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First-in-Human: BIO Submits Comments to EMA on Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

The Biotechnology Innovation Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the “Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.” 

The Biotechnology Innovation Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the “Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.”

 BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.

 In general, it is important that the guideline acknowledges and differentiates the requirements for trials conducted in high-morbidity and high-mortality disease states such as advanced stage cancers, as in such settings more flexibility should be applied, and as already recognized by regulators in other guidance documents (e.g., ICH S9 guideline). Key comments included in the below include discussion of maximum doses in healthy volunteer studies (line 424); sentinel dosing (line 557-578; and no need to submit an interim report necessarily as a substantial amendment (lines 634-636).

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