Technology Transfer Challenges in Pharmaceutical Industry

Joint CVG/Therapeutic Products Directorate International Convention and Exhibition Toronto, Canada, October 5 - 6, 2006

Technology Transfer Challenges in Pharmaceutical Industry

Le Trong Vu, P. Eng.Manager, ValidationPurdue Pharma

Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006

Agenda

Why Technology Transfer

Basic Conceptson How and When

Thoughts on Keys to Success

111

333

222

444

Success Criteria



The development and transfer of knowledge and technology has

been and will continue to be critical to success in

pharmaceutical industry



Stages in the Development of a New Medicine

Biological Evaluation

Discovery

4 –10 years

Research Target

Integrated Research

Candidate Drug

Formulation

Patents

3+ years

Commercialization

Launch

Sales

Process Development

Phase I - Clinical Trials

Phase II - Clinical Trials

Phase III - Clinical Trials

3+ years

Exploratory Development

Build/Select API Manufacturing Facilities

Formulation Development

3+ years

Regulatory Development

Manufacturing

Registration

Built/Select Manufacturing

Facilities



When does technology transfer occur?Idea to Discovery Lab

Discovery Lab to Development Lab

Development Lab to Kilo Lab

Lab to Pilot Plant

Kilo Lab to Pilot Plant

Pilot Plant to Semi-works (other pilot plant)

Pilot Plant/ Semi-works to Manufacturing

Manufacturing to Manufacturing



Technology Transfer Importance to Industry

Process development and commercial production are on critical path because of compressed time-to-market expectations

Technology Transfer is a vulnerable time for companies

Loss of knowledge or experience, leading to “reinvention of the wheel”Confused ownership and responsibilitiesDelayed approvals


Stakeholders in the Quest for Effective Technology Transfer

IndustryR&DCommercial

Stakeholders

Customers PatientsHealthcare providersThe public

Regulators



Regulators’ roles: Protect public health

Standardize regulationsEnsure safe, pure, and effective drug productsDrug approvals

Affect healthcare systemFacilitate and regulate, bringing new, more effective products to market fasterReduce the cost of healthcare



Industry’s role: Innovative R&D

Develop new, more effective compounds, delivery systems, and medical devices

Compliant and effective commercializationEnsure safe, pure, and effective drug productsConsistent interpretation of GMP regulationsBringing new, more effective products to market faster Adherence to all applicable regulations and guidelinesCost-effective production and distributionSuperior return on investment to shareholders / stakeholders



Customers & Patients:Safe and effective treatments

New, more effective products to market faster

Affordable healthcare cost

Election of governments


Technology Transfer – A Paradigm Shift

Continuous Knowledge Transfer Industry’s Paradigm Shift

Continuous transfer of knowledge and technology

Improved “lifecycle” management

Good business practice

Speed to market

Globalization

Advances the state-of-the-artProject Conception Launch

Invo

lvem

ent

Research and DevelopmentCommercial Operations


Technology Transfer – A Paradigm Shift

Research and Development Commercial Operations

Project Conception

Launch

Invo

lvem

ent

Regulatory Stakeholder Opportunities

Highly interpretable regulations and

guidelines

Intermittent transfer of knowledge

Reactive inspection and review practices

Reg

s &

Gui

delin

es

Pre-

IND

IND

Pre

Continuous Knowledge Transfer

-Tri a

l sse

s II

&

A t prov

al

Pha

III

ND

PAI

Pos

Ap

Project Conception

Invo

lvem

ent


Technology Transfer - How and When

Knowledge Transfer Process

Need an effective transfer process that plugs the leaks and yields better retention


Then a miracle occurs…

“I think you need a few more details here in the Transfer protocol”

R&D Processes…

Commercial Operations …



ISPE Guide for Technology Transfer



TT Guide is designed to:Present standardized process

Recommend minimal base of documentation to support the technical transfer process

Define key terms and consistent interpretation

Facilitate timely and cost effective technology transfers

Consider regional requirements of US, Europe and Asia (Japanese Ministry of Health Labor and Welfare)



TT Guide & Manufacturing Science

Encompasses Research, Development, Analytical, Process and Quality

Guide focuses on the level, quality, and type of Information

Enables the capture and sharing of the “Right Knowledge”



Technology Transfer Task Relationships Model


Technology Transfer Success Criteria

Success Criteria?

"You can tell pharmacy we finally have three batches of on-spec product."



What Constitutes A Successful Technology Transfer?*

Success criteria from Definition of Technology Transfer:“… ability of a Receiving Unit to … perform …transferred technology, to the satisfaction of all parties and any, or all,

applicable regulatory bodies”

“Technology transfer can be considered successful if a Receiving Unit can routinely reproduce the transferred product, process or method against a predefined set of specifications as agreed with a Sending Unit and/or a

Development Unit.”

*From ISPE Technology Transfer Guide



Success Criteria: Demonstrate with data conformance to success criteria standards as outlined in the technology transfer plan:

Process parameters and control mechanisms

Material suppliers

Analytical methods

Health, safety and environmental concerns

Compliance with all registered commitments



Technology Transfer must also be completed:

Safely

The process being transferred runs as expected (yield, purity, cycle time, etc.)

On time (product launch)

On budget

No “CRISIS” situations

There Is More To Successful Technology Transfer:



Change Control

Audit process performanceStatistical review

Continual process improvement programStatistical process control

Critical Success FactorsPost Approval :



If technology transfer isn’t done right…Process validation may be unsuccessful

Delayed regulatory approval and/or product launch

Flawed processing may resultHigh rate of batch rejections, costly schedule revisions, excessive labour requirements

Analytical methods cannot support production

Incomplete documentation

Product does not perform as intended!


Keys to Success

What Is the Key to Successful Knowledge Transfer?

− It Must Be Understood and Managed by ALL Stakeholders


Keys to Success

CommunicationOpen communication between all team members

Direct communication between technical members

Effective and timely communication with regulators


Keys to Success

CommunicationCultural / Organizational Differences

Germany

Austria

Switzerland



Sending and Receiving Unit

Technology transfer is not a “one way street”.

The sending unit and receiving unit must be equally involved in the process to ensure success.

FormulationDevelopment

ProcessDevelopment

AnalyticalDevelopment

Production

QualityControl

TechnicalServices



Team work, most of the time



Effective technology transfer is critical to success in pharmaceutical industry

Commercial

Post Approval

Regulators

APPR

OVA

L

Development

Project Conception

Invo

lvem

ent

Regulators

Regulatory BodiesCommercial OperationsResearch and Development


Thank You


References

1. ISPE Technology Transfer Guide, 2003

2. F. Sexton, Effective and Efficient Knowledge Transfer from R&D to Manufacturing, Purdue Pharma’s SMC Meeting, March 2004

3. G. Millili, Ph. D, Technology Transfer: Manufacturing Perspective, Pharm Tech Conference 1996

4. S. Liebowitz, Ph. D, Pharmaceutical Technology Transfer: Pre and Post NDA Submission, Pharm Tech Conference 1995

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Technology Transfer Challenges in Pharmaceutical Industry

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