Critical Path: The Industrialization Dimension

1
Critical Path The Industrialization Dimension

• Ajaz S. Hussain, Ph.D.
• Deputy Director
• Office of Pharmaceutical Science
• CDER, FDA

2
Innovation or Stagnation? Challenge and
Opportunity on the Critical Path to New Medical
Products
http//www.fda.gov/oc/initiatives/criticalpath/whi
tepaper.html
3
http//www.fda.gov/oc/initiatives/criticalpath/whi
tepaper.html
4
http//www.fda.gov/oc/initiatives/criticalpath/whi
tepaper.html
5
http//www.fda.gov/oc/initiatives/criticalpath/whi
tepaper.html
6
D. Stanski
7
http//www.fda.gov/oc/initiatives/criticalpath/whi
tepaper.html
8
Quality by Design A Challenge to the Pharma
Industry (CAMP, R. Scherzer. FDA Sci. Board.
4/9/02)
9
Industrialization Research and Training Needs

• Our Nations educational and research
  infrastructure adequate to meet the critical
  path challenges? No!
• Need for a focused effort on Pharmaceutical
  Engineering
• Centers for Excellence in Pharmaceutical
  Engineering Education and Research
• How should FDA support the case for a focused
  effort on Pharmaceutical Engineering?

10
Industrialization Research and Training Needs

• OPS/CDER Research
• OTR Research programs are being aligned to the
  goals of the Critical Path Initiative
• PAT Research
• Physical characterization (e.g., nanotechnology)
• Computational methodologies
• Support for Generic Drugs Efficient methods for
  bioequivalence
• Projects/topics that we should consider?