Dr Crawley is the Executive Director of the Good Clinical Practice Alliance – Europe (GCPA) in Brussels, Belgium and a World Health Organization (WHO) Expert in ethics. Responsible for the coordination of the Strategic Initiative for the Developing Capacity in Ethical Review (SIDCER). He is a philosopher specialising in legal, regulatory and ethical issues concerning medical research, teaching at several European Universities. He is the past Secretary General, Ethics Officer and Chairman of the Ethics Working Party at the European Forum for Good Clinical Practice (EFGCP) where he also was the editor of the EFGCP news. He is currently Chairman of the Ethical Review Committee of the International Network for the Cancer Treatment and Research Association (INCTRA). He has been a member of the EMVI-AMVTN Ethical Review Committee, a permanent liaison to the International Bioethics Committee of UNESCO.
In 1995 Sergey Dubrovin received MD from the Moscow Medical Density University (Medical Faculty). Finished his post-graduation in the same university (Chair of Therapy) and worked as a general practitioner and a gastroenterologist in Moscow City Clinical Hospital #67. In 2002 I’ve received PhD in internal diseases. He’s joined the industry in 2001 (Janssen Pharmaceutica) as a CRA and starting from 2005 have held position of Local Trail Manager being in charge of oncology and hematology studies. In 2014 Sergey joined Pfizer as a Reginal Medical Monitor for Russia, Ukraine, Georgia, Belarus, Bulgaria and Israel specializing in oncology and hematology studies. In 2016 Sergey was appointed to the position of Director of Clinical Site Management, Russia and Belarus.
Dr. Mikhail Samsonov is currently Head of Development, Medical and Regulatory at R-Pharm managing all activities across several therapeutic areas (cardiology, oncology, infectious and autoimmune disease) in fast growing R&D company. He is a member of several Joint Steering Committees with Merck, Eli Lilly, UCB, Theravance, Quintiles etc dedicated to technology transfer, development and commercialisation of innovative medicines, biosimilars and generics .
Prior R-Pharm he was Chief Scientific Officer at Novartis Russia & CIS overseeing all R&D activities for Novartis in one of key complex emerging markets and member of Board of Directors Association of Clinical Trials Organizations in Russia in 2009-2011.
Dr Samsonov was Executive Director Regional Clinical Operations at Bristol-Myers Squibb Company overseeing EMEA and Asia Pacific regions including such emerging markets as China, India and Eastern Europe during last three years in BMS. With over 14 years of experience at BMS in variety of roles in medical affairs and clinical operations, Dr Samsonov has dedicated much of his career to building capabilities in fast-growing clinical research markets , continuous productivity improvement in well established R&D markets and developing 10 new molecules in several areas ( antibiotics, autoimmune, CNS, CVS, oncology, virology). He was based at several BMS offices in the US, UK, Russia and Belgium.
Dr. Samsonov’s education includes MD from Moscow Medical University, National Cardiology Centre (Moscow) training in Clinical Cardiology, Ph.D. in Cardiology & Immunology from National Cardiology Centre, BA from Open University, London and several business courses at INSEAD and OWEN business school.
He is an active speaker and panel expert at Columbia Business School, NY and various international conferences DIA, BIO USA, industry and investor meetings on development strategies, operational models, vendor management in established and emerging markets.
Medical doctor (cardiology, intensive care) by training, with scientific and clinical expertise, MBA education, working in international pharma industry research since 2004. Currently in a position of Clinical Research Director, with overall responsibility for international phase 2-3 clinical trials delivery in Russia.
Clinical Research Director at AstraZeneca (2014 – Present)
Clinical Research Manager at AstraZeneca (2013 – 2014)
Clinical Research Manager at Abbott Laboratories (2010 – 2013)
Overall responsibility for organization of local clinical trials (phase 2-4, PMOS and investigator-initiated studies)
Clinical Project Manager at Abbott Laboratories (2007 – 2010)
Clinical Project Leader, Clinical Research Associate at AstraZeneca (2004 – 2007)
Cardiologist, Intensivist. Clinical co-investigator at Peoples’ Friendship University of Russia and Moscow Municipal Clinical Hospital 64 (2001 – 2004)
Co-investigator in phase 2-3 studies, post-graduate student, research fellow. Publications in clinical pharmacology, clinical trials, evidence based medicine.
Moscow International Higher Business School MIRBIS (Institute): MBA, Strategic Management 2009 – 2011
Peoples’ Friendship University of Russia: MD, Medicine, Cardiology1994 – 2004
2004 — Intensive Care Unit Specialist, specialty certificate
2003 — Cardiologist, specialty certificate
2001 — MD, Russian Peoples' Friendship University, Diploma with honors. French-Russian Translator, Diploma with honors
Publications: over 20 (original publications on clinical and epidemiology studies, reviews in evidence-based medicine, cardiology).
Establishing clinical development strategy from the pre-IND setting to pivotal trials and registration with focus on biosimilars of insulin and insulin analogues.
Joined GEROPHARM as a head of clinical trials department in Oct 2016.
Successfully performed several clinical trials including hyperinsulinemic euglycemic clamps and bioequivalence, Phase III trials. Incorporates elements of Risk Based Monitoring into clinical trials department at GEROPHARM.
Has joined clinical trials since Jan 2011. Worked in Quintiles in Endocrinology, Rheumatology, Cardiovascular, Oncology trials.
MD, PhD in the field of medicine. Experienced as a research fellow in preclinical studies (gastroenterology, respiratory diseases, rheumatology, diabetes mellitus, metabolic syndrome, acute pancreatitis, multiple sclerosis).
Graduated from the State University of Management in 1996 and the Project Management Institute in 2016. In Clinical Research Since 2015 (Data Manager; Programmer; Director of DM). EDC development and management in Phase I-IV, BE and post-marketing trials. Head of the DM Department of IPHARMA since 2017
Sergei Lomakin is a partner in the Moscow office of Baker McKenzie. Sergei specializes in a wide array of life science areas: pharmaceuticals, medical devices, healthcare, cell technologies, food, veterinary medicines and feeds. He advises on research and development, regulatory, reimbursement, public procurement, advertising, liability, compliance and other issues important for life science businesses in Russia.