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© G.K.Raju, Ph.D. Confidential
FDA Manufacturing Subcommittee Meeting
July 20, 2004
G.K. Raju, Ph.D.Executive Director, MIT/PHARMI
Massachusetts Institute of Technology
PHARMACEUTICAL MANUFACTURING IN THE 21st CENTURY:A “Science” Perspective
© G.K.Raju, Ph.D. Confidential
OUTLINE
THE “FRAME”
A VOCABULATORY
THE DESIRED STATE: “THERE”
THE CURRENT STATE: “HERE”
FROM “HERE” TO “THERE”: LEVERAGES
IMPLICATIONS
NEXT STEPS
ACKNOWLEDGEMENTS
© G.K.Raju, Ph.D. Confidential
Pharmaceutical Manufacturing:A Social Capability
Regulator
Pharmaceutical Industry
Patients
Academia
Government
Pharma MfgHealth Care
© G.K.Raju, Ph.D. Confidential
OUTLINE
INTRODUCTION
A “SCIENCE” PERSPECTIVE
THE DESIRED STATE: “THERE”
THE CURRENT STATE: “HERE”
FROM “HERE” TO “THERE”: LEVERAGES
IMPLICATIONS
NEXT STEPS
ACKNOWLEDGEMENTS
© G.K.Raju, Ph.D. Confidential
“MANUFACTURING SCIENCE” :
Mfg.Science
LEVEL 1
LEVEL 2
LEVEL 4
LEVEL 5
LEVEL 3
CORRELATIVE KNOWLEDGEWhat Is Correlated to What?
“CAUSAL" KNOWLEDGEWhat “Causes” What?
MECHANISTICKNOWLEDGE
How?
FirstPrinciples
Why?
DESCRIPTIVE KNOWLEDGE: What?
© G.K.Raju, Ph.D. Confidential
A Science Perspective:1. “SCIENCE”
• “Science” (noun)
A body of knowledge, body of facts or information, body of laws or principles, body of truths, or verities or realities……
• “Science” (a process)
A means for solving problems…
© G.K.Raju, Ph.D. Confidential
A “Science” Perspective:2. MANUFACTURING “SYSTEM”
A “manufacturing system” is a set of processes and systems (and people) bound by a common material and information flow.
Material
Material
InformationInformation
WEIGH WETGRANULN
STEP FB DRY
STEP
BLEND
ENCAPSULATESIEVE
QC1QC3 QC4
DRY MIX
QC2
© G.K.Raju, Ph.D. Confidential
A “Science” Perspective:3. Manufacturing “Capability”
Voice of Your Customer
Voice Of Your Process
ManufacturingCapability =
CEOScientist VP Operations Regulator Patient
© G.K.Raju, Ph.D. Confidential
OUTLINE
INTRODUCTION
A “SCIENCE” PERSPECTIVE
THE DESIRED STATE: “THERE”
THE CURRENT STATE: “HERE”
FROM “HERE” TO “THERE”: LEVERAGES
IMPLICATIONS
NEXT STEPS
ACKNOWLEDGEMENTS
© G.K.Raju, Ph.D. Confidential
“MANUFACTURING SCIENCE” : Desired State (“There”)
Mfg.Science
LEVEL 1
LEVEL 2
LEVEL 4
LEVEL 5
LEVEL 3
CORRELATIVE KNOWLEDGEWhat Is Correlated to What?
“CAUSAL" KNOWLEDGEWhat “Causes” What?
MECHANISTICKNOWLEDGE
How?
FirstPrinciples
Why?
DESCRIPTIVE KNOWLEDGE: What?
© G.K.Raju, Ph.D. Confidential
“PROCESS UNDERSTANDING”:THE DESIRED STATE
ProcessUnderstanding
Time
LEVEL LEVEL 11
LEVEL LEVEL 22
LEVEL LEVEL 44
LEVEL LEVEL 55
LEVEL LEVEL 33
FDA Minimum Requirement
Manufacturing Centric Approach to
Manufacturing Science(“learning by doing”)
Design/Development Centric Approach
Manufacturing Science(“learning before doing”)
Launch
© G.K.Raju, Ph.D. Confidential
OUTLINE
INTRODUCTION
A “SCIENCE” PERSPECTIVE
THE DESIRED STATE: “THERE”
THE CURRENT STATE: “HERE”
FROM “HERE” TO “THERE”: LEVERAGES
IMPLICATIONS
NEXT STEPS
ACKNOWLEDGEMENTS
© G.K.Raju, Ph.D. Confidential
“MANUFACTURING SCIENCE” : Current State (“Here”)
Mfg.Science
LEVEL 1
LEVEL 2
LEVEL 4
LEVEL 5
LEVEL 3
CORRELATIVE KNOWLEDGEWhat Is Correlated to What?
“CAUSAL" KNOWLEDGEWhat “Causes” What?
MECHANISTICKNOWLEDGE
How?
FirstPrinciples
Why?
DESCRIPTIVE KNOWLEDGE: What?
© G.K.Raju, Ph.D. Confidential
Time
LEVEL LEVEL 11
LEVEL LEVEL 22
LEVELLEVEL 44
LEVEL LEVEL 55
LEVEL LEVEL 33
FDA Minimum Requirement
ProcessUnderstanding
“PROCESS UNDERSTANDING”:THE CURRENT STATE (“HERE”)
© G.K.Raju, Ph.D. Confidential
OUTLINE
INTRODUCTION
A “SCIENCE” PERSPECTIVE
THE DESIRED STATE: “THERE”
THE CURRENT STATE: “HERE”
FROM “HERE” TO “THERE”: LEVERAGES
IMPLICATIONS
NEXT STEPS
ACKNOWLEDGEMENTS
© G.K.Raju, Ph.D. Confidential
FROM “HERE” TO “THERE”:STRATEGIC LEVERAGE
Time
LEVEL LEVEL 11
LEVEL LEVEL 22
LEVELLEVEL 44
LEVEL LEVEL 55
LEVEL LEVEL 33
FDA Minimum Requirement
ProcessUnderstanding
What is “development”?Vocabulary?How do you measure?Knowledge to understanding
© G.K.Raju, Ph.D. Confidential
FROM “HERE” TO “THERE”:TACTICAL LEVERAGE
Time
LEVEL LEVEL 11
LEVEL LEVEL 22
LEVELLEVEL 44
LEVEL LEVEL 55
LEVEL LEVEL 33
FDA Minimum Requirement
ProcessUnderstanding
InvestigationsTrue Root CausesSeparate Critical From Non-critical
© G.K.Raju, Ph.D. Confidential
OUTLINE
INTRODUCTION
A “SCIENCE” PERSPECTIVE
THE DESIRED STATE: “THERE”
THE CURRENT STATE: “HERE”
FROM “HERE” TO “THERE”: LEVERAGES
IMPLICATIONS
NEXT STEPS
ACKNOWLEDGEMENTS
© G.K.Raju, Ph.D. Confidential
“SCIENCE” PERSPECTIVE:
IMPLICATIONS
1. Finally, A Positive Vision …..
2. Enabling Vocabulary
© G.K.Raju, Ph.D. Confidential
“SCIENCE” PERSPECTIVE: IMPLICATIONS 3. Basis For VERY Different Relationship With Regulator
Mfg.Science
LEVEL 1
LEVEL 2
LEVEL 4
LEVEL 5
LEVEL 3
CORRELATIVE KNOWLEDGEWhat Is Correlated to What?
“CAUSAL" KNOWLEDGEWhat “Causes” What?
MECHANISTICKNOWLEDGE
How?
FirstPrinciples
Why?
DESCRIPTIVE KNOWLEDGE: What?
• Lower Risk• Quality By Design• More Harmonized• Lower Cost• High Quality• Lower Times
© G.K.Raju, Ph.D. Confidential
cGMPS FOR 21st CENTURY Science Based Risk Based Modern Quality Management Techniques Harmonization
PAT – A FRAMEWORK FOR INNOVATIVE PHARMACEUTICAL MANUFACTURING AND QUALITY ASSURANCE
“SCIENCE” PERSPECTIVE: IMPLICATIONS 4. Connectivity to Current Momentum
© G.K.Raju, Ph.D. Confidential
“SCIENCE” PERSPECTIVE: IMPLICATIONS 5. A Basis To Collaborate With Your “Competitor”
Mfg.Science
LEVEL 1
LEVEL 2
LEVEL 4
LEVEL 5
LEVEL 3
CORRELATIVE KNOWLEDGEWhat Is Correlated to What?
“CAUSAL" KNOWLEDGEWhat “Causes” What?
MECHANISTICKNOWLEDGE
How?
FirstPrinciples
Why?
DESCRIPTIVE KNOWLEDGE: What?
© G.K.Raju, Ph.D. Confidential
“SCIENCE” PERSPECTIVE: IMPLICATIONS6. An Inside-Out View That Enables A Systems View
Regulator
Pharmaceutical Industry
Patients
Academia
Government
Pharma MfgHealth Care
© G.K.Raju, Ph.D. Confidential
“SCIENCE” PERSPECTIVE: IMPLICATIONS 7. A Foundation To Transform Lives All Over Again..
Time
1978 1988 20081998 201820031983 1993 2013 2023
Last 25Years
2028
Next 25Years
1978 1988 20081998 201820031983 1993 2013 2023
Last 25Years
2028
Next 25Years
A NewShared Vision
Manufacturing
Capability
© G.K.Raju, Ph.D. Confidential
Time
SocialResources Required
“Ensure”
1978 1988 20081998 201820031983 1993 2013 2023
Last 25Years
2028
Next 25Years
A NewShared Vision
Time
To
Quality
1978 1988 20081998 201820031983 1993 2013 2023
Last 25Years
2028
Next 25Years
A NewShared Vision
“Science” Perspective:7. A Foundation To Transform Lives All Over Again
© G.K.Raju, Ph.D. Confidential
OUTLINE
INTRODUCTION
A “SCIENCE” PERSPECTIVE
THE DESIRED STATE: “THERE”
THE CURRENT STATE: “HERE”
FROM “HERE” TO “THERE”: LEVERAGES
IMPLICATIONS
NEXT STEPS
ACKNOWLEDGEMENTS
© G.K.Raju, Ph.D. Confidential
NEXT STEPS
Broaden Shared Vision
Long Term Social Roadmap
A “Real” Economic Case
“Real” Case Studies
“Pilot” The Future
© G.K.Raju, Ph.D. Confidential
OUTLINE
INTRODUCTION
A “SCIENCE” PERSPECTIVE
THE DESIRED STATE: “THERE”
THE CURRENT STATE: “HERE”
FROM “HERE” TO “THERE”: LEVERAGES
IMPLICATIONS
NEXT STEPS
ACKNOWLEDGEMENTS
© G.K.Raju, Ph.D. Confidential
ACKNOWLEDGEMENTS
Consortium For The Advancement Of Manufacturing Of Pharmaceuticals (CAMP)
Charles Cooney (MIT)
Steve Byrn and Kenneth Morris (PURDUE)
Janet Woodcock, Helen Winkle and Ajaz Hussain (FDA)
