1. The opportunities and challenges of sharing genomics data with the pharmaceutical industry Shahid Hanif, Head of Health Data & Outcomes, ABPI DNA digest 21 Aug 2015

2. Using health data to get new medicines to the right patients Biological and health data can be used by industry from drug discovery, to supporting patient access and evaluating health outcomes. Many opportunities for using health data, but need the right environment (regulatory, funding, open innovation, skills etc) to maximise potential ABPI Big Data Roadmap 2013

3. How can data be used in the pharmaceutical industry?

4. What (new) types of data can be used in the pharmaceutical industry?

5. Driving the right environment: ABPI Priorities  Communication –Communicate health data requirements to external stakeholders in the UK –Communicate UK health data opportunities within industry, both local and global  Capacity Building –Engage and support providers of data, information and capabilities –Continue to collate and publicise demonstrator projects  External environment –Articulate industry wants the environment to look like in the near and long term –Identify how industry can contribute towards shaping this environment –What are the factors to determine the environment in 10 years time?

6. Opportunities for using genomic data Many ways in which genomics data can be used for patient benefit including: –Understand disease aetiology identify new drug target develop new medicines (particularly rare and complex diseases) –Stratify populations for precision medicine (get the right medicine to the right patient at the right time, e.g. may be differences in efficacy or safety) –Clinical decision making –New diagnostics

7. Opportunities for sharing genomic data Many advantages of working precompetitively to share genomic data: –Access to more data from more populations/patients – particularly important for research into rare diseases –Share innovation in genomics research from the best scientists across sectors (e.g. academia, SMEs, pharma) –Skills: - leverage skills, ideas and perspectives from different sectors - capacity building in skills for future researchers –Generate a community of experts with shared understanding and shared goals Better medicines for more patients more quickly

8. Challenges in sharing genomic data Data privacy and information governance: –Ensuring data privacy and information governance for patients/research participants is the utmost priority. –Leads to technical (information security, ensuring integrity of safe havens etc), regulatory, and governance challenges –EU Data Protection Regulation: need to balance data privacy with ability to carry out research effectively and efficiently

9. Challenges in sharing genomic data  Engagement with variety of stakeholders required: – Patients – Healthcare professionals – Researchers – Industry (SME, tech companies, pharm)  Challenge of communication value to public – Patients are often positive as can see the benefits – More of a challenge to communicate with wider public

10. Current Initiatives and Examples –An IMI project with 17 partners (pharma, academic centres and SMEs) –The project looks to build a sustainable IMI translational research informatics/ knowledge management platform which can be used across different projects and harmonise data format –Will also develop best practice guidelines and resources for reuse of research data

11. Current Initiatives and Examples –100 000 genomes project, particularly focussing on rare disease and cancer –10 companies (incl. biotech, pharma and SMEs) will work as part of the GENE consortium aiming to sharing knowledge, funding, and skills on research projects with common interest –Companies will work with researchers, clinicians and analysts to accelerate development of new diagnostics and treatments

12. Conclusions  Genomic data has huge potential for drug discovery and development  Precompetitive sharing has the potential to accelerate this and bring new medicines to patients more quickly  However…there are challenges to sharing genomic data, particularly around data privacy  Industry are moving towards increased sharing of genomic data, with a number of ongoing collaborative initiatives. We need to maintain and further develop a facilitative environment for sharing genomic data in the UK and EU to maximise the potential of genomics data for the benefit of patients.

13. Acknowledgements Dr Nicola Platt - Science Policy Officer, ABPI