A biotech sponsor based in China with a focus on innovating novel immunotherapy treatments, encountered a setback in its US Phase 1 study for patients with Advanced/Metastatic Solid Tumors. To address this challenge, the sponsor sought assistance from Novotech, engaging them to conduct a thorough pre-clinical and full-service CRO activities to salvage the struggling program.
Novotech was chosen based on its diverse range of capabilities:
In-house expertise in both pre-clinical (Novotech Drug Development Consulting) and comprehensive clinical CRO services.
Regional Strength across the Asia-Pacific region.
Flexibility and agility to adapt to program changes while ensuring quality and budget adherence.
Global CRO capabilities to support the management of the US arm of the study.
Global Strategic Approach:
Protocol Improvement: Novotech performed an extensive review of the Investigator Brochure (IB) and collaborated to revise the protocol, integrating expert insights into the study design.
- MRCT Strategy in APAC Implementation: Acknowledging the benefits of the Asia-Pacific region, Novotech initiated a Multi-Regional Clinical Trial (MRCT) strategy to effectively gather essential Investigational Product (IP) data, vital for Phase II planning.
- Strategic Growth: Launching a Phase 1 escalation study in Australia leveraged the country's streamlined regulatory pathway, ensuring a rapid study start-up and accessing a favourable 45.3% R&D cashback incentive. Simultaneously, study arms were introduced in Singapore and South Korea to leverage rapid regulatory timelines and ample patient pools concurrently.
Milestones: Novotech 's interventions resulted in noteworthy accomplishments:
- Impact of IB Review Impact: Novotech 's Drug Development Consulting team’s assessment uncovered missing data and offered crucial insights into the challenges faced in the US study, pivotal for securing local regulatory approval.
- Streamlining of Timelines: Collaborative input from Medical Writers on study design significantly decreased the dosing timeline, resulting in a considerable 40-day savings for the sponsor.
- Recruitment: Successful recruitment milestones were achieved in three key regions:
- In Australia, 46 patients were enrolled within 29 months, initiating site activities immediately post-Ethics Committee (EC) submission and meeting patient recruitment goals by completing six cohorts within seven months.
- South Korea reached its patient recruitment goal by enrolling 13 patients within a recruitment duration spanning from FPFV to LPFV, covering six months across three sites.
- Likewise, Singapore accomplished its patient recruitment objective at a single site, enrolling seven patients within a 12-month recruitment duration from FPFV to LPFV.
In summary, Novotech 's expert consulting and MRCT strategy not only addressed the challenges in the US study but also enhanced study design, shortened timelines and achieved recruitment milestones across various APAC regions. The success of this rescue effort highlights the significance of strategic partnerships and a global outlook in overcoming clinical trial challenges, demonstrating the critical role played by intelligent MRCT strategies in the changing landscape of pharmaceutical research.