Joxel Garcia,
FounderandCEOofAmbitna
Title: Accelerating Clinical Trials to Automatically Match More Diverse Patients to Eligible Studies
Biography
Biography: Joxel Garcia,
Abstract
The 21st Century Cures Act (Cures Act), signed into U.S. law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. Furthermore, the Cures Act facilitates development and approval of genetically targeted and variant protein targeted drugs for treatment of rare diseases. While the Cures Act has the potential for positive transformational delivery of innovative care, it also created uncertainty in the operationalization of the regulations for industry for compliant, sustainable service and payment models. Presently only 4-8% of eligible candidates for clinical trials participate in them. Patients have difficulty understanding or accessing the opportunity for clinical trial therapies. This represents a delay to the approval of new drugs and therapies, understanding of all side effects and true dosing. This also increases the chances that after drug approval, the number of side effects, complications and dosing issues create a major liability burden for the pharmaceutical and the health care system involved. In partnership with Meharry Medical College, the U.S. largest private, independent historically black academic health sciences center, Ambitna designed an automated system to match patients based on diagnosis with eligble clinical trials and connect with CROs. The regional clinical trial matches can increase success of a CRO fulfilling the cohort with more diversity on gender, race, ethnicity and age, thus decreasing liability and increasing ROI on the product.