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.”  

  Today, Inova Software and the Biotechnology Innovation Organization (BIO) are announcing the first international series of virtual partnering events focused on three critical therapeutic areas with great unmet need -  oncology, neuroscience and infectious diseases, happening until the end of the year. Recognizing that COVID-19 forced an abrupt halt to global travel and conferences, the virtual partnering is an innovative approach for the scientific world to continue to meet and discover new opportunities for forging strategic partnerships. Building on their respective track record of organizing hundreds of thousands of meetings to accelerate partnering across the life sciences industry and large digital gatherings, Inova and BIO are creating a dedicated space for face-to-face interaction between top biotech companies, research labs and biopharma companies. The single therapeutic focus for each partnering event enables participants to cut through the noise and conduct targeted one-on-one business development meetings that bring the best science forward to advance product pipelines.  The first event, on oncology, will take place 22-24 September. Even with a record number of novel oncology drugs and a spate of new treatment options, such as immunotherapies and cytokine modulation, oncology is still one of the toughest areas in medical R&D. Challenges include severe competition, substantial risk of failure and lengthy timeline from bench to bedside. Many biotech start-ups lack the resources to develop, produce and distribute their innovations, which is why partnering can have a real impact. Fostering partnering between large and small companies in this space will lead to early-stage discovery collaborations, platform deals for preclinical or discovery-stage assets, licensing agreements, fresh paths to drug repurposing and new diagnostic tests or biological markers and  the resources to advance these treatments through the pipeline. Dr…