Creating an Ecosystem of Life Science Innovation

Have investments in R&D efforts over the past few years produced sufficient results to meet expectations? The FDA recently announced the number of drugs approved in fiscal year 2011. While 35 is the largest number of approvals in a single year during the past decade, is that a sign that R&D investments are paying off or is innovation stalling out in much of the life sciences industry?

As more and more pharmaceutical companies outsource resources and forge partnerships with research organizations and early stage biotechs, the idea of a translational ecosystem may be closer to reality than once thought. TCI anchor institute, the Torrey Pines Institute for Molecular Studies, provides insight on what it takes to create an ecosystem of life science innovation and what affect it can have on R&D and pipelines.

According to Richard Houghten, Ph.D., founder and President of Torrey Pines Institute for Molecular Studies (TPIMS), “The vision of life science innovation at Torrey Pines Institute for Molecular Studies is, and has always been, a “bench-to-bedside” approach. This “mindset” brings novel discoveries and innovations to patients to address unmet medical needs and makes a difference in the lives of these patients. Traditionally, strengths of TPIMS’ scientists have been in discovery and innovation, but today even greater efforts are focused on developing these discoveries and innovations into novel treatments."

What elements are essential to make this vision a reality?

Houghten notes that, “Key elements for success include teamwork, collaboration, and a willingness to take risks and not be afraid to fail. Throughout the drug discovery and development process, many different skillsets are required and the ability to integrate all of the various activities into a unified goal is essential.”

Where within the translational continuum is this effort currently failing? Where is it succeeding?

For Houghten he sees room for improvement in specific areas of early stage development. “Within drug discovery, often a program encounters difficulties translating compounds optimized in in vitro assay systems (“test tube” assays) to the desired in vivo activity (activity in an animal model). These failures to observe activity in the animal model can occur for many reasons, including compound toxicity, bioavailability, tissue distribution, metabolism, etc. These failures can also be target related in that inhibiting a given target may not provide the overall in vivo outcome that is desired.”

However, Houghten sees translational success occurring when, “The scientists follow the science and make decisions based upon the science. This, more often than not, may lead to the realization that the planned project will not be successful “as planned” and changes are required or the project is “killed” as these decisions are again “science-driven.””

While there is still a lot to be learn about translational medicine and how to make it a successful practice, there are steps that drug developers can take to improve their bench to bedside approach.

Houghten believes in taking chances. “Drug developers need to take chances, but must also know when to accept failure. Many blockbuster drugs on the market today only grew to blockbuster status over time, as the performance in the general population, following FDA approval, continued to be studied. This is an example of following the science. Few could have predicted the success that Lipitor would achieve when first approved by the FDA. This was due to the fact that there were already numerous compounds approved in the same class of drugs. However, no one can doubt the success of the Lipitor franchise that has occurred since approval,” he says.