Members of our compliance and clinical team recently gathered with other leaders in the field of regenerative medicine to draft initial industry standards and discuss important next steps at a workshop hosted by the Standards Coordinating Body, titled “Realizing the Benefit of 21st Century Cures Through Standards Development.” The workshop focused on the advancement of the standards specifically for the regenerative medicine community, which includes cell-based therapies, gene therapies and tissue engineering.
The workshop takes part of its name from the 21st Century Cures Act that was signed into law in December 2016. The act is meant to quickly advance medical products and procedures, including regenerative medicine, to improve the lives of the patients who need them. The Standards Coordinating Body ensures that the quickly advancing field of regenerative medicine continues to do so in a safe and effective manner.
The standard drafting during this workshop was highly relevant to the work that we do at Lung Health Institute, where our goal is to provide the highest quality of patient care, delivering best-in-class results for those with chronic lung disease. Following the initial standards my colleagues and I drafted for the biologics industry, I want to share some of the key themes and takeaways that resonated with me:
Standards are critical to the success of the industry: While the industry is regulated, it lacks standards. Because Lung Health Institute holds itself to internal standards, we have a lot to offer in the conversation. Standards in biologic use can help the industry move forward and get approval on products quickly and safely. However, creating standards is difficult because providers want to protect their intellectual property. Health care providers are administering cell products directly to patients, so it’s important to keep patient safety at the forefront of the conversation. Patients must always be the priority.
Standardization involves many groups: The industry has many different facets and involves a variety of different groups: suppliers, medical professionals, researchers, lawmakers, patients. Collaboration is key, and this workshop allowed many individuals from these groups to come together, speeding up development of future standards.
Consistency brings accessibility: Standardization can assist regulators with the approval process to make treatments available to more patients with chronic or degenerative conditions. That means patients with conditions that don’t have a cure will have greater access to life-changing treatments.
To learn more about how Lung Health Institute is advancing the field, please visit our website.