Dr. Tausif Monif - President – Global Operations
President – Global Operations
Dr Tausif brings with him a rich experience of more than 24 years in the Clinical Research Industry.
During his tenure with Ranbaxy and subsequently Sun Pharmaceuticals, he played a pivotal role in the success of the company’s multiple marketing authorizations in the US, EU and RoW markets. He was also in parallel heading their Clinical Operations in Eastern Europe.
He has numerous publications and academic accreditations to his credit and has successfully faced multiple Regulatory Audits across the world in his illustrious career.
His last assignment was as Vice President-Sun Pharmaceuticals heading their Clinical Pharmacology and Pharmacokinetic division globally and played a pivotal role in advancing their New Drug Development portfolio with his varied experience.
Dr. Mrinal Kammili - Business Development (Global)
Member of Board of Directors and Global Head – Business Development
Dr. Kammili possesses more than 22 years of combined industry experience, in Hospital and Clinical Research domains in the Health Care Industry. Dr. Kammili is ICH-GCP certified, well versed in Indian and International Regulatory guidelines applicable to Bioequivalence and Bioavailability studies, Phase 1, Phase II-IV Trials, Medical Writing, Data Management, Pharmacovigilance and Medical Imaging.
Presently, Dr. Kammili is a member on the Board of Directors and Global Head–Business Development for International (US / EU / Turkey / S.E. Asia / ROW and Emerging) markets and Indian domestic market.
He is actively involved in all M&A activities of Lambda group of companies and as a successful P&L executive, has built and managed teams to deliver stretched goals with high profitability by creating improved systems, processes and synergies within the organizations to build efficiencies, credibility and trust among the stakeholders.
Apart from the Clinical Research Domain, Dr. Kammili is also a trained Intensivist, having assisted in various Interventional Cardiac emergency procedures like Primary Angioplasties, Coronary Angiograms, and Thrombolytic therapies.
He is also a certified Basic Life Support (BLS) and Advanced Cardiac Life Support (ACLS) provider by the American Heart Association.
Dr. Kiran Marthak - Phase I & Regulatory (India)
Member of Board of Directors and Global Head – Clinical Development
Dr. Marthak has more than 30 years of experience in the field of clinical research. Dr. Marthak is awarded with an MD in Medicine from Dr. Grant Medical College and also possesses a Business Management degree. Dr. Marthak has vast experience in Phase I to Phase-IV clinical trials. He pioneered Phase I studies in India during his 13 year stint with Novartis as early as 1978-79.
He was President – Association of Medical Advisors of Pharmaceutical Industry and an Executive Committee Member – International Federation of Association of Pharmaceutical Physicians as well as a Board Member for designing the modules for Academy of Clinical Research, Chief organizer of the International conference of Clinical Research held by CII-New Delhi in the year 2002 and a member of the Faculty for Pharmaceutical medicine – University of London, Fellow member – American College of Chest Physician, and Fellow member – Royal Society of Medicine. Dr. Marthak is actively involved with regulatory authorities like US FDA, UK MHRA, China SFDA, South Africa MCC, MHCW and India – DCGI.
Dr. Prashant Kale - Early Phase Operations/BA-BE (India)
Sr. Vice President – BA/BE Operations
Dr. Kale has 25 years of immense experience in the analytical and bioanalytical domain. Dr. Kale is awarded with a Ph.D. (Chemistry) and also possess an MBA degree. He has numerous publications to his credit. He has been with Lambda for over 17 years. Prior to Lambda he was associated with SGS India Ltd. Presently, Dr. Kale is functioning as a Senior Vice President – BE Operations with Lambda Therapeutic Research and is responsible for the technical and administrative functions of the BE unit located at Ahmedabad and Mumbai, India. He is also responsible for bioanalytical laboratory at Toronto, Canada. Dr. Kale has faced several regulatory audits and inspections from leading regulatory bodies including but not limited to DCGI, USFDA, ANVISA, Health Canada, UK MHRA, Turkey MoH, WHO.
Dr. Sumit Arora –Clinical Trial Management (India)
Vice President – Clinical Trial operations and Medical Services
By Qualification, Dr.Sumit is a physician with specialization in Clinical Pharmacology and has more than 16 years of experience in the field of Medical Affairs and Clinical Research. Prior to joining Lambda, Dr. Sumit experience includes working in both Pharmaceutical companies and Contract Research Organizations like Dabur, Ranbaxy, PAREXEL, Lotus Labs (subsidiary of Allergan, US; Actavis, now Teva).
Dr. Sumit has a rich experience of developing and managing teams involved in medical affairs, medical monitoring, and clinical operations. He has also been deeply involved in new product development, preparing medical rationales for new formulations and has formulated strategies for launches and promotion of new and existing brands.
Dr. Niraj Limbachiya – Pharmacovigilance (India)
Deputy General Manager – Pharmacovigilance Operations
By Qualification, Dr. Niraj Limbachiya is an MBBS from M.S. University, India. Dr. Niraj has more than 12 years of experience in Global Pharmacovigilance, Clinical Research and Hospital Industry. Prior to joining Lambda, Dr. Niraj was associated with Torrent Pharma as a Global Pharmacovigilance Responsible Person.
In the area of Drug Safety and Global Pharmacovigilance, Dr. Niraj has faced regulatory audits and inspections from Health Authorities of UK-MHRA and Health Canada.
Dr. Naveen Chamalli – QPPV (London, UK)
Assistant General Manager – Qualified Person for Pharmacovigilance
By Qualification, Dr. Naveen Chamalli Shiva Kumar is a physician with a General Management Programme for Healthcare Executives from IIM-B and has more than 11 years of experience in end to end Drug Safety & Global Pharmacovigilance and Clinical Research. Prior to joining Lambda, Dr. Naveen experience includes working in Pharmaceutical companies, Contract Research Organizations and Business process outsourcing companies like Aurobindo Pharma Ltd, Bluefish Pharmaceutical Pvt Ltd, Quintiles Technologies Pvt Ltd (Now IQVIA), Accenture Service Pvt Ltd, BGS-Global Hospital and Allergy Asthma Associates.
In the area of Drug Safety and Global Pharmacovigilance, Dr. Naveen has faced several regulatory audits and inspections from Health Authorities of Sweden-MPA, UK-MHRA, Health Canada, US-FDA, Malta- Medicines Authority, The Netherlands- Medicines Evaluation Board & Portugal- INFARMED.
Dr. Netal Desai – Early Phase Operations/BA-BE (Canada)
By qualification, Dr. Desai is an MBBS and an MD in Pharmacology from M.S. University, India. Dr Desai has over a decade of experience in the CRO and Pharma. domain. His research experience includes design and management of early and late phase studies in Canada and India.
Prior to joining Lambda, Dr. Desai was associated with Intas Pharmaceuticals Ltd, India as a Medical Advisor. In the past, he has also worked in ICCU as a Medical Officer. Dr. Desai has faced several regulatory audits and inspections from leading regulatory bodies.
Dr. Jude Coutinho – Phase I & Early Phase/BA-BE (Canada)
Principal Investigator – Phase I & Early Phase/BA-BE
Dr. Coutinho obtained his M.D and MBA from the University of Toronto in 1988 and 2003, respectively. Dr. Coutinho has functioned as a qualified investigator since 2003 and is experienced in both Phase 1 and bioequivalence trials. Since 2003, Dr. Coutinho has been a Medical Advisor at the Ministry of Health and Long-Term Care.
Mr. Evgueni Fedorov – Bio Analytical (Canada)
Director, Bio Analytical Laboratory
By Qualification, Mr. Fedorov graduated from the Chemistry Department of Lomonosov Moscow University (Russia) in 1979. He has more than 20 years of rich experience in research and development in bio-analytical CROs of Canada.
Prior to joining Lambda, Mr. Fedorov was associated with Biotrial and has contributed immensely towards the development and validation of several hundreds bio-analytical LC-MS/MS methods.