HTAi_GPF22_program_20220314 (1)

HTA to optimize health • Improved technology utilization can be achieved by high quality, relevant, Background Paper technology utilization: using timely HTA advice; funding for the technology; coherent decision-making implementation initiatives systems; professional engagement; sufficient infrastructure; and patient and monitoring processes, participation. 2009 • More effective engagement of all stakeholders throughout the HTA Harmonization of evidence process requirements, 2008 Coverage with evidence • “Intelligent dissemination” needed development, 2007 • Monitoring must be scientifically robust, feasible and fundable; “minimum data sets” informed by VoI? (greater partnership is needed) • HTA requires clear policy receptor functions; more initiatives that drive decision maker or provider behaviours • Harmonization of HTA should not aim to produce a single decision on reimbursement and utilization of a technology; harmonizing on clinical evidence most potential • Transparency is essential • Greater collaboration with regulators (divergent evidence requirements) • Better inclusion of patient views and data/inputs to CED Case Studies Alzheimer’s Disease One example of a disease that embodies many of the issues highlighted within this paper is that of Alzheimer’s Disease and the pharmaceutical treatments available. Alzheimer’s Disease is a progressive neurodegenerative disorder that causes loss of cognitive function, changes in behavior and interference with daily functioning. It is the leading cause of dementia around the world with an estimated 50 million cases, placing significant burden on healthcare systems and also the families and carers of people living with the disease (62). Alzheimer’s Disease typically has a slow onset and can be challenging to diagnose in a timely and accurate manner. Before the early 2000s, the only way to definitely diagnose Alzheimer’s Disease was at autopsy, however advances in imaging mean that a formal diagnosis can now be obtained with a CT Scan, MRI or PET Scan. However, logistical challenges and limited capacity and access to these technologies across the world mean that some people still have a delayed diagnosis of Alzheimer’s Disease, which may alter treatment effectiveness and determine treatment pathways. In addition, the benefit of advanced screening has been debated, given that available treatments are of questionable effectiveness (see below). Horizon scanning efforts and preparing the health system for an increase in this type of imaging has been noted as challenging (interview communication). In 2006, the drugs donepezil, galantamine, rivastigmine and memantine were licensed for the treatment of mild, moderate and severe Alzheimer’s Disease. The HTAs of these drugs were globally controversial, with some countries initially recommending that the drugs did not demonstrate clinical effectiveness and that they should not be used for mild disease but rather they would only be cost-effective if used for moderate disease. Patient groups and the technology manufacturers appealed these recommendations. As a result, and as previously mentioned in this paper, efforts were made by the Green Park and CMTP to try and set some standards on how progression and outcomes in Alzheimer’s Disease should be measured in the future to avoid situations such as this again. However, it appears that the concerns remain, and both challenges in outcome measurement and the importance of including relevant stakeholders in determining value was reiterated by Bauer et al in 2020 (63), who conducted a literature review of Alzheimer’s Disease HTAs in England, Germany and the Netherlands. The authors found that outcomes measured using clinical scales dominated the decision making and did not always allow for the inclusion of outcomes relevant to people living with Alzheimer’s Disease or their families and carers. Methodological work in this space is ongoing. Horizon scanning shows that there are many new technologies in development for Alzheimer’s Disease. While 49

Background Paper there have been a number of other promising technologies, most have not received regulatory approval. In June 2021 however, the FDA approved aducanumab (Aduhelm™) for the treatment of Alzheimer’s Disease. This is the first drug to receive regulatory approval that works by targeting amyloid plaques in the brain that are the underlying cause of the disease. However, evidence of plaque removal was not accompanied by material improvements in cognition or slowing of disease progression. The approval was therefore highly controversial. This has been followed by the US Centers for Medicare and Medicaid Services releasing the proposal to cover the FDA-approved treatment through a coverage with evidence development model. This means that the drug will only be reimbursed by Medicare if it is provided in the context of a qualifying clinical trial. This has also been controversial, and depicts in sharp relief the challenges associated with accelerated approvals that carry limited evidence. Conversely, in December 2021, the EMA adopted a negative opinion citing that “although Aduhelm reduces amyloid beta in the brain, the link between this effect and clinical improvement has not been established…In addition, the studies did not show the medicine was sufficiently safe as images […] showed abnormalities suggestive of swelling or bleeding which could potentially cause harm” Aduhelm: Pending EC decision | European Medicines Agency (europa.eu). Advanced Therapy Medicinal Products (ATMPs); lifecycles of the future Advanced Therapy Medicinal Products (ATMPs) are medicines for human use that are based on genes, tissues or cells and offer groundbreaking new opportunities for treatment of disease and injury (64). ATMPs are classified into three main types: gene therapy medicines; somatic-cell therapy medicines; tissue-engineered medicines. In addition, ATMPs may contain one or more medical devices as an integral part of the medicine. ATMPs have the potential to offer curative or regenerative options for treating diseases that were previously incurable and/or required lifelong medical interventions. This has a huge possible value to patients and health systems with some “one-shot” style treatments being developed. There are a few examples already considered by HTA bodies and the uncertainty created with the relatively small studies, lack of control groups, surrogate endpoints, and short-term follow up has proved challenging to mitigate. Additional complexities came from the poorly defined subgroups which created inconsistencies throughout the world in how the technologies were evaluated. Discrepancies in the economic modelling across HTA bodies was noted in a recent review of gene therapy HTAs (65). In addition, these therapies typically come with a high price tag; Zolgensma, a gene therapy for use in spinal muscular atrophy, is the most expensive drug in the world at $2.1 million USD. To date, all ATMPs considered by HTA bodies have been recommended for use only when a MEA is also in place. The challenges with monitoring these and following patients up for a sufficiently long period has been highlighted previously (55) and there is a linked increase in use of RWD to support and monitor the use of ATMPs in practice that becomes more important as these technologies are introduced. Whether these technologies will lose exclusivity and naturally reduce in price, evolve as versions or be displaced by new technologies remains to be seen. Dynamic pricing (if feasible) and discounting become key issues in the assessment of these technologies. The effect of ATMPs on the broader spectrum of the technology lifecycle has yet to be fully determined. It is possible that if these technologies offer true innovation and benefits to patients as yet previously unseen, they will become the dominant technology type for all diseases they are developed for. This may actually simplify the management of diseases with fewer technologies for each disease area. Patient variability, choice and ultimate deterioration of ATMP effect must be expected though with a continued requirement for more traditional technologies post-ATMP treatment; there will inevitably again be challenges in developing evidence bases for these patients who have experience of ATMPs followed by other technology types. How individual ATMPs and their lifecycles may evolve over time is still to be observed given the relative infancy of these technologies; how and whether health systems can disinvest from these technologies over time, and still ensure continued patient care is likely to be a challenging issue to tackle. 50

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Attendees Attendees Rob Abbott In-Person Executive Director HTAi Canada Rob Abbott is a pioneering strategy and social responsibility catalyst in Canada; a much sought-after facilitator, moderator and content-weaver; a coach to entrepreneurs and executives; and a professor of global management and strategy. Rob’s experience in medical life sciences includes appointments as a member of the Board and Executive Committee of the Canadian Genetic Diseases Network (CGDN), and the Canadian Gene Cure Foundation. He subsequently became CEO of CGDN, a role that required him to regularly discuss advances in gene-based medical research on the one hand, and the translation of that research into practical diagnostics and therapeutics on the other. He has also advised provincial and federal health authorities in Canada and abroad on a wide variety of issues, including the role of artificial intelligence and advanced robotics in the delivery of health care. Rob writes and speaks on strategic environmental issues regularly, and is the author of Uncommon Cents: Thoreau and the Nature of Business; Conscious Endeavors: Business, Society and the Journey to Sustainability; and co-author of the forthcoming book, The Future of Mining: 7 Steps to a Globally Sustainable Industry. Rob is also working on a book, called Walking Toward the Edge: From Heartbreak to Hope in an Age of Loss. Rob has taught courses and delivered lectures at several universities in North America including the University of Toronto, the University of British Columbia, and Harvard. He has also taught at universities in China, Thailand, and Mexico. Email: [email protected] Naomi Aronson Virtual Executive Director - Clinical Evaluation and Innovation Blue Cross Blue Shield Association United States Dr. Naomi Aronson leads BCBSA clinical effectiveness and policy engagement with government, regulatory agencies and policy consortia. Her areas of leadership include comparative effectiveness, patient centered research, safety surveillance, regulatory science and methodological standards. She is a member of the Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI), the Health Technology Assessment International Health Policy Forum, the New Drug Development Paradigms (NEWDIGS) initiative of the MIT Center for Biomedical Innovation, and the Medical Device Innovation Consortium (MDIC) National Evaluation System for Health Technology (NEST) Governing Committee. Phone: 13122975530 Email: [email protected] 55

Attendees Susanna Axelsson Virtual Director General SBU Sweden I am General Director at SBU. The Swedish Agency for Health Technology Assessment and Assessment of Social Services since 2015. Phone: +46768568784 Email: [email protected] Indranil Bagchi Virtual Worldwide Value & Access Head Novartis Pharmaceuticals Corporation United States Dr. Indranil Bagchi is Senior Vice President and Head of Global Value and Access at Novartis Oncology. In this role, Indranil drives the overall strategy on value demonstration and market access, through efforts on pricing & reimbursement, health economic modeling, outcomes research, real world evidence and health policy that increase access to our cancer medicines. Indranil has more than two decades of experience in market access across several major companies in the pharmaceutical industry. In 2014, Indranil received the 'Outstanding 50 Asian Americans in Business' award and in 2010, Indranil was recognized in Pharmaceuticals Executive magazine's annual roster of Emerging Leaders. \"\" The New Breed of Leadership.\"\" Indranil is a frequent speaker and contributor to forums, articles and conferences addressing issues related to access to medicines. Previously at Pfizer, he was Vice President and Global Head of Payer Insights and Access and prior to that, Indranil was Senior Director of Market Access at Wyeth Pharmaceuticals. Before Wyeth, Indranil was first with SmithKline Beecham and subsequently with GlaxoSmithKline with their Health Economics and Outcomes Research departments. Dr. Bagchi has an undergraduate degree in Pharmacy, a master's degree in Pharmacy and Healthcare Administration and a doctoral degree in Pharmaceutical Socioeconomics. Phone: 1-862-371-4576 Email: [email protected] 56

Eric Barrette Attendees Virtual Senior Director, Global Health Economics and Outcomes Research Medtronic United States Eric Barrette, Ph.D., MA., is Senior Director, Global Health Economics and Outcomes Research at Medtronic, a global leader in medical technology, services, and solutions. Eric provides scientific leadership and technical expertise on projects related to health economics and outcomes research data and methods and health policy evaluations. Prior to joining Medtronic, he was Director of Research at the Health Care Cost Institute (HCCI), a non-profit research organization that maintains a US claims database for public reporting, research, and price transparency. He has previously worked as an economist at a litigation consulting firm conducting analyses for federal and state regulatory agencies, economic expert witnesses, and private clients in matters related to health care and life sciences. He is an adjunct lecturer at University of Minnesota’s Carlson School of Management where he teaches graduate level courses in medical technology evaluation and analytics. Eric holds a Ph.D. in Health Services Research, Policy and Administration from The University of Minnesota, an MA in Economics from the University of Arizona, and a BS in Economics and Actuarial Science from The University of St Thomas in St Paul, MN. Phone: 202.664.0669 Email: [email protected] Karin Becker In-Person Head, Global HEOR CoE Boehringer Ingelheim Gmbh Germany Karin Becker is the Head of the Global HEOR (Health Economics and Outcomes Research) Centre of Excellence at Boehringer Ingelheim GmbH in Ingelheim, Germany. With 20+ years in pharmaceutical industry, she has extensive experience in HEOR, Pricing and Market Access. Prior to joining BI, Karin led Global Pricing & Reimbursement at Serono in Geneva, Switzerland. Before that, she had various roles in Sales and Marketing at MSD Merck Sharp & Dohme in Germany. She is a member of ISPOR, iHEA and HTAi, and an invited lecturer at Erasmus University in Rotterdam, Netherlands, and Hochschule Fresenius in Wiesbaden, Germany. Karin received her PhD in Molecular Biology from Ludwig-Maximilians-University in Munich, Germany, followed by postdoctoral research in Immunology at the University of Lausanne, Switzerland. Karin holds a PG Diploma in Health Economics from the University of York, UK. Phone: +49-178-2904521 Email: [email protected] LinkedIn: linkedin.com/in/karin-becker-8465b61 57

Attendees Neil Bertelsen In-Person Past Chair HTAi Patient & Citizen Involvement In HTA Interest Group Germany Neil Bertelsen is an independent consultant with over 25 years of experience bringing the patient voice to health care decision makers and communicating the science of health care to patients in a way that truly informs their own personal health choices. Neil is passionate about bringing the patient experience and perspectives to decision-makers including industry and health technology assessment (HTA) bodies. Neil is the past chair of ‘Health Technology Assessment International’s (HTAi) Patient and Citizen Involvement Interest Group’, an international group whose remit is to work closely with HTA organizations and patient organizations to bring patient involvement processes and patient insights and experiences into decision making process. Neil is currently on the steering committee of this group. Neil is also a board member of PFMD (Patient Focused Medicines Development), an international consortium of stakeholders working towards more integrated inclusion of the patient voice across the medicine lifecycle. Neil works directly with the patient advocacy community, the industry, and authorities such as HTA agencies to facilitate collaborations and co-creation of approaches to improve access to healthcare and better provision of care. As a facilitator of meetings and advisory boards, Neil has global experience working with multiple stakeholder on demanding issues that require a coordinated response. In the 1990s Neil was a patient advocate in the field of HIV and since that time has devoted his activities to supporting the role of patients in healthcare decision making. He was the editor of Positive Times, the UK’s first national magazine for people with HIV. This pioneering magazine tackled the relevant issues of the day in a time that spanned the era before the advent of combination therapy, through to its successful introduction. As well as an individual patient advocate, Neil served for 6 years on the board of trustees of Terrence Higgins Trust, Europe’s largest HIV and sexual health advocacy group. Neil has also worked within the pharmaceutical industry at Bayer Pharma AG where he worked as part of the Global Market Access Function to bring the patient perspectives into access decision making and into the early research and development organization. Prior to this, Neil was the managing director of several specialist health care consultancies where he developed integrated strategy, education, communication and engagement programs that considered the patients as an equal partner in the health care landscape. Neil has also been editor and deputy editor of several peer review journals. He was also a successful television director and producer making science documentaries that brought new technologies to life for the public and patients. This included making ‘Horizon’ for the BBC, where he was part of the team awarded a BAFTA (British Academy of Film and Television Awards) for best factual series. Phone: +49 151 26968601 Email: [email protected] LinkedIn: linkedin.com/in/neilbertelsen/ 58

Murtuza Bharmal Attendees In-Person Executive Director, Global Evidence and Value Development EMD Serono United States Murtuza Bharmal, BPharm, MS, PhD, has a clinical background (pharmacist) with over 20 years of experience within R&D and commercial organizations in the pharmaceutical industry. He is a globally experienced leader having lived and worked in the US, India, Germany, and China within epidemiology, health economics, market access and commercial strategy roles. Dr Bharmal has managed and provided methodological, study design and operational inputs to numerous real world evidence studies including prospective clinical studies, retrospective data analysis studies, psychometric validation studies, market research studies and economic modeling studies all undertaken to improve market access of products in a wide range of therapeutic areas. Murtuza has authored over 150 publications and presentations in peer- reviewed international conferences and journals. Phone: 7814900188 Email: [email protected] Chris Bidad Virtual Head of Payer Engagement and Capabilities Astrazeneca United Kingdom Chris Bidad is the Head of Payer Engagement and Capabilities for the Biopharma Business Unit at AstraZeneca, having joined March 2022. Within this Chris and his team are responsible for developing meaningful and impactful partnership opportunities with payers and developing industry-leading capabilities to enable broader and faster patient access to medicines. Prior to this role Chris spent 15 years at Pfizer in a number of local and global access, medical and commercial roles and started his career as a clinical hospital pharmacist in the UK NHS. Phone: 07980311882 Email: [email protected] 59

Attendees David Boudreau Virtual Director General Health Canada Canada David Boudreau has a biochemistry degree and a chemical engineering degree with honour, both from the University of Ottawa. While at university he did lab work at the National Research Council (NRC). Once he completed his studies, he worked for three years at i-STAT, as a Process Engineer in the manufacturing of medical devices for blood tests. He then joined the Patent Office at the Canadian Intellectual Property Office (CIPO) in January 2004, as a Patent Examiner, where he specialized in diagnostic methods, and devices thereof. In March 2010, he joined the Office of the Commissioner of Official Languages (OCOL), as Special Advisor. In January 2014, he was promoted to the position of Assistant Director and was in charge of external audits and evaluations. As OCOL is an Agent of Parliament, he was exposed to the wiring of the government. In November 2014, he came back to the Patent Office as Director, where he was responsible for a group of 145 employees in the sectors of Quality, IT, Training and Operations. In January 2018, he has taken on new challenges at Health Canada, as Executive Director of the Medical Devices Bureau, and then in January 2020, the role of Director General of the Medical Devices Directorate. Phone: 8196394117 Email: [email protected] Ailsa Brown Virtual Lead Health Economist Healthcare Improvement Scotland United Kingdom I am the lead health economist for the Scottish Medicines Consortium. Phone: 00447970542101 Email: [email protected] Andrew Bruce In-Person Head of HTA and Payment Policy Amgen Australia Phone: +61408697520 Email: [email protected] 60

Kjetil Brurberg Attendees Virtual Department Director Norwegian Institute of Public Health (NIPH) Norway Currently responsible for HTA-deliveries to the national system for managed introduction of health technologies in Norway. Worked with systematic reviews and HTA since 2008. MSc in biophysics and medical technology, and PhD within tumor physiology and radiology. Phone: +47 91619280 Email: [email protected] Maria Rachele Busca In-Person Market Access Leader EMEA and Japan W.L. GORE Italy Graduated in Chemistry & Pharmaceutical Technology at Bologna University and completed education in Health Economics & Outcomes Research with a Master at the University of Milan and an MBA at the Bologna Business School. Market Access & Health Economics & Outcomes Research expert / Director level professional with over 15 years of experience in Medical Device, including Health Economics & Outcomes Research, Reimbursement & Access and Value strategies, delivering data and tools to effect reimbursement, funding and Health Technology Assessments at International level. Currently Leader of the EMEA and Japan Market Access Teams at W.L GORE – a Global Devices manufacturer known for innovation and a modern, distinctive company culture. Previously served for over 7 years the Italian Pharmaceutical business in Bayer, Recordati and consultancy group Pbe. Most recently as Director Pricing and Reimbursement Strategy at BTG and Principal Manager at Medtronic assisting several divisions: interventional pulmonology, cardiology, cardiac disease management, structural heart, peripheral products. Specialties: market access strategies, pricing, HEOR, incorporation of market access requirements into clinical, medical & commercial strategies, new market assessment, due diligence. Phone: +393427566362 Email: [email protected] Barbara Calvert Virtual Director, Medical Products Reimbursement Abbott United States Barbara is currently Director, Medical Products Reimbursement, responsible for obtaining reimbursement for new products, HTA and healthcare policy. She previously held positions with medical device and pharmaceutical manufacturers and healthcare providers. Phone: 12022624917 Email: [email protected] 61

Attendees Vania Cristina Canuto Santos Virtual Director MoH - Brazil Brazil Vania Canuto is Director of National Committee for Health Technology Incorporation (CONITEC) in Brazil. Vania’s education includes a Bachelor of Economics (Universidade Federal do Rio de Janeiro – UFRJ), a postgraduate of Pharmacoeconomics and Health Economics (Universidad Pompeu Fabra – UPF/Barcelona) and a Master of Science in Health Technology Assessment (Escola Nacional de Saúde Pública – ENSP/ Fiocruz). Phone: +5561981449924 Email: [email protected] Er Chen In-Person Director, Health Economics and Value Demonstration Biomarin United States Er leads US value demonstration, Health Technology Assessment (HTA), evidence generation, model development/adaptation strategies within BioMarin. Er had 16 years of experience in developing and executing health economic strategies to support commercialization and value demonstration for pipeline and in-line products both within the industry and from consulting capacities. Er also spent a year in Italy with hands on experience on European HTA and innovative contracting mechanisms. Phone: 16502966169 Email: [email protected] Seth Clancy In-Person VP, GHER THV Edwards Lifesciences United States Seth is Vice President, Global Health Economics and Reimbursement (GHER) at Edwards Lifesciences supporting Transcatheter Heart Valves and Corporate Medical Affairs. In this position, Seth leads the development and implementation of evidence generation and market access strategies and has helped to address a complex and growing set of challenges related to health technology assessment, reimbursement and emerging evidence needs globally. Prior to joining Edwards in 2008, Seth worked at Cerner Lifesciences, where he served as Senior Research Associate, responsible for consultative services to biopharmaceutical companies in the areas of comparative effectiveness research, health technology assessment, and health economics. Seth holds an undergraduate degree from the University of California, Irvine and a Masters of Public Health from the University of California, Los Angeles. Phone: 5626520402 Email: [email protected] 62

Tammy Clifford Attendees Virtual Vice-President, Research - Learning Health Systems Canadian Institutes of Health Research Canada Dr. Tammy Clifford is Vice-President, Research at the Canadian Institutes of Health Research (CIHR), a post she has held since joining the Agency in October 2018. In this role, Dr. Clifford provides leadership for the design, development, and administration of CIHR’s funding programs and science policies. As a member of CIHR’s Executive Management Committee, she also works with Governing Council and Scientific Directors to help define and oversee the organization's strategic directions. Before joining CIHR, Dr. Clifford was the Chief Scientist and Vice-President, Evidence Standards, at the Canadian Agency for Drugs and Technologies in Health (CADTH), where she served in a number of senior leadership roles over more than a dozen years. As a member of CADTH’s executive team, she led the implementation of four strategic plans, piloted important organizational changes, and oversaw the production of evidence synthesis reports for Canadian decision makers. Dr. Clifford received her PhD in Epidemiology and Biostatistics from the University of Western Ontario, and her BSc and MSc from McGill University. She is currently an adjunct professor with the School of Epidemiology and Public Health at the University of Ottawa, where she supervises a number of masters, doctoral, and post-doctoral students. She is recognized for her exceptional leadership abilities, as well as for her passion and commitment to knowledge translation, and to mentoring the next generation of health researchers. Phone: 6138662553 Email: [email protected] Twitter: @TammyJClifford LinkedIn: linkedin.com/in/tammy-clifford-a088932b/ Ed Clifton Virtual Scottish Health Technologies Group - Unit Head Healthcare Improvement Scotland United Kingdom Ed Clifton is the Unit Head of the Scottish Health Technologies Group (SHTG). SHTG is a national health technology assessment (HTA) agency that provides evidence support and advice to NHSScotland on the use of new and existing health technologies (excluding medicines). Ed’s focus for SHTG is to ensure that HTA is relevant, flexible and timely towards better quality health and care in Scotland. Prior to his current role, Ed has gained over 10 years of experience working as an economist within NHSScotland. Phone: 07970 687637 Email: [email protected] 63

Attendees Nick Crabb In-Person Programme Director, Scientific Affairs NICE United Kingdom Nick Crabb is Programme Director, Scientific Affairs at the National Institute for Health and Care Excellence (NICE). Prior to joining NICE in 2010 to establish and manage the Diagnostics Assessment programme, Nick had a 20-year career in analytical science, process technology and general management in the chemical, pharmaceutical and contract laboratory industries. In 2014 he was appointed to his current role where he oversees the Science Policy and Research programme. Nick has broad scientific and policy interests relating to the evaluation of technologies and interventions to support the development of clinical, public health and social care guidance. His experience includes consideration of HTA issues arising from the availability of novel new products such as cell and gene therapies and work on methods and policies for the evaluation and purchasing of antimicrobials. Phone: +447785515790 Email: [email protected] Sophie Cros Virtual Director, Market Access, EMEA Abbott Belgium Sophie is Director, responsible for Health Economics & Reimbursement of the Structural Heart division at Abbott for Europe, Middle East and Africa. In this position, she is responsible for defining E.M.E.A. strategies for market access and building interactions with health policy makers as well as building the evidence needed to support funding and reimbursement for Abbott Structural Heart therapies. Sophie has 25+ years of experience, and held various market access positions in the pharmaceutical sector before joining the MedTech Industry. Before joining Abbott, she was Director of Reimbursement and Health Economics at Medtronic European Headquarter for Western Europe at the Neurological business unit. Before serving in the Medical Devices industry, she held various positions at international and French level on Reimbursement, Pricing and Health Economics in the Respiratory and Dermatological area in GlaxoSmithKline, Pfizer and Novartis. Sophie is the Vice-Chair of the HTA Working Group at Medtech and seats at the HTAi Policy Forum since 2009. Sophie received her Pharmaceutical Doctorate in the Paris XI University and holds a Specialized Master in Healthcare management from Ecole Superieure de Commerce de Paris. Phone: +32478824553 Email: [email protected] 64

Francesca Di Stasi Attendees In-Person Market Access Strategy W.L. GORE & ASSOCIATES Italy Background in Pharmacy with more than 15 years’ experience in both Pharma and Medical Device environment. Currently responsible for Italian Reimbursement and Market Access at W.L.GORE & ASSOCIATE. Key areas of expertise: Development of Health Economic Evaluation, working closely with the Public Affairs Business Unit to approach National/Regional Institutions on health economic topics. Analysis of public and private health spending at National and Regional level and their impact on the policies of hospitals. Review of national and international economic literature. Pricing and reimbursement strategy and dossier Phone: +393428640601 Email: [email protected] Breanne Dickhout In-Person Project Coordinator, Events HTAi Canada Breanne Dickhout has worked in the Hospitality industry for the past 10 years with a focus in the event industry. Breanne attended Niagara College to complete her Tourism and Event Management Program. Throughout her career she has planned many Weddings, and Social events in the Canadian Rockies, at various venues. Phone: 2504095087 Email: [email protected] Lea Drye Virtual Director, Clinical Science Services Blue Cross Blue Shield Association United States Dr. Drye is Director of Clinical Science Services with the Office of Clinical Affairs, joining the team in 2016. Dr. Drye received graduate degrees in Statistics from the University of Wisconsin-Madison and Epidemiology from the Johns Hopkins Bloomberg School of Public Health. Dr. Drye advises on methodology for medical reference policies and develops health technology assessments. She is engaged in BCBSA initiatives with regulatory agencies and industry stakeholders. Prior to coming to BCBSA, Dr. Drye was faculty at Johns Hopkins in the Epidemiology Department and the Center for Clinical Trials and Evidence Synthesis where she had more than 10 years of experience in the design, implementation and data analysis of randomized controlled clinical trials and observational studies. She taught classes in clinical trials to graduate students at Johns Hopkins, Fellows in federal regulatory agency programs and on the open courseware platform Coursera. Phone: 4435386761 Email: [email protected] 65

Attendees Kelly Estrada-orozco Virtual Head Evidence and Health Technology Managment Instituto De Evaluación Tecnológica En Salud Iets (Colombian Health Technology Assessment Agency) Colombia • Head of Evidence Synthesis and Management of Health Technologies of the Institute for the Evaluation of Health Technologies IETS. • Professor at the Clinical Research Institute, Faculty of Medicine, National University • Physician from the National University of Colombia • Master in Neuroscience and Behavioral Biology from the University of Murcia in Spain • Master in Clinical Epidemiology from the National University of Colombia • Research Fellow in diagnostic test methodologies at the University of Kansas- Kansas University Medical Center USA. • Research Fellow in continuous improvement of quality and patient safety of the Institute for Healthcare Improvement USA. • Candidate for a doctorate in Public Health. National university of Colombia • PhD candidate in Clinical Epidemiology. Pontifical Javeriana University. Phone: 00573013806510 Email: [email protected] LinkedIn: linkedin.com/in/kelly-estrada-orozco-96b97b125/ Aikaterini Fameli Virtual Global Oncology Policy Lead GSK United Kingdom Aikaterini Fameli is Global Oncology Policy Lead in Global Oncology Market Access and Pricing, GSK. In this role, she is responsible for devising and implementing comprehensive market access and HTA policy strategies to support key brands within Oncology, promote the acceptability and appropriate valuation of oncology novel endpoints and supporting access to new treatments for the benefit of cancer patients, healthcare systems and GSK. She has represented GSK at EFPIA Industry Association WG related to HTA topics and currently she is the Vice-Chair of the Oncology Platform WG. She joined GSK in 2016 and since then she has held above country roles for Government affairs and Market Access Policy in Europe and globally leading on public policy developments related to flexible pricing and reimbursement (P&R) approaches, payment models and HTA. Prior to GSK, she has worked in different leading roles as government official (regulator and payer organizations), has participated in EUnetHTA and has a deep knowledge in the field of oncology and in how health systems operate. She is an economist and holds a PhD in Change Management in Healthcare. Phone: +447341079698 Email: [email protected] 66

Christoph Glaetzer Attendees In-Person Chief Global Value and Access Officer Janssen United States • More than 25 years global experience in the development and implementation of pharmaceutical market access and commercialization strategies • Worked and lived in Europe, North America and Asia • Currently Chief Global Value and Access Officer for Janssen, Pharmaceutical Companies of Johnson&Johnson • Global responsibilities include Health Economics, Pricing, Patient Reported Outcomes (PRO) and Real- World Evidence (RWE) • Previous roles included the head of the regional Commercial and Access Strategy Organization for Janssen in Asia Pacific • Representative of Janssen at various international forum and initiatives (e.g. PhRMA, EFPIA, GHC, ISPOR, HTAi) • Champion of new Access and Pricing Concepts to improve Health Outcomes globally • International thought leader and speaker on Commercial Strategies, Health Care Policy and Pharmaceutical Market Access aspects • Educational background: Economist, Health Economist, Certified Nurse Phone: +16094957777 Email: [email protected] Wim Goettsch In-Person Special Advisor HTA Zorginstituut Nederland Netherlands Wim Goettsch, PhD is currently Special Advisor HTA at the Dutch National Health Care Institute He was the Director of the EUnetHTA JA3 (2016-2021) Directorate and Chair of the Executive Board of EUnetHTA between June 2016 and March 2018. Since 2019, he also has a position as an Associate Professor at Utrecht University (NL) where he is leading a new H2020 consortium with fifteen partners around Europe, called HTx on new methods for Health Technology Assessment for personalized medicine (2019-2024). He is currently Director in the Board of HTAi (2019-2022). Phone: +31651134099 Email: [email protected] Twitter: @wim_werk LinkedIn: linkedin.com/in/wimgoettsch 67

Attendees Adrian Griffin In-Person VP HTA Policy Johnson & Johnson United Kingdom Adrian has worked in the life sciences industry for over 25 years, predominantly in the fields of health economics, outcomes research, and reimbursement policy, with experience across the pharmaceutical, medical device, and diagnostic sectors. His present role is Vice President, HTA and Access Policy at Johnson & Johnson. Adrian is actively engaged in numerous multi-stakeholder forums where key issues of HTA and access policy are debated and shaped, such as the HTAi Policy Forum, and initiatives that have brought regulators and HTA agencies together with companies, thus improving transparency and appreciation of different stakeholder perspectives. Adrian served on the NICE Technology Appraisal Committee between 2003 and 2020 and was on the Board of Directors for ISPOR (the International Society for Pharmacoeconomics and Outcomes Research), between 2013-15. Phone: +447976607094 Email: [email protected] LinkedIn: linkedin.com/in/adrian-griffin Sandro Gsteiger Virtual Access Evidence Lead F. HOFFMANN-LA ROCHE AG Switzerland Sandro Gsteiger holds the position of Access Evidence Lead within the Global Access Department at F. Hoffmann-La Roche Ltd. In this role, he contributes to access evidence generation, strategy development, the development of novel HTA methods and the adaptation and implementation of such methods for decision making. He has contributed to HTA focused public-private partnerships such as those led by the Innovative Medicines Initiative. He has strong interest in HTA Science, Evidence Synthesis, HEOR methods and their application, and the evolving HTA landscape. He holds an MSc in mathematics (University of Fribourg, Switzerland), a PhD in statistics (Swiss Federal Institute of Technology in Lausanne), and an MSc in HTA from the University of Glasgow, UK. Phone: +41793878351 Email: [email protected] Twitter: @SandroGsteiger LinkedIn: linkedin.com/in/sandro-gsteiger 68

Benjamin Gutierrez Attendees In-Person VP, Value Evidence & Outcomes - Oncology Glaxosmithkline United States Ben Gutierrez, Ph.D. is currently VP and Oncology TA Head for Value Evidence & Outcomes at GlaxoSmithKline. Over the past 25 years, he has held various roles in both the pharmaceutical industry and US health care sector. Phone: 14843565518 Email: [email protected] Tatiana Hagerty In-Person Senior Coordinator, Governance & Executive Projects HTAi Canada Tatiana was born and raised in Omsk, Russia. She began her career in Moscow as a teacher, subsequently moving into the tourism industry allowing her to work in many corners of the world. After a move to Canada in 2002, she began her Canadian work experience as a contract English Teacher in a German bilingual school with Edmonton Public School Board. For the last 13 years Tatiana has been working as a professional administrator specializing in board and executive support. Tatiana’s experience includes senior administrative support service with large, member-based and not-for-profit organizations. She has led numerous administrative process improvement initiatives and has supported boards of directors with a range of fiduciary and strategic activities. Most recently Tatiana worked at MacEwan University in the office of the Provost as Executive Assistant providing support to the General Faculties Council and its committees. Tatiana holds a Bachelor of Arts and Education from Omsk Teachers’Training University, and she is currently pursuing her Certified Association Executive designation to remain current on best practices in all aspects of governance. As HTAi’s Governance and Executive Projects Coordinator, Tatiana provides a range of administrative services, including support for Board and executive activities, governance matters, scheduling meetings and responding to information requests. Phone: 7808936544 Email: [email protected] 69

Attendees Liesl Hargens Virtual Senior Director, Health Economics Boston Scientific United States I am a highly collaborative, agile, adaptable, and passionate global health care leader with extensive experience in strategy, epidemiology, evidence development, and market access in medical device, hospital, clinic, and payer environments. I have specific expertise in sizing market potential, identifying barriers to access, and developing strategies, evidence, and solutions to drive growth. I enjoy using fact- based analysis to develop and execute new innovations in large, complex health care organizations. Phone: +1 612-300-5829 Email: [email protected] LinkedIn: linkedin.com/in/lieslhargens/ Niklas Hedberg In-Person Chief Pharmacist TLV Sweden Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV). Niklas is the Chair of the Consortium Executive Board for EUnetHTA21. He was 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. Phone: 0730222058 Email: [email protected] 70

Jo Carol Hiatt Attendees In-Person VP, HEPV MDIC United States Jo Carol Hiatt, MD joined the Medical Device Innovation Consortium (MDIC) as Vice President, Health Economics and Patient Value (HEPV) in October 2020. Her portfolio currently includes two workstreams: Patient Perspective/Risk Tolerance Research (PPR) and Real-World Evidence (RWE). Areas of focus are close collaboration with CMS and FDA to support improved clarity around applications of RWE and PPR to inform decisions by health technology assessment organizations and payers. In June, 2021, Dr. Hiatt was elected Secretary and member of Board of Directors, Health Technology Assessment International. Phone: +1 3102706929 Email: [email protected] Kyle Hivdsten In-Person Head, Specialty Care HEVA Sanofi United States Kyle Hvidsten is Head of the Global Specialty Care Health Economics and Value Assessment department. In this role, Kyle oversees input into clinical trial design and the development of economic models and RWE studies to support scientific exchanges with health technology assessment agencies and healthcare payer organizations across the globe. Prior to joining Sanofi, Kyle held several positions in US and Global health economics and outcomes research with increasing levels of responsibility over the past 20+ years. He holds a MPH degree from Columbia University and a BA from Emory University. Phone: 19088427194 Email: [email protected] Dorothy Hoffman Virtual External Engagement and Market Access Policy Lead Pfizer United States Dorothy Hoffman is External Engagement and Access Policy Lead in the Global Healthcare Innovation Center at Pfizer. Dorothy's team is focused on developing innovative payment and affordability go-to- market models to optimize the value and access strategy of Pfizer brands and assets. Prior to joining Pfizer, Dorothy was Vice President of Prescription Drug Policy at UnitedHealth Group. Dorothy has a Masters in Public Policy and lives in the NYC area with her family. Phone: 9292375081 Email: [email protected] 71

Attendees Grace Li Ying Huang Virtual Director CDE, Taiwan Taiwan Dr. Li Ying (Grace) Huang is a director of the Division of the Health Technology Assessment, Center for Drug Evaluation, Taiwan (CDE/HTA). Before joining CDE/HTA in 2008, she worked for around ten years as a clinical pharmacist in a leadership role in the department of pharmacy in one of the major medical centers in Taipei. She completed her Ph.D. degree in Graduate Institute of Health Policy and Management, College of Public Health, National Taiwan University and Master’s degree in pharmaceutical science from the National Taiwan University as well. She has authored and co-authored articles published in several international journals and also serves as a reviewer of manuscripts. Her current research focuses on comparative efficacy of new drugs, applying mixed treatment comparison methods, patient involved HTA and therapeutic inertia among adult DM patients in Taiwan. In 2020, Dr. Li Ying (Grace) Huang currently serves on the board of Directors for the Board of Directors for the HTAi. Grace has been a member of the INAHTA Board for the following terms: Director 2016-2018 and 2019-2021. Phone: +886-0976506608 Email: [email protected] Mohit Jain In-Person VP, Market Access - Emea Commercial Ops Europe Biomarin United Kingdom Mohit is Vice President, Market Access EMEA in BioMarin, leading market access in the EMEA region, global coordinating the function and heading BioMarin’s Centres of Excellence for HEOR and Patient Outcomes. BioMarin is a company focused on developing life transforming therapies for rare disease patients with a number of innovative treatments launched and in development including gene therapies. Mohit has been with BioMarin for ten years and prior to this worked in other companies including large pharma and consulting. By background a scientist and then worked in corporate finance before finding a calling in Market Access, where Mohit has a specific interest in alternative approaches to economic evaluation specifically around rare diseases. Mohit is married with two lovely girls aged 11 and 13 years, occasionally tries to fit in a run. Phone: +44 7825296115 Email: [email protected] 72

Rabia Kahveci Attendees In-Person Senior Technical Advisor Management Sciences for Health (MSH) Turkey Ms. Kahveci has 20 years of professional life, 15 of which dedicated to improving evidence based clinical practice and policy making, quality of health care, health policy support, systems strengthening and systems thinking. Majority of her work included integration of priority setting strategies –including health technology assessment- to health reform activities in low and middle income countries, as well as driving policies for pricing and reimbursement of health technologies. She has broad experience in all health care decision-making levels including primary care, hospital care, hospital management and policy-making at the national level. Dr Kahveci is known for her active work in NGOs and is Vice President of International Health Technology Assessment Society and President Elect for the same society as of 2023. She currently serves as Senior Technical Advisor, Pharmaceutical Policy and Governance, at the USAID funded SAFEMed Project, led by Management Sciences for Health, and based in Kiev, Ukraine. Phone: +905057120153 Email: [email protected] Brendon Kearney In-Person Consultant RAH Australia Works as a Consultant Physician, Haematology Unit, Royal Adelaide Hospital, and is Site Clinical Director RAH, SA Pathology. He is a past chair of Euroscan International and chaired Health PACT, National and International Committees that advise on new and emerging health technologies. He chaired the Population Health Research Network which is building a national data linkage system for health researchers. He has been Chair of the SA Health Commission, CEO, Royal Adelaide Hospital, and Director, Institute of Medical and Veterinary Science, and has been awarded the Sidney Sax Medal and an AM for his work in health. Phone: +61418830797 Email: [email protected] Sukyeong Kim In-Person Senior Research Fellow National Evidence-based Healthcare Collaborating Agency South Korea Phone: +821063447406 Email: [email protected] 73

Attendees Sarah Kleijnen Virtual Head of Research, Development And International Affairs Zorginstituut Nederland Netherlands Phone: +31646163416 Email: [email protected] LinkedIn: linkedin.com/in/sarah-kleijnen-7929161 Megan Klopchin Virtual Associate Director- Value, Evidence, And Outcomes Eli Lilly And Company United States Megan Klopchin is an Associate Director at Eli Lilly and Company in the Center of Expertise within the Value, Evidence, and Outcomes (VEO) department where her main priorities include overseeing its policy capability. Via this capability, VEO is externally engaged to address policy and environmental issues related to scientific standards and methods to appropriately support value assessments and the utilization of real world evidence. Prior to joining Lilly, Megan was a microbiologist for the federal government’s BioWatch Program which was housed at the Indiana State Department of Health. Megan received her Master of Public Health with a concentration in Health Policy and Master of Health Administration from Indiana University, and her bachelor’s degrees in biology and sociology from Millikin University in Decatur, Illinois. Megan enjoys volunteering for several local nonprofit organizations in Indianapolis where she resides, and she serves on the Damien Center Board and Indiana Youth Group Board. At Lilly, she has been recognized as one of its Top 100 Innovators and recently received the Lilly Research Lab President’s Diversity and Inclusion Award. Phone: 13172259933 Email: [email protected] Helen Knight In-Person Programme Director NICE United Kingdom Helen Knight is a Programme Director at the National Institute for Health and Care Excellence (NICE) responsible for the health technology assessment methods used to produce national guidance. With an academic background in biochemistry and health economics, she spent 6 years working as a health economist for a health outcomes consultancy before joining NICE in the Technology Appraisal Programme in 2007. She has extensive experience of health technology assessment over a wide range of technologies and disease areas. As Programme Director, she is responsible for the methods for developing and delivering of guidance within the Centre for Health Technology Evaluation. Phone: +44 7967 004153 Email: [email protected] 74

Nathalie Largeron Attendees Virtual Global Head of Health Technology Assessment Strategy Sanofi France Nathalie Largeron is Head of Global Health Technology Assessment (HTA) Strategy within Sanofi. In this role, she leads Sanofi efforts on HTA strategy and internal alignment. She also represents the company on HTA related topics with external stakeholders, including HTA bodies and policy organizations, industry associations and public health institutions. Nathalie has a strong understanding of the role of market access, health economics, and HTA in clinical drug development process, pipeline strategy and life-cycle management. She joined Sanofi in 2017 where she created the Global Health Economics and Value assessment department within Sanofi’s Vaccines Business unit and led the team during nearly 5 years. Before joining Sanofi, she has been working 14 years in several European roles, in the field of market access and outcomes research at Sanofi Pasteur MSD, a joint venture between Sanofi and Merck & Co, dedicated to the commercialization of vaccines in Europe. Today Nathalie is an active member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) HTA Working Group where she is engaged in the debate and process related to the implementation of the new HTA regulation in Europe, she contributes also to the Vaccines Europe Access Working Group. She published more than 35 peer- reviewed papers and is a reviewer of several scientific journals. She is a member of ISPOR & HTAi. Nathalie is a pharmacist, hold a Master’s in health economics from the University of Lyon, France and a post-graduate degree in epidemiology. Phone: +33672594020 Email: [email protected] Anne Lee Virtual SMC Chief Pharmaceutical Adviser Healthcare Improvement Scotland United Kingdom Anne Lee is the Chief Pharmacist and lead officer for the Scottish Medicines Consortium (SMC), based in Healthcare Improvement Scotland. SMC carries out health technology assessment (HTA) of new medicines on behalf of the NHS in Scotland. Anne has been the lead officer for SMC for 10 years. Phone: 07966913844 Email: [email protected] 75

Attendees Martin Lerner Virtual Department Director Norwegian Institute of Public Health (NIPH) Norway Martin Lerner is a Department Director at the Department of Reviews and Health Technology Assessments within the Division for Health Services at the Norwegian Institute of Public Health (NIPH). His current responsibilities include horizon scanning and disinvestment of health technologies for the specialist health care in Norway as well as being involved in rapid reviews and more extensive HTAs. He is the representative of NIPH in the International Horizon Scanning Initiative (IHSI) and is also co-chair in the IHSI Medical Devices Working Group. Martin Lerner is originally from Sweden and obtained his medical degree at the Karolinska Institute in Stockholm and has 15+ years of clinical experience in cardiology and internal medicine. Phone: +47-40658412 Email: [email protected] Gavin Lewis Virtual Vice President Global Value and Access Amgen Switzerland Gavin Lewis is Amgen’s VP Global, Value and Access based at the company’s European Hub in Switzerland. Founded in California in 1980, Amgen is a global leader in biotechnology. Gavin originally was an undergraduate in Economics and Politics, before working for the Scottish Government as an Economist in the Health Department. After obtaining an MSc in Health Economics from York University, he joined the Pharmaceutical industry for Roche in the UK where he worked for over 10 years developing and leading their Health Economics and Pricing department. He has experience in leading over 50 Health Technology appraisals and contributed to the development of the NICE Guide to Methods for Technology Appraisal. In 2012 Gavin transferred to Basel to start a new role for Roche as Head of Pricing and Market Access for Region Europe, where he has developed a new team with responsibilities for strategic pricing, payer marketing and real world evidence for Europe. Gavin was then Global Head of Market Access for Oncology at AstraZeneca from 2015-17, before joining Amgen. Phone: +41794579140 Email: [email protected] 76

Alessandra Lo Scalzo Attendees Virtual Senior HTA Research Officer Agenas Italy Alessandra Lo Scalzo is senior HTA research officer at AGENAS. She has BA in political and social science at University of Florence and owns a M.Phil in Health Sociology University of Bologne and an International Master in HTA and Management – Ulysses Project - Università Cattolica del Sacro Cuore (Rome). She has been member of HTAi for several years and her main fields of expertise and interest are related to qualitative methods in HTA, patient involvement in HTA, Real World Evidence, evidence based prevetion, genomic and HTA, quality and accreditation in healthcare, healtcare systems comparisons, patients/ physicians relationship. She has been member of the EUnetHTA Executive Board. She authored several publications on peer reviewed journals, collaborated with the European Observatory on Health care Systems in Transition and authored many HTA reports on medical devices and procedures. Phone: +393479822813 Email: [email protected] Elizabeth Loughren Virtual Managerial Senior Consultant Kaiser Permanente United States Elizabeth Loughren is a senior consultant at Kaiser Permanente who currently manages the organization’s Interregional New Technologies Committee and coordinates new medical technology assessment support for physician-led teams. Liz joined the Southern California Permanente Medical Group’s Evidence- Based Medicine Services team in 2003 after receiving a Master of Public Health degree in Healthcare Management and Policy from UCLA. She has managed medical technology assessment committees and performed rapid reviews on new and emerging technologies for many years. Phone: 213-444-9524 Email: [email protected] 77

Attendees Guy Maddern In-Person Surgical Director Research & Evaluation RAAS Australia Professor Guy Maddern is the RP Jepson Professor of Surgery at the University of Adelaide, Director of Research at the Basil Hetzel Institute for Translational Health Research at The Queen Elizabeth Hospital and Director, Surgical Research and Evaluation (incorporating ASERNIP-S) of the Royal Australasian College of Surgeons. He was trained at the University of Adelaide and became a Fellow of the Royal Australasian College of Surgeons in 1989. His clinical interests include the development of techniques to manage metastatic hepatic disease and hepatic approaches to optimise resection options. He has also published widely on new surgical techniques and their introduction into surgical practice. He has over 500 publications in scientific journals, has contributed to over a dozen surgical texts and attracted $65 million of research funding. The evaluation of new technologies and in particular surgical technologies is another area of focus and interest. Under his supervision, ASERNIP-S has been responsible for assessing these technologies before exposing the Australian population to them and has provided this service to the Australian and International community for the past 20 years, and is recognised, nationally and internationally, as the premier surgical innovation assessment group. He is a past President of HTAi and a past Chair of INAHTA. Phone: 0418444620 Email: [email protected] Jan Maly Virtual Associate Director, Global Policy And External Affairs Merck Serono United Kingdom Global Policy And External Affairs (2022 - Present) Head of Government and Public Affairs, UK (2020-22) Phone: +44 7971 552271 Email: [email protected] LinkedIn: linkedin.com/in/janmaly86/ Marco Marchetti Virtual Director Agenzia Nazionale per i Servizi Sanitari Regionali Italy Responsible for HTA activities of the National Agency of Regional Health Services. Phone: +393386111294 Email: [email protected] 78

Newell McElwee Attendees Virtual Vice President, HEOR Boehringer Ingelheim Pharmaceuticals, Inc United States Newell McElwee is Vice President, Health Economics and Outcomes Research at Boehringer Ingelheim Pharmaceuticals, Inc. He is a recognized leader in HEOR with 30+ years experience in the pharmaceutical industry. Prior to coming to Boehringer Ingelheim, Newell led outcomes research groups at Pfizer and Merck. He has been actively engaged with a number of outcomes research related organizations, including AHRQ, IOM/NAM, HTAi, ISPOR, SMDM, Academy Health and AMCP. He is also a member of the Tufts Medical Center CTSA Executive Advisory Committee. Newell received his PharmD from Mercer University and his MSPH (epidemiology) from the University of Utah. He completed a clinical pharmacy residency at Osteopathic Medical Center of Texas and a postdoctoral fellowship in clinical pharmacology and toxicology at the University of Utah Medical Center. Phone: 14848322429 Email: [email protected] Suzanne McGurn Virtual President and CEO CADTH Canada Ms. Suzanne McGurn joined CADTH in July 2020 as its President and Chief Executive Officer. She brings to the role a deep understanding of the complex issues surrounding the management of pharmaceuticals, medical devices, and clinical interventions in Canadian health systems. Prior to joining CADTH, Ms. McGurn’s distinguished career spanned clinical practice, patient support, and senior roles in government. Within the Ontario Ministry of Health, she served as the Assistant Deputy Minister of the Drugs and Devices Division and the Executive Officer of the Ontario Public Drug Programs. She also led the implementation of the pan-Canadian Pharmaceutical Alliance and served as its first chair. Ms. McGurn holds both a Bachelor of Nursing Sciences and a Master of Public Administration from Queen’s University. Phone: 613-929-9645 Email: [email protected] Twitter: @Suzanne Mcgurn LinkedIn: linkedin.com/in/suzanne-mcgurn-13832713/ 79

Attendees Antonio Migliore Virtual Manager HTAi Italy Antonio has a Master’s Degree in Biomedical Engineering from the University of Pisa (Italy) and a Master’s in Health Economics and Management from the University of Rome “Tor Vergata”. After a couple of years spent as a researcher at University of Pisa and Scuola Superiore di Studi Universitari e di Perfezionamento “S. Anna” di Pisa, he joined Agenas (the Italian national agency for regional healthcare). From 2007 to 2019, he was involved in research activities linked to the national HTA program, the Italian regional network for HTA (RIHTA), the EUnetHTA network activities, and the EuroScan International Network for new and emerging health technologies. More recently, he has been working as an independent consultant and assisting the WHO on projects related to medical devices for cancer, cardiac diseases, stroke, and diabetes management. Email: [email protected] LinkedIn: linkedin.com/in/antonio-migliore-51976516/ Andrew Mitchell Virtual Strategic Adviser, Evaluation PBAC & MSAC Australia Government, Department of Health and Ageing Australia Andrew Mitchell is Strategic Adviser, Evaluation in the Australian Government Department of Health. He has long experience in using clinical and economic evaluations of medicines and other health technology types. He has helped steer the development of several approaches to use this information systematically to guide resource allocation decisions in a publicly funded health care system. Phone: +61402000617 Email: [email protected] 80

Nicole Mittmann Attendees In-Person Vice President and Chief Scientist, Evidence Standards CADTH Canada Dr. Nicole Mittmann is CADTH’s Chief Scientist and Vice-President of Evidence Standards. Dr. Mittmann leads CADTH’s shared science groups, including the Health Economics, Research Information Services, and Scientific Affairs teams. Dr. Nicole Mittmann joins CADTH from Cancer Care Ontario, where she held the position of Chief Research Officer. She holds a faculty position as an assistant professor at the University of Toronto in the Department of Pharmacology & Toxicology, and is an associate scientist at Sunnybrook Health Sciences Centre. Dr. Mittmann is also the co-chair of the Committee on Economic Analysis (CEA) at the Canadian Cancer Trials Group. Responsibilities include embedding economic parameters into clinical trials, economic evaluations, and guidelines development. In her academic capacity, Dr. Mittmann has conducted and collaborated on notable research in the areas of economic evaluations, outcomes research, and drug/patient safety. Research methodologies include the examination of large databases, economic methodologies, and decision analysis. Dr. Mittmann holds an MSc and PhD in pharmacology from the University of Toronto. Phone: 416 904 5483 Email: [email protected] Jani Mueller In-Person Senior Researcher University of Pretoria South Africa Debjani Mueller is a Senior Researcher and lecturer at the University of Pretoria. She has gained practical experience in assessing medical devices over the last decade and shared her experience on HTA through training in South Africa and other countries. Her work includes health technology policy and response strategies, and her research focuses on methodologies for medical device and digital technology assessment to improve their utility in the context of real-world decision-making, which includes a life-cycle approach to medical technology assessment. Jani is committed to promoting, collaborating, and raising awareness about the development and implementation of sustainable HTA solutions. She is currently a member of the HTAi Board of Directors and chair of the Interest Group on developing HTA in emerging countries (DCIG). She is a co-founder of the South African HTA Society, SAHTAS, and is an Associate Editor for IJTAHC. Additionally, she serves on the Board of the ISPOR South Africa Chapter. Jani has a strong interest in developing capabilities, education, and training in HTA, particularly fitting to the context of the developing countries. She has published and co-authored several publications, contributed to book chapters, and presented her research findings at a number of sessions. Phone: +491637788204 Email: [email protected] Twitter: @DebJaniMueller LinkedIn: linkedin.com/in/debjani-b-mueller-4726884/ 81

Attendees Lynne Nakashima Virtual Senior Director, Provincial Pharmacy BC Cancer Canada Senior Director, Provincial Pharmacy at BC Cancer, Vancouver, Canada. Phone: 604-760-6204 Email: [email protected] LinkedIn: linkedin.com/in/lynne-nakashima-b45a8b3a Christian Nguyen Virtual Vice President Eli Lilly United States Phone: 6233308706 Email: [email protected] Megan O'Brien Virtual Executive Director Merck United States Megan O’Brien, PhD, MPH, is currently an Executive Director with Global Market Access at Merck. In this role, Dr. O’Brien leads the Policy Evidence Research team. The focus of this team is to generate evidence to inform policy related discussions around access to pharmaceuticals, and to contribute to real-world evidence, health technology assessment and value framework policies and standards development Dr. O’Brien received a PhD in health economics from the Johns Hopkins Bloomberg School of Public health and a Masters Degree in Public Health from Emory University. Phone: 6177940666 Email: [email protected] 82

John O'Donnell Attendees Virtual SVP and Head, WW Health Economics & Outcomes Research Bristol Myers Squibb United States John C. O’Donnell, MPP, PhD, is Senior Vice President, Worldwide Health Economics and Outcomes Research at Bristol-Myers Squibb. He leads a diverse Global team dedicated to defining, developing and delivering evidence of value to ensure patients, payers and providers have the best possible information about, and optimal access to medicines. He was the inaugural Chair of AcademyHealth’s Corporate Council, is an Institutional Council member of the International Society of Pharmacoeconomics and Outcomes Research. John received a PhD in Health Policy and Administration from the University of North Carolina at Chapel Hill. He has thirty years of experience in health services and outcomes research in industry, in academia and in US State and Federal governments, with over 20 years of experience in the pharmaceutical industry. While in government and academia, John advanced health policy research in rehabilitation services, veterans’ health and the aged through his work with the US Department of Veterans Affairs and Duke University’s Center for the Study of Aging and Human Development. John is Adjunct Professor at the University of North Carolina at Chapel Hill. He has published in the areas of health economic evaluation, health and regulatory policy, health services research, geriatrics and rehabilitation and is a reviewer for leading journals including Medical Care, Value in Health, American Journal of Psychology, and the Archives of Internal Medicine. Phone: 4847884239 Email: [email protected] Dan Ollendorf In-Person HTAi Global Policy Forum Chair Director, Value Measurement & Global Health Initiatives Tufts Medical School Center for the Evaluation of Value and Risk in Health United States Dan Ollendorf is Director of Value Measurement and Global Health Initiatives at the Center for the Evaluation of Value and Risk in Health (CEVR) at Tufts University Medical Center, as well as Assistant Professor of Medicine. An internationally recognized expert in health technology assessment (HTA), Dan’s research interests include expanding the use of HTA and economic evaluation in low- and middle-income settings (particularly rapidly-growing economies), as well as refinement and use of value assessment tools in the US and other high-income settings. Prior to joining CEVR, Dan was Chief Scientific Officer at the Institute for Clinical and Economic Review (ICER) for over 10 years. His 30 years of health care experience also include work in the hospital, informatics, insurance, managed care, and consulting sectors. Dan holds a Ph.D. in clinical epidemiology from the University of Amsterdam, a Master’s of Public Health from Boston University, and a Bachelor of Arts from the University of Rochester. He currently serves as a non-resident Fellow at the Center for Global Development, is a member of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) HTA Council Working Group, and is the Chair of the Health Technology Assessment International (HTAi) Global Policy Forum. Email: [email protected] Twitter: @dollendorf 83

Attendees Wija Oortwijn In-Person HTAi President Radboud University Medical Centre Netherlands Wija Oortwijn holds a position as senior researcher in the field of global HTA at the Radboud University Medical Centre (Radboudumc) in Nijmegen and is also associate professor at Leiden University Medical Centre (Public Health and Primary Care) in the field of measuring the impact of health research. She studied health sciences and holds a PhD in Medicine (priority setting for HTA). She has 30 years of relevant professional experience in HTA and health policy analysis around the globe, with her key expertise including health priority setting, policy evaluation and measuring the impact of research. Since 1992, she has been extensively involved in the development of HTA and health system strengthening around the world. She is a founding member of the Dutch Society for HTA (NVTAG) and the international HTA Society (HTAi). Currently, she is President of HTAi, co-chairing the HTAi-ISPOR Good Practices Task Force on deliberative processes for HTA. co-initiator of the HTAi-DIA working group on uncertainty in HTA, and she is associate editor of the International Journal of Technology Assessment in Health Care. Furthermore, she was the scientific secretary of HTAi’s Global Policy Forum from June 2016 until June 2019. Phone: +31653448254 Email: [email protected] Twitter: @OortwijnW Valérie Paris Virtual Board Member - Chair of the Economic and Public Health Committee Haute Autorité de Santé France Valérie Paris joined the French National Authority for Health in 2020 as a member of the Board and President of the Economic and Public Health Committee (CEESP). Before that (2005-2020), she was a senior analyst at the OECD Secretariat where she contributed to the work undertaken by the Health Division. Since then, she has contributed to several projects on health systems’ characteristics and performance, providers’ payments, pharmaceutical policies and regional variations in health care use. She co-ordinated and co-authored the OECD reports New Health Technologies - Managing Access, Value and Sustainability (2017) and Pharmaceutical Innovation and Access to Medicines (2018). She was responsible for most OECD projects related to pharmaceuticals and medical devices. Previously, she was researcher at the French Institute of Research and Information on Health Economics (IRDES), a non-for-profit organization. She participated in research projects on pharmaceutical policies, physicians’ payment schemes, health accounts and comparative analysis of health systems. She holds a master’s degree in Economics, statistics and econometrics from the University of Paris 1-Sorbonne (1990). Phone: +33781420700 Email: [email protected] LinkedIn: linkedin.com/in/val%C3%A9rie-paris-79986514a/ 84

Steven Pearson Attendees In-Person President ICER United States Steven D. Pearson, MD, MSc is the Founder and President of the Institute for Clinical and Economic Review (ICER). Dr. Pearson is also a Lecturer in the Department of Population Medicine at Harvard Medical School. An internist, health services researcher, and ethicist, Dr. Pearson has served in many advisory and leadership roles in academia and government. In 2004 he was awarded an Atlantic Fellowship from the British Government and chose to serve as Senior Fellow at the National Institute for Health and Clinical Excellence (NICE). Returning to the United States in 2005 he was asked to serve during the George W. Bush Administration as Special Advisor, Technology and Coverage Policy, at the Centers for Medicare and Medicaid Services, and also accepted an appointment as Visiting Scientist in the Department of Bioethics at the National Institutes of Health, a position he maintained from 2005-2019. In other roles, Dr. Pearson has also served as the Vice Chair of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC). Dr. Pearson’s publications include over 150 peer-reviewed articles and commentaries on the role of evidence in the health care system, and the book No Margin, No Mission: Health Care Organizations and the Quest for Ethical Excellence, published by Oxford University Press.\" Phone: 6175284013 Email: [email protected] Amy Peasgood In-Person Patient/public Representative CADTH Canada Amy Peasgood earned her LL.B. from Dalhousie University in 2005 and has been diagnosed with four types of cancer since 2006, including Metastatic Breast Cancer (MBC) in 2014. During this time, Ms. Peasgood was diagnosed with a genetic cancer predisposition called Li-Fraumeni Syndrome (LFS), which inspired her to write a children’s book about LFS with her daughter. Over the years, Amy has volunteered to promote family engagement in research; shed light on the mental health challenges that often accompany a cancer diagnosis; and raised awareness of MBC and LFS. She has also shared her story through public speaking engagements, in personal essays and online, in the hopes of building the patient voice and supporting those who face similar challenges. Amy lives in Kelowna, BC with her husband and two daughters. Phone: 1-416-400-0736 Email: [email protected] 85

Attendees Alicia Powers In-Person Manager, Policy Forums & Events HTAi Canada Alicia (known as Ali) is an event organizer with over 15 years of experience in every aspect of events management, including large and small conference management in national and international locations, workshop development, and annual gala productions. Ali’s experience also includes event work with professional sports teams, universities, hospital foundations, and health technology startup organizations. Before joining HTAi, Ali held a position in the Corporate Communications and Marketing department at Alberta Innovates. She has also executed over 60 weddings over the past decade and was recently shortlisted in the “future leader” category at the Edmonton Event Awards. Ali also sits on the Board of Directors for the International Live Events Association (ILEA – Edmonton Chapter). Email: [email protected] Gowri Raman Virtual Senior Program Officer Patient-centered Outcomes Research Institute (PCORI) United States Gowri Raman is a Senior Program Officer at the Patient-Centered Outcomes Research Institute, Washington D.C., USA. Dr Raman is a physician-researcher by training and oversees the New Technology Program at PCORI. Phone: +1-617-605-7818 Email: [email protected] 86

Andrea Rappagliosi Attendees In-Person VP Public Affairs EMEACLA Edwards Lifesciences Switzerland Andrea is currentlyVice-President Public Affairs EMEA, Canada and LATAM at Edwards Lifesciences and member of the regional Executive LeadershipTeam. He is leading the Government Affairs, Market Access, Communication and Patients Advocacy engagement for the company. Born in Rome, Andrea received a law degree from the University of Rome, La Sapienza. Andrea began his professional career in the Italian Senate. Recently he worked in the Sanofi group asVP Public Affairs Europe and before asVP, Market Access, Health Policy and Medical Affairs at Sanofi Pasteur MSD. At SPMSD JointVenture he was member of its Executive Committee from 2012 to 2016. Before, he worked at Baxter Healthcare, Serono International and GSK in different European and International positions in the public affairs and market access policy area. In the last ten years, Andrea represented the healthcare Industry in several European EU Commission and Member States initiatives such as the HTANetwork, EUnetHTA Joint-Action 3, and the EU Active & Healthy Aging Innovation Partnership and the EU Joint Action onVaccination. He was President of EuropaBio the European Association of the biotech Industry (2009-2011), and ofVaccines Europe, the EuropeanVaccines manufacturers association (2013-2017). Andrea is a founding member of the Global Policy Forum at HTAi – the scientific and professional society for all those who produce or use health technology assessment (HTA). Phone: + 41 79 5968808 Email: [email protected] David Rind In-Person Chief Medical Officer Institute for Clinical and Economic Review United States David Rind is CMO of ICER and an academic primary care physician at Beth Israel Medical Center in Boston. He has a background in clinical epidemiology and evidence-based medicine. Phone: 617-794-5009 Email: [email protected] Murray Ross In-Person Vice President Kaiser Permanente United States Murray Ross is a Vice President with Kaiser Permanente in Oakland, California, where he leads the Kaiser Permanente Institute for Health Policy. He also serves as Senior Lecturer at the Kaiser Permanente Bernard J. Tyson School of Medicine. Dr. Ross chairs the boards of the Institute for Clinical and Economic Review and the Network for Excellence in Health Innovation and served on the board of the Canadian Foundation for Healthcare Improvement. Phone: 925-348-0331 Email: [email protected] LinkedIn: linkedin.com/in/murraynrossphd/ 87

Attendees Alric Rüether In-Person Head International Affairs Institute For Quality And Efficiency In Health Care (iqwig) Germany Education / Professional career • S tudied medicine in Budapest, Munich and Alicante. • D octoral Thesis: The acute phase of thrombosis of the superior sagittal sinus. An experimental study (m.c.l.) • T raining in internal medicine and haematology / oncology in Munich and Freiburg, Germany. • C ollaboration in the establishment of the German Cochrane Centre (Director: Dr, G. Antes). • Establishment of the \"Health Economic Evaluation Information System\" and the \"Health Technology Assessment\" department at the German Institute for Medical Documentation and Information (DIMDI), founder and head of the German Agency for Health Technology Assessment (DAHTA) of the DIMDI (2000 - 2007). • H ead of the Quality of Care Department, Institute for Quality and Efficiency in Health Care (IQWiG), Cologne. (2007 -2015) • S ince 2015 Head of \"International Relations\", IQWiG. Other Activities • S ince 1999 Member of the International Network of HTA Agencies (INAHTA) , 2006 - 2009 Vice-Chair; Member of the Board from 2021 • M ember of Health Technology Assessment international (HTAi) since its foundation (2003), Board member 2013 - 2019, Chair of the Scientific Development and Capacity Building Committee (SDCB) 2018-2020; organisation of the annual meeting of HTAi 2019 in Cologne • F ounding member of the European Network for HTA (EUnetHTA). Co-Chair of the Executive Board EUnetHTA-21. • Member of the German Network of Evidence-Based Medicine (DNEbM) since its foundation (2000), co- chair of the HTA section. • Member of the working groups \"Health Technology Assessment (co-chair)\", \"Health Economics\" and \"Medical Decision Making\" of the German Society for Medical Informatics, Biometry and Epidemiology (GMDS) e. V. • Board member of the German society \"Promotion of Technology Assessment in Health Care (HTA) e.V Teaching • Teaching in Health Technology Assessment at the University of Bielefeld. Phone: 015117444593 Email: [email protected] 88

Michael Ryan Attendees Virtual SVP, Worldwide Value, Access, Payment & Heor Bristol-myers Squibb United States Dr. Ryan is the Senior Vice President and Head for U.S. and Worldwide Value, Access, Pricing and Health Economics and Outcomes Research for Bristol-Myers Squibb. In this role, Dr. Ryan is responsible for Strategic Payer Marketing, Pricing and Contracting, Real World Evidence Generation & Analytics, Access Clinical Development, Payer and Organized Customer Sales, Market Access Scientific Liaison Program, and Health Economics and Outcomes Research across the $42B BMS worldwide biopharmaceutical and biomarker portfolio. Dr. Ryan serves on a number of BMS executive leadership teams including the BMS Commercial Leadership Team, Digital Health Steering Committee, Commercial Innovation Strategy Team, Commercial Development Operating Committee, Business Development Steering Committee, Pipeline Steering Committee, and Portfolio Strategy Governance Team. Dr. Ryan also serves as the Chair for the National Pharmaceutical Council (NPC) and has served as the BMS board member on the Biotechnology Organization (BIO), National Pharmaceutical Council (NPC), and the University of Southern California Schaeffer Center for Health Policy. Prior to joining Bristol-Myers Squibb, Dr. Ryan spent 16 years at Amgen as the Vice President and General Manager of the Nephrology Business Unit for Amgen, where he was responsible for the P&L and life cycle management of Amgen’s three products used to treat patients with kidney disease; Epogen®, Aranesp® and Sensipar®.He also served as the Vice President and General Manager for Reimbursement, Value and Access, where he was responsible for all pricing, contracting, government price reporting, payer strategy and Value and Access Marketing across the $13B U.S. Amgen portfolio. Prior to Amgen, Dr. Ryan served as the Vice President, Department of Pharmacy, Center for Biomedical Informatics, and UPMC For Profit Operations at the University of Pittsburgh Medical Center. Dr. Ryan also served as Chairman, Department of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy, and he held affiliated faculty appointments with both the University of Pittsburgh School of Medicine, Department of Clinical Pharmacology, and the Center for Biomedical Informatics. Dr. Ryan is a graduate of the University of California at Los Angeles and the University of California at San Francisco, and completed his residency program at the University of Michigan. After completing his residency, Dr. Ryan directed all clinical pharmacy research, education and operations at University of Michigan Medical Center and College of Pharmacy. During his career, Dr. Ryan has been invited to present over 100 national platform presentations, and has over 40 refereed journal and textbook publications. The primary focus of Dr. Ryan’s research is U.S. health economics, biomedical informatics, and healthcare policy. Among his many and varied responsibilities, Dr. Ryan has led over 12 Pharmacy and Therapeutics Committees, implemented seven for-profit businesses, and served on numerous national health care committees and boards. Phone: 18054790848 Email: [email protected] 89

Attendees James Ryan In-Person Director of HTA Policy. Head of Oncology Health Economics and Payer Evidence AstraZeneca PLC United Kingdom Experienced economist and health economist with 25 years experience in the field of HTA. Currently responsible for HTA Policy for AstraZeneca, James also heads up a team of health economists accountable for the delivery of payer evidence requirements for HTA bodies around the world in AstraZeneca’s extensive oncology portfolio. Phone: +447557319740 Email: [email protected] Vasilisa Sazonov Virtual VACD Global Head Value, Access & TA Policy Strategy Novartis Pharma AG Switzerland I hold a Masters’ degree in Pharmacy from the University of Ljubljana, an MSc in Health Economics from the University of York and a PhD in Pharmaceutical Economics from Purdue University. I have worked in the Pharmaceutical Industry for 19 years, in a variety of senior access, pricing, health outcomes, commercial and customer solutions roles, across the product lifecycle and in a broad variety of therapy areas. I currently lead the Novartis VACD Global Access and Therapy Area Policy Strategy. Phone: +41792200757 Email: [email protected] Alicia Segrave Virtual Director Department of Health Australia Director, Medical Services &Technology Assessment Section, Office of Health Technology Assessment. Phone: +61262893983 Email: [email protected] 90

Aline Silveira Silva Attendees In-Person Patient Partner HTAi Interest Group for Patient & Citizen Involvement in HTA Canada Dr. Aline Silveira Silva is a researcher, independent patient advocate and patient partner at the Patient Voices Network, British Columbia, Canada. Aline is also a Steering Committee member of the Health Technology Assessment international Patient and Citizen Involvement Interest Group (HTAi PCIG) and co- leader of the HTAi PCIG project \"Stakeholders' Perspectives of Impact of Patient Involvement in HTA\". Phone: 16044011607 Email: [email protected] Twitter: @AlineSvSilva LinkedIn: linkedin.com/in/alinesilveirasilva/ Racho Strauven In-Person Sr Director Health Economics And Market Access Boston Scientific Switzerland Senior Director, EMEA at Boston Scientific with 20 years of experience in the pharma and medical device industry. Successful track record of driving evidence generation, reimbursement, market access and product commercialization. Held progressive global leadership roles in Europe, US, Asia Pacific and Latin America. Phone: +41798593128 Email: [email protected] LinkedIn: linkedin.com/in/racho-strauven-6100a22/ 91

Attendees David Strutton Virtual VP Outcomes Research MERCK CO INC United States David R Strutton, PhD, MPH is Vice President and Head of Global Pharmaceuticals in Merck’s the Center for Observational and Real-World Evidence (CORE). David’s organization has global responsibility for developing the integrated evidence strategy, including HTA/ reimbursement and overall real-world evidence strategies to support the value of in-line and pipeline global pharmaceutical assets, as well as to address the evidence needs of payers, health systems, and clinicians. The first decade of David’s career was spent as a health economics and outcomes research consultant to the pharmaceutical industry. Prior to Merck, David was Vice President for Vaccines Global Health and Value at Pfizer, responsible for research programs demonstrating the public health and economic value of Pfizer’s vaccines, and market access and pricing strategies that led to accelerated and sustained reimbursement for national immunization programs throughout the world. David received his BA from the University of Rochester, his MPH from The George Washington University, and his PhD in Health Economics from the Johns Hopkins University Bloomberg School of Public Health. David has had a faculty appointment at the Johns Hopkins University Bloomberg School of Public Health since 2005. Phone: 2673066710 Email: [email protected] LinkedIn: linkedin.com/in/david-strutton-1297524/ Jae Kyung Suh In-Person Associate Research Fellow National Evidence-based Healthcare Collaborating Agency South Korea Dr. Jae Kyung Suh received her Ph.D from the University of Southern California. She is an associate research fellow in National Evidence-based Healthcare Collaborating Agency (NECA) in Seoul, Korea. Her research interest includes economic evaluation, health technology assessment, and outcomes research. She is currently working on health technology re-assessment. Phone: 82-10-8887-8678 Email: [email protected] 92

Lonneke Timmers Attendees In-Person Strategic Advisor, Secretary SAB National Health Care Institute (Zorginstituut Nederland) Netherlands Lonneke Timmers works at the National Health Care Institute as the secretary of the scientific advisory board and as a strategic advisor. She is a pharmacist by training and founded the outpatient pharmacy in VU University Medical Center in Amsterdam where she worked as head of the pharmacy till 2013. She obtained her PhD in oncology. In the period 2013-2019 she worked at Menzis, a Dutch health insurance company. She was responsible for the procurement, policy and medical affairs on specialised (hospital) drugs. Nowadays, she focusses on future-proof management of the insurance package and she is involved in several (inter) national projects and programs concerning pricing and reimbursement of (innovative) care, registries, molecular diagnostics and appropriate use. Lonneke is co-chair of the DTF HTA of the Beneluxa Initiative. Phone: +31612038017 Email: [email protected] Rebecca Trowman Virtual Global Policy Forum Scientific Secretary HTA advisor for the medical services advisory committee MSAC Australia Rebecca is the Scientific Secretary for the HTAi Global Policy Forum. She also holds a position as HTA advisor for the Medical Services Advisory Committee in Australia. Rebecca has almost 20 years of HTA experience, ranging from academia, research institutes, government and HTA bodies in England (where she is from ) and Australia (where she now lives). Rebecca has been involved with HTAi for many years as a member and as a member of the Secretariat. Phone: +61451788259 Email: [email protected] 93

Attendees Sean Tunis In-Person Principal Rubix Health, LLC United States Sean Tunis, MD, MSc. is a Principal with Rubix Health where he consults with public and private sector organizations on health technology issues at the interface of regulatory and reimbursement policy, market access, comparative effectiveness, outcomes measurement and health technology assessment. He is also a Senior Fellow in the Tufts Center for the Evaluation of Value and Risk in Health and a Mentor-in-Residence at Johns Hopkins Tech Ventures. Phone: 4109638876 Email: [email protected] Twitter: @SeanTunis LinkedIn: linkedin.com/in/sean-tunis-8b36815 Joice Valentim Virtual Global HTA Strategy Lead ROCHE Pharma Switzerland Joice Valentim is Global HTA Strategy Lead, and prior Global Access Evidence Lead and Latin America HTA Lead, at Roche Pharma. Joice is responsible for the Global HTA Strategy, leading the organization towards an unified HTA position to partner with stakeholders for early, holistic and deliberative HTA, locally appropriate and innovation-ready. Joice represents Roche at efpia, CIRS, PhRMA, and HTAi, and for academia. For HTAi, currently collaborating with the HTAi GPF and HTAi Annual Meeting committees. Before, in the HTAi LA PF committee, ISPOR Industry Committee as LA president, and FIFARMA. She was an invited professor at the University of São Paulo (MBA HTA, Health Economics/FIPE), a reviewer of scientific journals and author of articles and abstracts on HTA and HE. Prior to Roche, she worked at Novartis, and universities in Brazil as professor and researcher, including projects for the Ministry of Health (HTA for inclusion of new vaccines into the National Immunization Program/PNI) and the National Regulatory Agency for Private Health Insurance and Plans (ANS) of Brazil, PAHO, IDB and the World Bank. Economist, Joice holds a master degree in Economics and a doctorate degree in Preventive Medicine from the University of São Paulo. Phone: +41795633832 Email: [email protected] LinkedIn: linkedin.com/in/joicevalentim-phd 94

Meghana Vijaysimha Attendees Virtual Program Associate Patient-centered Outcomes Research Institute (PCORI) United States Program Associate for the Research Synthesis and New Technology Department at Patient-Centered Outcomes Research Institute. Phone: 9739004022 Email: [email protected] Rosa Maria Vivanco-Hidalgo Virtual Head of Health Technology Assessment at AQuAS Agency For Health Quality And Assessment of Catalonia (AQuAS) Spain MD, PhD MPH, Head of Health Technology Assessment at AQuAS. Phone: 0034634695848 Email: [email protected] Franz Waibel In-Person Senior Advisor Independent Consultant Switzerland Dr. Franz Waibel serves as HTAi Board Director since July 2020. He is member of HTAi since 2005. He chairs the Business Development Committee and is a member of the Finance & Audit Committee. He has engaged over many years in the Global Policy Forum and the Patient and Citizen Involvement Interest Group (PCIG). He has over 30 years of experience in the field of value assessment of medicines and medical products and has been involved in HTA matters throughout his career. He worked for over 25 years in leading BioPharma companies at locations in Europe and the US and in global leadership roles in the fields of patient access, public affairs and policy. Since 2014, he provides services as an independent strategic advisor and consultant on strategic matters in the healthcare & life sciences business. He also engages in investment and innovation promotion for the Basel Area, Switzerland, where he resides with his family. He is passionate about strengthening patient involvement in HTA and Healthcare, keen to further multi- stakeholder dialogues and engages in healthcare system and HTA policy matters across many jurisdictions worldwide. Franz Waibel holds a a PhD in Cell Biology from Basel University, Switzerland, an MBA from Birmingham University, UK and a BS from Freiburg University, Germany. He holds Swiss and German citizenships. Phone: +41795454458 Email: [email protected] 95

Attendees Tatia Woodward Virtual Vice President, Value & Evidence Strategy Pfizer United States Tatia is passionate about improving patient lives through meaningful outcomes and sustainable patient- centered market access policies. With over 15 years of experience, Tatia has held leadership roles in market access, health economics, and outcomes research in biopharmaceutical organizations and consultancies. She has successfully led matrix teams to demonstrate product value across multiple therapeutic areas (i.e., respiratory, autoimmunity, and immuno-oncology therapeutic areas), resulting in orphan drug designations, accelerated patient access and reimbursement in US and EU5. Phone: 443-771-4524 Email: [email protected] 96



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