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9th CMO Quality Oversight & Risk Management Summit - Hyatt Regency Boston Harbor

9th CMO Quality Oversight & Risk Management Summit
September 23 - 24, 2019
Hyatt Regency Boston Harbor
Boston, MA

Enhance the collaboration of sponsors and CMOs by understanding the complexities of risk management, quality systems and vendor relationships.

Agenda – 9th CMO Quality Oversight & Risk Management Summit



DAY ONE

 MONDAY - 23 SEPTEMBER 2019

9:00 – 9:15

Co-Chairpersons' Opening Remarks


Ben Locwin, Senior Vice President of Quality, LUMICELL
Bill Weiser, Senior Director, Pharmaceutical Development Services, THERMO FISHER SCIENTIFIC

9:15 – 10:00

Keynote Address


Ben Locwin, Senior Vice President of Quality, LUMICELL

10:00 – 10:45

Lessons Learned: Tech Transfer in Emerging Markets and Risk Management


Eyad Salman, Principle Quality Site Manager, GENENTECH

10:45 – 11:15

NETWORKING BREAK


11:15 – 12:00

Seven Stages of Lifecycle Management for Risk Assessment


Adnan Sabir, Principal Consultant, Pharma Consulting Services, Former Associate Director of QA, KOWA PHARMACEUTICALS

12:45 – 1:45

LUNCHEON


1:45 – 2:30

Refine the Relationship Between Drug Product Quality and Timeline


Li-Chung Huang, Executive Director, CMC Management, WUXI BIOLOGICS

2:30 – 3:15

A Quality Perspective: Drive Success Through Effective CMO Selection


Naymisha Patel, Vice President, Quality, OCULAR THERAPEUTIX
Simon Levett, Director, Compliance QA, OCULAR THERAPEUTIX

3:15 – 3:45

NETWORKING BREAK


3:45 – 4:30

PANEL DISCUSSION: Outsourcing Models: Evaluate and Understand the Different Services Offered by Various CDMOs to Aid Your Selection Process


Moderated by:
Ben Locwin, Senior Vice President of Quality, LUMICELL
Panelists:
Adnan Sabir, Principal Consultant, Pharma Consulting Services, Former Associate Director of QA, KOWA PHARMACEUTICALS
Heidi Hoffman, Executive Director, CMC and Supply Chain, SUTRO BIOPHARMA

4:30 – 4:30

Day One Concludes



DAY TWO

 TUESDAY, 24 SEPTEMBER 2019

9:00 – 9:15

Co-Chairpersons' Recap of Day One


Ben Locwin, Senior Vice President of Quality, LUMICELL
Bill Weiser, Senior Director, Pharmaceutical Development Services, THERMO FISHER SCIENTIFIC

9:15 – 10:00

A Risk-Based Approach for Managing Projects With CMOs


Jayet Moon, Quality Engineering Lead, TERUMO MEDICAL

10:00 – 10:45

Improve Efficiency and Collaboration Through CMO Relationship Management


Scott Duncan, Director of CMC, CENTREXION THERAPEUTICS

10:45 – 11:15

NETWORKING BREAK


11:15 – 12:00

PANEL DISCUSSION: Improve Vendor Relationships to Create Operational Excellence


Moderated by:
Ben Locwin, Senior Vice President of Quality, LUMICELL
Panelists:
Nadine Jahn, Third Party Quality Management, BOEHRINGER INGELHEIM INTERNATIONAL GMBH
Gerd Kochendoerfer, Senior Vice President, Head of Operations, PELLEPHARM
Scott Duncan, Director of CMC, CENTREXION THERAPEUTICS
Jim Stahl, Senior Director of Analytical Development, PROMEDIOR

12:00 – 1:00

LUNCHEON


1:00 – 1:45

Lessons Learned: Utilize Centers of Excellence to Improve End-to-End CMO Management


Jonathan Patroni, Global Head of Quality Assurance, gulations Jonathan Patroni, Global Head ofQuality Assurance, K

1:45 – 2:30

Contract Negotiation Strategies That Help Align Quality and Supply Goals


Gerd Kochendoerfer, Senior Vice President, Head of Operations, PELLEPHARM
David Vario, VP of Quality, TEDOR PHARMA

2:30 – 3:15

Establish Quality Systems and Prepare for FDA and EMA Inspections


Amnon Eylath, President, BROAD SPECTRUM GXP COMPLIANCE


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