Agenda – 6th Technology Transfer for Biologics

  • Day One
  • Day Two

Day One

 Monday, September 23

9:15AM – 10:15AM

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

10:15AM – 11:00AM

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

11:00AM – 11:30AM

Networking Break

11:30AM – 12:30PM

A Road Map to Collaboration and How to Overcome Obstacles Throughout the Tech Transfer Process
Moderator:
Jim Leverone, Senior Engineer, Manufacturing Sciences, IMMUNOGEN

12:30PM – 1:30PM

Luncheon

1:30PM – 2:15PM

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

2:15PM – 3:15PM

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

3:15PM – 3:45PM

Networking Break

3:45PM – 4:45PM

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

10:15AM – 11:15AM

Ensure the Use of Improvement Tools to Increase the Likelihood of Technology Transfer Success
Lei Lei Sengchanthalangsy, Senior Director Project Management, EMERGENT BIOSOLUTIONS
Daniel Rudolph, Ph.D., Principal Engineer, Manufacturing Development, BioDefense Division, EMERGENT BIOSOLUTIONS

11:15AM – 11:45AM

Networking Break

11:45AM – 12:30PM

A Holistic Approach to the Management Process From Transfer to Manufacturing
Claudia Buser, Scientific Director, SANOFI GENZYME

12:30PM – 1:15PM

Explore Methods to Leverage an Accelerated Technology Transfer
Jody Logan, Senior Manufacturing Technical Specialist, GENENTECH

1:15PM – 2:15PM

Luncheon

2:15PM – 3:15PM

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

4:00PM –

Closing Remarks