Event Date/Time: Feb 25, 2004 End Date/Time: Feb 27, 2004
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The Institute for International Research is proud to present the 2004 7th Annual Technology Transfer Conference for the pharmaceutical and biotech industries. The mission of this program is to clarify regulatory guidelines and identify efficient technology transfer strategies. We plan to achieve this mission by dedicating day one to technology transfer methodologies and strategies and dedicating day two to best practice case studies.

The full Day Workshop on Wednesday February 25th, led by Daniel Harpaz, PhD, HARPAZ CONSULTING addresses the prerequisites for successful process validation, cleaning validation, analytical method validation for API's by properly developing a lab scale, pilot scale and technology transfer to commercial scale. The morning workshop on the TRIZ systematic innovation system, led by Ellen Domb, President of PQR Group, identifies process problems and develops powerful solutions. This workshop is designed for technical and projects managers, manufacturing and process development professionals at pharmaceutical biotech and contract manufacturing organizations. The afternoon workshop, Three Stages of Effusivity Adoption as a PAT Tool is led by Dr. Nancy Mathis of Mathis Instruments along with Dr. Prasad Adusumilli of GSK. They discuss the use of an innovative PAT (Process Analytical Technology) tools to perform real-time online measurement of evolving quality in order to ensure process conditions are optimized. This workshop is specifically designed for formulation scientists, managers and directors of technical services or technical operations, solid dose manufacturing, and members of PAT teams.

On Thursday February 26th the conference addresses specific methodologies to understand regulatory requirements for technology transfer and strategies for data sharing, knowledge management and alliance management.

Thursday Highlights:

Combine business needs with regulatory requirements for a successful site-to-site transfer with SCHERING-PLOUGH

Update: licensing agreements, intellectual property and confidentiality in technology transfer with MORGAN & FINNEGAN

Eliminate obstacles when transferring analytical methods with ELAN

Comply with cGMP requirements for cleaning validation during a tech transfer with G & W LABORATORIES

Enhance knowledge transfer including how hard and soft data is capture with ABBOTT LABORATORIES

Streamline data acquisition and enhancing data sharing processes with BAXTER HEALTHCARE

Industry Panel Discussion: ISPE Guidance Document

Day Two is a full day of technology transfer case studies detailing the process, challenges, and lessons learned with both API and drug products.

Friday Highlights:

PFIZER attains a customer-centric approach when transferring dosage forms, API's and advanced intermediates

VAXGEN secures commercial scale cell culture manufacturing capacity from facility design though operation

ELI LILLY improves process efficiencies of tech transfer during early phase development

CELLTECH PHARMACEUTICALS builds strategic partnerships for multiple transfer collaborations

FLUOR complies with international regulations for streamlined global transfers

WYETH VACCINES process requirements for both API and drug products

We have expanded the 2004 event to incorporate many API and drug product transfer scenarios including scale up technology transfer, biologics technology transfer, and technology transfer to contract manufacturer.