Risk-sharing is not a new idea. When Pfizer signed strategic deals with Parexel and Icon in 2011 it prompted both CROs to go on profit-sapping hiring sprees before either saw an increase in business.
Clearly this was a risk for Parexel and Icon, but Pfizer has the financial clout to absorb a few failures. For smaller firms and the contractors they partner with the risks are even higher according to Cromos’ CEO Vlad Bogin.
He told Outsourcing-pharma.com that: “For many early stage companies there is a catch 22 situation, they need clinical evidence to get the funding that will allow them to get clinical evidence.”
Medistem – a stem cell developer bought by R J Kirk backed Intrexon in 2013 – had faced a Yossarian-like quandary according to Bogin, who explained he had to take his former firm from “pre-IND to clinical stage before it was acquired.”
This experience drove development of Cromos’ risk sharing model which, according to Bogin, is “most applicable to smaller pharma and biotech players who have limited resources to advance their clinical programs.”
Free trials
The CRO uses a number of models with the basic idea being that it designs and performs studies for free or at reduced cost in return for an equity stake in the sponsor and licensing rights in certain markets.
Bogin told us: "First we perform rigorous due diligence of available clinical and preclinical data on each drug candidate that we feel has promise. We have both internal and external experts who dissect every detail, from MOA to pharmacoeconomic feasibility and competitive intelligence."
Chromos is US-based, but Eastern Europe focused with operations in Russia, Ukraine and Georgia, which is another advantage for potential customers according to Bogin, who said: “We have very strong ties with local pharma companies that are often interested in acquiring promising early stage candidates.”
The idea of running clinical trials for free, or at reduced cost, is in keeping with Cromos’ branding of itself as an operator in “post-Soviet Space,” however, Bogin is very clear about the business pros and cons of the CROs approach.
“We fully understand that early stage drug development has a rather high failure rate. Thus, we are selective in what projects we take on and we never embark on projects that would drain our resources.”