On Friday, March 26th, BIO submitted comments on the U.S. Food and Drug Administration (FDA)’s public meeting announcement titled, “Best Practices for Development and Application of Disease Progression Models.” BIO appreciates that FDA is seeking input from stakeholders on three key areas, including: the development and application of different types of disease progression models; modeling natural history of disease, specifically methodological considerations and challenges in characterizing the natural relationship between pharmacodynamic markers and clinical outcomes; and clinical trial simulations based on disease progression/natural history models to support drug development and regulatory decisions. Within each topic area, BIO proposed a list of specific issues that would highlight the opportunities and limitations in the development and application of disease progression models. In its comments, BIO also encouraged FDA to include case study examples from the public domain that would be illustrative of disease progression models, and to invite sponsors to present case examples that may not yet be in the public domain, including those that highlight both positive outcomes, lessons learned from negative outcome use cases, and use cases from the Model Informed Drug Development (MIDD) pilot program. To support this discussion, BIO members are willing to offer case study examples for inclusion in the agenda topics. BIO further encourages FDA to develop hypothetical case examples based on Agency experience that illustrate key issues and serve to generate discussion on how those challenges may be overcome.

The Biotechnology Innovation Organization is delighted to support the Inventor Diversity for Economic Advancement Act of 2021 and urge swift enactment of this important measure.

The Biotechnology Innovation Organization is pleased to submit a statement for the record to the United States House of Representatives Committee on Science and Technology and Space and Aeronautics Subcommittee hearing entitled, "Examining R&D Pathways to Sustainable Aviation." BIO applauds the committee for holding this hearing on sustainable aviation. To tackle the climate crisis, it is crucial to lead with science and U.S. innovation. We must incentivize the adoption of innovative and sustainable technologies and practices and streamline and expedite regulatory pathways for new technology solutions to reduce carbon in hard to abate sectors. In doing so, the federal government can support pioneering breakthroughs that reduce greenhouse gas emissions in manufacturing, transportation, and agricultural supply chains to build a stronger, more resilient, and environmentally sustainable economy. BIO is committed to working with the Committee, Congress, and the Administration to address the climate crisis. Policy that advances pioneering technology like SAF will lead to breakthroughs reducing emissions in the aviation sector. By supporting science and innovation, we can return our Nation and the world to health and prosperity by taking bold and drastic action to address the climate crisis.

I write today on behalf of the Biotechnology Industry Organization (BIO) – the world’s largest biotechnology trade group – to urge you to put Senate Bill 11 – the New Mexico Clean Fuel Standard Act – on the agenda for the March 31 special session of the New Mexico Legislature. I appreciate your leadership in pushing SB 11 during the 2021 regular session of the Legislature and respectfully ask that you add it to the agenda for the special session.