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The 2018 industry pushing  agenda 

07:30 - 08:50
Registration & Coffee in the Exhibition Area
08:50 - 09:00
Chairman Opening Remarks

NICE Anne-Toni Rodgers Former Global Head Operations Payer & Real World Evidence AstraZeneca and Founding Director NICE

09:00 - 09:25
The Impact of Innovation on Market Access
  • Better: Empower R&D to differentiate your company through innovation in the time of tighter access requirements
  • Faster: Streamline your development process with more payer interactions earlier in the process
  • Smarter: Create higher quality, fluid and adaptable evidence packages

Janssen Steve Wooding Head, Global Commercial and Market Access Strategy Organisation Janssen

09:25 - 09:55
Case study: The proliferation of health care data has created the opportunity for life sciences innovators to drive insights across the value chain using real-world evidence (RWE)
  • Understand how the convergence of capabilities from new technology platforms to external partnerships is creating new operating models
  • Learn how a major biopharma company has found success utilising evidence as a critical asset to inform decision-making
  • Examine an industry-leading, global platform spanning from data ingestion to knowledge sharing and how it is improving R&D

Deloitte MCS Limited Sebastien Burnett Director Deloitte MCS Limited

Celgene Patrick Loerch Senior Director, Data Sciences Celgene

09:55 - 10:35
Panel: Shape transition to a data-led world with external education, collaboration and partnership
  • Build trust in real-world evidence (RWE) amongst regulators and payers with consistent behaviour across the industry
  • Reshape public perception of data use to make data sharing the new norm
  • Unleash Europe’s real-world study possibilities by aiding the advancement of data linkage capabilities

Takeda Silvia Nicht Head of Market Access & Value Demonstration Europe & Canada Takeda

NIHR Sheila McCorkindale Local Clinical Research Speciality Lead (Primary Care), NIHR

Sanofi Chris Chinn Head of RWE Strategy for Market Access Sanofi

PAREXEL Bengt Anell Senior Director, Real World Evidence PAREXEL

10:35 - 11:00
Coffee Break and Networking in the Exhibition Area
11:00 - 11:25
Case study: Explore how the IMI’s flagship Big Data for Better Outcomes (BD4BO) programme is shaping sustainable, outcomes-driven healthcare in Europe
  • Hear about the IMI BD4BO programme, it’s vision, objectives and comprising disease-specific and enabling projects
  • Learn about the development of capabilities through the defining of outcomes measures and the development of data and informatics platforms
  • Understand how the programme is tackling data privacy issues with the development of minimum data privacy standards, and address legal and ethical issues of sharing data

ABPI Dr. Shahid Hanif Head of Health Data and Outcomes ABPI

11:25 - 12:35
Interactive Roundtable Discussions
  • Understand the private payer model in France
  • Italian innovation: Performance pricing models to gain reimbursement
  • How to create win-win situations in contracts between payers and pharma companies?
  • The use of RWE to inform drug pricing and reimbursement decisions in Canada: pharma perceptions, current platforms, barriers and limitations, and future developments
  • Learn about the new strategic drug policy in Poland
  • Involve payers earlier to create better value propositions
  • Discuss emerging data models (i.e. standardised formats) and data automation techniques (i.e. converting multiple data sources to these standards)
  • Uses of RWE/Big Data in clinical trials: is it a real need or only new trend/reimagined hop topic?
  • Real-world patients: Discover how to further bring the patient voice into the development of RWD processes
  • Label extension on existing therapies – how best to use RWE? The case of Oncology
  • Academic collaboration in real-world studies: An underused resource?

Instituto Superiore di Sanità Marco Marchetti Director National Center for Health Technology Assessment Instituto Superiore di Sanità

NIHDI Vinciane Knappenberg Coordinator for Procedures – Directorate Pharmaceutical Policy NIHDI

CADTH Tarry Ahuja Manager of Program Development (Drug) CADTH

AOK Hessen Isabella Erb-Hermann Member of the executive board AOK Hessen

AXA Charles De Cidrac Director of Health AXA

Ministry of Health, Poland Iga Lipska Director of Drug Policy and Pharmacy Department, Ministry of Health, Poland

NICE Carla Deakin Associate Director, Office of Market Access NICE

12:35 - 13:55
Lunch and Networking in the Exhibition Area
RWE
Access
13:55 - 14:00
Chairman Opening Remarks

Syneos Health Alastair MacDonald Vice President, Client Engagement, Real World and Late Phase Syneos Health

Chairman Opening Remarks

NICE Anne-Toni Rodgers Former Global Head Operations Payer & Real World Evidence AstraZeneca and Founding Director NICE

14:00 - 14:30
Build a framework for considering RWE as part of Integrated Brand Planning
  • Learn how to better demonstrate effectiveness of marketed products to support RCTs
  • Understand how to identify and present data generation needs from a recent Bayer implementation example
  • Explore how RWE methodology differs for a given therapeutic area and/or brand

Bayer Shurjeel Choudhri SVP and Head, Medical & Scientific Affairs Bayer

Engaging early with NICE – why and how?
  • The rapidly evolving landscape requires new approaches on the product development to adoption journey
  • Early engagement is a key enabler
  • How NICE is facilitating early engagement

NICE Carla Deakin Associate Director, Office for Market Access NICE

14:30 - 15:00
Move From Real-World Data to Real World Intelligence Using Next-Generation Analytics
  • Discover the pivotal role of the analytics platform in enabling diversity, managing scale and delivering trustworthy insights
  • Learn about the impact of disruptive trends of Artificial Intelligence, Machine Learning and IOT (Internet of Things) on RWE
  • Hear about new areas of value for market access across the entire product life cycle - driven by evidence, enabled by analytics

SAS Institute Patrick Homer Advisory Industry Consultant SAS Institute

Four reasons your pricing and market access strategy fails, of which two are false
  • European pricing and market access challenges and requirements
  • Distinguish between the true and false reasons your European pricing and market access strategy fails
  • Identify when to initiate pre-launch efforts and what to focus on from a European pricing and market access perspective

Lundbeck Martin Strandberg-Larsen Director and Head of Global Pricing Lundbeck

15:00 - 16:05
Pharma-only break-out workshops:
Workshop 1: Why the future of real world research lies in collaboration with local physician groups and patients leveraging real world data

A 60 minute interactive workshop with Health iQ, GE Healthcare Partners and an NHS partner.

  • Learn how a pioneering collaboration is enabling Primary Care clinicians to use real world data to run innovative studies that help to inform local priorities and explore opportunities for personalised interventions.
  • Explore how you can engage with the partnership to work with local physicians to drive research with available data.
  • We will have a hands-on discussion on how we co-create real world research studies that are grounded in the needs of the individual person and aimed at generating insights that benefit everyone - patients, the system and industry.

Health iQ Hassan Chaudhury Chief Commercial Officer Health iQ

Health iQ Rebeka Morley Director of Accounts Health iQ

GE Healthcare Dr. Abdullahi Sheriff Partner & Senior Client Leader GE Healthcare

NHS Paul Massey Partner & Executive Director of Business Development & Finance Minden Family Practices & Tower Family Healthcare

16:05 - 16:30
Coffee Break and Networking in the Exhibition Area
16:30 - 17:10
Panel: Accelerate the adoption of pragmatic trials in Europe
  • Build internal confidence in pragmatic studies with understanding of long-term capabilities required to run trials more cost-effectively
  • Understand best practise study design variables to more effectively gain accurate real-world results
  • Explore the collaborative undertaking required with the full stakeholder environment to meet operational capability requirements
  • Maintain full transparency by building patient education and consent programs into study design

NIHR Clinical Research Network Martin Gibson Director Greater Manchester NIHR Clinical Research Network

Company_Name Tina Lidén Mascher Strategist, International Registry Projects and Collaborations Swedish Association of Local Authorities and Regions

AstraZeneca Mats Sundgren Director Health Informatics AstraZeneca

Panel: Take early access mainstream: explore how early access can support your drug development programme
  • Gain a sound understanding of the early access environment, evaluate unmet need and the potential assets to meet this need and set the right precedent for a full-scale launch
  • Learn how to formulate the best launch plan in concert with the patient ecosystem and payers
  • Utilize early access data to support your clinical development plan by tailoring R&D, H2H studies and health economics outcomes
  • Understand the reimbursement options and possibilities at the EU level and what payers need in order to recognise value beyond efficacy in clinical studies

EUCOPE Dr. Alexander Natz Secretary-General EUCOPE

UCB Florence Penicaud Head of Market Access, Switzerland UCB

Humedics Dimitar Tonev Medical Director Humedics

17:10 - 17:40
How innovation in data networks is driving advances in Real-World Evidence generation
  • The increasing need for deep data insights is driving new data network approaches
  • Explore the challenges and opportunities of new federated networks (e.g. Sentinel, OHDSI, EHDN)
  • Deep dive into how the FDA & OHDSI collaboration "BEST" is expanding safety/efficacy monitoring

IQVIA Christian Reich Vice President, RWAS IQVIA

Private healthcare payer perspectives and initiatives in the context of a challenged Healthcare System & Ageing Population

More information coming soon…

AXA Charles De Cidrac Director of Health AXA

17:40 - 18:10
Case Study: Explore how AstraZeneca’s pioneering pragmatic RWD studies are influencing regulatory decision-making
  • Understand how the study design incorporated a range of RWD sources to assess the outcomes of 300,000+ patients internationally
  • See how payer and regulatory decision-making has been accelerated by the successful findings of the type 2 diabetes study

AstraZeneca Mats Sundgren Director Health Informatics AstraZeneca

End of Day 1 Market Access Track
18:10 - 19:40
Networking Drinks Reception in the Exhibition Area
RWE
Access
08:55 - 09:00
Chairman Opening Remarks
Chairman Opening Remarks

IQVIA Thomas Baker Vice President, Consulting Services, Central, Southern, and Eastern Europe IQVIA

09:00 - 09:30
Case study: Federated networks: the gateway to cross regional real-world evidence – learning from EMIF and looking towards EHDN (European Health Data Network)
  • The next decade of RWD/RWE-based research in Europe – the federated model and edge analytics
  • Data harmonisation – an international initiative and the Rosetta Stone of RWD?
  • Understand how to meet the needs of multiple stakeholders through key actor collaboration

Janssen R&D Bart Vannieuwenhuyse Senior Director Health Information Sciences Janssen R&D

Enable value-based pricing with the predictive power of real-world evidence
  • Enhance the value of post-registrational evidence with the use of predictive analytics
  • Create multi-stakeholder partnerships founded on new insights allowing for sustainable access
  • Understand the mid–long term private–public partnerships and risk-sharing needed to improve the lifetime profile of certain diseases

Takeda Ioannis Petrakis Head of Global GI Patient Access and Value Takeda

09:30 - 10:00
Learn how to build an operational and user-friendly RWE platform
  • Understand the complexities of modelling Real-World Data and how an enterprise multi-model database solves this challenge
  • Connecting graph-based data such as ICD taxonomies with Patient Electronic Data Records
  • Creating a flexible platform to easily add and combine new data sources

MarkLogic Sasha Mitrovich Principal Sales Engineer MarkLogic

MarkLogic Bill Fox, JD, MA CTO, Healthcare, Life Sciences and Insurance MarkLogic

Roundtable Discussions
  • Accelerated regulatory pathways in the EU - does an early MA hurt or help market access preparations?
  • Early access programmes - is it more appropriate to request reimbursement or provide for free? 
  • Does an early launch in the UK still hold value for a European market access strategy?
  • Pricing and reimbursement preparation for personalised medicine - what new approaches will be needed from manufacturers and payers?
  • Is the time now for agreements to be made between payers and manufacturers linking early access programmes to drug pricing/reimbursement?
10:00 - 10:30
How new technologies (CRSPR, nanotechnology, machine learning) are impacting the traditional treatment model
  • Move from value-based pricing to “wellness-based pricing”
  • See the evolution of evidence generation in supporting value

Eli Lilly Enkeleida Nikai Director of Real World Evidence Eli Lilly

Innovative Pricing Models for gene therapy reimbursement
  • Overcome the challenges caused by one-time treatments in gene therapy
  • Understand the wider implications of these models with the growth in personalised medicine
  • Glimpse the future of reimbursement in a world where all medicine is personalised

European Confederation of Pharmaceutical Entrepreneurs Dr. Alexander Natz Secretary-General EUCOPE

10:30 - 11:00
Case study: The new federated EHR technology approach – the case of InSite hospital network in Europe
  • Understand how the InSite EHR platform is enhancing protocol design and patient recruitment across Europe
  • Learn how both industry and health care can benefit from EHR enabled services
  • See how understanding of the full stakeholder environment involved enables optimum use of EHR

AstraZeneca Mats Sundgren Director Health Informatics AstraZeneca

The cures are coming: How to secure market access for high-value drugs
  • Understand that the emergence of curative treatments requires innovative payment models for market access
  • Get data on the global pipeline for “cures” and estimates for budget impact
  • Learn about payer perspectives on payment models for “cures”

University of Southern California Soeren Mattke Professor and Director, Center for Improving Chronic Illness Care University of Southern California

11:00 - 11:25
Coffee Break and Networking in the Exhibition Area
11:25 - 12:05
Panel: Explore the differences in RWE assessment between different European regulatory and payer bodies
  • See where RWE fits into the overall evidence hierarchy amongst a number of key European assessment agencies
  • Understand how to tailor your evidence generation strategy to account for the differences in preference between organisations

Eli Lilly Enkeleida Nikai Director of Real World Evidence Eli Lilly

Bayer Stefan Schröder VP, Head of Data Generation & Business Excellence Bayer

Humedics Dimitar Tonev Medical Director Humedics

Panel: Differentiate between payers and meet individual needs for better access
  • Incorporate the local & national payer perspective early in the drug development lifecycle to support commercialisation post-launch
  • Understand how your therapy will fit into or change current and future treatment paradigms
  • Develop a product strategy that leverages the current and future health delivery system and infrastructure for successful therapy uptake

AXA Charles De Cidrac Director of Health AXA

NICE Anne-Toni Rodgers Former Global Head Operations Payer & Real World Evidence AstraZeneca and Founding Director NICE

CADTH Tarry Ahuja Manager of Program Development (Drug) CADTH

12:05 - 12:35
Changing trends in real-world evidence
  • Explore emerging changes to the regulatory landscape and payer expectations
  • See the paradigms of data access boosting real-world study capabilities
  • Understand the increasing impact of the patient voice on the future of RWE
  • What is in store for sponsor-CRO partnerships

Syneos Health Alastair MacDonald Vice President, Client Engagement, Real World and Late Phase Syneos Health

How Blockchain can enable value-based Pricing and unlock RWE insights 
  • Learn how utilising blockchain solutions can enable value-based healthcare delivery
  • Grasp how Blockchain solutions for Pricing, Reimbursement and RWE can work for patients and industry.
  • Find out how to overcome barriers to patient access and innovative pricing, reduce costs for all stakeholders, and bypass infrastructural limitations to drive value improvement

Health iQ Hassan Chaudhury Chief Commercial Officer Health iQ

Digipharm Ahmed Abdulla Founder/CEO Digipharm

12:35 - 13:05
Use real-world data to satisfy regulatory pathways for label change
  • Hear about developments in the European and U.S. regulatory spaces around the use of RWD
  • Learn how this is providing increased transparency and opportunity for use of such data to expand drug labels
  • Understand the current limitations for potential label change based on such data sources

Astellas Billy Franks Senior Director, Head of Analytics, Real-World Informatics Astellas

Improve access through innovative pricing models
  • Navigate the access challenges associated with alternative pricing schemes for expanded therapy uptake
  • Review the alternative payment model spectrum and position your company in a regime measured by performance and outcomes
  • Understand the European appetite for pricing schemes and build models which payers will want to buy into

Roche Esther Haik Regional Market Access Roche

13:05 - 14:15
Lunch and Networking in the Exhibition Area
14:15 - 14:45
Case study: See the research opportunities and challenges within the MSBase international registry
  • Real-world data solutions in the post-marketing world: the multiple sclerosis experience
  • Understand the methods for separating drug signals from bias in observational data
  • Explore the multitude of pharma / disease registry collaborations across Europe in a comparative effectiveness analysis
  • Big data: Big MS and beyond

Synergus Tim Spelman Senior Scientist Synergus

Panel: Healthcare out of the hospital and into the patient’s home
  • Tap into strategic partnerships, which will improve patient satisfaction and optimise overall patient care
  • Position industry as a credible expert and best partner to stimulate innovation, efficiency and better service design
  • Plug healthcare gaps and alleviate capacity constraints in the health economy to optimise health gains and reduce health inequalities

Bayer Amanda Cunnington Head of Market Access Bayer

UCB Mata Charokopou Market Access & Patient Value Lead, UCB

Celgene Jessica Leygues Patient Advocacy Lead Celgene

14:45 - 15:30
Panel: Generate high quality RWD during clinical trials leveraging the latest wave of digital health tools
  • Map and evaluate the myriad providers to ensure investment leads to meeting evidence generation needs
  • Ensure data impact through early communication with regulators, HTAs and payers to increase relevance and quality
  • Work with patients to maximise personal device use and improve data intake with understanding of device potential pitfalls and perceived benefits
  • Use proof-of-concept trials to reduce investment risk with greater understanding of product real-life performance

Merck KGaA Merat Bagha Director of Marketing, Digital Health & Patient Care Business Merck KGaA

UCB Hervé Dumas Patient Care Solutions Lead UCB

Pfizer Thomas Kleine BT Country Lead - Germany, Austria & Switzerland Pfizer

End of Day 2 Market Access Track
07:30 - 08:50
Registration & Coffee in the Exhibition Area
08:50 - 09:00
Chairman Opening Remarks

NICE Anne-Toni Rodgers Former Global Head Operations Payer & Real World Evidence AstraZeneca and Founding Director NICE

09:00 - 09:25
The Impact of Innovation on Market Access
  • Better: Empower R&D to differentiate your company through innovation in the time of tighter access requirements
  • Faster: Streamline your development process with more payer interactions earlier in the process
  • Smarter: Create higher quality, fluid and adaptable evidence packages

Janssen Steve Wooding Head, Global Commercial and Market Access Strategy Organisation Janssen

09:25 - 09:55
Case study: The proliferation of health care data has created the opportunity for life sciences innovators to drive insights across the value chain using real-world evidence (RWE)
  • Understand how the convergence of capabilities from new technology platforms to external partnerships is creating new operating models
  • Learn how a major biopharma company has found success utilising evidence as a critical asset to inform decision-making
  • Examine an industry-leading, global platform spanning from data ingestion to knowledge sharing and how it is improving R&D

Deloitte MCS Limited Sebastien Burnett Director Deloitte MCS Limited

Celgene Patrick Loerch Senior Director, Data Sciences Celgene

09:55 - 10:35
Panel: Shape transition to a data-led world with external education, collaboration and partnership
  • Build trust in real-world evidence (RWE) amongst regulators and payers with consistent behaviour across the industry
  • Reshape public perception of data use to make data sharing the new norm
  • Unleash Europe’s real-world study possibilities by aiding the advancement of data linkage capabilities

Takeda Silvia Nicht Head of Market Access & Value Demonstration Europe & Canada Takeda

NIHR Sheila McCorkindale Local Clinical Research Speciality Lead (Primary Care), NIHR

Sanofi Chris Chinn Head of RWE Strategy for Market Access Sanofi

PAREXEL Bengt Anell Senior Director, Real World Evidence PAREXEL

10:35 - 11:00
Coffee Break and Networking in the Exhibition Area
11:00 - 11:25
Case study: Explore how the IMI’s flagship Big Data for Better Outcomes (BD4BO) programme is shaping sustainable, outcomes-driven healthcare in Europe
  • Hear about the IMI BD4BO programme, it’s vision, objectives and comprising disease-specific and enabling projects
  • Learn about the development of capabilities through the defining of outcomes measures and the development of data and informatics platforms
  • Understand how the programme is tackling data privacy issues with the development of minimum data privacy standards, and address legal and ethical issues of sharing data

ABPI Dr. Shahid Hanif Head of Health Data and Outcomes ABPI

11:25 - 12:35
Interactive Roundtable Discussions
  • Understand the private payer model in France
  • Italian innovation: Performance pricing models to gain reimbursement
  • How to create win-win situations in contracts between payers and pharma companies?
  • The use of RWE to inform drug pricing and reimbursement decisions in Canada: pharma perceptions, current platforms, barriers and limitations, and future developments
  • Learn about the new strategic drug policy in Poland
  • Involve payers earlier to create better value propositions
  • Discuss emerging data models (i.e. standardised formats) and data automation techniques (i.e. converting multiple data sources to these standards)
  • Uses of RWE/Big Data in clinical trials: is it a real need or only new trend/reimagined hop topic?
  • Real-world patients: Discover how to further bring the patient voice into the development of RWD processes
  • Label extension on existing therapies – how best to use RWE? The case of Oncology
  • Academic collaboration in real-world studies: An underused resource?

Instituto Superiore di Sanità Marco Marchetti Director National Center for Health Technology Assessment Instituto Superiore di Sanità

NIHDI Vinciane Knappenberg Coordinator for Procedures – Directorate Pharmaceutical Policy NIHDI

CADTH Tarry Ahuja Manager of Program Development (Drug) CADTH

AOK Hessen Isabella Erb-Hermann Member of the executive board AOK Hessen

AXA Charles De Cidrac Director of Health AXA

Ministry of Health, Poland Iga Lipska Director of Drug Policy and Pharmacy Department, Ministry of Health, Poland

NICE Carla Deakin Associate Director, Office of Market Access NICE

12:35 - 13:55
Lunch and Networking in the Exhibition Area
RWE
Access
13:55 - 14:00
Chairman Opening Remarks

Syneos Health Alastair MacDonald Vice President, Client Engagement, Real World and Late Phase Syneos Health

Chairman Opening Remarks

NICE Anne-Toni Rodgers Former Global Head Operations Payer & Real World Evidence AstraZeneca and Founding Director NICE

14:00 - 14:30
Build a framework for considering RWE as part of Integrated Brand Planning
  • Learn how to better demonstrate effectiveness of marketed products to support RCTs
  • Understand how to identify and present data generation needs from a recent Bayer implementation example
  • Explore how RWE methodology differs for a given therapeutic area and/or brand

Bayer Shurjeel Choudhri SVP and Head, Medical & Scientific Affairs Bayer

Engaging early with NICE – why and how?
  • The rapidly evolving landscape requires new approaches on the product development to adoption journey
  • Early engagement is a key enabler
  • How NICE is facilitating early engagement

NICE Carla Deakin Associate Director, Office for Market Access NICE

14:30 - 15:00
Move From Real-World Data to Real World Intelligence Using Next-Generation Analytics
  • Discover the pivotal role of the analytics platform in enabling diversity, managing scale and delivering trustworthy insights
  • Learn about the impact of disruptive trends of Artificial Intelligence, Machine Learning and IOT (Internet of Things) on RWE
  • Hear about new areas of value for market access across the entire product life cycle - driven by evidence, enabled by analytics

SAS Institute Patrick Homer Advisory Industry Consultant SAS Institute

Four reasons your pricing and market access strategy fails, of which two are false
  • European pricing and market access challenges and requirements
  • Distinguish between the true and false reasons your European pricing and market access strategy fails
  • Identify when to initiate pre-launch efforts and what to focus on from a European pricing and market access perspective

Lundbeck Martin Strandberg-Larsen Director and Head of Global Pricing Lundbeck

15:00 - 16:05
Pharma-only break-out workshops:
Workshop 1: Why the future of real world research lies in collaboration with local physician groups and patients leveraging real world data

A 60 minute interactive workshop with Health iQ, GE Healthcare Partners and an NHS partner.

  • Learn how a pioneering collaboration is enabling Primary Care clinicians to use real world data to run innovative studies that help to inform local priorities and explore opportunities for personalised interventions.
  • Explore how you can engage with the partnership to work with local physicians to drive research with available data.
  • We will have a hands-on discussion on how we co-create real world research studies that are grounded in the needs of the individual person and aimed at generating insights that benefit everyone - patients, the system and industry.

Health iQ Hassan Chaudhury Chief Commercial Officer Health iQ

Health iQ Rebeka Morley Director of Accounts Health iQ

GE Healthcare Dr. Abdullahi Sheriff Partner & Senior Client Leader GE Healthcare

NHS Paul Massey Partner & Executive Director of Business Development & Finance Minden Family Practices & Tower Family Healthcare

16:05 - 16:30
Coffee Break and Networking in the Exhibition Area
16:30 - 17:10
Panel: Accelerate the adoption of pragmatic trials in Europe
  • Build internal confidence in pragmatic studies with understanding of long-term capabilities required to run trials more cost-effectively
  • Understand best practise study design variables to more effectively gain accurate real-world results
  • Explore the collaborative undertaking required with the full stakeholder environment to meet operational capability requirements
  • Maintain full transparency by building patient education and consent programs into study design

NIHR Clinical Research Network Martin Gibson Director Greater Manchester NIHR Clinical Research Network

Company_Name Tina Lidén Mascher Strategist, International Registry Projects and Collaborations Swedish Association of Local Authorities and Regions

AstraZeneca Mats Sundgren Director Health Informatics AstraZeneca

Panel: Take early access mainstream: explore how early access can support your drug development programme
  • Gain a sound understanding of the early access environment, evaluate unmet need and the potential assets to meet this need and set the right precedent for a full-scale launch
  • Learn how to formulate the best launch plan in concert with the patient ecosystem and payers
  • Utilize early access data to support your clinical development plan by tailoring R&D, H2H studies and health economics outcomes
  • Understand the reimbursement options and possibilities at the EU level and what payers need in order to recognise value beyond efficacy in clinical studies

EUCOPE Dr. Alexander Natz Secretary-General EUCOPE

UCB Florence Penicaud Head of Market Access, Switzerland UCB

Humedics Dimitar Tonev Medical Director Humedics

17:10 - 17:40
How innovation in data networks is driving advances in Real-World Evidence generation
  • The increasing need for deep data insights is driving new data network approaches
  • Explore the challenges and opportunities of new federated networks (e.g. Sentinel, OHDSI, EHDN)
  • Deep dive into how the FDA & OHDSI collaboration "BEST" is expanding safety/efficacy monitoring

IQVIA Christian Reich Vice President, RWAS IQVIA

Private healthcare payer perspectives and initiatives in the context of a challenged Healthcare System & Ageing Population

More information coming soon…

AXA Charles De Cidrac Director of Health AXA

17:40 - 18:10
Case Study: Explore how AstraZeneca’s pioneering pragmatic RWD studies are influencing regulatory decision-making
  • Understand how the study design incorporated a range of RWD sources to assess the outcomes of 300,000+ patients internationally
  • See how payer and regulatory decision-making has been accelerated by the successful findings of the type 2 diabetes study

AstraZeneca Mats Sundgren Director Health Informatics AstraZeneca

End of Day 1 Market Access Track
18:10 - 19:40
Networking Drinks Reception in the Exhibition Area

Purchase the Post-Conference Materials

Event Presentations • Event Audio • On Demand Subscription

RWE
Access
08:55 - 09:00
Chairman Opening Remarks
Chairman Opening Remarks

IQVIA Thomas Baker Vice President, Consulting Services, Central, Southern, and Eastern Europe IQVIA

09:00 - 09:30
Case study: Federated networks: the gateway to cross regional real-world evidence – learning from EMIF and looking towards EHDN (European Health Data Network)
  • The next decade of RWD/RWE-based research in Europe – the federated model and edge analytics
  • Data harmonisation – an international initiative and the Rosetta Stone of RWD?
  • Understand how to meet the needs of multiple stakeholders through key actor collaboration

Janssen R&D Bart Vannieuwenhuyse Senior Director Health Information Sciences Janssen R&D

Enable value-based pricing with the predictive power of real-world evidence
  • Enhance the value of post-registrational evidence with the use of predictive analytics
  • Create multi-stakeholder partnerships founded on new insights allowing for sustainable access
  • Understand the mid–long term private–public partnerships and risk-sharing needed to improve the lifetime profile of certain diseases

Takeda Ioannis Petrakis Head of Global GI Patient Access and Value Takeda

09:30 - 10:00
Learn how to build an operational and user-friendly RWE platform
  • Understand the complexities of modelling Real-World Data and how an enterprise multi-model database solves this challenge
  • Connecting graph-based data such as ICD taxonomies with Patient Electronic Data Records
  • Creating a flexible platform to easily add and combine new data sources

MarkLogic Sasha Mitrovich Principal Sales Engineer MarkLogic

MarkLogic Bill Fox, JD, MA CTO, Healthcare, Life Sciences and Insurance MarkLogic

Roundtable Discussions
  • Accelerated regulatory pathways in the EU - does an early MA hurt or help market access preparations?
  • Early access programmes - is it more appropriate to request reimbursement or provide for free? 
  • Does an early launch in the UK still hold value for a European market access strategy?
  • Pricing and reimbursement preparation for personalised medicine - what new approaches will be needed from manufacturers and payers?
  • Is the time now for agreements to be made between payers and manufacturers linking early access programmes to drug pricing/reimbursement?
10:00 - 10:30
How new technologies (CRSPR, nanotechnology, machine learning) are impacting the traditional treatment model
  • Move from value-based pricing to “wellness-based pricing”
  • See the evolution of evidence generation in supporting value

Eli Lilly Enkeleida Nikai Director of Real World Evidence Eli Lilly

Innovative Pricing Models for gene therapy reimbursement
  • Overcome the challenges caused by one-time treatments in gene therapy
  • Understand the wider implications of these models with the growth in personalised medicine
  • Glimpse the future of reimbursement in a world where all medicine is personalised

European Confederation of Pharmaceutical Entrepreneurs Dr. Alexander Natz Secretary-General EUCOPE

10:30 - 11:00
Case study: The new federated EHR technology approach – the case of InSite hospital network in Europe
  • Understand how the InSite EHR platform is enhancing protocol design and patient recruitment across Europe
  • Learn how both industry and health care can benefit from EHR enabled services
  • See how understanding of the full stakeholder environment involved enables optimum use of EHR

AstraZeneca Mats Sundgren Director Health Informatics AstraZeneca

The cures are coming: How to secure market access for high-value drugs
  • Understand that the emergence of curative treatments requires innovative payment models for market access
  • Get data on the global pipeline for “cures” and estimates for budget impact
  • Learn about payer perspectives on payment models for “cures”

University of Southern California Soeren Mattke Professor and Director, Center for Improving Chronic Illness Care University of Southern California

11:00 - 11:25
Coffee Break and Networking in the Exhibition Area
11:25 - 12:05
Panel: Explore the differences in RWE assessment between different European regulatory and payer bodies
  • See where RWE fits into the overall evidence hierarchy amongst a number of key European assessment agencies
  • Understand how to tailor your evidence generation strategy to account for the differences in preference between organisations

Eli Lilly Enkeleida Nikai Director of Real World Evidence Eli Lilly

Bayer Stefan Schröder VP, Head of Data Generation & Business Excellence Bayer

Humedics Dimitar Tonev Medical Director Humedics

Panel: Differentiate between payers and meet individual needs for better access
  • Incorporate the local & national payer perspective early in the drug development lifecycle to support commercialisation post-launch
  • Understand how your therapy will fit into or change current and future treatment paradigms
  • Develop a product strategy that leverages the current and future health delivery system and infrastructure for successful therapy uptake

AXA Charles De Cidrac Director of Health AXA

NICE Anne-Toni Rodgers Former Global Head Operations Payer & Real World Evidence AstraZeneca and Founding Director NICE

CADTH Tarry Ahuja Manager of Program Development (Drug) CADTH

12:05 - 12:35
Changing trends in real-world evidence
  • Explore emerging changes to the regulatory landscape and payer expectations
  • See the paradigms of data access boosting real-world study capabilities
  • Understand the increasing impact of the patient voice on the future of RWE
  • What is in store for sponsor-CRO partnerships

Syneos Health Alastair MacDonald Vice President, Client Engagement, Real World and Late Phase Syneos Health

How Blockchain can enable value-based Pricing and unlock RWE insights 
  • Learn how utilising blockchain solutions can enable value-based healthcare delivery
  • Grasp how Blockchain solutions for Pricing, Reimbursement and RWE can work for patients and industry.
  • Find out how to overcome barriers to patient access and innovative pricing, reduce costs for all stakeholders, and bypass infrastructural limitations to drive value improvement

Health iQ Hassan Chaudhury Chief Commercial Officer Health iQ

Digipharm Ahmed Abdulla Founder/CEO Digipharm

12:35 - 13:05
Use real-world data to satisfy regulatory pathways for label change
  • Hear about developments in the European and U.S. regulatory spaces around the use of RWD
  • Learn how this is providing increased transparency and opportunity for use of such data to expand drug labels
  • Understand the current limitations for potential label change based on such data sources

Astellas Billy Franks Senior Director, Head of Analytics, Real-World Informatics Astellas

Improve access through innovative pricing models
  • Navigate the access challenges associated with alternative pricing schemes for expanded therapy uptake
  • Review the alternative payment model spectrum and position your company in a regime measured by performance and outcomes
  • Understand the European appetite for pricing schemes and build models which payers will want to buy into

Roche Esther Haik Regional Market Access Roche

13:05 - 14:15
Lunch and Networking in the Exhibition Area
14:15 - 14:45
Case study: See the research opportunities and challenges within the MSBase international registry
  • Real-world data solutions in the post-marketing world: the multiple sclerosis experience
  • Understand the methods for separating drug signals from bias in observational data
  • Explore the multitude of pharma / disease registry collaborations across Europe in a comparative effectiveness analysis
  • Big data: Big MS and beyond

Synergus Tim Spelman Senior Scientist Synergus

Panel: Healthcare out of the hospital and into the patient’s home
  • Tap into strategic partnerships, which will improve patient satisfaction and optimise overall patient care
  • Position industry as a credible expert and best partner to stimulate innovation, efficiency and better service design
  • Plug healthcare gaps and alleviate capacity constraints in the health economy to optimise health gains and reduce health inequalities

Bayer Amanda Cunnington Head of Market Access Bayer

UCB Mata Charokopou Market Access & Patient Value Lead, UCB

Celgene Jessica Leygues Patient Advocacy Lead Celgene

14:45 - 15:30
Panel: Generate high quality RWD during clinical trials leveraging the latest wave of digital health tools
  • Map and evaluate the myriad providers to ensure investment leads to meeting evidence generation needs
  • Ensure data impact through early communication with regulators, HTAs and payers to increase relevance and quality
  • Work with patients to maximise personal device use and improve data intake with understanding of device potential pitfalls and perceived benefits
  • Use proof-of-concept trials to reduce investment risk with greater understanding of product real-life performance

Merck KGaA Merat Bagha Director of Marketing, Digital Health & Patient Care Business Merck KGaA

UCB Hervé Dumas Patient Care Solutions Lead UCB

Pfizer Thomas Kleine BT Country Lead - Germany, Austria & Switzerland Pfizer

End of Day 2 Market Access Track

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