8th CMO Quality Oversight & Risk Management Summit - Boston, MA

8th CMO Quality Oversight & Risk Management Summit
March 21–22, 2018
Boston, MA
Boston, MA

Ensuring Compliance and Robust Partnerships Through Rigorous Discourse and Disseminations of Tactical Operations, Oversight and Quality Systems

Agenda – 8th CMO Quality Oversight & Risk Management Summit

Day One


10:00AM – 10:45AM

Ensure Quality Through Effective Relationship Management and CMO Support

Natasha Bussard, Director of Research and Development, UPM PHARMACEUTICALS
Laura Kalegaric, Associate Director, Quality Assurance, AKEBIA THERAPEUTICS

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

Support Inspection and Audit Readiness Through Culturally Sensitive Oversight and Management 

Sonali Balwani, Quality Control, Lead, ADVAXIS

12:00PM – 1:00PM


1:00PM – 1:45PM

Assure Quality With Collaborative Ventures From Disparate Deal Types

Joseph Kudla, Associate Director QA Operations/Systems, ASTRAZENECA/MEDIMMUNE

1:45PM – 2:30PM

Case Study: Mitigate Risk Through Cultural Change and Mindset Management

Wendy Summers, Director of Quality, CHIESI USA

2:30PM – 3:15PM

Case Study: Avoid Surprises by Performing Robust Due Diligence in Partner Selection

Suzanne Murray, VP of Quality, AGIOS PHARMACEUTICALS

3:15PM – 3:45PM

Networking Break

3:45PM – 4:30PM

Case Study: Hear Celgene's Approach to Streamlining Procedures

Eva Urban, Senior Manager, OpEx Risk Management, CELGENE

4:30PM – 5:15PM

Maintain the Top Position on Your CMO’s Priority Ladder

Julia N. Hart, Head of Quality, APTEVO THERAPEUTICS

5:15PM – 6:00PM

Case Study: Limit the Impact of Product Recall From Purdue's Interactions With CMOs

Gerald Zemble, Senior Quality Manager, PURDUE PHARMACEUTICALS

Day Two


8:00AM – 9:00AM

Continental Breakfast

9:15AM – 10:00AM

Compare and Contrast Technical (Quality) Agreements Guidelines in the U.S. and the EU

Nadine Jahn, Senior Manager, Third Party Quality Management, BOEHRINGER INGELHEIM

10:00AM – 10:45AM

Case Study: Discuss CMO-Owner Collaboration in Continuous Manufacturing that Maintains Quality While Maximizing Savings  

Michelle Bailey, Associate Director, Validation for Continuous Manufacturing and Automation, VERTEX

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

Achieve Organizational Excellence and a Culture of Quality: Medtronic's Approach

Prakash Patwardhan, Director of Corporate Quality, MEDTRONIC

12:00PM – 12:45PM

Negotiate a Quality Agreement, As a Supplier, With a Business Partner That Has Licensed Your Drug

Amnon Eylath, Associate Vice President, Head of Quality, KARYOPHARM THERAPEUTICS

12:45PM – 1:45PM


1:45PM – 2:30PM

Explore the Difference Between Quality Agreements and Contract Manufacturing in the U.S. and Canada

Sandra Edwards, Director, Corporate Quality Compliance and Risk Management, TARO PHARMACEUTICALS

2:30PM – 3:15PM

Case Study: Study Lessons Learned in Tech Transfers in Emerging Markets

Eyad Salman, Principal Quality Site Manager, GENENTECH

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