Translational Research

Enhance Your Proof of Concept Clinical Study

We create custom tools that help you understand how your drug behaves in the body.

Our goal is to help you uncover some simple yet hard-to-answer clinical questions:

DOES MY DRUG ACTUALLY BIND TO ITS TARGET?

IS MY DRUG GETTING TO ALL SITES OF DISEASE?

IS MY DRUG RIGHT FOR THIS PATIENT?

By answering these fundamental questions, we help our clients create clinical programs that are brimming with information. Information that will aid in the success of your clinical development program.

See The Difference

Our partners are developing amazing, precision-targeted therapies that are advancing personalized medicine. The increased precision of molecular targeting means that defining the correct patient population is critical, and understanding how to select those patients can be mystifying. CPDC’s translational research programs can help.

Traditional tissue biopsy can only provide a random sliver of information on a patient’s disease, one that is often imprecise or even misleading. Diseases like cancer are both heterogeneous and extremely complex, with differences found within a single tumor, and even larger differences found from one tumor to the next. By producing an imaging surrogate to your drug, the CPDC can provide you with a tool that you can use to understand critical differences between patients, and thereby help you create trials designed for a higher chance of success.

What We Do

At CPDC, we create custom tools that we call probes, which allow you to visualize how your drug behaves in the body. We do this by incorporating a radioisotope into your drug allowing it to be used for molecular imaging. Our expertise in radioisotope labelling of a wide variety of compounds used in various drugs means we can give you a powerful tool to evaluate how your drug interacts with the body.

We have created probes from all ranges of products, including small molecules, biologics and nanoparticles. We are experienced with almost every medical isotope you have heard of, and others you may have not. Our professional scientists will work with your team to design a probe that best mimics the chemical and biological properties of the drug, with an integrate radionuclide suitable for molecular imaging.

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Here’s How We Do It

When it comes to creating a probe for your clinical program, there are a lot of moving parts. It’s our job to make it look easy!

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We assemble a team with all the right experience for your program. At first, you will work closely with our chemists, radiochemists and biologists to design the probe and test it using in vitro and in vivo pre-clinical models. Our goal is to make sure the probe still binds its target molecule with the same affinity and retains its biological activity.

Next, we develop the animal model of your choosing for the disease of interest.  We have experience setting up models for oncology, immuno-oncology, neuroscience, inflammation, cardiovascular and metabolic diseases. We can then assess the probes’ pharmacokinetics, and when we’ve determined the probe has the properties we’re looking for, we perform pre-clinical SPECT/CT or PET/CT imaging to prove that we have a tool ready for you to take to the clinic.

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With successful pre-clinical proof of concept it will be time to translate to clinical trials. We will add new members to your team with expertise in manufacturing process and analytical development, RA and QA, and clinical operations related to trials. This team will create the GMP processes within our state-of-the art facilities, craft the non-clinical safety package, design the clinical protocol, draft the investigational new drug (IND) submission, and setup and manage the clinical trial sites, in a location of your choosing.

Whether you want us to handle it all or just carve out a slice, we will build a program to fit your budget and your timelines. Speak with us about your clinical program and we will suggest how to help you leverage your current CMC, non-clinical and clinical data to accelerate the path to an IND with your probe, and how to design a trial for rapid enrollment and one that’s enhanced with relevant data.