Clinical Trials in the UK

Badania Kliniczne w Wielkiej Brytanii

Clinical Trials in the UK

 

As part of a block co-organized by the British Embassy in Warsaw and the British Science and Innovation Network, constituting the British experience and opportunities for cooperation in research.

Block schedule
11:15 - 11:30 Block Opening by James Hughes, Minister-Counsellor for Economic Affairs, British Embassy Warsaw
11:30 - 11:45 Presentation on "Non-commercial clinical research conducted in collaboration with NHS that leads to the formulation of NICE guidelines for the whole sector" by NICE
11:45 - 12:15 Panel discussion with Dr Michał Gryz, Director of the Department of Medicinal Products and Medical Devices’ Inspection, URPL (Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, PL), Dr Nikola Kirilov (Medical University, Pleven, BUL), Dr Regina Grossmann, Head of the Clinical Trials Centre at the University Hospital Zurich (CHE) on: "Non-commercial clinical research leading to the formulation of guidelines for the whole sector
12:15 – 12:30 Keynote speech presentation by the UK researcher, ICL on "Practical use of the results of clinical research".
12:30 – 13:00 Discussion panel with Dr Katrina Pollock, Senior Clinical Research Fellow and Honorary Consultant in GUM/HIV, Imperial College London (acting also as a moderator), Karolina Maria Nowak PharmD, PhD, MBA, Director of the Department of Innovation and Biotechnology Development in Polish Medical Research Agency (PL), GSK representative (confirmed) and Prof Katarzyna Kolasa, Koźmiński University (confirmed) on: "Practical use of the results of clinical research".
13:00 - 13:15 Q&A

Non-commercial clinical research conducted in collaboration with NHS that leads to the formulation of NICE guidelines for the whole sector

Nikola Kirilov
Dr Nikola Kirilov

Medical University, Pleven

Dr. Kirilov graduated medicine from the Medical University Sofia. He holds a bachelor’s degree in software engineering and a master's degree in bioinformatics from Sofia University St Kliment Ohridski. In 2020 he defended a phd thesis in Orthopedics and Traumatology and in 2021 he completed a master’s degree in public health and health management. Dr Kirilov has an extensive scientific knowledge in the field of medicine and the application of computer innovations such as computer vision and machine learning and has authored many publications. He participated as a study coordinator in over 10 clinical trials studying the treatment of musculoskeletal diseases in the last 10 years and he worked as an assistant-professor in computer science at Assen Zlatarov University, Burgas.

A major milestone in the research career of Dr Kirilov was the creation of the Bulgarian FRAX model, which was achieved in cooperation with Prof. Kanis, his team, Bulgarian rheumatologists and the Regional Health Insurance Fund in Stara Zagora. The model should enhance accuracy of determining fracture probability among the Bulgarian population and help to guide decisions about the treatment of osteoporosis. It is published on the website of the University of Sheffield: https://www.sheffield.ac.uk/FRAX/tool.aspx?country=9 as a FRAX calculator for Bulgaria, through which every Bulgarian between the age of 40 and 90 years can calculate his/her 10-year fracture risk by entering age, sex, height, weight and risk factors with or without bone mineral density data. Furthermore, Dr Kirliov has supported the work of patient organizations as a speaker, facilitator and workshop leader at the European League EULAR.
Regina Grossman
Regina Grossman, MD

Head of the Clinical Trials Centre at the University Hospital Zurich

Studies of human medicine at University of Zurich (1999-2006).  Dissertation / thesis in Clinical Atherosclerosis Research in Zurich (2003-2006).  Specialization in Pharmaceutical Medicine, FMH Pharm. Med. (2007-2013). 

More than 15 years of experience in clinical research, in pharmaceutical industry (Sanofi-Aventis, medical liaisons), Swiss Agency for Therapeutic Products Swissmedic (Medical Review, more than 30 GCP Inspections). Regular participation in EMA GCP inspectors trainings.   Since 2011 working at Clinical Trials Center (CTC; ISO 9001:2015 certified institution) of University Hospital Zurich (USZ) in different positions, since 2019 head CTC 

Additional activities, Boards and Pannels:  SCTO Board of CTU directors (Swiss Clinical Trials Organisation SCTO) ICN Steering Board (International clinical Trials Center Network; ICN) Board Member of SAPM (Swiss Association of Pharm. Med. SAPM),  SSPT Council (Swiss Society of Pharmacology and Toxicology SSPT) Board Member Health Tech Park Zurich  Data Governance Board USZ  Compliance Committee USZ Clinical Ethics Committee USZ

Michał Gryz
Michał Gryz

Director of Department for Inspections of Medicinal Products and Medical Devices of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

He graduated in pharmacy in 2000 and obtained his PhD in chemistry in 2008. He completed post-graduate studies “Methodology of clinical trials” in 2010.  He is a member of GCP Inspectors Working Group at the European Medicines Agency. He has participated in more than  150 inspections and audits in areas of GCP, GVP, GLP and ISO 9001. Since  2009 he has been working as a reporting and lead inspector for EMA coordinated inspections for clinical sites, sponsors, CROs and laboratories. He has authored and co-authored  around  30 articles in Polish and international journals. Dr. Gryz is also an experienced university teacher and trainer for GCP/PV inspectors. 

Practical use of the results of clinical research

Dr Katrina Pollock

Dr Katrina Pollock is a Senior Clinical Research Fellow in Vaccinology and Honorary Consultant at Imperial College London. Katrina studied as an undergraduate in Medicine at Newnham College, University of Cambridge and Imperial College London, before qualifying as a junior doctor and undertaking specialist professional training in Genitourinary and HIV Medicine. 

Dr Pollock is the clinical Principle Investigator across the diverse portfolio of vaccine studies at the Imperial NIHR Clinical Research Facility. Working closely with Professor Robin Shattock in the Department of Infectious Disease, this work involves the crucial early-stage development of potential vaccines against pathogens such as HIV and chlamydia and includes first-in-man studies of potential vaccines. Katrina also works closely with the Oxford Vaccine Group and Jenner Institute developing vaccines against diverse infections including ebola and malaria.

Katrina holds a St. Mary’s Development Trust award for human vaccine research to investigate how T cells orchestrate the response to immunogens in the blood and secondary lymphoid tissue. This work is particularly important in helping to design sophisticated vaccines that can induce the broadly neutralising antibody response required to protect against difficult targets such as HIV.

In 2019, Dr Pollock was awarded the Margaret Johnson prize by the British HIV Association for work on influenza vaccine.

Prof. Katarzyna Kolasa

Vice President HEOR Science Parexel Europe

Driven by a passion for health economics, Katarzyna Kolasa has over 20 years of academic and industry experience in the healthcare sector. Her strength is identifying the patients’ unmet needs and developing value story for advanced medical technologies and generating relevant evidence in support of commercial objectives. She lead many pricing & reimbursement processes for global pharmaceutical and medical devices companies across the globe. Katarzyna recent research focus is the digital health. With her vision of the future role of medicine in human life, she strongly advocates for the greater empowerement of patients in the decision-making processes. That’s why her research is focus on the role of artificial intelligence in driving the digital revolution towards decentralized healthcare system. She also specializes in topics related to the post-COVID reality with digital solutions replacing human service model

Karolina Nowak
PharmD, PhD Karolina Maria Nowak, MBA

Dr Karolina Nowak is a director of the Department of Innovation and Biotechnology Development in Medical Research Agency.  

She was a visiting scientist at Harvard Medical School, Dana-Farber Cancer Institute. She received a prestigious scholarship at Stanford University and did an Internship at Stanford Biomaterials and Advanced Drug Delivery Laboratory. Doctor Nowak is a graduate of Executive MBA at ESG University of Quebec at Montreal and SGH. She is a patent inventor of new pharmaceutical drug formulation dedicated for patients with alveolar osteitis and she is an active scientist in the field of Pharmaceuticals, drug formulations and molecular biology.

She has participated in numerous national and international projectsBeside her scientific activities she has experience in managing  2 commercial projects in area of drug development.

Natalia Tomkiewicz
Natalia Tomkiewicz

Natalia Tomkiewicz currently holds a position of a Head of Study Delivery Management at GSK and is leader of a growing Global GSK R&D Hub in Warsaw. She led AbVie country clinical operations in the UK & Ireland and was a Country Head, Site Management & Monitoring in Astrazeneca, Ukraine. During more than 17 years of professional career, she managed teams across diverse organizations (top CRO and pharma companies) in multiple local and global positions. She gained broad experience in managing global registration trials in various therapeutic areas. Have been responsible for successful setup, change management and strategic planning related to clinical operations and CRO management. She created and provided various training programs and was a successful multiple times speaker at international congresses.