Biotech Leaders Outline Principles to Ensure the “Public’s Trust” in New Medical Products for Eradicating Covid-19
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. As these long-standing leaders within the biotech industry note:
“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. …
“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.”
The open letter articulates the following core principles:
- 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.
- Companies should disclose important clinical data via well-respected scientific meetings or rigorous, independent peer review journals, and companies that need to release data in advance of publication should do so thoughtfully and not through press release alone.
- The FDA should maintain its historic independence as the gold-standard international regulatory body, free from external influence.
- The appropriate use and distribution of any new products should be data-driven, including through data collected during longer-term studies.
- Political considerations should be put aside by leaders in both parties and they should “reassure the public that politics will not influence the development and approval of new medicines.”
In conclusion, the letter urges everyone “involved in the development, review, approval, and distribution of COVID-19 therapeutics and vaccines to commit themselves to these principles." To read the entire letter, click here. The letter was signed by the following individuals who are leaders within both BIO and the biopharmaceutical industry writ large:
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)