Professional Documents
Culture Documents
Challenges in Techn Transfer Final
Challenges in Techn Transfer Final
Agenda
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
The development and transfer of knowledge and technology has been and will continue to be critical to success in pharmaceutical industry
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
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
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
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
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Industry
R&D Commercial
Stakeholders
Regulators Customers
Patients Healthcare providers The public
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Regulators roles:
Protect public health
Standardize regulations Ensure safe, pure, and effective drug products Drug approvals
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Industrys role:
Innovative R&D
Develop new, more effective compounds, delivery systems, and medical devices
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Pre-IND
Highly interpretable regulations and guidelines Intermittent transfer of knowledge Reactive inspection and review practices
Involvement
IND
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Launch
Need an effective transfer process that plugs the leaks and yields better retention
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
I think you need a few more details here in the Transfer protocol
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Success Criteria?
"You can tell pharmacy we finally have three batches of on-spec product."
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
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
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Analytical methods cannot support production Incomplete documentation Product does not perform as intended!
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Keys to Success
What Is the Key to Successful Knowledge Transfer? It Must Be Understood and Managed by ALL Stakeholders
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Keys to Success
Communication
Open communication between all team members Direct communication between technical members Effective and timely communication with regulators
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Keys to Success
Communication
Cultural / Organizational Differences
Germany
Austria
Switzerland
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Process Development
Quality Control
Technical Services
Production
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Regulators
Regulators
APPROVAL
Involvement
Development
Post Approval
Commercial
Project Conception
Regulatory Bodies
Commercial Operations
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
Thank You
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006
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
Joint CVG/Therapeutic Products Directorate International Convention and Exhibition, Toronto, Canada, October 5 - 6, 2006