Responsible innovation:
the translational turn and the ethics of
clinical risk
A. Blasimme, MA, PhD INSERM UMR1027 - Unive...
ELIAS ZERHOUNI
“It is the responsibility of those of us
involved in today’s medical research
[…] to translate the remarkab...
NIH Roadmap for Medical Research
Tuesday 8 July 2014 3
National Institute of Health, August 2006
Stagnation in drug development
Tuesday 8 July 2014 4
Tuesday 8 July 2014 5
“Regenerative medicine is the process of creating living,
functional tissues to repair or replace ti...
Approved Advanced Therapy Medicinal Products in
EU
Tuesday 8 July 2014 6
Stamina scandal: public protests
Tuesday 8 July 2014 7
Stamina: the international echo
Tuesday 8 July 2014 8
Tuesday 8 July 2014 9
Tuesday 8 July 2014 10
“When I was commissioner of the Food
and Drug Administration (FDA) from 2005
to 2009, I saw first h...
Tuesday 8 July 2014 11
Tuesday 8 July 2014 12
Tuesday 8 July 2014 13
Tuesday 8 July 2014 14
Tuesday 8 July 2014 15
What is Responsible Innovation
“RI is a transparent and interactive
process by which societal actors
and innovators become...
What is Responsible Innovation
“Responsible Innovation is a
collective commitment of care for
the future through responsiv...
The four dimensions of RI
1. Anticipation
2. Reflection
3. Inclusive deliberation
4. Responsiveness
Tuesday 8 July 2014 18
Thank you for your attention!
alessandro.blasimme@inserm.fr
virginia.sanchini@ieo.eu
Tuesday 8 July 2014 19
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Responsible innovation: the translational turn and the ethics of clinical risk

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Authors: 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

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Responsible innovation: the translational turn and the ethics of clinical risk

  1. 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. 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 Tuesday 8 July 2014 2
  3. 3. NIH Roadmap for Medical Research Tuesday 8 July 2014 3 National Institute of Health, August 2006
  4. 4. Stagnation in drug development Tuesday 8 July 2014 4
  5. 5. Tuesday 8 July 2014 5 “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. 6. Approved Advanced Therapy Medicinal Products in EU Tuesday 8 July 2014 6
  7. 7. Stamina scandal: public protests Tuesday 8 July 2014 7
  8. 8. Stamina: the international echo Tuesday 8 July 2014 8
  9. 9. Tuesday 8 July 2014 9
  10. 10. Tuesday 8 July 2014 10 “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
  11. 11. Tuesday 8 July 2014 11
  12. 12. Tuesday 8 July 2014 12
  13. 13. Tuesday 8 July 2014 13
  14. 14. Tuesday 8 July 2014 14
  15. 15. Tuesday 8 July 2014 15
  16. 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 Tuesday 8 July 2014 16 René Von Schomberg
  17. 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 Tuesday 8 July 2014 17 Richard Owen
  18. 18. The four dimensions of RI 1. Anticipation 2. Reflection 3. Inclusive deliberation 4. Responsiveness Tuesday 8 July 2014 18
  19. 19. Thank you for your attention! alessandro.blasimme@inserm.fr virginia.sanchini@ieo.eu Tuesday 8 July 2014 19
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