What Should Biotechs Keep
in Mind When Seeking a CRO Partner to Bring Their Oncology Assets to Market?

Selecting the Right Oncology CRO

Challenges abound for small to midsize biotech companies with an oncology asset preparing to enter the next phase in development. The transition from the discovery and preclinical stages to partnering with a large CRO can be daunting but necessary to advance your product, whether your goal is market approval, the sale or licensing of your product or an acquisition. What should you consider when choosing a CRO to help scale quickly, smoothly and successfully?

For insight, we spoke with medical and operational oncology leaders at PPD, a part of Thermo Fisher Scientific.

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What to look for when seeking a CRO partner to bring your oncology assets to market?

One area that will cut across all of our major themes in this document is flexibility and forward thought. For complex oncology studies, it is important to have a CRO with deep oncology expertise across a variety of indications, modalities, targets and mechanisms of action. However, it is also critical to have a partner that can easily adapt to novel approaches and changing needs.

“Look for a CRO that is able to pivot quickly, whether that means adding cohorts based on emerging data or augmenting your country strategy in-stream,” Jai Balkissoon said. “Quick, real-time discussions can enable rapid changes without losing momentum.” A solid understanding of trial needs ideally comes from robust early engagement.

In the pages ahead our experts will go into detail on the importance of:

Early Engagement

Identify the Right Direction Early

Ensure early in the relationship that your CRO understands both your company and your product goals. “Often focused on groundbreaking work,” Balkissoon said, “biotech companies must concentrate on meeting endpoint expectations of agencies while ensuring patient safety and an efficient path to market approval. At PPD Biotech we work closely with our clients to identify the right designs for their studies.”

In Phase I dose-finding studies, for example, we collaborate to make critical decisions that will impact the life of the trial, such as:

Selecting a 3+3, an adaptive continuous reassessment method (CRM) or other statistical design
Focusing on a maximum tolerated dose (MTD)-based design or an optimal biological dose (OBD)-based design

“Having the right design can often be more efficient at finding the right dose and can reduce costs,” said Balkissoon. “We walked through a CRM strategy for a company that was approaching a Phase I/Phase II trial and was initially uncomfortable with an adaptive model. They ultimately saw value in the new approach, which saved them about $1.5 million in patient costs and $2 million in timeline reductions.”

Hear more from our experts on the power of early engagement and innovative trial design.

Development Landscape Insight

How Many Trials Does Your CRO Draw Experience From

While the size of a large, global CRO can be intimidating to an emerging company, a CRO's breadth of capabilities and depth of experience provides high levels of adaptability, stemming from multifaceted knowledge of what is and isn’t working in the current development landscape.

“For example, we have been able to help smaller clients source tissue for advanced therapies,” Balkissoon said. “And with our frequent regulatory engagements, we can see when agencies take a more conservative approach to dose-limiting toxicity (DLT) periods for certain mechanisms of action. In addition, we work with our clients to make sure dose-finding and dose optimization is done in accordance with the FDA’s Project Optimus initiative.”

A large CRO can help biotech companies plan for and navigate around these challenges.

Regulatory insights are just one aspect. You will want to ensure your CRO has the data to give you superior insights. For example, how can your CRO help you:

Gain a global understanding of standard of care to help prioritize unmet therapeutic need and evaluate early phase assets
Monitor market affordability to adjust commercial efforts and product life cycle
Optimize feasibility studies and protocol design by identifying treatment patterns across geographies

See how PPD is using OncoLocator to provide a real-time understanding of treatment patterns in oncology.

Global Reach

In Oncology, Reach and Reliability Matter

The need for breadth of capabilities and depth of experience is also a foundational requirement for confidently identifying patient sources. This is true across all phases of development, but geographic reach that covers large academic centers and community sites is a must for accurate feasibility and predictable enrollment for studies:

Testing novel treatments, such as cell and gene therapy
Enrolling rare cancer and pediatric populations
Ensuring equity and inclusion targets are met

Patient diversity is an important CRO selection criterion, given the growing FDA requirements for oncology studies. You will want to look for a CRO that not only has greater reach into community sites, but one with a working knowledge of:

Demographically appropriate I/E criteria
Diversity-focused feasibility questions

Targeted site selection based on epidemiology, disparity and prevalence
Diverse KOL engagement to identify typically untapped sites and PIs
Cultural competency training for CRA and site facing employees

We are seeing more rare genetic marker and specialty therapies, but the increasing challenge is that genetic testing may not be standard of care in all places. However, the tide is turning. “PPD is at the forefront of the patient journey and is part of the global solution to design pathways for patients to join registries and have access to genetic testing”, shared Nathalie Toussenel, executive director, oncology project delivery.

“We can use on-site, in-clinic testing to help patients find their best options and, if it’s best fit for the patient, bring them in to a clinical trial” shared Andrea Armfield, who leads portfolio oversight for biotech clients.

Global Reach

Not only is this helpful for patients, but it also enables us to:

Get insights into where specific genetic screenings are taking place for better feasibility and site selection
Expand global recruitment reach beyond large academic sites
Meet FDA diversity requirements in oncology by increasing the geographic footprint of a trial
Reduce vendor complexity, time and cost associated with biomarker labs

PPD has the ability to help physicians make rapid treatment assessments, which makes us a good partner for patient care. “At the end of the day, our goal is to serve patients, so the more solutions we offer that ease site and patient burden, the better,” said Armfield.

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