The only international event dedicated to discussing regulatory, ethical and operational aspects of running clinical trials in Russia

13-14 November 2018

Speaker confirmations in 2018:

Steven Bukvic graduated from Coventry University in 1982 with a degree in Applied Biology. After serving in the commercial sector of the UK motor industry for 8 years, Steven joined the Pharmaceutical Industry in 1990. For the next 27 years Steven’s career in the Pharmaceutical / CRO sectors has covered a broad range of disciplines within the field of clinical research, including clinical site monitoring, project management, pharmacovigilance, training, quality assurance and business operations. Steven has worked in Covance, GSK, MSD and Pfizer to name just a few of the key companies in his career and has had extensive geographical exposure having worked in the UK, US, Germany, China and the Russian Federation. Steven joined Synergy in 2017.

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.

Experience

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.

Education

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).

 

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.  

From December 1999 to May 2000 worked as a medical representative in the company "Glenmark Ph" (India) - SF unit,
From May 2000 to May 2001 worked as a medical representative of the company "Cadila Helstcar" (India) -SF unit,
From May 2001 to September 2003 worked as a medical representative in the company "Alkaloid Ph" (Macedonia) - SF unit,
From November to December 2003 worked as a medical representative in the company "Medocemi" (Cyprus) - SF unit,
From February 2004 to May 2006 worked as a medical representative in the company "Sanofi C.A." - SF unit,
From May to November 2006, she worked as a junior product manager in Sanofi C.A. on Cordarone and Trental- marketing department,
Since November 2006- April 2012 worked as a medical adviser in Sanofi CA on Rx products (antibiotics (Tavanik, Rovamycin), treatment of patients with benign prostatic hyperplasia (Dalfaz) and treatment of rheumatoid arthritis (Arava and Plakvenil)) and OTC products (Magne B6, Ercefuril, Pinosol, Uppsarin Oopsa, Fervex, antimycotics and others) - the medical department,
From April 2012 to February 2013 worked as a medical adviser in the company "Astellas Pharma" on antibiotics (Cefixim, Flemoxin Solutab),
From April 2013 to January 2014 I worked as a medical adviser in the company "Ipsen Pharma" on prescription drugs company (Diferelin, Somatulin) - medical department,
From January 2015 to December 2015 worked as a medical manager in the company Ipsen Pharma on prescription and over-the-counter drugs of the company (Diferelin, Somatulin, Dysport, Smekta, Forlax, Fortrans) - medical department,
Since December 2015 till the present moment I have been working at Ipsen Pharma as the Head of the Medical and Clinical Research Group, Russia and the CIS. I am the leader of the global project at the level of the cluster countries of the company for patient support programs - the medical department.

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).

Yuri Zaretsky, M.D. is the President and CEO of ZM CRO GROUP, a group of Canadian, Russian, and Chinese CROs established in 2004, specializing in medical affairs and drug safety. Dr. Yuri Zaretsky graduated from 2nd Moscow State Medical University, Russia in 1987. He completed residency in abdominal surgery, also residency in anesthesiology, resuscitation and intensive care. Following his post-graduate work, he served at the Vilnius University Hospital, Vilnius, Lithuania as a senior anesthesiologist/resuscitation specialist and director of pain management clinic.
Dr. Zaretsky’s professional career in clinical trials began as a primary investigator where his interest in the design, conduct of clinical trials and analysis of data evolved. Dr. Zaretsky has more 20 years clinical trials experience in a variety of therapeutic areas. In 2004, he established ZM CRO GROUP, a medical affairs and drug safety group of CROs, which over the years, has evolved into a respected force in the CRO field. Dr. Zaretsky’s continuing research interests lie in drug safety, medical monitoring, medical review, and data management.

null

Irina Efimenko is a founder and CEO of the Semantic Hub Company. She has got her PhD in Moscow State University and currently is an Associate Professor in computational linguistics. During her career, she accumulated 15 years of experience in natural language processing (NLP), semantic technologies, cognitive technologies, artificial intelligence and Big Data, technology mining and decision support systems with emphasis on Pharma and Healthcare. Irina is a member of the Scientific board of the Russian Association for Artificial Intelligence, and a member of the European Association for Artificial Intelligence. She is also an expert of WHO in the field of digital tools. She is an author of more than 50 scientific papers and book chapters, as well as several patents in NLP, and participated as a speaker in multiple international conferences in Europe and USA. Together with her team (100+ years of total experience in AI and NLP), she has successfully completed over 60 commercial projects in the area of semantic technologies including those for national and international pharmaceutical companies.

Maria completed her Ph.D. course in the Rheumatology Department of the Moscow Medical Academy named after I.M.Setchenov in 2002. She holds an MD degree from the same institution.
Maria possesses over 5 years of experience (2001-2006) with Novartis Pharma Russia in the positions of Local Drug Safety Officer and then Medical Adviser.
Maria works in ALMEDIS since May 2006. In 2006-2012 she was responsible for ALMEDIS Quality Management System development and maintenance. As QA Manager, she was ensuring compliance with international standards at all stages of project execution (from scientific concept development to data analysis and clinical study report preparation).
As ALMEDIS Executive Manager, since 2012 Maria Nassonova manages high-level, strategic aspects of CRO business.
Maria represents ALMEDIS and participates in the work of the Association of Clinical Trials Organizations (ACTO) – non-commercial organization of the companies/ legal entities and clinical research community engaged in clinical trials in Russia, since 2015 Member of the Board, since 2017 Сo-Сhair of the Board.

Professor at the department of pharmacy Institute of Medical and social technologies, Moscow State University of Food Production Clinical pharmacologist at the Scientific Clinical Centre of JSC “Russian Railways” Member and national coordinator of the International Society of Cardiovascular Pharmacology (ISCP), member of the cardiovascular pharmacology working group of the European Society Cardiology, Medical expert of the Romualdo del Bianco international foundation, Florence, Italy.
Experience in clinical trials: has an experience of participation in Clinical trials since 1996 (Investigator and Co-investigator, Monitor), experience as a Project Manager in International Clinical Trials on Cardiology, Pulmonology, Neurology, Oncology, Hematology, Dermatology.

Dr. Aleksandr Solodovnikov has 14 years of clinical trial expertise as an  investigator, CRA, clinical operations trial lead and clinical operations manager in fields of Endocrinology, Psychiatry, Cardiology, Pulmonology, Oncology, Hematology, Dermatology, Neurology, Surgery and Infectious Diseases (more than 30 trials, phase I-IV).

Aleksandr graduated from the Ural State Medical Academy (now University) in 2003 and started his scientific career at the Chair of preventative and family medicine resulting in a PhD in Rheumatology in 2009. Dr. Solodovnikov is now an associate professor of this Chair supervising edivence-based medicine and biostatistics fields.  Aleksandr received his training in statistics and epidemiology at the University of Manchester, UK, and at the Erasmus University, the Netherlands, and personally prepared and conducted more than 300 various statistical analyses in various statistical software packages (NCSS, Stata, R, SPSS, Statistica and other) and provided a lot of consultations in this field. He further developed his professional skills in clinical research by taking the “Principles and Practice of Clinical Research” course at Harvard Medical School in 2014. In 2016, Aleksandr also successfully completed the “Project Management Professional”.

Dr. Solodovnikov is a skillful trainer and lecturer, and has conducted numerous GCP trainings as well as seminars in biostatistics, evidence-based medicine, clinical research, drug development and regulations in clinical trials. He knows local, regional (EAEU) and international clinical trial regulations and guidelines well, and took part in the development of hundreds of clinical trial documents for medicines, medical devices, cosmetic and dietary products, and biologically active substances, starting from study concept and ending with the final protocol.

He founded and is engaged in the ARNA project for more than 10 years with the mission to save people's lives from cancer. Economist by education, businessman by spirit and experience. In the roles of the founder, the co-founders or the CEO, he was a participant in several start-ups in various fields: advertising and production activities, international logistics, integration of complex IT solutions for large state and commercial customers, and managed an international telecom operator. Yegor's goal is to realize the ARNA project.