Addressing the Unique Needs of Emerging Biopharma in Drug Development

Fueled by increased funding, emerging biotech firms are on the rise. Despite their small size and sometimes limited resources, emerging biopharma can often be quite nimble, helping to drive 63% of new prescription drug approvals over the last five years, says HBM Partners. Big pharma is taking note, leveraging these smaller firms for development, investing in them, or acquiring them to augment rare disease or other pipelines. In this interview, Steve Powell, CEO of mid-sized CRO Synteract, discusses the advantages mid-sized CROs offer emerging drug developers to navigate continually changing processes.

Moe Alsumidaie: What should today's emerging biopharma companies (EBPs) look for in a CRO partner? 

Steve Powell: Emerging biopharma have been our core customer for nearly 30 years. They look for a CRO who

Steve Powell

understands them and knows how to plug the gaps they have within their own growing organizations. You see larger CROs creating biotech units dedicated to biotechs; but unless you've really worked closely and evolved with customers that fit the emerging biopharma model, I don't think you completely understand what they need.

At Synteract, we become an extension of their team. We know what’s needed to deliver trials, and we know when they don't have specific capabilities within the organization. Our process allows us to adjust to changes within the sponsor organization or within the trial dynamics as we move through the project. 

A significant number of Synteract team members have worked at large CROs, and when you work with large pharma, you have mirroring of departments, where team structures stay relatively static throughout the product’s development life cycle. But biotechs change and evolve. We start off working with a two-person company-or a 100-person company-and we fit and change our dynamics to the sponsor organization as the project and company develops, and the assets gain strength. We're used to and comfortable working in that environment and we can adapt. Many larger CROs have very rigid processes and find it harder to shift gears when projects and companies change.

I think our customers are looking for a CRO that can provide the scale and depth that we have now at Synteract to be able to run a Phase II and Phase III study, should the development plans require that. We know funding is now there for biotechs to take products much further in the development life cycle than they ever could before. We provide enough breadth and depth, paired with a close understanding of that organization. 

MA: How does Synteract plan to scale with the growth of emerging biopharma companies?

SP: We have a solid foundation of coverage in North America and in Europe and have made acquisitions into fast growth therapeutic areas, like dermatology and pediatric drug development, last year. This expanded our capabilities. In addition, we've made more critical investments into our rare disease center of development, which is where a lot of emerging biotech is focused. We couple the scientific elements and rigor in understanding rare disease across multiple different therapeutic areas. 

We’ve also built solid partnerships in Asia Pacific, so from our perspective, we don't need more geographic scale on tap day one, because our customers tend to grow over time into these areas. For the studies we're running and the organizations we're working with, we need the right resource, in the right country, at the right time, and we accomplish that through partnerships and organic growth with our customers. 

Instead, we like to ask, "What do you need? Where do you need it and, most important, when do you need it?" We have appropriate scale to expand to meet their requirements without having the overhead of all these people, in all of these regions, all of the time.

MA: What kinds of challenges do you expect to see in this growth?

SP: I think at the end of the day, all CROs have the same challenges: aligning resources, people, and scientific expertise to meet the demands of our customers. We are fortunate in that no single customer takes a significant percentage of our resources, so if that asset goes away, we don't have hundreds of people sitting around with nothing to do. We're much more flexible. And more stable for our employees, too. We bring the right people who understand this “sized-right” model to our customers. 

MA: How do you help EBPs overcome their challenges?

SP: A lot of the companies we work with have stable funding in place, whereas others don't. We try to understand what they're trying to achieve, both from clinical and patient safety and efficacy perspective related to the assets they have. That's number one. But then we also understand their reporting needs are two-fold. One is to the regulatory agencies. The other is to their board or investors: about how many patients do they need to enroll to be able to hit a milestone payment to get additional funding, and what's the timeline around that, and making sure we set them up successfully for that to happen, too.

EBPs have one shot, and they need to make sure that everything is going to be focused on that one opportunity. Their predominant challenges are making sure they've got the right assets, people and funding at the right scale. Then it's making sure they have the right CRO partner that can successfully help them steer through those early stages of study design, especially in rare diseases, where you need to have the funding for two, three, even four years to enroll and to get the data levels that you need to prove it successful.

If we know these things up front, we can position the trial design to effectively meet their requirements and to help them to hit their milestones. You need the right level of detail to be able to show your investors, or the market, or a scientific conference or publication how your drug is performing. 

Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials