The following statement may be attributed to BIO's Vice President for Agriculture and Environment Sarah Gallo:  “BIO looks forward to working with a proven leader like Dr. Califf as he takes the helm at FDA. Dr. Califf will lead an agency that contributes to the oversight of animal and plant biotechnology and is indispensable for the safety of our food system. Science is playing an increasingly critical role in our lives, as society navigates public health and environmental challenges. BIO members are developing innovations that stand to benefit people and the planet. But these breakthroughs are dependent on a clear, timely and science-based regulatory approval process that provides a viable path to market. BIO looks forward to working with Dr. Califf to ensure the United States remains a leader in innovation and embraces the solutions that technology provides.”

Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), made the following statement after Dr. Robert Califf was confirmed by the Senate to lead the Food and Drug Administration (FDA): “We congratulate Dr. Califf on his confirmation as FDA commissioner. Dr. Califf is an excellent choice to lead the FDA at this critical juncture. He’s a proven leader whose on-the-job experience and deep understanding of the agency will allow him to hit the ground running. I have known Dr. Califf for many years. He’s effective, inclusive and makes decisions by following the science. He’s driven efforts to modernize clinical trials, including the use of real-world evidence, and he’s pushed for greater diversity in science and clinical trials. BIO looks forward to working with Dr. Califf and his leadership team on these issues and ensuring that more patients, in more communities, have access to the medical breakthroughs they need to live healthier and more productive lives.”

Current pipeline “insufficient” to meet the threat of AMR, policy reforms critically needed   The Biotechnology Innovation Organization (BIO) today released a new report examining antibacterial innovation and the current pipeline for new antibacterial medicines, The State of Innovation in Antibacterial Therapeutics. The report analyzes the pipeline for new antibacterial medicines, the market’s unique investment challenges, and potential policy solutions to support the development of new treatments. “Over 1 million people worldwide lost their lives to drug-resistant bacteria in 2019. We urgently need new, effective antimicrobial medicines to keep up with ever-growing resistance,” said Dr. Michelle McMurry-Heath, President and CEO of BIO. “This new report illuminates the unfortunate reality of the antimicrobial market and why policymakers should act now to help address its unique challenges and support innovation.” The report, authored by David Thomas and Chad Wessel of BIO’s Industry Analysis team, includes several key takeaways for the current state of antibacterial innovation: Approved Antibacterial Drugs: Although there have been 164 FDA-approved direct-acting antibacterial new chemical entities (NCEs) since the early 1900s, only one new molecular target NCE has been approved over the last 35 years, illustrating a need to broaden the antibacterial discovery engine. There have been 11 indirect-acting NCEs approved, including seven drugs that work to extend the activity of existing drugs and four monoclonal antibodies specific for exotoxins. Pipeline: The breadth and novelty of the antibacterial clinical-stage pipeline is insufficient to meet the ongoing threat of wide-spread infection from drug-resistant strains. The clinical pipeline contains 54 direct-acting novel chemical or biochemical entities and 10 microbial entities. However, of the non-microbial candidates, 61% have targets for which marketed drugs already exist. More than 38% of candidate…