The idea of two men and a compound transforming into a company that makes a profit may seem like a pipedream without outsourcing, but experts from small biotech cautioned that companies should be weary of CROs during any stage of their development.
Bonne Adams, VP of clinical operations at Tracon Pharma, which is a company with only ten employees, offered a lot of scepticism around CROs to attendees at BIO 2014 in San Diego on Wednesday.
Tracon abandoned outsourcing in favour of in-house clinical development after trying the former apporoch a couple of years said Adams, who explained that by doing so the firm was able to cut cost 20% to 30% which was a big deal for a small company.
Adams noted that not only did Tracon save money but it also improved the quality of its clinical work and eliminated the “policing” of CROs, which she said can be burdensome.
Timeline delays and expenses were the two major challenges that Adams attributed to the company’s decision to insource all of its clinical work, though it still uses independent data monitors, as well as consultants to audit parts of the clinical process.
Investigator sites also “love working with sponsors directly,” Adams said, noting that some smaller biotech companies make the mistake of “outsourcing everything” without the proper oversight.
Mary Syto, director of clinical operations at Tragara Pharmaceuticals, who previously worked for CRO Parexel, echoed some of what Adams said, though the company still uses two CROs – a smaller, specialty oncology CRO and a larger CRO for some of its clinical work.
Syto, however, noted that in the case of one of its CROs, high turnover and changes in senior management added to the burden of outsourcing its clinical work.
She also cautioned that when selecting a CRO, small biotechs should not just assume that larger CROs will cost more as she was surprised when the large CRO Tragara selected actually offered a lower price for its services than smaller ones, which is perhaps a reflection of how even smaller contracts are difficult to acquire for a CRO of any size.
“It’s never good to look for a CRO when you only have a month or two,” Syto said, adding that small biotech companies need to really do their homework when selecting a CRO for a specific indication such as oncology. She also stressed the need to be picky when selecting a team of employees from within an outsourcing partner as often times CROs will only answer the questions asked by a sponsor and not provide any of their previous knowledge.
Still, Bonne noted that for some smaller biotech companies it’s not financially viable to bring clinical research operations in-house from the onset, and it can add to a study’s risk.
Regardless of whether new small biotech companies outsource their work or bring their research in-house, both women stressed the need to be flexible.
“CROs want small biopharma business because they get to think outside the box, it’s fast-paced work and they’re able to develop better relationships,” Syto said.