The first article in this series [blog.victech.com/fostering-life-science-innovation-part-1-an-ecosystem-roadmap] set the stage by defining the primary components, drivers and benefits of life science innovation ecosystems. Here, we delve into the concept of using unmet need in human health to guide this innovation. Much research in the life science space is not applicable to improving the human condition. This is not a criticism, but simply highlights the nature of fundamental research: Elucidating what was previously unknown. There is, however, a growing emphasis on redirecting fundamental science towards topics with the potential for real-world impact. This has been driven by several factors:
- Changes in the federal funding landscape: Decreases in agency budgets and limits on indirect cost charges; Increasing weight placed on creating products; Emergence of translationally focused programs.
- Increased pressure at research universities to monetize innovation: Fierce competition for grants; The reduced overhead mentioned above; Rising cost of fundamental research; Realization that alternative funding sources are needed. Prior to the recent upheaval, although the capital component was attractive, other factors such as prestige as well as the value of demonstrating the eventual value of fundamental research were at play.
- De-emphasis of early research and development at major life science companies requires tapping into external sources of innovation.
So, how do large, cumbersome entities like major universities—the primary drivers of life science invention—redirect their research programs towards product-driven topics? Some have made the “translatability” of the science a consideration when hiring new researchers, and/or used it as a metric for their performance reviews and tenure decisions. Others have created specific internal funding mechanisms to support these efforts [blog.victech.com/challenges-and-solutions-for-university-technology-commercialization-part-3-gap-programs]. Another initiative entails marketing innovation to prospective external investors and partners. The extent to which these resources are allotted to a given technology usually depends on an assessment of commercial viability, and raises the age-old question: Is this a product in search of a market, or a market in search of a product? Ideally, the research program was begun with a specific goal in mind, such as improved treatment or diagnosis of a disease, and considers the unmet needs of the specific application of the envisioned technology. This is not an absolute requirement in that many fundamental research discoveries have accidentally found market relevance after the fact. Yet, this is less often the case given the fierce competition to create novel solutions for diseases with sizeable unmet need and revenue potential.
Some of the best examples of product-driven science in the university setting stem from investigators who had personal motivation to discover a cure, e.g., a family member suffering from a disease. The resulting laser-like focus has led to numerous technologies proceeding from fundamental research to the clinic. But, in the absence of profound first-hand experience, how can this overall concept be applied as early as possible to early-stage research? Although this may be seen as heresy, including clinical insights in non-medical-track undergraduate and graduate students in the biological sciences would be an ideal first step. As a PhD, I can attest to the emphasis on molecular mechanisms, gene expression, cell signaling pathways, enzyme kinetics, anatomy, histology and other subjects during my training, without much in the way of connecting the dots to human disease. Maybe this was due to it being nearly 30 years ago, and many of the early findings not yet having been linked to specific health conditions, and so I can only hope that things have changed for the better in the last several decades.
A major factor impeding the “bench-to-bedside” mentality is this bifurcation of what should be a seamless continuum into separate camps: Fundamental (preclinical, mostly PhD) and applied (clinical, mostly MD) researchers.
Another component is the somewhat stereotypical mindset of the fundamental researcher: If it’s cool science, it must have a real-world application. To be clear, most university faculty are not incentivized to pursue translatable research. Their world revolves around securing grant funding, publishing in peer-reviewed journals, and mentoring lab members. For those who do believe that there may be a product opportunity stemming from their work, one of the most valuable uses of their limited time is for them to participate in an I-Corps or similar customer discovery program, through NSF or other offerors, ideally via a resource available at their university. From a life science product perspective, “customer” can include not only the intended patient, but also physicians, regulatory agencies, payor/providers, prospective partners, investors and other stakeholders. An often-overlooked addition to the list are disease-focused foundations, patient advocacy groups, and family led initiatives, which can have substantial influence on the development of therapeutics, medical devices and diagnostics, including providing funding in the form of grants and/or investment.
More often than not, the results of these interviews send a clear message that the product concept is either wide of the mark or totally unrelated to market need. Indeed, rigorous market validation should be a requirement before technologies are accepted into the university’s technology commercialization process. It is a cost-effective means of screening and prioritizing innovation for future support. Also, it should be a warning sign if the inventor doesn’t agree to take the time to participate in this critically important step.
The previously mentioned translational funding, such as SPARK, Proof-of-Concept and GAP programs offered by an increasing number of universities, can also influence research, especially as more faculty investigators experience difficulty securing grants from traditional sources and are forced out of necessity to explore new means of keeping their labs operating. Using these as leverage to influence innovation towards solving unmet patient needs is a powerful tool. Last but not least, awareness of what’s happening in the investing, partnering and M&A landscape can also inform the university inventor as to where there is—at least the perception of—market whitespace for specific types of life-saving solutions.
Taken together, these concepts should aid early-stage researchers and their institutions to redirect and optimize their work to address real-world challenges if that is a goal.
I would be remiss if I forgot to briefly touch on how working with Venture Studios like VIC Tech can support the concept of innovating with the end in mind. Our specific approach is to create companies to advance life science technologies licensed from universities here in the US and abroad. During due diligence, we include both technology- and market-driven analyses, the latter of which encompasses a thorough understanding patient requirements and unmet needs. When we pass on an opportunity, a frequent reason is that the innovation doesn’t meet these gaps in current care. By having this type of feedback earlier rather than later, university ecosystem participants can make informed decisions on which technologies in their portfolio to allocate precious resources to. It goes without saying that a single venture studio can’t provide this level of guidance for every university asset relevant to their areas of interest. By working with multiple groups, however, a university can obtain valuable insights into their most-promising inventions.
---
About VIC Tech: We are a life science-focused Venture Studio, creating portfolio companies based on best-in-class innovation sourced from universities, national labs and institutes around the world. Our team provides the operational expertise during the initial start-up phase, ensuring maximal impact while mitigating burn, allowing as much funding as possible to be allocated towards de-risking the licensed asset.