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Simon Stevens

Chief Executive Officer, NHS England

Simon Stevens

Chief Executive Officer, NHS England

Simon is CEO of NHS England, which leads the NHS’s work nationally to improve health and ensure high quality care for all. He is accountable to Parliament for over £100 billion of annual Health Service funding.

Simon joined the NHS through its Graduate Training Scheme in 1988.  As a frontline NHS manager he subsequently led acute hospitals, mental health and community services, primary care and health commissioning in the North East of England, London and the South Coast. He also served seven years as the Prime Minister’s Health Adviser at 10 Downing Street, and as policy adviser to successive Health Secretaries at the Department of Health.

Alongside his 16 years work for the NHS and UK public service, Simon spent a decade working internationally at United Health Group, including as its Medicare CEO and as president of its global health division, leading health services in the United States, Europe, Brazil, India, China, Africa, and the Middle East.

Simon was born in Birmingham, and was educated at Balliol College, Oxford University; Strathclyde University, Glasgow; and Columbia University, New York where he was Harkness Fellow at the New York City Health Department.  He is married with two school-age children, and volunteers as a director of the Commonwealth Fund, a leading international health charity.  He has also been a trustee of the Kings Fund and the Nuffield Trust, visiting professor at the London School of Economics, and an elected local councillor for Brixton in South London.

Simon took up post as NHS England CEO on 1 April 2014, following an open worldwide competitive appointment process led by the independent board of NHS England.

Steve Bates OBE

Chief Executive Officer, BIA

Steve Bates OBE

Chief Executive Officer, BIA

Since his appointment as Chief Executive of the BioIndustry Association in 2012, Steve has led major BIA campaigns for, amongst other things, improved access to finance, the refilling of the Biomedical Catalyst, anti-microbial resistance and the opportunity the sector presents to generalist long term investors. Steve champions the adaptive pathway approach to the licensing of new drugs, the need for Early Access and is particularly proud of the working relationship the BIA has established with the UK’s leading medical research charities.

 

A founder member of United Life Sciences, a strategic partnership representing over 1000 life science and healthcare member companies across the UK and internationally, Steve attends the UK’s Ministerial Industry Strategy Group, and sits on The Royal Society's Science, Industry and Translation Committee.

 

Beyond the UK Steve is a member of EuropaBio’s Board and its National Association Council and is a founder member of the International Confederation of Biotech Associations.  An expert and regular commentator on the sector in the media and at industry-leading conferences Steve has worked both in biotech (as Senior Director at Genzyme UK and Ireland) and at the highest levels of UK government (as Special Advisor to John Reid, MP, during his time in Tony Blair’s government) for over 15 years. Steve was awarded the OBE in January 2017.

Simon Bennett

Director, Regulatory Policy, EU and Global Emerging Markets, Biogen

Simon Bennett

Director, Regulatory Policy, EU and Global Emerging Markets, Biogen

Simon is currently Director of EU Regulatory Policy within the International Regulatory Sciences group at Biogen Limited, based in Maidenhead, UK.  In this role, Simon is responsible for developing and leading Biogen’s EU regulatory policy activities, including agenda-setting and prioritisation and representing Biogen in interactions with EU Trade Associations and regulators on key issues.

Simon began working for Biogen in 2003 within the clinical operations group, focusing on the initiation and management of clinical trial activities primarily in multiple sclerosis (MS) and other neurologic conditions.  In early 2008, Simon moved into Biogen’s regulatory group and has undertaken a number of senior regulatory roles within that function.  These roles provided broad experience of EU regulatory procedures and the EU regulatory environment through work on mid- and late-stage drug candidates. The oversight and further development of centrally licensed products for MS in the postmarketing setting was also a significant component of these roles.

Prior to joining Biogen, Simon worked in the field of medical communications in the areas of schizophrenia and infectious diseases. Simon is a biologist by training with an MSc in medical parasitology. 

Dr Nick Crabb

Programme Director, Scientific Affairs, National Institute for Health and Care Excellence (NICE)

Dr Nick Crabb

Programme Director, Scientific Affairs, National Institute for Health and Care Excellence (NICE)

Nick had a 20-year career in analytical science, process technology and general management in the chemical, pharmaceutical and contract laboratory industries prior to joining NICE in 2010 to establish and lead the Diagnostics Assessment Programme.  

In 2014 Nick was appointed Programme Director for Scientific Affairs where he oversees NICE Scientific Advice, the Science Policy and Research programme and the NICE Office for Market Access. Nick also leads NICE’s contribution to the European HTA network – EUnetHTA. 

 

Sir Andrew Dillon

Chief Executive, National Institute for Health and Care Excellence

Hugo Fry

General Manager UK and Ireland, Sanofi

Hugo Fry

General Manager UK and Ireland, Sanofi

Hugo is General Manager Sanofi UK and General Manager of Sanofi Pasteur in the UK.  Prior to assuming this role, Hugo has been the Chief Marketing Officer for Sanofi Pasteur MSD (SPMSD), leading the commercial effort for the European vaccine Joint Venture since 2015.

Hugo began his career in the pharmaceutical industry in the UK in 1993 in sales and marketing until moving to Paris to pursue General Management, Global Commercial and Strategic roles.

Hugo joined Aventis UK in 2003 as Head of Commercial Excellence.  Beginning in 2007, Hugo spent four years in Russia leading Sanofi’s Diabetes, Oncology, Cardiovascular, Internal Medicine and Consumer Healthcare businesses.  He was then appointed General Manager of Zentiva Russia, where he was instrumental in maintaining Zentiva as one of the fastest growing companies in Russia while integrating into the Sanofi Group.  Hugo then joined the Sanofi Diabetes Leadership Team as Global project Leader for the lixisenatide family before assuming his role at SPMSD.

Hugo holds a BSc in Chemistry from the University of Salford and Studied Finance at London Business School and is a member of the Board of the Association of the British Pharmaceutical Industry (ABPI) and a member of the European Medicines Group (EMG). 

Andrew Gregory

Deputy Director, Policy Division, Medicines and Healthcare products Regulatory Agency

Andrew Gregory

Deputy Director, Policy Division, Medicines and Healthcare products Regulatory Agency

Andrew has been Deputy Director of Policy at the MHRA since August 2015.  He leads on the negotiation and implementation of EU legislation, the Agency’s international work and co-ordination of its innovation agenda.  Since June 2016, he has been heavily involved in Brexit work and consideration of the future regulatory model for medicines and medical devices in the UK. 

Before joining the MHRA, Andrew held a range of jobs in the Department of the Environment, Food and Rural Affairs and the FCO, with experience in agriculture, environment and energy policy in particular.  He spent four years at the British Embassy in Paris, and the fours years prior to arriving at the MHRA in Brussels at the EU’s Permanent Representation to the EU.  

Robert Hemmings

Manager, Licensing Division, Medicines and Healthcare products Regulatory Agency, and Chair, CHMP's Scientific Advice Working Party, European Medicines Agency

Robert Hemmings

Manager, Licensing Division, Medicines and Healthcare products Regulatory Agency, and Chair, CHMP's Scientific Advice Working Party, European Medicines Agency

Rob has been with the Medicines and Healthcare products Regulatory Agency for 17 years and heads the group of medical statisticians and pharmacokineticists. The group provides methodological expertise to the assessment of marketing authorization applications, ‘scientific advice’ to drug developers and input to methodological and therapy area regulatory guidance documents. 

Rob holds the following positions and interests within the European drug regulatory system:

•  CHMP member co-opted for expertise in clinical trial methodology

•  Chair of the CHMP’s Scientific Advice Working Party (SAWP)

•  Biostatistics, Modelling and Simulation, Extrapolation, PRIME and Adaptive Pathways.

Dr Ian Hudson

Chief Executive, Medicines and Healthcare products Regulatory Agency

Dr Ian Hudson

Chief Executive, Medicines and Healthcare products Regulatory Agency

Ian became Chief Executive of the Medicines and Healthcare Products Regulatory Agency in September 2013.

He is a physician who practiced as a paediatrician for a number of years, before working in the pharmaceutical industry in clinical research and development between 1989 and 2001, when he joined the former Medicines Control Agency as director of its licensing division.

Before being appointed as chief executive, Ian was the agency’s licensing director, responsible for the majority of its medicines licensing activities. He was also the UK delegate to the Committee for Human Medicinal Products and was its vice chairman from October 2012 to September 2013.

Dr Paul Huckle

Chief Regulatory Officer, GlaxoSmithKline

Dr Paul Huckle

Chief Regulatory Officer, GlaxoSmithKline

Dr. Paul Huckle is Chief Regulatory Officer and Senior Vice-President of Global Regulatory Affairs and Quality Assurance at GlaxoSmithKline.  He chairs the Global Regulatory Governance Board for GlaxoSmithKline.  He is responsible for the filing of new submissions and support for existing licences worldwide.  He also leads the global regulatory support groups (CMC, preclinical, labelling, systems and operations), as well as Quality Assurance for the worldwide R&D organisation.

 

Dr. Huckle sits on the Scientific Advisory Board and the Advisory Management Committee for the Centre for Innovation in Regulatory Science (CIRS), and is a member of the Advisory Board for the Duke-NUS Centre for Regulatory Excellence (CoRE).  He recently served as the Designated Expert representing PhRMA on the ICH Expert Working Group for M4E(R2) (Benefit – Risk Information).  He is an Honorary Life Member of TOPRA – The Organisation for Professionals in Regulatory Affairs.


Before entering the regulatory field Dr. Huckle worked for ten years in pharmaceutical development with responsibility for leading the development of both prescription and OTC products.


Prior to joining industry Dr. Huckle held a position at The School of Pharmacy, University of London. He holds a degree in Pharmacy and a Ph.D. in Pharmaceutics from the University of London and is a Member of the Royal Pharmaceutical Society of Great Britain. He holds dual citizenship; UK and USA.

Stelphen Lee

Biosciences Team Manager, Devices Division, Medicines and Healthcare products Regulatory Agency

Stelphen Lee

Biosciences Team Manager, Devices Division, Medicines and Healthcare products Regulatory Agency

Stephen worked as a company microbiologist after training as a Biomedical Scientist in hospital pathology until 1996 when he joined the medical device regulator now known as the MHRA.

Stephen leads a team of specialist scientists who investigate adverse incidents and provide specialist advice on a range of medical devices including in vitro diagnostics.

Currently Stephen is on secondment to help develop the Agency strategy for genomics and companion diagnostics.

Stephen is the chair of the European Commission’s IVD working group which is responsible for drafting the Common Technical Specifications and providing advice and guidance on IVD regulatory issues.

Dr Tom Lillie

Vice President, Head of European Clinical Development, MSD

Dr Tom Lillie

Vice President, Head of European Clinical Development, MSD

Tom is the Vice President and Head of European Clinical Development for Merck, Sharp and Dohme.  He completed his undergraduate training at Brasenose College, University of Oxford, where he was awarded a first-class degree in pharmacology, cell biology and immunology, before earning his doctorate from the Department of Physiology at the University College of London.  Tom then completed his medical education at the University College London Medical School, receiving honors distinction in clinical pharmacology and surgery.  He is a member of the Royal College of Surgeons of England and the Faculty of Pharmaceutical Medicine of the Royal College of Physicians.

Tom has led global, regional and affiliate medical teams, encompassing both clinical development and medical affairs functions.  He has extensive experience in clinical research in phase 2 – phase 4, and in supporting regulatory, safety and reimbursement interactions.  During his clinical and industry career, he has specialised in oncology and haematology, but has also worked in cardiovascular and neurologic disease areas.

Chay Morgan

Head of EU Regulatory Affairs, BioMarin

Chay Morgan

Head of EU Regulatory Affairs, BioMarin

Chay is currently Vice President for EUMEA Regulatory Affairs for BioMarin, based in London.  In this role Chay is responsible for the EU and MEA/CIS regional regulatory affairs teams supporting BioMarin’s inline portfolio of orphan medicines for conditions including MPS IVA, MPS VI, PKU, and LEMS, and development programs in rare conditions including Haemophilia, Achondroplasia, CLN2 and MPS IIIB.

 

Chay has spent the majority of his 25 year career in the pharmaceutical industry within Regulatory, and has worked in a number of senior regional and global roles for Amgen and other large and medium sized pharmaceutical companies, in roles based both in the UK and in the US.

Alan Morrison

Chairman, BIA Regulatory Affairs Advisory Committee and Vice President, Regulatory Affairs International, MSD

Alan Morrison

Chairman, BIA Regulatory Affairs Advisory Committee and Vice President, Regulatory Affairs International, MSD

Alan is Vice President of Regulatory Affairs International at Merck Sharp & Dohme (MSD), joining mid-2015.   As a key member of the Global Regulatory Affairs and Clinical Safety (GRACS) global function, Alan leads a global ex-US regulatory organisation spanning Europe, Middle East and Africa, Latin America and Asia Pacific regional hubs and almost 60 local subsidiary offices, as well as for Merck Canada, plus supporting US-based cross-regional International teams.   His leadership covers a global team of 750 people operating across multiple therapeutic areas including anti-infectives, oncology, diabetes, cardiology, neuroscience and vaccines, and multiple modalities.   Alan is also a member of key cross-functional, strategic management committees with governance responsibility for the overall strategy and performance of MSD regional businesses in both established and growth markets/regions.

 

Prior to MSD, Alan was from 2004 Vice President of International Regulatory Affairs and Safety at Amgen managing an organiaation of 400 people both in the UK and across more than 30 local affiliate offices worldwide, as well as being part of the Global Regulatory Affairs and Safety (GRAAS) global functional leadership.   Alan was also key member of Amgen’s International Management Committee(s) for Europe and emerging markets.

 

Prior to Amgen, Alan previously held a number of regulatory affairs and safety executive positions at a number of companies including Baxter Bioscience.

 

He is currently Chairman of the UK BioIndustry Association’s Regulatory Affairs Advisory Committee and acts on a number of trade association committees related to biotechnology/biopharmaceuticals.

Hilary Newiss

Chair, National Voices

Hilary Newiss

Chair, National Voices

Hilary is a lawyer and former partner in Denton Hall solicitors, now Dentons.  She specialised in intellectual property law and has served on several public bodies in the science, innovation, health and ethics fields.  She is currently a Trustee of the Natural History Museum, Chair of National Voices (an umbrella group for 160 Health and Social Care charities), and recently advised on a Review of Access to Innovative Medicines for the Office of Life Sciences.

Until last year, Hilary was a Non-Executive Director of the Francis Crick Institute (the largest biomedical research institute in the UK).

Dr David Reynolds

Chief Scientific Officer, Alzheimer’s Research UK

Dr David Reynolds

Chief Scientific Officer, Alzheimer’s Research UK

David is the Chief Scientific Officer of Alzheimer’s Research UK, which is UK’s leading research charity aiming to defeat dementia. Previously David worked in the pharmaceutical industry for 18 years at Merck Sharp & Dohme, Lundbeck and latterly Pfizer, where he was the Cambridge Neuroscience and Pain research site head.  He has held a variety of R&D leadership roles with responsibilities ranging from exploratory biology, through drug discovery, early clinical development and business development in multiple disease areas, but with a focus on neuroscience and pain.

David’s external work included representing Pfizer at EFPIA (European Federation of Pharmaceutical Industries and Association) for the Innovative Medicines Initiative (IMI) and coordinating Pfizer’s participation in over 30 projects. He has served as a member of the Medical Research Council’s Neuroscience and Mental Health Board and on the Scientific Advisory Board of a pain-focussed biotech. David holds a BA in Natural Sciences and a PhD in Neuropharmacology both from the University of Cambridge.