Executives at small, or emerging, biopharmaceutical companies often think their only viable options are to out-license products to larger players or to be acquired. Quintiles, a leading biopharmaceutical services provider, says there is an alternative. Working with a full-service provider can provide specific expertise on-demand, without adding staff to the payroll. As a result, they gain the intellectual capital and management continuity to advance their projects through trials to commercialization.
Emerging biopharma solution
Most CROs work on a project basis, but Quintiles’ newly-launched Emerging Biopharma Solution goes beyond that to function like an extension of the company. This solution fosters a long term relationship rather than managing individual studies.
“We find companies really want a closer partnership with a single company that can provide management continuity, rather than involving a large number of vendors,” according to Laura Marquis, VP and global head of emerging biopharma for Quintiles. “Therefore, we are thought partners as well as operational experts.”
Laura Marquis, VP and Global Head of Emerging Biopharma for Quintiles
Quintiles’ Emerging Biopharma Solution launched in 2014 in Europe and North America, and in 2015 in Asia. It combines the nimbleness of a niche CRO with Quintiles’ own global resources and experience conducting approximately 500 clinical trials for some 240 small biopharma companies since 2009. This provides a wealth of development, regulatory and commercialization experience that emerging biopharmas can leverage “to operate more efficiently and develop their best solutions,” Marquis said.
This tailored, full-service operating model aligns services and budgets as projects advance from clinical to commercial, and then to post-marketing approval studies. “Depending on the company and its needs, that may include regulatory expertise,” Marquis said, as well as other skills needed for success.
“We spend a lot of time up front to understand small companies’ needs,” she continued. “Our relationship involves more than just running a clinical trial. We work with companies to develop a strategy and provide resources from first-in-humans trials to commercial, post-marketing and life cycle management.” By working together early to develop a clinical development plan that also considers regulatory and marketing concerns, companies can help ensure their projects are well-positioned to improve their probability of success.
“From a small biopharma company’s perspective, Quintiles’ Emerging Pharma Solution offers new options for commercialization beyond selling assets or partnering with larger pharmaceutical companies,” Marquis said. “Now, companies don’t have to build their own commercial infrastructures. We can be their feet on the ground, globally, as they work toward product launch.”
Execs have small company experience
The managers within Quintiles’ Emerging Biopharma Solution were selected based in part on their experience in working with smaller companies. “They bring a lot of passion and excitement to this sector,” Marquis said.
This small company experience is important because smaller companies’ expectations often differ from those of larger organizations. “Interactions are closer. Executives at emerging companies want their project leaders to feel the same passion for the portfolio and the same sense of urgency that they feel,” Marquis said. By choosing leaders that share those values, the entire team can make decisions quickly.
“Our solution also includes executive leadership for governance and to provide a voice within Quintiles. Small and emerging biopharmas have access to the senior executives, just as large biopharma companies do,” she emphasized.
Tips for choosing the right CRO
There are many CROs available as potential partners, but not all are the same. The factors that determine whether a potential match will be good aren’t necessarily obvious.
For example, while it’s evident the CROs must have the necessary therapeutic expertise—even in rare diseases—it’s also important that the CRO understands the global environment in which the drug will be developed. That includes understanding the needs and regulatory positions in the countries where the drug will be marketed. It also includes knowing how to recruit patients for clinical trials effectively in those regions and how to leverage providers in those markets.
Emerging biopharma companies also need CROs with state-of-the-art technology and data capabilities. “Many small companies have a limited technology stack, so they rely on technology from their providers. They expect real-time access to their data to make quick decisions,” Marquis said. Those systems also must be able to integrate data from throughout the world.
“From a financial perspective, emerging biopharma companies want to ensure their service providers not only deliver cost-effective solutions, but that they can provide the background and level of detail needed for productive discussions with the company’s board of directors and capital providers,” Marquis observed. That implies access to day-to-day data that helps them control project costs and see their work to completion, regardless whether they are out-licensing or commercializing the project in-house.
“Those are the key items companies look for when selecting a biopharmaceutical services provider, but the cultural fit also is important,” Marquis added. Partners should share common goals and a sense of urgency, and communicate effectively. “That sounds simple, but it isn’t.”
From Quintiles’ perspective, meetings with the C-suite—often the CEO and chief medical officer—provide a good sense of how they operate together and as a company. These meetings reveal the driving forces of the two organizations and their overall objectives, so it’s relatively easy to know if this will be a good fit.
“A good partnership of any type starts with aligned expectations about delivery, performance and governance, and how those elements are measured,” Marquis said. It’s important to understand what each partner expects from the relationship and how they each define success.
Marquis advises beginning discussions with a biopharmaceutical services provider when companies begin to plan the clinical development program and develop their protocols. “We want to be involved in those discussions to understand where we best fit with the organization and also to help ensure we have the right people working on the project.”
Executive involvement is critical. It helps ensure, from the top down, that both teams understand the importance of this alliance. The details, she said, including ensuring that team members at both companies know how to handle issues that arise—both internally and externally—and whom to contact so decisions can be made more quickly.
“Trust is important, but it has to be earned,” Marquis said. It helps to have transparent communications, to follow through on promises, and, she added, “to help ensure clients have a voice.”
Benefits of being virtual
Quintiles’ Emerging Biopharma Solutions was developed to enable small companies to remain nimble while still accessing the expertise and services they need to meet their milestones.
“There are many benefits in being a virtual company,” Marquis said. Basically, it’s easier to adjust to changes. For example, “if the pipeline changes, companies needn’t adjust headcount. They can rely on us, pulling the expertise they need when they need it. That helps small companies stay focused on their development needs.
“Larger companies are focused on how to save costs, but small firms have the advantage of focusing on how to avoid building-in unnecessary costs,” Marquis said. “The Emerging Biopharma Solution is a great opportunity for emerging biotechs.”
Small and emerging biopharma companies are drivers of innovation within the biopharma industry, supporting much of the pipelines of larger companies. Quintiles aims to support that innovation by working with these innovators to develop technology and therapies that will bring treatments to patients sooner than before.