Immunotherapy Program

In This Section

Regulatory Affairs Division

The primary role of the Regulatory Affairs & Quality Assurance Division (RAQAD) of the Cancer Immunotherapy Program is to oversee that development and manufacture of investigational new drug (IND) products meet USFDA Code of Federal Regulations to ensure the safety of clinical trial patients. Prior to FDA release of an IND-product for phase I clinical testing, the IND sponsor must present traceable and documented evidence in an IND application showing that the product is safe and effective in preclinical testing. Therefore, at the initiation of the preclinical development phase of an investigational drug, the RAQAD must develop regulatory strategies to provide quality assurance that procedures and operations performed by the Quality Control and Manufacturing Divisions, as well as by the Principle Investigator (PI), meet the requirements of federal regulations.

Such strategies are directed to assuring adherence to Good Laboratory Practices (GLP) in chemistry and Quality Control procedures as well as adherence to Good Manufacturing Practices (GMP) in product manufacturing through documentation of all operations and procedures using Good Document Practices (GDP). The RAQAD provides an internal auditing system to ensure that QC and Manufacturing Division staff meet compliance requirements for training, equipment & facility's validations, reagent screening, procedural documentation, manufacturing procedures and product distribution. Additionally, the scope of responsibilities of the RAQAD extends to managing communication between the PI and regulatory authorities through all stages of development, including submissions and annual progress reports for IBC, IACUC and IND applications. Therefore, the goals of the RAQAD are as follows:

  1. To develop a Quality Assurance Plan for investigational new drug/biological products that will facilitate compliance and thus provide a smooth transition from preclinical studies, through the IND application and FDA release procedure, and into phase I clinical trials;
  2. To verify GLP and GMP compliance through review and approval of all Quality Control Division and Manufacturing Division written SOPs, Master Data Forms, and Prep Records used by division staff or Principle Investigator;
  3. To assist PIs with submission of all regulatory (IBC, IACUC, FDA) applications, progress reports, and annual safety reports;
  4. To ensure that FDA review committees' requirements and criteria (composition, purity, sterility, and strength/potency), which the RAQAD documents in the Master Specifications for Batch Release, for each FDA-released IND product are observed and met prior to release of any product batch (lot) for clinical administration;
  5. To establish, verify, and monitor a federally compliant tracking and labeling system for all IND products to ensure patient safety.

To contact Quality Control or Regulatory Affairs, please call 401-456-5783.