Center for Advanced Drug Development Budget Narrative

State Appropriation $93,645

The Center for Advanced Drug Development (CADD) is a division of the University of Iowa, College of Pharmacy and a component of University of Iowa Pharmaceuticals. The Center offers contract analytical services to the pharmaceutical and biotechnology industry and is part of the UIP - the only comprehensive FDA registered facility in a College of Pharmacy in the U.S. UIP offers the unique capability to produce under contract limited quantities of new medicines under FDA regulations. The capacity is particularly valuable to firms wishing to bring new products through clinical trials. The present budget seeks funds to continue support for the companion CADD.

This Center, which is an integral resource in the states bioeconomy economic development agenda, offers analytical services and contract services relevant to the clinical trials process which complement those of UIP, and explicitly include:

  • Management of FDA requirements for clients, especially in the processing of drug applications,
  • Development and execution for new chemical assays for new dosage forms and chemical entities,
  • Development and execution of stability studies of candidate medicine dosage forms
  • Testing of active pharmaceutical ingredient/excipients for compliance.

This Center addresses a crucial economic need to shorten the lead time between new pharmaceutical discoveries in the laboratory and their commercialization in the market place.  Because pharmaceuticals occupy such a potentially important part of the state’s high technology portfolio as well as a critical role in the University’s economic development efforts, continued investment in the Center will increase economic resources in a strongly competitive environment.  In addition, as the state looks ahead to an investment to enhance its biotechnology infrastructure for both animal and human health, the Center will play a major role (along with the Center for Biocatalysis and Bioprocessing and the College of Pharmacy) in the University’s ability to interact with the biotechnology industry to shorten the time to market for new therapies.  This new initiative will also attract interest from a completely new industry base, composed of mainly start-up companies, who may be recruited to Iowa.

Use of State Budget Revenues

 

The allocation from the economic development appropriations for the Center for Advanced Drug Development for FY 2018 ($93,645) is used to help support the salary and fringe of one Associate Chemist at $35,935 and one Manager of Laboratory Quality at $57,710 at CADD. 

The Associate Chemists provide analytical expertise to perform qualitative and quantitative chemical analyses of pharmaceutical products, conducted following cGMP and ICH guidelines, internal SOPs, United States Pharmacopeia (USP) monographs, and client-supplied methods.  The Manager of Laboratory Quality assures testing is conducted in full compliance with FDA cGLP/cGMP regulations.