Leveraging extensive regulatory knowledge to develop the most effective biomarker development strategies

What We Do:

Flagship’s regulatory team drives biomarker development strategies at all stages of the approval process. We establish a development partnership with your team from early discovery through commercialization. Our deep understanding of the regulatory standards and pathways ensures concise, stepwise regulatory development in a timely and cost-efficient manner. The Flagship team will seamlessly integrate with your development plans to serve as a partner throughout the entire process.

We also have a successful track record working directly with the Food and Drug Administration (FDA) to ensure your therapeutic success.

What You Get:

Flagship will develop a strategic roadmap for the development of your required biomarker assay toward CDx. As a first step, Flagship will perform a preliminary gap analysis on any prior data or documentation in the context of requirements as set by applicable FDA regulations for companion diagnostic (CDx) development.

The details of this roadmap will be determined with greater level of granularity upon completion of the gap analysis and may include, but are not limited to:

  • Assay development timelines
  • Plan for completion of prospective and retrospective biomarker studies/analyses
  • Development of laboratory developed test (LDT) assay
  • Establishment of cutoff points, degree of variability, factors impacting tissue sample collection, processing, and handling
  • Analytical validation study designs according to the applicable regulatory requirements (e.g. Clinical Laboratory Improvement Amendments – CLIA), including development of acceptance criteria
  • Type of distribution needed
  • Regulatory communications: type of regulatory communications/interface with FDA or FDA/European Medicines Agency (EMA) as applicable, and timelines of regulatory response
  • Preparing regulatory submissions for each regulatory communication, in the FDA required electronic format and publishing
  • Value assessment of the biomarker assay: clinical, laboratory, and payer perceptions of the potential CDx or other suitable type of test
  • Development of an overall development decision tree/outcome flow chart

Our comprehensive multi-dimensional drug development expertise includes:

  • Biomarker development strategy and regulatory pathways
  • CDx planning and regulatory development
  • Data review and analysis
  • Regulatory meetings and interface with FDA
  • Commercialization support
  • Regulatory submissions and maintenance:
    • Pre-submission background information packages
    • Pre-Investigational Device Exemption (IDE) and IDE filings
    • Pre-Investigational New Drug (IND) submissions and materials
    • Preparation of IND files

Our Process