---
title: Will Your Cancer Drug Move Past Phase 1?
description: A sound preclinical plan coupled with expert oncology guidance can help identify biomarkers that can assist with patient selection—or..
---

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[Preclinical](https://blog.td2inc.com/tag/preclinical)

# Will Your Cancer Drug Move Past Phase 1?

April 18, 2019

> A sound preclinical plan coupled with expert oncology guidance can help identify biomarkers that can assist with patient selection—or help determine earlier when a patient is responding in the clinic. All of these can help boost the odds that your program will succeed where others have failed.

**Why Do Biomarkers Matter?**

Even though oncology drugs have low success rates when it comes to progressing from Phase I to Phase II, studies have shown that trials using biomarkers for patient stratification are better poised for success. Planning your preclinical programs to include a thorough evaluation of potential biomarkers for patient stratification and increased anticancer response is an essential part of the TD2 approach.

**3 Things to Look for in a Strong Preclinical Plan**

The best programs start with the end in mind: By identifying a drug’s clinical and regulatory strategy, it can save time and resources as the drug program progresses. To ready your program for success, build a forward-thinking preclinical plan around three elements: Strategic use of well-characterized models, applications of lessons learned from previous projects, and PK/PD analytics.

**TD2: The Premier Oncology Partner**

We’re a team of oncology experts who provide service and consulting throughout every study phase. We’re committed to helping our clients prove concepts as early as possible to increase chances of approval and get drugs to patients who need them the most.

As a TD2 client, you can choose from more than 400 oncology models, including [syngeneic models](https://td2inc.com/syngeneic-models/) for immune-oncology and cell therapy models in liquid and solid tumors including leukemia, lymphoma, pancreatic, ovarian and much more. Our full services include complete access to PK and PD analytics that enable sponsors to adapt and leverage insights as they move forward.

- [Advancing Bone and Sarcoma Cancer Research Through Robust In Vivo Models](https://blog.td2inc.com/advancing-bone-and-sarcoma-cancer-research-through-robust-in-vivo-models)
- [How the FDA’s Plausible Mechanism Framework Signals the Future of Precision Oncology](https://blog.td2inc.com/how-the-fdas-plausible-mechanism-framework-signals-the-future-of-precision-oncology)
- [What Makes Radioligand Therapy IND Strategy Fundamentally Different?](https://blog.td2inc.com/what-makes-radioligand-therapy-ind-strategy-fundamentally-different)
- [Receptor Mediated Therapies in the Clinic: From Targeting to Impact](https://blog.td2inc.com/receptor-mediated-therapies-in-the-clinic)
- [A Translational Lens on Synergistic Cancer Therapy: Insights from Our Recent Case Study](https://blog.td2inc.com/a-translational-lens-on-synergistic-cancer-therapy-insights-from-our-recent-case-study)
- [Redesigning Preclinical Oncology: A Framework for Improving Clinical Translatability with AI, RECIST-Inspired Metrics, and Systems-Level Thinking](https://blog.td2inc.com/redesigning-preclinical-oncology)

[Preclinical](https://blog.td2inc.com/tag/preclinical)

[Preclinical](https://blog.td2inc.com/tag/preclinical)

### [Redesigning Preclinical Oncology: A Framework for Improving Clinical Translatability with AI, RECIST-Inspired Metrics, and Systems-Level Thinking](https://blog.td2inc.com/redesigning-preclinical-oncology)

September 25, 2025

Despite decades of investment in oncology drug development, the translational pipeline from preclinical models to clinical success remains ...

[Read more +](https://blog.td2inc.com/redesigning-preclinical-oncology)

[Preclinical](https://blog.td2inc.com/tag/preclinical)

[Preclinical](https://blog.td2inc.com/tag/preclinical)

### [The Rise of Humanized Mouse Models in Oncology: What Drug Developers Need to Know](https://blog.td2inc.com/the-rise-of-humanized-mouse-models-in-oncology-what-drug-developers-need-to-know)

August 6, 2025

Traditional mouse models remain a cornerstone of preclinical oncology research. Syngeneic and xenografts mouse models continue to play a critical ...

[Read more +](https://blog.td2inc.com/the-rise-of-humanized-mouse-models-in-oncology-what-drug-developers-need-to-know)

[Preclinical](https://blog.td2inc.com/tag/preclinical)

[Preclinical](https://blog.td2inc.com/tag/preclinical)

### [Flow Cytometry User Groups And The Relaunch Of The NWFCS](https://blog.td2inc.com/flow-cytometry-user-groups-and-the-relaunch-of-the-nwfcs)

July 31, 2025

By Jennifer J. Stewart, PhD

[Read more +](https://blog.td2inc.com/flow-cytometry-user-groups-and-the-relaunch-of-the-nwfcs)

[Preclinical](https://blog.td2inc.com/tag/preclinical)

[Preclinical](https://blog.td2inc.com/tag/preclinical)

### [Live Dead Measurement and Cell Viability](https://blog.td2inc.com/live-dead-measurement-and-cell-viability)

July 24, 2025

By Marrisssa Bailey, BS

[Read more +](https://blog.td2inc.com/live-dead-measurement-and-cell-viability)

### Get Started

## Contact Us Today!

If you’re looking for an expert team to guide your trial with efficiency in mind, we can help. As the creators of the Dynamic Trial, TD2 provides start-to-finish support with trial strategy, design and execution for faster go-to-market potential.

[Get Started Now](https://td2inc.com/contact-us/)

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