1. TRANSLATION IN HEALTHCARE CONFERENCE EXPLORING THE IMPACT OF EMERGING TECHNOLOGIES Embedding Biobanks as Tools for Translational Research – Has the Biobank Bubble Burst? University of Oxford 23-25 June 2015

2. TRANSLATION IN HEALTHCARE CONFERENCE 1. Welcome 2. Our question – Embedding Biobanks as Tools for Translational Research – Has the Biobank Bubble Burst? 3. Topics  Promise of biobanks (Di)  Good governance and collaborations (Jane)  Levelling-off and sustainability (Don)  Discussion  Where to now?

3. 1. The Promise of Biobanks  The Promise of Biobanks -“ are increasingly seen as an essential tool in translating biomedical research into real improvements in healthcare” (1)  Time 2009 “Ten ideas changing the world” –Biobanks No 8  Biobanking and Biomolecular Resources Research Infrastructure(BBMRI), one of first of European Research Infrastructure roadmaps funded by European Commission (EC).  Green, Guyer& NHGRI Nature 2011 Charting a course for genomic medicine to support translational research and the genomic personal medicine. (2)  NHMRC Australia policy development - Biobanks Information Paper 2011

4. 1. The Promise of Biobanks  Reasons for biobank expansion?  Internationalisation of research -multi-centre collaborations; international clinical trials; open science and data-sharing; commercialisation.  To bring researchers in science and ethics together for common good  Technology – Sharp downward cost of genomic research - NHGRI Advanced Sequencing Technology Program $1000 genome (Illumina)  Political & Economic Vast increase the funding of scientific and medical research  “If properly supported, medical research will create new jobs, catalyse sustained economic growth and help to restore public finances by improving health.. making the NHS.. more cost effective” Academy of Medical sciences UK 2011 (3).

5. 2. Growth and Good Governance and Biobanks  Good research Governance –  National revisions of Ethical codes of research conduct clarifying Researcher responsibilities that research ethically and properly conducted for quality, safety, privacy, risk in interests of participants Institutional responsibilities - research effectively and properly managed in resourcing of ethics review; monitoring; and, complaints & accountability reporting to AHEC and insurance and indemnity, research contracts ; facilities and resources,  New consent models (broad and “dynamic”) and biobanks (4), public good and critical importance of biobank governance (5)  Governance -OECD Guidelines for Human Biobanks and Genetic Research Databases 2009

6. 3. Levelling Off? The Future of Biobanks  Funding of biobanks and their sustainability are emerging issues  Three dimensions of biobanking sustainability: operational, social, and funding in first 2014 issue of professional biobanker journal, Biopreservation and Biobanking (6)  Funding discussed in special issue 2014 Volume 12 (5) of Biopreservation and Biobanking (7)  Guest Editorial (8) proposed that “Tight economic realities in clinical and research operations have spurred the need to re- examine financial models that support the infrastructure of biobanking”  Cost-recovery approach to funding sustainability does not appear to have any success -Australian Breast Cancer Tissue Bank has such a policy and recovers negligible amounts (9)

7. 3. Levelling Off? The Future of Biobanks  Australia- National Health and Medical Research Council infrastructure grants for Biobanks funding not been renewed in Australia  Other key infrastructure organisations, like PHOEBE, established in 2006, only ever received short-term funding, with no expectation for continued longer term funds.  Many biobanks in Australia are going through a “levelling off phase”.  Many smaller biobanks do not have a lot of requests for access.  Biobanks can be “staggeringly expensive” resources

8. Discussion  Whether this Australian “levelling off phase” is occurring elsewhere.  What is the future of biobanks in an era of whole genome sequencing  Do Biobanks, like the proposed BBMRI-ERIC (10) initiative, need to be more strategic in ”improving accessibility and interoperability” between academic and industry partners?  Where will the for-profit sector fit in with 23andMe and its new therapeutics group for “translating genetic information into the discovery and development of new therapies for our customers and the world,”  “science is barrelling forward, but the ethics aren't … I don't want the science to slow down. I want the ethics to catch up.” Peter Singer (11)  Discussion and where to now?

10. Acknowledgements ARC Discovery Grant “The Age of Personalized Medicine: Regulatory Challenges for Australia” 2011-2015 (with Dianne Nicol, Don Chalmers and Margaret Otlowski) References 1. D Chalmers, D. Nicol, M. Otlowski and C. Critchley “Personalised Medicine in the Genome Era” (2013) Journal of Law and Medicine 20/3: 577-594 2. Green E.D., Guyer M.S. & National Genome Research Institute (2011) “Charting a course for genomic medicine from base pairs to bedside” Nature 470: 204-213 doi:10.1038/nature09764 (2a) 3. Academy of Medical sciences UK (2011) Biomedical research-a platform for increasing health and wealth in the UK 4. Kaye, J., L. Curren, N. Anderson, et al. 2012. Science and society: From patients to partners: participant-centric initiatives in biomedical research. Nature Reviews Genetics 13: 371-376 5. Marking Shifts in Human Research Ethics in the Development of Biobanking Public Health Ethics with M. Burgess; K. Edwards; J. Kaye; E. Meslin; D. Nicol( 2014); doi: 10.1093/phe/phu023 6. Watson, P.H. et al,A framework for biobank sustainability. (2014) Biopreservation and Biobanking 12(1): 60 – 68) 7. Biopreservation and Biobanking (2014 Volume 12 (5)) Guest Editorial.. (2014,)12(5): 287-291) 8. Simeon-Dubach D. and Henderson M. K.. Biopreservation and Biobanking. October 2014, 12(5): 287-291. doi:10.1089/bio.2014.1251. 9. Similar reports from Barnes R.O., et al Funding Sources for Canadian Biorepositories: The Role of User Fees and Strategies to Help Fill the Gap’ (2014) Biopreservation and Biobanking12(5):300-305 10. Gert-Jan B van Ommen et al (2015) “BBMRI-ERIC as a resource for pharmaceutical and lifescience industries: the development of biobank-basedExpert Centres” European Journal of Human Genetics 23: 893–900 11. Singer P.(2010)http://news.bbc.co.uk/2/hi/science/nature/2758191.stmhttp://news.bbc.co.uk/2/hi/science/nature/2758191.stm