WP Leadership Team for Precision Medicine Aarhus University

Marzia Mazzonetto

SMART-map Final Conference: “RoadMAPs to Responsible Industrial Technologies” Brussels, October 1st 2018

SMART Map in Precision Medicine

Introduction

2 Industrial Dialogues:

- Aarhus (Aarhus University – Denmark has a National

strategy for Precision Medicine)

- Valencia (Spain is planning a national strategy)

Pilot perfomed at IMEGEN in Valencia

IMEGEN

Founded in 2009 as a spin-off of the Genetics Department of the University of Valencia. The company has specialized in the diagnosis, prognosis, therapy and prevention of human diseases mainly by the development of diagnostic, pharmacogenomics tests and also provides services for Genetic Testing to Hospitals, Clinics, laboratories and Companies according to high quality standards.

Precision Medicine Scenario

Data access and control

Healthcare transformation & participative multi-stakeholder processes

Standardisation

Building trust

Creating capacities and education Need

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Toolboxes

Because of the multi-stakeholder nature of RRI, participants proposed complex toolboxes, rather than individual tools.

Data Sharing Toolbox

Decision Aid for Personalised Medicine Treatments

Accreditation Toolbox

Living Lab

Communication Toolbox

Tools Message box for suggestions

End user experience advisory panel

RRI advisory panel

Workforce training

Standards for RRI.

Best practice examples

Open lab day

Open access study design support

Tool chosen at the end of the process for the pilot in IMEGEN Initially part of the ”Decision Aid Toolbox Include the ”experience” as part of both doctors and patients reported outcomes

Pilot – Product and Lifecycle

EXOME SEQUENCING: IMExoma The sequencing of DNA from the patient and of his/her parents is recommended for cancer and some hereditary diseases. These studies require a specific Sequencing system offered by IMExoma.

Pilot (2)

Phase 1 Phase 2 Phase 3

Kick-off meeting

Analysis follow-up, survey, contacts

Closing webinar Commitment to actions

End User Advisory Panel 5 doctors (medical genetics specialist, working in medium-large hospitals) 6 patients (5 representatives of Patients Associations and one civil society representative)

Pilot (3) Activities to follow-up Communication - Information sharing, and exchange between doctors with

different backgrounds - Improve the report with information on follow-up and

additional genetic testing - Create additional tools and materials to improve patient

experience Awareness - Provide additional means, to facilitate doctors-patients

communication - Modify the report to clarify its target Training - New products for learning: online training, training resources

Feedback from IMEGEN The experience has validated and made stronger some of the long-term objectives that the company has. We would repeat the experience We are considering the option of running similar inclusive workshops as a valuable resource to define priorities that the company’s external communication should address.

Actions for companies

Actions for other stakeholders

Funders - Support participation to multi-

stakeholder events - Requirements for innovation grants

CSOs - Active participation

- Advocate for shared governance

Policy Makers - Professional recognition - RRI as criterion for career

progression

RRI community - Assist companies keen to RRI - Adapt to better respond to

specificities of industry

Benefits for Industry – Scenario 1

SMART-map tools can help you gather higher-quality input and run the exercise in a more customer-focused manner

Tools like an end user advisory panel, or a multi-stakeholder responsible innovation group can offer independent views on what is important for your market, and support in anticipating trends.

“This kind of instruments helped us understand which will be the needs and barriers of physicians with less experience who are addressing genetic testing for the first time. It helps us anticipate and address their needs.”

Chief Technology Officer or Head of Marketing assess new technologies for the company and/or evolve the current product roadmaps – often within a 5-10 year timeframe.

Benefits for Industry – Scenario 2

Research and Development While many pharmaceutical and MedTech companies propagate "patient-centricity" as the vision for their company, surprisingly few companies have translated this vision into requirements for the R&D process. Co-development of solutions together with physicians and patients is a powerful antidote to internal bureaucracy.

SMART-map tools that can enable greater patient-centricity and agility: co-creation multi-stakeholder groups, end-user advisory panels, different types of participatory feedback tools can help rapid prototyping and agile design. Different methods for RRI workforce training help scientific and technical staff understanding and making the best use of external ideas.

“Waiting for the test results without any information in the meanwhile is pretty difficult” reported one of the patients involved in the pilot.

Benefits for Industry – Scenario 3

Commercialisation and assessment As a product reaches the later stages of R&D, the regulatory audience typically is top of mind. Regulators have become increasingly interested in the patient perspective in recent years.

SMART-map tools can help addressing gaps in health technology assessment, and particularly in patient-reported outcomes, to know better their audience and prepare for regulatory approval. Repositories for subjective experience of treatments can help comparing patient experiences with the view or needs of other stakeholders; RRI standards and accreditation, including labelling of the product, will help commercialising activities.

One of the patients involved in pilot: “psychological care, as well as a comfortable environment where the results are communicated face-to-face are really important to understand and deal with the conclusions of diagnostic report”,

Benefits for other stakeholders

Better tailored products and services

Opportunity to interact with industrial players

Recognition, rewarding and visibility

Scaling up and new business opportunities

Involvement of the private sector in RRI processes

Multiplying impact

Danish National Strategy on Personalised Medicine

Responsible Industry in Health event 2017

Conclusion

- We highlight what are the current challenges

- We provide some tools to addressed them, in a way that implements RRI and thus provide some clear benefits to key industrial needs

- We show how all stakeholders benefit from this approach

- We indicate some of they key elements each of us can act on, when leaving this meeting