Joga Gobburu FDA · 2 Gobburu, ACoP 2008 Pharmacometrics 2020 Academia, industry and regulatory agencies are in the Business of Pharmacometrics together These are really my opinions

Gobburu, Gobburu, ACoPACoP 20082008

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Joga Joga GobburuGobburuFDAFDA

Breakthrough

Breakthrough

BuildupBuildup

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GobburuGobburu, , ACoPACoP 20082008

Pharmacometrics 2020Pharmacometrics 2020

Academia, industry and regulatory Academia, industry and regulatory agencies are in the agencies are in the Business of Business of Pharmacometrics Pharmacometrics togethertogether

These are really my opinions and not These are really my opinions and not FDA policy. Please provide feedback FDA policy. Please provide feedback on this presentation & visionon this presentation & vision•• [email protected]@fda.hhs.gov

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Pharmacometrics 2020Pharmacometrics 2020Current State of Affairs

Vision – ‘Business of Pharmacometrics’

Questions that need discussion

Strategic goals

Commitment

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Strategic goals

Commitment

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PharmacometricsPharmacometrics is transforming the quality of drug is transforming the quality of drug development and regulatory decision making!!!development and regulatory decision making!!!

Pro

gre

ssP

rog

ress

-Entrepreneurial success-↑ Influence -Org structure

-Technology-Prelim success-Regulatory policy

2008

2010-20202000-20101990-2000

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FDA PharmacometricsFDA Pharmacometrics

0

5

10

15

FTEs

1995 2000 2005 2006 20080

50100150200250

Rev

iew

s

1995 2000 2005 2006 2007

0%25%50%75%

100%

Effo

rts

1995 2000 2005 2007

PolicyDesignApprovalLabeling

QTResources Demand

Focus

77


Presentation at Advisory Committee Meetings

Influenced key decisions

QT Policy &Leadership

Non-small lungCancer model

AC MeetingMarch 18, 2008

Parkinson Disease:Modification Claims

Conference, DCApril 28-29, 2008

Recognized bySenior Mgmt

GRMP

Fellowships/Sabbaticals-Brundage, Don Berry-Fellows, AAPS CRADA-Critical Path


GRMP=Good Review Mgmt Processes

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PharmacometricsPharmacometrics is transforming the quality of drug is transforming the quality of drug development and regulatory decision making!!!development and regulatory decision making!!!

Pro

gre

ssP

rog

ress

-Entrepreneurial success-↑ Influence -Org structure

-Technology-Prelim success-Regulatory policy

-Standardize processes-↑ Pharmacometricians-Expand scope

Consequence of NOT

stimulating progress

2010-20202000-20101990-2000

2008

99





Strategic goals

Commitment

1010


PGx

Innovativetrial

designsPredictive

Biology

PharmEco/

Health Policy

“Assay”technology

Computnladvances

External Advances Affecting

Pharmacometrics

R&D Productivity

1111


2020 Vision2020 Vision‘‘Business of PharmacometricsBusiness of Pharmacometrics’’

Reducing late phase attrition from 50% to

25% in 2015, 10% in 2020

Requiring of dose individualization

Pharmacometrics will lead/influence -

Pharmacometrics is the science that deals with quantifying pharmacology and disease to influence drug development and regulatory decisions

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Strategic goals

Commitment

1313


How do we increase our influence on drug development/regulatory decisions?

Who are our customers in 2020?

What are our core products in 2020?

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Strategic goals

Commitment

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Pharmacometrics 2020Pharmacometrics 2020Strategic GoalsStrategic Goals

Train 500 Pharmacometricians-Technical track-Disease track-Drug development track

Design by Simulations: 100% Protocols

-Late/early phase clinical trials-Dynamic ‘Learn-Apply’ cycles

Industry, Foundationsshould fund

academia

Academiashould adaptto industry/regulatory

needs

Efficient data visualization/analysis tools

-Soft/hardware should not be bottlenecks-Ready access to prior information

Increase Pharmacometric Awareness

-↑ Presence at Clinical conferences-Publish success stories-Hire diverse expertise

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FDA Pharmacometrics 2020FDA Pharmacometrics 2020Strategic GoalsStrategic Goals

Train 20 Pharmacometricians

-Technical track-Disease track-Drug development track

Implement 15 Standard Templates

-Develop disease specific data,analysis standards-Expect industry to follow

Develop 5 Disease Models

-Create public disease model library

International Harmonization

-Share expertise between globalregulatory bodies

Integrated Quantitative CP Summary

-All NDAs should have exposure-response analyses

Design by Simulation: 100% Pediatric WRs

-Leverage prior knowledge to designPediatrics Written Request trials

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Specific Challenges

Potential Solutions

Commitment

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Pharmacometrics 2020Pharmacometrics 2020Strategic GoalsStrategic Goals

Train 500 Pharmacometricians-Technical track-Disease track-Drug development track

Design by Simulations: 100% Protocols

-Late/early phase clinical trials-Dynamic ‘Learn-Apply’ cycles

Industry, Foundationsshould fund

academia

Academiashould adaptto industry/regulatory

needs

Efficient data visualization/analysis tools

-Soft/hardware should not be bottlenecks-Ready access to prior information

Increase Pharmacometric Awareness

-↑ Presence at Clinical conferences-Publish success stories-Hire diverse expertise

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2020


““This is not the end. It is not This is not the end. It is not even the beginning of the end. even the beginning of the end. But it is, perhaps the end of the But it is, perhaps the end of the

beginning.beginning.””Winston ChurchillWinston Churchill

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AcknowledgementAcknowledgement

FDA Pharmacometrics group, Larry FDA Pharmacometrics group, Larry LeskoLesko and all other colleagues for and all other colleagues for their encouragement and guidancetheir encouragement and guidance

Documents

Joga Gobburu FDA · 2 Gobburu, ACoP 2008 Pharmacometrics 2020 Academia, industry and regulatory agencies are in the Business of Pharmacometrics together These are really my opinions