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 16 years of Healthcare Industry experience, in Hospital and Clinical Research domains. 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, Pharmacovigilance and Medical Imaging.
Presently, Dr. Kammili is functioning as a Board of Director and Head – Global Business Development with Lambda Therapeutic Research Ltd and is responsible for Business Development in international (US / EU / Turkey and ROW) markets, Indian domestic markets and in M & A activities of the Group.
Apart from the Clinical Research Domain, Dr. Kammili is a trained Intensivist, having assisted in various Interventional Cardiac emergency procedures like Primary Angioplasties, Coronary Angiograms, and Thrombolytic therapies. He is 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. 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.
Mr. Kayode Awaiye – Bio Analytical (Canada)
Director – Bio Analytical Laboratory
Mr Awaiye has over 25 years of experience in the pharmaceutical and Contract Research industries. He was responsible for setting up a new Bio analytical Laboratory to support established clinical activities, achieving several successful regulatory inspections and the necessary accreditations. By qualification, he has a BSc and MBA degree.
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.
Dr. Parham Davoudpour – Phase I & Early Phase/BA-BE (Canada)
Co Investigator – Phase I & Early Phase/BA-BE
Dr. Parham Davoudpour is an experienced emergency physician with extensive experience in clinical trials and medical education as a principal investigator and assistant professor at McMaster University. He graduated from Western University, Canada and also holds a Master of Business Administration (MBA) from Kellogg School of Management, Northwestern University, USA.
Ms. Beata Gralak-Dabrowska - Late Phase Clinical Trials (Poland)
Senior Project Manager
Beata Gralak-Dabrowska graduated from the Faculty of Pharmacy at Medical University in Warsaw. In her scholarly career, she conducted research concerning, among others, therapeutic monitoring of anti-retroviral drugs. Currently, she nears her doctoral studies at the Faculty of Pharmacy of Medical University in Warsaw. She is a co-author of science publications in Poland and abroad. She has also presented her research at conferences in Poland and abroad (including France).
Beata Gralak-Dabrowska has been supervising the work of the Polish branch of Lambda Therapeutic Research Poland since December 2014.
She has over 13 years of experience in the pharmaceutical industry, gained through her work at GlaxoSmithKline and other pharmaceutical companies. Her abundant experience in the field of clinical trials comes from working at international CRO companies such as PAREXEL, Chiltern International and others where she was conducting international clinical trials in accordance with applicable law, the principles of good clinical practice (GCP), and internal standard operating procedures (SOP).
Mr. Rakesh Barmy – EU QPPV (UK)
EU QPPV – Pharmacovigilance
Mr Rakesh Barmy, M Pharm (Pharmacology) has more than 10 years of experience in the areas of pharmacovigilance and clinical research. He has excellent working knowledge of the EU/US legislation as well as local requirements in the ROW. He has been involved in various pharmacovigilance audits and has also gained exposure to EU and ROW authority inspections which has enhanced his understanding of regulatory requirements.
Presently, he is working as EU-QPPV for various clients and is responsible for establishing and maintaining pharmacovigilance system at Lambda for various premier clients. He specializes in Pharmacovigilance Audits, Pharmacovigilance System strategic design, signal & risk management, Quality Management & SOP development, PV System Master File (PSMF) Development, etc.