Food and Drug Administration (FDA) Modernization Act 2.0 –
What It Means and The Role for Bio-Spun™ 3D Scaffold Technology
President Biden signed the Food and Drug Administration (FDA) Modernization Act 2.0 into law in December of 2022. This new law revises the Federal Food, Drug, and Cosmetics Act of 1938, which mandated animal testing for every new drug development protocol. The original mandate was intended to ensure certain quality and safety standards for drugs and medical devices. However, to date, over 92% of drugs that have been shown to successfully work in both benchtop and animal studies fail in human clinical trials. The disconnect between animal testing and successful outcomes in humans has driven the need to develop new technologies to better screen and predict future success of new drugs in vitro.
The new act authorizes the use of certain alternatives to animal testing, ranging from cell-based tests to computer models, in order to obtain an exemption from the FDA to investigate the safety and effectiveness of new drugs. Cell-based testing, which involves developing partial or full thickness tissue models that replicate part(s) of the body where the drug targets, has continued to advance over the past two decades for this purpose. These models can be used under static (no flow) or under dynamic (fluid flow) conditions. One of the areas that needs to improve for these test methods is the membrane and scaffold onto which these tissue models are grown.
Most of the current tissue models involve using a two-dimensional (2D) membrane with pre-formed holes (porosity). This membrane does not provide the cells the three-dimensional (3D) environment they require. To compensate for this, researchers are required to use animal derived collagen or hydrogels like Matrigel™ to mimic the human cellular matrix. Similar to what is seen with in vivo animal testing, interaction with these animal derived matrices lead to unanticipated cellular response. Our Bio-Spun™ scaffolds are made from 100% animal free material that forms a natural 3D structure that closely resembles the body’s natural scaffold and overcomes the common challenges associated with animal derived test models. These same Bio-Spun™ scaffolds have also been implanted into various animal models, showing excellent healing in vivo with minimal scar formation (fibrosis). Therefore, the Bio-Spun™ scaffold is one of the only scaffolds that has shown excellent cell response both outside and inside the body.
BioSurfaces is positioned to lead the 3D synthetic scaffold needs of its static and dynamic tissue model customers. The company is already working with numerous customers in both spaces, serving as a scaffold provider as well as a co-development partner. While there is still much work to be done, the push toward reducing or eliminating animal testing for drug screening is a global mandate and BioSurfaces is ready to rise to the occasion! Come visit us at www.biosurfaces.us/ivrt for more information.