Early-phase clinical trials represent a critical milestone in drug development, yet they pose significant challenges for biotech companies. Recent data shows approximately 50% of drugs fail to progress beyond phase 1 trials, which involve substantial financial investment and time commitment.
Small and medium-sized biotech firms often operate with limited resources, making it difficult to manage all aspects of clinical development internally. A recent survey conducted by ICON in 2024, involving 149 biotech industry professionals, revealed key challenges in phase 1 preparation. The most significant concerns included regulatory compliance (38%), biomarker selection (35%), and protocol uncertainties (31%).
To address these challenges, many biotechs are increasingly turning to contract research organizations (CROs) for support. The survey indicated that 84% of respondents were considering CRO partnerships for their phase 1 trials. These collaborations provide comprehensive support across multiple areas, including regulatory guidance, funding consultation, therapeutic expertise, and operational management.
Operational capabilities rank high among biotechs’ priorities when selecting partners. Survey results showed that 40% of respondents valued access to patient and healthy volunteer populations, while 35% prioritized dedicated early-phase data management and reporting services. These operational aspects are particularly crucial as they can significantly impact trial timelines and resource allocation.
CROs bring more than just operational expertise to the table. Their experience with various therapeutic modalities and indications provides valuable strategic insights that can help minimize risks and accelerate development timelines. The survey revealed that 34% of respondents considered asset development consulting, including dose selection guidance, as a crucial service requirement.
Clinical development planning presents another significant challenge. This comprehensive process encompasses protocol development, regulatory compliance, and commercial viability considerations. The survey showed that most biotechs seek external expertise for development planning, with 37% partnering with CROs and 25% engaging multiple consultants. Only 38% of companies rely exclusively on internal resources for this crucial aspect.
The survey highlights how strategic partnerships can be tailored to meet specific biotech needs at various development stages. For companies operating with limited resources, external partners can provide crucial expertise and infrastructure support. These
partnerships help bridge gaps in knowledge, resources, and
capabilities that many lean biotech operations face.
The complexity of early-phase clinical trials demands specialized expertise across multiple domains. From managing regulatory
requirements to selecting appropriate biomarkers and developing robust protocols, biotechs face numerous challenges that can impact their success rates. External partnerships, particularly with CROs, offer a solution by providing access to specialized knowledge, operational support, and strategic guidance.
The trend toward external partnerships reflects the evolving landscape of drug development, where expertise in both therapeutic innovation and clinical trial execution is essential. For many biotechs, these partnerships represent a strategic approach to overcome resource limitations while maintaining focus on their core therapeutic innovations.
The data suggests that successful early-phase clinical development increasingly relies on a combination of internal capabilities and external expertise. As the complexity of drug development continues to grow, particularly in emerging therapeutic modalities, the role of strategic partnerships becomes increasingly vital for biotechs navigating the challenging path from discovery to clinical success.