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Early Phase Drug Development in the UK

Department for International Trade

Friday, September 28, 2018 from 8:00 AM to 10:00 AM (EDT)

Early Phase Drug Development in the UK

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General Admission Ended Free  

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Event Details

Come learn how you can accelerate your early stage clinical programs in the UK at a breakfast Friday 28th September 2018 in Boston.

Please join Richmond Pharmacology and the UK’s Department for International Trade to learn about innovative early drug development opportunities in the UK. The discussion will focus on how the UK’s pragmatic regulations, pioneering study design and seamless clinical trials approvals across Europe can help drive your early stage clinical programs and maximize data. 


Guests will also hear the latest developments in the UK government’s Brexit negotiations and the likely impact of Brexit on the regulatory environment as well as the UK life sciences sector more broadly.

 

Agenda

 

7.30-8.00

Registration and breakfast

 All

8.00-8.05

Opening remarks and introduction of speakers

John Maclennan

DIT

8.05-8.30

A Case Study: Outcomes of an early phase integrated adaptive trial – FIH to POC

Ulrike Lorch
Richmond Pharmacology

8.30-9.00

Supporting innovation in early drug development

Martin O’Kane
Medicines and Healthcare products Regulatory Agency (MHRA)

9.00-9.30

The use of GMP-embedded efficiencies in maximising the benefits of adaptive study design

Radivoj Arezina
Richmond Pharmacology

9.30-10.00

Accessing the clinical and research expertise within London and the Greater South East of England

Neelam Patel

MedCity

10.00-10.15

Open discussion, Q&A and close

All

 

Speakers Confirmed:

Dr Martin O'Kane MRPharmS
Head of Clinical Trials Unit, 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 Ulrike Lorch MD FRCA FFPM
Medical Director, Richmond Pharmacology

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 Radivoj Arezina MD MSc,

Research Director, Richmond Pharmacology

Dr Arezina is a founding director of Richmond Pharmacology and an MHRA-licensed Qualified Person (QP) with the overall responsibility for the IMP aspects of clinical trial conduct at this leading contract research organisation. He qualified in medicine in 1987 at the Medical School of the University of Zagreb, Croatia. Having spent one year in clinical medicine, most of his professional life thereafter has been in clinical research.To date, Dr Arezina has been co-investigator on over 200 clinical trials ranging from bioequivalence to first-into-human and covering different therapeutic areas including cardiovascular, gastrointestinal, CNS, pain, dermatology, endocrinology and urology. Dr Arezina also teaches modules on investigational medicinal products in clinical trials to undergraduate and postgraduate students at University College London (UCL). He is a member of the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI, UK) and a fellow of the Royal Society of Medicine.

 

Neelam Patel

Chief Operating Officer, MedCity

Neelam joined MedCity as it was forming in 2014 as an advisor on clinical trials and then was appointed as COO in December 2016.  MedCity is a small, but influential organisation with an ambition to position the greater south east of England as a world-leading, interconnected region for life sciences research, development, manufacturing and commercialisation to stimulate greater economic growth. MedCity plays a pivotal role in bridging industry, NHS and academia.

 

Neelam’s significant experience, has included private and public sector and not-for-profit. She has held a number of leadership roles with the pharmaceutical industry including, Head of Pharmacovigilance Operations, HR Manager for European Commercialization and Strategy Director for Global Clinical Operations. Neelam has also sat on industry research committees at the Association of British Pharmaceutical Industries and has represented industry on a European Innovative Medicines Initiative exploring the linkage of electronic health records for research.  Outside of the pharma industry, Neelam has led national projects within the public sector including with the National Institute of Health Research. She has also supported innovation development within the NHS, eg implementation of a programme to promote innovation within the Chelsea and Westminster Hospital Foundation Trust. 

Have questions about Early Phase Drug Development in the UK? Contact Department for International Trade

When & Where


Cafe ArtScience
650 East Kendall Street
Cambridge, MA 02142

Friday, September 28, 2018 from 8:00 AM to 10:00 AM (EDT)


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Organizer

Department for International Trade

The UK's Department for International Trade (DIT) has overall responsibility for promoting UK trade across the world and attracting foreign investment to our shores.

DIT works to promote UK exports of goods and services; deliver the best international trading framework for the UK outside the EU; and maximise opportunities for wealth creation through supporting Foreign Direct Investment, with a renewed focus on overseas direct investment.

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