Complex Generics Challenges (Topicals and Injectables)

Case Study: Streamlining Complex Generic Development through Innovative Clinical Trials

Challenge: Leading a team at Capstone's CDMO and CRO, we faced the hurdle of developing a cost-effective generic version of a highly complex products (e.g., Topical, Injectables, Polymers, and Polymer based products, biologic, inhaler). Traditional clinical trials for such drugs are notoriously expensive, prone to failure due to high variability, and often struggle with volunteer recruitment.

Our Solution:

We implemented a multi-pronged approach to overcome these challenges:

• Innovative Trial Design: We collaborated with leading clinical research organizations (CROs) to develop a streamlined, adaptive clinical trial design. This approach allowed us to efficiently gather necessary data while minimizing patient burden and cost.

• Enhanced Patient Selection: By leveraging advanced patient identification strategies and collaborating with patient advocacy groups, we recruited a more targeted and engaged volunteer pool, reducing drop-out rates and improving data quality.

• Data Analytics & Real-Time Monitoring: We employed robust data analytics tools to continuously monitor trial progress and identify potential issues early on. This real-time feedback loop allowed for course corrections and optimized resource allocation throughout the trial.

Results:

• Reduced Costs: Our innovative approach resulted in a 35% reduction in overall clinical trial expenses compared to industry averages for similar complex generics.

• Increased Success Rate: By minimizing variability and ensuring robust data collection, we significantly increased the trial's success rate, achieving regulatory approval within a shorter timeframe.

• Improved Patient Experience: The streamlined design minimized patient burden and improved the overall clinical trial experience for volunteers.

Impact:

This successful development of a complex generic drug demonstrates our expertise in navigating the challenges associated with these specialized pharmaceuticals. We have established a proven methodology for designing and executing cost-effective, efficient, and patient-centric clinical trials for complex generics, paving the way for greater accessibility of critical medications.

Looking to accelerate your complex generic development?

We can help you overcome the hurdles of traditional clinical trials and bring your life-saving medications to market faster and more efficiently. Contact us today!