Baldwin Pushes For New Standards In Regenerative Medicine Industry

U.S. Sen. Tammy Baldwin has introduced new legislation to create industry standards for regenerative medicine.

The bill would create a public-private board to set guidelines for regenerative medical products, including those developed from stem cells. Dr. Bill Murphy, co-director of University of Wisconsin-Madison’s Stem Cell and Regenerative Medicine Center, said the standards used currently aren’t specific to the cells and tissues used in the therapies. As these products start to be manufactured outside the research lab, Murphy said companies need guidelines in order for those medicines to be “safe and effective for a broad range of patients.”

Murphy said it’s important that all stakeholders in regenerative medicine play a part in creating effective guidelines.

“We need to understand, what is the current state of the art in manufacturing these therapies; what do we know about the relationship between the manufacturing process for a product and its safety and efficacy in clinical trials in people; and what are the best practices for manufacturing,” Murphy said.

In order for that to happen, said Murphy, there needs to be collaboration between product developers, regulators, and scientists who are involved in the field.

Murphy also noted that other industry organizations like the National Institute for Standards in Technology are also working to set standards for these products.