Biomedical sciences are transforming the way we treat disease with the goal of ultimately curing what has been considered incurable. Many of these advances are paving the way for a meaningful increase in quality of life. Amid this confluence of changes—from the onslaught of technology to the innovative methodologies and globalization prevailing in clinical trials, it is encouraging when an innovative product is able to forge new territory and advance science to clinical reality. However, a key to this innovation and succeeding in this new global economy lies in collaboration.
In this vein, when XenoTherapeutics, a Boston-based non-profit focused on genetically engineering foreign tissues and cells for clinical xenotransplantation, the team knew it wasn’t an easy endeavor. Their initial sights were set to meet the needs of burned patients who require skin transplantation. Today XenoTherapeutics—committed to advancing the field of xenotransplantation from theory to therapy —has been successful in assembling a core group of experts and partners that under its senior leadership have advanced the first FDA-cleared, live-cell xenotransplantation program into the clinic at the Massachusetts General Hospital.
Such an impressive feat, as XenoTherapeutics admits, would not have been possible single-handedly. In this ambitious journey, XenoTherapeutics collaborated with companies like Biomedical Research Models Inc. (Biomere) that provided the experience, knowledge, and skill required to advance development prior to initiating clinical trials. Specializing in personal and customized preclinical contract research, Biomere is a preclinical CRO based in Worcester, MA that offers an extensive portfolio of discovery and development services from proof-of-concept, pharmacology and surgical models to safety testing for the biomedical industry.
“What differentiates or sets Biomere apart is the uniqueness of service which stems from the cornerstone of who we are—At Biomere, it’s personal,” says Mark Nedelman, CEO of Biomere. Committed to delivering discovery-based services, the CRO draws on its rich expertise of industry veterans across a variety of therapeutic areas to ensure that the services are personalized and customized to each client’s specific requirements. The team of experts at Biomere fosters personal relationships with sponsors and works in close collaboration with them to deliver the highest quality services. Furthermore, clients are also empowered with the utmost flexibility and adaptability in their discovery.
“The customized and personalized nature of our services is not restricted to discovery alone. While more of our clients are looking to transition from early-stage discovery to development, they stand in need for services to meet the rigorous standards required by different regulatory agencies. As a part a strategy aimed at meeting the needs of our clients, Biomere is constantly in discussion with all stakeholders in an effort to better understand where to invest for our future growth.
One example of this is in our quality and compliance initiatives, which have expanded dramatically out of the need our clients have asked for,” informs Nedelman.
We have expanded our services on the development side, presenting specialty services and capabilities under GLP that companies often need for regulatory submission.
As medicine and drug development continues to evolve, the CRO industry will need to adapt. Through globalization and M&A initiatives for accelerating discovery and development, JOINN Laboratories (China), the first preclinical CRO in China to have successfully been inspected and approved by US FDA, recently acquired Biomere as part of a strategy to expand its reach and better serve a global customer base. As part of a multi-phase strategy, Biomere opened a new west coast site in Richmond, CA just north of San Francisco providing options to US-based clients looking for a “personal” approach to helping them achieve their objectives. Biomere’s impressive growth and reputation led by a personal approach to customer service combined with JOINN Laboratories’ comprehensive capabilities in drug development and commercial GLP services is expected to reap enormous benefits for both the CROs and their clients. “Our collective goal and the goal of merger is to provide our clients with better options and value for their discovery and development,” adds Nedelman.
Poised to launch a bi-coastal presence with locations in the two major life sciences hubs in the US, Biomere aims at providing the sponsors with the most efficient way of delivering actionable information. Besides its highly customized services and sprawling facilities, Biomere also takes immense pride in working closely with its clients and providing round-the-clock customer services, as and when required. “Unlike in other large preclinical and clinical services companies where clients do not have access to a one-on-one conversation with the CEO. Clients have my cell number. I and my team take personal accountability for what we do and understand what is at stake,” states Nedelman.
With a strong value proposition in place, Biomere is primed to witness rapid growth. In the future, Biomere’s west coast operations will be housed in the JOINN Innovation Park, encompassing 60 acres. Furthermore, the company looks forward to empowering its clients with the services delivered by its parent company in China. As JOINN Laboratories has a strong track record in regulatory-driven work, it will be interesting to observe how the collaboration will benefit the clients.