4th FDA/PQRI Conference on Advancing Product Quality

4th FDA/PQRI Conference on Advancing Product Quality: Patient-Centric Product Design, Drug Development, and Manufacturing

On April 9-11, 2019, FDA and PQRI hosted a public Conference, the 4th FDA/PQRI Conference on Advancing Product Quality: Patient-Centric Product Design, Drug Development, and Manufacturing.  This Conference brought together leaders from regulatory agencies, industry experts, and academia to discuss key, critical topics in drug product delivery. Input from attendees will aid in future FDA guidance development.

Following morning plenary sessions, attendees broke into themed concurrent tracks:

• • • Track #1: Novel Approaches to Improve Treatment Outcome and Patient Safety
      • Providing the intended therapeutic effect, in a safe manner, is the centerpiece of a quality drug product. The complexity of novel formulations and modalities increases the needs for robust characterization of such products and integration of knowledge/data to first understand and subsequently project their clinical behavior. Novel characterization methodologies and tools and modeling and simulation approaches will be discussed towards these goals.
    • Track #2: Emerging Technologies and Patient Centricity in Early Drug Development
      • Current and future thinking on the role of new/emerging technologies in driving contemporary early development across the broad small-to-large molecule spectrum. Advancing understanding, dialogue and awareness of opportunities to “design in” patient centricity as a core attribute and consideration in early drug development to enhance the overall patient experience.
    • Track #3: Novel Manufacturing Technologies and Challenges for the Production of Patient-Centric Drug Products
      • The rapidly evolving manufacturing methods for gene and cell based therapies and continuous processes require new approaches related to analytics, validation and registration.  This Track will explore each of these areas and the evolving expectations.

Day 3 included a Special Plenary Session with FDA.  FDA launched its latest initiative, KASA (Knowledge-aided Assessment and Structured Application), a creative regulatory approach for modernizing the quality assessment and enhancing submission format. This initiative was outlined by an expert FDA panel moderated by Dr. Lawrence Yu, Deputy Director of CDER’s Office of Pharmaceutical Quality with distinguished presenters from the FDA including Dr. Susan Rosencrance.  

POSTER SESSION

To view the Posters and poster abstracts, click on Conference Poster Abstracts.

FINAL PROGRAM

• • • The final Workshop Program is available here.

PRESENTATIONS

Click here to Access Conference Presentations.

QUESTIONS

Please contact the PQRI Secretariat if you have any questions at +1(202) 230-5607 or PQRISecretariat@pqri.org.