A call to accelerate human-focussed medical research

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A call to accelerate human-focussed medical research

A call to accelerate human-focussed medical research

An open letter to:

  1. International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
  2. The International Coalition of Medicines Regulatory Authorities
  3. European Medicines Agency
  4. European Directorate for the Quality of Medicines and Healthcare
  5. European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM)
  6. Home Office
  7. Department of Health and Social Care
  8. Department for Business, Energy & Industrial Strategy
  9. Medicines & Healthcare products Regulatory Agency
  10. National Institute for Health and Care Excellence (NICE)

We are calling for a change of mindset and a clear timetable for regulatory change to enable accelerated development of medicines which are likely to be safer, more effective and cheaper, without the use of animals. Investment in human relevant science offers a golden opportunity to revitalise medical research, save money, create wealth and improve public health.

We find ourselves in a time of global health emergency, one that will challenge our healthcare, social fabric and economy for years to come. Hard choices today have been borne out of great and immediate need. Yet there are patterns emerging in the scientific response that will have far reaching consequences for how we progress medical science in the future.

In March 2020, Moderna Therapeutics, one of the first companies to begin research into COVID-19, trialled a vaccine in humans in parallel to animals1 – a break from the linear process requiring animal trials before clinical trials. The University of Oxford also subsequently trialled COVID-19 vaccines in humans without the usual preceding animal trials2.

Given the urgency of the crisis and that both vaccines contain components known to be safe to use in people, the opportunity to fast-track trials straight into humans was approved in order to save lives. Moderna Therapeutics Chief Medical Officer Tal Zaks stated, “I don’t think proving this in an animal model is on the critical path to getting this to a clinical trial.”3

The International Coalition of Medicines Regulatory Authorities (ICMRA) agreed that “it is not required to demonstrate the efficacy of the SARS-CoV-2 vaccine candidate in animal challenge models prior to proceeding to [first in human] FIH clinical trials.”4

The European Medicines Agency and European Commission have expressed their commitment to advancing animal free new approach methodologies for drug development and safety assessment in the context of COVID-19.5

Prioritising human relevant approaches in the search for a COVID-19 vaccine sets a powerful precedent. The emergency has forced an appraisal of what is truly necessary to deliver safe and effective medicines as quickly as possible. Traditional animal-based tests are too slow and unreliable to meet the ambitious goal of a vaccine or treatment within a year6. As Dr Francois Busquet and colleagues from the Center for Alternatives to Animal Testing-Europe state, human relevant approaches offer crucial advantages of speed and “much more robust and exacting data than any animal experiment could deliver.”7

Myriad human relevant technologies are currently available and increasingly used within basic and clinical research, such as 3D human ‘lungs-on-a-chip’ that more accurately reflect human biology and enable study of the disease in real human tissue8. There has never been a more pertinent moment to embrace these new approach methodologies and to step up investment in advancing technologies which are representative of the whole human system. This is how we will save precious time, replace invasive animal experiments and avoid the unreliability inherent in extrapolating from species with very different immune systems.

We now need the vision to adopt this approach for all human disease and illness – from COVID-19 to cancer, dementia to diabetes – as outlined in the Alliance for Human Relevant Science White Paper, ‘Accelerating the Growth of Human Relevant Life Sciences in the United Kingdom’8. Something good can come from the COVID-19 emergency.


Aysha Akhtar, MD, MPH, President and CEO, Center for Contemporary Sciences

Professor Alberto Alemanno, Founder and Director of The Good Lobby

Kathy Archibald, Chair, Safer Medicines Trust

Dr Jarrod Bailey, Director of Science and Technology, Center for Contemporary Sciences

Marc Bekoff, Ph.D., Professor emeritus Ecology and Evolutionary Biology, University of Colorado, Boulder

Dr Adrian Biddle, Queen Mary University of London

Dr Charlotte Blattner, Senior Lecturer and Researcher, University of Berne

Dr Simon Brooman, Senior Lecturer Law, Liverpool John Moores University

Dr Kit Byatt, Retired Consultant Geriatrician

Dr Eleanor Burt, citizen

Dr Martin Clift, Associate Professor, Biomedical Sciences, Swansea University

Professor Michael D. Coleman, Professor of Toxicology, Aston University

Professor Mark Cunningham, Trinity College Dublin, Ireland

Prof Matthew Dalby, Director of the lifETIME Centre for Doctoral Training in Engineered Tissues

Dr Lori Leigh Davis, Lecturer in Responsible Enterprise

Tamara Drake, Director of Research and Regulatory Policy, Center for Responsible Science

Christina Dodkin, Lord Dowding Fund

Dr Stephen Dunne, University of Sunderland

Professor Amanda Ellison, Durham University

Dr Luis Falcon, President, GNU Solidario

Professor Sebastien Farnaud, Faculty of Health & Life Sciences, Coventry University

Professor Robert Garner, School of History, Politics and International Relations, University of Leicester

Professor Lorna Harries, Professor of Molecular Genetics, University of Exeter

Robyn Hederman, Fellow, Oxford Centre for Animal Ethics

Revd Professor Martin Henig, Wolfson College Oxford

Dr. Carolina Herrera, PhD, Imperial College London

Professor Jon Heylings, Dermal Technology Laboratory Ltd and Professor of Toxicology, Keele University

Dr Ewelina Hoffman, Principal Lead Scientist, Immuone

Prof. Dr. Kai Horsthemke, Associate Professor, KU Eichstätt-ingolstadt, Germany

Dr Kimberley Jayne, Lord Dowding Fund

Dr Nicola Jeffery PhD, University of Exeter Medical School

Rebecca Jenkins LL.B, LL.M, Associate Fellow, Oxford Centre for Animal Ethics

Linda Johnson, Ph.D, Visiting Professor, University of Michigan-Flint

Dr Shireen Kassam, Consultant Haematologist and Lifestyle Medicine Physician

Dr Gerry Kenna, Pharmaceutical Director, Safer Medicines Trust

Andrew Knight, Professor of Animal Welfare and Ethics, & Founding Director, Centre for Animal Welfare, University of Winchester

Dr Tomasz Kostrzewski, Director, Biology, CN Bio Innovations Limited

Dr Laura Leslie, Biomedical Engineer, Aston University

The Revd Professor Andrew Linzey, PhD, DD, HonDD, Director of the Oxford Centre for Animal Ethics

Dr Clair Linzey, PhD, Professor of Animal Theology, Graduate Theological Foundation

Dr Zaynah Maherally, Research Fellow, Neuro-Oncology Research Group, School of Pharmacy and Biomedical Sciences, University of Portsmouth.

Michael Mansfield QC

Dr Hayley McMillan, Queens University, Belfast

Dr Monika Merkes PhD (public health), Honorary Associate, La Trobe University

Dr Les Mitchell, Research Fellow, University of Fort Hare Hunterstoun

Dr Dania Movia, Trinity College Dublin

Dr Sam Murray, Senior Research Fellow, University of Portsmouth

Leonid Nikitenko PhD DSc SFHEA FRSB, Lecturer in Biomedical Sciences, University of Hull

Dr Alpesh Patel, Animal Free Research UK

Professor Mike Philpott, Professor of Cutaneous Biology, Queen Mary University London

Professor Geoff Pilkington, Emeritus Professor of Neuro-oncology, University of Portsmouth

Dr Muhammad Rahman, Blizard Institute, Queen Mary University

Dr Ruman Rahman, Associate Professor of Molecular Neuro-Oncology, University of Nottingham

Rebecca Ram, Scientific Consultant, Safer Medicines Trust

Professor Manuel Salmeron-Sanchez FRSE, Chair of Biomedical Engineering, University of Glasgow

Joan Schaffner, Associate Professor of Law, The George Washington University Law School

Jeff Sebo, Clinical Assistant Professor of Environmental Studies, Affiliated Professor of Bioethics, Medical Ethics, and Philosophy, New York University

Dr Hannah Short, General Practitioner, Oakfield Surgery, Newmarket

Dr Claire Smith, UCL Great Ormond St Institute of Child Health

Dr Rebecca Rose Stanton, Associate Fellow at the Oxford Center for Animal Ethics

Dr Katy Taylor, Director of Science and Regulatory Affairs, Cruelty Free International

Dr Katya Tsaioun, Director, Evidence-based Toxicology Collaboration, Johns Hopkins Bloomberg School of Public Health

Dr Jan Turner, Director, Safer Medicines Trust

Dr Mark C Turner, Research Fellow in Endocrinology and Metabolism, Coventry University

Dr Richard Twine, Co-Director, Centre for Human-Animal Studies (CfHAS), Edge Hill University

Alliance for Human Relevant Science

Animal Free Research UK

Certara

CN Bio Innovations Limited

Cruelty Free International

Cyprotex

Dermal Technology Laboratory (DTL Ltd).

Institute of Bio-Sensing Technology

Kirkstall Ltd

Lord Dowding Fund

Safer Medicines Trust

UPM Biomedicals

*The open letter illustrates the view and opinion of the signatories but not necessarily of their associated organisations.


References

1 https://endpts.com/breaking-moderna-posts-a-promising-snapshot-of-human-data-for-a-leading-covid-19-vaccine (Accessed 28/05/2020); https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins (Accessed 07/04/2020)

2 https://covid19vaccinetrial.co.uk/blog-how-long-will-it-take-get-oxford-vaccine-deployment (Accessed 01/06/2020)

3 https://www.statnews.com/2020/03/11/researchers-rush-to-start-moderna-coronavirus-vaccine-trial-without-usual-animal-testing/(Accessed 28/05/2020)

4 http://www.icmra.info/drupal/sites/default/files/2020-03/First%20regulatory%20COVID-19%20workshop%20-%20meeting%20report_March%202020.pdf (Accessed 28/05/2020)

5 https://www.uni-konstanz.de/en/university/news-and-media/current-announcements/news-in-detail/how-nam-can-speed-up-covid-19-drug-discovery/ (Accessed 16/06/2020)

6 https://www.statnews.com/2020/03/11/researchers-rush-to-start-moderna-coronavirus-vaccine-trial-without-usual-animal-testing/(Accessed 28/05/2020)

7 Busquet F, Hartung T, Pallocca G, Rovida C, Leist1 M. Harnessing the power of novel animal‑free test methods for the development of COVID‑19 drugs and vaccines. Archives of Toxicology, 2020; https://doi.org/10.1007/s00204-020-02787-2

8 Alliance for Human Relevant Science. Accelerating the Growth of Human Relevant Life Sciences in the United Kingdom. A White Paper by the Alliance for Human Relevant Science, UK, 2020.