- Strategize Regulatory Positioning of Diagnostic with Therapeutic
- Close collaboration with agencies developing Companion Diagnostic guidance
- Evaluate and select best clinical protocol for shared Rx and Dx sampling information
- Coordinate clinical trials communication process with agencies
- Advocate and represent best interests of Rx development and Dx industry partners
- Drive successful joint meetings with Rx and Dx evaluation authorities
Joint submissions
- Analyze and guide Companion Diagnostic life-cycle, from Co-Development through clinical evaluation to joint submissions and post market coordination
- Lead agency / industry core team in Companion Diagnostic regulation development
- Work in close communication with industry associations to educate best practices
- Work in close communication with CDRH and CBER at FDA to enable interpretation of standards that apply to Companion Diagnostics
- Apply Personalized Medicine approach to Drug and Diagnostic development and submission
- Organize joint meetings and formulate presentations for agency review of Companion Diagnostics
- Educating Pharmaceutical and Diagnostic business partners on new subtleties of modern CDx processes
- Keep abreast and drive the latest industry best practices for Companion Diagnostics process
- Provide agencies with recommendations to achieve most transparent, safe and effective CDx regulations
- Serve as middle-man to educate Pharma and Diagnostics partners of latest regulations and interpretation for Companion Diagnostic products
