Navigating the Preclinical-to-FIH Transition 

Developing a new drug is a lengthy and costly endeavor, averaging 10–15 years and over $2 billion in investment . Despite rigorous preclinical testing, approximately 90% of drug candidates fail during clinical trials, with 40–50% due to lack of efficacy and 30% due to unmanageable toxicity. For sponsors, these statistics underscore the importance of efficient and effective strategies to transition from preclinical studies to FIH trials . ​  

The journey from preclinical studies to first-in-human (FIH) trials represents a pivotal phase in the drug development process, particularly for biotech startups. This transition, often termed the “Valley of Death,” is fraught with challenges that can impede progress and increase the risk of failure. Common obstacles include navigating complex regulatory landscapes, limited internal resources, and the need for specialized expertise to design and execute early-phase trials effectively. 

Challenges in Early-Stage Clinical Development 

Sponsors face several specific challenges during early-stage clinical research and development: 

• Regulatory Strategy and IND Preparation: Developing a comprehensive regulatory strategy and preparing an Investigational New Drug (IND) application require in-depth knowledge of regulatory requirements and meticulous documentation.​ 
• Trial Design Complexities: Designing early-phase trials involves selecting appropriate endpoints, determining dosing strategies, and ensuring patient safety, all of which necessitate specialized expertise .​ 
• Limited Internal Resources and Expertise: Startups often operate with lean teams, lacking the breadth of experience needed to manage complex clinical trials.​ 
• Financial Constraints: Budget limitations can restrict the ability to hire experienced personnel or invest in necessary infrastructure.​ 
• Site Activation and Patient Recruitment Issues: Identifying suitable trial sites and recruiting eligible patients are time-consuming processes that can delay trial initiation.​ 

Strategic Resourcing: A Flexible Approach 

Strategic Resourcing through Contract Research Organizations (CROs) offer a flexible and scalable approach to address these challenges. Through models like Functional Service Provision (FSP), sponsors can outsource specific functions—such as regulatory affairs, clinical operations, data management, and biostatistics—to experienced partners while maintaining control over the overall trial process. This targeted outsourcing allows for the efficient allocation of resources and expertise where they are most needed.  

To learn more about the FSP services model, click here.  

Benefits of the Strategic Resourcing Model for Biotech Startups 

Implementing an Strategic Resourcing model provides several advantages: 

• Access to Specialized Expertise: Engaging with experienced professionals ensures high-quality execution of complex trial components.​ 
• Scalability of Services: Services can be scaled up or down based on project needs, providing flexibility and cost-effectiveness.​ 
• Cost Savings Compared to Full-Service Models: Outsourcing specific functions reduces overhead costs associated with hiring and training full-time staff.​ 
• Faster Trial Initiation and Execution: Leveraging established processes and expertise accelerates trial timelines, facilitating quicker progression to subsequent development phases.​ 

TFS’ Expertise in Strategic Resourcing 

TFS offers customized, global Strategic Resourcing Solutions designed to streamline drug development processes from early discovery through clinical development and into post-market phases. Their flexible approach ensures access to top-tier professionals, whether a single specialist or a fully managed team is required . With a proven track record in supporting early-phase trials across various therapeutic areas, TFS tailors solutions to meet the unique needs of sponsors, facilitating efficient and effective trial execution.​  

Looking Ahead: Gathering Insights from Biotech Leaders 

Understanding the specific challenges sponsors face in early development is crucial for developing effective support strategies. TFS is launching a mini-survey aimed at gathering insights from biotech leaders on their experiences transitioning from preclinical to FIH trials. Participation in this survey will contribute to a broader understanding of industry needs and inform the development of tailored solutions.​ 

To participate in this year’s survey, please click here. 

Conclusion: Partnering for Success 

Strategic partnerships are essential for sponsors navigating the complex journey from preclinical studies to FIH trials. By leveraging Strategic Resourcing, companies can access the necessary expertise and resources to overcome early development challenges efficiently. TFS’ commitment to providing flexible, expert-driven solutions can aid in accelerating drug development and bringing innovative therapies to market. 

About TFS HealthScience CRO  

TFS HealthScience is a global CRO that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey across several therapeutic areas, including Dermatology, Oncology, Neuroscience, and more. In partnership with customers, we build solution-driven teams working for a healthier future. As a trusted CRO partner throughout the entire clinical development journey, we understand the importance of providing essential and diverse services to streamline clinical trials for our clients with robust FSP services and strategic resourcing solutions (SRS). Visit our website to learn more about the solutions TFS can offer for your next clinical trial or connect with a TFS representative today!