Galien week of innovation

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Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV).

Niklas is the Co-Chair of the HTAR Coordination Group with special expertise in pharmaceuticals. He was the Chair of the Consortium Executive Board for EUnetHTA21 (2021-2023) as well as the Chair of the EUnetHTA JA 3, Executive Board between 2018 and 2021.

Niklas has been working with pricing and reimbursement since 2001. He has held positions as medical assessor, project leader, Head of the Department for New Submissions (between 2009 and 2014) and he is now the Chief Pharmacist.

Niklas has a broad experience of different aspects of value based evaluation and over time has seen the increasing importance for health technology assessment (HTA) both across health care systems and on local level to prepare accurate decision making.

Among Niklas special interests have been the early development of joint scientific advice in 2009 and onwards (pilots both nationally with MPA and on European level with EMA) and strategic discussions about RWD.

Sam Roberts is the Chief Executive of the National Institute for Health and Care Excellence.

She has worked in healthcare for 20 years in a combination of clinical, operational, private sector and academic roles. She originally trained as a doctor before undertaking an MBA and joining McKinsey and Company. Her focus for the last 15 years has been on improving quality of clinical care and supporting uptake of innovation - as Head of Operations at a large teaching hospital in London (UCLH), Director of Innovation, Research and Life Sciences at NHS England and Improvement and Chief Executive of the Accelerated Access Collaborative.

Prior to joining NICE she invested in early stage digital health and diagnostics companies. She has an academic interest in the influence of health economic analysis on policy and clinical practice, having worked at the London School of Economics followed by doctoral studies at the University of Oxford.

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Valentina Strammiello currently holds the role of Director of Strategic Initiatives at the European Patients Forum. On behalf of EPF, she brings the patient perspective in HTA.

She has been an active contributor to shaping the HTA Regulation since 2017.

Before joining EPF, Valentina worked as freelance Open Source Intelligence analyst in Security and Energy sectors. She is among the founders of ecpa2.0 (European Centre for Public Affairs 2.0), a Brussels-based forum of young professionals in Public Affairs. She holds master’s degrees in International Relations and in European Studies.

Steffen Thirstrup is a medical doctor and board-certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine with special emphasis on adult respiratory medicine.

Additionally, Dr. Thirstrup was appointed adjunct professor in pharmacotherapy at the Faculty of Health Sciences, University of Copenhagen, in 2012.From 2004-09 Steffen Thirstrup worked at Danish Medicines Agency first as the Danish member of CHMP at the European Medicines Agency (EMA) for five years including 10 months as joint CHMP- and CAT-member, followed by a short period as head of Danish Institute for Rational Pharmacotherapy dealing with HTA and best practice guidelines for primary care.

In 2011 Prof. Thirstrup rejoined the licensing division at the Danish Medicines Agency acting as Head of Division for Medicines Assessment and Clinical Trials. During this period Prof Thirstrup co-chaired the European Commission’s working group on market access for biosimilars medicinal products and acted as key scientific contact for the managing entity of the IMI beneficiaries for the PROTECT collaboration (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium).

In March 2013, Prof Thirstrup joined the pharmaceutical consultancy company NDA Group AB as a full-time medical advisor on NDA’s regulatory advisory board. In April 2014 Prof Thirstrup was appointed as director for the Regulatory Advisory Board at NDA Regulatory Services Ltd.

Since June 2022 Prof Thirstrup has been the Chief Medical Officer at the European Medicines Agency, Amsterdam, The Netherlands

Dr June Raine DBE is CEO of the Medicines and Healthcare products Regulatory Agency.

She trained in medicine in Oxford after completing a master’s degree by research in Pharmacology.  Her interest in drug safety led to a career in medicines regulation which has spanned a number of roles in assessment, management and strategic development within the UK national authority.

She was elected in 2012 as the first chair of the European Pharmacovigilance Risk Assessment Committee and is also co-Chair of the WHO Advisory Committee on Safety of Medicinal Products.

Her special interests are in monitoring the outcomes of regulatory action, risk communication and patient involvement in the regulatory process.

Janet Woodcock recently completed a long career at FDA. She served as Director of the Center for Drug Evaluation and Research for over twenty years in several stretches.

Most recently she served as Principal Deputy Commissioner and prior to that as Acting FDA Commissioner.

She held multiple other senior positions at FDA including at the Center for Biologics Evaluation and Research.

She was the therapeutics lead for "Operation Warp Speed" during the COVID pandemic.

Her most recent effort was spearheading a major reorganization of FDA's foods program and the Office of Regulatory Affairs.

Dr. Woodcock completed many major regulatory initiatives during her FDA tenure.

She was instrumental in getting the biosimilars legislation enacted and worked to ensure adoption in the clinical community.

Additionally, she worked with industry and Congress to bring about the first GDUFA.

After passage of the legislation, she oversaw an extensive reorganization of the generic drug review program at CDER, that successfully met the aggressive targets of the legislation and led to eventual reauthorizing, with elimination of backlogs and approval of thousands of generic drugs.

Professor Darzi is the Paul Hamlyn Chair of Surgery and Co-Director of the Institute of Global Health Innovation at Imperial College London. He is a Consultant Surgeon at the Imperial College Hospital NHS Trust and Royal Marsden NHS Foundation Trust. Professor Darzi is Chair of the NHS Accelerated Access Collaborative and Chair for the Pre-emptive Health & Medicine Initiative at Flagship Pioneering, United Kingdom. In 2024, at the request of the Secretary of State, he completed an Independent investigation of the NHS in England.

Professor Darzi is also the Executive Chair of the Fleming Initiative, an innovative programme under the patronage His Royal Highness the Prince of Wales, to address the rising burden of antimicrobial resistance worldwide through an inter-disciplinary approach.

He is a Fellow of the Academy of Medical Sciences and the Royal Society, Honorary Fellow of the Royal Academy of Engineering and Past President of the British Science Association.

In 2002, Professor Darzi was knighted for his services to medicine and surgery, and in 2007 was introduced as Lord Darzi of Denham to the United Kingdom’s House of Lords as the Parliamentary Under-Secretary of State for Health. He has been a member of His Majesty's Most Honourable Privy Council since 2009 and was awarded the Order of Merit in 2016.

Naveed Sattar is a Professor of Cardiometabolic Medicine in Glasgow. He has accumulated considerable expertise in obesity from clinical care, epidemiology, guidelines and trials of medicines and lifestyle interventions.

He has co-authored over 1400 papers which have been cited >200K, and contributed to over 10 international and national guidelines. He is Chair of the Obesity Health Care goals programme, working with others to make the UK a better place for future trials of weight loss drugs. He has been awarded several national and international awards for his work and is currently an associate editor for Diabetes Care.

Rachel joined Lilly in 2023, prior to this she had spent 30 years in clinical practice, and held the role of Professor of Obesity, Diabetes and Endocrinology at University College London (UCL) and Honorary Consultant at University College London Hospital (UCLH).

She is recognised globally for her ground-breaking research that identified gut hormones as treatments for obesity and for her clinical expertise in managing people living with obesity.

Rachel has played a key role in defining national and international guidelines for obesity management, as a member of multiple guideline development and consensus groups including National Institute for Health and Care Excellence (NICE), European Association for the Study of Obesity (EASO), International Federation for the Surgery for Obesity and metabolic diseases (IFSO) and Lancet Commission on the Definition and Diagnosis of Clinical Obesity.

In 2022, she was awarded an OBE (Officer of the Order of the British Empire) by the late Queen Elizabeth II for services to people with obesity. This was in recognition of her 25-year career dedicated to improving the health of people living with obesity, spanning from basic research, through Phase 1 to 4 clinical trials to influencing public policy.

Melanie Davies is Professor of Diabetes Medicine at the University of Leicester and an Honorary Consultant Diabetologist at the University Hospitals of Leicester NHS Trust. She is the Co-Director of the Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust.

Professor Davies’ research interests include the causes, screening, prevention, self-management and treatment of type 2 diabetes mellitus. She is a National Institute for Health Research Senior Investigator Emeritus and Director of the NIHR Leicester Biomedical Research Centre and co-chair of EASD/ADA’s Consensus Report on T2DM Management.

Professor Davies has published over 960 original articles and has over £125M of grant funding. She was awarded the CBE (Commander of the Most Excellent Order of the British Empire) in the 2016 New Year’s Honour’s List for services to diabetes research.

Simon qualified from the London Hospital Medical College in 1986 and specialised in general practice. As a Wellcome Training Fellow he undertook doctoral study in Clinical Epidemiology and Public Health at the University of Southampton and London School of Hygiene and Tropical Medicine, before being appointed as a University Lecturer in Cambridge in 1998. In 2005 Simon joined the Medical Research Council Epidemiology Unit as Assistant Director and was appointed Professor of General Practice in May 2013.

Simon is an Honorary Doctor at Umeå University Sweden, Honorary Consultant at Cambridge University Hospitals NHS Foundation Trust and NHS England and Fellow of the Academy of Medical Sciences and the Royal College of General Practitioners. He undertakes two surgery sessions per week at Lensfield Medical Practice in the centre of Cambridge.

His research contributes to efforts aimed at preventing the growing burden of diabetes, obesity and related disorders by translating epidemiological knowledge into preventive action, and evaluating the effectiveness of a range of strategies from behaviour change to screening. He has completed over 40 trials and authored over 500 publications which have been cited over 42000 times, but what he really likes to do is surf.

Vicki Mooney is a Patient Advocate, Public Speaker, the Executive Director of the ECPO and Chairperson of the Board of ICPO.

Originally from Ireland, now living in Lanzarote, Vicki uses her voice to help address the stigma, bias and discrimination perpetrated against people living with Obesity. Whilst not only working on various projects across Europe & now globally as a co-chair of GOPA, to ensure we see better access to quality treatment, management and education, but also to help drive forward prevention of obesity across Europe and the globe.

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Professor Michael Browning is an academic psychiatrist who leads a research laboratory that bridges the gap between scientific discovery and patient care. His work focuses on understanding how the brain and mind work in psychiatric conditions by using advanced computer models.

He uses these insights to develop and test new treatments, including both talking therapies and medications. Professor Browning runs a specialized clinic in Oxford for people with depression that hasn't responded well to standard treatments. His work brings together scientists, doctors, and patients to advance our understanding and treatment of mood disorders.

Vanessa studied at the University of Nottingham, completing her Geography PhD within the field of mental health research. That began a 30 year research career working alongside people with mental health issues including at Kings College London and Rethink Mental Illness, honorary academic positions at UCL and University of Plymouth, as well as leadership of the Alliance of Mental Health Research Funders.

Today she leads the specialist mental health research charity she co-founded, building collaborations to deliver peer research, coproduction and public involvement programmes including within the mental health mission, UKRI mental health platform, Wellcome and NIHR funded projects.