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“Policy & Personalised Medicine - Making Access to Personalised Medicine a Reality for

P ti t ”Patients”

Denis Horgan, European Alliance for Personalised Medicine

Aegina, Italy

Key facts about EAPM• The European Alliance for Personalised Medicine (EAPM)• The European Alliance for Personalised Medicine (EAPM)

brings together European healthcare experts and patient advocates involved with major chronic diseases

• EAPM aims to improve patient care by accelerating development, delivery and uptake of personalised medicine and diagnostics. There are over 40 members in the Alliance.

• The EAPM is chaired by Helmut Brand, President of EHFG and David Byrne, Former EU Commissioner for Health. It was launched in March 2012.

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Political/Political Arena

Stakeholder Engagement‐ Communication

EAPM Stakeholders and Engagement

Political/

Insititutional

EAPM

Membership

ACADEMIA

PATIENTS’

Industry

Commission

EMA

Parliament

National Stakeholders

Membership

Pillars

Healthcare Plannes

PATIENTS’ORGANISATIONS

REGULATORS

Cancer Related Organisations

• European Cancer Patient Coalition (ECPC)

• Organisation of European Cancer institutes (OECI)

• EUROCAN Platform

• E-Cancer Medical Science

• European Association of Medical Oncology (ESMO)

Other Disease Organisations• European Association of Urology (EAU)• European Patients Forum• European Parkinson Disease Association• European Kidney Health Alliance• International Diabetes Federation

EURORDIS

EAPM Members

• European Oncology Nurses Association (EONS)

• ECP Biobanks

• European Haematology Association (EHA)

• European Society for Pathology (ESP)

• Cancer Research UK

• European Organisation for Research

• and Treatment of Cancer

• European Association of Cancer Research

• EURORDIS

• European Brain Council

Medical / Academic Organisations

• European Science Foundation

• Karolinska Institute

• European Society of Radiology• Institute for Public Health Genomics (IPHG)

I d tInstitutional Related Observers

• DG ENTER, DG Research, DG SANCO

• MEPS

Insuere

• Association Internationale de la Mutualité

• European Social Insurance Platform

Industry

• EDMA, EuropaBio, Eli-Lilly, Pfizer, Novartis,Amgen, Merck Serono, Siemens, Genomic Healthcare, Roche

Associations

• European Hospital and Healthcare Federatio

• European Association of Pharmaceutical Wholesalers

• Pharmacy Group of the EU

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Specialised Treatment for Europe’s Patient (STEPs) MEPs WG

STEP 1: Ensuring a regulatory environment which allows early patient access to novel and efficacious personalised medicine (PM)

STEP 2: Increasing research and development for PM, while recognising its value

STEP 3: Improving the education and training of healthcare professionals

STEP 4: Supporting new approaches to reimbursement and HTASTEP 4: Supporting new approaches to reimbursement and HTA assessment, required for patient access to PM

STEP 5: Increasing awareness and understanding of PM

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Challenges

PM

Challenges

PM

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Clinical TrialsClinical Trials

Data Protection/

C

Data Protection/

CInequalityInequality

Pharmaco-viglance

Pharmaco-viglance

Inequalityof AccessInequalityof Access

In-Vitro Diagnostic

In-Vitro Diagnostic

Delay in AccessDelay in Access

EU & National/Re

gional Policy

EU & National/Re

gional Policy

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PolicyPolicyAccess totreatemen

t

Access totreatemen

t

HealthLiteracyHealth

Literacy

Educationfor HCP

Educationfor HCP CBH

Setting the FrameworkEuropean

CommissionEuropean Parliament

Parliament Elections

2015 Lux Presidency

Council Conclusion)

Relevant DGs

EAPM EU Engagement on this action

Co c us o )

Formation of a Committeein 2017/18

Open Innovation in

Recommendations on Personalised Medicine

DG Sanco Support from the EPDG ResearchDG ConnectDG Enterprise

)

EAPM Survey

Competitiveness Council Conclusions

Health Council (EPSCO)

December 2014

Lativian & Irish Presidency

DG EnterpriseDG Internal MarketDG Trade

Key regulatory Dossiers: Revisions-EU Clinical Trials DirectiveEU Data Protection DirectiveEU Medical Devices & IVD Directive

EAPM submissions to EU consultations on key dossiersEAPM submissions to EU consultations on key dossiers

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Index

Patient Data & Big Data

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The Perfect Storm

Regulatory Initiatives

Changing Science

Increasing Data Volume,

Variety& Velocity

Shifting Reimbursement

Landscape & Velocity

$

Traditional Approaches are Limited

Lighthouse for PersonalisedMedicine

By 2020, the EU should achievewidespread benefits for patients andwidespread benefits for patients andcitizens from personalised healthcare bydefining in 2015, and subsequentlyexecuting a Data Strategy forPersonalised Medicine to drive policy,regulatory, research and innovationg y,activities to establish a Europe–wide Dataecosystem for personalised medicine.

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The First Health Data Chasm: Care Delivery and Research

DISCOVERY

CLINICAL DEVELOPMENT

QUALITY

SAFETY

ResearchCare Delivery

PERSONALIZED MEDICIINE

DECISION SUPPORT

COST

REVENUE

The Second Health Data Chasm: Users and Their Data

Clinical Admin Financial ‘Omics

Patients

Physicians

ResearchersResearchers

Care Givers

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The Third Health Data Chasm: Institutionsand Collaborators Across The EU

Academic Medical Center

Collaborators

Affiliates

Commission Communication: ‘Towards a Data Driven Economy’

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Draft Conclusion on making access to personalised a reality for patients

• NOTES that DNA sequencing technologies and

genomic data are developing rapidly and that thegenomic data are developing rapidly and that the

expectation is that this will make it possible to use

detailed risk profiling as a basis for targeted

interventions, improving health outcomes and

ensuring more cost-efficient use of healthcare. It may

lead to healthcare practices that are morelead to healthcare practices that are more

personalised, predictive, preventive (e.g.

population screening strategies), and patient-

driven;

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• Foster cooperation on the ll ti h i dcollection, sharing and

management of data necessary for effective research into and development and application of personalised medicine, while safeguarding personal privacy through suitable consent arrangements;

• Promote cross-disciplinary interaction between geneticistsinteraction between geneticists, biostatisticians and other concerned health professionals in order to ensure better understanding of the available data, more efficient integration and interpretation ofintegration and interpretation of information from multiple sources and appropriate decision-making on treatment options;

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• Develop common principles on d t ll ti b d ddata collection based on a sound legal framework and standards enabling the sharing of patient data and the availability of comparable data at EU level, allowing secondary use and analysis of data on a larger scale while ensuring the necessary protection of privacy;

• Examine, based on a study under th P bli H lth P hthe Public Health Programme, how to secure the full potential of Big Data, which is widely used in personalised medicine, in contributing to innovative, efficient and sustainable health systems;

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Bridge the Gap to 2017 (or before): Establishment of an Expert Group that would undertake preparatory work

Remit extends to EU policies relating to the access and utilisation of personal data for health-related purposes. It also includes the

measures needed to ensure continuing public confidence in the use g pof such data

Composition: Civil Society (incl Patients), Academia, Healthcare professionals, Payers, Commission, Parliament, Member States, Data

Protection Authorities, Individuals appointed on the basis of specific expertise

Area 1

Harmonization

Area 2

Self Regulation

Area 3

Patient

Area 4

Interoper-

Area 5

HealthHarmonization Self Regulation Patient Access

Interoperabilty &

StandardsSystem Data

Clinical Trials

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• Kick‐Off:  ESMO Congress, Madrid ‐ EAPM organized a roundtable to bring together multiple stakeholders to address how Europe can stay at the forefront of clinical 

BACKGROUND

p yresearch in oncology in personalized medicine

• Why?• clinical trials supporting personalised medicine:

• require new approaches, • relevant stakeholders need to align on how:

• to best organize these studies • to establish the right evidence • by tailoring access to smaller populations who may benefit from a particular treatment. 

All stakeholders need to align and agree onEvidence requirements (quality, safety & effectiveness, and health economics) to support the

id i t d ti f li d di irapid introduction of personalised medicine

• Patients• Medical professionals• Pharmaceutical company• Diagnostic company• Clinical Investigator• Clinical Investigator• Regulators• HTA bodies

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1. What solutions could be offered to optimize

5 Questions to be addressed:

research to better address the objectives of different stakeholders with competing interests

5 Questions to be addressed:

2. What solutions could be offered to optimize the finite opportunities to address important clinical questions in research?

3. What solutions could be offered to increase cross border collaborations especiallycross border collaborations especially among different stakeholders?

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4. What solutions can be offered to betterincentivize the successful development of bi k th t l t

5 Questions to be addressed:

biomarkers that can acceleratepersonalized medicine?

5.What solutions could be offered to optimize information sharing regardingexisting research to avoid suboptimalexisting research to avoid suboptimalclinical decision making that can delay the implementation of best practices in clinicalresearch and practice?

WG: Better treatment through better education:

A European education strategy for the Personalised Medicine era

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500.000.000 potential patients of the European UnionEuropean Union

expect healthcare professionals to be fit forup to date

practice and care

Need for a dedicated Education and TrainingStrategy on PM for all HCP

EAMP flagship for 2015

An education programme for HCPs

t h l li th t ti l f PMto help realise the potential of PM

based on 4 pillars of knowledge

Compatibility Keeping pace Interdisciplinarityp y Coordination

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Compatibility

Id tif d f t d f t PM• Identify needs for current and future PM skills

• Avoid silos: involve all European Universities, European HCP organisations

• Raise awareness of the complexity of PM Cearly in an HCP’s career

Keeping pace: 2 aspects

• Update of PM knowledge: CME/CPDEff ti d fi d t l t d d– Effective defined tools, standards

– Adapted a method- a time- an HCP

– Efficient online, learning methods

– Multi-disciplinary mixing fields, skills, HCPs, patients

M lti l tf l i• Multi-platform learning

– Real-time access to an information repository

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Education Strategy for HCP in PM

D l i f t t i l• Develop infrastructures, curriculum development, management, governance

• With the support of European Commission

forbetter diagnosis,treatment and careg

of patients accross the EU

Thank you!European Alliance for Personalised Medicine

For more information about EAPM, please email: D i H EAPM E Di t d i h @Denis Horgan,EAPM Exec Director, denishorgan@euapm.eu