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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

8:45 – 9:00

Co-Chairperson’s Opening Remarks


Ben Locwin, Senior Vice President of Quality, LUMICELL
TBD representative from THERMO FISHER SCIENTIFIC

9:00 – 9:45

Keynote Address


Ben Locwin, Senior Vice President of Quality, LUMICELL

9:45 – 10:30

Lessons Learned: Tech Transfer in Emerging Markets and Risk Management


Eyad Salman, Principle Quality Site Manager, GENENTECH

10:30 – 11:00

NETWORKING BREAK


11:00 – 11:45

Seven Stages of Lifecycle Management for Risk Assessment


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

12:30 – 1:30

LUNCHEON


1:30 – 2:15

Refine the Relationship Between Drug Product Quality and Timeline


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

2:15 – 3:00

A Quality Perspective: Drive Success Through Effective CMO Selection


Naymisha Patel, Vice President, Quality, OCULAR THERAPEUTIX

3:00 – 3:30

NETWORKING BREAK


3:30 – 4:15

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


Heidi Hoffman, Executive Director, CMC and Supply Chain, SUTRO BIOPHARMA
If you are interested in joining this panel, please contact Christopher Summa at csumma@questex.com or 917-932-0432.

4:15 – 5:30

CMO/CDMO SHOWCASE


A select few manufacturing and development organizations will present to an audience filled with key decision-makers. This
showcase will give the attendees a look into the inner-workings or CMOs and CDMOs of varying sizes.

  • 15-minute blocks designed solely for CMO & CDMO professionals
  • Take center stage and deliver insightful content and experiences to your targeted buyers
  • Present a case study that details your facilities, capabilities, resources, and competitive advantages
  • Answer questions received directly from decision-makers in the audience

TBD representative from THERMO FISHER SCIENTIFIC
If you would like to join the CMO/CDMO showcase, please contact Christopher Summa at csumma@questex.com or 917-932-0432.

5:30 – 5:30

DAY ONE CONCLUDES



DAY TWO

 TUESDAY, 24 SEPTEMBER 2019

8:45 – 9:00

Chairperson’s Recap of Day One


Ben Locwin, Senior Vice President of Quality, LUMICELL
TBD representative from THERMO FISHER SCIENTIFIC

9:00 – 9:45

A Risk-Based Approach for Managing Projects With CMOs


Jayet Moon, Quality Engineering Lead, TERUMO MEDICAL

9:45 – 10:30

Improve Efficiency and Collaboration Through CMO Relationship Management


Scott Duncan, Director of CMC, CENTREXION THERAPEUTICS

10:30 – 11:00

NETWORKING BREAK


11:00 – 11:45

PANEL DISCUSSION: Improve Vendor Relationships to Create Operational Excellence


Scott Duncan, Director of CMC, CENTREXION THERAPEUTICS
Jim Stahl, Senior Director of Analytical Development, PROMEDIOR

11:45 – 12:30

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

12:30 – 1:30

LUNCHEON


1:30 – 2:15

Contract Negotiation Strategies That Help Align Quality and Supply Goals


Gerd Kochendoerfer, Senior Vice President, Head of Operations, PELLEPHARM
Terry Novak, Chief Operating Officer, TEDOR PHARMA

2:15 – 3:00

Establish Quality Systems and Prepare for FDA and EMA Inspections


Amnon Eylath, President, BROAD SPECTRUM GXP COMPLIANCE

3:00 – 3:45

Lessons Learned: China Rx: Exposing the Risks Associated With Outsourcing


Rosemary Gibson, Author of China Rx, Senior Advisor, THE HASTINGS CENTER


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