In the increasingly cost-contained world of medical device market access, Payers (including ministries of health, insurers private & public, hospitals and local governments) are seeking to justify investment in new medical technologies. Health Technology Assessment (HTA) agencies are now widely spreads across Europe assess new technologies and interventions not only on the grounds of clinical effectiveness, but also based on cost-effectiveness, cost-utility and cost-benefit, to ensure the payers’ limited funds are well invested. This HTA and value demonstration requirement has evolved the “commercialisation” landscape of medical devices across the world and this next barrier is one that all medical device companies seeking to gain reimbursement and approval from payers and tendering bodies, need to overcome.
The variety of commercial channels, customers and payers within the medical device space is as diverse as the different business models being used for the different product types (e.g. Imaging Vs Surgical products) and only increases the complexity and specificity of the “value message” which needs to well-delivered, in order to ensure an optimal outcome. This three-day event is the “must-attend” event for all senior directors at medical device companies who are looking to enhance market access for their products. We look forward to meeting you in Berlin!
Deputy Institute Director
Institute for Quality and Efficiency in Health Care (IQWiG), Germany
Legal & Policy Officer
European Commission
Vice President - Strategic Procurement and Supply of Pharmaceuticals and Medical devices
Amgros, Procurement Service for Regional Authorities, Denmark
Scientific Adviser
RIZIV-INAMI, Belgium
Head of service
Healthcare-associated infections & antimicrobial resistance (Sciensano), Belgium
Scientific Coordinator, Agenas HTA Projects
Agenas (Agency for Regional Health Services), Italy
Head of Clinical Engineering Service
Humanitas Research Hospital, Italy
Health Economist
HTA Unit of Hospital Clinic of Barcelona
Foundation Medicine Access Innovation and PHC Lead, Pharma International, F. Hoffmann-La Roche
Chair of the “Funding Medical Technologies” group, MedTech Europe
Senior Director, Global Health Economics & Reimbursement
Edwards Lifesciences, USA
Vice President International Access, Policy & Advocacy
Myriad
Senior Director, Head of Health Economics, Market Access & Policy Affairs Europe, Middle-East and Africa
Fresenius Medical Care, Germany
Government Affairs Manager, Iberia
Stryker, Spain
Director, Global Market Access
Intuitive Surgical, USA
Senior Advisor
MedTech Europe
Director, Government Affairs, Policy & Health Economics
GE Healthcare
Senior Director DACH, Payers & Health Economics
Coloplast
Director, Market Access – EMEA
Teleflex
Senior Manager in Health Economics, Market Access & Policy Affairs
Fresenius Medical Care, Germany
Sr. Consultant Health Economics, MD squared
Professor & Head of Health Economics & Healthcare Management Division, Kozminski University
Market & Business Insights Manager EMEA
Smith & Nephew
Senior Manager Health Policy & Economics EMEA
Zoll
General Manager
Alifax, Italy
CEO
Oxford Endovascular
Secretary General
EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs
Senior Pricing Manager Patient Care and Monitoring Solutions
Philips Healthcare, Germany
Director Value-Based Healthcare
ValueConnected
Principal and Founder
Hull Associates
Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting
Head of MedTech Consulting
Huron Consulting Group
Director, Life Sciences
Huron Consulting
CEO
Device Access UK
CEO
AIM Gmbh (Assessment-in-Medicine), Germany
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 on the medical devices they fund, 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.
Director Value-Based Healthcare
ValueConnected
Vice President - Strategic Procurement and Supply of Pharmaceuticals and Medical devices
Amgros, Procurement Service for Regional Authorities, Denmark
Head of Clinical Engineering Service
Humanitas Research Hospital, Italy
Scientific Coordinator, Agenas HTA Projects
Agenas (Agency for Regional Health Services), Italy
Deputy Institute Director
Institute for Quality and Efficiency in Health Care (IQWiG), Germany
While evidence requirements have changed under the new European framework for CE arking, the movement towards pan-European Health Technology Assessment also has gained traction, prompting greater conformity of HTA evidence requirements and "transplantation" of evidence reviews across geographies within the European Union. Companies can expect CE Mark requirements to be more aligned with the demands of HTA bodies for reimbursement, but the challenges for medical device firms are greater, as local HTA bodies may be commissioned to implement assessments that have a pan-European impact.
Principal and Founder
Hull Associates
Vice President - Strategic Procurement and Supply of Pharmaceuticals and Medical devices
Amgros, Procurement Service for Regional Authorities, Denmark
Scientific Coordinator, Agenas HTA Projects
Agenas (Agency for Regional Health Services), Italy
Head of Clinical Engineering Service
Humanitas Research Hospital, Italy
Senior Advisor
MedTech Europe
Scientific Adviser
RIZIV-INAMI, Belgium
Head of MedTech Consulting
Huron Consulting Group
Director Value-Based Healthcare
ValueConnected
Senior Manager in Health Economics, Market Access & Policy Affairs
Fresenius Medical Care, Germany
Health Economist
HTA Unit of Hospital Clinic of Barcelona
The principles of market access differ greatly from traditional 4 P product price place promotion Marketing. The winning combination of clear demonstration of Patient, Provider Payer and Product benefits (Optimizing price but maximising the availability to patients who need the technology most) to HTA’s leads to faster adoption meaning patients receive great technologies sooner.
CEO
Device Access UK
Before our panel of Subject Matter experts and practitioners, participants will prepare short briefs to demonstrate the value of several fictional case study products to a panel for approval.
As all MedTech market access industry practitioners know, you only get one chance to make a great first impression on payers and procurement decision makers, so this workshop will allow participants to practice their presentations in a safe environment.
Assessors will look at: Content of the presentation & Evidence used in order to give constructive feedback.
Participants will be grouped into product specific areas which will enable them to tailor their learnings for their products.
The product natures will be:
Chairperson:
The Panelists will be:
Deputy Institute Director
Institute for Quality and Efficiency in Health Care (IQWiG), Germany
Scientific Adviser
RIZIV-INAMI, Belgium
Scientific Coordinator, Agenas HTA Projects
Agenas (Agency for Regional Health Services), Italy
Senior Director, Head of Health Economics, Market Access & Policy Affairs Europe, Middle-East and Africa
Fresenius Medical Care, Germany
Medical device firms are increasingly under pressure from payers, HTA agencies, healthcare providers and other stakeholders to provide real evidence of their product’s benefit. Increasingly, especially when a technology is expensive, the CE Mark alone is no longer sufficient to gain market access. Robust health economic evidence demonstrating the clinical and economic value of a device is either becoming mandatory, or at least can be a source or competitive advantage to differentiate apparently similar products. Evidence can still be generated from scientific publications, but on top of this, sophisticated and expensive clinical trials and even real-world studies are now being designed and implemented. Getting the trial design right from the beginning is essential, so that the right research questions are being asked and robust methodologies are used to demonstrate improved health outcomes. Protocols must also be operationally feasible to ensure not just messy data is developed, but real evidence so that payers can gain insights into the value and make better reimbursement decisions. This stream will detail how clinical, real-world, economic and scientific publication data sources can be integrated to prepare a sophisticated value dossier to demonstrate value to payers and other key stakeholders.
Director, Life Sciences
Huron Consulting
Government Affairs Manager, Iberia
Stryker, Spain
CEO
Oxford Endovascular
Director, Global Market Access
Intuitive Surgical, USA
Director, Market Access – EMEA
Teleflex
Senior Director DACH, Payers & Health Economics
Coloplast
Senior Manager Health Policy & Economics EMEA
Zoll
Senior Director DACH, Payers & Health Economics
Coloplast
Director, Market Access – EMEA
Teleflex
Senior Manager Health Policy & Economics EMEA
Zoll
Government Affairs Manager, Iberia
Stryker, Spain
Medical devices are coming under greater scrutiny by payers and hospital procurement directors than ever before. Manufacturers today are required to understand and quantify the cost savings for hospitals & payers based on the direct & indirect savings their products deliver. Changes to the European directives on public procurement are directly impacting the way medical device companies communicate and market their products via public procurement channels for high-value products. This one-day event will bring together procurement experts from European Policy-level, leading industry associations, hospitals (procurers) and the MedTech industry to join the conversation and to understand better the needs of their strategic partners. It will enable all participants the opportunity to benchmark procurement processes and tender approaches at a regional, local and hospital perspective. Medical device companies will understand in greater detail what their customers are looking for as drivers of value, and what is attractive for them to enhance their tender and public procurement strategy.
CEO
AIM Gmbh (Assessment-in-Medicine), Germany
Senior Advisor
MedTech Europe
Legal & Policy Officer
European Commission
Senior Pricing Manager Patient Care and Monitoring Solutions
Philips Healthcare, Germany
CEO
AIM Gmbh (Assessment-in-Medicine), Germany
Director, Government Affairs, Policy & Health Economics
GE Healthcare
Product and service offerings need to follow the legal requirements of a country. But additionally a big grey exists - called corruption. Market Access activities might be legally allowed but still negatively impact companies’ reputation. It is important to be aware of potential traps. Examples will be discussed to increase awareness and sensitivity for the benefit of companies’ offerings.
Market & Business Insights Manager EMEA
Smith & Nephew
Senior Director, Global Health Economics & Reimbursement
Edwards Lifesciences, USA
Senior Director, Global Health Economics & Reimbursement
Edwards Lifesciences, USA
Market & Business Insights Manager EMEA
Smith & Nephew
Legal & Policy Officer
European Commission
As the product nature of In Molecular and companion diagnostics becomes increasingly complex, so too is the market access process surrounding these essential tests
and procedures. These diagnostics bring unique market access & procurement challenged through DRG coding, bundling and procurement for laboratory test service
providers. As the cost of these tests increases, so too does the requirement to justify the value and ROI to all necessary stakeholders. For companion diagnostics, partnering and strategic alliances with pharma (if not already vertically integrated) provides a strong market access vector, but achieving this has been proven difficult with only a handful of successful examples to date. As payers, procurers, HMOs and purchasers demand more evidence to justify costs, the challenges surrounding market access for molecular diagnostics to bring their benefit to clinical settings have never been greater. This stream will discuss the market access challenges affecting In Vitro diagnostics and companion diagnostics globally with case studies of successful
Vice President International Access, Policy & Advocacy
Myriad
Secretary General
EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs
Head of service
Healthcare-associated infections & antimicrobial resistance (Sciensano), Belgium
Foundation Medicine Access Innovation and PHC Lead, Pharma International, F. Hoffmann-La Roche
Chair of the “Funding Medical Technologies” group, MedTech Europe
General Manager
Alifax, Italy
Head of service
Healthcare-associated infections & antimicrobial resistance (Sciensano), Belgium
Foundation Medicine Access Innovation and PHC Lead, Pharma International, F. Hoffmann-La Roche
Chair of the “Funding Medical Technologies” group, MedTech Europe
General Manager
Alifax, Italy
Secretary General
EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs
Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting
Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting
Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting
Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting
Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting
Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting
Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting
Connected Healthcare is now a reality, as well as Digital Interventions and Software as a Medical Device (SaaMD). “Digital patients” are increasingly being “connected” to the IoMT ecosystem through digitally-enabled devices, their mobile phones and electronic health records data. There is a treasure trove of information out there from a multitude of sources which promise both exciting opportunities and daunting challenges. Not surprisingly, physicians are now starting to see the clinical value of such technologies and payers increasingly realise there can be great health economic benefits worth paying for, yet they are extremely difficult to define, measure and value.
This unique event will discuss:
Foundation Medicine Access Innovation and PHC Lead, Pharma International, F. Hoffmann-La Roche
Chair of the “Funding Medical Technologies” group, MedTech Europe
Foundation Medicine Access Innovation and PHC Lead, Pharma International, F. Hoffmann-La Roche
Chair of the “Funding Medical Technologies” group, MedTech Europe
Sr. Consultant Health Economics, MD squared
Professor & Head of Health Economics & Healthcare Management Division, Kozminski University
Scientific Coordinator, Agenas HTA Projects
Agenas (Agency for Regional Health Services), Italy
Senior Director, Head of Health Economics, Market Access & Policy Affairs Europe, Middle-East and Africa
Fresenius Medical Care, Germany
Sr. Consultant Health Economics, MD squared
Professor & Head of Health Economics & Healthcare Management Division, Kozminski University
Medical Device & Diagnostic Companies: Market Access, Health Economics, Pricing & Reimbursement, Government & Stakeholder Relations, Payer Relations, Value Strategy, Regulatory Affairs, Strategic Marketing, Commercial Excellence, Business Unit and Country Managers Regulatory Affairs
External Stakeholders: Health 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
Deputy Institute Director
Institute for Quality and Efficiency in Health Care (IQWiG), Germany
Stefan Lange completed his medical studies at the Heinrich-Heine-University in Düsseldorf in 1989 and received his MD in 1994. From 1989-1993 he was initially in practical training at the Ferdinand-Sauerbruch-Clinic in Wuppertal, then assumed the position of intern/resident physician. In 1993 he joined the department of medical biometry at the Ruhr-University in Bochum and was appointed to the position of research assistant in 1995. In 2003 he received his Habilitation (qualification for a professorship) and venia legendi (award of title of Privatdozent) in Medical Biometry and Clinical Epidemiology.
He joined the Institute for Quality and Efficiency in Health Care in 2004, and has held the position of Deputy Director of the institute since 2005.
Legal & Policy Officer
European Commission
An holds a Belgian law degree issued by the University of Leuven as well as a master of laws issued by the Albert-Ludwig University of Freiburg im Breisgau (Germany). Prior to the Commission An has worked in the area of health law, first an assistant at the University of Leuven and thereafter in the private sector. Since more than twelve years, An has been working for the Commission dealing with different internal market issues. Since three years she works in the field of public procurement. In particular, she deals with Austrian and German complaints. She also is responsible for the policy work related to the application of public procurement rules in the health and waste management sector.
Scientific Adviser
RIZIV-INAMI, Belgium
Eva D’Haese graduated from Ghent University as a pharmacist. She obtained a PhD in the field of pharmaceutical sciences and she continued working as a research scientist at Ghent University during several years.
In 2005, she joined the Scientific Institute of Public Health (WIV-ISP) in Brussels as a scientific collaborator. At the Belgian Competent Authority for IVD she was responsible for vigilance matters.
She started working at the RIZIV-INAMI in 2009. There, she is mainly involved in the scientific evaluation and the reimbursement of medical devices.
Head of service
Healthcare-associated infections & antimicrobial resistance (Sciensano), Belgium
Boudewijn Catry (DVM ° 2000, PhD ° 2005) is a researcher with a special interest in antimicrobial resistance with regard to both veterinary and human medicine. Between 2000 and 2007, he combined ambulatory practice & obstetrics as a veterinary surgeon with laboratory research (Ghent University). He started to work at Sciensano in 2007, the Belgian Scientific Institute of Public Health, where he has headed the Care Infections & Antimicrobial Resistance Service since 2009 (www.nsih.be). He is involved in several committees on the prudent use of antimicrobials and infection prevention. He is co-founder (° 2013) of the outbreak support team for multidrug resistant organisms in Belgian hospitals (MDRO-OST). Since 2018 he is lecturer epidemiology at the Free University of Brussels (Université libre de Bruxelles, ULB).
Scientific Coordinator, Agenas HTA Projects
Agenas (Agency for Regional Health Services), Italy
Tom Jefferson is a physician, epidemiologist and researcher. Tom’s field of expertise is evidence synthesis applied to Cochrane and other systematic reviews and Health Technology Assessment. Tom is a Senior Associate Tutor at the University of Oxford, a researcher at the Nordic Cochrane Centre and the scientific coordinator for the production of HTA reports on non-pharmaceuticals for Agenas, the Italian National Agency for Regional Healthcare.
Head of Clinical Engineering Service
Humanitas Research Hospital, Italy
Paolo joined Humanitas Research Hospital in July 2017. He graduated from University of Naples Federico II with a Bachelor’s degree in Biomedical Engineering. He completed his Master’s degree in Clinical Engineering at the same University and subsequently completed his second level Master’s degree in Health Economics at SDA Bocconi School of Management. Prior to joining Humanitas Research Hospital, Paolo worked for 3 years as Clinical Engineer and Operation Manager at PLV Fatebenefratelli private Group of Hospitals.
Foundation Medicine Access Innovation and PHC Lead, Pharma International, F. Hoffmann-La Roche
Chair of the “Funding Medical Technologies” group, MedTech Europe
Markus A. Ott is a Global Medical Technology Professional with more than twenty years successful experience in international/global commercial & non-commercial roles he has become a highly effective and creative industry leader with extensive knowledge of the healthcare market.
Currently he is leading the Market Access & Health Policy department at Roche Diagnostics International (CPS) based in Rotkreuz/Switzerland.
His passion are all aspects of his job but primarily Value Based Healthcare & the digitalization of our industry.
He is/has been a member of global Management teams for various companies and associations. So, Markus has been member of the Executive Board of MedTech Europe as well as the Swiss Diagnostic Association. He acted as Chair Elect and Executive Board Member of EPPOSI (European Platform for Patient's Organizations, Science & Industry). Currently he chairs the HTA IVD & Value of Diagnostics Working groups @ MedTech Europe.
Finally, he is author of multiple publications as well as chair, panelist and speaker at many global conferences.
Senior Director, Global Health Economics & Reimbursement
Edwards Lifesciences, USA
Seth has worked in the field of Market Access for more than 15 years – primarily in support of medical device and biopharmaceutical companies. In his current role, Sr. Director, Global Health Economics & Reimbursement at Edwards Lifesciences, he leads the development and implementation of evidence generation and market access strategies for transcatheter heart valves. Seth has helped to address a complex and growing set of global challenges related to value-based payment, health technology assessment, health economics and hospital procedural optimization. Prior to joining Edwards in 2008, Seth worked at Cerner Lifesciences, where he served as Senior Research Associate, consulting with biotech and pharmaceutical companies in the areas of comparative effectiveness research, evidence-based medicine and health economics.
Seth received a Bachelor of Arts degree from the University of California, Irvine and a Master of Public Health, from the University of California, Los Angeles.
Vice President International Access, Policy & Advocacy
Myriad
Benjamin Gannon joined Myriad Genetics in March 2019 and is responsible for international market access, policy and advocacy. Mr Gannon has over 20 years of European and international experience with the life sciences and biotech sector. Before joining Myriad, he was responsible for international government affairs, policy and patient engagement with Vertex Pharmaceuticals. In this role he established and led government affairs and patient engagement for Vertex’ operations internationally – this included support to market access strategy and regulatory policy. Mr Gannon is a Board member of EUCOPE, the European Confederation of Pharmaceutical Industries.
Before joining Vertex, Mr Gannon was Vice President for Group Public Affairs for SCA and has held senior government affairs and policy roles with Gilead, Johnson & Johnson and GlaxoSmithKline. He is a dual German/ UK national and holds Bachelor and Masters degrees in Biology from Southampton University (UK) and Imperial College (UK) respectively.
Senior Director, Head of Health Economics, Market Access & Policy Affairs Europe, Middle-East and Africa
Fresenius Medical Care, Germany
Christian has an academic background in human medicine, biomedical sciences, health policy & health economics. Before joining Fresenius Medical Care, Christian worked in different strategic and management positions of a medium sized care provider in Germany. In Fresenius Medical Care he is heading the Health Economics, Market Access & Policy Affairs activities for Europe, Middle-East and Africa.
Government Affairs Manager, Iberia
Stryker, Spain
2000-2005 - Graduation Pharmacy, Univ. de Salamanca, Spain
2005-2006 - MBA on Pharmaceutical Industry. Univ. Alcalá de Henares, Spain
2019 - Leadership and Management Program, Harvard University
Working in Stryker since 2007 currently with the Market Access and GA Team
Director, Global Market Access
Intuitive Surgical, USA
Ben currently serves as Director, Global Market Access at Intuitive Surgical. He previously worked with HeartFlow as Director of Health Economics and as an Investment Analyst with Citigroup, where he focused on Emerging Medical Technologies. Ben received degrees in Economics and International Studies from Brigham Young University and a Masters in Business Administration from Stanford University.
Senior Advisor
MedTech Europe
Graduated in 1987 as Electro-Mechanical Engineer with specialty electronics at the Catholic University of Leuven, followed by a post-graduate year of Master of Business Administration. A first working experience in the field of Clinical Engineering at Intermedics, a US based pacemaker and implantable defibrillator company. Build out and directed the European Clinical Research Department. Holder of 5 patents in field of cardiac stimulation in health failure and co-author of 3 publication in this period. Joined in 1999 Medtronic to head the European Heart Failure clinical outcomes & research department ensuring the development of Clinical and Health Economic Outcome Evidence. In close cooperation with Clinical Community landmark trials were designed, conducted and published in the Int’l journals as New England Journal of Medicine, Circulation and others with a high impact factor. A contribution of to 8 publication of which 3 as co-author. This evidence based ensured : Cardiac Resynchronization therapy obtained a class I indication level of evidence A in clinical guidelines; Cardiac Resynchronization therapy obtained a positive HTA appraisals for the full population studied . In September 2008, took on the responsibility of Assistant Director Health Economics, EurMEA at Alcon in the field of Ophthalmology for both medicinal and medical devices ranging from treatments of bacterial conjunctivitis, dry eye and glaucoma to Implantable Ocular Lenses. Developed comprehensive Patient Report Outcomes instrument to support patient diagnosis and assessing the outcome value of dry eye treatment to patients. Supported and co-authored to an additional 8 publications. As of 1st May 2012, head of Market Access and Economic Policies for MEDTECH EUROPE to strive to balanced pro-innovation policies and to shift to a Value based Access model within EU frameworks. Initiatives in dialogue with procurers, payer, HTA member states representatives and other stakeholders are MEAT Value Based Procurement, Value of Diagnostic Information, Modern HTA Cooperation in Europe, new evidence and financing schemes to shift to access of medical technologies of value for patients, healthcare, society and our economy.
Director, Government Affairs, Policy & Health Economics
GE Healthcare
MASSIMO G. BARBERIO is actually GovernmentAffairs, Policy& Health Economics Director Italy in GE Healthcare Italy He started his career working in the commercial department of a medium size pharmaceutical company, dealing with diagnostic hospital pharma products. After several assignments in marketing field for several large pharmaceutical companies, in 2007 he joined GE Healthcare, as South Europe Marketing Director for the Pharmaceutical Division.Since 2011Massimocovers the role of GovernmentAffairs, Policy& Health Economics Director Italy in GE HealthcareMedical Systems, dealing with the technological and pharmaceutical product portfolio and managing the Market Access activities in General Electric Healthcare. In his activity he managesthe Company official relationships with Institutions like Government and Parliament members, Health and University Ministry, Government Agencies, Professional Societies. He is in the staff of the Southern Europe President of GE Healthcare. He is member of the Italian Society of Clinical Radiology since 1995, and he is also part of the Italian Association of Nuclear Medicine, Massimo obtained also several academic assignments: appointed as Visiting Professor at the Radiology School of the Medicine Faculty at the Milano Bicocca University and as lecturer at the MBA courses at L. Bocconi University and Management School in Milan and at LUISS University in Rome, he is actually Visiting Professor at the Research Centre for study on Healthcare Management at the LIUC University of Castellanza and member of the steering committee and Professor atthe School of Finance and Management at Universitàdel Piemonte Orientale di Novara. He is author of several clinical and pharmacoeconomy papers published on some national and international peer reviewed journals, as the Italian Journal of Radiology and the California Management Review. He has a master’sdegree in Biology and a Master in Strategic Marketingandalso MasterinHealthcareEconomy and Management Born in Milan 60years ago,Massimo is married with Angela and they have one son, Daniele, 31years old and one daughter, Martina 27years old. He enjoys spending his time with his family and reading, and after a brilliant career as Italian major league Handball referee, actually his sport activity is limited todiscussions with friends on soccer games seen on TV.
Senior Director DACH, Payers & Health Economics
Coloplast
Christian spent the first half of his career in the German Statutory Health Insurance, covering different positions and ended up with the project lead of one of the first huge Managed Care models in the country. As a consultant, Christian supported sickfunds to introduce the German DRG system and Managed Care approaches before he started with his first market access projects. Prior to joining Coloplast in 2017 he held different national and international market access positions at Johnson & Johnson, Accuray and in a pharmaceutical startup. Christian holds a Bachelor of Science degree in Health Communication and Healthcare Management. As a Director Payers & Health Economics at Coloplast, Christian is now responsible for Regulatory Affairs, Public Affairs and Payer Managenment.
Director, Market Access – EMEA
Teleflex
Marcus has worked in medical devices for longer than he would care to admit. He began his career in UK hospitals as a cardiac technician. After only eight years he joined St Jude Medical as a junior member of the UK clinical operations team. Quickly promoted to the European headquarters he spent a number of years in Brussels performing various roles in clinical trials and medical affairs covering both European and International markets before crossing over to the market access team, again supporting both European and international markets. Marcus left St Jude to join Second Sight, a small company pioneering retinal implant technology. Marcus is currently the European market access head for Teleflex. He lives in Brussels with his wife and two children.
Senior Manager in Health Economics, Market Access & Policy Affairs
Fresenius Medical Care, Germany
Ellen is a senior manager in the Health Economics & Market Access (HEMA) department, in the EMEA region of Fresenius Medical Care, the world’s largest provider of products and services for renal patients. The HEMA activities are therefore not limited to products only, but are performed across the entire lifecycle from development to provision of care.
Ellen is responsible for the HEMA Community in the EMEA markets, ensuring the implementation of value-sales argumentation, localization and other local market access / reimbursement support. On a strategic level, she is focused on EMEA reimbursement monitoring, developing value documentation and assessing health policy developments on EU level in HTA and value-based procurement.
Ellen is originally from the Netherlands and holds a BSc and MSc in European Public Health from Maastricht University (the Netherlands) and a MLitt in Management from St. Andrews University (Scotland).
Sr. Consultant Health Economics, MD squared
Professor & Head of Health Economics & Healthcare Management Division, Kozminski University
Driven with the passion to health economics, I have more than 20 years of academic and industry experience in the field of healthcare. Holding various Regional and Global leadership positions, I have been working extensively within public health sector as well as pharma and medtech industry.
After six years employment at the Kalmar County Council in Sweden, I held global and regional Health Economics & Outcomes Research (HEOR) positions at AstraZeneca and BiogenIdec respectively. At Bristol Myers Squibb and Lundbeck I lead Market Access teams in Central Eastern European (CEE) and Nordic Region. In the last five years, I gained experience with the pricing &reimbursement challenges in the field of medical devices. I supported Straub Medical as Global Market Access Lead. Before that, I was Senior Sales Director responsible for HEOR at GE Healthcare.
Since 2018 I am a Professor at the Kozminski University heading Health Economics & Healthcare Management Division (HeM). I am the leader of the International Master Program Health Economics & Big Data (HEBDA) financed by the EU research grant. In October 2020, I was nominated to the ISPOR’s Health Sciences Policy Council (HSPC). Since January 2020, I am chair elect of ISPOR Special Interest Group Digital Health as well.
My biggest strength is the market access planning for a successful pricing & reimbursement strategy. Knowledgably of HTA guidelines, DRG financing and hospital procurement pathways across EU & US settings, I will be able to advice on the optimal market entry that ensures the best differentiation of a given technology against alternative treatment options
Market & Business Insights Manager EMEA
Smith & Nephew
Berit Dahl is a market and business insights manager for Smith & Nephew in the Europe and Canada region. This role supports the decision-making process on strategic commercial projects. She works for 5 years in the MedTech industry and collected extensive experience as finance business partner for the sales and marketing organisations in B2C and B2B environment of FMCG and Food before. The driver for
work is the continuously striving for better insights in the decision-making process for
all participants. Berit received a diploma in business informatics and holds an MBA in International Management. She is German and currently lives in Switzerland.
Senior Manager Health Policy & Economics EMEA
Zoll
My name is Dr. Frank Semrau, I was born and went to school in the northern part of Germany (Lüneburg near Hamburg). I studied Biology in Göttingen and got the Diploma in Biology (Biochemistry, Microbiology) at the Georg-August University of Göttingen. I conducted my thesis at the University Hospital of Göttingen, Center for Hygiene and Human Genetics and got a PhD from Georg-August University of Göttingen (Biochemistry, Medical Microbiology), as well.
I started my business career at, then, one of the 10 biggest pharmaceutical companies Pharmacia which merged with Pfizer some years later, as a Regional Manager Health Politics, dealing with Associations of Statutory Health Insurance Physicians which control ambulatory prescriptions of pharmaceuticals.
In 2004 the DRG system was introduced in Germany and I attended and supported the implementation as a Manager Health Economics/Government Affairs with Boston Scientific (Medical devices) for almost nine years, the last years as a department deputy. While I started with responsibility for all products, with growing department I specialized in vascular and cardiac medical technologies like stents, ICDs and pacemaker.
Since 2012 I am with ZOLL CMS as a Strategic Reimbursement Manager for European countries. I am responsible for European market access and reimbursement of the wearable cardioverter defibrillator (WCD) “LifeVest” with a strong focus on Germany. From this point of view I have a very broadly defined idea of MA & Reimbursement, including preparation and optimization of reimbursement applications and coding, as well as initiating support by physicians, clinical studies, guidelines, patient organizations, health economic assessments and models, HTAs, pricing, politics, PR and social opinion. Currently my main goal is the seamless protection of patients with high risk for sudden cardiac death (SCD) in and particularly outside the hospital.
General Manager
Alifax, Italy
Current Position in the Company:
Since April 2004:
International Marketing Manager of Alifax Srl and R&D project coordinator for the bacteriology product line of SIRE Analytical Systems (R&D and manufacturing company of the Alifax Group).
Since September 2015
Managing of Alifax srl after the incorporation of SIRE Analytical Systems in the company with the responsibility of the Nimis plant (R&D and instrument and reagents manufacturing unit of the Alifax group) and Microbiology division.
Professional Skills:
Twenty years experience in sales and marketing of innovative microbiology IVD systems (rapid bacteriology systems), competence in phenotypic and genotypic methods (molecular device) for sensitivity to antimicrobial tests (AST) , bacterial Identification , Resistance Mechanisms detection.
June 2008
I was appointed by SIRE Analytical Systems as General Manager of the company with the responsibility of the Bacteriology Division R&D activities and instrument and reagents manufacturing
September 2015
Appointment as General Manager of Alifax srl after the incorporation of SIRE Analytical Systems in the company with the responsibility of the Nimis plant (R&D and manufacturing unit of the Alifax group) and Microbiology division.
CEO
Oxford Endovascular
Mike is the CEO and co-founder of Oxford Endovascular Ltd, a spinout from Oxford University.
The company is developing a revolutionary medical device for patients suffering from brain aneurysms; a life-threatening disease affecting 1 in 50 persons. In 2017 it won ‘Best Med-Tech Start-Up’ at the Oxford Bio Network awards, 1st place at the BioTrinity ‘Perfect Pitch’ competition and an award at the ‘European Health Catapult’ finals.
Mike is a business leader in with over 25 years strongly growing international businesses in large corporations, start-ups & SMEs, including Boston Scientific & HeartWare.
Experienced in strategic planning, execution, team building, marketing programs, gaining regulatory approvals & fund raising. Mike also mentors business students, start-ups and is a presenter and panellist at European life science conferences.
Mike studied Pre-Clinical Medicine, Physiology & Pharmacology at Southampton University before entering industry and later gaining his MBA at Henley Business School.
Secretary General
EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs
Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (www.eucope.org) in Brussels and works as a lawyer in the healthcare boutique law firm NOVACOS in Düsseldorf (www.novacos-law.com). He advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective.
From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements and licensing of pharmaceuticals. Alexander has also worked in the field of competition law with the European Commission and in the pharmaceutical industry. As a research assistant at Duke University (USA) he has dealt with international pharmaceutical law. His doctorate was supervised by the former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling.
Alexander represents innovative life sciences companies at the EU institutions, before national authorities, HTA agencies, payers and courts. Alexander has a particular expertise in EU regulatory law such as GMP, lifecycle management, distribution and clinical trials, as well as in pricing and reimbursement procedures in Germany. He advises serveral US biotech and medtech companies in market access & government affairs related issues in Germany, offering strategic advice on value demonstration, pricing, tendering and other reimbursement matters. Alexander offers full-service legal support throughout all phases of the AMNOG-procedure, including drafting of dossier, G-BA benefit assessment, price negotiations with the GKV-Spitzenverband and arbitration board proceedings. He has a particular expertise in orphan drugs, medical devices as well as gene & cell therapies. His work also focuses on strategies for early value demonstration towards payers and national HTA bodies next to early patient engagement.
Senior Pricing Manager Patient Care and Monitoring Solutions
Philips Healthcare, Germany
Loon Lee is a senior pricing manager with more than 10 years of experience in the healthcare industry, and previously held positions in product management and marketing. Currently in the team of Global Pricing and Competitive Portfolio Analytics at Philips, he is responsible to drive solution pricing and new business models, and to develop effective tactical CI programs by collaborating with stakeholders across the organization. In addition, he leads the editorial team of an internal competitive newsletter that delivers competitive insights, counter arguments, strategies and tools to help sales organizations compete effectively in the field.
Director Value-Based Healthcare
ValueConnected
Richard has over 15 year of industry experience across both the Healthcare and Financial services sectors. Richard is currently the Director of Value Based Healthcare at ValueConnected, a company focusing on implementing Value Based Healthcare. Richard was formerly at Becton Dickinson, where held various senior roles in Market Access & Pricing. Richard is currently the Co-Chair of the ISPOR Medical Devices Interest Group, where he also teaches the short course on Market Access for Medical Devices. Richard is also the co-chair of HTAi Medical Device Interest Group, where he is frequently called on as a guest speaker. Richard is currently the industry Advisor to COMED, an EU funded consortium measuring outcomes and costs in medical devices. Richard graduated from SDA Bocconi in Italy with a Masters in Healthcare Management, Economics & Policy, as well as from the University of Guelph in Canada, in Management Economics & Public Policy.
Principal and Founder
Hull Associates
Stephen Hull is Principal and Founder of Hull Associates LLC, a specialized global reimbursement and market access consultancy. He and his firm leverage over 25 years of experience in US and global reimbursement and in-market expertise on behalf of pharma, medical device and diagnostics Clients. Prior to forming Hull Associates in 2007, he served as SVP for Global Reimbursement at AdvaMed, in Washington, D.C. and as chair of the ISPOR Medical Devices Council. Stephen holds a Master’s degree in health policy from the Johns Hopkins Bloomberg School of Public Health, and a bachelor’s degree in international relations and French from Colgate University.
Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting
Oleg is a recognized expert in the field of market access for medical devices in Europe. His experience derives from the several hundreds of projects in market access and health economics he has worked on. His specific areas of expertise include European reimbursement pathways, evidence requirements for approval by payers and sound value stories for medical technologies.
Head of MedTech Consulting
Huron Consulting Group
Anne has over 20 years of broad healthcare experience from leadership positions spanning the life sciences industry, hospital management, and strategy consulting.
At Huron, she leads the medtech business within the Life Sciences Strategy practice. Her expert knowledge of the clinical and market dynamics and trends impacting medical devices, technologies, and tools enables her to develop customized growth strategies and value creation opportunities. Working closely as a thought partner with clients, she has delivered actionable strategic insights to medtech companies and investors that support them in achieving their business objectives. Her specific areas of expertise include: Business development and investment support (diligence, forecasting, portfolio strategy); Commercial / go-to-market strategy; and Market access / market development strategy.
Prior to joining Huron, Anne was a Managing Director at ClearView Healthcare Partners, where she built and led the global Medtech strategy business. She also spent several years at Navigant in the Life Sciences Strategy practice (formerly Easton Associates) and was a core member of the Medtech leadership team. Previously, Anne managed the Neurosurgery Department at The University of Chicago and the Pulmonary and Critical Care Medicine Division at NYU. She started her career at Vertex Pharmaceuticals as part of the original Strategy and R&D Planning groups.
Director, Life Sciences
Huron Consulting
Sotiris has been working with market access, marketing and policy teams of Fortune 500 Life science companies to assess health system trends and stakeholder needs, develop value propositions for innovative medical technologies and develop Access strategy.
Prior to joining Huron, Sotiris held senior positions at Boston Healthcare Associates and GfK Market Access where he lead teams on various commercial, pricing & market access and marketing engagements at the product- and portfolio- level.
Sotiris started his consulting career at IMS Consulting group working in the Pricing and Market Access practice.
Sotiris has expert working knowledge in various quantitative and qualitative methodologies and research tools (e.g., conjoint, MaxDiff, MCDA, virtual ad boards, IDIs, scorecards).
Focus areas
• Access strategy
• Payer and Provider dynamics
• Value proposition development
• Innovative Business models
Education
• PhD in Strategic Management, Warwick Business School (Economic & Social Research Council fellow)
• M.Sc. International Health Management, Imperial College London
CEO
Device Access UK
Michael Branagan-Harris is the CEO of Device Access UK, and IGES Group Company. Michael has been involved with Medical Devices for 30 years and founded Device Access UK in 2010. Since then he and his team have helped over 30 companies successfully though NICE leading to guidance or advice on adoption to hospitals across NHS England.
CEO
AIM Gmbh (Assessment-in-Medicine), Germany
Michael Weisser, CEO, has been working at AiM for ten years, providing consultancy services to industry. His field of work comprises the reimbursement of diagnostic and therapeutic procedures that are based on the use of medical devices. This involves the research, processing and analysis of circumstances in various health and insurance systems in the European and German context and the subsequent derivation of market access strategies. In addition, Mr. Weisser accompanies the implementation of recommendations given for optimized market access. This refers to the compilation of reimbursement-related applications, evidence-based benefit dossiers and submissions to health care coverage authorities. Furthermore, he plans and holds international workshops as well as conference contributions related to the named topics. Mr. Weisser holds a Master equivalent degree in Economics from the Albert Ludwig University of Freiburg (i. Brsg.), focusing on hospital management and social security systems.
“I have attended and presented at a couple of different NextLevel events and can’t help but be impressed with the way the Next Level team put these events together. They have been a joy to attend which is testimony to the experience and professionalism of the NextLevel team. The level of knowledge from participants is always very high and NextLevel encourage interactive discussions providing a great opportunity for exchanging ideas. They also make for fantastic networking events – highly recommend the networking dinner.”
Senior Scientific Advisor
NICE
"I attended the meeting thinking it was likely to be a boring academic event where my colleagues try scoring points off each other. It was nothing of the kind. It gave me the opportunity to get to know, listen to and discuss with payers, manufacturers and consultants in a civilised and frank atmosphere. If you want to know what and how other people think, it's the event for you".
Scientific Coordinator, Agenas HTA Projects
Agenas, Italy
(Only available for corporate registrations)
For more information click here to learn more: https://www.evidencelifescience.com/membership