4th Technology Transfer for Biologics -

4th Technology Transfer for Biologics
October 16 - 17, 2017
Boston, MA

Maximizing Quality Control in Technology, Facilities and Project Management as You Transfer and Scale Up Bioprocessing for New Molecules and Markets

Agenda – 4th Technology Transfer for Biologics



Day One

 Monday, October 16, 2017

9:15AM – 10:30AM

IN-DEPTH WORKSHOP: Improve the Design of Your Tech Transfers to Eliminate Risks and Accelerate Project Timelines


John Herberger, Chief of Staff, New Product Introductions (API), AMGEN

10:30AM – 11:00AM

Networking Break


11:00AM – 12:15PM

Workshop Resumes


12:15PM – 1:15PM

Luncheon


 MAINTAIN QUALITY CONTROL DURING EVERY STEP

1:15PM – 2:00PM

Ensure Quality of Biologics During Upstream Engineering


Seth Kitchener, Associate Director, Cell Line and Upstream Process Engineering, IMMUNOGEN

2:00PM – 2:45PM

CASE STUDY: An Overview of Quality by Design (QbD) for Technology Transfers


Emily Xiao, Scientist, BRD Formulation and Stability Platform, SANOFI PASTEUR

2:45PM – 3:15PM

Networking Break


3:15PM – 4:00PM

Key Considerations for Safeguarding Biologics During Technical Transfers


Adnan Sabir, QA Associate Director, KOWA PHARMACEUTICALS

5:00PM – 5:00PM

Day One Concludes



Day Two

 Tuesday, October 17, 2017

8:00AM – 9:00AM

Continental Breakfast


 EFFECTIVE LICENSING, OUTSOURCING, AND PARTNERING

9:15AM – 10:00AM

CASE STUDY: Improve Biopharmaceutical Licensing to Advance Global Public Health


Steven Ferguson, Special Advisor, NIH OFFICE OF TECHNOLOGY TRANSFER

10:00AM – 10:45AM

Identify Critical Stage Gates for Biological Technology Transfers


Robert Beall, Director, Product Lifecycle Management, PROPHARMA GROUP

10:45AM – 11:15AM

Networking Break


11:15AM – 12:00PM

Analyze Hot Topics in Outsourcing, Technology Transfers, and Supply Chains


Pankaj Paranjpe, Director of Biologics Manufacturing-Drug Product, CELGENE
Adam Elhofy, CSO, Bio-Ess Laboratories
Kumar Dhanasekharan, Senior Director and Head, Biologics Process and Analytical Development, AMICUS THERAPEUTICS

12:00PM – 12:45PM

Considerations for Partnering With CMOs, CDMOs, and Contract Laboratories for Late State Product Development and Future Commercial Manufacturing


Nick Vrolijk, Vice President, Manufacturing Operations, CELLDEX THERAPEUTICS

12:45PM – 1:45PM

Luncheon


1:45PM – 2:30PM

Best Practices to Identify Risks and Streamline Management of Your Technology Transfers


Jose Caraballo, Director of Quality, Product Quality Steward, Product Supply Biotech, BAYER

2:30PM – 3:15PM

A Call for Further Guidance on Quality by Design and Process Analytical Technology


Adnan Sabir, QA Associate Director, KOWA PHARMACEUTICALS
Kumar Dhanasekharan, Senior Director and Head, Biologics Process and Analytical Development, AMICUS THERAPEUTICS

3:30PM – 3:30PM

Conference Concludes



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