations, Teammanagement and Regional Leadership.

In depth operational experience in various phases of clinical researchfrom phase I to IV. Served as Global Operations Lead on many ClinicalDevelopment Programmes and played an important role in

bringing novel drugs and vaccines to market. During career span workedfor Global Pharma, Biotech and CRO companies gaining a good insight ofclinical development, resource optimization and outsourcing models.

Exposed to a broad range of therapeutic areas including Oncology,Cancer immunotherapeutics,Immunology, Pediatrics, MetabolicDisorders, Anti infectives, Nephrology and Psychiatry. Specific

expertise and experience in running studies across diverse geographicterritories including Asia pacific, EU, Middle East and Africa, Japan andLatin America. Strong hands on experience and involvement in studiesinvolving China, Japan, Australia and other APAC countries.

Holds Masters degree in Pharmacy, is Board Certified Medical AffairsSpecialist, registered pharmacist with Delhi Pharmacy Council, lifemember of Indian Pharmaceutical Association and member of ProjectManagement Institute, USA and Singapore chapters. Executive boardand founding member of Association of Pharmaceutical Medicine,Singapore (APMS).’

Partha Chatterjee Head of Clinical Research, CTS and in charge of

Clinical Operations, Siro ClinPharm Mr. Partha Chatterjee is the Head of Clinical Research, CTS and

in charge of Clinical Operations at Siro.

Mr. Chatterjee joined Siro Clinpharm in 1998 as a Clinical Research Associate and slowly grew up the ladder to lead the global clinical operations panning across 10 countries. His knowledge and expertise has been pivotal in managing numerous key clinical trials across multiple therapeutic areas such as oncology, nephrology, endocrinology, infectious diseases etc. His leadership has facilitated the Clinical Operations team to successfully execute complex clinical trials across diverse domains like Epidemiology, Medical Devices, and Food & Nutritional products. It has also allowed for Siro¹s diversification into new arenas like the booming FMCG sector.

A post-graduate in Microbiology from the Institute of Science, Partha is an influential member of the Indian Society of Clinical Research. He has been actively involved in the drive to transform the Indian Clinical Research scenario and his contributions and suggestions have been crucial in shaping the way forward.