Clinical trials are an essential part of pharmaceutical development, but they come with high costs and often place significant burdens on patients. Unfortunately, the productivity of pharmaceutical research and development (R&D) is declining due to the increasing failure rates in clinical trials. As clinical development progresses through its stages—from pre-clinical to phase 3—the costs, time, and resources grow exponentially. A failed phase 3 trial not only incurs direct costs but also the costs associated with previous trials, as well as the loss of time spent on pursuing a potentially unviable alternative.
Unique Challenges for Small and Medium Biotech Companies
Small and medium-sized biotech companies face many of the same challenges as large pharmaceutical companies when entering the clinical research stage. However, these challenges are often more pressing for smaller firms, where a failed clinical trial could jeopardize the survival of the company and the technology it is developing.
Regulatory Strategy: A Key to Success
One of the key hurdles in clinical research is navigating the regulatory landscape. Many companies miss the correct regulatory path forward or fail to ask the right questions during early interactions with regulators. These oversights can delay progress or result in costly setbacks.
BBCR Consulting’s Strategic Approach: The SCIO Process
BBCR Consulting has set itself apart from competitors by implementing the Strategic Clinical Innovation Organization (SCIO) process. This process, developed by BBCR, is designed specifically to help pharmaceutical innovators address the complexities and challenges of developing high-tech therapies while meeting evolving regulatory requirements. By integrating expert knowledge, additional necessary expertise, and being located in one of the world’s top life science hubs, BBCR is uniquely positioned to offer tailored, innovative solutions to clinical development challenges.
The Benefits of the SCIO Process: Efficiency, Risk Mitigation, and Cost Savings
The SCIO process offers significant time and cost efficiencies, while mitigating risks associated with clinical trials. It provides a clear strategy for meeting goals, streamlined protocols for cost-effective trials, a flexible roadmap, and robust clinical data—resulting in a clearer and faster path to market.
Real-World Evidence (RWE): A Game-Changer in Drug Development
Real-world evidence (RWE) plays a crucial role in understanding patients’ unmet medical needs and their experiences with specific conditions. It also aids in patient recruitment and product marketing. Furthermore, RWE drives the development of Patient Reported Outcome (PRO) questionnaires that capture valuable insights from patients. Both the FDA and EMA have shown increasing interest in incorporating RWE for Orphan Drug development, where it is proving to be a vital data source.
BBCR’s extensive experience with Orphan Drug development has allowed them to collaborate with the FDA in reviewing RWE cases, providing them with deep expertise in RWE selection and adoption.
The SCIO Process and Orphan Drug Success
BBCR’s foundation is built on the observation that Orphan Drug clinical research has a higher likelihood of success compared to non-orphan drugs. To capitalize on this, the SCIO process was developed to innovate the clinical research process. It impacts early-stage clinical research by taking a comprehensive, integrated approach. The SCIO process focuses on optimizing the clinical study, particularly in personalized drug development, streamlining clinical plans and trial designs, which can reduce trial time and cost by up to 30% while lowering the risk of late-stage failure.
Precision Medicine and the Role of Orphan Drugs
Precision medicine identifies that the drug's mechanism of action may only be relevant to a small subpopulation of patients within a disease. This subpopulation can define an orphan subset. Developing drugs for small, molecularly defined, pharmacologically relevant subpopulations within the same clinically recognized disease is increasingly seen as a viable approach to bringing drugs to market.
BBCR’s Flexible Strategy: Adopting the Right Technology
BBCR is agnostic about which technology to adopt, focusing instead on selecting the best tools for each specific product and development need. They assess a product’s mechanism of action (MOA) and disease pathophysiology using a combination of bioinformatics sources. Additionally, BBCR is evaluating various artificial intelligence (AI) platforms to further enhance the SCIO process. By integrating AI with their current bioinformatics data, BBCR aims to optimize development plans, trial designs, and risk management strategies in clinical research. They are targeting 2022 for the full integration of AI into the SCIO process.