By: Sarah Anderson, Director Therapeutic Strategy & Pedro Rodriguez-Noriega, Associate Therapeutic Strategy Manager
ASH 2025 in Orlando, brought together nearly 40,000 attendees, and showed clear progress across hematology. Funding sentiment is improving and we’re seeing more dependable study start dates with fewer delays. Discussions with investigators and industry leaders point to a shift in how companies are choosing trials execute to balance science, speed, and cost.
Regional execution trends
- Asia-Pacific: APAC remains attractive as a cost-effective foundation for global studies. Rising U.S. site costs are influencing early planning, and both Australia and China were frequently raised in conversations. Interest in investigator-initiated trials (IITs) in China is increasing as sponsors look for early data generation options.
- Brazil: Sponsors are giving Brazil more consideration following regulatory changes that have shortened approval timelines to roughly three months and reduced overall trial costs compared to the U.S.
- United Kingdom (MHRA): Investigators report faster and more consistent approval timelines often around 60 days which is improving the region’s competitiveness.
Scientific spotlight
A session on belantamab mafodotin (Blenrep, ADC anti-BCMA for multiple myeloma illustrated the dual reality of advanced therapeutics. Despite significant ocular toxicity (observed in 92% of patients), the drug delivered strong results, including a tripling of progression-free survival versus the comparator (10.7 vs. 30 months) and an 81.5% response rate. Due to safety requirements, administration is limited to REMS-certified sites with ophthalmologic oversight, reinforcing the operational demands of bringing these therapies to patients.
What sponsors should do next
- Use regional strengths strategically Combine APAC’s speed and cost advantages with selected U.S. and European sites to meet scientific and regulatory goals.
- Match program scale to the funding climate: With more stability returning to the market, sponsors can plan with greater confidence while maintaining flexibility.
- Create options early: IITs and adaptive designs can support faster signal detection, dose refinement, and clearer go/no-go decisions.
How Novotech helps
With experience delivering 80+ hematology trials delivered across APAC, North America, and Europe, Novotech partners with sponsors across planning, feasibility, regional start-up and regulatory strategies, site engagement, and data/biostatistics. Our teams help sponsors maintain predictable timelines and readiness for inspection as programs advance.
If you are evaluating country strategies or preparing Phase I–III hematology programs for 2026, we’d value the conversation. Talk to an expert: https://novotech-cro.com/talk-to-an-expert