Washington, D.C. (September 9, 2020) – U.S. Agriculture (USDA) Secretary Sonny Perdue will join leaders across the bioeconomy—in agriculture, sustainable fuels, and biobased manufacturing— for discussions on the role of biotechnology in protecting our planet’s resources, driving a strong economy and improving people’s lives. Hosted by the Biotechnology Innovation Organization (BIO), the BIO IMPACT Agriculture & Environment Digital Conference will be held virtually September 21-22, 2020. The event builds on the legacy of the BIO World Congress on Industrial Biotechnology and Agriculture—the world’s largest conference on industrial biotechnology—which convened for more than a decade. Secretary Perdue will join Brian Brazeau, Vice-chair of BIO’s Food and Agriculture Section Governing Board and President of Novozymes North America, for a fireside chat on USDA’s Leadership in Driving Innovation in Agriculture on September 22, 10:00 am (ET). USDA’s Agriculture Innovation Agenda was announced earlier this year and aims to cut the environmental footprint of agriculture in half while increasing production by 40 percent. This session will highlight how biotech applications on the farm and in food production are supporting these goals by combatting climate change and driving sustainability. Other notable speakers include: Dr. Michelle McMurry-Heath, BIO’s President and CEO Barb Glenn, National Association of State Departments of Agriculture (NASDA) Greg Jaffe, Center for Science in the Public Interest (CSPI) Jason Kelly, Ph.D., Gingko Bioworks Christophe Schilling, Genomatica Joshua Hoffman, Zymergen John Melo, Amyris Sylvia Wulf, AquaBounty The full program can be found here. Complimentary media registration is available to editors and reporters working for print, broadcast, or web publications with valid press credentials. For more information on the conference, please visit bio.org/bioimpact. Please contact Connor McKoy (CMcKoy@bio.org) if you…

As America’s researchers race to develop the scientific solutions needed to eradicate Covid-19, leaders within the Biotechnology Innovation Organization (BIO) released an open letter to their biopharmaceutical colleagues that articulates key principles to ensure the “integrity, transparency, and objective assessment” of Covid-19 clinical data and secure public trust in new medical products developed in response to the pandemic. As these long-standing leaders within the biotech industry note: “The biopharmaceutical industry is at the center of the world’s fight against Covid-19, leading the effort to develop new vaccines, therapeutic medicines and diagnostics. Over time, we expect these efforts to be successful, resulting in a range of new healthcare products for the benefit of the entire world. … “As data begin to emerge from clinical trials of an array of vaccines and therapeutics, we believe that it is important for us in the biopharmaceutical industry to articulate the principles we see as essential for assessing these data and determining their potential value. We believe that public health, and the public’s trust in new medical products, are dependent upon the integrity, transparency and objective assessment of new data as they emerge.” The open letter articulates the following core principles: Clinical trials should be conducted according to best practices to assure credibility of the data, as well as the ethical participation of a diverse population of subjects. Companies should disclose important clinical data via well-respected scientific meetings or rigorous, independent peer review journals, and companies that need to release data in advance of publication should do so thoughtfully and not through press release alone. The FDA should maintain its historic independence as the gold-standard international regulatory body, free from external influence. The appropriate use and distribution of any new products should be data-driven, including through…

Today, the Centers for Medicare and Medicaid Services finalized this year’s inpatient prospective payment system (IPPS) rule, which includes a new diagnosis-related group (DRG) to streamline reimbursements for providers administering CAR T-cell therapies to patients with cancer. Following CMS’ announcement, BIO’s Executive Vice President for Health Policy, Dan Durham, said the following: “This final rule reaffirms the many benefits transformational therapies – such as CAR T-cell therapy -- provide patients and society more broadly. Medicare reimbursement should not serve as a barrier to life-saving treatments, and the final policy announced today validates this basic principle. It’s vital the Trump administration continue to build on these steps to ensure that seniors benefit from the next generation of innovative cures and treatments, including CAR T-cell therapy.”

Washington, D.C. (September 1, 2020) – A U.S. regulatory system that keeps pace with science will put much-needed tools into the hands of farmers, help combat climate change, and advance sustainable farming practices, according to the Biotechnology Innovation Organization (BIO). “BIO strongly believes these modernized regulatory approaches must be science-based and provide meaningful transparency to consumers so we can establish a system that drives innovation over the long term,” said Dr. Clint Nesbitt, BIO’s Senior Director of Science and Regulatory Affairs for Food & Agriculture. A proposed rule released today by the U.S. Environmental Protection Agency (EPA) updates the regulatory treatment of Plant-Incorporated Protectants (PIPs) that are developed using new technologies such as gene editing. “While we are still reviewing the proposal, BIO applauds the Administration for its continuing efforts to modernize the regulatory framework for agricultural biotechnology products consistent with the Executive Order released last year,” said Nesbitt. “An efficient, risk-based regulatory system fosters innovation and paves the way for global solutions such as crops that require fewer chemical inputs and tolerate extreme weather.”   The proposed rule released by EPA today represents an approach that started with development of the National Bioeconomy Blueprint in 2012. In the eight years since, both the Obama and Trump Administrations have initiated regulatory improvements to maintain oversight while recognizing the economic, environmental, and societal benefits of biotechnology. “BIO will be submitting comments and looks forward to engaging with the agency as it develops a final rule,” said Nesbitt. “We are also continuing our work with stakeholder partners to make sure that any regulatory reform is accompanied by tangible transparency measures that bolster public confidence.”