BIO Praises the Release of the 21st Century Cures Initiative Discussion Draft

The Biotechnology Industry Organization (BIO) has released the following statement on the 21st Century Cures Initiative discussion draft shared by Chairman Fred Upton (R-MI).

Jim Greenwood, BIO President and CEO said: “Today, we recognise and thank the Committee on Energy and Commerce for releasing its 21st Century Cures Initiative discussion draft intended to accelerate the discovery, development and delivery of next-generation modern medicines to transform patient care.

“Working with member companies, patient advocacy groups, and other stakeholders, we developed numerous proposals to create a public policy environment that encourages the use of 21st century scientific tools, advancements in molecular biology, and novel bioinformatics to continuously develop and improve upon therapies that can prevent, diagnose and treat all stages of disease.

“We are pleased to see several of our priority suggestions in the discussion draft, including the need for a large-scale national research commitment to study precursors and signs of disease and disease risk factors for chronic conditions. Through the 21st Century Cures Initiative, we hope to work with the Congress, the NIH, and the patient community to develop a study that has the potential to revolutionize our understanding of disease, thus resulting in better treatments and cures.

“We also embrace the focus on precision medicine through genomics and regulatory science. Industrial-scale biomarker qualification and full genome sequencing will help us better understand the molecular basis of disease and develop precision therapies tailored to each patient.

“We believe that placing patients at the center of the drug development process will spur the development of therapies for the most prevalent conditions, as well as encourage development of treatments focused on unmet medical needs. We strongly support establishing a framework for incorporating patient views into the development and regulatory review process in a more structured and transparent way, with respect to benefit-risk assessments and use of patient experience data.

“Further, we support modernising clinical trials to expedite and accelerate drug development through the use of alternative clinical trial designs, biomarkers and surrogate endpoints, and modern scientific approaches and greater utilization of post-market validation and other confirmatory techniques, including the use of real-world data.

“We also strongly support provisions intended to further incentivize biomedical innovation and help expedite the development of new treatments and cures, particularly in areas of unmet medical need where existing incentives may be inadequate to drive sufficient investment.

“In addition, we support enhancing the FDA’s scientific capacity by improving access to adequate funding, recruiting world-class scientific and technical experts, and expanding management processes and human resource functions to meet the complexities of 21st Century scientific discovery.

“While we are still reviewing the many proposals contained within the discussion draft, we look forward to working with Chairman Upton and Rep. DeGette to ensure that the 21st Century Cures Initiative expedites the delivery of the next generation of modern medicines that will save lives and reduce and eliminate suffering.”