Oncology

Overview

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. Invicro combines operational excellence with extensive scientific and medical expertise to support you with preclinical work through late phase clinical trials. Our consultative approach allows us to design, execute and deliver results that can be used to make critical decisions across all stages of the cancer drug development continuum. We have experience working with a wide-range of therapeutics, including small molecules, peptides, antibodies, multi-specific proteins, CAR-T cells and many more. Our comprehensive oncology biomarker services, include:

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Download Radiopharmaceutical Therapy Info Sheet

Invicro's Oncology Leaders

Kenneth Bloom, M.D., F.C.A.P.| CMO, Pathology and Genomic Services

Dr. Bloom serves as the Chief Medical Officer for Advanced Pathology and Genomic Services at Invicro and Ambry Genetics, both Konica Minolta Precision Medicine companies. Dr. Bloom brings more than 30 years of clinical and business experience in pathology, oncology, telemedicine and bioinformatics. His role is to expand, strengthen and commercialize the full-suite of precision medicine capabilities offered within the pathology and genomics markets for Invicro and Ambry Genetics.

Jacob Hesterman, Ph.D. | CTO and Founding Partner

Dr. Hesterman has over 10 years of experience in instrumentation development, image processing, and quantification. As CTO, Dr. Hesterman manages a large technical team of engineers, scientists, and mathematicians, comprising Invicro’s software and analytics teams. He has overseen the development of Invicro’s image processing platform supporting translational and clinical analysis in PET, MR, CT and histology across multiple disease areas. Dr. Hesterman also oversees Invicro’s software platform, including the iPACS® data management and VivoQuant™ image processing applications.

Phillip Kuo, M.D., Ph.D. | Senior Medical Director, Scientific and Medical Services

Dr. Kuo is board-certified in Internal Medicine and Radiology with a special certification in Nuclear Medicine. Prior to taking on the role of Senior Medical Director for Invicro, he was Chief of Nuclear Medicine at a university medical center for 10 years. Dr. Kuo has more than 100 publications and has served as principal investigator and co-principal investigator on multiple NIH grants and investigator-initiated trials. His experience includes design and supervision of phase I-III clinical trials including theranostics with PET, SPECT, MRI, and radiotherapeutics. Dr. Kuo’s experience also includes participation in USFDA and EMA meetings for regulatory approval. As a reader for clinical trials, he has reviewed over ten thousand scans for oncology or neurology.

Gisela Montgomery, M.D., Ph.D. | Medical Director, Scientific and Medical Services

Dr. Montgomery has seven years of national and international experience in phase I-IV breast cancer clinical imaging trials, and has published several scientific peer-reviewed manuscripts in journals, such as Radiology and European Radiology, as first author. She has expertise in protocol design, statistical analysis, imaging evaluation, oncology response criteria, regulatory affairs, artificial intelligence and business development.

Radiopharmaceutical Therapy/Theranostics

Overview

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.

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:

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

Watch Theranostics Panel Discussion
Download Radiopharmaceutical Therapy Info Sheet

Imaging/Theranostic Agent Development Process

Capabilities

Radiochemistry

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 Invicro’s CMO partners. Invicro has experience working with the following isotopes:

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

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Preclinical Solutions

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

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Download Radiopharmaceutical Therapy Info Sheet

Early/Late Phase Clinical

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. Invicro has the unique blend of scientific expertise and operational experience to deliver on studies from Phase 0-IV. Clinical radiopharmaceutcal 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

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Dosimetry and Advanced Analytics

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

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Discovery and Preclinical Capabilities

Invicro’s discovery and preclinical services team provides study design, study execution and data analysis services for a broad-range of solid and non-solid tumor studies. Our preclinical oncology team uses state-of-the-art imaging techniques to characterize the behavior of novel therapies, including antibodies, radioligand therapies, peptides, cell therapies (e.g., CAR-T), exosomes and other tumor-targeting modalities in diverse tumor model types (e.g., subcutaneous, orthotopic, metastatic). Non-clinical work supported by Invicro can be used to move into first-in-human studies to late-stage clinical multicenter trials. Our core capabilities include the measurement of multiple readouts, including:

Biodistribution of test articles
Target density/engagement
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Tumor growth properties
Therapeutic efficacy
Dosimetry

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Clinical Capabilities

Invicro’s clinical team has expertise in medical imaging and a vast range of tools to support your cancer drug discovery and development needs. With over 200 scientists and 3,500+ qualified imaging centers and clinical sites across the globe, Invicro has the advanced scientific, medical and regulatory expertise and project management scale to deliver studies from Phase 0-IV. Our technology platforms support key decision-making in:

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

Our imaging core lab offers criteria-driven reads for standard-of-care projects and our state-of-the-art in-house software enables 3D region-of-interest generation to support quantitative analysis methods, such as PERCIST. We also partner with subspecialist independent readers that focus on specific areas of expertise. Some of the validated criteria examples include:

RECIST 1.0/1.1
PCWG 2.0/3.0
RANO
LUGANO
IMWG
CHESON
iRECIST
irRECIST
LYRIC
irRC

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Quantitative Oncology Image Analytics

Invicro’s medical image analysis team supports standard analysis of FDG PET imaging, including PERCIST and other SUV-based metrics, metabolic tumor volume and total lesion glycolysis. The image analysis team also specializes in developing and applying a broad range of tools to support advanced quantitative oncology tracer characterization and analytics across a broad range of modalities and studies. Some examples include:

Powerful, multi-modal tumor and organ Segmentation tools
A range of flexible Biomathematical Modeling tools
Dosimetry calculations across radionuclide, administration route, and species
Integrated Radiomics pipelines using standard and custom feature vectors
Preclinical and clinical support for Tracer Characterization
Sophisticated batch Image Triage and preprocessing methods

For more information, check out some of our most popular case studies. A full list is also available in our case studies section.

Dosimetry Analysis

Radiomics

Biodistribution

Multi-Modality – Oncology

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Radiochemistry

Invicro’s radiochemistry team has experience with most commercially available radioisotopes used for PET/SPECT imaging and several used in targeted radiotherapy. Our capabilities span from first-in-human clinical studies to GMP implementation of novel radiotracers, including:

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Advanced Pathology Services

Invicro provides comprehensive pathology services to support all phases of oncology and immuno-oncology drug development applications. Our multidisciplinary team of scientific and medical experts provide a unique approach by leveraging cutting-edge and proprietary molecular pathology detection and analysis technologies. From experimental design to developing and validating biomarker assays, we deliver actionable insights in both a research and CAP-CLIA environment. Our capabilities include: