3 EVENTS IN ONE: - Medical Devices Payers’ Perspectives - Market Access for Medical Devices in Established Markets - Market Access for Medical Devices in Emerging Markets Hear keynote presentations from the experts: Dr. Geoff Wilson, Head of Health Economics & Reimbursement EMEA, GE Healthcare, UK Dr. Stephen Stefani , President, ISPOR, Chair of Health Care Policy makers & Payers Committee, ISPOR Latin America Consortium, Coordinator of the Oncology Unit, UNIMED, Brazil Professor Stefano Capri, Head HTA committee of the Lombardy Region, Italy David W. Watson, Ph.D., Vice President of European Operations ECRI Institute - USA Paula Polman Coordinator, Dutch Health Care Insurance Board (CVZ) Netherlands Market and Patient Access Challenges for Medical Technology Manufacturers whilst Containing Costs and Maximising Health Outcomes. for M l l & more than 35 expert medical device speakers
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3 E V E N T S I N O N E :
- M e d i c a l D e v i c e s P a y e r s ’ Pe r s p e c t i v e s
- M a r k e t A c c e s s f o r M e d i c a l D e v i c e s i n E s t a b l i s h e d M a r k e t s
- M a r k e t A c c e s s f o r M e d i c a l D e v i c e s i n E m e r g i n g M a r k e t s
H e a r k e y n o t e p r e s e n t a t i o n s f r o m t h e e x p e r t s : Dr. Geoff Wilson, H e a d o f H e a l t h E c o n o m i c s & R e i m b u r s e m e n t E M E A , G E H e a l t h c a r e , U K
Dr. Stephen Stefani, P r e s i d e n t , I S P O R , C h a i r o f H e a l t h C a r e Po l i c y m a k e r s & P a y e r s C o m m i t t e e , I S P O R L a t i n A m e r i c a C o n s o r t i u m , C o o r d i n a t o r o f t h e O n c o l o g y U n i t , U N I M E D, B r a z i l
P ro f e s s o r S t e f a n o C a p ri , H e a d H TA c o m m i t t e e o f t h e L o m b a r d y R e g i o n , I t a l y
D a v i d W. Wa t s o n , P h . D . , V i c e P r e s i d e n t o f E u r o p e a n O p e r a t i o n s E C R I I n s t i t u t e - U S A
Pa u l a Po l m a n C o o r d i n a t o r, D u t c h H e a l t h C a r e I n s u r a n c e B o a r d ( C V Z ) N e t h e r l a n d s
M a r k e t a n d P a t i e n t A c c e s s C h a l l e n g e s f o r M e d i c a l Te c h n o l o g y M a n u f a c t u r e r s w h i l s t C o n t a i n i n g C o s t s a n d M a x i m i s i n g H e a l t h O u t c o m e s .
f o r M ll
Eurostars Hotel, Berlin
& more than 35 expert medicaldevice speakers
Day One – 28th November, 2012: International Medical Device Payer & HTA Forum Policy challenges to contain costs and maximise health outcomes
Global healthcare systems are evolving daily. At a time of increased health economic reform, ageing populations and budget austerity, leaders in medical technology look to achieve optimal market access and commercialization of their products. As payers worldwide demand more value for money, the importance of achieving patient access by demonstrating cost effectiveness and enhanced health outcomes is of the utmost importance.With payers in both developed and developing countries under extreme budgetary pressure, we will provide a platform for attendees to examine how health technologies are assessed, tough decisions are made and how we define “value”. This exclusive forum is the opportunity to meet and network with a broad spectrum of senior representatives who wish to encourage innovation whilst managing a limited budget.
Day Two – 29th November, 2012: Medical Device Market Access Strategies in Advanced Markets Challenges to access for medical technology manufacturers in leading markets
In the developed markets, significant changes to the regulatory processes for bringing medical devices to market are being considered. With budget pressures forcing companies to be innovative and efficient, medical device manufacturers must adhere to best practices in planning, development and manufacturing of next generation health technologies in order to attain market access. Demonstrating value to HTA agencies and payers has never been more important to medical device manufacturers and in Berlin we will present strategies for creating compliant medical devices and bringing products to market faster. Uniquely this event will be the only medical device meeting looking at the specific requirements in 3 main product areas; surgical devices & implants, imaging & capital equipment and in-vitro diagnostics.
Day Three – 30th November, 2012: Medical Device Market Access Strategies in Emerging Markets Meeting the needs of payers to achieve emerging market access in the MedTech Arena
Health technology device companies are increasingly turning to emerging markets to accelerate growth. Budget cuts, ageing populations and an emerging middle class have resulted in opportunities and challenges for medical device manufacturers entering emerging markets. The primary risks and challenges vary from market to market and present a complex playing field for medical device companies. Companies that lack a well-planned emerging market chain strategy are at risk of ending up with limited growth and profitability. Manufacturers with extensive emerging market experience will present case-study examples of successful market-penetration strategies and explore the real potential for further growth.
Who Will Benefit:Device manufacturers & distributors: Marketing, Market-access, Business Development, Country Managers, Health Economics, Pricing & Reimbursement, Government & Stakeholder Relations, Regulatory Affairs
StakeholdersHealth Plans & Insurers, Payers, Health Technology Assessors, Hospitals, Health Ministry, Regulatory Agencies, Independent Health Economists, Academics, Physicians and Patient Groups
Solution providers & consultants CEOs, Business Development, Senior Consultants, Global and Regional Heads, Independent Academics, Health Economists, Public & Private Healthcare Providers, Senior Doctors & Patient Representatives
PAGE ONE
DAY 1
AM
DAY 2 DAY3
International Medical Device Payers & HTA Forum
Market Access Strategies in Established Markets
Market Access Strategies in Emerging Markets
PM
STREAM 1 STREAM 2 STREAM 3
Surgical Devices, Interventions & Implants
Imaging & Capital Equipment
In- Vitro Diagnostics
Event Structure:
EventOver v iew
IndustryMartin BraeckleinHead of technical consortium: Partnership for the HeartRobert Bosch Healthcare GmbH, Germany
Robert DownesMember of the BoardGetemed, Germany
William GartnerCEOProvista Life Sciences, USA
Dr. Geoff WilsonHead of Health Economics & Reimbursement EMEAGE Healthcare, UK
Syed RashidDirector of Health Economics & Reimbursement, EMEAKCI Medical, UK
Andrea ZanellaCountry General Manager – Italy/GreeceBecton Dickinson, Italy
Carolin Miltenburger, PhDSenior Director Global Health Economics & Reimbursement - Spine & Biologics Medtronic, Switzerland
Nava Barit Ben-DavidBusiness Development & HE&R DirectorJohnson & Johnson, Israel
Giulio PianaDirector of International Marketing - Peripheral Intervention StentsBoston Scientific, Italy
Payers & HTAsDr. Iñaki Gutiérrez-IbarluzeaKnowledge ManagerOsteba, The Basque Office of HTA
Prof. Thomas PenzelHead of Sleep CentreCharite, Germany
Academics & Solution Providers
Csaba DozsaAssociate ProfessorUniversity of MiskolcHungary
Prof. Dr. med. Dr. rer. pol. Christian ThielscherPrincipal HEORIMS Health, Germany
Dr. Vince S. ThomasPrincipal Consultant - Healthcare Asset Valuation, Market Access & Strategic, EpidemiologyV.S. Thomas Global Health Strategy Consulting, Switzerland
IndustryMustafa KaramizrakGeneral ManagerSynthes, Turkey
Dr. Alexander NatzSecretary GeneralEuropean Confederation ofPharmaceutical Entrepreneurs (EUCOPE)
Carolin Miltenburger, PhD, Senior Director Global Health Economics & ReimbursementSpine & BiologicsMedtronic
Payers
Dr. Filiz CevirmeGeneral DirectorPrivate Hospitals and Healthcare Organisations Association (OHSAD), Turkey
Juozas GaldikasDirectorState Health Care Accreditation Agency, Lithuania
Guillermo MelendezScientific CoordinatorMexican Health FoundationMexico
Dr. Stephen StefaniPresident, ISPORChair of Health Care Policymakers & Payers Committee, ISPOR Latin America Consortium, Coordinator of the Oncology Unit, UNIMED, Brazil
Siniša Tomić, PhDAdvisor for EU Affairs Croatian Agency for Medicinal Products and Medical Devices
Solution Provider
Betty SuVice PresidentBoston Healthcare Associates, China
PAGE TWO
SpeakerPanel
Day 1 Day 2 Day 3Payers & HTA Forum Advanced Markets Emerging Markets
Payers & HTAsProfessor Stefano CapriHeadHTA committee of the Lombardy Region, Italy
John GraylandSenior Strategy and Redesign Manager, Long Term ConditionsNHS, UK
David W. Watson, Ph.DVice President of European OperationsECRI Institute – USA
Paula PolmanCoordinator, Dutch Health Care Insurance Board (CVZ)Netherlands
Ad SchuurmanHead of Business Contact Centre and International AffairsCVZ, Netherlands
Lorenzo TerranovaDirectorThe Italian Federation of Public Health Enterprises and Hospitals (FIASO), Italy
Academics & Solution Providers
Gijs Hubben, PhDChief Executive OfficerBaseCase
28th November, 2012
International Medical Device Payer & HTA Forum
Policy challenges to contain costs and maximise health outcomes
DAY 1
19:30 - Exclusive Complimentary Networking Dinner for all event participantsPAGE THREE
THE EVOLVING ROLE OF HTAs IN THE PROVISION OF ACCESS TO INNOVATIVE HEALTHCARE
09.10 What is the current state of play with HTA across Europe?
❖ HTA defined. ❖ Current status for HTA in Europe specifically for medical devices and diagnostics. ❖ Current issues with HTAs and some (possible) solutions. ❖ Beyond HTA: Communicating value.
Dr. Geoff Wilson, Head of Health Economics & Reimbursement EMEAGE Healthcare, UK
09.50 Health technology forecasting and the assessment of innovative health technologies
❖ Horizon scanning and health technologies. ❖ Innovative technology assessment. ❖ Medical device evaluation.
David W. Watson, Ph.D., Vice President of European Operations ECRI Institute - USA
NEW MEDICAL DEVICE & IVD REGULATIONS
10.30 Overview of the current and proposed EU regulation of medical devices & IVDs
❖ Overview of the Commission proposals. ❖ Impact on companion diagnostics. ❖ The new classification systems. ❖ Orally administered medical devices under the new system. ❖ Unique Device Identifier.
Dr. Alexander Natz, Secretary GeneralEuropean Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
EXPERIENCES WITH RISK-SHARING & ALTERNATIVE PRICING SCHEMES
11.00 Networking & Coffee Session
11.30 Medical devices: Assessment for reimbursement
Outpatient ❖ List of product categories. ❖ Assessment by CVZ
Paula Polman Coordinator at Dutch Health Care Insurance Board (CVZ)
Hospital ❖ Assessment expensive medicinal products: therapeutic value and cost
effectiveness. ❖ Innovative products.
Ad Schuurman, Head of Business Contact Centre and International AffairsCVZ, Netherlands
COMMUNICATING CRITERIA FOR PRIORITSING AND JUSTIFYING CAPITAL EXPENDITURES WITH LIMITED
BUDGET
12.10 Integrating evidence into the pricing and reimbursement decision making process for medical devices
❖ Description of agency’s responsibilities and co-operations with regional and country-wide health authorities.
❖ Format for health technology rapid assessment and comparative effectiveness. ❖ Examples of medical technologies that have effectively integrated evidence into
the pricing & reimbursement decision making process.
Professor Stefano Capri, HeadHTA committee of the Lombardy Region, Italy
12.50 Luncheon Break
14.20 Case-Study: Communicating economic value to healthcare providers - delivering tailored value messages across markets in an understandable format
❖ The challenges of effective value communication. ❖ How to deliver a tailored value story for different customers and ❖ customer segments. ❖ How can HQ provide effective support to countries.
Carolin Miltenburger, PhD,Senior Director Global Health Economics & Reimbursement Spine & BiologicsMedtronic
Gijs Hubben, PhDChief Executive OfficerBaseCase
15.00 Dealing with an increased demand for HTA in medical devices
❖ Context for HTA in medical devices. ❖ International experience / European perspective. ❖ Example of local HTA in medical device. ❖ Challenges and opportunities.
Martin Visnansky, Co-founderSLOVAHTA, Slovakia
15.40 Networking & Coffee Session
16.00 How to control the development of new health technology products; controlling and evaluating supply
❖ Establishing predetermined standards for medical devices. ❖ Innovative formats for measuring performance.
Lorenzo TerranovaDirectorThe Italian Federation of Public Health Enterprises and Hospitals (FIASO), Italy
16.40 Evaluating telehealth & telemonitoring schemes
❖ The commissioning of telehealth services for patients with long term conditions ❖ Methods of evaluating the cost effectiveness of each scheme ❖ Why there is a strong case for future investment in telemonitoring schemes?
John Grayland, Senior Strategy and Redesign Manager, Long Term ConditionsNHS, UK
17:20 Panel Discussion: An evaluation of health economic evaluations in different countries
❖ What are the large differences in payer expectations? ❖ How do we face the current methodological challenges when dealing with high
tech requirements? ❖ What are the pitfalls of health economic evaluations? How have some messages
failed in the past?
Professor Stefano Capri, Head, HTA committee of the Lombardy Region, Italy
Dr. Geoff Wilson, Head of Health Economics & Reimbursement EMEA, GE Healthcare, UK
17.50 Chairperson’s closing remarks 18.00 End of day
HTA
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19:30 - Exclusive Complimentary Networking Dinner for all event participants
Medical Device Market Access Strategies in Advanced Markets
Challenges to access for medical technology manufacturers in leading markets
MARKET ACCESS DRIVERS & MODELS
09.10 Developing Market-driven Strategies in Mature Markets
❖ Choosing where to compete ❖ Deciding how to compete ❖ Gaining access to market
Giulio PianaDirector of International Marketing - Peripheral Intervention StentsBoston Scientific, Italy
09.50 How states are moving ahead to translate HTA into new medical policies
❖ Establishing mechanisms for translating HTA results more actively. ❖ Recommendations that guide public and private insurers. ❖ International review of key healthcare reforms. ❖ The evolving role of post licensing appraisal within the medtech sector.
Csaba Dozsa, Associate Professor,University of Miskolc, Hungary
10.30 Networking & Coffee Session
11.10 An HTA bodies industry perspective on 510(k) and CE Marking
❖ Anticipated changes in laws governing medical devices. ❖ Similarities and differences between the regulatory procedures
governing medical devices in the US and EU. ❖ What to do after receiving a warning letter? Prompt and convincing
replies.
Dr. Iñaki Gutiérrez-Ibarluzea, Knowledge Manager, Osteba, The Basque Office of HTA
11.50 Evidence-based medicine and real-world evidence: Lessons pharma co’s had to learn in the past and medical device companies need to deal with in the future
❖ In the last years, pharma companies experienced significant changes in their environment.
❖ Pharma companies developed strategies to cope with new external requirements and organisational challenges.
❖ Medical device industry is likely to experience similar developments in the next years thus should look into their pharmaceutical peers’ solutions.
Prof. Dr. med. Dr. rer. pol. Christian Thielscher, Principal HEOR, IMS Health, Germany
12.30 Luncheon Break
13.30 Sleep medicine – an expanding opportunity
❖ An analysis of market access strategies in new medical devices.
Prof. Thomas Penzel, Head of Sleep Centre, Charite, Germany
14.10 Companion Diagnostics: Strategic Considerations for Maximizing Value-Based Positioning
❖ The real and potential monetary value assigned to diagnostic. ❖ Meeting the increasing manufacturing demands to employ stratifying
mechanisms that identify patients most likely to benefit. ❖ How payers evaluate diagnostics, as well as their willingness-to-pay and
evolving concerns with diagnostics. ❖ Examining methods for demonstrating how a diagnostic can contribute
to the identification of appropriate patients; and the various considera-tions.
Dr. Vince S. ThomasPrincipal Consultant - Healthcare Asset Valuation, Market Access & Strategic, EpidemiologyV.S. Thomas Global Health Strategy Consulting, Switzerland
14.50 Chairperson’s closing remarks
DAY 229th November, 2012
PAGE FOUR
Choose your afternoon stream for our product-specific focused case-study sessions:
STREAM 1Surgical Devices, Interventions & ImplantsSTREAM 2
Imaging & Capital Equipment
STREAM 3
In-vitro Diagnostics
PAGE FIVE
DAY 229th November, 2012
Medical Device Market Access Strategies in Advanced Markets
Challenges to access for medical technology manufacturers in leading markets
STREAM 1Surgical Devices, Interventions & Implants15.10
Achieving market access through certifications: An introduction to CE Marking for surgical devices
Syed RashidDirector of Health Economics & Reimbursement, EMEA, KCI Medical, UK
15.45
The combined approach of push & pull market access for surgical devices
Nava Barit Ben-DavidBusiness Development & HE&R DirectorJohnson & Johnson, Israel
16.20 Networking & Coffee Break
16.45 Panel Discussion
Choosing a business model which shows an ROI for payers
• Achieving greater penetration into hospital and clinical settings.
• Ethical training and retention practices of surgeons and KOLs.
Nava Barit Ben-David, Johnson & Johnson, Israel
Syed Rashid, Director of Health Economics & Reimbursement, EMEA, KCI Medical, UK
17.35 End of day
STREAM 2Imaging & Capital Equipment
15.10
Building an effective design and process validation program for capital equipment in order to successfully achieve market access
Claudia VolenikMarketing Director Infusion Devices & Consumables EMEA, Hospira - UK
15.45
New models of evidence generation for payers & regulators
Martin BraeckleinHead of technical consortium Partnership for the Heart; Business Development Bosch HealthcareRobert Bosch Healthcare GmbH, Germany
16.20 Networking & Coffee Break
16.45 Panel Discussion
Methods of engagement with doctors & practitioners
• Demonstrating the increased value of innovations in imaging devices.
• Where can the industry better work with the tendering process?
• Future business models for capital equipment manufacturers (e.g. hospital partnerships).
Dr. Geoff Wilson, GE HealthcareMartin Braecklein, Bosch HealthcareClaudia Volenik, Hospira - UK
17.35 End of day
STREAM 3In-vitro Diagnostics
15.10
Tackling the increasing international challenges in compliance for IVD products and how this impacts market entry
William GartnerCEOProvista Life Sciences, USA
15.45
Learn best practices of protocol and report writing – Target Groups, ECG Technology, Analysis tools, Telemonitoring & Data transmission
Robert DownesMember of the BoardGetemed, Germany
16.20 Networking & Coffee Break
16.45 Panel Discussion
Marketing & commercial models for diagnostics
• What do manufacturers need to know when submitting marketing authorisations for CDx products?
Andrea Zanella, BDRobert Downes, GetemedWilliam Gartner, Provista
17.35 End of day
PAGE SIX
NEW MARKET STRATEGIES: HURDLES WITHIN THE HEALTH TECHNOLOGY INDUSTRY
09.10 An evaluation of health economic evaluations in different countries
❖ How important is emerging market growth for medical device companies?
❖ What countries and regions are the highest priorities? ❖ The current theory? Drugs first then devices. ❖ The emerging middle class in high growth markets. ❖ What innovative products do developing nations really need when
budgets are limited? “Rolls Royce” treatment or a “Hyundai”?
Dr. Stephen Stefani, President, ISPORChair of Health Care Policymakers & Payers Committee, ISPOR Latin America Consortium, Coordinator of the Oncology Unit, UNIMED, Brazil
09.50 Case Study: Hospitals and healthcare organisations in Turkey
❖ The market by numbers. ❖ Hospital products – how to understand the needs of local decision makers
(hospitals).
Dr. Filiz Cevirme, General DirectorOHSAD, Turkey
10.30 Panel Discussion: The main obstacles in launching a medical device in an emerging market and achieving commercial access
❖ Slow registration processes and domestic specific protocols. ❖ The increasing investment of domestic companies. ❖ The struggle to keep pace with increasing health care access outside of major
cities. ❖ The challenge of local distributors and agents.
Stephen Stefani, Professor, ISPOR, BrazilDr. Filiz Cevirme, General Director, OHSAD, Turkey
11.00 Networking & Coffee Session
FUTURE AND GLOBAL CHALLENGES TO REGULATORY COMPLIANCE
11.30 Regulatory & Reimbursement Uncertainty
❖ Overcoming inefficient regulation and registration processes. ❖ Complex tendering processes. ❖ The challenge of pricing controls. ❖ Working with local suppliers in order to influence panel experts
Juozas Galdikas, Director, State Health Care Accreditation Agency, Lithuania
12.10 Challenges of bringing a device product into the China market
❖ Understanding the context: An overview of China’s healthcare system. ❖ The market access challenges with a focus on regulatory, pricing &
reimbursement. ❖ Implications for the industry players. ❖ Contemporary trends and future prospect.
Betty Su, Vice PresidentBoston Healthcare Associates, China
12.50 Luncheon Break
14.20 Medical device regulation in an EU candidate country - adjusting market access strategies in times of on-going reform and health system modernization?
❖ What evolving healthcare reform means for health technology manufacturers looking to enter new markets?
❖ What type of device is the priority within limited budgets?
Siniša Tomić, PhD, Advisor for EU Affairs, Croatian Agency for Medicinal Products and Medical Devices
CHALLENGES FOR MANUFACTURERS IN GAINING MARKET ACCESS
14.55 Case Study: Achieving market access for medical devices in Turkey
❖ Acquiring a distributor or starting up a fresh company? ❖ Turkish medical device market outlook: An overview of companies, growth
potential and macroeconomics of the country. ❖ The development of Turkish health systems and the 5 year outlook. ❖ Reimbursement models, the pilot project on establishing DRG system.
Mustafa Karamizrak, General Manager, Synthes, Turkey
15.30 Networking & Coffee Break
16.00 Case study: Medical devices HTA and approval in Latin America
Guillermo Melendez, Scientific CoordinatorMexican Health Foundation, Mexico
16.40 Panel Discussion: Bringing your innovative device to the market – What you need to know?
❖ How to leverage data and information from submissions? ❖ How can medical manufacturers improve communication with government? ❖ What are the strategies that should be followed to develop a sustainable
regulatory framework that ensures safety and promotes innovation?
Guillermo Melendez, Scientific CoordinatorMexican Health Foundation, Mexico
Mustafa Karamizrak, General ManagerSynthes, Turkey
17.10 Chairperson’s closing remarks
17.20 End of day
Market Access Strategies in Emerging Markets Meeting the needs of payers to achieve emerging market access in the MedTech Arena
DAY 330th November, 2012
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PAGE SEVEN
EventPar tner s & Networ k ing
Are you interested in presenting your company products and services to this senior-level audience? If so please contact: [email protected] Our team will be happy to tailor a package to suit your needs and get you the optimal level of exposure!
Thanks to our event partners:
NetworkingThe Medical Devices Leaders Forum will provide all delegates the chance to meet one another through our many networking opportunities. With pre-event, mid-morning and mid-afternoon breaks as a standard, this event will also feature a complimentary networking dinner for all participants. This evening will allow you to meet with our expert speaker panel who represent many stakeholder groups in a less formal setting. Our networking lunches will also allow you plenty of time to meet with your peers and colleagues whilst you refuel through the event.
Event Partners
Media Partners
Logo Partner
Professor Stefano Capri, Institute of Economics, Cattaneo – LIUC University, Member of HTA committee of the Lombardy Region, ItalyProf. Stefano Capri is Senior Research Fellow on Health Economics at Cattaneo University-LIUC, Castellanza (VA), Institute of Economics. He holds a position of Adjunct Professor of Economics and Industrial Economics. He has been involved for many years in economic analysis of health care systems and economic evaluations of health care programmes and technology assessment for pharmaceutical companies and Public Authorities (Ministry of Health, Ministry of Economy, Regional Health Authorities). He was educated at Bocconi University, Milan, in Economic and Social Disciplines, and at University of York, UK (Health Economics). He has been recently appointed as member of the HTA Board (Health Technology Assessment) of the Lombardy Health Authority. Stefano Capri is author of about 100 scientific publications and 8 books. He has a specific interest in and publishes on drug pricing and risk sharing agreements, and on HTA methods and studies. He also worked on developing the Italian guidelines for economic evaluations as recommended by the Italian Group of Pharmacoeconomic Studies and by AIES (Italian Association of Health Economics).
Robert Downes, Member of the Board, Getemed, GermanyRobert Downes, born 1963 in Dublin, Ireland, began his career with GETEMED Medizin - und Informationstechnik AG in 1987 as a hardware developer after completing his electrical engineering studies in Dublin. In 1996 he took over the responsibility of the product development department and joined the Board of Directors in April 2010. He also has a B.Sc.(Eng.), M.Sc.
Csaba Dozsa, Associate Professor, University of Miskolc HungaryCsaba Dózsa was born on 27th May 1969 in Vác, Hungary. He obtained his degree in economics in 1994 at the Budapest University of Economic Sciences on the Faculty of Social Sciences with speciality on Social Policy and Planning.From 1997 to 1999 he was continuing postgraduate studies by the mean of a World Bank scholarship (Universidad de Barcelona y Pompeu Fabra, Barcelona) in the field of health economics and obtained a master degree in health economics (Máster en Economía de la Salud). He is an honorary associate professor at the Corvinus University of Budapest, currently he is taking part in the Doctoral Program of the Faculty of Economics.From 1994 to May 2005 he worked for the National Health Insurance Fund Administration, where he was the Deputy Director General for Health Policy and Health Care from June 2002. Then he worked for the Ministry of Health as the Deputy Secretary of State for Economic and Strategic Affairs and led the planning of the health care and health industry programs of the National Development Plan.Since June 2006 he has been the executive director of the Med-Econ Ltd., which main profiles are: project management, organization development consulting, planning and management of EU projects and programs.
Juozas Galdikas, Director, State Health Care Accreditation Agency, LithuaniaIn 1983 Juozas got a doctorate from the Faculty of Medicine at Vilnius University. He was Professor at the Clinic for Vascular Surgery at the same university. From 1995 through to 1996 he was Head of Health Care, Sanitation and Hygiene Division of the Vilnius municipality and in 1996 he became a Member of the Parliament for The Republic of Lithuania. He was Minister of Health of the Republic of Lithuania before taking over as Director of the State Health Care Accreditation Agency under the Ministry of Health.In the past he has prepared amendments to the laws, needed for the introducing of the Compulsory Health Insurance and in 1997 started the reformation of Lithuanian Health system from Semashko model (centralization of management and financing of health system) to Bismark model (insurance based health system with the principles of solidarity, accessibility and equity
William Gartner, CEO, Provista Life Sciences, USAMr. Gartner has 20 issued patents and more than 35 years’ experience in the environmental and medical fields, with an extensive history of product development, operational oversight, corporate acquisitions and technology transfer. He founded Gartner Research & Development Company, which offered contract product development services and licenses of its own patented products. As a branch of Gartner R&D, he created a water and wastewater testing laboratory, which successfully grew into a national multimillion-dollar network of environmental labs. Mr. Gartner sold Gartner R&D to the Ocean Group, which later became the largest network of labs in the United States. He then acquired a small laboratory in Phoenix, which he grew to five locations in four states with nearly 200 employees and a full-scale radiochemistry lab. Mr. Gartner’s patents range from water purification units to a self-test for Alzheimer’s disease.
Martin Visnansky, Co-founder, SLOVAHTA, SlovakiaMartin Visnansky is a co-founder of the Slovak Agency for HTA (SLOVAHTA). He has earned his MSc in Clinical Pharmacy, PharmD in Pharmaceutical Management and PhD in Corporate Management from Comenius University, Bratislava, Slovakia. On top of that he has obtained MBA from the University of Pittsburgh, USA and MSc in HTA & Health Management from Universita Cattolica, Roma, Italy (the Ulysses Program). He has more than 15 years of management consulting experience in healthcare and pharmaceuticals, working for pharma (Novartis, Boehringer and Chiesi), private equity groups and the Government. He has served as an advisor to three Ministers of Health for drug policies and pharmacoeconomics. Co-founder of the Slovak Pharmacoeconomic Society, ISPOR Local Chapter Slovakia past-president, chairman of the Board in the Slovak Association of Pharma Companies.
Prof. Dr. med. Dr. rer. pol. Christian ThielscherChristian Thielscher studied medicine at the university hospital in Bonn and economics at Hagen and Frankfurt University. He earned a PhD in both professions, worked as a physician for 5 years and as McKinsey consultant for 6 years. He conducted several strategy projects mainly in the healthcare sector. His work included portfolio analyses and the restructuring of pharmaceutical companies, and managed care projects for statutory health insurers. He also established one of the first German disease management projects and restructured a DAX beverage company. Christian then co-founded GHX Europe and worked as a consultant on a series of projects including the development of a cooperative patient- and healthcare provider-friendly concept for the ‘health card’, the development of the first German internet-based hospital guide and the repositioning of a major bank in the healthcare sector. He was also in charge of an R&D department which developed innovative products for the public health sector.Christian is founding president of the DGFM e. V. and a member of several other scientific associations. His current research interests include quality in medicine and healthcare business management. He is editor of the leading German textbook on medical economics, ‘Medizinökonomie’. Christian is a Professor of Health Economics at the FOM University of Economics and Management. Since January 2012, he manages IMS Health’s German Health Economics and Outcomes research (HEOR) department.
Dr. Alexander Natz, Secretary GeneralEuropean Confederation of Pharmaceutical Entrepreneurs (EUCOPE)Dr. Natz is Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (www.eucope.org). He is also heading the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer with Sträter Law Firm in Germany and also worked in the pharmaceutical industry. As a research assistant at Duke University (USA) he has dealt with international pharmaceutical law. He wrote his PhD on pricing and reimbursement law in Germany with the former judge at the European Court of Justice Professor Ulrich Everling. PAGE EIGHT
SpeakerBiogr aph ies
PAGE SEVEN
Dr. Iñaki Gutiérrez-Ibarluzea, Knowledge Manager, Osteba, The Basque Office of HTAIñaki Gutiérrez-Ibarluzea BSc, MSc, PhD is the Knowledge Manager and Coordinator of the early awareness and alert system of Osteba, the Basque Office for HTA. He is member of the HTAi ISG on information resources, the HTAi ISG group on Membership and dissemination and chairs the HTAi-ISG on disinvestment of technologies of low-added value. He has been collaborating in different European Union funded projects such as: InnoHTA, EunetHTA, PHGEN I and II and Health ClusterNet playing different roles. He is also coordinating different projects at the Spanish level such as: GENTecS or Information resources group. He is currently the chairman of EuroScan, the International Network for the identification and assessment of new and emerging health technologies. He is also professor at the Nursing School of the Basque Health Service Osakidetza and collaborates with the University of the Basque Country and the University Oberta of Catalonia in different academic activities. He was actively involved in the e-text on HTA promoted by the ISG on information resources and in the development of the HTAi vortal on information resources. At the Spanish level he coordinates the Spanish Group of Agencies for the Identification and assessment of new and emerging technologies and is member of the groups for the assessment of obsolete technologies and the development of post-introduction systems for the assessment of health technologies leaded by the Galician Agency (Avalia-T).
Paula Polman, Coordinator, Dutch Health Care Insurance Board (CVZ), NetherlandsPaula Polman completed her study in Utrecht as a social psychologist in 1977. She subsequently worked for five years as advisor for a regional organisation for women’s health and welfare. In the following years, as advisor of the Ministry of Health, she developed the governmental policy on prevention of child abuse and sexual violence and the assistance for victims. After 5 years she switched to another topic. The innovation of the mental health care sector in the direction of a more client centered approach became her responsibility at the Ministry. In the meantime she completed studies on public health (MPH). In 2000 she became head of the Reimbursement Department for long term care of the Dutch Health Care Insurance Board (CVZ). Since 2004 Paula is Coordinator of the Reimbursement Department for medical procedures, medical devices, paramedics and dental health care.
Ad Schuurman, Head of Business Contact Centre and International Affairs, CVZ, NetherlandsAd Schuurman completed his study in Utrecht as a clinical psychologist in 1980. He subsequently worked for five years as head of a patients’ association. In the following years, as staff officer of a regional Institute for Mental Health, he organized the cooperation the Regional Institutes for Mental Health and the other healthcare organisations. After spending several years as manager of the national project relating to pharmacotherapeutic dicisionmaking, he became head of a geriatric department. In the meantime he completed studies on management consultancy and on business administration (MBA). As deputy director of the Dutch College of General Practitioners (NHG), he set up the Electronic Prescription System. In recent years, as manager of the Pharmacy department, he was responsible for the pharmacy-related activities of the CVZ. Since 2006 he was head of the Reimbursement Department, covering the heathcare reimbursement issues in the Netherlands. In 2006 he became President of the Medical Evaluation Committee (MEDEV) in Brussels, in which reimbursement authorities of 18 EU countries cooperate. Since 2010 is Ad is Head of Business Contactcentre and International Affairs of the Dutch Health Care Insurance Board (CVZ).
Dr. Stephen Stefani, President, ISPOR, Chair of Health Care Policymakers & Payers Committee, ISPOR Latin America Consortium, Coordinator of the Oncology Unit, UNIMED, BrazilStephen graduated from the Universidade Federal do Rio Grande do Sul Medical School, in Brazil, in 1994. He was clinically trained in Internal Medicine and Clinical Oncology by the Hospital de Clinicas de Porto Alegre and attended the University of California San Francisco, as a clinical fellow. Holding an MBA in health business, he is a professor of a post-graduation course with the Fundação Universidade UNIMED and Escola Superior de Gestão e Ciências da Saúde. Dr. Stefani also serves as a regular consultant for the major private health insurance company in Brazil, with over 70 companies in his portfolio. Currently he is the Coordinator of the Oncologic Drugs Benefits Program of CAPESESP (self-financed insurance linked to Ministry of Health) and Coordinator of the Oncology Unit of UNIMED (with 11 million people covered). He is the author or co-author of over 50 national and international arbitrated journals and chapters of books about oncology, medical audit and pharmacoeconomics and has have presented more than 150 lectures. His work in pharmacoeconomics is focused on cancer related therapy. He is also the founder of the ISPOR Brazilian Chapter and Chair of the ISPOR Latin America Health Care Policymakers & Payers Committee.
Siniša Tomić, PhD, Advisor for EU Affairs, Croatian Agency for Medicinal Products and Medical DevicesSiniša Tomić is Head of the Croatian Agency for Medicinal Products and Medical Devices and adjunct associate professor at the University of Split. He studied medical biochemistry at the University of Zagreb, Croatia and received his Ph.D. in Biochemistry at the Friedrich Schiller University of Jena, Germany, in 1996. From 1996 to 1999 he was postdoc in pharmaceutical biotechnology at the National Research Council of Canada and McGill University in Montréal. He was awarded a Max Planck Society Fellow and Canadian Government Visiting Fellowship.In 1999 he is back to Zagreb and worked at the Ministry for European Integration and in he 2001 moved to Rijeka and worked for JGL Ltd. where he gained experience in generic industry. In 2003 he took over as head of the newly established Agency. Professor Tomić teaches regulatory affairs and pharmaceutical marketing at three Croatian universities and presides over the Regulatory section of the Croatian Pharmaceutical Society.
Dr. Geoff Wilson, Head of Health Economics & Reimbursement EMEA, GE Healthcare, UKGeoff earned his Bachelor’s degree and Doctorate in microbiology and cell biology, he has later completed a Master’s degree in Health Economics from City of London University, UK. His current areas of interest include: Demonstrating value to support optimal payment for diagnostic procedures wherever these are carried out – in hospitals & clinics, outpatient, in the community, etcDr Wilson’s previous professional appointments include: European Product Manager for in vitro diagnostics with Abbott Diagnostics; 3 years with Allergan as their Head of Pricing, Reimbursement & Health Economics for therapeutic applications of BOTOX® across Europe, Middle East & Africa (EMEA). Prior to Allergan, Geoff was with GlaxoSmithKline (GSK) for 18 years in various positions of responsibility within Europe and globally for pricing & reimbursement of pharmaceutical products. He is currently the Head of Health Economics & Reimbursement for EMEA at GE Healthcare.
Dr. Vince S. Thomas, Principal Consultant - Healthcare Asset Valuation, Market Access & Strategic, EpidemiologyV.S. Thomas Global Health Strategy Consulting, SwitzerlandSubsequent to obtaining a B.A. (Hons.) at the University of Toronto and further training, Dr. Thomas worked as a Health Policy Analyst/Consultant for the Canadian Ministry of Health while completing his doctoral training at Duke University. He then undertook concurrent postdoctoral fellowships, during which time he also served as a Pharmaco-economic Consultant ton the initial launch of an Alzheimer’s disease therapy, before completing his postdoctoral training at the NIA-NIH. From 1998 to 2005, Dr. Thomas received USD 0.75 million in peer-reviewed research funding as a PI/Co-PI and published more than 20 peer-reviewed manuscripts in clinical epidemiology, geriatrics and public health while holding tenure-track/Visiting academic appointments in Internal Medicine and Epidemiology in the U.S.A., Sweden and Canada. Dr. Thomas subsequently assumed roles of increasing strategic responsibility in Strategic Pricing, Health Economics & Outcomes Research and Market Access at Novartis, Novo Nordisk and Roche. During this time, Dr. Thomas first-authored the Epidemiological Report for a successful Orphan Drug filing; acted as the Health Economic representative in the first-ever Early Payor Engagement with NICE in the UK; first-authored a Briefing Book to the EMA for a positive end-of-Phase II Request for Follow-up Advice; held global responsibility for creating the value evidence for, and overseeing, all HTA/reimbursement evaluations of a breakthrough therapy in age-related macular degeneration; was responsible for GLP-1 global market access strategy and planning while leading the market access efforts for North America and Germany; and led the development of a new Economic Strategy function for an entire portfolio of in-vitro diagnostic tests where, among other things, he guided the completion of the first-ever NICE Early Payor Advice with an in-vitro diagnostics manufacturer. Dr. Thomas has contributed many published reports on health care policy, financing, and market dynamics to the world’s leading business analysis periodical; and acts as a consultant to biopharmaceutical companies, strategic advisory and investment management firms on activities ranging from the appraisal of outcomes-related regulatory strategies, to strategic pricing, disease area reviews, portfolio analysis, and the assessment of value in business development, licensing, and investment opportunities.
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