Covance Gene Therapies

Gene Therapies

Gene therapies have already had a profound impact on patients’ lives and have the potential to impact many more, in particular those with rare genetic diseases. Whether you’re developing a viral vector-based therapy, such as an adeno-associated virus (AAV) or lentivirus (lenti) product, or applying gene editing technologies such as CRISPR/cas9, you’ll benefit from our Expert Teams’ deep knowledge and experience.

Assess safety, establish proof of concept and feasibility to support IND/IMPD/CTA submissions, and rapidly transition to first-in-human trials

Conduct Phase I, II, and III trials to support BLA/MAA submissions and preparation for post-marketing studies

Conduct real-world evidence studies, fulfill post-marketing commitments & ensure patient access to your gene therapy

Preclinical Solutions

  • In vitro & in vivo pharmacology & toxicology (acute & chronic)

  • Bioanalysis/PK: biodistribution, persistence & shedding

  • Biomarker strategy, assay development & testing

  • Regulatory & strategic product development consulting

  • Clinical development preparation & planning

  • BioCMC Testing– safety, identity, strength & purity

  • Commercialization Strategy Development

Clinical Trial Solutions

  • Patient identification & recruitment

  • Protocol modeling & development

  • Project & logistics management and oversight

  • Medical monitoring and specialized training for AEs

  • First in Human/dose range-finding/escalation studies

  • Proof of mechanism/proof of concept (PoM/PoC) trials

  • Lab testing: PK, Biomarkers, Central Labs, Genomics, Specialty Testing and BioCMC

  • Regulatory & strategic product development consulting

  • Long-term follow-up preparation and testing strategy development

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