Drug Development & Regulatory

Services

Services provided by the drug development and regulatory group will vary according to the individual needs of the investigators. For example, services to help investigators could include:

  • Preclinical consultation
    • Develop an IND gap analysis and outline a plan to advance a compound to IND
  • Provide preclinical study support
    • Protocol design, and report writing
    • Evaluation of vendors and study monitoring
    • Assessment of qualification of excipients, impurities, extractables and leachables
    • Scientific and regulatory advice
  • Provide guidance for CMC activities
    • Drug substance and drug product manufacturing
    • Evaluation of manufacturers
    • Formulation development
    • Scientific and regulatory advice
  • Regulatory writing and consulting
    • Preparation of regulatory documents and FDA communications
    • FDA meeting support
    • Pre-Investigational New Drug Application (IND) briefing packages
    • IND preparation and submission
    • Investigator brochures
    • Clinical study support
    • Scientific and regulatory advice

Levels of Service

The focus and amount of services provided fall within three general service tiers:

Tier 1: Consultation and Initial Planning
2-10 hours

Tier 1 services are designed to make an initial determination of the need for drug development and regulatory support services, and the likelihood of success. One or more members of the drug development team will meet with interested investigators to discuss the project of interest, the clinical endpoints and review the supporting data currently available.

Another service available is support by the UNC Regulatory Specialist in the preparation and submission of the IND or IDE application (in most cases for publication driven research). The goal of Tier 1 services is to determine whether there is sufficient interest and potential to move a drug development program forward.

Tier 2: Strategic Planning and Development
10-40 hours

The goal of Tier 2 services is to provide more targeted support to potential projects for which there is a clear justification and success is potentially achievable (metrics for success will need to be defined). One or more drug development team members will work with interested investigators to develop a strategic plan, including a literature review if needed to define a plan for continued preclinical or clinical development and limited regulatory document writing or communications to FDA (i.e., pre-IND briefing package).

Services may also include consultation on GLP studies or drug substance/drug product manufacturing. The drug development group will help to support and assist in meetings among investigators and other stakeholders as needed to facilitate the advancement of the project. At the conclusion of Tier 2, investigators who wish Tier 3 support will need to prepare a business and research proposal.

Tier 3: Comprehensive regulatory support for advancement of a preclinical program into the clinic
> 40 - TBD

The goal of Tier 3 services is to provide extensive regulatory support including the submission of multiple documents to FDA, such pre-IND briefing package, orphan drug application and IND. Tier 3 services could also include guidance and monitoring of GLP studies and manufacturing of drug substance or drug product activities to support an IND submission and clinical studies.

A maximum of 1-2 Tier 3 projects will be supported in any given year. Movement to Tier 3 is usually contingent on approval from the Translational Sciences Advisory Board and/or support by the 4D Strategic Initiative.


Point of Contact: Diana Severynse-Stevens, PhD

Request help with Drug Development & Regulatory

View the Drug Development & Regulatory information brochure (pdf)

View the UNC-RTI Partnership information brochure (pdf)