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

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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

Friday 7 April 2023 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

NIH Roadmap for Medical Research Friday 7 April 2023 3

National Institute of Health, August 2006

Stagnation in drug development

“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

Stamina scandal: public protests

Stamina: the international echo

“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

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

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

Richard Owen

The four dimensions of RI

1. Anticipation

2. Reflection

3. Inclusive deliberation

4. Responsiveness

Thank you for your attention!alessandro.blasimme@inserm.fr

virginia.sanchini@ieo.eu

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

Government & Nonprofit