2026 Oncology Drug Development Planning Realities

• Phase I
• Phase I trials
• Phase II

As we kickoff 2026, here are the operational and strategic realities shaping Q1–Q2 2026 oncology starts.

Reality #1: Phase I Site Bandwidth for Early 2026 Is Tightening

Top U.S. Phase I units begin prioritizing their Q1–Q2 workload in November and December. They rarely “close,” but capacity—PI time, infusion space, biopsy slots, PK windows—tightens quickly.

If you want to start in early 2026:

• If your IND is approved → finalize site contracts and activation steps now.
• If IND is pending → initiate site engagement so feasibility and budget work run in parallel with FDA review.
• If IND is planned for Q2 → pre-qualify sites so activation can move quickly post-IND.

Why sites decline new studies:

• PI bandwidth is maxed out
• A competing study enrolled first
• Protocol complexity or design issues

Reality #2: Platform Technologies Are Driving Investment Strategy

BIO Europe made one trend clear: investors are favoring platforms capable of generating multiple assets from a single R&D engine—ADC scaffolds, bispecific platforms, CAR-T constructs, mRNA systems, and more.

Implications for sponsors:

• If you have a platform, articulate how your lead program validates the engine.
• If you have a single asset, clarify how success de-risks future programs or pathways.
• Investors increasingly want proof-of-platform, not just proof-of-concept.

Reality #3: Expedited Regulatory Pathways Are Active—But Expectations Are Higher

Oncology continues to dominate Fast Track, Breakthrough Therapy, Priority Review, and Orphan designations. But FDA’s expectations are clearer and more rigorous.

Programs that qualify often show:

• Serious unmet need
• Strong biological rationale or early efficacy
• Biomarker-driven patient selection
• Evidence that confirmatory strategies are feasible

If you qualify:

• Apply early—Fast Track may be obtained preclinically; Breakthrough requires preliminary clinical activity.
• Understand that FDA increasingly expects confirmatory trials to be well-defined early.
• Use expedited programs to gain more frequent FDA interactions and reduce review timelines.

What We’re Watching in 2026

Based on BIO Europe conversations and recent FDA activity, here’s what’s on our radar:

1. After Merck’s $588M global license for LM-299, PD-1×VEGF bispecifics have become a major focus area for next-gen IO + anti-angiogenic strategies.
2. MTAP-deleted tumors (PRMT5/MAT2A), ATR/WEE1, POLQ and other DNA-repair synthetic lethal targets.
3. GDF-15 inhibitors for cancer cachexia (Pfizer’s ponsegromab and others) are moving into pivotal development. If late-stage data hold up, expect cachexia co-therapies to become a serious consideration in solid tumor programs.
4. ctDNA-based MRD detection is rapidly being integrated into Phase II designs—especially in colon, lung, and breast—as an exploratory endpoint and stratification tool, with a clear trajectory toward broader standardization.
5. mRNA cancer vaccines have moved firmly into Phase II and Phase 2b—mRNA-4157 in melanoma and BNT122 in GI cancers are early examples—with more indications expected to follow in 2026

Let’s Talk About Your 2026 Strategy

Whether we met in Vienna, exchanged emails this year, or this is your first time hearing from Medelis, we’d welcome a conversation about your Phase I or II oncology program.

We’re not the biggest CRO. We don’t pitch everyone. But if you’re developing a drug with a novel mechanism, backed by solid science, and you want a CRO partner who actually understands oncology biology—let’s talk.

How to Connect:

1. Book a 30-Minute Strategy Call — No sales pitch, just insights on your program
2. Request: “2026 Phase I Budget Reality Check” — Site costs, timelines, what to expect

Email, request or call Medelis here.