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Visioning the Next Decade: NIPTE-FDA Collaboration

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NIPTE Seminar at US FDA, 16 March 2016.
QBR as an Organizing Principle for the Proposed NIPTE Center of Excellence for Pharmaceutical Formulations (CEPF)

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Visioning the Next Decade: NIPTE-FDA Collaboration

  1. 1. The Next Decade: Visioning a Collaboration between NIPTE & FDA CDER OPQ Ajaz S. Hussain, Ph.D., President The National Institute of Pharmaceutical Technology & Education, Inc.
  2. 2. NIPTE 501(c)(3) Non-profit organization Founded in 2005 Incorporated in 2007 Headquarters: Minneapolis, MN 12 Schools of Pharmacy, 3 Schools of Engineering, 1 Medical School Improving Quality and Lowering Costs with Confidence March 16, 2016 2FDA CDER White Oak, Building 22, Room 2205
  3. 3. Pharmaceutical Science & Quality: Looking Back Regulatory Science: FDA Review & Inspection Thawing the “PSF”: OPS, SUAPC, BCS,…, PQRI,… PAT to Pharmaceutical Quality in 21st Century to Critical Path Initiative & NIPTE OPQ: One Voice for Quality, Integrated, Metrics, Culture …… & NIPTE Pre-OPS OPS- Early Days OPS in 21st Century OPQ March 16, 2016 3FDA CDER White Oak, Building 22, Room 2205
  4. 4. NIPTE 2005 – 2015 and beyond 2005 – 2015 Highlights • FDA – NIPTE MOU, June 2005 • Developing QbD guidance elements on process design space (2008-2010) • Critical Path Manufacturing Research Sector Initiative Grant (U01) Awarded by FDA in 2011 for 5 years with funding at up to $7,000,000 annually • Reviewer Education in State of the Art Pharmaceutical Manufacturing Technology Lessons & Aspirations • What worked: Integrated multi-disciplinary research based solutions to complex development/regulatory challenges • For example - Gabapentin stability design space • What can and should work better • Knowledge transfer and management • Understanding FDA’s challenges & FDA feed- back • Proactive planning for ‘grand’ vs ‘brushfire’ challenges • NIPTE’s Centers for Excellence – aligned with OPQ: One Voice of Quality March 16, 2016 4FDA CDER White Oak, Building 22, Room 2205
  5. 5. Optimal efficiency via stochastic basis for clinical relevance March 16, 2016 FDA CDER White Oak, Building 22, Room 2205 5 To optimal efficiency with confidence Via Stochastic, Clinical Relevance Research Related to Formulation and Pharmaceutical Product Stability. Advisory Committee for Pharmaceutical Science. April 14, 2010
  6. 6. Integrated solutions need multi-disciplinary expertise March 16, 2016 FDA CDER White Oak, Building 22, Room 2205 6 Integrated Solution Needs Multi-disciplinary Expertise Research Related to Formulation and Pharmaceutical Product Stability. Advisory Committee for Pharmaceutical Science. April 14, 2010
  7. 7. FDA CDER OPQ’s mission is to assure that quality drugs are available to the American public. Assure that all human drugs meet the same quality standards to safeguard clinical performance; Enhance science- and risk-based regulatory approaches; Transform product quality oversight from a qualitative to a quantitative and expertise-based assessment; Provide seamless integration of review, inspection, surveillance, policy, and research across the product life cycle; and Encourage development and adoption of emerging pharmaceutical technology • NIPTE’s Mission • The mission of NIPTE is to improve human health through multi-university collaborative research to advance the quality, safety, affordability and speed to market of medicines through interdisciplinary research and education in pharmaceutical technology March 16, 2016 FDA CDER White Oak, Building 22, Room 2205 7
  8. 8. Grand Challenge in Pharmacutical Quality • The FDA’s PAT Guidance opened the door to continuous manufacturing; ‘tipping point’ reached in 2015 • ICH Q8 outlined a methodology for ‘Quality by Design’; methodology without 21st century ontology curtails progress • Weak epistemology reduces confidence generally and in rapidly globalized supply chain it raises serious concern such as “are these data too good to be true?” • Through its research and educational programs NIPTE will contribute towards realizing CDER OPQ vision, in this context the Nation needs a Center of Excellence for Pharmaceutical Formulations (CEPF)! March 16, 2016 8FDA CDER White Oak, Building 22, Room 2205
  9. 9. Today we share our initial thoughts on CEPF • NIPTEs’ Center of Excellence for Pharmaceutical Formulations (CEPF): Making the case • Stephen R. Byrn, Ph.D., Purdue University • QBR as one of the Organizing Principles for NIPTE CEPF • Kenneth R. Morris, Ph.D., Long Island University– Brooklyn Campus • Critical Roles of Raw Materials and Manufacturing Processes in Product Quality • Stephen W. Hoag, Ph.D., University of Maryland Baltimore • Robert (Bill) O. Williams, Ph.D., University of Texas at Austin • Feng Zhang, Ph.D., University of Texas at Austin • Advanced Characterization of Drug Substance and Drug products • Raj Suryanarayanan, Ph.D., University of Minnesota • Eric J. Munson, Ph.D., University of Kentucky • Q&A and FDA Feedback March 16, 2016 FDA CDER White Oak, Building 22, Room 2205 9

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