UIP Chosen as Vendor for NCATS Drug Product Development, Manufacture, and Stability Studies

The University of Iowa Pharmaceuticals (UIP) is very excited that it has been chosen as a vendor for the NCATS (National Center for Advancing Translational Sciences) Request for Proposal (RFP) No. N01TR-17-2003, “CRO Support for NCATS Drug Product Development, Manufacture, and Stability Studies”.  NCATS at the NIH (National Institutes of Health) studies translation on a system-wide level as a scientific and operational problem to accelerate the development of treatments and preventive strategies for a wide range of diseases.  Within NCATS, the Division of Pre-Clinical Innovation (DPI) plans, conducts, and uses both internal and contract resources to advance collaborative research projects across the pre-clinical phases of the translational science spectrum.  The goal of NCATS in selecting UIP as a vendor is to obtain contract research services to support the development, manufacturing, and stability studies of dosage forms of experimental therapeutics.  The UIP application for this contract also included faculty from the UI College of Pharmacy that participate in the UIP Development Consortium (UIPDC).  UIPDC is a formal connection between UIP and faculty in the College of Pharmacy where faculty can work with UIP and/or their students on pre-clinical drug development activities.

This project has been funded in whole or in part with Federal funds from the National Center for Advancing Translational Sciences, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN271201700019I.

UIP & Fervent

UIP will be working with Fervent Pharmaceuticals to develop its treatment for hot flashes and other vasomotor symptoms.  UIP involvement will be focused on formulation development aspects of the Fervent program, and UIP will manufacture development-scale clinical batches for its upcoming Phase II trial.  Fervent CEO George Royster is excited about the partnership: “UIP offers Fervent the perfect blend of drug development expertise and experience. They’ve been practicing cGMP-compliant formulation development and product manufacturing for 40 years. I’ve been extremely impressed by their capabilities and their facility, which is the only one of its kind offering the range and scope of services needed by commercial clients like us.”  For more information go to:

http://ferventpharma.com/university-of-iowa-pharmaceuticals-added-to-growing-list-of-fervent-strategic-partners/

http://ferventpharma.com/

UIP TO PARTICIPATE IN NIIMBL VIA NIPTE

U.S. Secretary of Commerce Penny Pritzker announced on December 16, 2016 an award of $70 million to the new National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), the eleventh institute in the Manufacturing USA network.  This is the first institute with a focus area proposed by industry and the first funded by the U.S. Department of Commerce (DOC).  UIP is part of NIIMBL through the UI College of Pharmacy via NIPTE (National Institute for Pharmaceutical Technology and Education).  NIIMBL will help to advance U.S. leadership in the biopharmaceutical industry, foster economic development, improve medical treatments and ensure a qualified workforce by collaborating with educational institutions to develop new training programs matched to specific biopharma skill needs.

UI BREAKS GROUND ON NEW PHARMACY BUILDING

On September 29, 2016 UI officially broke ground on a new $96.3 million pharmacy building that will feature cutting-edge research laboratories, innovative technology, and collaborative learning spaces.  The lower level of this new building will be home to UIP’s new sterile products manufacturing area.  This new sterile manufacturing area will be approximately 16,000 square feet and include two complete isolator lines, each with its own lyophilizer.  This will increase UIP’s batch size capacity approximately 5-fold to 20,000 vials/batch.  UIP will continue to retain its ability to make small, IND enabling batches for clinical supplies with this facility.