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…