Within the biopharmaceutical industry, there are companies of various sizes sharing a common goal: to create new treatment options. Successful companies must constantly evaluate their capabilities and know when to expand internally to fill a need or when to collaborate with an external organization to advance their pipeline. Coming from the perspective of an emerging biotech company, we have firsthand experience recognizing the specific skills needed in a collaborator. This is particularly important for biotech companies looking to take their lead candidates to the clinic, because they often do not have the internal operational capacity to carry out necessary studies themselves and rely on dedicated external support to move the pipeline forward.

Three Tips for Growth-Stage Biotech Firms Aiming to Outsource Clinical Development

Partnering with a contract research organization (CRO) can optimize and streamline the clinical development process while giving a company the flexibility and freedom to dedicate internal resources to mission critical research and development. A CRO can add value on several fronts, notably bringing in a skilled team with a proven track record of successfully executing clinical studies through an established process. The right CRO also brings systems and additional third-party vendor relationships that ensure an integrated and fruitful long-term collaboration.

To assure a mutually beneficial collaboration, it is important to initiate a partnership with a CRO that is the best fit for your company size and capabilities. A CRO’s particularly deep understanding comes from a track record of successful relationships with similarly sized companies, giving them firsthand insight into the unique pressures faced by small biotech companies looking to scale their growth. The CRO must also be able to provide all needed services, which are often greater than with larger companies with more internal capabilities. This understanding and level of service are paramount to a successful and mutually beneficial collaboration. Based on our collective experience of over 50 years of clinical development, we offer three takeaway points that small biotechs can utilize when developing partnership with a CRO tailored to their unique needs.

Identifying the Right CRO

Every biotech and pharmaceutical company is different and has distinct needs to complement their internal resources for clinical development, and this is the case for science/therapeutic area and company culture. Over time, CROs have gained specific experience in working with different types of biotech and pharma companies, from large and midsize pharmaceutical organizations to emerging biotech firms, and successful CROs will be flexible to adapt both services and approach to the needs of the partnering company. Additionally, some CROs specialize in running clinical trials in different geographic locations, and finding one that matches its regional expertise with clinical enrollment plans can also help to de-risk the partnership.

From the perspective of a small biotech company, it’s critical to initiate a partnership with open, honest communication, specifically related to aspects of implementation and task allocation to avoid any surprises partway through the process. This includes setting clear expectations on which tasks will be the responsibility of the CRO and which ones will be internal to the company. Careful attention to task assigning will help avoid unpleasant late discovery of unassigned tasks that a small biotech may not have the manpower to take on if resources were not properly allocated at the start of the project. For smaller biotechs, this is especially important to avoid late discovery of incomplete tasks that could result in overall operational or quality gaps. There is often a rush to action for study start-up, but problems will emerge later in the project if expectations are not clear and well defined up front.

Another key to successfully selecting a CRO that fits a small biotech’s needs is ensuring that they can offer the same dedicated focus and solutions to the company’s program(s) in other aspects of the business. These include — but are not limited to — real-time bidirectional communications, ability to execute according to plan, timely reporting of data, and predictability of costs. While some small biotechs “throw the ball over the wall,” other companies participate in each and every decision made in the trial and require detailed and daily communication and collaboration. Similarly, if a company has detailed involvement, any changes to the plan must be discussed and agreed upon between sponsor and CRO. And finally, close financial management is required when changes to individual study budgets are material to the company’s financial picture. Larger companies may set operational goals for limiting change orders, but smaller companies require the predictability for cash runway projections and planning. Problems in areas like these can be particularly painful for small biotechs, whose progress and costs are reported in detail to stakeholders and often to the public.

Nurturing Bidirectional Communications

Once identified, the CRO should be fully integrated into the organization’s team to foster a sense of trust. Bidirectional, open, and honest communications should have been established when the partnership was initiated but need to be nurtured to help the CRO develop a sense of shared ownership of the process. Consider allocating time to develop and grow the relationship by sharing historical background information on the company: their origin story, first milestones, recent achievements, and why they feel passionate to help progress treatments for a specific disease state. You could also share the significance and stakes of the trial, as it is likely the culmination of years of research, and, for smaller biotechs, may have a significant impact on the company if it fails. This can be done at the start of the relationship and should be revisited as needed throughout the duration of the collaboration to ensure a thriving partnership between two equally invested partners. While these may seem like common-sense approaches, we often hear that our CRO partners really enjoy working with us specifically because of this approach. And it’s not so common in their experience.

Integrating both teams fosters transparency and also reinforces the shared vested interest that both partners have in the successful completion of the study. Additional ways to nurture the relationship include committing to addressing any communications issues as they arise to avoid frustrations and delays and setting time aside for bidirectional feedback. Frequent feedback can proactively create a mechanism to resolve any unforeseen issue impacting timelines and/or deliverables.

Tailoring the Partnership to Meet Unique Needs

One of the most difficult parts of maintaining any partnership as a small biotech is dealing with growth as the pipeline advances. Small biotechs can undergo tremendous shifts in their staffing models and development programs in short periods of time, and partnerships need to be constantly evaluated to ensure that each party is bringing necessary skills and resources to the table. As a company expands their resources, they may find that some tasks may no longer need to be outsourced and could be brought in-house. Conversely, a growing pipeline may call for scaled-up trials and additional outsourcing of new or upsized tasks. Consider setting internal check-in times to keep the collaboration nimble by reviewing needs and right-sizing the partnership by discussing key drivers of success for each partner. From the perspective of a small biotech company, these drivers may include staff allocation, cadence of meetings, and payment milestones. We have seen significant benefit of working with a partner on more than one study, so that standards and efficiencies of work can be realized and leveraged for both people and processes. We have also customized the governance of our important partnerships to involve more of the team in review of progress, identification of process improvements, and broader partnership building. Flexibility on behalf of both the company and the CRO will facilitate a continued vested interest in generating high-quality clinical data, and foresight to include prespecified interim check-ins during a partnership creates natural attention to these fine details.

In Conclusion

In the challenging field of drug development, small biotech companies with promising candidates may find it daunting to build a clinical program geared toward bringing a new product to market and to potentially compete with big pharma. Yet such programs are vital to the growth of the company, the advancement of its pipeline, and the fulfillment of its mission to improve patient outcomes. Here, we outlined a few considerations that a small biotech company can keep in mind when partnering with a CRO. A tailored and dynamic collaboration with a CRO well-versed in the unique needs and operational framework of small biotechs can propel companies forward and bring their lead drug candidates closer to the patient. However, it is a shared responsibility to foster communication and shared interest in clinical advancement that will ultimately lead to a successful partnership. While some may say these are simple and straightforward ideas, we are confident they have been key to our successful partnerships and our track record of execution in a very challenging environment.

Authors: Kathryn King, Ph.D., Dan Watson, and Kerrin Young, Aptinyx

About the Authors

Kathryn King, Ph.D., is a pharmaceutical executive with 25 years of clinical development achievements, presently serving as Senior Vice President, Clinical and CMC Operations at Aptinyx.  She teaches clinical research courses as an Adjunct Instructor in the Graham School at the University of Chicago. Kathryn held leadership roles at Levo, AbbVie, Veeva, Takeda, and Abbott.  She earned a BS in biochemistry from Notre Dame, a MA in health care ethics and a Ph.D. in philosophy from Loyola University Chicago.

Dan Watson is an experienced clinical research professional with almost 20 years in various roles in the pharmaceutical industry. Currently serving as an Associate Director at Aptinyx, Dan has held management positions at Baxter Healthcare and various roles at other Biotech and CRO organizations. He earned a BS in biological sciences from Wright State University in Dayton, Ohio. 

Kerrin Young is an experienced professional with 20 years in the pharmaceutical industry. Presently serving as Associate Director at Aptinyx, Inc. Kerrin has held management positions at Takeda, Astellas, BioSante, and Novartis Gene Therapies. He earned a BS in chemistry and psychology from the University of Illinois at Urbana Champaign.  He has professional affiliations with DIA and ACRP.