In Vivo Imaging Solutions
Preclinical imaging is an established technology combining both functional and structural imaging to evaluate specific in vivo processes relating to spatial orientation within the model of interest. The unique characteristics of molecular imaging provide investigators with an early-stage solution to evaluate critical principles of new entity development: exposure at the target site, binding to the target of interest, and expressing the desired pharmacology. Incorporation of molecular imaging solutions into new entity development programs allows you to rapidly assess results and make essential decisions earlier in the drug development process.
In vivo imaging can be used in many development efforts, such as those targeting insight into disease processes, validity of new therapeutic targets, target/non-target organ interaction, mechanism of action, biodistribution, and others.
Imaging Services, Capabilities, and Technology
With over 80 years of combined experience, our scientists have executed hundreds of preclinical imaging trials over the last two years. Our team of scientists and technical staff are eager to partner with you on your drug development goals to make faster go/no-go decisions. Our comprehensive in vivo preclinical imaging solutions, radiopharmaceutical, and data analysis solutions include:
ANIMAL MODEL IMAGING MODALITIES
- MicroPET (positron emission tomography)
- MicroSPECT (single photon emission computed tomography)
- Large and small animal (computed tomography)
- Quantitative whole-body autoradiography (QWBA), long- and short-lived isotopes
- two-dimensional, GLP-compliant
- Radiolabeling of cellular therapeutics
- Radiolabeling of antibodies, peptides, oligonucleotide, nanoparticles, and small molecules
- Tracers for translational imaging
- SPECT for mice
- Large molecules: 125I, 123I, 111In, 99mTc
- Small molecules: 125I, 123I
- PET tracers for large animals
- Large molecules: 124I, 89Zr, 11C, 18F
- Small molecules: 124I, 11C, 18F
- Chemistry: organic and radiochemical to label any drug or tracer
- Regulatory support: current ANDAs, INDs, and DMFs; clinical trials
- Our cyclotron produces 11C,13N,18F, 124I, 89Zr
DATA ANALYSIS & INTERPRETATION
Our scientists provide analysis of preclinical imaging datasets in real time, allowing streamlined workflow with application-specific tools. Key features include:
- Powerful visualization of complex data and trends
- Manual, semi-automatic, or automatic tools to export return on investment values into spreadsheet formats
- Various threshold methods applied to individual, multi-modal, and dynamic datasets
- Batch processing with customizable analysis routines for fast, quantitative assessments
- Reliable quantification of distribution of radiopharmaceuticals, biologics, and small molecules in whole-body, organ, and sub-organ regions
- Multi-disciplinary integration of in vitro/ex vivo characterization and in vivo imaging for a better understanding of distribution, kinetics, and targeting
- Kinetic modeling
- Automated processes for organ segmentation
- Availability of brain atlases for rodents and large animals
ADDITIONAL IMAGING MODALITIES
- Dedicated cyclotron
- All major in vivo imaging modalities for large and small animal
- laser doppler
- Complementary assays
- in vivo imaging
- ex vivo biodistribution
- animal model development
- Quantitative autoradiography
- long- and short-lived radioisotopes
- two-dimensional, GLP-compliant
- Discovery neurological imaging
- Discovery dynamic PET imaging
- Discovery oncology in vivo imaging
- Discovery nuclear imaging services
- Discovery functional ultrasound imaging
- Discovery MRI in vivo imaging
- Discovery high content imaging
- Preclinical IND-enabling programs
- Preclinical DMPK/ADME studies
- Preclinical and clinical analysis
Answering Preclinical Imaging Fundamental
In drug development, a critical factor is how quickly a drug candidate will result in an effective clinical product. Our multidisciplinary scientists provide a true collaborative, translational research team to our clients. The ultimate goal is to enhance the decision-making process for clients based on evaluating three primary criteria – exposure at the target site, binding to the pharmacological target, and expression of the intended pharmacology.
Clients are then provided with an effective preclinical imaging solution that generates a translational dataset to facilitate clinical program development. When applied to early and mid-stage development, these imaging solutions answer key questions about drug candidates with just a handful of studies. Preclinical molecular imaging can provide multiple translation endpoints for product refinement for late-stage developers.
Frequently Asked Questions (FAQs) about Preclinical Imaging
What is preclinical molecular imaging?
Generally speaking, molecular imaging is commonly defined as the application of radiopharmaceutical production in combination with PET and/or SPECT preclinical imaging to assess a multitude of endpoints as part of in vivo study designs. Most commonly, an anatomical imaging platform, such as CT and/or MRI, are also used to allow co-register of the PET/SPECT data sets to facilitate spatial orientation of the PET/SPECT data relative to the imaged subject.
How will preclinical molecular imaging help my drug development project?
In vivo imaging solutions allows for longitudinal assessment of a single or multiple subjects across an extended duration to provide a vast number of endpoints. This allows for an efficient assessment of various aspects of the drug candidate and also reduces total number of subjects as compared to traditional preclinical approaches. This results in less time to reach critical path decisions in drug development and to also potentially reduce costs.
Is preclinical molecular imaging required by the FDA?
Preclinical imaging is generally not required by the FDA or other regulatory bodies, other than for specific drug candidates, such as those intended for use as a radiotherapeutic. These guidelines for exploratory IND studies explain the support of imaging solutions.
How does radiochemistry support preclinical imaging?
Advanced radiochemistry capabilities are critical to the provision of robust imaging capabilities, whether preclinical or clinical. It is essential for providers to have a wide variety of advanced techniques at their disposal to ensure the appropriate radioisotope and radiolabeling methods are applied to differing chemical entities matched to the overall intent of the study or program. Careful consideration of radiopharmaceutical solutions for individual projects and/or programs is key to program success and should include considerations for potential translation from preclinical applications to clinic where desired.