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BIO Comments on FDA Guidance on Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials

Human Health • Letters, Testimony & Comments • June 12, 2022

On Monday, June 13th, BIO submitted comments in response to a recently published FDA draft guidance providing recommendations to sponsors on developing a Race and Ethnicity Diversity Plan to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in the United States. In addition to a number of specific line edits, BIO highlighted several, key areas where the Guidance could be improved. First, with reference to the critical role community engagement plays in enrolling underrepresented populations, BIO urged FDA to take steps to ensure the Agency has the expertise necessary to address concerns related to enrolling and retaining diverse patients. Secondly, BIO advised FDA to work with sponsors to ensure that FDA-sponsor communications are streamlined and consistently implemented across the Agency, building from provisions described in the PDUFA VII Commitment Letter. For example, providing further clarity on the timing and operational considerations for the FDA’s initial and subsequent review of sponsors’ diversity plans would help to ensure robust and productive communications. Given the emphasis on socio-cultural issues contributing to underrepresentation of certain racial and ethnic groups also BIO noted the importance of collecting and analyzing data by “self-assigned” or “self-reported” race and ethnicity. Finally, given clinical development programs are often conducted globally, BIO suggested that the Agency provide additional detail on how sponsors should incorporate this guidance along with existing international guidelines.

Letters, Testimony & Comments • June 10, 2022

On Friday, June 10th, BIO submitted comments in response to the FDA’s draft guidance on Chimeric antigen receptor (CAR) T cell products (i.e., human gene therapy products in which the T cell specificity is genetically modified to enable recognition of a desired target antigen for therapeutic purposes). In the comments submitted, BIO expressed appreciation for the FDA’s statement that recommendations in the guidance will be applicable to other genetically modified lymphocytes. However, as the title of the guidance is limited to (CAR) T cells and there is little mention of therapies beyond (CAR) T, BIO raised the need for additional clarity on which principles within the guidance the Agency plans to apply more broadly. To that end, BIO urged FDA to expand the scope of the guidance and provide further detail on the breadth of products the guidance would apply to, especially given the unique scientific considerations presented by certain cell types. Finally, in addition to a number of specific line edits, BIO highlighted that the landscape of regenerative medicines is continually expanding and evolving and there are a number of topics where sponsors could benefit from the issuance of additional guidances.

Letters, Testimony & Comments • June 10, 2022

On Friday, June 10th, BIO submitted comments in response to the FDA’s draft guidance on developing human gene therapy products that incorporate genome editing (GE) of human somatic cells. Overall, BIO found the guidance to be a well-written resource that will be useful once further experience is gained with these therapies. However, given the field is rapidly advancing, BIO recommended the Agency revise certain sections of the guidance to make it more informative and practical for sponsors to implement. For example, expanding the scope of this guidance beyond human somatic cells to include cells derived from adult and pluripotent stem cells, would provide valuable insight to sponsors on FDA’s current thinking. Additionally, the Guidance would be enhanced by a more comprehensive discussion of how safety, efficacy, durability, and quality of a GE product are factoring into FDA’s regulatory decisions. In particular, given the field of GE products is rapidly maturing, BIO believes the Guidance should more fully discuss the benefit-risk considerations at marketing application review, including discussion of how the perspectives of patients will be incorporated. Furthermore, BIO challenged FDA’s implication that sponsors should be incorporating the best available technology in each GE product application, as newly discovered and yet untested and unproven technologies, should not distract from the objective and focused review of existing technologies that have matured to the point of being incorporated into GE products.

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Do You Know a Game-Changer in the Bioeconomy? Nominations for BIO’s Prestigious Innovation Awards Open Today

Agriculture & Environment • Press Release • June 8, 2022

The Biotechnology Innovation Organization today announced the opening of nominations for two awards to honor significant leaders driving cutting-edge, sustainable breakthroughs in the fields of agriculture and the environment. The George Washington Carver Award recognizes individuals who have advanced biotech innovation to make supply chains greener and have worked successfully toward that goal in the private sector, government or academia. Those submitting nominations should single out individuals who have demonstrated significant and innovative accomplishments within the industry to advance a biobased economy and industrial sustainability. Named for celebrated agricultural scientist George Washington Carver, whose discoveries improved the lives of farmers and the health of American soils, the award pays tribute to those who are building on Carver’s legacy. “Just as George Washington Carver’s vision and achievements transformed agriculture and addressed the soil conservation challenges of his day, today’s scientists are applying the tools of biotechnology to help farmers and manufacturers of biobased products be the problem solvers our world needs now, to ensure we can meet our food and resource demands sustainably,” said BIO President Michelle McMurry-Heath. The Rosalind Franklin Award is presented to a pioneering woman in the agricultural and environmental biotechnology sectors. The award recognizes women who are leading today’s innovations in agriculture, food systems, sustainable energy and biobased manufacturing. Rosalind Franklin is renowned for her work to map the molecular structure of DNA in the 1950s, a time when women did not have as many opportunities as men to enter science and research or to be credited for their contributions to the field. “We still have work to do to improve gender equality in science careers and research,” said McMurry-Heath. “That’s why we at BIO are proud to honor women whose work is expanding knowledge and…

Agriculture & Environment • Press Release • June 8, 2022

The Biotechnology Innovation Organization today announced the opening of nominations for two awards to honor significant leaders driving cutting-edge, sustainable breakthroughs in the fields of agriculture and the environment. BIO will accept nominations until 5:00 p.m., Friday, June 24, 2022. The George Washington Carver Award recognizes individuals who have advanced biotech innovation to make supply chains greener and have worked successfully toward that goal in the private sector, government or academia. Those submitting nominations should single out individuals who have demonstrated significant and innovative accomplishments within the industry to advance a biobased economy and industrial sustainability. Named for celebrated agricultural scientist George Washington Carver, whose discoveries improved the lives of farmers and the health of American soils, the award pays tribute to those who are building on Carver’s legacy. “Just as George Washington Carver’s vision and achievements transformed agriculture and addressed the soil conservation challenges of his day, today’s scientists are applying the tools of biotechnology to help farmers and manufacturers of biobased products be the problem solvers our world needs now, to ensure we can meet our food and resource demands sustainably,” said BIO President Michelle McMurry-Heath. The Rosalind Franklin Award is presented to a pioneering woman in the agricultural and environmental biotechnology sectors. The award recognizes women who are leading today’s innovations in agriculture, food systems, sustainable energy and biobased manufacturing. Rosalind Franklin is renowned for her work to map the molecular structure of DNA in the 1950s, a time when women did not have as many opportunities as men to enter science and research or to be credited for their contributions to the field. “We still have work to do to improve gender equality in science careers and research,” said McMurry-Heath. “That’s why we at BIO are proud…