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 DATA EVALUATION TO SUPPORT THE DISTRIBUTION OF MEDICINAL PRODUCTS
Joseph Zelhof, Director, Global Stability, BRISTOL-MYERS SQUIBB

10:45AM – 11:15AM

NETWORKING BREAK

11:45AM – 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

IMPLEMENT A RISK-BASED APPROACH FROM DEVELOPMENT THROUGH COMMERCIALIZATION
Emily S. D. Trubee, M.S., Stability Manager, R&D, ADARE PHARMACEUTICALS

2:30PM – 3:15PM

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

3:15PM – 3:45PM

NETWORKING BREAK

3:45PM – 4:45PM

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

4:45PM – 4:45PM

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
Joseph Zelhof, Global Stability, BRISTOL-MYERS SQUIBB

10:00AM – 10:45AM

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

10:45AM – 11:15AM

NETWORKING BREAK

11:15AM – 12:00PM

REGULATORY FILING AND REPORTING REQUIREMENTS FOR STABILITY TESTING
Joshua Ayers, Senior Director, Analytical CMC, ASTRAZENECA

12:00PM – 1:00PM

LUNCHEON

1:00PM – 1:45PM

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

1:45PM – 2:30PM

STABILITY IN THE INTERNATIONAL OTC AND NUTRITIONAL SUPPLEMENT INDUSTRY
Chris Vitkun, Analytical Chemist/Stability Systems, A&Z PHARMACEUTICALS, INC.

2:30PM – 2:30PM

CONFERENCE CONCLUDES