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, Validation Purdue Pharma
Agenda
Why Technology Transfer 2 Basic Concepts on How and When
3 Success Criteria 4 Thoughts on Keys to Success
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Why Technology Transfer
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

Discovery
4 10 years
Research Target Biological Evaluation Integrated Research Candidate Drug Formulation Patents
Exploratory Development
3+ years
Formulation Development Process Development Phase I - Clinical Trials
Regulatory Development
3+ years
Manufacturing
Commercialization
3+ years
Registration Launch Sales
Phase II - Clinical Trials Phase III - Clinical Trials
Build/Select API Manufacturing Facilities
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 timeto-market expectations Technology Transfer is a vulnerable time for companies
Loss of knowledge or experience, leading to reinvention of the wheel Confused ownership and responsibilities Delayed approvals
Stakeholders in the Quest for Effective Technology Transfer
Industry
R&D Commercial
Stakeholders
Regulators Customers
Patients Healthcare providers The public
Regulators roles:
Protect public health
Standardize regulations Ensure safe, pure, and effective drug products Drug approvals
Affect healthcare system

Facilitate and regulate, bringing new, more effective products to market faster Reduce the cost of healthcare
Industrys role:
Innovative R&D
Develop new, more effective compounds, delivery systems, and medical devices
Compliant and effective commercialization

Ensure safe, pure, and effective drug products Consistent interpretation of GMP regulations Bringing new, more effective products to market faster Adherence to all applicable regulations and guidelines Cost-effective production and distribution Superior 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

Industrys Paradigm Shift
Continuous transfer of knowledge and technology Improved lifecycle management Good business practice Speed to market Globalization Advances the state-of-the-art
Project Conception Research and Development Commercial Operations Launch Involvement
Technology Transfer A Paradigm Shift
Continuous Knowledge Transfer

Pre-Trials Phases II & III
Pre-IND
Highly interpretable regulations and guidelines Intermittent transfer of knowledge Reactive inspection and review practices
Involvement
IND
Project Conception Research and Development Commercial Operations
NDA PAI Post Approval
Regulatory Stakeholder Opportunities
Regs & Guidelines
Launch
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
R&D Processes Commercial Operations
I think you need a few more details here in the Transfer protocol
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
There Is More To Successful Technology Transfer:

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
Critical Success Factors Post Approval :

Change Control Audit process performance
Statistical review
Continual process improvement program

Statistical process control
If technology transfer isnt done right

Process validation may be unsuccessful Delayed regulatory approval and/or product launch Flawed processing may result
High 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
Communication
Open communication between all team members Direct communication between technical members Effective and timely communication with regulators
Keys to Success
Communication
Cultural / 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.
Formulation Development Analytical Development
Process Development
Quality Control
Technical Services
Production
Team work, most of the time
Effective technology transfer is critical to success in pharmaceutical industry
Regulators
Regulators
APPROVAL
Involvement
Development
Post Approval
Commercial
Project Conception
Regulatory Bodies
Research and Development
Commercial Operations
Thank You
References
1. ISPE Technology Transfer Guide, 2003 2. F. Sexton, Effective and Efficient Knowledge Transfer from R&D to Manufacturing, Purdue Pharmas 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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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, Validation Purdue Pharma

Why Technology Transfer 2 Basic Concepts on How and When

3 Success Criteria 4 Thoughts on Keys to Success

Why Technology Transfer

Why Technology Transfer

Stages in the Development of a New Medicine

Registration Launch Sales

Phase II - Clinical Trials Phase III - Clinical Trials

Build/Select API Manufacturing Facilities

Built/Select Manufacturing Facilities

Why Technology Transfer

When does technology transfer occur?

Why Technology Transfer

Stakeholders in the Quest for Effective Technology Transfer

Stakeholders in the Quest for Effective Technology Transfer

Affect healthcare system

Stakeholders in the Quest for Effective Technology Transfer

Compliant and effective commercialization

Stakeholders in the Quest for Effective Technology Transfer

Customers & Patients:

Technology Transfer A Paradigm Shift

Continuous Knowledge Transfer

Technology Transfer A Paradigm Shift

Continuous Knowledge Transfer

Project Conception Research and Development Commercial Operations

NDA PAI Post Approval

Regulatory Stakeholder Opportunities

Regs & Guidelines

Technology Transfer - How and When

Knowledge Transfer Process

Then a miracle occurs

R&D Processes Commercial Operations

Technology Transfer - How and When

ISPE Guide for Technology Transfer

Technology Transfer - How and When

TT Guide is designed to:

Technology Transfer - How and When

TT Guide & Manufacturing Science

Technology Transfer - How and When

Technology Transfer Task Relationships Model

Technology Transfer Success Criteria

Technology Transfer Success Criteria

What Constitutes A Successful Technology Transfer?*

Technology Transfer Success Criteria

Technology Transfer Success Criteria

There Is More To Successful Technology Transfer:

Technology Transfer Success Criteria

Critical Success Factors Post Approval :

Continual process improvement program

Technology Transfer Success Criteria

If technology transfer isnt done right

Technology Transfer Success Criteria

Sending and Receiving Unit

Technology Transfer Success Criteria

Team work, most of the time

Technology Transfer Success Criteria

Effective technology transfer is critical to success in pharmaceutical industry

Research and Development

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