Cell & Gene Therapy Expert Teams

Overview:

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 your development journey. 

• Designated Subject Matter Experts for gene therapies and cell therapies across scientific, regulatory and commercialization disciplines
• Dedicated experts in Rare Diseases, Pediatrics, Oncology and cellular immunotherapy
• Patient-centric approaches to improve study recruitment, incorporate the voice of the patient and apply cutting-edge decentralized clinical trial (DCT) models

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