Leen Kawas Profiles Biotechnology Firms’ Partnerships with Contract Research Organizations

As the global biotechnology industry continues to expand, the healthcare contract research organization (or CRO) market is also seeing solid growth. In July 2024, the BioSpace life sciences digital news hub noted that the global healthcare CRO market size was USD 52.19 billion in 2023. By 2033, the global market is projected to reach approximately USD 104.60 billion.

For perspective, the United States demonstrated a USD 13.95 billion CRO market size in 2023. By 2033, the U.S. CRO market is expected to be valued at USD 27.44 billion. For reference, biotechnology companies, pharmaceutical firms, and medical device businesses frequently form CRO partnerships.

Contract Research Organization Snapshot

A contract research organization (or CRO) offers one or more clinical research services. Within the drug development cycle, services may include drug discovery, commercialization, post-approval, and pharmacovigilance.

A sponsor (typically a biotech or pharmaceutical firm) that selects a full-service CRO to handle all these functions essentially outsources the entire clinical trial. That said, the sponsor still retains overall responsibility for the clinical trial’s conduct and outcome.

Other CROs specialize in a specific phase of drug development. These phases include the drug discovery, preclinical, clinical, and laboratory sciences stages. Alternatively, the sponsor can recruit a CRO to assist internal company teams.

Leen Kawas’ Clinical Trial Perspectives

Leen Kawas, Ph. D. is Propel Bio Partners’ Managing General Partner. This Los Angeles-based venture capital firm supports start-up and early-stage biotech companies that require financial, technological, and operations assistance. Although Leen Kawas welcomes applications from all biotech businesses, she is particularly open to pitches from female or minority founders.

Prior to Leen Kawas’ current role, she excelled as Athira’s Chief Executive Officer (or CEO). During her Athira tenure, Kawas successfully directed multiple drug development programs. She is intimately familiar with the challenges that can occur during the multi-phase development cycle.

5 Benefits Biotechs Receive from a CRO Partnership

Biotechnology firms can realize multiple benefits from a CRO collaboration. Leen Kawas highlighted five advantages a well-regarded CRO can provide.

Global Research and Medical Experience

In the 21st century, biotech firms increasingly operate on the global stage. A reputable CRO will be familiar with international research and medical landscapes. Equally importantly, the CRO will maintain current knowledge of each country’s applicable regulations.

The CRO can harness this knowledge to conduct a specific country’s required drug study. If the drug subsequently receives approval, the CRO’s marketing team is prepared to market the medication in that nation.

Familiarity with Trial Sites and Investigators

Clinical trials take place in numerous hospitals and research facilities across the United States. High-population states attract a substantial number of clinical trials. States such as New York, Florida, Texas, and California are home to many clinical trials.

A CRO maintains knowledge of a city’s available trial sites. Equally importantly, CRO team members are connected to the region’s highly regarded lead trial investigators. Together, these advantages help promote higher participant enrollment figures.

Suite of Systems and Resources

Each clinical trial involves complex project management and collaboration between all relevant parties. Clinical trial participants must also receive ongoing logistical and personal support. Together, these responsibilities can challenge a biotech’s often-limited resources. Delays and inefficiencies can negatively impact the trial’s timeline.

In contrast, a CRO maintains ongoing logistics capabilities and resources. This ensures its readiness to quickly move forward once an agreement is in place.

Turnkey Clinical Trial Delegation

A biotech’s often-limited technological and human resources could prevent the company from successfully conducting a clinical trial. Without the trial, followed by subsequent drug development phases, the biotech cannot get its drug approved.

Here, a CRO can provide a game-changing advantage. When a biotech can delegate all clinical trial functions and responsibilities to a CRO, the biotech can effectively maintain a drug development program that would otherwise be difficult (or impossible) to operate.

Lower Overall Clinical Trial Costs

Each multi-phase clinical trial carries a substantial price tag. A biotech firm (especially a newer company) may not have the equipment and financial resources to successfully complete the trial.

Here, a CRO’s robust resources and streamlined efficiencies can help reduce the trial’s overall cost while complying with meticulous regulatory criteria. Taken together, these advantages can help position the biotech firm for successful trial completion and market entry.

3 Potential Downsides to a CRO Collaboration

Along with the clear advantages of a CRO partnership, a biotech faces three potential downsides. Leen Kawas discussed each challenge and offered recommendations that could turn the situation around.

Insufficient CRO Resource Allocation

Each CRO likely works with multiple biotechs. Particularly during a specific trial’s early phases, the biotech may become frustrated if they don’t receive regular updates from their CRO partner. Lack of good communication can foster concern that the CRO isn’t devoting sufficient resources to the biotech’s trial. The biotech could also be concerned about a perceived lack of CRO team members with specialized expertise.

To alleviate these concerns, the biotech should implement a framework that dictates when (and how) the CRO will update its biotech sponsor. Finally, the biotech should proactively integrate its preferred project management tools into the trial.

Excessive CRO Staff Turnover

In any industry, an extended project inevitably sees some rate of staff turnover. In a clinical trial, CRO staff turnover and subsequent new hire training can mean expensive delays.

To minimize CRO staff turnover problems, the biotech can choose a CRO with better employee retention rates. The biotech may also consider integrating key employee retention provisions into the biotech-CRO agreement. Even with these proactive strategies, however, some level of CRO staff turnover will likely take place.

Inability to Adhere to Project Timelines

Often-preventable delays can drive up clinical trial costs. Biotech sponsors may believe that the firm’s CRO doesn’t accurately predict every complicating factor that could extend the timeline and increase expenses. That said, a clinical trial’s multiple components and fluid dynamics can make it difficult to achieve that goal.

To minimize timeline issues, the biotech should include minute detail in its project plan. Breaking each task into subtasks can help identify potential bottlenecks. Integrating a clinical trial readiness functionality can identify the areas in which CRO team members may have subpar capabilities. Earlier identification can lead to useful remediation measures.

How CROs Can Better Serve Biotech Sponsors

Forward-thinking CROs will likely consider ways to better position themselves for biotech partnerships. Toward this end, Leen Kawas recommended that CROs discontinue incentives that favor large pharmaceutical firms over biotechs. Outcome-focused contract agreements, superb service throughout the contract, and higher-level talent recruitment and retention will together foster improvements throughout the biotech sponsor-CRO relationship.

This story originally appeared on https://www.theamericanreporter.com/leen-kawas-profiles-biotechnology-firms-partnerships-with-contract-research-organizations/