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.
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.
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.
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.
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.