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• Incorporated in 2011 Fribourg Switzerland
• Market: Operating Instructions – Production
• Sectors Biopharma, Medtech
• Unique blend of expertise
• Engineering
• Multimedia,
• Web portal
• Video
High Value Product Technology Transfer Conference 2014 Durham, UKMay 15 2014
Agenda• Technologies Transfer
– Definition
– Review of experiences
• Examples of Actual Technologies to Transfer
• Learn from Existing Inspections Track Records
• Assist Knowledge Transfer
• Case study
• Support Tech Transfer Till Handover
• Conclusion
What is Technology Transfer?¹
• Transfer of Technology (TOT), is the process of transferring skills,
knowledge, technologies, methods of manufacturing, samples of
manufacturing and facilities …..It is closely related to (and may
arguably be considered a subset of) knowledge transfer.
Horizontal Transfer is the movement of technologies from one area
to another.
• Transfer of Technology (TOT) is primarily horizontal. Vertical
Transfer is when technologies are moved from applied research
centers to research and development departments.
[1] Excerpts from http://en.wikipedia.org/wiki/Technology_transfer
Speaking by experience
• Relevant Findings: “…Over 90% of vaccines are produced by less than 15 manufacturers, and over 80% of vaccines are produced in LMICs (compared with only 7% of drugs).” - Dr. Wenfeng Gong -
• NVI (Nederland Vaccin Instituut) high requirement for technical know-how :– Production, – Quality Control, – QA Regulatory
• referring to Amie Batson and Julie B. Milstien - Health Affairs 27, no. 1 (2008): 140–142; 10.1377/ hlthaff.27.1.140
• Jean-Marie Préaud JAPANESE ENCEPHALITIS project :“Capacity building” in China. “…It takes a long time for training and implementing Quality Management Systems…”
– Language barrier leading to misinterpretation of documents.– Training have to be repeated to make sure that lessons are understood correctly.
• Michel BAIJOT: FIOCRUZ – GSK: – Develop people by training and empowerment– Learning by doing and the learning curve: The recipient of technology must adapt a “do-it “ attitude
• Jean-Marie Préaud: Development of MenAfriVac™ in IndiaAn example of efficient technology transfer to develop a needed vaccine– communication was the key to the success of this project
Workshop on Technology Transfer WHO HQ – Geneva, November 30th – December 1st, 2010. http://www.who.int/phi/news/workshop_tt_vaccines2010/en/
Storyboard• Transfer the full actual instructions into a synopsis of
operations• Customer project team approval
Capture• Video capture on-site• Selection of key steps
Project• Create Customer Platform• Organize the procedure relevant information• Deliver Draft Mediabooks
Libraries• Released Final Mediabooks• SOPs, Specimens, Warnings & Symbols Publishing• Simplifying update and revision exercise
NDA
How is it used during a ToT ?
?Coordination
– Proactively “export” Tech context
– Leverage from the ToT stakeholders
– Ensure to capture adequate practical knowledge
– Build up a Repository of Knowledge
– Secure Start up Phase
Minimize Variability– On-the-job assistance
• Contribute to standardization
– Staff training management• Secure know-how in-house • Prevent skillsets loss
New training model: “Flip the Classroom”
Assign «Lectures» as Homework:
Watch contextualized operations prior to hands-on sessionsi. Start, Pause, Replay, without fearing interrupting ii. Free up Expert time
Hands-on sessions
i. Efficient vs time and costsii. Minimize risk on production lines
Optimize skill sets
i. Mentoring, ii. Learn by peer
Minimizing variability in process operations using knowledge management platform
Herman van HerkScientist USPVaccine Process and Analytical Development Archimedesweg 4-6PO Box 20482301 CA LeidenThe NetherlandsTel: +31 (0)71 519 9197Email: [email protected]