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Precision for Medicine  |  Precision Value & Health

 * About
   * Our Story
   * Leadership Team
   * Partner With Us
     * For Principle Investigators
     * Donor Information
     * For Reference Labs
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     * Overview
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 * About
   * Our Story
   * Leadership Team
   * Partner With Us
     * For Principle Investigators
     * Donor Information
     * For Reference Labs
   * Thought Leadership
   * Quality Assurance
   * Precision Value & Health
   * Precision for Medicine
 * COVID-19
 * Biospecimens
   * Overview
   * Viable Cells
     * Overview
     * PBMCs
     * BMMCs
     * Leukopaks
     * Purified Cell Subsets
     * DTCs
   * Tissues
     * Overview
     * FFPE Tissue
     * Fresh & Frozen Tissue
     * Tissue Microarrays
     * DTCs
   * Blood, Biofluids, and Derivatives
   * Remnant Diagnostic Specimens
   * Liquid Biopsy
   * Custom Biospecimen Collections
 * Solutions & Services
   * Overview
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   * Study Specimen Collection Kits
   * Custom Biospecimen Collections
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   * Precision for Medicine Links
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 * Contact Us
 * Log In





BIOBANK PARTNERING FOR CLINICAL TRIAL ASSAY/CDX DEVELOPMENT AND HIGH-THROUGHPUT
IHC & NGS SCREENING

ROBERT SNYDER, PHD

Associate Director, Genomics, Precision for Medicine



For clinical trial assay or companion diagnostic (CDx) development, the journey
from bench to bedside requires access to specialized lab services and
high-quality, fit-for-purpose biospecimens accompanied by a strategic pathway
for regulatory approval.

On March 7, 2023, Robert Snyder, PhD, Associate Director of Genomics at
Precision for Medicine, delivered a presentation entitled, Biobank Partnering
for Clinical Trial Assay / CDx Development and High-throughput IHC & NGS
Screening, at the 30th International Molecular Med Tri-Con Conference & Expo. As
an end-to-end provider of biospecimens, specialty labs, and regulatory
consulting services, Precision for Medicine has been supporting the development
of advanced diagnostics and therapeutics for more than a decade.

In his talk, Dr. Snyder discussed how Precision for Medicine's team of
experienced lab services and biospecimen solutions providers helps to simplify
and streamline the development of clinical trial assays and CDx.




TAKING A PLATFORM-AGNOSTIC APPROACH

Precision for Medicine has focused on creating an infrastructure that enables
researchers to develop whatever they need on platforms best suited to their
goals. To that end, Precision for Medicine has adopted a platform-agnostic
approach to assay development that allows the scientific objective and intended
application of the assay to guide platform selection. In addition, our specialty
lab and biomarker assay services team has expertise across all sample types,
from nucleic acids and proteins to cells and tissues.

For immunohistochemistry (IHC)-based assays, researchers can select among the
top staining platforms—Roche/Ventana, Dako, and Leica—and can access a full
range of biomarker analysis services, from assay and scoring system development
to custom kitting, sample processing, and centralized pathology reading. To
highlight Precision for Medicine’s experience in IHC-based assays, Snyder
reviewed a case study involving the design, development, and validation of a
custom p-cadherin IHC assay and scoring system to be used for patient selection
in a global Phase 1 oncology study.

Figure 1. Precision for Medicine comprehensive IHC biomarker analysis services

For high-throughput next-generation sequencing (NGS)–based assays, researchers
have access to the Illumina NovaSeq and NextSeq platforms and the ThermoFisher
Genexus system, and Precision for Medicine can onboard other systems as needed.
Beyond IHC and NGS, Precision for Medicine also offers proprietary technologies
such as Epiontis ID® for epigenetic immunophenotyping and ApoStream® for
isolation of circulating tumor cells (CTCs) and other rare cells.


USING AN EXISTING BIOBANK TO ADVANCE CDX DEVELOPMENT

Precision for Medicine has over 3 million formalin-fixed, paraffin-embedded
(FFPE) samples and several million histology slides covering a full spectrum of
oncologic and other diseases. In late 2020, Precision for Medicine launched an
ambitious program to prospectively sequence many of the stored tissue blocks to
identify those with mutations of particular interest for targeted drug
development. Through a single partnership, more than 10,000 FFPE samples were
characterized across 11 oncology indications using a targeted 50-gene panel that
screens for single nucleotide variants (SNVs), indels, fusions, and
amplifications. As part of an even larger initiative, 800 FFPE samples are being
sequenced per month using a broad, 500+ gene panel for tumor mutational burden
(TMB), microsatellite instability (MSI), SNVs, indels, copy number variations
(CNVs), fusions, and splice variants for verification, validation, and
generation of orthogonal data for regulatory submissions.


FOR RESEARCHERS, HAVING ACCESS TO SPECIMENS ACCOMPANIED BY AN EASILY SEARCHABLE
DATABASE OF NGS-CHARACTERIZATION AND ASSOCIATED VARIANTS AVAILABLE FOR PURCHASE
SIMPLIFIES ASSAY DEVELOPMENT.

Moreover, partnering with a third-party lab services provider for external
validation helps accelerate the development and regulatory submission process.


ACCELERATING THE PATH FROM BENCH TO BEDSIDE

Deeply annotated samples are critical for clinical trial assay and CDx
development. The strategic approach to assay development differs depending on
how the assay will be applied, whether it is to obtain CLIA validation, support
a clinical trial, or submit for companion diagnostic approval. However,
regardless of application, the development process can be made easier with
access to pre-characterized samples, pathology expertise, NGS services, and
regulatory support.



Figure 2. Precision for Medicine accelerates assay commercialization from bench
to bedside

Precision for Medicine works with a global network of partner hospitals across
more than 55 countries for prospective patient sample collections, all under
IRB-approved protocols with end-to-end chain of custody. We also offer central
and specialty lab services, regulatory guidance, and an integrated data platform
called QuartzBio®, which enables virtual sample inventory management for
real-time tracking of samples across sites, labs, and repositories. With our
expertise in assay development, validation, regulatory submissions, and
commercialization, Precision for Medicine can help developers map out the best
path from bench to bedside.

To learn more about how Precision for Medicine accelerates clinical trial assay
and CDx development, contact us.

To learn more about Precision for Medicine’s biospecimens, visit
www.PrecisionBiospecimens.com


ABOUT THE AUTHOR

Dr. Snyder is a chemical and biomedical engineer with 20 years of genomics
experience. His career in this space began at the Institute for Genomic Research
shortly after the completion of the Human Genome Project. His path to Associate
Director at Precision for Medicine included working in NGS oncology assay
development with a focus on regulatory submission study design for verification
and validation.


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ACCELERATING THE PACE OF SCIENTIFIC DISCOVERY AND APPROVAL



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BIOSPECIMENS

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SOLUTIONS & SERVICES

 * Overview
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 * Study Specimen Collection Kits
 * Clinical Trials
 * Data Sciences
 * Regulatory Strategy
 * Commercial Consulting
 * Custom Biospecimen Collections


ABOUT

 * Our Story
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 * For Principle Investigators
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 * For Reference Labs
 * Thought Leadership
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 * Precision Value & Health
 * Precision for Medicine


SAY HELLO

Contact us today to discuss your biospecimen requirements

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Precision for Medicine is part of the Precision Medicine Group. Learn more at
Precision Medicine Group.

Copyright © 2023 Precision For Medicine, Inc. All Rights Reserved.

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CLINICAL TRIALS

End-to-end CRO services for your biomarker-driven clinical trials.

Learn More:

 * Clinical trial feasibility, design and management
 * Specimen Biostorage
 * Virtual sample inventory management
 * Study Specimen Collection Kits

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DATA SCIENCES

Data aggregation, harmonization, and analysis for your biomarker program
leveraging our proprietary QuartzBio platform and team.

Learn More:

 * Translational Informatics and Computational Biology
 * Biostatistics
 * Clinical Data Management
 * Biometrics

Contact Us


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REGULATORY STRATEGY

Our specialists can support you through regulatory strategy and submissions for
CDx, IVD and therapeutics.

 * Regulatory pathway & strategy
 * Global Submissions including US (510(k), De Novo, PMA), EU (CE Mark to IVDD
   and IVDR), Japan (PMDA), Health Canada, and more, applied to traditional
   diagnostics, LDTs, or CDx.
 * Pre-submission package development
 * Quality Systems Implementation and Oversight

Learn More


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COMMERCIAL CONSULTING

Our team of experienced market access and reimbursement strategists can help you
develop and execute on your go-to-market strategy.

 * Market Access & reimbursement
 * Coding & payment
 * Demonstrating utility

Learn More


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LAB SERVICES

Precision for Medicine has a global footprint of CLIA, CAP specialty labs
available to generate robust biomarker data for your research projects.

Learn More:

 * Immune Monitoring
 * Flow Cytometry
 * Genomics
 * Tissue and Liquid Biopsy
 * Bioanalytical Testing
 * Cytokine Analysis
 * Sample Processing

Contact Us


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BIOREPOSITORY

Precision for Medicine’s CAP-certified, biorepository provides specimen
processing, storage, management, logistics, and distribution of your critical
research specimens.

Learn More:

 * BioStorage
 * Biospecimens

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AL BLUNT, MD

Senior Vice President, Medical

Noted authority in the drug development industry. Sought-after strategist
providing guidance for and oversight of the design, conduct, and analysis of
oncology trials, and hands-on leadership for Precision’s team of oncology
medical monitors. Expertise honed in clinical trials from phase 1-3 for a wide
variety of anticancer drug classes and cancer types.

 

 

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