We write as a coalition of advocates for the startup ecosystem to voice our strong support for the IGNITE American Innovation Act, legislation to support startups through the economic crisis by allowing companies to monetize tax assets generated through a focus on researching and producing products and technologies that create long-term value. Your legislation is by far the most significant proposal under consideration to provide liquidity to startups and sustain critical economic activity that will pay long-term dividends to American workers and the economy. We commend your strong leadership during this crisis and look forward to working with you to include the IGNITE American Innovation Act in an upcoming economic recovery package.

July 31, 2020 Re: Docket No. FDA–2020-N-0837: Raare Disease Clinical Trial Network; Request for Information. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the Request for Information on the Global Rare Disease Clinical Trial Network. 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’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of diseases, and to prevent diseases in the first place. BIO appreciates FDA’s efforts to address challenges associated with developing therapies for the thousands of rare diseases that do not yet have treatments. We further appreciate FDA efforts to seek feedback from the stakeholder community on the third component of the Rare Disease Accelerator focused on the development of a global rare disease clinical trial network. However, given the number of identified rare diseases, we have concerns and questions regarding the potential scope of a single rare disease clinical trial network. As discussed in greater detail below, it may be more appropriate to consider the development of more than one rare disease clinical trial network. It will also be important for FDA to clearly outline the scope and mission of the clinical trial network(s). It is also important to note that rare disease drug developers still face key challenges unrelated to the availability of robust, high quality global trial networks. These challenges include limited, well-matched natural history data, lack of natural history data for less-prevalent phenotypes within a given disease,  limited established or relevant endpoints and surrogate biomarkers that can be used to support drug development and…

The Biotechnology Innovation Organization (BIO) is pleased to respond to the U.S. Department of Agriculture’s (USDA) Solicitation of Input from Stakeholders on Agricultural Innovations. BIO applauds USDA for taking a proactive approach and seeking information about facilitating the transformative breakthroughs for agriculture to meet the challenges of the 21st Century and increase agricultural production by 40 percent while cutting the environmental footprint by 50 percent. Achieving this goal and addressing the challenges of climate change and inequality in society, will require the rapid development and deployment of biology-based technologies throughout the agricultural supply chain. It will require USDA and the federal government to establish supportive policies and regulations, provide robust funding for research and development, modernize infrastructure, support all farmers and ranchers, and build public support of new technologies. We urge the Administration to seize the opportunity to expand on this American leadership, by acting and supporting the pro-innovation technologies and policies we outlined in our comments. We look forward to our continued partnership in this critical endeavor.  

July 30, 2020 Re: Docket No. FDA–2019-D-5799: FDA’s Public Meeting, Modernizing the Food and Drug Administration’s Data Strategy. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding FDA’s Public Meeting, Modernizing the Food and Drug Administration’s Data Strategy. 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’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. When discussing “data” throughout this letter, BIO takes a broad definition as laid out in FDA’s Technology Modernization Action Plan (TMAP), “…the data that is collected during the routine care of patients, coupled with traditional clinical trial evidence, will be used to generate steady improvements in future patient care. Other data types, such as genomic or toxicology data, and output from medical devices, are a part of the data ecosystem. Data-informed technologies, such as distributed ledger solutions like blockchain, will be critical to support FDA’s track-and-trace priorities.” We support FDA’s efforts to modernize its data strategy to ultimately transform the way data is shared, analyzed, and utilized for regulatory purposes. It will be important to keep in mind, however, as FDA considers these advancements that just as it will take FDA time to implement appropriate IT infrastructure and capabilities to enable these modernizations, industry will need time to implement compatible technologies and processes as well. FDA’s engagement with stakeholders, including industry, in these cases is critical and should, most importantly, allow for flexibility, optional adoption by industry…