2018 Conference Speakers & Topics (please check back for 2019 details)

Wednesday, September 26th: Registration and exhibitor setup: 7:30 p.m.- 8:30 p.m.
A Reception will be held 8pm – 9pm Sponsored by Federal Equipment

Thursday, September 27, 2018

8:30-9:15    Continental Breakfast     Sponsored by Emergent BioSolutions

9:15-9:20    Opening remarks    Moderator Dr. Frank A. Chrzanowski

9:20-10:00    Keynote Pharma Future: Trends Driving
Innovation & Successful Collaboration    • Ben Locwin, Karyopharm Therapeutics

10:00-11:15    Mid-morning break in Exhibit Hall    Sponsored by AbbVie

11:15-12:00    FDA Keynote Mutual Recognition of Inspections &
Pharma Manufacturing Compliance Trends    • Brian Hasselbalch • FDA, CDER

12:00-1:30    Luncheon in Exhibit Hall

1:30-2:00    Pfizer Keynote Pfizer’s External Drug Product
Planning and Management    Paul McGuirk • Pfizer

2:00-2:30    CMO & CDMO Market Analysis    David Windley • Jefferies

2:30-3:00    Data Integrity Executive Panel
Rob Marohn • Kite Pharma
John Moser • Gilead
Jose Jusino • Kite Pharma
Juan Wu • Roche

3:00-4:00    Haagen-Dazs Break in Exhibit Hall & Prize Drawings    Sponsored by Advanced Analytical Labs
Grand Prizes sponsored by: Jubilant, Catalent, SGS, AbbVie

4:00-5:15    Networking and Cocktail Reception    Sponsored by ANI / WellSpring

Friday, September 28, 2018

7:30-8:30    Continental Breakfast    Sponsored by Grand River Aseptic Manufacturing

8:30-9:00    FDA & Data Integrity at Suppliers     John Avellanet • Cerulean Associates

9:00-9:30    Quality Metrics Guidance    Donna Gulbinski • Lachman Consultants

9:30-10:00    FDA Keynote Investigator Updates & Insights    Jogy George • FDA, NJ Dist.

10:00-10:15    Mid-morning Break

10:15-10:45    Drug Development and Partnerships with CDMOs    Jim Spavins • Spavins Consulting

10:45-11:30    R&D Outsourcing panel    Marazban Sarkari • Teva
Arindam Bose • AbiologicsB
Jim Spavins • Spavins Consulting

11:30-11:45    Closing Remarks / Prize Giveaway    Moderator Dr. Frank A. Chrzanowski