3 Reasons to attend online:

1. Understand how to most efficiently develop global evidence that can best provide value to key local markets

2. Benchmark what are today’s and tomorrow’s ideal market access & cross-functional capabilities to maximise effectiveness in larger or smaller companies

3. Appreciate how to best leverage evidence to demonstrate value to key payers and HTAs

Speakers List

INDUSTRY EXPERTS

Larry Dooley

Vice President National Accounts/Pricing
Stryker 

Former Foundation Medicine Access Innovation and PHC Lead, Pharma International, F. Hoffmann-La Roche
Chair of the “Funding Medical Technologies” group, MedTech Europe

Market & Business Insights Manager EMEA
Smith & Nephew

Director, Market Access & Economic Policies
MedTech Europe

Sarowar Muhammad Golam

Vice President, Health Economics and Payer Evidence
Implantica 

Secretary General
EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs

Senior Manager Health Policy & Economics EMEA
Zoll

 

Director Reimbursement Germany
CytoSorbents Corporation

International Sales Director Italy, Central Europe, Russia and Eurasia
Echosens

Quentin L'Huillier

Global Access & Business Intelligence Manager

Echosens

Academic Perspective

Mondher Toumi

Professor of Public Health
University of Aix-Marseille 

Guest Professor, Health Economic Evidence 
University of Ghent

EXPERIENCED SOLUTION PROVIDERS

Principal and Founder
Hull Associates

CEO and Founder
ValueConnected

Event Structure

Event Program

STRATEGIES FOR EVIDENCE DEVELOPMENT & VALUE DEMONSTRATION

Day 1 - 28th June, 2022
Log-in & registration
07:30 NYC/13:30 Paris
Chairperson's opening remarks
08:00 NYC/14:00 Paris

CEO and Founder
ValueConnected

The future EU HTA for medical devices
08:10 NYC/14:10 Paris

Secretary General
EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs

Successful evidence development for global launches
08:40 NYC/14:40 Paris

In today's demanding world of national requirements, how can companies develop the right evidence portfolio to succeed? How can they integrate evidence for payers with their regulatory studies?  This in depth review will discuss core principles in evidence development for diagnostics and therapeutic medical devices, and how these concepts can align with the requirements of the major global markets -- the UK, France, Germany, Japan and the USA. Learn about the evolving landscape of evidence demands in:

  • The UK, with NICE's development of new pathways for innovative devices
  • France's Forfeit Innovation and evidence demands
  • Germany's NUB evidence review requirements for high risk devices
  • Japan's emerging new pathways for breakthrough innovations
  • The US Medicare programs special coverage of FDA designated Breakthrough Devices

Principal and Founder
Hull Associates

Humanitarian? Digitalisation in healthcare
09:10 NYC/15:10 Paris

Market & Business Insights Manager EMEA
Smith & Nephew

Break
09:40 NYC/15:40 Paris
Case Study: Estimating evidence needs in the EU from a US manufacturer’s perspective
10:10 NYC/16:10 Paris

Senior Manager Health Policy & Economics EMEA
Zoll

 

MedTech: How can we combine new data types with traditional registry data to provide personalised treatments?
10:40 NYC/16:40 Paris

Guest Professor, Health Economic Evidence 
University of Ghent

Developing evidence to establish market access and enable scalable commercialization of innovative medical devices
11:10 NYC / 17:10 Paris
Sarowar Muhammad Golam

Vice President, Health Economics and Payer Evidence
Implantica 

Panel Discussion: Developing robust, quality evidence of a device‘s value
11:40 NYC/17:40 Paris
  • Data to evidence: What data sources are available that add value? (i.e. clinical, real-world, publications)
  • What data really makes a difference for external stakeholders to aid decision-making?
  • What can companies do to better develop evidence in a cost-effective manner?
  • Possible solutions to a lack of evidence
Larry Dooley

Vice President National Accounts/Pricing
Stryker 

Secretary General
EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs

Senior Manager Health Policy & Economics EMEA
Zoll

 

Guest Professor, Health Economic Evidence 
University of Ghent

Sarowar Muhammad Golam

Vice President, Health Economics and Payer Evidence
Implantica 

Director Reimbursement Germany
CytoSorbents Corporation

End of day one
12:10 NYC/18:10 Paris

THE IMPACT OF EVIDENCE GENERATION ON REIMBURSEMENT AGREEMENTS

Day 2 - 29th June, 2022
Log-in & Registration
07:30 NYC/13:30 Paris
Chairperson's opening remarks
08:00 NYC/14:00 Paris

Principal and Founder
Hull Associates

Overview: EU Regulation on HTA for MedTech
08:10 NYC/14:10 Paris

Director, Market Access & Economic Policies
MedTech Europe

Do's and Don'ts of Value Demonstration
08:40 NYC/14:40 Paris
  • It is not about your technology
  • Clinical Evidence: Quality, not quantity
  • Shift the perception from price to value
  • Bad and good case examples
  • Best practices and recommendations

CEO and Founder
ValueConnected

Benchmark what are today’s and tomorrow’s ideal market access & cross-functional capabilities to maximize effectiveness in larger or smaller companies
09:10 NYC/15:10 Paris
  • Small & Mid size’s company’s access/value team: Relying on multiple internal and external support due to limited resources
  • Identifying the right partners (both internal and external): A key to support market access strategic and tactical implementations.
  • Behaviors & skill required : Agility and strong cross-functional alignment (with sales & marketing teams in particular) is instrumental in achieving your goals
Quentin L'Huillier

Global Access & Business Intelligence Manager

Echosens

International Sales Director Italy, Central Europe, Russia and Eurasia
Echosens

Break
09:40 NYC/15:40 Paris
The impact of registries, AI & big data on MedTech access agreements
10:10 NYC/16:10Paris
Academic Perspective
  • Evolving drug development context & challenges for Market access
  • RWE initiatives
  • RWE acceptability for device-decision making process
  • Renewed interest in performance-based agreements and new types of deals
  • MedTech partnerships in RWE era
Mondher Toumi

Professor of Public Health
University of Aix-Marseille 

Demonstrating the value of MedTech digital solutions to Payers and HTAs
10:40 NYC/16:40 Paris

Former Foundation Medicine Access Innovation and PHC Lead, Pharma International, F. Hoffmann-La Roche
Chair of the “Funding Medical Technologies” group, MedTech Europe

Panel discussion: Implementing device & diagnostic value-based models to satisfy payer needs and build trust
11:10 NYC/17:10 Paris
  • What can the industry do to better reflect the product’s through value in the product’s dossier?
  • Overcoming measurement, monitoring & implementation difficulties in reality
  • How can companies adjust their value demonstration in global markets? What are the different ‘’value’’ requirements in different markets?
Quentin L'Huillier

Global Access & Business Intelligence Manager

Echosens

Larry Dooley

Vice President National Accounts/Pricing
Stryker 

Former Foundation Medicine Access Innovation and PHC Lead, Pharma International, F. Hoffmann-La Roche
Chair of the “Funding Medical Technologies” group, MedTech Europe

Director, Market Access & Economic Policies
MedTech Europe

Mondher Toumi

Professor of Public Health
University of Aix-Marseille 

Director Reimbursement Germany
CytoSorbents Corporation

End of day two
11:50 NYC/17:50 Paris

EVENT PARTNERS

Speaker Biographies

Markus Ott

Former 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.

Berit Dahl

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.

Yves Verboven

Director, Market Access & Economic Policies
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.

Alexander Natz

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.

Frank Semrau

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.

Franziska Preissing

Director Reimbursement Germany
CytoSorbents Corporation

Being a marketing expert with over a decade of international experience in the medical device industry, Franziska Preissing has been able to gather extensive experience, particularly in the field of introducing innovative products and therapies into intensive care and cardiac surgery. In the position of International Marketing Director of several medical device companies, as well working as a consultant, she has, over the years, acquired profound knowledge on reimbursement strategies and health economics, with a focus on how to proceed as a small and medium sized enterprise. Today Franziska Preissing is responsible for global reimbursement strategies and health economics at CytoSorbents Europe, who launched the CytoSorb adsorber, an extracorporeal therapy that enables innovative adsorption in SIRS (systemic inflammatory response syndrome) and sepsis patients.

Nicolas de Ricou

International Sales Director Italy, Central Europe, Russia and Eurasia
Echosens

Nicolas holds a Master in Business from ESSEC (2008) and a master in History from the Sorbonne University in Paris (2005).

Having started as a consultant for Izsak Grapin & Associés in 2006 where he worked noticeably for ROCHE Pharma, he joined the Consumer Products division of L’OREAL in 2010 as a territory Manager to develop sales through the structuring and the optimization of the local distribution network. In 2012, he integrated L’OREAL Marketing team in Paris to reinforce the Matrix haircare brand in France.

After 2 years with Septodont where he managed and developed the international distribution network in the CIS Countries, he joins Echosens in 2017 where he currently works as International Sales Director for Italy, Central Europe, Russia and Eurasia.

Tove Holm-Larsen

Guest Professor, Health Economic Evidence 
University of Ghent

Tove is a professor of health economic evidence at the University of Ghent.

Tove has more than 20 years pharmaceutical experience in the field of health economics, outcome research, and evidence based documentation of health improvements. 

Stephen Hull

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.

Ernesto M. Nogueira

CEO and Founder
ValueConnected

Ernesto is the Founder and Managing Director of ValueConnected. He has over 23

years of experience leading healthcare strategies to drive access and expansion for new products, developing value propositions for both public and private stakeholders and assessing global market opportunities. He has worked for both government agencies and global healthcare companies in roles ranging from strategic marketing and new product development to health economics and reimbursement. Ernesto has led several Market Access projects across Europe, US, Middle East and Latin America. Ernesto holds an MBA from the University of Texas at Austin and is fluent in English, Spanish and Portuguese.

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Pricing & Registration

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