p {color: #ffffff;}

BioFabConsulting: Histogenics Corporation

Histogenics Corporation has long had a clear goal: to become a leading regenerative medicine company that develops, markets and commercializes products in the musculoskeletal segment of the marketplace. Since joining ARMI | BioFabUSA, they have been actively involved in the growing ecosystem. They have offered their expertise, collaborated with other members of the community and taken advantage of the benefits available to its members – all in effort to advance the tissue engineering and regenerative medicine industry.

Histogenics’ platform combines their expertise in cell processing, scaffolding, tissue engineering, bio-adhesives and growth factors to provide innovative treatments that may be used individually or in concert to treat musculoskeletal conditions. By combining these technologies, they were able to develop NeoCart, a restorative cell therapy from a patient’s own cells or regenerative medicine treatment for cartilage defects in the knee.

Cartilage tissue repair has been described as the ‘holy grail’ of orthopedics given that the body does not have truly reparative or restorative capabilities,” said Adam Gridley, President and Chief Executive Officer of Histogenics. He continued, “NeoCart is intended to restore a patient’s damaged knee cartilage to rapidly relieve pain and enable the patient to quickly return to their daily activities.

The NeoCart manufacturing process is unique and transformative because Histogenics is able to symbiotically combine the patient’s own cartilage cells with a biocompatible collagen-based scaffold that is then engineered to create a fully functional tissue. “We are able to grow tissue outside of the body and effectively jumpstart the healing process in our manufacturing facilities, which appears to result in early pain relief, quicker restoration of function and overall better durability of the tissue,” Gridley stated.

Completing one of the largest Phase III randomized clinical trials in North America for a cartilage repair product as outlined in FDA guidance for these types of products, Histogenics is currently engaging with the FDA to discuss its planned Biologics License Application strategy, and hopes to gain approval for NeoCart as early as 2020. As a member of ARMI | BioFabUSA, Histogenics took advantage of the services provided by Dr. Richard McFarland and Dr. Becky Robinson-Zeigler through BioFabConsulting, which provides a range of regulatory, preclinical study design and early phase commercialization consulting.

With the pair’s expertise in various divisions and therapeutic specialties within the FDA, Histogenics has been able to engage deeply with Drs. McFarland and Robinson-Zeigler on technical manufacturing questions, clinical design, and policy questions related to Histogenics’ therapeutic products. Additionally, they are working with BioFabConsulting on projects related to expanding their pipeline and developing regulatory strategies.

When asked about their experience with BioFabConsulting, Gridley was extremely positive, stating that “We have found the BioFabConsulting experience to be outstanding overall – efficient, cost-effective, and focused on a common goal of advancing products and processes into the clinic to approval in partnership with the FDA.

He concluded by stating, “There are no cutting corners from a safety perspective, but there are ways to shorten your development and regulatory review times with thoughtful, well researched regulatory strategies. BioFabConsulting has been a true partner in bringing our therapies through the review process more effectively.”    

Click here for more information on BioFabConsulting, and to initiate a BioFabConsulting engagement, please email BioFabConsulting@armiusa.org.