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 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.

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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.