A team dedicated to advancing cancer treatment

BioPharma Services

Paradigm’s BioPharma Services team has a successful history of partnering with pharmaceutical, biotech, and research institutions to provide state-of-the-art comprehensive analyses of DNA, mRNA, and miRNA.

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Biopharma Services

What we offer

Paradigm offers the latest molecular techniques, high-throughput sequencing, and translational biobanking expertise. This is combined with deep knowledge of the oncology market and successfully introducing molecular testing into patient care to assist clinical trials for our pharmaceutical, hospital, and research partners and to better individualize therapy and advance patient care.

Paradigm’s BioPharma Services team has a successful history of partnering with pharmaceutical, biotech, and research institutions to provide state-of- the-art comprehensive analyses of DNA, mRNA, and miRNA (collaborators). Our logistics team has core competencies in high throughput complex projects for advanced clinical trials and research studies.

Core BioPharma Services

 

Core services include:

  • Personalized Clinical Trial Assays
  • Molecular Services
  • Biorepository consultation
  • Biostorage facility
  • Nucleic Acid Isolation
  • Laser capture enrichment
  • Biospecimen collection, storage,
    processing, and analysis
  • PCDx Cancer Diagnostic Translational
    Collaboration: Clinical Trial Enrichment
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Personalized Clinical Trial Assays

Paradigm will work with your team to develop and provide custom biomarker analysis for specific targeted or non-targeted therapies.  We will utilize our expertise in next-generation sequencing (NGS), IHC and other methods to help enrich patient populations for your clinical trials.  The analysis will be specifically developed and validated for each therapeutic agent.

 
 

PCDx Cancer Diagnostic Translational Collaboration: Clinical Trial Enrichment

Driving increased enrollment when the % of patients harboring a specific genomic alteration is small presents significant challenges for today’s targeted clinical trials. Paradigm collaborates with both industry and research partners at a national level to assist in identifying the right patients with key genomic abnormalities for your studies.

 
 

Molecular Services

  • Next-generation sequencing: Next-Generation Sequencing for DNA, mRNA expression, DNA CNV, chromosomal deletions, translocations, inversions. Paradigm routinely provides profiling for industry and academic researchers to help provide a molecular context to their clinical trial data.
  • Immunohistochemistry (IHC): The Paradigm team has extensive experience with both standard and new immunohistochemistry lab technologies with deep expertise in developing and validating new assays. All work is performed in a CLIA/CAP facility with quick turnaround and to the highest standards of quality. Digital imaging is available in addition to automated and semi-automated protocols.
 
 

Biorepository consultation

Paradigm, in collaboration with the International Genomics Consortium, offers over 100 years of combined expertise and resources to assist industry, researchers, and academic medical centers to:

  • Optimally procure specimens
  • Preserve targets
  • Strategize on the best detection methods to maximize outcome
  • Assist in providing leading genomic and proteomic analysis to complement and maximize clinical findings.
 
 

Biospecimen collection, storage, processing, and analysis

Our CAP/CLIA certified laboratory offers full-service biospecimen management to support prospective clinical trials and translational research projects. We offer one-stop shopping for biospecimen procurement and quality control, storage, tracking, molecular analyte extraction, interpretation, protocol design/ validation, regulatory compliance, re-distribution, and executive style reporting.

 
 

Biostorage facility

Long and short-term storage and tracking of DNA, RNA, tissue, blood, FFPE tissue blocks, plasma, serum, saliva, and buccal cells available in our CAP-certified biorepository.

 
 

Nucleic Acid Isolation

Extensive experience with numerous protocols for high quality extraction of DNA and RNA.  These methods were validated by top national projects from many tissue types and sample conditions, including frozen and FFPE tissue. Fully and semi-automated protocols available.

 
 

Laser capture enrichment

Laser Capture Enrichment (LCE) isolates specific microscopic subpopulations of normal, reactive and tumor cells in frozen and formalin-fixed tissues (FFPE). LCE offers a unique proprietary high throughput process utilizing robotic automation, a web-based interface, and a network of pathologists. Third-party academic reviews of molecular quality for TCGA determined that the Next-Gen sequencing results from LCE-dissected specimens were indistinguishable from non-LCE fresh- frozen specimens for both messenger RNA and miRNA.

Contact us to learn more about how we can help your organization

 

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