|Adam Ruskin, GenturaDx|
Adam's answer: Finding qualified laboratories is by far the biggest challenge. Even laboratories which have passed extensive screening often do not pass pre-trial testing runs. There are no lists to help find qualified laboratories in a manner similar to finding physician investigators for specific therapeutic areas that are interested in participating in clinical studies.
Q: Working in a start-up company presents a unique set of challenges and lessons learned. What are your primary challenges when it comes to outsourcing?
Adam's answer: The main challenge at start-ups when it comes to core labs is consistently money. Many start-ups place clinical trials as an afterthought, as the key competencies of the founders are generally in chemistry, engineering, etc., who have little to no experience with clinical studies, and routinely go through all of the company's funding prior to the investigational product ever making it to human testing state. As the clinical lead you are generally scrutinized for every penny as there is no budget when it comes to your tasks, while those in pre-clinical routinely go millions of dollars over budget when plenty of money was available. You are expected to have the laboratories perform their tasks for free (or close to it). In many cases, this actually happens, by coming up with creative ways to minimize costs (publication rights, speaker sponsorship, etc.).
Another large challenge is that no one has ever heard of your company, or is familiar with your investigational product or technology. Many lab directors have run the risk of working with start-ups only ending up never being paid when the start-up went out of business, and won't do that again. You have to get buy-in from the lab directors on your investigational product and they really need to see where it could benefit them if you are in a start-up, which is a hurdle you generally don't have to deal with so much at a larger company.
Q: What new technologies or assays are you using at your organization?
Adam's Answer: New technologies included PCR that was a hands-off, all-in-one sample prep to answer in about 2 1/2 hours for both DNA and RNA for any liquid medium and could detect as few as 50 base-pairs. The assays were for an extensive array of bacteria, viruses and solid tumor types.
Q: What new developments (presumably in the next 5 years) in the pharmaceutical/biotech industry are you most excited about?
Adam's Answer: Moving away from the physician-consented study paradigm to the laboratory-based non-consented study trial paradigm with data not traceable to a specific patient from the sponsor perspective. Many companies are doing this now, but laboratories are having a hard time keeping up, leaving only selective laboratories available to participate in these types of trials. As trial costs rise, this will continue to become more common. These studies can dramatically decrease overall trial time and cost for the types of studies that these are appropriate for.