Radioligand Therapy & Theranostics

Radiopharmaceutical therapies represent an effective way to treat solid cancers by using tumor targeting small molecules, peptides or biologics to deliver a cytotoxic payload that induces DNA damage in tumor cells, while limiting damage to normal and healthy tissue.

Overview

Streamlined development, evaluation and clinical translation of radiopharmaceuticals requires a partner that has extensive scientific, regulatory and operational expertise. Working with a CRO that provides a complete solution ensures data is delivered in a timely manner to make a go/no-go decision on your imaging or
therapeutic candidates.

Services Include:

Single-site, first-in-human through multi-site, late phase clinical study support
Investigational New Drug (IND)/Clinical Trial Application (CTA) submission support with clinical protocol development
Preclinical and clinical dosimetry and advanced quantitative image analysis
Radiochemistry development – conjugation, radiolabeling, stability and immunoreactivity
Preclinical proof-of-concept studies – biodistribution, efficacy, toxicology
Good manufacturing practice (GMP) radiochemistry development and production support for imaging agents

Solutions

Clinical Radiopharmaceutical Therapy

Seamless transition of your radiopharmaceutical into the clinic requires an imaging partner with experience supporting first-in-human, single-site and late phase, multi-site global clinical studies. Perceptive has the unique blend of scientific expertise and operational experience to deliver on studies from Phase 0-III.

Clinical radiopharmaceutical therapeutic development services include:

First-in-human, single-site clinical trial support
Study design and consultation
Criteria-based centralized independent reviews and internal analysis
Late stage, global multi-center clinical trial support with response criteria reads
Advanced image analytics including dosimetry
Safety profile and therapeutic efficacy studies

Radiochemistry - Radioisotopes for Targeted Radiotherapy

Our team has experience with novel and commercially available radioisotopes used for targeted radiotherapy. Our capabilities for novel radiotracers span preclinical to first-in-human clinical studies and GMP production with Perceptive CMO partners.

Perceptive has experience with many isotopes including:

225Ac
177Lu
131I
111ln
68Ga/177Lu
111In/225Ac
203Pb/212Pb
67Cu/64Cu

Discovery_Radioligand-Therapy-Theranostics_Solutions

Dosimetry and Advanced Image Analytics

Our in-house image analytics team has experience supporting preclinical and clinical radiopharmaceutical therapy studies.

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Three-Dimensional Dosimetry for Radiation Safety Estimates from Intrathecal Administration

Our in-house image analytics team has experience supporting preclinical and clinical radiopharmaceutical therapy studies, spanning from customized and automated image processing techniques using deep learning to dosimetry analysis for safety profile analysis.

Some advanced image analytic techniques include:

Algorithms for automated and semi automated lesion identification
Image quality control and co-registration
Preclinical dosimetry safety studies and validated clinical workflows
Extrapolating dosimetry of therapeutics from imaging agents
Expertise across various species, radionuclides and novel administration routes

CTA

Preclinical Radiopharmaceutical Therapy Solutions

Bringing new therapeutic radiopharmaceuticals to the market is a complex and challenging process.

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Antibody Imaging and Radionuclide Therapy – Imaging radiotherapy distribution in tumor positive mice

When filing an Investigational New Drug (IND) or Clinical Trial Application (CTA) prior to the initiation of human trials, it is crucial to have strong non-clinical data to support a new candidate. Perceptive provides complete preclinical support of your project, including:

Study design and consultation
Radiolabeling/conjugation to support alpha, beta, and gamma emitting isotopes
in vitro/ex vivo cell and tissue-based assays
Primary pharmacology studies to demonstrate MOA
in vivo Imaging model development to support theranostic imaging
Advanced image analytics
Dosimetry
IND support
Development of chemistry, manufacturing and controls package for imaging agents

Learn more

Learn about Perceptive’s extensive imaging experience and capabilities in:

Oncology

Bringing new cancer therapies to the market is a complex and challenging process that requires a partner that can support you every step of the way.

Learn more

Central Nervous System (CNS)

Person pointing at musculoskeletal image scan on computer screen with a ballpoint pen

Bringing new cancer therapies to the market is a complex and challenging process that requires a partner that can support you every step of the way.

Learn more

Radioligand Therapy & Theranostics

Overview

Solutions

Clinical Radiopharmaceutical Therapy

Radiochemistry - Radioisotopes for Targeted Radiotherapy

Dosimetry and Advanced Image Analytics

Three-Dimensional Dosimetry for Radiation Safety Estimates from Intrathecal Administration

Preclinical Radiopharmaceutical Therapy Solutions

Antibody Imaging and Radionuclide Therapy – Imaging radiotherapy distribution in tumor positive mice

Learn about Perceptive’s extensive imaging experience and capabilities in:

Oncology

Central Nervous System (CNS)

Contact us for more information

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