The Silicon Review
In the modern world we live in, contract research organizations (CROs) play a significant role in drug development. Before any new drug can advance to clinical trials, it requires the support of one if not more professional organizations that have the necessary infrastructure, dedicated management, and well-established scientific and technical skills. In the last few years, we have seen a significant rise in the demand for non-clinical contract research organizations. This spike in demand is fueled by a variety of factors including but not limited to an increase in R&D spending, need for specialty services and capabilities, as well a shift in business model. This evolution in the way new therapies are developed has been validated and demonstrated to be cost and time-efficient. Few major CROs in the segment are also now offering one-stop-solutions and generate billions in revenues.
Globally there are a variety of CROs capable of delivering quality services, but Biomere and JOINN stand out and distinguish themselves from the pact in several ways. Biomere is a rapidly growing, discovery-based, client-focused nonclinical CRO with locations strategically located outside of Boston/Cambridge and San Francisco. As part of JOINN Labs, the largest nonclinical CRO in China, Biomere can provide its clients with access to a portfolio of unique development services and expertise to support global regulatory submissions. Biomere was founded in 1996, and is based in Worcester, Massachusetts.
In conversation with Mark Nedelman, CEO of Biomere
Q. Can you tell us about your creative support for challenging studies?
We operate in a very competitive and dynamic ecosystem. Our success comes from a singular focus on how we approach every challenge. We take what we do personally. That means doing what is best for our clients. A CRO is simply a means to an end; a service provider whose job is to help its partner develop a new treatment that can improve the quality of life and benefit us all. Nothing is more important. It is bigger than any one lab, and it is not (or shouldn’t be) only about profit; a business model not embraced by all CROs. When you put your clients first, solutions are easier to find. These can be in the form of an investment (i.e., pilot studies), integration of KOLs (key opinion leaders) for guidance, or even referring a client to another lab that you know is better suited or able to help.
Q. There are a number of researches that need to be done on a process so that it can be used as a form of treatment line. Tell us about your efforts in the research segment.
Biomere has become an industry leader in supporting the development of xenotransplantation. The US-FDA cleared XenoTherapeutics to conduct the first-in-human, investigational clinical trial to evaluate the safety and tolerability of a novel, live-cell xenotransplant sourced from a clinical-grade, genetically optimized porcine donor. The clearance of this pivotal clinical trial was based on a comprehensive body of evidence gathered from a series of XenoTherapeutics’ preclinical studies performed under GLP by surgeons and scientists at Biomere. For this work, XenoTherapeutics and Biomere received the American Burn Association’s 2019 Burke/Yannas Bioengineering Award. This is what true collaboration looks like and the value that can be delivered when “it’s personal.”
Q. Tell us about JOINN Labs’ contribution to your growth.
Our acquisition by JOINN Labs in 2019 served as the basis for establishing a global leader in nonclinical services. This partnership has provided Biomere with the opportunity to expand its reach in the US and become a bi-coastal CRO with the launch of our new site in 2021 just outside of San Francisco. Our CA site, part of the JOINN Innovation Park in Richmond, CA, is a 60,000 sq ft, purpose-built, start-of-the-art vivarium that will provide our clients with capabilities like those available in our Worcester, MA facility. Biomere will be one of the only, if not only, CRO with operations located just outside of the two top biopharma hubs in the US with capabilities in small to large animals. This will provide clients with the ability to leverage our capabilities in discovery and specialty services with a direct link to JOINN for integrated services for safety testing and IND-enabling programs. A portfolio aimed at serving our clients across the globe with the most time and cost-efficient offering in the industry.
Q. How do you bridge the gap between academic research and industrial development with CRO?
Interesting question. The answer starts with knowing the difference between work performed in the different settings and understanding the objectives and needs of both. Each serves a different purpose. CROs have often been looked to as a place where research out of academia can be reproduced or confirmed. While no CRO can compete with the intellectual “horsepower” found in academia, a CRO provides value and can bridge the gap between the two by delivering a product that can stand up to an audit and used for different reasons. As a fee-for-service provider, a CRO provides quality data that speaks for itself without any bias in the outcome. Having close ties to leading academic institutions provides Biomere with an advantage that most CROs don’t have.
Q. Do you have any new services ready to be launched?
Biomere has an array of new and established services ranging from our newly formed bioanalytical chemistry service to our expertise in genetically modified animal program, surgical capabilities, and dedicated colonies of instrumented animals to the unique ways we are able to customize a product that delivers a service and product that fits our client’s needs.
Q. What does the future hold for your company and its customers? Are exciting things on the way?
With our addition to the JOINN family approaching its 2-year anniversary, Biomere and JOINN are uniquely positioned to provide our clients with a service that is “best of breed.” The capital raised in JOINN’s Hong Kong IPO also provides us with the means to add to our existing portfolio while strengthening our current facilities and capabilities. Expansion and investment in our services and personnel will better meet the needs of a marketplace desperate for options. Central to our compelling value proposition is the integration with our JOINN colleagues. As the largest non-clinical CRO in China with a strong track record in supporting international regulatory submissions, JOINN is strategically expanding in a way that will also benefit Biomere and our US and EU clients. Work placed in China is managed by our US client liaison team, which includes a member with 10 years of experience with the US FDA. Seamless, timely communication and client management support make placing studies easy, cost and time efficient. The future for Biomere, JOINN, and our clients could not be any brighter.