LBG’s technical expertise enabled a client to advance their immuno-oncology products.
Challenge:
A small preclinical immuno-oncology product developer on the East Coast needed assistance managing their subcontractors and supplementing their technical capabilities in order to ensure that their products in development were appropriately supported. The client, which is predominately a virtual company, has multiple products that are advancing to the clinic over the next several years, and they are using subcontractors for all major activities.
Virtual companies operate with limited staffing levels that must be supplemented as the need for various types of expertise rises and falls. The client needed support for their subcontractor management and technical needs, so they could advance their products to clinical testing.
The client engaged LBG because of our technical expertise in the product development of similar products.
Solution:
We provided a team of experts in program management, logistics, process development (USP and DSP), nonclinical development (safety and toxicology), analytics (characterization, release and stability), and quality systems to help the client advance their programs. We worked as an extension of their team in these areas in a collaborative manner. Moreover, we are in daily communication to help their programs advance to the clinic.
By providing a team with expertise across several areas, we enabled the client to advance their products to the clinic. In addition to supporting their programs, we have also drafted and supported the filing of the regulatory documents to advance their leading product to the clinic. We have provided this service over multiple years and have added or reduced support across our various areas to meet the client’s needs as their programs have progressed.
Results and Impact:
Our support has allowed the client to advance their lead immuno-oncology product to the IND filing and Phase 1 testing stage, while continuing to advance several other products toward the IND stage. The most obvious benefit is having resources at the ready when they need them, which has enabled them to advance several products simultaneously given their limited internal resources. The long-term benefit from our support is the rapid development of their pipeline of immuno-oncology products and the ability to commercialize them more rapidly given their limited internal staffing. Having a flexible team who is able to support the client from the bench to IND/Phase 1 testing (and beyond) gives them greater flexibility as they develop their pipeline of products.
