Emma Du Four is Head of International Regulatory Policy at AbbVie. She leads a team providing strategic guidance on key regulatory policy issues and external advocacy in support of access for patients to innovative medicines.

Emma has an honours degree in Biochemistry, a Masters degree in Business Administration and is a Fellow of the organisation for professionals in regulatory affairs. She partners with an extensive external network of industry, government, academic and healthcare system partners and has a broad range of experience across all aspects of innovative medicines development. Specific areas of expertise include regulatory policy & strategy development, clinical trials, biotechnology, real world evidence, pharmacovigilance and paediatric drug development.

Emma regularly represents AbbVie and industry more broadly on scientific and technical issues. She is Chair of the BioIndustry Association Regulatory Affairs Advisory Committee and Vice-Chair of the European Regulatory Expert Group. She has been influential in shaping the current global regulatory environment.

Kate is a Chemist by training and has worked in the Pharmaceutical Industry for over 25 years. She has spent more than 20 years in Regulatory Affairs covering policy, generics, small molecules, biologics and advanced therapies as country, EU and global lead for new biological and small molecule products across several therapy areas. Kate has recently left AstraZeneca where she was a Brexit Lead for regulatory and development.

Dr Ward trained as an anaesthetist before joining the pharmaceutical industry in 1990. He held a number of positions in the pharmaceutical industry, principally involved in clinical research, leaving to join the MHRA as the Head of the Clinical Trials Unit in April 2004.
He chaired the European Clinical Trials Facilitation Group (CTFG) between January 2005 and 2008, and between September 2012 until January 2018 was co-chair. He represents the UK on the EU Commission Expert Group on clinical trials and also represented the UK on the EU Council Working Party negotiating the new Clinical Trials Regulation. He is now actively leading the implementation of the CTR in the UK in relation to the various Brexit scenarios.

Following medical training in London and subsequent specialist training in Medical Oncology in Cambridge and the Royal Marsden Hospital, Sarah was awarded a CRUK Junior Clinician Scientist PhD fellowship in 1999 at Cambridge University and later held a Clinical Fellowship at the Institute of Cancer Research’s Drug Development Unit.

In 2006 she was appointed as Senior Lecturer and Honorary Consultant at Imperial College before becoming Associate Professor of Medical Oncology at University of Oxford in 2015. Here she leads their Early Phase Trials Unit, is their ECMC lead and runs a laboratory studying the dysregulation of mRNA translation in cancer. She has been chief or principal investigator for a number of national and international clinical studies of novel cancer therapeutics. Complex innovative designed trials are important innovations to fast-track drug development but pose a number of challenges in the clinic. In her talk, Sarah will be discussing the researcher’s perspective around conducting these trials and how the main challenges can be addressed.

Kate is a Chemist by training and has worked in the Pharmaceutical Industry for over 25 years. She has spent more than 20 years in Regulatory Affairs covering policy, generics, small molecules, biologics and advanced therapies as country, EU and global lead for new biological and small molecule products across several therapy areas. Kate has recently left AstraZeneca where she was a Brexit Lead for regulatory and development.

Following medical training in London and subsequent specialist training in Medical Oncology in Cambridge and the Royal Marsden Hospital, Sarah was awarded a CRUK Junior Clinician Scientist PhD fellowship in 1999 at Cambridge University and later held a Clinical Fellowship at the Institute of Cancer Research’s Drug Development Unit.

In 2006 she was appointed as Senior Lecturer and Honorary Consultant at Imperial College before becoming Associate Professor of Medical Oncology at University of Oxford in 2015. Here she leads their Early Phase Trials Unit, is their ECMC lead and runs a laboratory studying the dysregulation of mRNA translation in cancer. She has been chief or principal investigator for a number of national and international clinical studies of novel cancer therapeutics. Complex innovative designed trials are important innovations to fast-track drug development but pose a number of challenges in the clinic. In her talk, Sarah will be discussing the researcher’s perspective around conducting these trials and how the main challenges can be addressed.

Steve joined Parkinson's UK as Chief Executive in 2005 after a career as General Manager and Chief Executive in the NHS.

Under his leadership, we've made significant progress towards our vision to find a cure and improve life for everyone affected by Parkinson's.

Steve believes strongly that change is best delivered in partnership. He's bringing together everyone in the Parkinson's community to speed up research, raise standards of care and empower people affected by the condition to take more control of their lives.

Putting people living with Parkinson's at the heart of the charity has created passion and urgency. Steve believes that is the key to achieving our ambitious goals.

Dr Beth Thompson is Head of UK & EU Policy at the Wellcome Trust. Wellcome is a global foundation that exists to improve to improve health for everyone by helping great ideas to thrive. We spend around £1 billion a year to support research, innovation and public engagement.

Beth leads Wellcome’s UK & EU policy and advocacy activities, covering issues including Brexit, research investment and emerging technology.
In 2017 Beth was awarded an MBE for services to science for successfully advocating against amendments to the EU General Data Protection Regulation that would have been severely damaging for research.

Beth holds a PhD from the Medical Research Council Laboratory of Molecular Biology in Cambridge and a degree in Natural Sciences (Biochemistry) from the University of Cambridge.

Dr Ward trained as an anaesthetist before joining the pharmaceutical industry in 1990. He held a number of positions in the pharmaceutical industry, principally involved in clinical research, leaving to join the MHRA as the Head of the Clinical Trials Unit in April 2004.
He chaired the European Clinical Trials Facilitation Group (CTFG) between January 2005 and 2008, and between September 2012 until January 2018 was co-chair. He represents the UK on the EU Commission Expert Group on clinical trials and also represented the UK on the EU Council Working Party negotiating the new Clinical Trials Regulation. He is now actively leading the implementation of the CTR in the UK in relation to the various Brexit scenarios.

Bharti Navsariwala is Senior Director Regulatory Affairs at Takeda, and is responsible for the Oncology portfolio for the Europe Region. She has extensive experience in the biopharmaceutical industry, with expertise across the whole development and marketing lifecycle, encompassing product development and regulatory strategy. Bharti holds an Honours degree in Biochemistry & Immunology as well as the TOPRA Diploma in Regulatory Affairs.

She has contributed to regulatory initiatives for EFPIA and other trade associations, as well as the Cancer Drug Development Forum, and has been working with BIA on the Regulatory Affairs Consultative Committee for many years.

Samantha Roberts has recently been appointed as Chief Executive of the Accelerated Access Collaborative, the national umbrella organisation for health innovation, hosted in NHS England and NHS Improvement.

She originally trained as a doctor and practiced medicine in South Africa, the UK, and Australia before undertaking an MBA and joining McKinsey and Company, where she worked in a wide range of industries before specialising in healthcare.

After McKinsey she moved into the NHS as a senior manager at a large teaching hospital in London (UCLH) and a director in an Academic Health Sciences Centre and Network (UCLPartners). Before taking on the role of Director of Innovation, Research and Life Sciences at NHS England and NHS Improvement last year.

Over the last five years she has become involved in research, working with health economic models to inform evidence-based policy, initially at the London School of Economics before moving to the University of Oxford to undertake a DPhil (PhD).

David originally trained as a pharmacologist receiving an MSc in Neuropharmacology from the University of Toronto and a PhD in Cardiovascular Pharmacology from the University of Western Ontario in Canada. Since completing his PhD, David has worked in the pharmaceutical industry for the last 27 years both in Canada and globally based in Europe. During this period, he has held various roles including clinical research; pharmacovigilance; product development; in-licensing and regulatory affairs. David is currently working in the role of Regulatory Policy and Intelligence at Takeda based in the UK with global responsibility (excluding the US & Canada).

Prior to joining Takeda (formerly Shire), David was working at Novo Nordisk in a global regulatory intelligence role with a focus on the Asia Pacific region. David has worked for the last 20 years with the global development and registration of Orphan Medicinal Products. Prior to working at Novo Nordisk, David was the acting medical director working for Swedish Orphan International which specialised in the development of older compounds for rare diseases. He is currently the co-chair on the EFPIA/EuropaBio Joint Rare Diseases & Orphan Medicinal Products Task Force.

David joined NICE in December 2018 as Associate Director for its new Commercial Liaison Team. He qualified as a pharmacist from Strathclyde University in the last millennium and spent his formative years as a cancer pharmacist in acute Trusts, culminating in his appointment as Lead Pharmacist for the Yorkshire Cancer Network, working across 7 acute Trusts and 12 Primary Care Trusts.

In this role he worked closely with the National Cancer Action Team (NCAT) resulting in a part-time secondment to a national role with them in support of their work in managing the regionally administered Cancer Drugs Fund. In 2013 David became Lead Cancer Pharmacist at the newly formed NHS Commissioning Board and in this role supported the work of nationally administered Cancer Drugs Fund and of the Chemotherapy Clinical Reference Group.

He has developed a strong interest in the pricing and reimbursement of medicines which led him to successfully complete an MSc in International Health Technology Appraisal, Pricing and Reimbursement from the School of Health and Related Research (SCHARR) at the University of Sheffield in 2014.

David is a Fellow of the Royal Pharmaceutical Society and of the British Oncology Pharmacy Association (BOPA) and is a past Chair of BOPA.

Bharti Navsariwala is Senior Director Regulatory Affairs at Takeda, and is responsible for the Oncology portfolio for the Europe Region. She has extensive experience in the biopharmaceutical industry, with expertise across the whole development and marketing lifecycle, encompassing product development and regulatory strategy. Bharti holds an Honours degree in Biochemistry & Immunology as well as the TOPRA Diploma in Regulatory Affairs.

She has contributed to regulatory initiatives for EFPIA and other trade associations, as well as the Cancer Drug Development Forum, and has been working with BIA on the Regulatory Affairs Consultative Committee for many years.

David originally trained as a pharmacologist receiving an MSc in Neuropharmacology from the University of Toronto and a PhD in Cardiovascular Pharmacology from the University of Western Ontario in Canada. Since completing his PhD, David has worked in the pharmaceutical industry for the last 27 years both in Canada and globally based in Europe. During this period, he has held various roles including clinical research; pharmacovigilance; product development; in-licensing and regulatory affairs. David is currently working in the role of Regulatory Policy and Intelligence at Takeda based in the UK with global responsibility (excluding the US & Canada).

Prior to joining Takeda (formerly Shire), David was working at Novo Nordisk in a global regulatory intelligence role with a focus on the Asia Pacific region. David has worked for the last 20 years with the global development and registration of Orphan Medicinal Products. Prior to working at Novo Nordisk, David was the acting medical director working for Swedish Orphan International which specialised in the development of older compounds for rare diseases. He is currently the co-chair on the EFPIA/EuropaBio Joint Rare Diseases & Orphan Medicinal Products Task Force.

David joined NICE in December 2018 as Associate Director for its new Commercial Liaison Team. He qualified as a pharmacist from Strathclyde University in the last millennium and spent his formative years as a cancer pharmacist in acute Trusts, culminating in his appointment as Lead Pharmacist for the Yorkshire Cancer Network, working across 7 acute Trusts and 12 Primary Care Trusts.

In this role he worked closely with the National Cancer Action Team (NCAT) resulting in a part-time secondment to a national role with them in support of their work in managing the regionally administered Cancer Drugs Fund. In 2013 David became Lead Cancer Pharmacist at the newly formed NHS Commissioning Board and in this role supported the work of nationally administered Cancer Drugs Fund and of the Chemotherapy Clinical Reference Group.

He has developed a strong interest in the pricing and reimbursement of medicines which led him to successfully complete an MSc in International Health Technology Appraisal, Pricing and Reimbursement from the School of Health and Related Research (SCHARR) at the University of Sheffield in 2014.

David is a Fellow of the Royal Pharmaceutical Society and of the British Oncology Pharmacy Association (BOPA) and is a past Chair of BOPA.

Rob is a partner at Consilium. Consilium is my consultancy partnership with Tomas Salmonson, a long-standing member of the EMA’s CHMP and formerly the chair of that committee. Tomas and I support companies in the development, authorisation and life-cycle management of medicines.

Previously I worked at AstraZeneca and for 19 years at the Medicines and Healthcare products Regulatory Agency, heading the group of medical statisticians and pharmacokineticists. I am a statistician by background and whilst working at MHRA I was co-opted as a member of EMA’s CHMP for expertise in medical statistics and epidemiology. At CHMP I was Rapporteur for multiple products and was widely engaged across both scientific and policy aspects of the committee’s work. I was fortunate to chair the CHMP’s Scientific Advice Working Party for 8 years and have also chaired their expert groups on Biostatistics, Modelling and Simulation and Extrapolation. I wrote or co-wrote multiple regulatory guidance documents, including those related to estimands, subgroups, use of conditional marketing authorisation, development of fixed-dose combinations, extrapolation and adaptive designs. I have a particular interest in when and how to use data generated in clinical practice to support drug development.

Andrew oversees the provision of methodological and analytic expertise to the Epidemiology group in support of Drug Development and Regulatory & Safety activities worldwide. Prior to joining Pfizer in 2009, Andrew was at the WHO Collaborating Centre for International Drug Monitoring in Sweden for more than 12 years, where he was responsible for Research. Andrew has over 100 academic publications on the development for methods and tools for Real World Data analysis and Real World Evidence generation and has contributed to several international initiatives and partnerships around the appropriate use of Real World Data.
Andrew holds a Masters degree in Chemistry from Oxford University, and a PhD in Clinical Pharmacology from Umea University, Sweden. He was a Visiting Professor in Information Systems and Computing, at Brunel University, London, UK and is an Adjunct Associate Professor in Clinical Pharmacology at NYU School of Medicine and was affiliate faculty of the NYU Center for Health Informatics and Bioinformatics.

Ane Auraaen is working as a health policy analyst at the OECD Health Division in Paris, France, and authored the OECD/EU report on Using Routinely Collected Data to Inform Pharmaceutical Policies.

Coming from a background in public health and health economics, most of her previous work has been focused on mental health and including patient-reported measures in the assessment of quality of care for people with mental disorders in France.

At the OECD, Ane has continued the focus on quality of care and safety. Since 2017, she has been involved in producing a series of reports on the Economics of Patient Safety in hospital care and primary/ambulatory care settings. The first two reports were presented at the Global Ministerial Summits in Bonn, Germany and Tokyo, Japan, and two new reports will be presented at the upcoming summit in Switzerland 2020. More recently, her work has focused on pharmaceutical policies, analysing the efficiency of their decision-making processes and the extent to which routinely collected data are used to inform clinical practice, health technology assessments, pricing and reimbursement decisions. One of the key outputs have been the OECD report on routinely collected data published in February 2019.

Ane Auraaen is working as a health policy analyst at the OECD Health Division in Paris, France, and authored the OECD/EU report on Using Routinely Collected Data to Inform Pharmaceutical Policies.

Coming from a background in public health and health economics, most of her previous work has been focused on mental health and including patient-reported measures in the assessment of quality of care for people with mental disorders in France.

At the OECD, Ane has continued the focus on quality of care and safety. Since 2017, she has been involved in producing a series of reports on the Economics of Patient Safety in hospital care and primary/ambulatory care settings. The first two reports were presented at the Global Ministerial Summits in Bonn, Germany and Tokyo, Japan, and two new reports will be presented at the upcoming summit in Switzerland 2020. More recently, her work has focused on pharmaceutical policies, analysing the efficiency of their decision-making processes and the extent to which routinely collected data are used to inform clinical practice, health technology assessments, pricing and reimbursement decisions. One of the key outputs have been the OECD report on routinely collected data published in February 2019.

Andrew oversees the provision of methodological and analytic expertise to the Epidemiology group in support of Drug Development and Regulatory & Safety activities worldwide. Prior to joining Pfizer in 2009, Andrew was at the WHO Collaborating Centre for International Drug Monitoring in Sweden for more than 12 years, where he was responsible for Research. Andrew has over 100 academic publications on the development for methods and tools for Real World Data analysis and Real World Evidence generation and has contributed to several international initiatives and partnerships around the appropriate use of Real World Data.
Andrew holds a Masters degree in Chemistry from Oxford University, and a PhD in Clinical Pharmacology from Umea University, Sweden. He was a Visiting Professor in Information Systems and Computing, at Brunel University, London, UK and is an Adjunct Associate Professor in Clinical Pharmacology at NYU School of Medicine and was affiliate faculty of the NYU Center for Health Informatics and Bioinformatics.

As Director of EU Regulatory Policy, Simon is responsible for developing and leading Biogen’s European 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 neurological 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 the EU regulatory environment and procedures 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 medical communications and publishing in areas of schizophrenia and infectious diseases. Simon is a biologist by training with an MSc in medical parasitology.

Rob is a partner at Consilium. Consilium is my consultancy partnership with Tomas Salmonson, a long-standing member of the EMA’s CHMP and formerly the chair of that committee. Tomas and I support companies in the development, authorisation and life-cycle management of medicines.

Previously I worked at AstraZeneca and for 19 years at the Medicines and Healthcare products Regulatory Agency, heading the group of medical statisticians and pharmacokineticists. I am a statistician by background and whilst working at MHRA I was co-opted as a member of EMA’s CHMP for expertise in medical statistics and epidemiology. At CHMP I was Rapporteur for multiple products and was widely engaged across both scientific and policy aspects of the committee’s work. I was fortunate to chair the CHMP’s Scientific Advice Working Party for 8 years and have also chaired their expert groups on Biostatistics, Modelling and Simulation and Extrapolation. I wrote or co-wrote multiple regulatory guidance documents, including those related to estimands, subgroups, use of conditional marketing authorisation, development of fixed-dose combinations, extrapolation and adaptive designs. I have a particular interest in when and how to use data generated in clinical practice to support drug development.

Emma Du Four is Head of International Regulatory Policy at AbbVie. She leads a team providing strategic guidance on key regulatory policy issues and external advocacy in support of access for patients to innovative medicines.

Emma has an honours degree in Biochemistry, a Masters degree in Business Administration and is a Fellow of the organisation for professionals in regulatory affairs. She partners with an extensive external network of industry, government, academic and healthcare system partners and has a broad range of experience across all aspects of innovative medicines development. Specific areas of expertise include regulatory policy & strategy development, clinical trials, biotechnology, real world evidence, pharmacovigilance and paediatric drug development.

Emma regularly represents AbbVie and industry more broadly on scientific and technical issues. She is Chair of the BioIndustry Association Regulatory Affairs Advisory Committee and Vice-Chair of the European Regulatory Expert Group. She has been influential in shaping the current global regulatory environment.

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

He is a physician who practised 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 MCA (Medicines Control Agency) as Director of the Licensing Division.

Before being appointed as Chief Executive, Dr Hudson was the MHRA'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 (CHMP) and was its vice-chairman from October 2012 to September 2013.

Ms Nolan is a chemist having completed her Ph.D. and post-doctoral research at Trinity College Dublin in transdermal drug delivery. She worked for a number of years in private industry in the area of enhancing and developing drug delivery systems, and also within the state forensic science services.

Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming the role of Chief Executive she was Director of Human Products Authorisation & Registration. Ms Nolan is a member of the Management Board of the European Medicines Agency and the EU HMA Management Group.

Emma Du Four is Head of International Regulatory Policy at AbbVie. She leads a team providing strategic guidance on key regulatory policy issues and external advocacy in support of access for patients to innovative medicines.

Emma has an honours degree in Biochemistry, a Masters degree in Business Administration and is a Fellow of the organisation for professionals in regulatory affairs. She partners with an extensive external network of industry, government, academic and healthcare system partners and has a broad range of experience across all aspects of innovative medicines development. Specific areas of expertise include regulatory policy & strategy development, clinical trials, biotechnology, real world evidence, pharmacovigilance and paediatric drug development.

Emma regularly represents AbbVie and industry more broadly on scientific and technical issues. She is Chair of the BioIndustry Association Regulatory Affairs Advisory Committee and Vice-Chair of the European Regulatory Expert Group. She has been influential in shaping the current global regulatory environment.

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

He is a physician who practised 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 MCA (Medicines Control Agency) as Director of the Licensing Division.

Before being appointed as Chief Executive, Dr Hudson was the MHRA'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 (CHMP) and was its vice-chairman from October 2012 to September 2013.

Ms Nolan is a chemist having completed her Ph.D. and post-doctoral research at Trinity College Dublin in transdermal drug delivery. She worked for a number of years in private industry in the area of enhancing and developing drug delivery systems, and also within the state forensic science services.

Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming the role of Chief Executive she was Director of Human Products Authorisation & Registration. Ms Nolan is a member of the Management Board of the European Medicines Agency and the EU HMA Management Group.