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.

NIPTE501(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

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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

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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

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Optimal efficiency via stochastic basis for clinical relevance

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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

Integrated solutions need multi-disciplinary expertise

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Integrated Solution Needs Multi-disciplinary Expertise

Research Related to Formulation and Pharmaceutical Product Stability. Advisory Committee for Pharmaceutical Science. April 14, 2010

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

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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)!

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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

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