Mary Syto, global clinical operations at Receptos, reflects on her previous experiences working for a virtual drug development company (VDDC) as the Sr. Director of Clinical Operations at Tragara Pharmaceuticals.
Clinical Trials Arena: What are the biggest challenges in working for a virtual drug development company?
Mary Syto: The requirements for drug development do not change in a virtual environment. It can be a huge challenge to move clinical trials and programs forward with just a handful of people. There is a high reliance on external parties for the study conduct and limited oversight. A virtual company using a CRO must entrust its trial to a third party, and that same performance is ultimately the measure upon the success of the trial.
One of the biggest challenges is finding the right mix of CROs and consultantswho can fit the ever changing needs of the virtual company. Flexibility and the commitment to collaboration is criticalbecause a virtual company frequently doesn’t run at same straight course than a larger company and may need creative thinking (as well as direction) from its CROs and consultants. The full service CRO model may not be the best fit depending on in-house expertise, the phase of the trials, the number of the trials, etc. "Cafeteria-style/selective insourcing" may suit a virtual company better.
In my experience, you contract work to a CRO (or consultant) or you can choose to take on responsibilities that would normally be done by a department at a larger company depending on your background and expertise. For example in my role as Sr. Director of Clinical Operations, I contracted most of the work to clinical CROs but also found that it was more cost-effective to take in some of the services in-house or use a consultant. Some of these responsibilities include writing the protocols and protocol amendments and also negotiating the site contracts and budgets at the start of the trials.
There aren’t as many points of contact in a VDDC compared to a larger company. There usually isn’t a "governance" structure put in place to review the overall quality of the trial. In a VDDC, you essentially have to review every moving piece of the trial because the final oversight (with all the responsibility and accountability) falls on you. So, it’s important to constantly evaluate the relationship you have with your CROs and consultants to ensure that there is clear, transparent communication about expectations and the progress of your clinical program. This is critical to ensure that you are receiving the highest quality of service that you expect. I found that the best way to ensure that I had the attention of my CRO teams and consultants was to develop a good working relationship with all members of the team and to be actively involved so that I understood all their challenges. Stressing the importance of our collaboration and my willingness to listen to all ideas helped to strengthen the bond with my CRO teams.
CTA: What was it like having that level of autonomy where you had to be involved in every aspect of the process?
MS: Virtual drug development can be challenging butfun and rewarding. Being accountable and responsible for a majority of the company’s operations (without the internal departmental support of a larger company), can be daunting for most people.For others, the experience of working in a virtual company is exhilarating because there is less bureaucracy and critical decisions can often be made swiftly and carried out efficiently. You are not mired in processes in a VDDC. I enjoyed this level of autonomy and embraced the challenges. To be successful, it requires someone who is comfortable with going outside of the company bubble to seek knowledge. Because I didn’t have the benefit of networking within a large company at Tragara, I frequently met with colleagues in other small companies to share knowledge and seek additional guidance in areas that were not my expertise. I did not limit myself to connecting with people on the "client" pharma side but also met with business development people in various service areas to keep up with what products were available, what services were changing or have expanded, and tracking their "health" as a business(i.e., annual reports, news, alliance changes, financial changes, etc.)
CTA: What are your thoughts on the preferred partnership model for small and virtual companies?
MS: For very small and virtual companies, the preferred partnership model typically isn’t a realistic option. A hybrid of this has always existed, however, for small companies, we are much more likely to award our subsequent trials to our current service provider. There is a significant advantage to the incumbent, including awareness of upcoming trials, existing relationships, ease of contracting, etc. However, there are many examples of the incumbent losing the next subsequent trial because of inconsistent performance. Good service and flexibility to meet the small company’s needs is the best form of business development for repeat business.
For slightly larger small companies, one key advantage of this model is improved leverage at the start of the relationship. Even if the plan calls for a relatively small number of future trials, the promise of future business can lead to improved support from the business development function and better internal support or credibility. A common approach (processes, tools, methodologies) to multiple clinical trials is extremely valuable for small company internal clinical operations groups, who are often overtaxed or suffering from growing pains.
However, single provider relationships are sometimes more comforting to investors. A preferred provider relationship can be detrimental to some small companies. A large percentage of small companies change CRO providers from one trial to the next, implying that dissatisfaction with providers is high, and locking in the relationship might be a bad idea. Assumed efficiencies with multiple trials don’t always materialize – may be an incentive to push losses on one trial over to another (erasing the benefit). CRO industry remains in flux – acquisitions can change the nature of the relationship and might give cause for a small company not to be locked into a preferred provider relationship. One of my CROs went through several organizational changes including an acquisition of another specialty CRO, an expansion, and then lastly an acquisition from a larger CRO. The staff of my teams completely turned over several times and it was challenging to re-train and get the new team members acclimated and committed to my studies.
CTA: How can small companies overcome the cons / challenges of this model?
MS: It remains valuable for a small company to spend most of their time developing a capable internal clinical operations function. The best relationships seem to begin with an experienced and empowered internal operations group to direct and liaise with the CRO, regardless of size or partnership model. Internal organizations should be built with the intent of interfacing with the CRO. Too many are designed to reflect a big Pharma model, or even a CRO-like organization. CRO selection should be led by clinical, but broad input should be specifically sought from the rest of the company. CRO cost comparisons should include internal expenses associated with the interface between the company and the CRO, which can fluctuate between small and large providers.
*The opinions presented are those of the author and may not be held by Tragara, Receptos, its investors, or partners.
