A Q&A with Paul Gonzales of TD2 on the essentials for preclinical success—and what researchers should know going into every project.
Q. What makes a preclinical project successful?
You need a clear understanding of project goals, model systems and variables that could impact study outcomes, but it’s equally important to work with a team that also understands those goals and can execute strategically to ensure the best chance for success.
Q. What should researchers know going into every project?
You should know the value of your study’s data and how it directly supports your compound’s progress toward the clinic. Each study should move your compound along its development path and take you one step closer to treating patients.
Q. What are some common mistakes that researchers make during preclinical projects?
Not identifying all the study variables can be the difference between a successful outcome and a failed study. Another common mistake is when researchers latch on to a single indication strategy; instead, maintain an open mind and let the science drive decision-making.
Q. What are some of the top challenges researchers face, and how can they overcome them?
Results from studies performed solely in the originator’s lab can be viewed suspiciously, so it’s critical to have independent third-party confirmation of experimental data. Also, data reproduction is challenging, so work with a team that has a track record of ensuring uncompromised, reproducible data.
As TD2 client, you’ll get exclusive access to an integrated and diverse suite of preclinical tools (in vitro, in vivo and specialized PDx models) that can provide strong experimental support for a well-defined clinical and regulatory strategy, including bioanalytical and ADME support services.