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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.
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: 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.
Access unparalleled solutions across the entire cell and gene therapy development continuum– right from the start
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
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.
Covance by Labcorp is a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries.
COVANCE is a registered trademark and the marketing name for Covance Inc. and its subsidiaries around the world.