US Government Wants to Know More About the Biotech Ecosystem

Regulatory NewsRegulatory News
| 10 September 2019 | By Zachary Brennan 

The White House’s Office of Science Technology and Policy (OSTP) on Tuesday sought input from any and all biotech stakeholders on the innovation, products, technology and data derived from biologically-related processes and science that drive economic growth, promote health and increase public benefit.

Referred to as the “Bioeconomy,” OSTP said it’s seeking comments before 23 October from the public, including those with capital investments, those performing research or developing enabling platforms and applications in the field of biological sciences, including healthcare, medicine, pharmaceuticals, biotechnology and manufacturing.

In 10 pages or less, the comments should, among other topics, address any policy or regulatory opportunities and gaps related to basic science translation, product development and commercialization, as well as scientific areas where research funding could be targeted to further stimulate discovery.

OSTP is also seeking information on when the US government could partner with the private sector, academia, professional organizations and others, specifically within “basic science, translational research, product development, and commercialization.”

The office, headed by Kevin Droegemeier, also wants input on what scientific, regulatory, manufacturing standards and/or benchmarks and/or best practices around data should be developed to best accelerate Bioeconomy growth.

According to the results of an expert survey published in May in the journal PlosOne, “Global trade in bio-based products has been booming over the last decade. While bio-based products represented about 10% of total international trade in 2007, this figure reached 13% in 2014.”

By 2020, US Food and Drug Administration (FDA) officials have said they expect to receive upwards of 200 INDs for cell and gene therapies each year, adding to the 800 active INDs for such products already filed with the agency. By 2025, they predict the agency will be approving between 10 and 20 cell and gene therapy products annually.

Federal Register


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