USP Workshop: Focus on Excipient Quality, Compendial Testing,
and Regulatory Impact
Excipient Workshop #2
November 17-18, 2015
USP Headquarters, Rockville, Maryland
Preliminary Agenda
(Updated August 24, 2015)
Goals and Anticipated outcomes:
• Engage stakeholders in identifying gaps in the current excipient monograph specifications for use
in pharmaceutical and biopharmaceutical industries in a global supply chain environment.
• Highlight issues, challenges and opportunities surrounding development and update of excipient
monographs in setting specifications for intended pharmaceutical use. Seek input from excipient
stakeholders, including industry (pharmaceutical/biopharmaceutical users, excipient makers,
excipient suppliers/distributors) and regulatory bodies in establishing the most appropriate
excipient specifications through modernization and harmonization initiatives given the current
complexity of pharmaceutical manufacturing and high demands of product quality.
Day 1
8:00 – 8:30 a.m.
8:30 – 8:45 a.m.
Registration and Coffee
Welcome and Introductions
Morning Session I: (8:45 - 12:00 p.m.)
Title: Strategy to bring USP-NF Excipient Monograph specifications up to date
Moderator: Jeff Medwid
Speakers: TBD
8:45 – 9:15 a.m.
Keynote Speaker:

Speaker: TBD (Excipient manufacturer/distributor perspective)
9:15 – 9:45 a.m.
Industry Perspective
Presentation 1: FDA /OPQ IID issues and potential resolutions

Speaker: Katherine Ulman , DOW Corning Accepted
9:45 – 10:10 a.m.
USP Perspective
Presentation 2: Challenges and Opportunities in Excipient Monograph
development and modernization
Workshop Preliminary Agenda (August 24, 2015)
Page 1

Speaker: Kate Houck, Chair, Excipients Monograph 2 Expert
Committee; Accepted
10:10 – 10:40 a.m.
BREAK
10:40 – 11: 10 a.m.
FDA perspective
Presentation 3: CDER Update on Recent IID Improvements

Speaker: Susan Zuk; Accepted
11:10 – 11:40 p.m.
Academic perspective
Presentation 4: Global Excipient Databases – NIPTE Overview

Speaker: Prof. Steve Hoag, UMD; Accepted
11:40 – 11:45 p.m.
PQRI Survey Results on Excipient Variability (poster presentation)

Speaker: Prof. Lawrence Block, Member, Excipients Monograph 2 and
General Chapters Physical Analysis Expert Committees; Accepted
11:45 – 12:00 p.m.
Q & A (15 min)
12:00 – 1:00 p.m.
Lunch Break
Afternoon Session II (1:00 - 5:00 p.m.)
Title: Challenges and opportunities in excipient monograph development and modernization
Moderator: Kevin Moore
Speakers: TBD
Topic 1: USP Modernization initiatives for USP-NF monographs
1:00 – 1:30 p.m.
1:30 – 2:00 p.m.
2:00 – 2:30 p.m.
2:30 – 3:00 p.m.
FDA Perspective
Presentation 5: FDA Perspective on Excipient Monograph Modernization

Speaker: Accepted
USP Perspective
Presentation 6: What Does USP-NF Up-To-Date Mean For Excipients?

Challenge faced with updating Excipient monograph specifications

Speaker: Prof. Eric Munson, Chair, Excipients Monograph 1; Accepted
Industry Perspective
Presentation 7: Challenges and Opportunities in Development of Novel
Excipients and Monographs in USP

Speaker: Shaukat Ali, BASF; Accepted
Break
Topic 2: Global Harmonization activities for excipients
Workshop Preliminary Agenda (August 24, 2015)
Page 2
3:00 – 3:30 p.m.
Presentation 8: USP Update on Harmonization/modernization activities
 Discuss current and future PDG activities
 Expert Panel update (Povidones, Talc, Glycerin)
 Prospective harmonization
 Excipient Stakeholder Forum - Project team launch and scope (bilateral
harmonization)
 Speaker: Larry Block; Accepted
3:30 – 4:00 p.m.
Presentation 9: PDG update on harmonization/modernization activities - JP

Speaker: Accepted
4:00 – 4:30 p.m.
Presentation 10: USP update on harmonization/modernization activities - ChP

Speaker: Prof. Jason Tu, Member, Excipient Monograph 2 Expert
Committee; Accepted
4:30 – 5:00 p.m.
Roundtable Discussion /Q & A (30 min) – Challenges and opportunities for
harmonization, modernization and development of excipient specifications
(presenters from Topics 1 and 2)
ALL times are tentative until we obtain acceptance.
5:00 p.m.
Adjourn
Day 2
8:00 – 8:30 a.m.
Registration and Coffee
Morning Session III (8:30 – 4:45 p.m.)
Title: Challenges and opportunities in development and modernization of excipient monographs used for
Biologics and Biotech (B&B) drug applications
Moderators: Chris Moreton, Member, Excipient Monograph 1 Expert Committee; Accepted
Speakers: TBD
8:30 – 9:00 a.m.
9:00 – 9:30 a.m.
9:30 – 10:00 a.m.
Keynote Speaker:

Speaker: Marla Phillips, Xavier Health; Accepted
USP Perspective
Presentation 1: Understanding USP’s role vis-a-vis excipients used in B&B drug
products: identifying gaps in current excipient monograph and developing
monographs for missing excipients

Speaker: TBD (EC or staff)
Regulatory Perspective
Presentation 2 (FDA): FDA review of excipient submissions in BLA

Speaker: Accepted
Workshop Preliminary Agenda (August 24, 2015)
Page 3
10:00 – 10:30 a.m.
BREAK
10:30 – 11:00 a.m.
Presentation 3 (FDA): Management of excipient data for review of Biologics

Speaker: Accepted
11:00 – 11:30 a.m.
Presentation 4 (FDA): European agencies – EMA

Speaker: TBD
11:30 – 12:00 p.m.
12:00 – 1:00 p.m.
1:00 – 1:30 p.m.
Industry Perspective
Presentation 5: Impact of raw material variability for upstream/downstream
processes to Drug Substance quality attributes and yield.

Speaker: TBD
Lunch Break
Industry Perspective (Contd.)
Presentation 6: Drug product manufacturer’s perspective on use of
pharmaceutical excipients in B&B finished final product/ formulation

Speaker: TBD
1:30 – 2:00 p.m.
Presentation 7: Excipient manufacturer’s perspective on pharmaceutical
excipients used for B&B finished final product/formulation use

Speaker: Dora Meissner, BioSpectra; Accepted
2:00 – 3:30 p.m.
Parallel Breakout Sessions: Rationalization of Terminology used in upstream
process/final formulations for B&B application. Breakout sessions will explore
and report back on learnings relating to the use of the current terminology and
provide recommendations/path forward.
 Moderator(s): TBD – Four accepted
Closing Summary
3:30 – 3:45 p.m.
3:45 – 4:00 p.m.
4:00 – 4:45 p.m.
Session I
Session II
Session III
15 min
15 min
15 min
ALL times are tentative until we obtain acceptance.
4:45 p.m.
Adjourn
Workshop Preliminary Agenda (August 24, 2015)
Page 4