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Cell & Gene Therapy Expert Teams

Knowledge, experience and rapid transitions

Cell & Gene Therapy Expert Teams

Achieve your next breakthrough with expert, experienced and committed teams

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Every cell therapy and gene therapy is unique and has different scientific and regulatory challenges. Our expert teams have a proven track-record in both product types that can support you at every step of the development journey. 

What the Expert Teams Do: 

  • Provide consultative insights to refine your strategies, study designs and execution
  • Apply best practices for your candidate selection, IND/IMPD-enabling programs (preclinical Proof of Concept), early and later-stage clinical strategy, operations and logistics
  • Support regulatory submissions, agency meetings and interactions
  • Seamlessly coordinate and identify efficiencies across the multiple disciplines needed to achieve your objectives
  • Leverage trouble-shooting and problem-solving know-how for more rapid issue resolution in your program

Areas of Expertise: 

Our Cell & Gene Therapy Expert Teams have executive-level oversight and subject matter expert team leads from the following functional areas:

  • Preclinical Pharmacology
  • Toxicology
  • Bioanalysis / Pharmacokinetics
  • Biomarkers, Central Labs, Genomics & Specialty Testing
  • Clinical Trial Strategy, Operations & Logistics
  • Global Regulatory Affairs
  • BioCMC Testing
  • Commercialization & Market Access

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