Will Your Cancer Drug Move Past Phase 1?
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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About Translational Drug Development (TD2)
TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit TD2inc.com.