Cell Therapies

Cell Therapies

Cell therapy products have the potential to treat 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 optimize availability to your cell 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

New cell and gene therapy suite

A macro investment in micro science

Cell and gene therapies are incredibly intricate, but they’re making a huge difference in the drug development market and in the lives of patients. Learn all about our $9.2 million investment in cell and gene therapy.

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