Learn how scientific advice from the MHRA (The Medicines and Healthcare Product Regulatory Agency) will benefit your pre-clinical and clinical development plans and how you can lever the advantages of the UK’s excellent trial environment for your global and US- IND strategies.Understand how patient trials can be rapidly deployed across Europe with short approval and completion timelines.
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10h00 – 10h05: Opening remarks Esther Williams
The British Embassy
10h05 – 10h25: Running an entire Phase I protocol: FTIM to POC Dr Ulrik Lorch
10h25 – 10h45: Adding value to Phase I proposals:Integration of ethnic (Japanese) data in FTIM studies and cardiac safety assessments after the amendments to ICH E14 guidelines. Dr Jorg Taubel
10h45 – 11h05: Opportunities and regulatory context for Proof of Concept trials in the UK and Europe. Dr Martin O’Kane
The Medicines and Healthcare Product Regulatory Agency (MHRA)
11h05 – 11h25: TBC Dr Yukihisa Namiki
Department for International Trade (DIT)
11h25 – 11h45: The benefits of using dedicated early phase sites to optimise POC patient trials Prof. Dr. Frank-Dietrich Wagner
Charite Research Organisation GmbH
11h45-12h05: Patient Feasibility Studies; their contribution to cost and timeline efficient clinical trial conduct in Phase I to POC patient trials Keith Berelowitz
12h05-12h25: Open discussion, Q&A and close All
12h25-13h35 Buffet & Reception
Dr Ulrike Lorch MD FRCA FFPM
Ulrike trained as an anaesthetist at St. George’s Hospital in London. She is a co-founder and Medical Director of Richmond Pharmacology. Ulrike has more than 15 years’ experience in conducting early phase clinical research as principal investigator and has special expertise in innovative adaptive study designs. Ulrike is an appraiser for physicians revalidating with the UK’s General Medical Council. She is a member of the Faculty of Pharmaceutical Medicine’s Board of Examiners and an Educational Supervisor for specialist trainees in Pharmaceutical Medicine. Ulrike is a stakeholder representative on the UK’s National Research Ethics Service Phase 1 Advisory Group, the Medicines and Healthcare Products Regulatory Agency’s Clinical Trials Stakeholder Reference Group and the European Medicines Agency’s European Union clinical trials portal and Union database stakeholder group. These stakeholder groups discuss, amongst others, the implementation of the new EU Clinical Trial Regulation.
Dr Martin O’Kane MRPharmS
Medicines and Healthcare products Regulatory Agency (MHRA)
Dr Martin O’Kane is Head of the Clinical Trials Unit at the MHRA. He is a pharmacist by training with a PhD in neuropharmacology and post-doctorate research experience in neuroscience. Following a period in Japan working within the pharmaceutical industry, he joined the MHRA working for the British Pharmacopoeia and was a member of the European Pharmacopoeia Commission’s Working Party on Cell Therapy Products. He moved to the Clinical Trials Unit as a Pharmaceutical Assessor in 2007 and has been involved in the assessment of chemical, biological and advanced therapy applications for all phases of study. He became Head of the Unit in 2015 and is currently involved in European Medicine Agency and UK projects to prepare for implementation of the new clinical trials Regulations.
Dr Jörg Täubel MD FFPM
Dr Jörg Täubel is a medical practitioner and CEO of Richmond Pharmacology a commercial clinical trials unit based at St George’s University in London which he co-founded in 2001. He has trained in clinical pharmacology and been Principal Investigator since 1995 conducting studies in patients and healthy volunteers ranging from first time in man (FTIM) to later phase studies particularly in cardiology, neurology, and gastroenterology. He provides expert advice in cardiac safety assessments and ethnic comparison studies. Dr Täubel is an honorary fellow at St George’s University and author of over 75 posters and publications in scientific journals. His academic research is focussed on the role of hyperglycaemia in relation to sudden cardiac death in Type I diabetic patients.
Keith Berelowitz PhD
A scientist by training, Keith has worked in clinical research (academic and commercial) for over 16 years, having spent the majority of that period working for Richmond Pharmacology. In his role as Director of Operations at Richmond Pharmacology he is focused on the efficient conduct of all functions within the company whilst ensuring maintenance of quality standards. Having played an operational role in over 150 studies, across the commercial, project and recruitment related management of these studies, his specialist area of interest has focused on the assessment and understanding of the feasibility of conducting early phase patient trials in a phase I environment. Keith has worked with a number of sponsors advising them on the viability of conducting such trials within the UK, a number of which have gone on to be conducted successfully with Richmond Pharmacology. He is a member of the National Research Ethics Service Phase 1 Advisory Group (Health Research Authority, UK), the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI, UK), Chairperson of the EUCROF Early Phase Working Group, and a UK based representative on the EUCROF Extended Executive Board.
Prof. Dr. med. Frank Wagner
Charité Research Organisation
Board certified in both clinical pharmacology and internal medicine, Dr. Wagner is author of more than 40 peer reviewed publications and over 100 published abstracts. Dr. Wagner has previously served as the head of intensive care medicine at the The Deutsches Herzzentrum Berlin (DHZB, German Heart Institute Berlin). He is a faculty member of Charité – Universitätsmedizin Berlin and founded Charité Research Organisation in conjunction with the university hospital to provide a platform for bringing patients, clinical expertise and diagnostic technologies into the exploratory clinical development setting.
Dr Yukihisa Namiki
Department for International Trade (DIT)
I am very pleased with the Project Management of both studies undertaken on behalf of (blank) and any future studies we have to outsource will automatically be contracted to you.
Many thanks for your time today, most impressed with the quality of the follow up to our enquiry.
Please know that it has been an absolute pleasure collaborating with you and that I am most appreciative of the key contributions RPL has made to this project thus far. I hope I have the opportunity to work with RPL again in the very near future.
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