FEBRUARY 2024LIFE SCIENCES REVIEW8IN MY OPINIONCLINICAL RESEARCH VENTURES: A NEW MODEL FOR GLOBAL INVESTMENT IN CLINICAL-STAGE COMPANIESIN MY OPINIONBy Nuno Arantes-Oliveira, Founder | Partner, Clinical Research Venturest is common knowledge in most industries that a good idea is not enough to make a successful company. Indeed a large number of scientifically fascinating, cutting-edge technologies never make it to the market due to a myriad of factors, from incapacity of the team to execute to poor market fit; from flaws in IP protection to the absence of early-stage investors willing to back truly groundbreaking ideas. This story is about one initiative that will help increase the chances of good ideas and competent teams actually making a positive impact in healthcare innovation and in people's lives.In biotech and in many areas of medtech a major hurdle in the development of a new product is obtaining the financial means to run early clinical trials, namely Phases 1 and 2. Although the number of patients involved in these phases is relatively low ­ typically in the low tens for Phase 1 and low hundreds for Phase 2 ­ the costs such trials entail are a significant step up for any company that has previously been running experiments with their product only in vitro and in animals ­ i.e. at a pre-clinical stage. Many startups set out to raise their first multi-million round of funding precisely in order to enter the clinic.For investors, however, this is a significant risk. The rate of compounds approved for Phase 1 that make it to the end of Phase 2 successfully is less than 20%. And what's more, entrepreneurial teams often lack the experience and knowledge to make the right choices when it comes to trial design, site selection, and use of funds. This is part of the reason why compounds and devices that look like breakthrough products fail to produce clear enough results in the clinic before the money is exhausted, and thus end up dying ­ along with the hopeful startups that conceived them ­ before proving their potential.Many companies in these industries are already working on trial systems, but most will have to wait until the national and global infrastructures are built outThe hurdle of funding clinical trials is even greater in geographies with less of a history of successful biotech ventures, where founders may not have as many close connections to world-class KOLs and clinical resources as they would if they were based in, say, Boston, the Bay Area or half a dozen other hubs scattered around Western Europe and the U.S. Moreover, local investors in those regions may not have the industry knowledge and/or the deep pockets that could steer a company safely through their initial attempts at clinical development.The challenge is yet more dauting if you are developing a truly novel, untried technology, or targeting disease indications where many other products have failed before ­ precisely those where there will be a greater need. Many venture capital funds, especially smaller ones, may tend to shy away from risky indications (stroke, septic shock) and unproven INuno Arantes-Oliveira
< Page 7 | Page 9 >