Agenda – Stability Testing Summit

  • MAIN CONFERENCE DAY ONE
  • MAIN CONFERENCE DAY TWO

MAIN CONFERENCE DAY ONE

 MONDAY, SEPTEMBER 23, 2019

8:00AM – 9:00AM

CONTINENTAL BREAKFAST

9:00AM – 9:15AM

INTRODUCTION FROM CHAIRPERSON
Peju Odunusi, Ph.D., Group Leader, Stability, ABBOTT VASCULAR

9:15AM – 10:00AM

ALIGN STABILITY TESTING AND VALIDATION THROUGHOUT THE PRODUCT LIFE CYCLES
Peju Odunusi, Ph.D., Group Leader, Stability, ABBOTT VASCULAR

10:00AM – 10:45AM

STABILITY TESTING PROGRAM DESIGN
Heather Egland, Stability Coordination Manager, FRESENIUS KABI USA

10:45AM – 11:15AM

NETWORKING BREAK

11:15AM – 12:00PM

MONITOR OF STABILITY DATA THROUGH PRODUCT LIFE CYCLE
Anthony Chikere, Ph.D., MSAT-BT Process Management and Systems, BAYER PHARMACEUTICALS, BERKELEY CALIFORNIA

12:00PM – 12:45PM

KEY THEMES OF RECENT STABILITY-RELATED REGULATORY QUERIES: PFIZER’S STRATEGY TO MEET EVOLVING EXPECTATIONS
Amy St. Charles, Senior Principal Scientist/Group Leader of Biotherapeutics Stability, Reference Materials and Raw Materials, PFIZER

12:45PM – 1:45PM

NETWORKING LUNCH

1:45PM – 2:30PM

ESTABLISHING A STABILITY BUDGET FOR DISTRIBUTION OF BIOLOGICAL DRUG PRODUCTS
Jeremy Pariseau, Stability Lead, R&D Quality, SANOFI

2:30PM – 3:15PM

A ROAD MAP TO MANAGING AND IMPROVING A STABILITY PROGRAM
Chris Latoz, Manager Stability and Analytical Services, HOLLISTER INCORPORATED

3:15PM – 3:45PM

NETWORKING BREAK

3:45PM – 4:30PM

STABILITY STRATEGIES AND CONSIDERATIONS FOR ACCELERATED PRODUCTS
Kayla Woodlief, Senior Manager, Biologics Stability and Analytics, BIOGEN

4:30PM – 4:30PM

DAY ONE CONCLUDES


MAIN CONFERENCE DAY TWO

 TUESDAY, SEPTEMBER 24, 2019

8:00AM – 9:00AM

CONTINENTAL BREAKFAST

9:00AM – 9:15AM

DAY TWO CHAIRPERSON INTRODUCTION
Peju Odunusi, Ph.D., Group Leader, Stability, ABBOTT VASCULAR

10:00AM – 10:45AM

PREVENTING AND HANDLING STABILITY STUDY EXCURSIONS
John O’Neill, Facilitator, STABILITYHUB.COM

10:45AM – 11:15AM

NETWORKING BREAK

11:15AM – 12:00PM

ACCELERATED VS. REAL-TIME STABILITY TESTING: CLOSING THE GAP
Timothy Forsyth, Ph.D., MSAT-BT Process Management and Systems, BAYER PHARMACEUTICALS, BERKELEY CALIFORNIA

12:00PM – 1:00PM

LUNCHEON

1:00PM – 1:45PM

REGULATORY FILING AND REPORTING REQUIREMENTS FOR STABILITY TESTING
Joshua T. Ayers, Ph.D., Former Stability Manager, ASTRAZENECA

1:45PM – 2:30PM

STABILITY BATCH SELECTION AND EXPIRY ASSIGNMENT CONSIDERATIONS FOR CLINICAL PROGRAMS
Kamran Simani, Stability Director, ALNYLAM PHARMACEUTICALS

2:30PM – 2:30PM

CONFERENCE CONCLUDES