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BIO leaders urge biopharmaceutical companies to apply scientific principles in seeking drug and vaccine approvals.
Amid public and healthcare expert concern about trust in vaccines and medicines in development to combat COVID-19, leaders of the Biotechnology Innovation Organization (BIO) released a letter to biopharmaceutical industry colleagues that listed principles to ensure the “integrity, transparency, and objective assessment” of clinical data.
The Sept. 3, 2020 letter signed by current and former BIO board members commends the biopharma industry’s efforts to develop, manufacture, and distribute vaccines, therapeutics, and diagnostics, but warns that “widespread adoption will be based on trust in the integrity of the scientific and public health principles governing their development and approval.”
The letter noted that as data from clinical trials for vaccines and therapeutics, is released “… it important for us in the biopharmaceutical industry to articulate the principles we see as essential for assessing these data and determining their potential value.”
The letter listed core principles including the need to conduct clinical trials according to best practices to ensure participation of a diverse population of subjects. Clinical data should be released at scientific meetings or in peer-review journals; data released in advance of publication should not be through a press release alone.
In addition, the letter noted that “FDA should maintain its historic independence as the gold-standard international regulatory body, free from external influence” and both political parties should “reassure the public that politics will not influence the development and approval of new medicines.”