Managed the NDA development and hands-on submission process for two NDAs. One project involved supporting the CMC content in the NDA submissions and related FDA liaison activities. The second NDA project involved all FDA liaison activities, including clinical, labeling, and chemistry.
Requests for Orphan Drug Designation
Outlined the document requirements and submitted several Requests for Orphan Designation with the FDA Center for Biologics Evaluation and Research (CBER) on behalf of a foreign client. The requests concerned three gene therapy biologics, one involving ex-vivo cell transduction, and the other two were for infusion. Continue to represent the foreign client as their US Agent.
Drug Master Files
Outlined the document requirements, and filed two Type II Master Files and two Type V Master Files to the Center for Biologics Evaluation and Research (CBER) for a foreign client. The Type II Master Files involve an antibody for cell selection and a viral supernatant for cell transduction. The Type V Master Files were for foreign facilities. All four Master Files were filed to support Phase I/II clinical trials in the US. Reviewed and edited a Drug Master File for a foreign Active Pharmaceutical Ingredient (API) manufacturer. Based on the review, a reduced testing plan was recommended which would result in savings to the company, while maintaining regulatory compliance and product quality. Continue to represent the foreign client as their US Agent.
Labeling Changes for Commercial Products
Evaluated and outlined the regulatory requirements for label changes for a client with commercial products in the US. The responsibility also included assistance in managing the implementation of the change. For example: changes to NDA ownership, addition of safety information, and new information on drug interactions.
Chemistry-related Changes to Commercial Products
Evaluated and provided regulatory requirements for a US client in the area of manufacturing process and facility changes, expiration dating and stability program changes, excipient and API analytical testing changes, packaging and product specification changes, establishment registration and drug listing activities.
Legacy Safety Database
Managed project to establish a safety database for NDA submission. This entailed contracting and working with a third party on data entry (including data collection requirements), working with the client and another consultant on the statistical analysis plan, and contracting and managing an additional CRO for the data base generation and data displays.
NDA Launch Teams
Supported client in a regulatory/project management capacity on two NDA product launch teams.
Clinical Study Management
Developed and filed clinical protocols in conjunction with clinical investigators and a CRO. Managed the CRO activities to complete the studies and handled all FDA liaison activities.
Provided regulatory support and representation in FDA and Canadian health authority inspections of facilities including a drug substance supplier and drug product manufacturers. One of these facilities was an inhalation aerosol manufacturer, two others involved aseptic processing. These activities included review of SOPs, analytical methods, and manufacturing procedures, generation and review of company presentations for quality and manufacturing systems, behavioral training of staff, and preparing responses to FDA observations.
Bruce E. Thompson, BSc, MBA
28 Hungerford Terrace
Burlington, VT 05401