Midwest Regional Forum 2020 - Day 1
Sep 9, 2020 9:00am ‐ Sep 9, 2020 12:00pm
Chair(s):
- Julie Heflin, Abbvie, Inc.
- Tom Schomogy, Pfizer, Inc.
Speaker(s):
- Patricia Hughes, CDER, FDA, CDER, FDA
- Lutz Asmus, AbbVie, Inc.
- Katrina Kearns, Pfizer, Inc.
- Rob Warburton, Eli Lilly and Company
Regulatory Perspectives on In-use Storage of Biologic Products: Phase Appropriate Microbial Challenge Studies
Sep 9, 2020 9:15am ‐ Sep 9, 2020 10:00am
A review of the regulatory requirements and guidance recommendations to support storage conditions of reconstituted and/or diluted drug products during IND development and for BLA approval will be presented. Microbial challenge study design and data analysis will be discussed. Case studies will be presented to illustrate how the microbial challenge data support the label instructions for storage conditions.
Speaker(s):
- Patricia Hughes, CDER, FDA, CDER, FDA
Antimicrobial Effectiveness Testing: A Case Study in Finding the Right Balance
Sep 9, 2020 10:40am ‐ Sep 9, 2020 11:10am
Antimicrobial effectiveness testing (AET) is used to confirm that preservative included in a formulation or diluent is effective at inhibiting growth of microorganisms, and AET is a requirement for multi-use drug products. This talk summarizes basic concepts of AET and discusses when testing is necessary. A case study is presented that highlights the need to understand AET variability and its relationship to preservative concentration during early development of a multi-dose program.
Speaker(s):
- Katrina Kearns, Pfizer, Inc.
Panel and Q&A*
Sep 9, 2020 11:15am ‐ Sep 9, 2020 11:55am
*Speaker Lutz Asmus has not allowed the sharing of slides or the archived recording.
Chair(s):
- Tom Schomogy, Pfizer, Inc.
Panelist(s):
- Lutz Asmus, AbbVie, Inc.
- Patricia Hughes, CDER, FDA, CDER, FDA
- Katrina Kearns, Pfizer, Inc.
- Rob Warburton, Eli Lilly and Company
Summary and Adjournment
Sep 9, 2020 11:55am ‐ Sep 9, 2020 12:00pm
Chair(s):
- Julie Heflin, Abbvie, Inc.
Midwest Regional Forum 2020 - Day 2
Sep 10, 2020 9:00am ‐ Sep 10, 2020 12:00pm
Chair(s):
- Tom Schomogy, Pfizer, Inc.
- Julie Heflin, Abbvie, Inc.
Speaker(s):
- Sarah Demmon, Eli Lilly and Company
- Dan Boisvert, Pfizer, Inc.
- Bhargav Patel, AbbVie, Inc.
Welcome Day 2
Sep 10, 2020 9:00am ‐ Sep 10, 2020 9:05am
Analytical Considerations for Low Dose DAI Studies
Sep 10, 2020 9:30am ‐ Sep 10, 2020 9:55am
Dosage Administration Instructions are required prior to clinical dosing throughout a product lifecycle. Oftentimes, multi-specific antibodies as well as traditional antibodies are evaluated at dosing ranges (protein concentrations) significantly below the analytical capacity of product specific or platform established methods. This requires coordination between clinicians, formulators, and analytical groups. The material presented provides an overview of Pfizer’s analytical approach, describing a pre-verification workflow employed to rapidly identify alternative methods. In addition, there will be a discussion of alternative methods used in DAI studies and development considerations for these studies. Finally, a case study will be discussed in which these concepts were applied successfully.
Speaker(s):
- Dan Boisvert, Pfizer, Inc.
Panel and Q&A
Sep 10, 2020 9:55am ‐ Sep 10, 2020 10:30am
Panelist(s):
- Sarah Demmon, Eli Lilly and Company
- Dan Boisvert, Pfizer, Inc.
