COVID-19 Vaccines & Therapeutics – Industry Standards/Commitments

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COVID-19 Vaccines & Therapeutics – Industry Standards/Commitments

Biopharma industry updates on COVID-19 treatments progress and warns about upholding regulatory standards of quality – IFPMA
Geneva, 3 September 2020 – Seven months into the pandemic, the innovative biopharmaceutical industry continues to step up work on researching and testing therapeutics that could lower mortality rates or lessen the severity of COVID-19. Over recent months, the results of rigorous clinical trials of repurposed medicines to achieve quick wins have been mixed, while the pipeline for new treatments does hold promise. Considerable efforts are going into planning to scale up and share manufacturing capacity should treatments prove safe and effective.

 

IFPMA is strongly committed to rigorous regulatory standards for approval of COVID-19 treatments and vaccines. No matter how urgently action is needed against the coronavirus public health emergency, it is imperative that the highest standards of quality, safety and efficacy are upheld everywhere. IFPMA member companies are fully committed to transparency in reporting clinical trial results whether these are good or bad; they support the need to inform the public of what they know, as well as what they don’t know about the vaccines in development.

The innovative biopharmaceutical industry believes that ensuring the right level of engagement with society whilst assessing and approving vaccines will be key to gaining the public’s trust in COVID-19 vaccines and helping end the coronavirus pandemic.

Vaccines may ultimately bring an end to the pandemic, but there is an urgent need for therapeutic innovation that can offer clinical benefits to COVID-19 patients. Today, more than 300 COVID-19 treatments are being researched or are in clinical trials around the world: some repurposed medicines proven to work against other deadly diseases, others as novel as the virus itself.

Today, 22 leading IFPMA member companies are involved in R&D for therapeutics and together have enacted or are conducting 81 clinical trials evaluating therapeutics’ effectiveness. The main COVID-19 treatments being looked at are antivirals, antibodies and convalescent plasma, as well as anti-inflammatories. This is encouraging as the clinical response to help patients with COVID-19 requires multiple treatment options but there is no magic bullet to treat or cure patients with the virus.

For some repurposed treatments, hopes have been dashed. Rigorous clinical trials have shown that hydroxychloroquine for patients with mild COVID-19 does not work. Tocilizumab has also proven to show no marked improvement in adult patients with severe COVID-19-associated pneumonia. In contrast, dexamethasone has proven effective in seriously ill COVID-19 patients. Researchers are now waiting for results of repurposed treatments used in combination.

Elsewhere, hopes have been fulfilled: remdesivir has gone in a matter of months from an investigational compound to an available therapy that shortens recovery times among hospitalized patients. Further down the line, other novel treatments may help patients with weakened immune systems. Progress is being made, but at a slower pace than society would have hoped for. Should a treatment prove safe or effective, biopharmaceutical companies are already planning upfront how to scale up and be ready to share manufacturing capacity in order to meet potential demand…

Thomas Cueni, Director General of IFPMA, commented on progress in finding treatments for COVID-19: “We’re still on a learning curve. However, we remain on course with single-minded focus and a willingness to take on the risks inherent in all innovation while pulling together our R&D capabilities for the benefit of patients living up to our commitments. What we’ve learnt so far is that there will unlikely be a magic bullet for everyone against COVID-19, but that is no excuse for cutting corners in our haste to approve new treatments or vaccines.”

 

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BIO [to 5 Sep 2020]
https://www.bio.org/press-releases
Press Releases
Biotech Leaders Outline Principles to Ensure the “Public’s Trust” in New Medical Products for Eradicating Covid-19
September 3, 2020
As America’s researchers race to develop the scientific solutions needed to eradicate Covid-19, leaders within the Biotechnology Innovation Organization (BIO) released an open letter to their biopharmaceutical colleagues that articulates key principles to ensure the “integrity, transparency, and objective assessment” of Covid-19 clinical data and secure public trust in new medical products developed in response to the pandemic:

AN OPEN LETTER TO THE BIOPHARMACEUTICAL INDUSTRY
September 03, 2020
The biopharmaceutical industry is at the center of the world’s fight against Covid-19, leading the effort to develop new vaccines, therapeutic medicines and diagnostics.

Over time, we expect these efforts to be successful, resulting in a range of new healthcare products for the benefit of the entire world. These new products will need to be manufactured in large quantities and distributed rapidly to all segments of our society. Physicians, public health officials, patients and healthy citizens will need to be educated as to their safety, efficacy, and risk/ benefit. Their widespread adoption will be based on trust in the integrity of the scientific and public health principles governing their development and approval.

If this is done correctly, we will halt the pandemic, save lives, reignite our economy and enable a return to a more normal life. We will emerge from this pandemic better prepared to address and react to future biological threats.

As data begin to emerge from clinical trials of an array of vaccines and therapeutics, we believe that it is important for us in the biopharmaceutical industry to articulate the principles we see as essential for assessing these data and determining their potential value. We believe that public health, and the public’s trust in new medical products, are dependent upon the integrity, transparency and objective assessment of new data as they emerge.

Accordingly, we are articulating the following principles:
[1] Clinical trials should be conducted according to best practices to assure credibility of the data, as well as the ethical participation of a diverse population of subjects.

[2] Companies should disclose important clinical data via well-respected scientific meetings or rigorous, independent peer review journals. The disclosure of key scientific and clinical data through meetings and journals is the gold standard. However, companies may need to release some clinical data in advance of publication. In these instances, companies should approach any pre-publication press activity thoughtfully, and data should not be released by press release alone. Sponsors should ensure that data included in any press statement are clear and include accurate descriptions of key data points while reinforcing that the full data will be submitted for peer review.

 

[3] FDA should maintain its historic independence as the gold-standard international regulatory body, free from external influence. This will assure the public that the FDA review process will adhere to the highest standards of scientific and medical integrity, and that any approved products therefore will meet the required standards of safety and efficacy.

[4] The appropriate use of any new products should be data-driven. Different sub-populations are likely to react differently to different medicines. These differences will begin to be revealed in larger long-term studies. The public should be assured that only rigorously considered data will dictate the subsequent use of any product. Distribution of any vaccines should be done with these considerations in mind.

[5] Political considerations should be put aside by Republicans and Democrats alike. Our nation’s leaders should reassure the public that politics will not influence the development and approval of new medicines. Conclusions about both the safety and effectiveness of such medicines should be based on rigorous collection and assessment of data by all the appropriate bodies, and their distribution should be based on sound public health considerations. This approach is all the more vital considering the unprecedented pace and scale of the effort to develop treatments and vaccines for Covid-19.

We urge all parties involved in the development, review, approval, and distribution of COVID-19 therapeutics and vaccines to commit themselves to these principles.

Sincerely,
Jeremy M. Levin, DPhil, MB BChir
Chairman of the Board and CEO Ovid Therapeutics
Chair, Biotechnology Innovation Organization (BIO)

Paul J. Hastings
President and CEO Nkarta Therapeutics, Inc.
Vice Chair, Biotechnology Innovation Organization (BIO)

Ted W. Love, MD
President and CEO Global Blood Therapeutics
Chair, Emerging Companies Section Governing Board
Biotechnology Innovation Organization (BIO)

Michelle McMurry-Heath, MD, PhD
President and CEO
Biotechnology Innovation Organization (BIO)

Ron Cohen, MD
President and CEO Acorda Therapeutics, Inc.
Past Chair, Biotechnology Innovation Organization (BIO)

Rachel K. King
Founder and CEO GlycoMimetics, Inc.
Past Chair, Biotechnology Innovation Organization (BIO)

John Maraganore, PhD
CEO Alnylam Pharmaceuticals, Inc.
Past Chair, Biotechnology Innovation Organization (BIO)

Richard Pops
Chairman & CEO Alkermes, Inc.
Past Chair, Biotechnology Innovation Organization (BIO)