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

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.

Government & Nonprofit◦Technology◦Health & Medicine◦
Related topics:
Stem Cell Therapies•
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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
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
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 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
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
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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
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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
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
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