DAY WISE SPEAKER LIST
Day 1: (Mon) 7 March 2022 | Framework for Successful Lead Optimization
Director South Asia (India) at Drug for Neglected Diseases Initiative ( DNDi)
Dr Singh is a senior medical professional with an extensive knowledge and in-depth understanding of healthcare product development and Indian R&D eco-system. She has worked in leadership positions across pharmaceutical/biotech industry, government, and not-for-profit organizations. She served as Mission Director, National Biopharma Mission, Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Undertaking of Department of Biotechnology (DBT), Ministry of Science & Technology, Govt. of India; as Program Director, Multi Vaccines Development Program; as Director, Business Development at Fortis Clinical Research Limited, etc. These are a few important roles she has essayed in her career spanning more than twenty years.
Dr Singh is a life member of the Indian Association of Medical Microbiologists and Indian Society of Clinical Research. She is a member of WHO’s Product Development Vaccine Advisory Committee (PDVAC).
She currently holds an important portfolio as Director South Asia DNDi.
General Secretary of Indian Society for Clinical Research (ISCR) for 2019-21 and President (Elect) for 2021-23
Dr Sanish Davis has been in the clinical Research industry for over 17 years and has worked on both sides of the fence – in academia as well as in Pharmaceutical Industry. He is currently R&D Director, Global Clinical Operations, Johnson & Johnson India where he also is involved in Portfolio prioritization for New Product planning. He has worked in the domains of clinical development & Regulatory strategy for development of compounds for Emerging markets. He has an active interest in external environment shaping activities in clinical research and in operationalizing “ethics” in Industry research. He is also General Secretary of Indian Society for Clinical Research (ISCR) for 2019-21 and President (Elect) for 2021-23. He has a Postdoctoral degree in Clinical Pharmacology (D.M) and postgraduate and graduate degrees in Pharmacology and Medicine (M.D). He is also a Fellow of American College of Clinical Pharmacology (FCP).
Director, Venture Center | Head, NCL Innovations
Premnath V is currently the Head, National Chemical Laboratory (NCL) Innovations – the group within NCL charged with the responsibility of championing the cause of technology innovation within NCL. Dr Premnath is also the Founding Director of the Venture Center – a technology business incubator on NCL campus. Dr Premnath is also a Scientist, Polymer Science & Engineering Division at NCL with an interest in technology development for biomedical products. He holds a B. Tech. from the Indian Institute of Technology – Bombay and a Ph.D. from the Massachusetts Institute of Technology, USA. He has also been a Chevening Technology Enterprise Fellow with the Centre for Scientific Enterprises, London Business School and Cambridge University, UK. He brings with him considerable experience in technology development and commercialization (two successfully commercialized families of products), working with start-up companies (in Cambridge-UK and India) and engaging with large corporations on research and consulting projects as project leader.
Executive Director of THSTI, Faridabad
Dr. Pramod Garg, currently the Executive Director of THSTI, Faridabad, is a Professor of Gastroenterology and former Associate Dean (Research) at the All India Institute of Medical Sciences, New Delhi. He is an internationally renowned physician scientist with significant research contribution in the field of pancreatic diseases. He has published >200 original articles including several seminal papers. He is a JC Bose Fellow and a Fellow of Indian National Science Academy (FNA), Indian Academy of Sciences (FASc), National Academy of Sciences (FNASc), Fellow of National Academy of Medical Sciences (FAMS), India and Royal College of Physicians (FRCP) (Glasg). He has been conferred with many awards including ‘Om Prakash Bhasin Award’ in ‘Health & Medical Sciences’, ‘Basanti Devi Amir Chand Prize’ for excellence in Biomedical research presented by ICMR, and ‘Hoechst Om Prakash Award’ by the Indian Society of Gastroenterology for outstanding contribution to Gastroenterology. He is an Editor/ Editorial board member of many international journals. He serves as Chair/ co-chair of various research committees in the Department of Health Research, ICMR, and DBT.
Discovery Open Innovation Leader at the Drugs for Neglected Diseases Initiative (DNDi)
Dr Perry joined DNDi in April 2015 in as project manager of the NTD Drug Discovery Booster project. Dr Perry is a medicinal chemist with 13 years’ experience conducting early stage drug discovery across a variety of disease indications including oncology, autoimmune disorders and psychiatry. Dr Perry has held research positions at the University of Colorado (US), Celltech (UK), and UCB (UK; Belgium). Most recently Dr Perry was Associate Director, Medicinal Chemistry at Addex Pharmaceuticals (Switzerland). His areas of research interest include the use of chemoinformatic and computational tools within medicinal chemistry, and the use of new technologies and research collaborations to further the drug discovery process.Dr Perry holds a Master’s degree in Chemistry from the University of Wales, Swansea, and a PhD from Imperial College London
Division of Biological Chemistry and Drug Discovery, School of Life Sciences, Sir James Black Centre, University of Dundee, Dundee, DD1 5EH, UK.
Prof Ian Gilbert is currently the head of Division of Biological Chemistry and Drug Discovery, School of Life Sciences, Sir James Black Centre, University of Dundee. He is a medicinal chemist. His research interests are in drug discovery, particularly focused on infectious diseases. He is interested in the design and synthesis of potential new therapeutic agents and computational chemistry approaches to drug discovery. He is also interested in mode of action studies, deconvolution of the molecular targets of phenotypically active molecules.
Operations Lead, Medicines for Malaria Venture
Dr Kirandeep Samby is a Drug Discovery leader with 20 years of experience in Medicinal Chemistry and moving molecules through various stages of discovery to translation. Responsible for providing leadership to multiple project teams and managing a diverse portfolio of projects in various stages from conception to candidate nomination. Possess established track record and passion for creating alliances and implement programs in areas of global health. Armed with a PhD in Organic Chemistry from Delhi University, she began her career as a medicinal chemist with Ranbaxy Research Laboratories in India,
working in the area of urology, respiratory and metabolic disorders. She then worked with Daiichi Sankyo (RCI), leading group of medicinal and computational chemists in the research areas of infection and inflammation. She is a coinventor of three IND molecules for overactive bladder and severe asthma.
Research Associate Professor at Northeastern University, Department of Chemistry and Chemical Biology, Boston, USA
Dr. Ferrins’ research is focused on drug discovery for Neglected Tropical Diseases (NTDs), which are a collection of 20 communicable diseases as defined by the World Health Organization. Currently, she is leading three projects in the Pollastri lab which focus on repurposing known human kinase inhibitors for use against the parasites responsible for malaria (P. falciparum), and the NTDs human African trypanosomiasis (Trypanosoma brucei), Chagas disease (T. cruzi), leishmaniasis (Leishmania spp.), and schistosomiasis (S. mansoni).
Dr. Ferrins has also been involved with the International Younger Chemists Network (IYCN) since early 2017, first as chair of the Public Outreach Subcommittee and more recently as the vice-chair of the organization. The goal of IYCN is to reach like-minded scientists and create a platform for scientific exchange. With a focus on building a global network, IYCN is working to spread scientific knowledge, mentorship, and encourage a passion for chemistry in all.
Day 2: (Tue) 8 March 2022 | Pharmaceutical Development
Head – Formulation Research Services at Aurigene Pharmaceutical Services Limited
Ravinder Kodipyaka comes with 26 + Years of experience and expertise in formulations space including pre-formulation, preclinical formulation design, formulation development, technology transfer and scale-up of solid oral and Injectable formulations, dossier leverage and project management. He has deep knowledge and experience in solubility and bioavailability enhancement of insoluble/poorly bioavailable molecules using different techniques/technologies including complexation, ASD (Amorphous Solid Dispersions), Lyophilization and Lipid based drug delivery systems. He has designed and developed multiple formulations in both Generics and NCE space many of which have been successfully commercialized in US and European markets. He has previously worked with Gufic, Zydus Cadila, Suven Life Sciences and Dr. Reddy’s Laboratories.
Ravinder has established track record on building R&D capabilities which include infrastructure, processes, systems and procedures in line with global regulatory requirements. Ravinder received Masters in Pharmacy from Kakatiya University (Warangal, India). Ravinder has published articles and filed 10+ patents in formulations research and development area.
Senior Group Leader at Syngene International Limited
Vivek Kumaravel is a Senior Group Leader at the Pharmaceutical development department at Syngene. He holds a Ph.D. in Pharmaceutical Sciences from the Maharaja Sayirao University, Vadodara, India with over 16 years of industrial experience in formulation development of various dosage forms (human and animal health), including solid orals, liquids, topicals and parenterals. Prior to joining Syngene in 2016, Vivek worked with Sun Pharma, Ranbaxy Laboratories Limited and Novartis. During this tenure, he has experience working on Oral Solid dosage form development (generics, 505b2 and FIH) and Technology Transfer.
Pharmaceutical Development Director at the Drugs for Neglected Diseases Initiative (DNDi)
Dr Stephen Robinson joined DNDi in May 2012 with responsibility for all Pharmaceutical Development (CMC) activities. Dr Robinson has over twenty years’ pharmaceutical industry experience gained in R&D, manufacturing and CMC project/portfoliomanagement roles. Prior to joining DNDi, he held several senior positions in Pfizer Worldwide R&D, including Director in Analytical R&D and Research Portfolio Director in Pharmaceutical Sciences. During this time he gained extensive experience of pharmaceutical development, quality and regulatory requirements, as well as managing international CMC teams to deliver three major projects.
Stephen has a PhD in physical organic/peptide chemistry from the Open University (1993) and an MBA from the University of Kent (2011). He is a Chartered Chemist and Fellow of the Royal Society of Chemistry in the UK
Day 3: (Wed) 9 March 2022 | PK-PD Relationships and Safety Pharmacology
Executive Director and DMPK LEAD Head, Drug Metabolism and Pharmacokinetics, IFM Therapeutics, Cambridge, Massachusetts, USA
Dr. Ayman El-Kattan is Executive Director and DMPK LEAD Head at IFM Therapeutics. Previously, he was the Associate Research Fellow at the Pharmacokinetics, Dynamics, and Metabolism Department, Pfizer Inc. Cambridge Laboratories where he worked for 17 years. He earned his bachelor degree in pharmacy with distinction from University of Jordan and a Ph.D. in Basic Pharmaceutical Sciences at University of South Carolina in the US. His main research interests are focused on understanding the role of transporters in influencing drug disposition and oral absorption. Also, it involves studying the utility of physiological based pharmacokinetic modeling (PBPK) tools in projecting drug disposition and drug-drug interaction liabilities in man for new molecular entities (NME). He is also an Adjunct Professor at College of Pharmacy-University of Rhode Island in Rhode Island, US where he lectures in the graduate-level pharmacokinetic courses and serves as external advisor on dissertation committees. Dr. El-Kattan is active member of the American Association of Pharmaceutical Scientists (AAPS) and serves on the committee of the Drug Transporter community. He has been invited speaker over 50 times at national and international conferences and meetings and has published over 100 papers in peer-reviewed Journals and book chapters. Dr. El-Kattan also published a book by Wiley and titled: Oral Bioavailability Assessment: Basics and Strategies for Drug Discovery and Development (Wiley Series on Pharmaceutical Science and Biotechnology: Practices, Applications and Methods).
Clinical Liaison Expert – Branded Markets & Head DMPK – Proprietary Products, Dr. Reddy’s Laboratories
Over two decades of Pharmaceutical R&D experience in drug discovery research, clinical pharmacokinetics, differentiated formulations development and generics research, in numerous therapeutic areas. Ardent believer of success in research alike orchestra is an ultimate symphony of teamwork and collaboration. Integrator of product development strategies from concept to commercialization. Identified and build alliances for new and emerging technologies/platforms having possibilities of providing creative solutions and concepts for addressing challenging scientific problems.
Major research interest in predictive modeling and simulation to support designing formulations targeted to a differentiated profiles and establish translational models in early and late stage product development.
During the long-standing tenures in pharma companies acquired proficiency in people management, building and training highly motivated and delivery-oriented teams. Enjoy working with people – managing relationships and interactions by inspiring, motivating and empowering them to participate and act with accountability and transparency.
Vice President Subject Matter Expert – Safetry Assessment at Eurofins Advinus Limited
Dr. K.S. Rao (M.V.Sc., Ph. D, DABT), is a Board-Certified Toxicologist with more than 40 + years of global experience in safety evaluation. Started his career in 1971 at G.D. Searle and later moved to Dow Chemical and Quintiles, USA. After returning to India,
has been providing guidance on product development to hundreds of companies across the world with major emphasis on testing schemes/strategies and Risk Assessment. He is an Emeritus Member of the Society of Toxicology (SOT) in USA. Dr. Rao is the recipient of the Toxicologist Mentor Award from the Society of Toxicology (SOT). Dr. Rao is the First Indian origin to receive such an award in the 60-years history of the existence of the SOT.
Day 4: (Thu) 10 March 2022 | Toxicology and Toxicokinetic
Toxicology Project Lead, Bayer AG Pharmaceuticals
Dr. Senthilkumar Mariappan is a Veterinarian by training with Masters in Veterinary Pathology and a Toxicologist by profession in Pharmaceutical Industry for the past 15 years. He is an expert leading development of new molecules/ differentiated medicines/ standard and complex generics where his primary role is to design and execute required studies, generating integrated summaries and ensuring successful regulatory submissions as a Regulatory Toxicologist . During the early part of his career, he worked for CROs in India as a Toxicology Study Director.
Later he established himself as a Project Toxicologist in development of NCEs and generics in India before relocating to Germany in 2016 where he was associated with Sandoz International Ltd, a Novartis company and involved in development and registration of standard/ complex generics and differentiated medicines. He is currently working for Bayer Pharmaceuticals in Germany where he is associated with supporting development projects of diverse modalities (small and large novel molecules) as Toxicology Project Lead. He is a Board certified (DABT) and European-registered Toxicologist (ERT) and also a Board certified Regulatory Affairs Professional (RAC).
Associate Director at Absorption Systems
Dr. Venkata Mukkavilli is a Drug Metabolism and Pharmacokinetics executive with pharmaceutical R&D and CRO experience. Venkata has Ph.D. in Drug Metabolism and Pharmacokinetics; M.S. in Analytical Chemistry and M.S. in Organic Chemistry. He has supervised and mentored in-vitro ADME, in-vivo pharmacokinetics (PK), toxicokinetics, bioanalytical mass spectrometry, and business operations groups. He is a central conduit in collaborating with project teams for lead selection and optimization across various therapeutic areas. He has authored and reviewed developmental plans and IND documents for first-in-
human clinical trial approvals. Published innovative findings in 23 peer-reviewed articles, contributed to book chapters and two patent applications.
Independent expert in Toxicology and Toxicologic Pathology
Dr. Nigel Roome MSc PhD worked in the Pharmaceutical Industry for more than the last 35 years as a Pathologist and Toxicologist with Sanofi or its’ previously incorporated companies. He is currently an independent expert in Toxicology and Toxicologic Pathology working with a wide variety of small and large pharmaceutical companies, Non-Governmental Oganizations (NGOs) and consulting firms on scientific problem solving for toxicology and pathology issues, dossier preparation, review and submission, in addition to due diligences and interactions with regulatory agencies. He is also involved in teaching on several European and International programs. He is based in Paris, France.
Nonclinical Development Senior Manager at the Drugs for Neglected Diseases Initiative (DNDi)
Stéphanie Braillard, as Nonclinical Development Senior Manager, is a member of the DNDi Translational Sciences team since 2019. She is responsible for all nonclinical matters through the portfolio as soon as a compound is entering into the preclinical phase. Before that role and since 2011, she was part of DNDi Discovery team and was contributing to Lead Optimisation and preclinical projects.
She previously served as Scientist in various biotech companies in the fields of anti-bacterial drug discovery and development of treatments for onco-urology diseases.
Ms. Braillard obtained a master’s degree in Molecular and Cellular Biology from the University of Lausanne.
Day 5: (Fri) 11 March 2022 | Goalpost: First in Human Clinical Trial
Head of Translational Sciences at the Drugs for Neglected Diseases Initiative (DNDi), Geneva
Dr Jean-Yves Gillon joined DNDi as Head of Translational Sciences in 2016 and is responsible for advancing the development of new investigational drugs from preclinical to early clinical development. In this role, he has led the Phase 1 development of the anti-filarial drug Emodepside and the First in Human studies with the Leishmaniasis drugs DNDI-0690 and DNDI-6148. He has also contributed to the preclinical development of several other NCEs and to the understanding of the pharmacokinetics characteristics of several advanced drug candidates, including through in-silico models.
Prior to joining DNDi, he was Director of Drug Development at Innovative Medicines For Tuberculosis (IM4TB), a spin-off of the Swiss Federal Polytechnic Institute in Lausanne, Switzerland and led the early development of the anti-tuberculosis drug PBTZ169 (Macozinone).
He has over 25 years of pharmaceutical industry experience gained in R&D and portfolio management roles in biotech, mid-size and big pharma companies and has led the preclinical and early clinical development of several new therapeutics for the treatment of cancer, auto-immune and infectious diseases.
Dr Gillon graduated in 1986 as PharmD and he was awarded a PhD in Neurosciences in 1989, both from Claude Bernard University, Lyon, France.
Medical practitioner and CEO of Richmond Pharmacology
Dr Jorg Taubel is medical practitioner and CEO of Richmond Pharmacology, a centre of excellence for phase I, II and III studies. A specialist in clinical pharmacology, Dr Taubel has extensive experience in cardiology, neurology, gastroenterology, and ethnic bridging studies. Dr Taubel has conducted over 500 clinical trials in many therapeutic areas but currently focuses on heart failure and diabetes.
Dr Jorg Taubel is a research fellow at the Molecular and Clinical Sciences Research Institute at St George’s University of London. He has a special interest in cardiac repolarisation changes related to iatrogenic interference with glucostasis. His most recent work involved dosing the first patient in a global FIH study of NTLA-2001 in patients with hereditary transthyretin amyloidosis with polyneuropathy. The first ever CRIPR treatment for TTR amyloidosis.
Dr Taubel has authored over 140 publications in peer reviewed journals and presented his research at international events in Europe, Japan and the USA.
Current President of the ‘Association Française de Pharmacologie Translationnelle (AFPT) – Le Club Phase 1’ and founding member of ‘The European Federation for Exploratory Medicines Development’ (EUFEMED)
Dr. Henri Caplain, MD, MSc, is a physician, independent senior adviser in early clinical development, translational pharmacology, and drug safety risk management. He is the current President of the ‘Association Française de Pharmacologie Translationnelle (AFPT) – Le Club Phase 1’ founding member of ‘The European Federation for Exploratory Medicines Development’ (EUFEMED). After 15 years as primary investigator for early phase clinical trials (particularly first-in-human in healthy subjects) and medical scientific director within an International CRO ‘Aster-Cephac Group’ based in Paris, he joined for 12 years the Sanofi-Synthelabo Research R&D as head of clinical pharmacology and Exploratory, member of the R&D board. He became associate VP, deputy-head of worldwide clinical pharmacology for Sanofi-Aventis R&D, then head of the risk management center of excellence within Sanofi, responsible of all DRMPs and RMPs, and member of the Benefit-Risk Assessment Committee chaired by the Sanofi Chief Medical Officer (CMO).
Senior Director, Child Health Innovation and Leadership Department (CHILD), Johnson and Johnson
Dr. Nambiar has expertise in pediatrics and pediatric infectious diseases and regulatory experience in the development of anti-infectives, including antibacterial, antifungal, antimycobacterial and anti-parasitic products. She worked in anti-infective product development at the US Food and Drug Administration for 22 years in different capacities, including 8 years as Director, Division of Anti-Infectives. In her current role, Dr. Nambiar provides scientific and regulatory expertise for the development of anti-infective products and vaccines for the pediatric population.
DAY WISE SESSION CHAIRS
Day 1: (Mon) 7 March 2022 | Framework for Successful Lead Optimization
Cofounder Sekkei Bio Pvt Ltd and Ex Bill & Melinda Gates Foundation, AstraZeneca, Biocon, Kinexum
Monalisa Chatterji, is an expert in early discovery having taken molecules from hit to Phase-1 clinical trials. She obtained Integrated M.S. & Ph.D.from Indian Institute of Science, India. She was awarded Young Scientist award, NASI, Govt of India for her doctoral research. She carried out postdoctoral research in David Schatz’s laboratory at Yale University, USA. Dr. Chatterji has 20+ years of experience, both in small molecules and biologics discovery and development, in AstraZeneca, and Biocon. She is the innovator for TBA-7371 (anti-infective), and T1h (Mab).During her career, Dr. Chatterji has led diverse functional domains and served as executive member for different consortia focused on drug discovery like MM4TB. She served as a Consultant with Kinexum Services, advising clients on aspects of pre-clinical drug development. Last three years, sheserved as Senior Program Officer, BMGF, Seattle, USA. She was responsible for discovery programs in tuberculosis and Covid19.She steered Covid19 preclinical therapeutics response and created a network of research groups focused on
therapeutics discovery. To support a coordinated Covid research, she has collaborated with WHO, DNDi, and NIH. She was part of CARE and ACT-Accelerator.
Chatterji is the co-founder of Sekkei BioPvt ltd which has developed computational workflows for the design of small molecules, peptides and proteins. The team is focused on building in country expertise in emerging technologies like mRNA platform. She has now relocated to Bangalore, India and is engaged as independent consultant.
Day 2: (Tue) 8 March 2022 | Pharmaceutical Development
Head of OSD R&D India , Mylan Laboratories Limited ( A Viatris Company) Hyderabad
Dr Amit Antarkar working in Pharmaceutical Formulation Research and Development from last 26 years. Well versed with Generic as well as NCE formulation development of various dosage form for Regulated, ROW and domestic markets . Well acquainted with Preformulation, technology transfer, manufacturing, regulatory and quality requirements of various dosage form.
Currently working as Head of OSD R&D India , Mylan Laboratories Limited ( A Viatris Company) Hyderabad . Before joining Mylan, worked for Teva, Actavis and Watson , Inventia , Cipla and Wander Ltd in their formulation research department. Amit completed his PhD in Pharmaceutical Technology from Mumbai University and B. Pharm and M.Pharm ( Pharmaceutics ) from University Department of Pharmaceutical Sciences, Nagpur University. More than 15 plus patents and publications.
Day 3: (Wed) 9 March 2022 | PK-PD Relationships and Safety Pharmacology
Founder Director and Chief Executive Officer of Foundation for Neglected Disease Research (FNDR)
Shridhar has more than 20 years of drug discovery and development experience in Indian pharmaceutical industry in various therapeutic areas. Shridhar holds a basic degree in Pharmaceutical Sciences from University of Mumbai, a PhD in Pharmacology from Ohio State University, and has post-doctoral experience in Neuropharmacology at the University of California, Los Angeles.
Shridhar, a serial entrepreneur, is currently Founder Director and Chief Executive Officer of Foundation for Neglected Disease Research (FNDR), a not for profit company with a mission to discover and develop drugs for diseases of the developing world. In this role, Shridhar has been responsible for the design and implementation of the scientific and business strategy for drug discovery and development, managing a team of scientists in chemistry, biology, DMPK, safety pharmacology, and regulatory toxicology and clinical development.
Prior to this, Shridhar was appointed Vice President and Head of Innovative Science for the Infection Innovative Medicines group at AstraZeneca, India and was responsible for the discovery and development of potential clinical candidates in TB and malaria.
Throughout his career, Shridhar has overseen the Discovery and Development of 1 drug and 18 clinical candidates in the areas of infection, oncology, diabetes, inflammation and respiratory diseases. He has also executed out-licensing deals with major pharma as well as in-licensing of candidates (NCE/NBE) which are in active development. This has generated revenues in excess of 180 million USD.
As part of FNDR, Shridhar has managed to raise donations worth 2.7 million USD from AstraZeneca, more than 2 million USD in grant money from the funding agencies and around 5 million USD in investment into preclinical and clinical asset development by partners over the last 4 years.
Shridhar is also the co-founder of Peptris Technologies Pvt. Ltd., an AI/ML company working in the discovery and development of new drugs.
Shridhar is a mentor to several start-ups, member of advisory boards, joint research committees, academic and industry collaborations and has served as a Ph.D. guide. Shridhar has more than 50 publications and 15 patents to his credit.
Day 4: (Thu) 10 March 2022 | Toxicology and Toxicokinetic
Chief Technical Officer at Bioneeds India Private Limited
Dr Nitin M Shetty is an experienced Toxicologist and Scientific administrator with a demonstrated history of working in the pharma and biotech industry. He has over 36 years of rich experience inclusive of 24 years in a leadership role in Preclinical drug discovery & development, Strategic Preclinical Business Planning, Research & Development, DMPK, Safety assessment, New Infrastructure Set-ups, Team building, Process Enhancements and Legal & Statutory Compliance in the Pre-clinical Business Domain. Currently he is working with Chief Technical Officer at Bioneeds India Private Limited, a Preclinical CRO with integrated discovery, development and Regulatory Services. He is a Life time member of the “Society of Toxicology, India (STOX).
Day 5: (Fri) 11 March 2022 | Goalpost: First in Human Clinical Trial
Global Chief Medical Officer at Cipla Ltd.
Dr Jaideep A Gogtay completed his medical graduation (M.B., B.S) from Grant Medical College and Sir J J Group of Hospitals in Mumbai. He then completed his M.D, in Pharmacology from Seth GS Medical College and KEM Hospital. During his post graduate days, he worked as a lecturer in pharmacology. Since 1994 he has been working with Cipla Ltd and is currently Global Chief Medical Officer. He has closely been involved in the development and introduction of several drugs in various therapeutic fields particularly HIV/AIDS, infectious diseases, and respiratory diseases. He has worked on several clinical trials in the field of asthma and COPD and infectious diseases. He has participated and spoken at several national and international forums and has been actively involved in educational activities. He was a member of the Association of Physicians of India guidelines 2005 on ‘Antiretroviral therapy’ and has more than 40 publications and over 50 presentations at conferences. He has also participated in several research methodology workshops
SESSION FACILITATORS
Dr. Geetanjali Uppal is a medical professional (MBBS, MD-Pharmacology) with about twenty years of experience in pharmaceutical industry conducting clinical trials, guiding drug development and new drug regulatory filings for Phase I/ II/ III clinical trials for investigational new drugs and vaccines. Worked as part of clinical and regulatory teams in Multi Vaccine Development Programme, erstwhile Ranbaxy Laboratories Limited now Sun Pharmaceuticals Pvt. Ltd and Dabur Research Foundation. She is the Founding Director, Saanvi Ethical Research LLP – a third party service provider for Pharma Industry and academia.
NonClinical Development Assosciate (Consultant)
Jayshree is pharmacologist by qualification, currently she is a part of Translational research, at DNDi. She is having prior experience of working with Dr. Reddy’s Lab, Hyderabad, and Bayer Zydus Pharma. Currently she is involved in preparing strategies for preclinical studies, coordinating with partners, CROs for successful execution of the studies and supporting regional office (India) for various activities
Amit Malik joined DNDi in January 2019 as Head of Operations of the Regional Office in India. Before joining DNDi, Amit was in finance leadership role with BBC Media Action, a UK international charity, specializing in development communication, based in Delhi, India. He has worked with different Country teams/offices in his past roles and has been instrumental in leading key strategic and financial insights to the business. Amit is a Chartered Accountant and PGDBM in Finance by qualification, with 18 years of experience in social and commercial sectors.
Mousumi Mondal is a senior manager at the Drugs for Neglected Diseases Initiative (DNDi) https://dndi.org/ and leads the business development and partnership in South Asia. Mousumi has more than two decades of cumulative experience in research, publication, and international partnership in the area of biomedical research and drug development. She is a Cell Biologist by training with her PhD from Jadavpur University, Kolkata and Post Doctoral Fellowship from Cornell Medical School, New York.
A senior project manager at the DNDi South Asia Office, Sauman holds engineering in biotechnology, an MPH (epidemiology) from École des Hautes Études en Santé Publique (EHESP, Paris) and masters in economic policy (University of Sorbonne Paris Cité) specializing on pharmaceutical markets. He finished his PhD in economics from the Aix-Marseille School of Economics, which focused on the access to essential medicines in Africa by analyzing the market entry and operation strategies of Indian pharmaceutical firms.
He is interested in access to pharmaceutical technologies and particularly in the model of “Knowledge Commons”.
Sauman has conducted successful fieldworks in India and Africa and has experience of working in a multicultural environment. Most recently, he worked as a WHO/TDR fellow at the University of Oxford and currently working as a consultant for DNDi. His experience has allowed him to build expertise on pharmaceutical regulations, intellectual property rights including TRIPS, Doha Declaration, and TRIPS+ provisions, organization of pharmaceutical markets in Africa as well as alternative models of drug development and access.
He teaches a course on pharmaceutical markets and regulations at EHESP and an organizing member of the Young Scholar’s Initiative (YSI).
Manisha Sharma is the Regional Communications Manager for the South Asia office of the Drugs for Neglected Diseases initiative. Manisha has over 20 years of experience working in field of media and communications. She holds a master’s degree in English literature as well in Journalism and Mass Communication. She also holds a Human Rights postgraduate diploma. She had worked for international organizations such as the German Development Corporation (GIZ), Oxfam, and the International HIV/AIDS Alliance before joining DNDi. She has worked as a full time journalist for The Hindustan Times and The Times of India, two of India’s most widely circulated English daily for a decade.
A Biotechnology Post graduate with Post Graduate Diploma in Clinical Research.
He has over 14 years of experience in pharmaceutical Industry with expertise in planning, organizing & controlling clinical research projects, project management and accountable for the successful delivery of all assigned projects and to provide customer-focused leadership in managing Phase II-IV clinical trials across various therapeutic indications. He has worked across various therapeutic areas like oncology, Infections/Parasitic Diseases, CNS, Ophthalmology, Hypertensive Disease, Musculoskeletal etc. He has exposure to CRO as well as pharmaceutical organizations with industry insight.
Smita as part of incubation team, facilitates incubator operations by interacting with incubatees, infrastructure and facilities creation and development of the ecosystem. She is leading Bio-incubation activities, Center for Biopharma Analysis (CBA) and BIRAC’s Regional Bioinnovation Center (BRBC) projects at Venture Center. She is actively involved in mentoring startups at Venture Center. She is Ph. D in Pharmaceutical Chemistry from Institute of Chemical Technology, Mumbai and prior to joining Venture Center has had academic experience of 12 years which includes research experience of 3.6 years
Akhila is a microbiologist post-graduate by qualification. Currently, she is Sr. Associate Quality Assurance at Venture Center. She is having 5+ years of experience as a Quality Control professional with Biocon Biologics Ltd and Emcure Pharmaceuticals Ltd. She is currently involved in reviewing and maintaining compliance with GLP standards and regulatory, coordinating with Sponsor, Lab team in conducting and inspecting studies.
