The document discusses responsible innovation (RI) in the context of clinical risk and translational medical research, emphasizing the ethical implications and societal responsibilities involved. It highlights the promise of regenerative medicine in repairing or replacing damaged tissues and the challenges in translating scientific breakthroughs into practical treatments for humans. The authors define RI as a process that fosters mutual responsiveness between societal actors and innovators, aiming for ethical acceptability, sustainability, and societal desirability.

1. Responsible innovation:
the translational turn and the ethics of
clinical risk
A. Blasimme, MA, PhD INSERM UMR1027 - Université Paul Sabatier,
Faculté de Médicine, Toulouse, France; Fondazione Giannino Bassetti
V. Sanchini, Department of Health Science, University of Milan;
Department of Experimental Oncology, European Institute of Milan, Italy;
Fondazione Giannino Bassetti
Tuesday 8 July 2014 1
EBEN – BERLIN, 14TH
JUNE

2. ELIAS ZERHOUNI
“It is the responsibility of those of us
involved in today’s medical research
[…] to translate the remarkable
scientific innovations we are
witnessing into health gains for the
nation”.
NEJM 2005 353;15
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3. NIH Roadmap for Medical Research
Tuesday 8 July 2014 3
National Institute of Health, August 2006

4. Stagnation in drug development
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“Regenerative medicine is the process of creating living,
functional tissues to repair or replace tissue or organ function lost
due to age, disease, damage, or congenital defects. This field
holds the promise of regenerating damaged tissues and organs in
the body by stimulating previously irreparable organs to heal
themselves”
Regenerative Medicine

6. Approved Advanced Therapy Medicinal Products in
EU
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7. Stamina scandal: public protests
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8. Stamina: the international echo
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“When I was commissioner of the Food
and Drug Administration (FDA) from 2005
to 2009, I saw first hand how regenerative
medicine offered a cure for kidney and
heart failure and other chronic conditions
like diabetes. Researchers used stem cells
to grow cells and tissues to replace failing
organs, eliminating the need for expensive
supportive treatments like dialysis and
organ transplants. But the beneficiaries
were laboratory animals. Breakthroughs
for humans were and still are a long way
off”.
WSJ, 15th
April 2012
Andrew von Eschenbach

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16. What is Responsible Innovation
“RI is a transparent and interactive
process by which societal actors
and innovators become mutually
responsive to each other with a
view on the (ethical)
acceptability, sustainability and
societal desirability of the
innovation process and its
marketable results”.
Von Schomberg 2013
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René Von Schomberg

17. What is Responsible Innovation
“Responsible Innovation is a
collective commitment of care for
the future through responsive
stewardship of science and
innovation in the present”.
Owen et al. 2013
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Richard Owen

18. The four dimensions of RI
1. Anticipation
2. Reflection
3. Inclusive deliberation
4. Responsiveness
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19. Thank you for your attention!
alessandro.blasimme@inserm.fr
virginia.sanchini@ieo.eu
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