Biobanks do not operate in isolation. They exist within a pretty diverse “ecosystem” of stakeholders which includes the public, patients, healthcare workers, scientists, government, funders, healthcare providers, ethicists, regulators and others.
At the heart of biobanking is the single step of donating a sample in good faith. By the end of my presentation I hope you will see that the true heart of a biobanking ecosystem is an informed, educated, empowered patient who not only has confidence in the biobankers and researchers they are working with, but also wants to be involved in the process.
I hope you will learn more about the role and value that patients and patient organisations like IPPOSI can bring as stakeholders both in biobanking and data analytics, and why patients need to be seen more as full partners in research, more generally.
A patient-led platform that provides a structured way of facilitating interaction between patients, government, industry, science and academia to put patients at the heart of policy and medicines development.
IPPOSI has been the primary contact and conduit for patients interested in engaging more actively in the R&D process. We have over 100 patient organisations as members, over 200 members of scientific community (academic, policy, agency) and 18 multinational pharma and clinical research organisations
In pursuit of our goals we hold workshops, discussion groups, training days and conferences on policy, legislation and regulation around the development of new medicines, products, devices and diagnostics for unmet medical needs.
This allows patient organisation/charity and academic partners to join without incurring financial burdens.
Membership is therefore FREE to patients’ organisations, scientists & clinicians.
We recognise that establishing a functional biobanking or indeed an eHealth system that has the confidence of the Irish public is a challenge that cannot be rushed, particularly in light of the (potential) uses of patient information.
It is our experience, in the area of clinical research, that patients are willing to donate samples, and share their data1 provided they receive in advance a clear explanation of: what the data will be used for; under what circumstances; and by whom it will be accessed.
Everyone thought they were guinea pigs. But through the process of explaining what clinical research is, what it is for, they embraced the concept and were motivated to get involved. Same could be said for ehealth…
Patients don’t have a problem with IP of a sample, so long a you are open and honest about how you are going to use it..
"More or less no one in Europe knows what a biobank is.”
Limited understanding of how one can participate (i.e. donating blood/tissue, medical information)
Interestingly, when you look at the breakdown, there’s a definite north-western trend, although you do see the greater positivity as a result of national biobanking programs, even despite controversial ones like in Iceland.
The SF was part of a public consultation and engagement process that assembled the inputs and establishing the requirements of the broad ecosystem of stakeholders BBMRI. Chaired by Michael Griffith, and managed by myself. We wanted to identify unmet needs, develop working relationships and create a community of international stakeholders.
We had, and continue to have big questions to chew on…. Interoperability: Most international guidelines on biobanking are based, not on scientific evidence, but on individual experience. How to achieve this interoperability, through compliance to minimal standards will require different solutions for different levels; for example the ethical and legal levels. Public Engagement Industry sharing
We created a consensus consultation document obtained from positions from European Patient Organizations on unmet and future needs for BBMRI Patient Stakeholders. It was designed as a guideline for basic principles reflecting patient participation in both new and existing biobanks within BBMRI-ERIC.
A draft document, containing the support of a number of representative patient organisations was presented to the Steering Committee of the BBMRI-PP to assist in the drafting of policies and procedures for the implementation of the research infrastructure.
Aside from the economic value of the funding for a FTE position, the value to our small patient-led organisation has been immense.
Even with our unsuccessful bids, the joint development of proposals and assembly of consortia had lead to further partnerships and we are targeting a number of future H2020, Marie Curie, Health action calls. This all came from the networks, collaborations established within BBMRI
Compartmentalizing biobanking at national level fails to capitalize on shared infrastructure, knowledge and expertise which collaboration affords Proven its ability to federate and align with multiple countries and offers a long-term solution for creation of the ERA.
The effective use of data, and its access, interoperability and compatibility are critical factors for realising the full potential of patient registries.
The value of patient registries to patient organisations is obvious, whether it is helping to attract research, inform service planning, lower the cost of treatments, or improve patient outcomes. Against this, the challenges of creating patient registries are stark – patient consent, data management, governance, the cost of capturing data
HIQA made recommendations to the Minister of Health in 2014, identifying three key challenges facing national data collections in Ireland: The absence of a strategic framework and any national oversight for national data collections The need for standardisation and improvement in data quality The use of information, which is not being optimised
IPPOSI will continue to represent patient interests in this key emerging area of healthcare through our meetings, consultations and events.
trust is vital patients must believe that their data is secure And only used for the purposes they consented to,
IPPOSI is a strong supporter of the need for IHI in Ireland and we hope we can be of assistance to the HSE team in forming a more rounded approach to the future elements (incl. the public consultation) of the PIA.
Use simple language at every stage use real-world examples
More information both technical & non-technical
Code of Practice for the Pharmaceutical industry in Ireland (IPPOSI - IPHA) Health Technology Assessment (HTA) in Ireland (IPPOSI - NCPE) Access to Drugs and targeted high cost treatments are a major concern. HTAs can not be the only tool in the decision making process, justice and fairness for the patient needs to be considered. HTA agencies need training too!
At the heart of the ecosystem is the empowered patient
We would like to create the situation where patients are the drivers of their data, ensuring it is utilised to improve their health. A patient who, with the right information, could start to gain control of their health.
I encourage you to keep the patient at the centre of this developing ecosystem
Insight 2016 cork
PATIENTS – SCIENCE – INDUSTRY
Biobanking from the patient perspective
Jan 7th, 2016
Heart of Biobanking Ecosystem?
“People perform better when they
are informed better”
My presentation today
• Patient Advocate Perspective on Biobanking
• ‘Patient Experts’
Unique partnership of Patient Groups,
Industry and Science
Expedite the development of and
patient access to innovative therapies
• Bring a patient perspective to clinical research, connected health, health economics
• Actively influence policy that impacts on research + access to innovative therapies
“Putting patients in policy and medicines development”
• Grant from Department of Health
(via Health Research Board)
• Industry membership fee
Irish public perception
Irish general public’s attitude
towards clinical research,
EU Public Perception
Source: Eurobarometer: Europeans and Biotechnology in 2010: Winds of change?
IPPOSI and BBMRI
• IPPOSI managed BBMRI Stakeholder’s Forum for the preparatory phase (FP7-
“Basic Principles for Patient Participation”
Endorsed by European / National Patient Organisations:
• International Alliance of Patient Organisations (IAPO)
• European Genetic Alliance Network (EGAN)
• European Federation of Neurological Associations (EFNA)
• Europa Donna – The European Breast Cancer Coaltion
• European Network for Research on Alternating Hemiplegia (ENRAH)
• Dutch Genetic Alliance (VSOP)
• Genetic Alliance UK
• European Organisation for Rare Diseases (EURORDIS)
• European Cancer Patients Coalition (ECPC)
• European Patients Forum (EPF)
• Europa UOMO
Value of BBMRI involvement for IPPOSI
• Strategic + Economic value
• Formed collaborative partnerships and networks
• Translated into long-term joint research + education initiatives
• Targeting IMI / H2020 / Marie Curie calls
• Governance value
• SF on steering committee for Prep. Phase - business plan, statutes
• Patients a central part of BBMRI - setting the agenda, quality, minimum standards
• ‘National Policy’ value
• Briefing Dept. of Health and biobanking community on progress
• Patient Registries
• Health Information
• Data Protection
Realising full potential of patient registries
• Current challenges are stark:
• Patient consent
• Data Management
• Cost of capturing data
• Under Health Info Bill, Minister will be able to insist that people mandatorily
return to a limited number of gold standard registries
• 109 ‘national data collections’ (HIQA, 2014)
National Register of Health Identifiers
Privacy Impact Assessment
• Data Security, Privacy and Access
• Guidelines to outline responsibilities
Where can we go from here?
More Patient & Researcher TrainingMore Public Information Improve Research Environment
Real solution? - The ‘Expert’ Patient
IPPOSI Training for Members
• Clinical Research
• Health Technology Assessment
• Pharmaceutical Code of Practices
• Health Informatics (coming soon!)
IMI-EUPATI produces Expert Patients on Medicines R&D
• Training & Education
• Disseminates through national platforms
IPPOSI = Irish National
• Rachel Lynch, FibroIreland
• Damien Peelo, COPD Support Ireland
• Julie Power, Vasculitis Ireland Awareness
• Sharon Thompson, Rare Dis. + Palliative care
• John Dowling, Men Against Cancer
• Caitriona Dunne, Fighting Blindness
• Joan Jordan, MS Ireland
• Katie Murphy, CF Ireland
8 Irish Trainees
The EUPATI project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are
composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.
2016 – Expert Patients on the road…..
Univ. of Limerick
Heart of Biobanking Ecosystem?
“Just because a system has
patient data at its core does
not mean it is patient-