Susanne Ausborn studied Chemistry at Humboldt University of Berlin and received her PhD in Biophysical chemistry from the Biozentrum Basel, Switzerland. She joined Roche in 2001 and held different positions within regulatory with increased responsibilities gaining extensive experience with global filings of new drug submissions, clinical trial applications as well as post-approval changes. Knowing the challenges of operating globally she is now a strong advocate for global convergence of regulatory requirements. Susanne is a member of EFPIA International regulatory expert group, chair of the EFPIA Russia regulatory network, member of EFPIA Turkey and Middle East regulatory network as well as IFPMA Africa network.
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.
In 2002 Yana graduated from the Faculty of Pharmacy of “Altai State Medical University” (Barnaul, Russia) with a degree “Pharmacy”. She started her professional career in “Altai State Medical University” (Barnaul, Russia) as an assistant and later on associate professor of the Faculty of Pharmacy. In 2006, she received a degree of Ph.D in Biological Sciences, speciality 14.00.25 – pharmacology, clinical pharmacology. In 2012, she received an invitation to work at LLC “Sciencefiles” – at that time a young company that currently occupies the leading position in the market for services in the field of consulting and documentation development for nonclinical and clinical studies. She has considerable experience in the development and editing reviews of nonclinical and clinical studies, Clinical Investigator’s Brochures and Modules 2, 4, 5 of the Common Technical Document for medical products of various pharmaceutical groups of home and foreign origin. For the time of her work in LLC “Sciencefiles”, Yana took part in 67 projects, including in the field of oncology, radiology, therapy, cardiology, hematology, gastroenterology, pulmonology, rheumatology, anesthesiology, neurology, psychiatry, dermatology, endocrinology, phlebology, obstetrics-gynecology, dietetics, phthisiology.
Polina has created a CRO business model, which today is the only one providing full scale pharmacovigilance services with full CIS country coverage and EU quality. The only company in the Baltic states with eSolutions department, offering full digitalisation of pharmaceutical companies for eCTD, pharmacovigilance various areas, as well as quality departments (GMP).
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.