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Experience across the entire process of gene therapy development

Leadership from the lab, to trials and through successful production Contact us

Why talk to Precision about your gene therapy project? Perhaps because we are purpose-built to solve the complex challenges posed by precision medicines like gene therapies. We’ve partnered with leading biotech and pharma companies to develop FDA and EMA approved treatments. Our services span from comprehensive biomarker assay suites to CRO services to leading the build and expansion of over 60 gene and cell therapy facilities. 

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Purpose-built to deliver on the promise of gene therapy

Gene therapy development has a wide range of challenges that include a dynamic regulatory environment, pre-existing and treatment-induced immunity to the viral vectors, intricate manufacturing processes, locating and recruiting patients.

Precision’s transformational approach to preclinical development, clinical trials and manufacturing ensures that your project has the comprehensive services and expertise needed to create solutions for every gene therapy development challenge, from IND-enabling assays to commercialization.

10 cell, gene and novel therapies industrialized
12 sample processing locations worldwide
50 rare disease clinical trials and trials for 100+ orphan projects
350 IVD and CDx global regulatory submissions and registrations

Solving complex challenges in gene therapy development

Proven expertise in gene therapy along with integrated development capabilities helps compress timelines and find efficiencies in every stage. Precision accelerates gene therapy development from the late pre-clinical phase through commercialization.

  • Explore

    Specialty Lab Services

    • NAb and TAb assays 
    • Immunogenicity testing e.g. ELISpot and Fluorospot
    • Viral capsid and transgene expression assays
    • Distribution and persistence assays
    • Central laboratory testing services for global trials
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    clinical-laboratory-support

    Clinical Trial Design

    • Full service CRO for global trials
    • Patient recruitment and enrollment: specialization in rare disease
    • Expertise with current regulatory environment
    • Operational excellence in cell therapy study conduct
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    regulatory-solutions

    Regulatory Consulting

    • Well versed in EMA and FDA regulatory requirements 
    • Access to FDA officials to review proposed approaches
    • Able to advise on the latest safety, efficacy and quality standards
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    sample-processing

    PBMC Processing Services & Clinical Sample Processing

    • Clinical sample kit development
    • PBMC processing at 11 labs in five continents
    • Global sample logistics, shipping and biostorage
    • Real-time sample data analytics
    • virtual Sample Inventory Management (vSIM)
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    commercialization

    CDx / LDT Development

    • Co-development timelines of treatment and CDx
    • TAb and NAb companion diagnostic development
    • Extensive experience with multiple AAV serotypes
    • Access, reimbursement, and channel analysis and strategy

     

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Delivering evidence at every critical inflection point

With leadership in immunogenicity, a regulatory team that coordinates therapeutic and companion diagnostic strategy, and a focus on executing end-to-end clinical trials in oncology and rare disease, Precision is guiding successful gene therapy development for life sciences innovators.

  • IND-Enabling

    IND-Enabling

    Safety :

    • AAV Tab/NAb assays primates
    • PK transgene assays
    • ELISpot - T cell response assays
    • Tissue Distribution assays

  • Clinical Proof

    Clinical Proof

    Safety :

    • TAb/NAb assays

    Efficacity: 

    • Comprehensive PK/PD assays
    • DFA Diagnostic presubmission
    • Protocol design
    • End-to-end trial execution
    • Branded recruitment campaigns


    Value :

    • Burden of illness studies
    • Indirect treatment comparisons
    • Scientist platform

  • Pivotal

    Pivotal

    Safety :

    • NAb assays - patient recruitment
    • Module PMA submissions
    • Complete LDT analytical studies
    • Diagnostic market access strategy

    Efficacity: 

    • Pivotal Trial Execution

    Value :

    • Endpoint design
    • Pricing and access strategy
    • Brand positioning 

  • Commercial

    Commercial

    Safety :

    • NAb companion diagnostic

    Efficacity: 

    • Postmarket trial

    Value :

    • Brand marketing
    • Budget impact

Optimizing Successful Gene Therapy Development

Optimizing successful development of viral vector gene therapies, gene therapy trials and companion diagnostics

Download The White Paper

Top leadership ratings for a CRO in the ISR Report 2024

  • CRO Awards Leadership2024Compatability
  • CRO Awards Leadership2024Capabilities
  • CRO Awards Leadership2024Reliability
  • CRO Awards Leadership2024Quality
  • CRO Awards Leadership2024Expertise

Our latest insights on gene therapy development

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Read: Key Strategies for Future-Proofing Gene Therapy Assay Validations Key Strategies for Future-Proofing Gene Therapy Assay Validations

Translational Research - Regulatory - Assays - Gene Therapies

Key Strategies for Future-Proofing Gene Therapy Assay Validations

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  • Deborah P. avatar

    Deborah P.
  • Travis H. avatar

    Travis H.
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Read: Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

Translational Research - Regulatory - Assays - Gene Therapies

Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1744844126301, description=Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Deb%20Phippard.webp',altText='Deb Phippard',fileId=165892372605}, linkedin=https://www.linkedin.com/in/deb-phippard-103b54, team=[{id=163072475007, name='Precision for Medicine Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716212769184, hs_created_at=1709645745106, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job= Chief Scientific Officer, slug=deborah-phippard, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778840, hs_child_table_id=0, hs_updated_at=1716132440837, hs_published_at=1744844126301, description=Maham Ansari, MS, RAC is a Senior Director, IVD Regulatory Affairs. Her focus is on companion diagnostic co-development programs, where she leverages her regulatory expertise to secure approvals in the US, Europe and beyond for companion diagnostics with a specific focus on gene therapy. She brings more than 16 years of global regulatory leadership experience in the medical device and in vitro diagnostics industry, spanning major multinationals to small start-ups, including full life cycle management across all stages of product development, execution of global regulatory strategies, and post-market surveillance.sh, avatar=Image{width=710,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Maham_Ansari.png',altText='Maham_Ansari',fileId=167373022876}, linkedin=https://www.linkedin.com/in/maham-ansari-ms-rac-6a735739, hs_name=, hs_path=, lastname=Ansari, hs_initial_published_at=1716212769184, hs_created_at=1709645745071, hs_is_edited=false, hs_deleted_at=0, name=Maham, job=, slug=maham-ansari, email=, hs_updated_by_user_id=51739740}, third={}})
  • Deborah P. avatar

    Deborah P.
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    Maham A.
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Read: Therapeutic Genome Editing – Reshaping the Landscape of Advanced Therapies Therapeutic Genome Editing

Regulatory - Gene Therapies

Therapeutic Genome Editing – Reshaping the Landscape of Advanced Therapies

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=169567234066, hs_child_table_id=0, hs_updated_at=1723217613021, hs_published_at=1744844126301, description=Precision Experts are among the most experienced specialists in clinical research. We focus our hiring strategy on select indications to deliver excellence across each role. , avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Precision%20Expert.png',altText='Precision Expert',fileId=164175466823}, lastname=Experts, hs_initial_published_at=1718988967067, hs_created_by_user_id=26433386, hs_created_at=1717603871601, hs_is_edited=false, hs_deleted_at=0, name=Precision, slug=precision-experts, hs_updated_by_user_id=51739740}, second={}, third={}})
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    Precision Experts
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