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 (UIP). The Center offers contract analytical services to the pharmaceutical and biotechnology industry - the only comprehensive FDA registered facility in a College of Pharmacy in the US. UIP offers the unique capability to produce new medicines that meet FDA’s cGMP regulations. This capability enables start-up biotech and researchers a path to accelerate novel vaccines and drug from discovery to clinical trials.

In FY21 we partnered with 2 companies to produce novel therapeutics to treat COVID-19 and one company to progress a novel vaccine for coronavirus into the clinic. Recently we were awarded an NIH grant to develop and manufacture an antiviral therapeutic for COVID-19 treatment.

Novel Biotech companies and governmental agencies such as NIH seek our expertise and ability to manufacture drug supplies under cGMP conditions for use in clinical trials. The present budget seeks funds to maintain UIPs cGMP compliance through support for CADD.

CADD, which is an integral resource in the bioeconomy economic development agenda of the state, offers analytical services to complement UIP’s cGMP manufacturing services, and explicitly include:

  • Compliance with FDA requirements for clinical trial materials and documentation in support of Investigational New Drug Applications (INDs)
  • Development, qualification, and transfer of chemical/biological assays for new dosage forms and chemical entities
  • Development and execution of stability study protocols to support clinical and market use of novel medicines
  • Testing of active pharmaceutical ingredient/excipients for compliance

CADD addresses a crucial economic need to shorten the lead time between pharmaceutical discoveries in the laboratory and clinical trials. In turn accelerating drug development timelines to product registration and commercialization. Continued investment in the Center will increase economic resources in the strongly competitive pharmaceutical environment. In addition, as the state enhances its investment in 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 partner with the biotechnology industry. A thriving CADD as part of UIP will continue to attract outside investment of biotech into the state which result in creating and retaining high technology positions within Iowa.

Use of State Budget Revenues

The allocation from the economic development appropriations for CADD for FY22 ($93,645) will be used to defray some of the cost for salary and fringe of the Quality Assurance group. The Quality Assurance group is vital to maintaining the high-level quality of our services and compliance with cGMP regulations. The ability to test materials under cGMP regulations is critical for advancing novel drugs and vaccines into the clinic. This capability differentiates CADD from typical research facilities and is a key factor in attracting outside business to our services.