Agenda – 6th Technology Transfer for Biologics

  • Day One
  • Day Two

Day One

 Monday, September 23

8:45AM – 9:00AM

Chairperson’s Opening Remarks
Karen Giraudo, Associate Director, Business Process Optimization, BioMarin Pharmaceutical

9:00AM – 10:00AM

KEYNOTE SESSION: “Ten Commandments” — The Keys to a Seamless Technology Transfer
Adnan Sabir, Principal Consultant, Pharma Consulting Services, Former Associate Director of QA, KOWA PHARMACEUTICALS

10:00AM – 10:45AM

QbD Tech Transfer to Streamline Cell Therapy Development Across Multiple Sites
Russell Beste, Sr. Director Global Process Development, MYLAN

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

A Structured Approach to Reduce Tech Transfer Lead Times Across a Company-Wide Portfolio
Sebastian Schneider, Ph.D., Group Lead Tech Transfer, Technical Product Management, F. Hoffmann La-Roche

12:00PM – 1:00PM

Streamline the Manufacturing Process of Biologics to Reduce Risk and Ensure Efficiency
Magdalena Leszczyniecka, Chief Executive Officer, President, STC BIOLOGICS
Dr. Zahra Shahrokh, Chief Development Officer, STC BIOLOGICS

1:00PM – 2:00PM

Luncheon

2:00PM – 3:00PM

Address Complications in CMO Relationship Establishment to Strengthen CMO-to-Client Connections
Jonathan Romero, Director, Biologics Development and Manufacturing, CELGENE

3:00PM – 3:30PM

Networking Break

3:30PM – 4:30PM

Remember When Engineering and Clinical Runs Were a Thing? Case Study: Direct Tech Transfer to Process Performance Qualification (PPQ)
Mitch Goetz, Senior Engineer II, BIOGEN
Carin Gray, Senior Engineer II, BIOGEN


Day Two

 Tuesday, September 24

8:45AM – 9:00AM

Chairperson’s Opening Remarks
Karen Giraudo, Associate Director, Business Process Optimization, BioMarin Pharmaceutical

9:00AM – 10:00AM

When Going Fast Isn't Fast Enough: A Comprehensive Approach to Accelerating Technology Transfer
Jody Logan, Associate Director of Tech Transfer, South San Francisco, Genentech

10:00PM – 10:45PM

A Regulatory Perspective: Government Technology Transfer Transactions
Yolanda Hawkins, Ph.D., M.B.A., Technology Transfer Specialist - Center for Drug Evaluation and Research (CDER), FDA

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

Explore a Lease Vs. Buy Scenario for Optimal Investments in the Tech Transfer Process
Joseph Mulvey, President, Ealain Technology Solutions, LLC

12:00PM – 1:00PM

Luncheon

1:00PM – 2:00PM

Case Study: Technology Transfer of Biological Processes Suitable for Rapid Response for Single-Use Facility
Daniel Rudolph, Ph.D., Principal Engineer, Manufacturing Development, BioDefense Division, MERGENT BIOSOLUTIONS

2:00PM – 3:00PM

Remain Agile and Maximize Successful Tech Transfers With the Help of Your CDMO
Mark Ramsey, Senior Manager MSAT, THERMO FISHER SCIENTIFIC

3:00PM – 3:45PM

Discuss Scalability Considerations for Technology Transfer Structures, Tools, and Systems
Jasmina Xie, Sr. Process Engineer, Technology Transfer, Bayer

3:45PM –

Chairperson's Closing Remarks
Karen Giraudo, Associate Director, Business Process Optimization, BioMarin Pharmaceutical