Covance Cell & Gene Therapy Solutions

Covance Cell & Gene Therapy Solutions

Reduce the time and risk in developing your cell or gene therapy– no matter what stage you’re at.

Deep expertise and experience in both cell and gene therapies, supported by expert teams

Full suite of coordinated and flexible solutions supporting rapid transitions within and between phases of development

Patient centric approaches for an enhanced patient experience and improved clinical trial outcomes


Cell & Gene Therapy Thought Leadership

Cell and Gene Therapy Leadership Announcement

Labcorp is pleased to announce the appointment of Maryland Franklin, PhD, as Vice President and Enterprise Head of Cell & Gene Therapy (CGT) for Labcorp’s Drug Development business unit, Covance.

Cell and Gene Therapy: Overview, Current Landscape and Future Trends

This white paper provides an engaging background on cell and gene therapies, a look into recent therapeutic applications and future trends in the cell and gene therapy technology space.

Medical Monitoring Approaches in CAR T Clinical Trials During COVID-19 Pandemic and Beyond

This webinar explains the steps involved in Medical Monitoring of CAR T therapy and explores additional considerations during COVID 19.

Potency assays for ATMPs: overcoming challenges on the path to commercialization

Potency evaluation, achieved through potency assays, is essential to transition an advanced therapy medicinal product or ATMP (also known as cell and gene therapy) through pivotal clinical stages to final market authorization. However, potency is a difficult parameter to assess for ATMPs, so it is important to start developing these assays early to minimize possible delays in ATMP commercialization. This blog provides insights into how and when to develop potency assays to help overcome regulatory and manufacturing barriers in ATMP commercialization.

Cell and Gene Therapies - How Prepared is Europe?

Cell and gene therapies promise a potentially life-long cure for many rare diseases and cancers. However, despite centralized regulatory approval, high costs and long-term clinical uncertainty have resulted in variable patient access across Europe. This white paper seeks to assess how prepared Europe markets are for cell and gene therapies and compare the 'preparedness' of these markets via a scoring system that considers key indicators and categorizes them into three equally weighted components: Budget and infrastructure, finance, reimbursement and implementation and HTA and pricing processes.

photo of a scientist

Access unparalleled solutions across the entire cell and gene therapy development continuum– right from the start

Let’s Get Started

Gene therapies continue to hold promise as treatments for many diseases but there are numerous and unique challenges to developing them for submission as an Investigational New Drug (IND)/ Investigational Medicinal Product Dossier (IMPD) application for use in clinical trials. These applications require an optimized scientific program designed to address the scientific, regulatory and practical challenges of gene therapy development.

Preclinical solutions:

  • Assess safety, establish proof of concept and feasibility rapidly

  • Successfully prepare for regulatory agency meetings and IND/IMPD/CTA submissions

  • Seamlessly transition to first-in-human trials 

Clinical trial solutions:

  • Identify, recruit and retain clinical trial participants using data-enabled solutions

  • Design and conduct patient-centric clinical trials 

  • Prepare and file for BLA/MAA and other submissions 

Today’s clinical trials have become more complex and expensive, pressuring pharmaceutical companies to further improve their clinical trial operations. Clinical trial data management is one area where both sponsors and contract research organizations (CROs) can uncover new efficiencies, increase cost-saving measures and better meet diverse operational reporting needs across the clinical development cycle.
The lasting image of the initial health exchange roll out is that of persistent technical problems that plagued the federal government’s insurance exchange website Healthcare.gov

Post-approval solutions:

  • Conduct long term follow up studies, Phase IV trials, and fulfill post-marketing commitments

  • Test for CMC lot release and stability of manufactured product

  • Support patient access to your new therapies

By the Numbers

Supported development of 5 most recent FDA approved cell & gene therapies
20+ years of delivering development solutions for advanced therapies
300+ preclinical studies conducted using cell and gene products in the last 4-years (mostly in vivo)
90+ clinical trials conducted for cell & gene products in the last 5 years

Cell & Gene Therapy Info Sheets

Cell & Gene Therapy Enterprise Solutions

Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.

Cell & Gene Therapy Preclinical Development Solutions

Cell & Gene Therapy preclinical development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.

Cell & Gene Therapy Clinical Development Solutions

Cell & Gene Therapy clinical development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.

Cell & Gene Therapy Post-Approval Solutions

Cell & Gene Therapy post-approval solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.

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