Covance Cell Therapies

Cell Therapies

Cell therapies have had a significant impact on patients’ lives and have the potential to improve the lives of many more, in particular those with a variety of cancers and other diseases. Whether you’re developing an allogeneic or autologous product, an adoptive cell therapy (such as CAR T, NK or DC) or a stem cell-derived product, 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 prepare for post-marketing approval studies

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

Preclinical Solutions

  • In vitro & in vivo pharmacology & toxicology

  • Bioanalysis/PK: infiltration/engraftment, persistence  & shedding

  • Biomarkers: strategy, assay development & testing

  • Regulatory & strategic product development consulting

  • Clinical development preparation & planning

  • BioCMC testing & analytical control strategy– safety, identity, strength & purity

  • Commercialization strategy

Clinical Trial Solutions

  • Patient identification & recruitment

  • Protocol modeling & development

  • Project & logistics management 

  • 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 strategies

Post-Approval Solutions

  • Real-world evidence studies

  • PIV and pharmacovigilance

  • Long-term follow-up studies (up to 15 years)

  • Differentiation studies

  • Combination Studies

  • Lab testing

  • Disease and product registries

  • Health economics 

  • Field reimbursement

  • Clinical education

  • Payer and customer relations

The pharmaceutical, medical device and diagnostics industries are very interested in the changing market access landscape in South and East Asia because of the vast commercial potential of this area.

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