ARPA-H launches new Exploration Topic with the aim of improving access to life-changing cellular therapies, including Autologous Cell Therapy (ACT) 

Today, the Advanced Research Projects Agency for Health (ARPA-H) launched its Decentralized Engineering of Cells Informed by Dynamic Evidence (DECIDE) Exploration Topic (ET). DECIDE-ET aims to advance new quality assurance technologies and accelerate the collection of evidence necessary to establish reimbursement pathways for rare disease therapies. If successful, ARPA-H believes the work in this arena would increase patients’ access to life-changing therapies from Academic Medical Centers (AMCs). 

AMCs have developed many life-changing therapies for adults and children with rare diseases, including those using autologous cell therapy, or ACT. ACT begins with harvesting the patient’s own cells or tissues, then processing them into a treatment specifically for that patient.  

However, before ACT can be more widely adopted, non-clinical barriers must be overcome to allow for decentralized and tunable-scale manufacturing.  Conventional large-batch production pathways are not cost-effective, and technological innovation and investment have not yet focused on tools and methods to robustly validate a therapy’s quality and consistency for small-batch production. As a result, the costs of manufacturing and securing regulatory approval for small-batch ACT production are high compared to anticipated revenues, making for an unsustainable business model.  

“Patients, especially children with rare diseases, urgently need greater access to ACT,” said ARPA-H Program Manager Darshak Sanghavi, MD, who leads DECIDE-ET. “Many academic institutions are not in a position to change the dynamics around these therapies. DECIDE-ET aims to help develop a more cost-effective manufacturing and quality assurance automation for smaller-scale ACT production.”  

ARPA-H will make the technologies and methods it develops through DECIDE-ET accessible to industry stakeholders. It will also work with federal agencies on relevant regulatory and reimbursement issues, that may also present formidable challenges to downstream development and adoption. 

DECIDE is a 24-month, three-stage Exploration Topic with a single Technical Area. The three stages include: (1) method development, (2) testing and prototyping, and (3) deployment and validation. For more information, view the draft DECIDE-ET on SAM.gov.  

Register today for the DECIDE ET Webinar on September 20, 2024, at 9:30 am ET.

ETs are fast-paced efforts that pursue topics strategically aligned with ARPA-H Mission Offices. They provide foundational proofs-of-concept to be used in future research. They also allow for a streamlined solicitation and acquisition approach.  

For questions, view DECIDE ET Questions and Answers.