ARG and Humacyte Collaborate on Human Acellular Vessel (HAV) Program Advancements in Vascular Trauma
February 23, 2024CHARLOTTESVILLE, VIRGINIA – ARG (Atlantic Research Group) proudly announces its ongoing collaboration with Humacyte, a leading biotechnology company, on the Human Acellular Vessel (HAV) interposition graft program. Since 2014, ARG has provided comprehensive full service support, contributing to the program's success in addressing vascular trauma injuries.
“ARG is proud of the hard work, dedication, and collaboration with Humacyte for the repair of vascular trauma injuries using the Human Acellular Vessel, which resulted in a successful BLA submission and acceptance by the FDA,” said Brad Whitlow, Director, Project Operations at ARG. ARG's dedicated team has delivered a full suite of services tailored to Humacyte's evolving needs. The partnership reflects Humacyte's search for a nimble and flexible Contract Research Organization (CRO) partner capable of adapting to the demands of the HAV program. ARG's corporate mission and culture align seamlessly with Humacyte's goals, fostering a collaborative environment focused on clear communication, active listening, and continuous learning.
Throughout the program, ARG and Humacyte encountered various challenges inherent to clinical studies, necessitating innovative solutions and risk mitigation strategies. These challenges included obtaining timely consent from trauma patients or their representatives, adherence to a well-organized protocol and procedures in a trauma setting that cannot be controlled due to the inherent nature of treating trauma patients, and managing challenging data collection processes for complex trauma cases.
To overcome these obstacles, ARG and Humacyte implemented proactive measures, working with trauma centers across the United States and large hospitals in Israel, ensuring robust enrollment and data collection. Furthermore, amidst global turmoil following the Russian invasion of Ukraine, Humacyte collaborated closely with regulatory authorities to provide humanitarian aid for vascular trauma injuries. Subsequently, the FDA requested the inclusion of data from Ukrainian patients receiving the HAV to be included in Humacyte's Biologics License Application (BLA) submission.
In response to this request, ARG facilitated seamless data collection and entry, collaborating with Humacyte and a local CRO in Eastern Europe, even amid challenging circumstances in a conflict-affected region. Despite the adversity, ARG remained committed to supporting Humacyte's mission, underscoring the resilience and dedication of both organizations.
Through unwavering collaboration and innovative problem-solving, ARG and Humacyte continue to advance the HAV program, driving progress in the treatment vascular trauma injuries.
For more information about ARG and its services, please visit atlanticresearchgroup.com.
About ARG:
ARG (Atlantic Research Group) is a leading Contract Research Organization (CRO) dedicated to supporting pharmaceutical, biotechnology, and medical device companies in the development and execution of clinical research programs. With a focus on quality, efficiency, and innovation, ARG provides comprehensive solutions across all phases of clinical development.
