Houston-based Clinical Research Organization (CRO) MedSource is growing its service-offering to include the early stages of clinical development and pipeline planning through Investigational New Drug (IND) submissions.
The service, rarely offered by CROs, will be provided by a new department—Scientific Development—which will be responsible for delivering a suite of clinical development services to biotech and pharmaceutical companies wishing to organize their pipeline strategy, prioritize indications, and develop strategies that will efficiently advance new drug candidates into the clinic.
The enhanced offering establishes MedSource as a partner that can offer its expertise throughout the entire drug development process, in complement to the execution of clinical trials that has been a mainstay for its 20-year history.
In addition to making these new services available to clients, MedSource is expanding, opening a new office in the Cambridge Innovation Center (CIC) in Cambridge, MA. The Scientific Development team will join other cross-functional roles to operate from this new location. As a booming biotechnology hub with a strong startup community and venture capital presence, the Cambridge locale will bring numerous benefits.
Not only will the new location establish a presence to support existing clients in the region, MedSource will be at the heart of a clinical testing mecca where scores of start-ups are innovating first-in-class drug candidates and therapies.
Serving as senior director of the Scientific Development department is Doris Sanchez, who brings more than 20 years’ experience in all phases of clinical research and development, and is uniquely qualified to advise clients on how best to outline their clinical development plan, map out their pipeline, accelerate their program and position their ‘Reason to Believe’ slides used when pitching to investors.
“At this early stage of the process, before human trials can be conducted, many smaller biotechnology organizations must seek financial backing by presenting a ‘selling document,’ which is a critical step for these programs,” Sanchez said. “With our expertise, we can help position a new drug or therapy in the best light, demonstrating how to maximize ROI and capitalize on the core elements of the science to show investors the strength of the asset or program.”
By becoming integrated into the process earlier than traditional CROs, MedSource can conduct indication prioritization, data mining, competitor analysis, and establish solid data and analysis to point to the possible pathways for accelerated regulatory opportunities, which is something biotech companies often do not have the resources or time to invest in when developing a clinical plan and pipeline. Presenting this information strategically and validating the clinical development plan can bring a valuable benefit to organizations seeking the financial backing needed to continue clinical trials.
Working with these biotech and pharmaceutical organizations throughout the whole IND enabling process – from early clinical development to the IND submission – positions MedSource as a partner well-equipped to execute the clinical trials they are helping design and get into the clinic.
“The exciting addition to our business offering and new Boston location once again sets MedSource apart from its competitors, delivering high-quality solutions and a flexible approach to serve individual client needs,” said Eric Lund, MedSource president and CEO. “As part of our commitment to be the best in industry, we are thrilled to have Ms. Sanchez leading our new focus area, bringing not only her extensive and strategic expertise to the table, but a passion for the work we do that may ultimately improve patient outcomes as a result of a new treatment.”
While the new services will be offered globally, the CIC in Cambridge provides access to a vibrant start-up community with a heavy biotech presence, allowing MedSource to be immersed in an innovative, high-energy think-tank environment. The region provides the company an impressive talent pool to grow its new division, as well as the ability to be in the mix to identify new opportunities and projects.
The Boston office brings the total number of MedSource locations to five, globally, and together with the addition of early clinical development support services and the most recent data services acquisition – that incorporated end-to-end clinical biometrics, data management and medical writing in-house – progress isn’t slowing down. The company remains on track to continue its positive growth story providing increased value to its clients through a full suite of services and superior clinical offerings.