Day 1: PHARMACEUTICAL PAYER & HTA FORUM
“Payers” (health plans, sick funds & insurers, payers, health technology assessors, hospital financial management & health department officials) in almost all circumstances, in both developed and developing countries are under extreme budgetary pressure. Many health systems in the developed world, face ageing populations, economic crisis and rapidly increasing healthcare costs in general, including the sustained cost increases of innovative and novel drugs. This is forcing payers to make difficult choices regarding which medical procedures & medications to fund and reimburse. No longer are “me too” drugs that have achieved regulatory approval simply approved for reimbursement at high prices. Payers need to make tough decisions based on what they define as “value”, unfortunately sometimes at the expense of funding treatments in some “lower priority” disease indications or individual patients. Despite intense political pressure from patients and stakeholders who believe healthcare is an inalienable “right” and should be “free for all,” the reality is that payers have a finite and limited budget, and face a high degree of risk in decision making. They operate within an environment where a multitude of products are on offer, each making various therapeutic claims of efficacy and safety, often with insufficient data to validate supposed health outcome improvements over existing treatment options. How can payers make the right decision in a high-risk, high uncertainty environment?
Various options and decision-making tools exist, some old, some novel. Traditional decision making based on, for example, price referencing, DRGs budgets or generic substitution are still significant. However, recent advances in the sophistication of HTA analysis and modeling, flexible pay for performance models, risk-sharing and value-based pricing schemes have become increasingly important to mitigate payer risk and allocate financial resources to the areas of pressing need. Savings and outcome improvements can also be found through finding efficiency gains at the healthcare delivery level, providing the right incentives for prescribers and improving patient adherence.
Why this meeting?
This meeting will provide an ideal opportunity for “payers” and other decision makers from both public and private organisations, to benchmark with peers internationally and provide pharma companies an invaluable insight into the decision-making processes and approaches of these vital stakeholders. Attendees will be able to understand and develop best practice approaches to such vital and common challenges, with the ultimate goal of encouraging innovation and improving patient access to novel and powerful medications.
Day 2, AM: INNOVATIVE PRICING & REIMBURSEMENT AGREEMENTS
Flexible pricing and reimbursement schemes, have been in existence for around a decade in Europe and places like Canada, and is starting to become popular in the USA. They are known by many other names including Managed Entry Agreements (MEAs), Value-Based Pricing, Pay for Performance or Outcomes-based schemes. Most agreements so far, in reality, have been more basic financial-based arrangements (such as budget-capping and refunds for payers), rather than more sophisticated value-based models, based on improved health outcomes. As ‘’patient-centricity” becomes more of a focus for pharmaceutical companies and payers alike, most would agree that in principle, paying for outcomes is ideal and a “win-win” for all stakeholders, especially the patient. In theory, this helps payers conditionally approve the reimbursement of an innovative, yet expensive therapy and allow patient access without delay. Quality evidence is very much lacking at the time of launch, so the “wait and see approach” that risk sharing can provide, can be a great compromise for the industry, payers and patients. Payers can also avoid wastage when drugs are unsuccessful, but only paying for positive outcomes. The pharmaceutical industry can benefit, by maintaining a higher list price to avoid the negative price spiral due to reference pricing. They can also benefit from early-access. There have been also some high-profile value-based pricing schemes in the USA, which will pay for outcomes and look very innovative and promising. On both sides of the Atlantic, innovative agreements are here to stay. However, implementing complex outcomes-based schemes in practice is very challenging. It is difficult enough to measure outcomes across a patient population, let alone individual patients. Electronic Medical Records are still not widespread or integrated enough to provide sufficient real-world data, so busy doctors have to still keep records the manual way, which are prone to error. This stream will clarify the process of establishing, preparing, implementing and delivering a successful risk-sharing / managed entry agreement s, outcome based and value-based schemes, to improve the access of innovative medicines for patients.
Day 2, PM: HEOR EXCELLENCE TO ACHIEVE MARKET ACCESS
This stream will feature best practice case studies of designing, collecting & presenting HEOR studies and economic models of products’ therapeutic and economic benefits to both enhance internal decision-making and value-demonstration to external stakeholders. Methodological robustness, realistic assumptions and local-level customisation will be discussed as well as the extent of data depth and breadth which HTAs, Payers & Hospitals require from their perspective to make the right reimbursement decision.
Associate Director, NICE Office for Market Access
National Institute for Health and Care Excellence, UK
Member, and former Interim Chief Clinical Officer
NHS Thurrock Clinical Commissioning Group, UK
Member
Joint Committee Vaccination & Immunisation (JCVI) London, UK
Prof. of Pharmacoeconomics
University of Groningen, The Netherlands
Head of Section, Health Economics
Amgros, Pharmaceutical Procurement Service for Regional Authorities, Denmark
Associate Professor, Economic Evaluations in Health Care
Erasmus School of Health Policy and Management (ESHPM)
Institute for Medical Technology Assessment (iMTA)
Erasmus University Rotterdam, Netherlands
General Director, Center of Healthcare Quality Assessment and Control
Ministry of Health, Russia
Coordinator assessments of pharmaceuticals, Internal HTA experts
National Institute for Health and Disability Insurance (RIZIV INAMI), Belgium
Chair, the Domain Task Force ‘Joined HTA’, the BeNeLuxA Initiative
Scientific Advisor, Project manager EUnetHTA JA3 WP5A – Early Dialogues
Federal Joint Committee (G-BA), Berlin, Germany
Senior Vicepresident, Global Marketing and Strategy,
EMD Serono, a company of MERCK KGaA, Darmstat, Germany
Vice President, Head of Operations and Payer Intelligence
Global Market Access
Sanofi, UK
Head of Market Access
Mundipharma International, UK
Senior Director, Value Evidence Leader, Immuno-inflammation
Value Evidence & Outcomes (VEO)
GSK, UK
Senior Director, Regional Health and Value Lead, International Developed Markets
Pfizer, UK
Director Health Technology Assessment & Outcomes Research Health & Value
Pfizer, Germany
Gene Therapy Global Market Access
GlaxoSmithKline, UK
Health Economics and Outcomes Research Leader
Mundipharma International, UK
Head of Pricing & Market Access Pharma
Novartis, Netherlands
Professor of Health Economics and Pharmacoeconomics
Università Cattolica del Sacro Cuore di Roma
Senior Researcher
Karolinska Institute, Sweden
Director Of Research
Tufts Center for the Study of Drug Development
Tufts University School of Medicine
CEO & Founder
PharmaPhorum, UK
CEO
Digipharm, Switzerland
Global Business Development Director
Clinigen, UK
Managing Director,
Valid Insight, UK
VP Pricing & Market Access
Parexel Access Consulting
Principal Consultant, (Pricing and Market Access)
Parexel, UK
Executive Director, Real World and Late Phase
Syneos Health, UK
Principal Consultant
Huron Consulting Group, UK
Senior Consultant
Pope Woodhead, UK
Associate Director
Valid Insight
VP Pricing & Market Access
Parexel Access Consulting
Scientific Advisor, Project manager EUnetHTA JA3 WP5A – Early Dialogues
Federal Joint Committee (G-BA), Berlin, Germany
Associate Director, NICE Office for Market Access
National Institute for Health and Care Excellence, UK
Head of Market Access
Mundipharma International, UK
Director Of Research
Tufts Center for the Study of Drug Development
Tufts University School of Medicine
Professor of Health Economics and Pharmacoeconomics
Università Cattolica del Sacro Cuore di Roma
Associate Director, NICE Office for Market Access
National Institute for Health and Care Excellence, UK
Member, and former Interim Chief Clinical Officer
NHS Thurrock Clinical Commissioning Group, UK
General Director, Center of Healthcare Quality Assessment and Control
Ministry of Health, Russia
Head of Market Access
Mundipharma International, UK
Managing Director,
Valid Insight, UK
Scientific Advisor, Project manager EUnetHTA JA3 WP5A – Early Dialogues
Federal Joint Committee (G-BA), Berlin, Germany
Vice President, Head of Operations and Payer Intelligence
Global Market Access
Sanofi, UK
There is a well-recognized long-standing decline in R&D productivity in the pharmaceutical industry which has driven exploration of new approaches to the clinical development of pharmaceuticals. These include innovative randomized controlled trial designs, including adaptive, umbrella, and basket studies. Adaptive trials, perhaps the best established of these, have already been the subject of guidance documents by both the European Medicines Agency and Food and Drug Administration. However, in many markets it is the reimbursement hurdle (rather than the regulatory hurdle) that is proving the major barrier to overcome in order to enable patient access. Therefore, payer perceptions on such innovative trial designs will be key to informing pharmaceutical company utilization of such approaches. This presentation will provide an overview of these innovative new designs and present payer perspectives on the benefits and challenges posed by conducting reimbursement assessments on data coming from these trial designs, based on discussions with a German and UK payer.
VP Pricing & Market Access
Parexel Access Consulting
Principal Consultant, (Pricing and Market Access)
Parexel, UK
Senior Vicepresident, Global Marketing and Strategy,
EMD Serono, a company of MERCK KGaA, Darmstat, Germany
Principal Consultant
Huron Consulting Group, UK
Senior Consultant
Pope Woodhead, UK
Member
Joint Committee Vaccination & Immunisation (JCVI) London, UK
Prof. of Pharmacoeconomics
University of Groningen, The Netherlands
Head of Section, Health Economics
Amgros, Pharmaceutical Procurement Service for Regional Authorities, Denmark
Associate Professor, Economic Evaluations in Health Care
Erasmus School of Health Policy and Management (ESHPM)
Institute for Medical Technology Assessment (iMTA)
Erasmus University Rotterdam, Netherlands
Director Of Research
Tufts Center for the Study of Drug Development
Tufts University School of Medicine
Coordinator assessments of pharmaceuticals, Internal HTA experts
National Institute for Health and Disability Insurance (RIZIV INAMI), Belgium
Chair, the Domain Task Force ‘Joined HTA’, the BeNeLuxA Initiative
Coordinator assessments of pharmaceuticals, Internal HTA experts
National Institute for Health and Disability Insurance (RIZIV INAMI), Belgium
Chair, the Domain Task Force ‘Joined HTA’, the BeNeLuxA Initiative
Principal Consultant
Huron Consulting Group, UK
Senior Director, Regional Health and Value Lead, International Developed Markets
Pfizer, UK
Head of Pricing & Market Access Pharma
Novartis, Netherlands
CEO
Digipharm, Switzerland
Senior Researcher
Karolinska Institute, Sweden
Gene Therapy Global Market Access
GlaxoSmithKline, UK
Senior Director, Regional Health and Value Lead, International Developed Markets
Pfizer, UK
Senior Researcher
Karolinska Institute, Sweden
Head of Pricing & Market Access Pharma
Novartis, Netherlands
Associate Director
Valid Insight
Global Business Development Director
Clinigen, UK
Executive Director, Real World and Late Phase
Syneos Health, UK
Health Economics and Outcomes Research Leader
Mundipharma International, UK
Senior Director, Value Evidence Leader, Immuno-inflammation
Value Evidence & Outcomes (VEO)
GSK, UK
Director Health Technology Assessment & Outcomes Research Health & Value
Pfizer, Germany
Panel Chairman:
Paul Tunnah
CEO & Founder
pharmaphorum, UK
Senior Vicepresident, Global Marketing and Strategy,
EMD Serono, a company of MERCK KGaA, Darmstat, Germany
Senior Director, Value Evidence Leader, Immuno-inflammation
Value Evidence & Outcomes (VEO)
GSK, UK
Director Health Technology Assessment & Outcomes Research Health & Value
Pfizer, Germany
Director Of Research
Tufts Center for the Study of Drug Development
Tufts University School of Medicine
CEO & Founder
PharmaPhorum, UK
Payers, HTAs & Policy Makers:
Senior representatives from Payers, health plans & insurers, Public health experts, health technology assessors, hospital financial management, government & health ministry officials, health management and managed care organizations, epidemiology, horizon scanning, scientific advice, pharmacy strategy & budget management.
Industry: Corporate senior management, vice presidents, directors, senior managers in:
Market access, health economics, pricing & reimbursement, health outcomes, government & regulatory affairs as well as those focused on designing studies to achieve value-adding endpoints, such as R&D strategy, clinical development and medical affairs.
Other Stakeholders:
Regulatory agencies, key-opinion leaders, independent health economists, health researchers and academics, physicians, patient groups, consultants & solution providers.
Associate Director, NICE Office for Market Access
National Institute for Health and Care Excellence, UK
Originally a biomedical scientist, Carla spent 25 years in the UK Diagnostics industry gaining both commercial and healthcare system experience in a variety of roles for a major global healthcare company. During this time, Carla was an active contributor in the UK laboratory diagnostics industry and professional body arena, holding a number of industry wide posts including that of chair of the executive board of BIVDA (British In-Vitro Diagnostics Association) 2012 – early 2014.
Carla joined NICE in February 2014 as Associate Director for the Diagnostics Assessment Programme, focusing in particular on raising the awareness of NICE’s diagnostics activities with external stakeholders. She became Associate Director for the NICE Office for Market Access in January 2017 and the Accelerated Access Collaborative Secretariat in January 2018. Carla holds an MSc in Health Economics and Health Policy from the University of Birmingham and was previously a Fellow of Institute of Biomedical Sciences,
Member, and former Interim Chief Clinical Officer
NHS Thurrock Clinical Commissioning Group, UK
Tham. Nimal Raj, BSc(Hons), MBChB, MSc(Hons), MRCGP, DMI, DMU, DMP, DFFP, CAc, CIDC, DMClPres, MICM, FRSM
Provost of St. Martinus Medical School U.K, Board Member and Faculty Chairman.
One of the influential, charismatic leaders in the medical profession, He has held a number of positions: Managing Director, Medical Director, Director, and Interim Accountable Officer. He has served on many boards and BMA Council. Prof N. Raj is a dedicated teacher committed to medical education and thrives seeing many of his students graduate and continue to succeed in their medical career in the U.K & USA. Prof. Raj has written books and is renowned for his powerful orator style. Prof. Raj has been an architect of many medical and non-medical business innovations and organizations. He well known as Professor of Longitivity for his famous lectures. ‘Age is a number it is calculated daily by the internal calculus of the mind, it is number based on how you, feel for that day makes, that is the age of an individual’ – Prof. Raj
Member
Joint Committee Vaccination & Immunisation (JCVI) London, UK
Prof. of Pharmacoeconomics
University of Groningen, The Netherlands
Prof Maarten J Postma (29/01/1960) holds the chair in Pharmacoeconomics at the University of Groningen (Netherlands). Also, he holds a chair in Global Health Economics at the University Medical Center Groningen (UMCG) and is director of UMCG’s research institute SHARE. He did his MSc in econometrics and his PhD in health economics. He specifically leads a team of 50 PhD and post-doc researchers in health- and pharmacoeconomics, contributing to many international research networks and scientific communications. Research areas comprise cost-effectiveness methods, for example, in vaccinology, transfusion science and personalized medicine. He serves (served) on various committees advising the Dutch government on reimbursement of drugs and vaccines (CVZ and Health Council). Also, he is advisor to various health-economics consultancy companies and pharmaceutical companies worldwide, Ministries of Health in neighbouring countries, member of editorial boards of scientific journals, on advisory boards for pharmaceutical companies and consultant for WHO. He is a member of UK’s Joint Committee of Vaccination & Immunization and advisor to the All Wales Medicines Strategy Group (Grwp Strategaeth Meddyginiaethau Gymru Gyfam). He is specialized in the role of pharmacoeconomics/health economics in the reimbursement process. He has over 350 MEDLINE-publications, an H-factor of 43 and extensive teaching/lecturing experience (Groningen, Heidelberg, Utrecht, Bielefeld, Ankara, Indonesia and Vietnam).
Head of Section, Health Economics
Amgros, Pharmaceutical Procurement Service for Regional Authorities, Denmark
Sune has been working in the pharmaceutical area for 10 years and in business intelligence for 15 years. Originally educated in finance and administration within the oil industry. Since 2007 he has been working at Amgros - the pharmaceutical organization of the Danish regions. He is part of the team that designed the Danish model for health technology assessments regarding hospital pharmaceuticals.
Associate Professor, Economic Evaluations in Health Care
Erasmus School of Health Policy and Management (ESHPM)
Institute for Medical Technology Assessment (iMTA)
Erasmus University Rotterdam, Netherlands
Dr Hakkaarts’ interest in the relation between cost and effects in health care is the result of a broad interest to explore economic evaluations from a societal perspective and report outcomes that helps decision making in health care on different levels. She was involved in the developed questionnaires to measure cost from a societal perspective. The iMTA Medical Cost Questionnaire (iMCQ), the iMTA Productivity Cost Questionnaire (iPCQ) and the Treatment inventory of Costs in Psychiatric Patients (TiC-P) were developed. Her special interest is to develop a research program for economic evaluations in mental health care and orphan diseases. Therefore, she works closely with a large number of other national and international institutions. Dr Hakkaart supervises PhD students on this topic. She is co-promoter of a PhD student conducting cost effectiveness analyses on orphan drugs. Recently, she supervised the update of the Dutch manual for costing studies in economic evaluations supported by the National Health Institute (ZiN). A collaborative partnership with TOPGGz, a foundation for highly specialized psychiatric care, was initiated. In this context, she developed a method to develop ‘Decision Tools’ (DT) to identify severe and complex patients for top clinical specialized care. Validated DTs for personality disorders, eating disorders, depression and anxiety were developed. She guides and teaches Bachelor and Master students in economic evaluations.
General Director, Center of Healthcare Quality Assessment and Control
Ministry of Health, Russia
In 1987 he graduated from Pirogov Russian National Research Medical University with a specialization in “General Medicine”. In 1998 he graduated from the Russian Presidential Academy of National Economy and Public Administration with a specialization in “State and Municipal Management”.
He defended his doctorate dissertation on clinical and economic analysis and pharmacoeconomics.
He has been General Director of Federal State Budgetary Institution “Center of Healthcare Quality Assessment and Control» of the Ministry of Health of the Russian Federation, Chief of the Research Laboratory of Technology and Healthcare Assessment of the Institute of Applied Economic Research of the Russian Presidential Academy of National Economy and Public Administration, Head of the «Center of Healthcare Finance» of the Financial Research Institute of the Ministry of Finance of the Russian Federation and President of the ISPOR Russia Health Technology Assessment (HTA) Chapter.
He is Doctor Med. Sci., PhD and Professor.
Coordinator assessments of pharmaceuticals, Internal HTA experts
National Institute for Health and Disability Insurance (RIZIV INAMI), Belgium
Chair, the Domain Task Force ‘Joined HTA’, the BeNeLuxA Initiative
He graduated in medicine at the Catholic University of Leuven (Belgium) in 1991. He is clinical specialist in internal medicine and made his PhD thesis in hepatology (1998), after PhD training in Leuven and Berne (Institute for Clinical Pharmacology, Switzerland). Nowadays, he is visiting professor of gastro-entero-hepatology at the Leuven university.
Since 2003, he is an HTA-expert for the Belgian Commission of Reimbursement of Pharmaceuticals. In 2013, he became the coordinator for assessments of pharmaceuticals for the Belgian Commission. He chairs the permanent working party on reimbursement of oncology drugs.
Since 2010, he has been involved in EUnetHTA, where he has a particular interest in Early Dialogues. He participates at Medev/MoCa as well. Within the BeNeLuxA Initiative on Reimbursement of Pharmaceuticals, he is nowadays the Domain Lead for HTA.
Publication list at the website of the Leuven University: https://lirias.kuleuven.be/cv?u=U0004468
Scientific Advisor, Project manager EUnetHTA JA3 WP5A – Early Dialogues
Federal Joint Committee (G-BA), Berlin, Germany
Stephanie Said studied Pharmacy at the Friedrich-Schiller-University Jena, and did her practical training partly in a public pharmacy in Germany and at the Department of Biopharmaceutical Sciences of the Wuhan University, China, before completing her studies as a licensed Pharmacist. She received her PhD from the Department of Pharmacology of the Freie Universität Berlin in 2016.
Since April 2016, Stephanie Said is a Scientific Advisor in the Pharmaceuticals Department of the Federal Joint Committee (G-BA) in Berlin and hereby specialized on the early benefit assessment of pharmaceuticals (AMNOG). Furthermore, she has taken over the responsibilities as project manager EUnetHTA JA3 WP5A – Early Dialogues in July 2016.
Senior Vicepresident, Global Marketing and Strategy,
EMD Serono, a company of MERCK KGaA, Darmstat, Germany
14 years of Senior Leadership experience in Pharma and Biotech industries. Country, Regional and Global responsibilities in Corporate Affairs. General Manager of nonprofit. Functional leadership of Market Access; Government Affairs; Patients Organizations; Communications and Corporate Responsibility; Regulatory Affairs; Corporate Innovation; Commercial Compliance.
PhD in Pharmacy in the areas of genetics and immunology by the UCM (2000), Ana holds a degree in Pharmacy by the UCM (1995), an Executive Master's Degree in Healthcare Institutions Management by Arthur Andersen (2001), and an Executive Degree in General Management by IESE (2009). She graduated as a bachelor and doctorate with high honor.
Ana is founder and director of the Executive Education Program on Institutional Relations & Market Access (ERIMAS) since 2012, and founding member of the organizational committee of the National Congress of Corporate Affairs since 2014 in Spain. She is also founding member of the LSE Market Access Academy (London School of Economics, London, UK).
Vice President, Head of Operations and Payer Intelligence
Global Market Access
Sanofi, UK
Ms. Katja Berg is Vice President, Head of Operations and Payer Intelligence at Global Market Access, Sanofi. In this role Katja is responsible for defining, driving and communicating transversal strategic initiatives and Payer Intelligence for Market Access in alignment with key internal and external business partners. Katja joined Sanofi from IMS Consulting Group, where she as Senior Principal led global teams in developing strategies for the pharma industry for more than a decade. Katja holds a PhD in chemistry and prior to consulting, worked as a research associate at Stanford University exploring biomimetic systems as well as a science lead for a biotech company.
Head of Market Access
Mundipharma International, UK
Will Heads up the Market Access team at Mundipharma International. In this role he leads on international strategic pricing and market access recommendations. Will and his team are also responsible for developing and publishing health economic data and real world evidence. His areas of research interest include improving the transparency of health economic decisions and value frameworks to enhance drug development. Before joining Mundipharma in 2009, Will worked in London for Merck Sharp & Dohme (MSD) as a Health Outcomes Manager, and prior to this the consulting firms IMS and Charles River Associates. Will completed his BA Honours Degree in 2001 in Economics, Political Science and Philosophy at the University of Otago, Dunedin, New Zealand. He then completed a Master of Economics degree at Monash University in Melbourne.
Senior Director, Value Evidence Leader, Immuno-inflammation
Value Evidence & Outcomes (VEO)
GSK, UK
Deven Chauhan has over 15 years of experience in healthcare, the last five of which have been with GSK. He currently leads a team responsible for the planning, development, and execution of the evidence generation strategies and Integrated Evidence Plans for a range of medicines in development, and has had experience across many therapy areas including Immune-inflammation, Oncology and Neuroscience. Prior to joining GSK, he worked above country at Takeda Europe and led a Health Economics Team at the Merck Serono UK Local Operating Company. Before pursuing a career in the Pharmaceutical Industry, Deven worked at the Office of Health Economics, and spent a number of years within the UK National Health Service involved in formulary decisions and local guideline development.
Senior Director, Regional Health and Value Lead, International Developed Markets
Pfizer, UK
Chris started off his career in the NHS as a clinical pharmacist before joining Pfizer in 2006. During his 11 years at Pfizer he has held positions within Medical, Commercial and Access at local, regional and global levels. Within his access roles he been the European and Global access strategist for a prominent biologic medicine and moved to his current role in 2014. As the Regional Health and Value Lead for International Developed Markets he focuses on environmental access issues and opportunities which span Pfizer’s broad portfolio of medicines and therapeutic areas and gathers insights that help build strategies which ultimately improve access to Pfizer medicines.
Director Health Technology Assessment & Outcomes Research Health & Value
Pfizer, Germany
After studying statistics at the University of Dortmund (Germany) in 1988, Friedhelm Leverkus worked at the Social Research Centre in Dortmund. In 1991 he started his career at Pfizer Pharma GmbH as a biometrician. In this capacity he planned and analyzed clinical studies. In 1995 he was named the Head of Biometrics. He was mainly responsible for biometric support of clinical trials and NIS studies. He has lead the Health Technology Assessment Group at Pfizer Germany, which is responsible for HTA and outcomes research, since 2010. The group is mainly responsible for the development of AMNOG-Dossiers.
Gene Therapy Global Market Access
GlaxoSmithKline, UK
Jim joined the Rare Disease team at GSK in May 2017 as Global Market Access Manager. He graduated from the University of Nottingham with a BSC in Genetics before joining the pharmaceutical industry. He has worked in a variety of commercial and market access roles in GSK before taking the opportunity to apply these skills to the rare disease area, focusing primarily on finding ways of supporting patient access to innovative treatments in emerging markets.
Health Economics and Outcomes Research Leader
Mundipharma International, UK
James has over 17 years health care industry experience in both research and commercial roles. He has been working as a European Health Economist for Mundipharma International Limited in Cambridge, UK for over 3 years working across several therapy areas. In this position he has supported the European market access activities of the Mundipharma network of independent associated companies, covering areas such as input to clinical trial design, pricing strategy, Health Economic modelling, Value proposition development, publication planning and new asset reviews. Prior to this James worked as a Heath Economics consultant. James has also previously held senior roles heading up commercial sales teams and started his career in research and development. James has a BSc in Genetics from University College London, a Masters degree in Health Economics from the University of York in the UK and an Executive MBA from Henley Business School in the UK.
Head of Pricing & Market Access Pharma
Novartis, Netherlands
Jolanda joined Novartis almost 10 years ago. She graduated from University of Amsterdam with a Master’s degree in Medical Biology. She subsequently completed her Master’s degree in Health Technology Assessments at the University of Nijmegen. Prior to joining Novartis Pharma the Netherlands, Jolanda worked in research & development and management of clinical trials in a variety of therapeutic areas among cardiovascular. Jolanda is currently heading one of the Market Access’ sub-departments, Pricing & Market Access, responsible for reimbursement by HTA assessments and innovative pricing models.
Professor of Health Economics and Pharmacoeconomics
Università Cattolica del Sacro Cuore di Roma
Matteo Ruggeri (born in 1976) gained his first degree in Economics at the University of Rome “Tor Vergata” in 2001 with a dissertation in Econometrics. In 2002 he gained a Msc in Economics and in 2003 a MA in Business Engineering both at the University of Rome “Tor Vergata”. In 2004 he was visiting scholar at the Thomas Jefferson University (PA-U.S.A.) and in 2005 at the University of Aberdeen and at the University of York (UK). In 2006 he gained a Phd in Health Economics at the Università Cattolica del Sacro Cuore (UCSC). Since 2007 he was lecturer in Health Economics and Pharmacoeconomics at UCSC where is actually Assistant Professor of Economic Poicy. He is Chief of Health Econnomics research at ALTEMS (UCSC Graduate School in Health Economics and Management) and at Ce.Ri.S.Ma.S (Center or research in healthcare - UCSC) and he teaches several graduate courses in Health Economics and Pharmacoeconomics. His research interests focus on Experimental Economics and decision modeling in the field of healthcare and Health Technology Assessment. He participates in several research projects both funded by industry and national and international institutions (Italian Ministry of Health, Italian health authorities and EU commission). He has published approximately 40 papers on peer reviewed journals including top health economics journals (Journal of Health Economics, Health Policy, Pharmacoeconomics, Value in Health). He frequently participates in international conferences of economics and health economics. He is member of several scientific and editorial boards and he serves as reviewer of many journals including Value in Health, International Journal of Public Health, Health Risk and Society, Journal of Health Economics. He holds the National Scientific Qualification (ASN) as Associate Professor of Economic Policy. He is an auxiliary Officer (Lieutenant) of the Italian Red Cross Military Corps. He is married with two children.
Senior Researcher
Karolinska Institute, Sweden
Since 2008, Brian has been working with the WHO, Governments, National and Regional Health Authorities, National Reimbursement Agencies, their advisers, and academics, across countries and continents, to recommend ways to enhance the quality and efficiency of prescribing of both new and existing medicines. This includes developing new models to optimise the use of new medicines and valuing them including managed entry agreements. This has resulted in multiple publications across countries with payers as well as chapters in books. Previously, Brian headed the International Division of a Global Consultancy Company advising corporations on key market access issues. Brian will bring his combined experiences to discuss potential ways forward with managed entry agreements.
Director Of Research
Tufts Center for the Study of Drug Development
Tufts University School of Medicine
Dr. Christopher Milne joined the Center for the Study of Drug Development at Tufts University (Tufts CSDD) in 1998 as a Senior Research Fellow and has published over 100 book chapters, CSDD reports, white papers, and journal articles. Dr. Milne received a BA from Fordham University, an MPH from The Johns Hopkins University, and holds doctoral degrees in veterinary medicine and law, respectively from the UNPHU and UNH School of Law. His research interests include: economic, policy, market access and public health implications of FDA regulations and initiatives; US, EU and Japanese government incentive programs to promote innovation; and, global disease prevalence, demographic and market access factors. He is currently Director of Research at Tufts CSDD, Research Associate Professor at Tufts University School of Medicine, formerly a visiting professor at Kyushu University in Japan and the University of Edinburgh, and serves on the editorial boards of Therapeutic Innovation & Regulatory Science and Pharma Focus Asia.
CEO & Founder
PharmaPhorum, UK
Dr Paul Tunnah founded pharmaphorum in 2009, which combines industry leading
publications (www.pharmaphorum.com) with a specialist strategy and content communications / marketing consultancy (www.pharmaphorumconnect.com). All aspects of his work at pharmaphorum align around the company’s vision of ‘bringing healthcare together’ – ensuring all stakeholders have a voice and can collectively engage to find mutually beneficial solutions.
He is a recognised author, speaker and industry advisor on content marketing, communications and digital innovation, having worked with many of the world’s leading pharmaceutical companies and the broader ecosystem of healthcare organisations. He is also a member of the steering committee for Frontiers Health, a leading event on digital disruption in healthcare, attended by industry, start-ups and investors.
Dr Tunnah has a scientific background, with a BA in Biochemistry and DPhil in Biological sciences, focussed on development of novel anticancer therapies, from Oxford University.
Connect with Dr Tunnah at https://www.linkedin.com/in/paultunnah/ or email paul.tunnah@pharmaphorum.com.
CEO
Digipharm, Switzerland
Ahmed is the founder and CEO of Digipharm, a digital health startup that is developing revolutionary platforms that aim to eliminate barriers to innovative pricing solutions, transform current evidence generation practices and enable patient empowerment. Prior to Digipharm, Ahmed worked as a Global health economist within the Global Pricing & Market Access division at Hoffmann La-Roche. He has prior experience working at an Evidence Review Group in the UK as a health economist. Prior to his foray into health economics, he has held roles across the pharmaceutical pipeline including early drug development, clinical data management and wholesale pharmaceutical pricing.
Global Business Development Director
Clinigen, UK
Kieron joined the Clinigen Group in 2014 and is responsible for consulting with Biotech and Pharmaceutical companies on Pre-Approval/Managed Access Programs. Kieron specializes in advising companies on strategy development, Program set up and the implementation of specialist access programs for unlicensed medicines. Prior to joining Clinigen, Kieron has spent 15 years within the Pharmaceutical industry fulfilling a range of roles including Senior Executive Roles at Servier Laboratories Ltd contributing to European and Global development plans. Within this time, Kieron has led a number of global pre-launch and launch activities for treatments addressing areas of high unmet medical need. Kieron now focusses his energies on working alongside Pharma and Biotech Companies around the world to consider their strategy for Early Access, developing Global Programs and allowing patients to gain access to treatments that would otherwise be unavailable within their respective countries.
Managing Director,
Valid Insight, UK
Steve Bradshaw is Managing Director of Valid Insight, an expert-led global market access consulting firm. Steve and his growing team work with pharmaceutical, biotech and medtech companies and specialise in the development of effective market access, pricing, value communication and commercialisation strategies.
Steve’s has worked for two decades’ in consulting and healthcare, supporting many of the well-known products on the market today. He is an active member of the market access community, including Advisory Board member at Pharma-IQ, Market Access Advisory Committee Member at the Global Pneumonia Prevention Coalition, and is quoted in publications including BioPharm Insight, Hospital Pharmacy Europe, FirstWord Pharma and Reuters; he also peer reviews for several academic journals.
A medic by training, Steve’s key interests centre around supporting access to better healthcare technologies.
VP Pricing & Market Access
Parexel Access Consulting
Janice joined Parexel in March 2017 as the Vice President and global head of the Pricing and Market Access team and brings a wealth of experience. From January 2012 until February 2017 she was the European P&MA lead in Quintiles Advisory Services.
Between 2006 to December 2011Janice was Senior Director Pricing and Market Access for Astellas Pharma Europe where she was responsible for:
Before joining Astellas in 2006, Janice worked in consultancy for 20 years, including 10 years at IMS Health/Cambridge Pharma Consultancy.
Principal Consultant, (Pricing and Market Access)
Parexel, UK
Richard Macaulay, Ph.D., is a Principal Consultant with PAREXEL Access in London. Richard has specialized for seven years’ in regulatory and market access strategy, in particular helping obtain regulatory and payer approval for treatments lacking Phase III trial data, with a specialist expertise in oncology treatments and rare diseases. He has completed over 40 research presentations in his field, including posters, webinars, conference presentations, and manuscripts. Richard has a PhD from University College London, and a BA (Hons) in Medicine from the University of Cambridge.
Executive Director, Real World and Late Phase
Syneos Health, UK
Noolie joined Syneos Health in March 2018 and acts as RWLP Subject Matter Expert in Client Engagement Solutions within the Real World and Late Phase business unit. She helps clients to build their RWLP strategy and support our Syneos teams on how to best deliver each solution to ensure the best result for our clients. Prior to this Noolie spent 14 years at AstraZeneca in a variety of roles. Most recently as part of Medical Affairs team. In this role Noolie worked with product teams to identify the evidence gaps needed to ensure success launch and life cycle management, and designed strategies to fill those gaps including; Interventional studies, Non-Interventional studies, Pragmatic Studies, Data Solutions, and Early Access programmes.
Principal Consultant
Huron Consulting Group, UK
Akshay is a Senior Director at Pope Woodhead & Associates and joined in 2016. Akshay has 10+ years of experience helping pharmaceutical and biotech companies develop market access & pricing solutions - which are aligned to their broader commercial, organisational and environmental context. These solutions could be at the product, process and/or capability level. Besides market access - Akshay also has supported pharmaceutical companies in allied commercial areas such as - epidemiology, opportunity assessments, product positioning, product performance tracking, customer insights, and organisational design.
Senior Consultant
Pope Woodhead, UK
Eugenia is a senior consultant at Pope Woodhead. She has more than 10 years of research and consulting to the pharmaceutical industry, with a particular expertise in modelling, meta-analysis and regulatory and HTA engagement, as well as evidence generation planning to support MA.
She led a broad range of HEOR projects in various indications, including oncology, chronic obstructive pulmonary disease, and multiple sclerosis, as well facilitated preparation for and moderated numerous advisory boards.