Partnering with larger CROs to run clinical programs is nothing new for most small and emerging biotech companies — but the value of these relationships is quickly changing. As consolidation across the CRO space continues, many sponsor companies are concerned about what this might mean for their studies.
Having worked on both the biotech and CRO sides of drug development over the last twenty-five years, Sol Babani, senior vice president and general partner of scientific and medical affairs at PRA Health Sciences, has a unique understanding of what it takes to form and nurture long-lasting partnerships that can bring life-changing drugs to market. Below, he shares five ways biotech sponsors and CROs can work together to navigate the changing clinical development landscape with ease.
1. Build effective and meaningful partnerships from the bottom up — and the top down.
It sounds simple, but it’s very unique for large CROs to know how to build effective partnerships with small biotech companies due to the imbalance in the size of the organizations. Of course, CROs need to have the therapeutic expertise and operational experience to execute studies on a global basis — that’s a nonnegotiable today. But once those two things have been established, it’s all about building trust and transparency from the bottom up.
It’s also critical to build trust from the top down. Assigning a senior leader or executive to each biotech company can make an otherwise large CRO feel small and intimate to a sponsor. The executive provides senior level oversight and is the go-to person for that sponsor whenever an issue arises, ensuring any issues are resolved quickly and effectively with strong communication.
2. Solve problems creatively and proactively.
Historically, the CRO space was built around the sponsor telling CROs how to run their trials. Over the years, much of the experience that was on the pharma side of the industry shifted over into the CRO space and changed the way sponsors and CROs work together. Today, sponsors expect a CRO to not just execute operations, but to also provide creative and effective solutions for issues as they arise — and to be able to identify and mitigate risks before they occur.
This shift is a game-changer for the industry, as sponsors can now lean on CROs to look at situations and problems that come up throughout the drug development process and provide recommendations on how to proceed. Sponsors don’t want their CRO waiting around to be told what to do — they want their partner to be proactive. After all, what good is all the experience and expertise if you don’t have the courage to use it to help your clients solve their problems?
3. Ensure seamless operational execution.
As more CROs grow and consolidate, many small and emerging biotech and pharma sponsors are apprehensive of what this means for their partnerships. However, consolidation in our industry is only scary if the primary goal is just about “getting bigger.” CRO growth should focus on adding operations, tools, and technologies that reduce the burden of clinical research and filling in any gaps in expertise and experience.
Customization is key for biotech sponsors, and large CROs must prove they’re not a one-trick pony who only knows how to run trials one way. Being able to provide a variety of services and solutions across a global landscape is critical; but even more important is the ability to help pick and choose the right solutions for each sponsor’s unique needs.
4. Establish teams with strategic and therapeutic expertise, but don’t forget the generalist.
Operational experience and therapeutic expertise go hand-in-hand. It’s important to build a team of experts with a wide range of experience and strengths, from operational, scientific, and medical expertise to data and technology. Include these experts in the upfront planning of studies where they can offer insight into protocol design, site selection, and more.
It’s also important to hire leaders who know how to bring teams together to work collaboratively and effectively. I’ve found that many of the best leaders aren’t specialists in one area, but generalists — individuals who are flexible and can apply their past experiences and expertise to a large number of areas.
5. Consider funding and partnership opportunities from the start.
One of the biggest challenges for the biotech clients I work with is knowing how to raise funds, find a co-development partner, or divest their asset. Biotech executives who have been in the industry for a long time often have an easier time raising money through venture capital or other angel investors because they have a track record. This can be extremely challenging for companies and executives with less experience.
CROs can support these emerging sponsors by looking at their asset and helping to analyze their data. They can also help them present and promote their data in a way that’s more attractive to investors. Additionally, CROs can leverage their existing relationships with investment banks and financial partners to make introductions and gather feedback regarding a particular asset.
PRA Health Sciences is a global CRO with a dedicated team of drug development experts and more than 35 years of experience working with biotech companies. We’re built for — and remain focused on — creating customized strategic, operational, and commercial solutions for emerging biopharma clients.
Learn how PRA can assist you with your asset development plans, partnerships, and funding at prahs.com/our-solutions/biotech.