Alliance for Regenerative Medicine Advocates for Science

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I spent the past two days at the annual Washington meeting of the Alliance for Regenerative Medicine (ARM), the advocacy organization that CIRM helped found in 2009.

Advocating in DC

I represented CIRM at that first organizing meeting, so it has been gratifying to watch ARM grow into an effective advocate for the field. The organization has achieved its goal of building a community where academic leaders, industry partners, patient advocates, and investors work together in a coordinated way.

ARM and CIRM share a mission to speed regenerative therapies to patients with unmet medical needs. ARM also supports our commitment to educating the public about the promise of the field. As its website notes, “ARM also works to increase public understanding of the field and its potential to transform human healthcare.”

That transformation depends heavily on federal action—both regulatory and legislative—which dominated discussions over the past two days.

While the iconic Capitol building is the most recognized footprint of our Congress, it is the House and Senate office buildings that ring three sides of the Capitol where most of the work gets done, like in the Rayburn building, which houses the office of Dianna DeGette, the Colorado congresswoman and champion of regenerative medicine.
While the iconic Capitol building is the most recognized footprint of our Congress, it is the House and Senate office buildings that ring three sides of the Capitol where most of the work gets done, like in the Rayburn building, which houses the office of Dianna DeGette, the Colorado congresswoman and champion of regenerative medicine.

Our shared goals

ARM members presented three specific proposals for advancing the field to members of congress and their staffs. These would:

  • Create a center of excellence to develop technical and process standards for regenerative medicine. This work may not seem exciting, but agreeing early on what regulators will accept can cut months or even years from the development timeline for new therapies.
  • Create a special pathway within the FDA—similar to the one for orphan diseases—for “Qualified Regenerative Medicine Products” (QRMPs). These products would show potential to change the course of a disease with unmet medical needs, and the FDA would need to meet with sponsors to discuss expedited review.
  • Advocate for a national regenerative medicine strategy that coordinates federal agencies, supports research, and reforms regulations to create a clear and predictable path for rapid approval of safe, effective products. To support this effort, ARM has proposed establishing a Regenerative Medicine Coordinating Council within the U.S. Department of Health and Human Services.
Jamie Goldfarb with her son Kai and husband Jeff. Photo courtesy Melanoma Research Alliance
Jamie Goldfarb with her son Kai and husband Jeff.
Photo courtesy Melanoma Research Alliance

Jamie Goldfarb, who overcame melanoma with a cell‑based immune therapy, delivered a clear and passionate call to speed access to these therapies at the ARM member dinner Tuesday night:

“Greater awareness of regenerative medicine makes a world of difference. It means less suffering, pain, fear, expense, hardship, and loss. It also brings more hope, determination, love, and strength to individuals and to society. Every person in this room, and every organization you represent, is improving lives.”

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