Attendee Registration: https://www.regonline.com/cpa2016
The $395 registration fee includes entrance to the exhibit hall, conference sessions, breakfast, lunch, the networking cocktail reception, and refreshment breaks!
Conference Agenda
Thursday, September 22: Exhibit Hall Hours 10:00 a.m. – 4:00 p.m.
8:30-9:15 Breakfast – sponsored by Emergent BioSolutions
9:15-9:20 Opening remarks, Moderator Frank Chrzanowski
9:20-10:00 Economies of Capability vs. Economies of Scale: Advancing CMO Decisions, Peter Stevenson, Pfizer
10:00-11:15 Mid-morning break in exhibit hall – sponsored by AbbVie
11:20-12:00 Serialization CMO Onboarding: Governance, Process and Lessons Learned, Chris Hauck, Allergan; Dawn Wang, KPMG
12:00-1:30 Lunch – sponsored by Pfizer CentreOne
1:30-2:00 Investigator Insights: Preparing for and Successfully Facilitating an FDA Inspection, Liatte Krueger, FDA
2:00-2:30 The CMO Landscape: Trends Update, Jim Miller, Pharmsource
2:30-3:00 Sustainable Materials Management in the Pharma Supply Chain, Mathy Stanislaus, U.S. EPA
3:15-4:00 Break in exhibit hall – sponsored by Pharma Tech Industries
4:00-5:15 Cocktail Networking Reception – sponsored by WellSpring
Friday, September 23
7:30-8:30 Breakfast
8:30-9:00 Ensuring the Integrity of Your Data at CMOs, John Avellanet, Cerulean Associates
9:00-9:30 GDUFA: Present and Future Challenges, Terri Nataline, Lachman Consultants
9:30-10:00 Biopharmaceutical Contract Manufacturing Trends, William Downey, HighTech Business Decisions
10:00-10:15 Mid-morning break
10:15-10:45 Pharmaceutical Processes: Batch or Continuous? Reality, Myth and Imagination, Girish Malhotra, Epcot International
10:45-11:30 R&D Outsourcing Panel: Ellie Krasney, Pfizer; Robert McKean, Teva; Arindam Bose, AbiologicsB
11:30-11:45 Closing Remarks/Prize Giveaway, Moderator Frank Chrzanowski
Conference Speakers include:
• Peter Stevenson, vice president and general manager, portfolio management, Global Established Pharma (GEP) Division, Pfizer
• Christopher Hauck, director, global serialization, Allergan
• Dawn Wang, manager, KPMG Life Science Advisory
• Liatte Krueger, consumer safety officer/investigator drug specialist, FDA
• Jim Miller, founder and president, Pharmsource
• Mathy Stanislaus, assistant administrator, Office of Land and Emergency Management (OLEM), EPA
• John Avellanet, founder and principal, Cerulean Associates
• Terri Nataline, principal consultant, Lachman Consultants
• William Downey, president, HighTech Business Decisions
• Girish Malhotra, president, Epcot International
• Robert McKean, vice president, chemistry, manufacturing & controls (US), Teva Pharmaceuticals
• Ellie Krasney, associate research fellow, Pfizer
• Arindam Bose, partner, AbioligicsB