New therapeutic development models build researchers’ commercialization savvy

Academic researchers and physician innovators are great at making research discoveries and developing inventions at an early stage. But if you were to fund them to turn their research findings into a product, would they have the expertise and experience needed to be successful? Most would not.

The investment community talks about the innovation funding gap a.k.a. the “valley of death.” But there is also a knowledge gap on the part of academic researchers when it comes to transforming their technologies into therapeutics. Most want their findings to lead to new treatments for patients, but they lack the experience and expertise that companies have to advance early-stage research to a clinical stage. That includes expertise in designing pre-clinical experiments and navigating regulatory pathways for commercial development.

Academics often enter agreements with pharmaceutical companies, many of which are early-stage research grants. Often, these industry-sponsored research projects end with a scientific publication and are unsuccessful in generating new therapeutics—a subpar outcome for the company investor. At the same time, pharmaceutical companies have faced pressures to reduce their R&D spending.

Recently, a new and more translational model has emerged: co-development deals in which pharma works with academic institutes explicitly to fill its pipelines. In return, academic researchers gain commercialization experience directly by working hand-in-hand with drug development experts.

One of the pioneers of this new model is the Pfizer Centers for Therapeutic Innovation (CTIs), of which Boston Children’s is a participant. CTIs locate themselves near biomedical research hubs and assign an academic principal investigator (PI) to work with the CTI PI to develop a research plan—scoped out to phase 2 clinical trials. The PIs then conduct the research together, blending the expertise of both parties to bridge the academic knowledge gap.

Another approach is to bring industry expertise in-house through mentorship guidance programs at academic medical centers. An example is the Technology Development Fund (TDF) launched by the Technology and Innovation Office at Boston Children’s Hospital in 2009. The fund was set up to invest in promising technologies that need enabling pre-clinical data to garner increased licensing interest from industry. Beyond funding, it provides industry mentorship and commercialization guidance for each project, building academics’ commercialization skill set.

The TDF advisory board is comprised of 15 life science development experts and investors who review and select projects for funding on a yearly basis. Once a project is selected for funding, the TDF project manager, investigator and advisory board mentor work together to design the development plan. As the project progress, the mentors monitor the progress and if necessary, pivot the plan based on the results. This mentorship transfer of knowledge to academia has paid off. To date, projects fostered by the TDF have led to five startup companies in five years.

Academic institutions have also begun to directly hire experts with commercial development knowledge. For example, Boston Children’s Translational Neuroscience Center brought in Robin Kleiman, PhD, a drug development expert with years of industry drug development experience. In addition to scoping out and guiding translational projects, Kleiman has set up an educational series to train researchers and clinicians to develop successful treatments. Her knowledge is invaluable to the success of this program.

“Partnering with industry requires a working knowledge of the drug discovery process, a mutual appreciation for what each side contributes and a shared understanding of key issues and bottlenecks,” says Kleiman. “We have been working with individual investigators to help them understand the potential shortfalls in trying to translate specific projects into ‘industry-ready’ collaborations.”

Time will tell if these new academic/industry knowledge-sharing models lead to new products and therapies for patients. But with companies’ willingness to contribute expertise and resources in addition to funding, the potential for biomedical research to make an impact is at an all-time high.

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