Industry joins regulators and U.S. NIH in developing coordinated research response to Covid-19

Country : France, U.S.

Keywords :
LONDON, 20 Apr (APM) - Several pharma companies and drug regulators have joined a global effort led by the U.S. National Institutes of Health (NIH) and non-profit Foundation for the NIH (FNIH) for a coordinated research response to the Covid-19 pandemic.
The NIH, which is the U.S. government's medical research agency, on Friday said it is forming the Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) partnership.
This partnership aims to develop a collaborative framework for prioritising vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics, according to a statement.
Partners include U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, the U.S. Food and Drug Administration, the U.S. Centers for Disease Control and Prevention (CDC) and the European Medicines Agency (EMA).
The life sciences firms involved are AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Evotec, GlaxoSmithKline, Johnson & Johnson, KSQ Therapeutics, Eli Lilly, Merck & Co, Novartis, Pfizer, Roche, Sanofi, Takeda and Vir Biotechnology.
NIH director Francis Collins said: "Now is the time to come together with unassailable objectivity to swiftly advance the development of the most promising vaccine and therapeutic candidates that can help end the Covid-19 global pandemic."
ACTIV partners will provide infrastructure, expertise and/or funding to identify, prioritise and facilitate the entry of some of the most promising candidates into clinical trials. 
Industry partners also will make available certain prioritised compounds, some of which have already cleared various phases of development, and associated data to support research related to Covid-19, said the NIH.

Key areas

The NIH identified four key areas for ACTIV. These include standardising and sharing preclinical evaluation methods in an open forum that allows for comparison and validation.
The other key areas are to prioritise and accelerate clinical evaluation of therapeutic candidates with near-term potential; maximize clinical trial capacity and effectiveness; and advance vaccine development.
Specific objectives as part of these overall goals include establishing a steering committee with relevant expertise and objectivity to set criteria for and rank potential candidates submitted by industry partners for first wave and subsequent evaluation.
Other objectives include connecting existing networks of clinical trials to build capacity and capabilities, and establishing a centralised process and repository for harmonising and sharing methods and evaluating models.
Paul Stoffels, chief scientific officer at industry partner J&J, said that it will take the whole healthcare community working together to end the pandemic.
"We will need to harness the best ideas from multiple stakeholders, including governments, regulatory authorities, academia, NGOs and industry to stop Covid-19."
His equivalent at Pfizer, Mikael Dolsten, agreed: "We are seeing an unprecedented level of collaboration across the innovation ecosystem to address this global health crisis, and this potentially powerful NIH initiative may allow us to further accelerate the delivery of much needed therapies to patients around the world."

Covid-19 efforts

The announcement comes a few days after global efforts led by the World Health Organization (WHO) were undermined by U.S. President Donald Trump's decision to cut U.S. funding for the WHO, claiming the organisation had promoted China's "disinformation" about the virus that likely led to a wider outbreak than otherwise would have occurred (APMHE 66943).
The WHO is leading on global trials for several possible treatments, including Gilead's remdesivir, which was initially developed for Ebola, as well as AbbVie's HIV drug Kaletra (lopinavir+ ritonavir) and the malaria drug chloroquine (APMHE 66656).
The French National Research Institute for Medical Research (INSERM) is also leading on European trials investigating remdesivir, Kaletra and hydroxychloroquine, another malaria drug.
Last week it was announced former GlaxoSmithKline chief executive Sir Andrew Witty has been given a leading role in the WHO's s efforts to support the development of a vaccine for coronavirus (APMHE 66959).
Other major vaccine efforts include Moderna, which is receiving up to $483 million in funding from the U.S. government for its mRNA-1273 (APMHE 66983). Sanofi, GSK, Pfizer and BioNTech are also working on vaccine programmes (APMHE 66274, APMHE 66719, APMHE 66935, APMHE 66919).

France partnering with WHO

France is preparing a worldwide initiative with the WHO to accelerate the development of vaccines and treatments for coronavirus and guarantee access to everyone, the President's office told APM on Friday. 
The initial details should be released next week, it added.
The French President Emmanuel Macron mentioned this project on Thursday during a meeting with the WHO's director general Tedros Adhanom Ghebreyesus and representatives of public and private organisms including the Global Fund to fight AIDS, tuberculosis and malaria, Unitaid, GAVI Alliance, Coalition for Epidemic Preparedness Innovations (CEPI), Wellcome Trust, the Bill & Melinda Gate Foundation and the World Bank.



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