A Two-Day Educational Experience and Pharma Expo with in-depth Workshops &

Educational Sessions from Industrys Top-Excipient Experts

Workshop DAY
Monday, April
25th

DAY 1
Tuesday, April 26th

Workshops I, II, III & IV

(9:00AM 4:00PM)
Workshops V, VI, VII & VIII
(9:00AM 4:00PM)

Key-Note Speaker (8:15AM 9:15AM)

Pharma Expo (8:30AM 6:00PM)
Poster Sessions (9:00AM 6:00PM)
Educational Sessions (9:15AM 3:00PM)
Lunch (12:00PM 1:30PM)
Poster Session Q&A (3:00PM 3:45PM)
Key-Note Speaker (3:45PM 4:15PM)
Speakers Roundtable (4:15PM 5:00PM)
ExcipientFest Cocktail (5:00PM 6:30PM)
th
IPEC 25 Anniversary Dinner (7:00 PM)

DAY 2
Wednesday, April 27th

Pharma Expo (8:30AM 6:00PM)

Poster Sessions (9:00AM 6:00PM)
Key-Note Speaker (9:00AM 9:45AM)
Educational Sessions (9:45AM 3:00PM)
Lunch & Poster Awards (12:00PM 1:30PM)
Key-Note Speaker (3:15PM 4:00AM)
ExcipientFest Cocktail (4:00PM 5:30PM)

Educational Sessions
DAY 1
From 7:00 AM

Tuesday, April 26

(*Invited Speaker)
th

Registration, Coffee & Pastries

Conference Hall A (Expo Area)

8:15 AM
8:30 9:15 AM
9:15 9:30 AM
9:30 10:15 AM
10:15 11:00 AM
11:00 11:30 AM
11:15 12:15 PM

Conference Hall B (Expo Area)

Welcome Speech
Dwight Mutchler ExcipientFest President and John Giannone - IPEC Americas Chair
KEY-NOTE SPEAKER: Excipient Evolution, past, present and future (Drivers and Challenges) Irwin Silverstein and Virginia Wotring,
Science & Technology Integration Manager at National Space Biomedical Research Institute
Coffee & Networking Break
The Art of Masking Hard-to-Mask Flavors Beverly Schad,
Sensient
Family Approach to Excipient Safety Review David
Schoneker, IPEC Americas
Coffee & Networking Break
Supplier Management: A Proactive Mindset Michael Barga,
MSD

Novel Excipients - Importance for Both Small Molecule and Biopharma Ray David, Chair of
the ACC Nanotechnology Panel
Compression of MCC Spheres In Tablets, Associated Challenges and Solutions
Tony Carpanzano, JRS Pharma LP
FDA/NIH Global Ingredient Archival System (GInAS) Project Launch Larry Callahan, FDA

12:15 1:30 PM

Lunch and Networking

1:30 2:15 PM

Effect of Common Excipients on the Oral Drug Absorption

of Biopharmaceutics Classification System Class 3 Drugs
James Polli, University of Maryland

Sustained Release Tablets Using a PVA DC Formulation Resistant to Alcohol Induced Dose
Dumping Dieter Lubda, MilliporeSigma

2:15 3:00 PM

The Cost of (Poor) Quality Jim Morris, NSF Health Sciences

The Importance of Lifecycle Supply Chain Oversight Rick Friedman, FDA

3:00 3:30 PM

Poster Q&A Session & Coffee Break

3:30 4:15 PM

KEY-NOTE SPEAKER: Jair Calixto: New Brazilian Regulations

4:15 5:00 PM

SPEAKERS ROUND TABLE: Demonstrating Compendial Compliances (Invited Speakers from FDA, USP, Rx Pharma Company, Gx Pharma
Company, Priscilla Zawislak Ashland, Nigel Langley,BASF Corp.

5:00 6:30 PM

ExcipientFest Cocktail with Live Music

DAY 2
From 7:30 AM

Wednesday, April 27th

Registration, Coffee & Local Pastries

Conference Hall A (Expo Area)

Conference Hall B (Expo Area)

9:00 9:45 AM

KEY-NOTE SPEAKER: How Does Modality Affect Excipient Expectations for Biotech Products - Robert Posgai, Biogen

9:45 10:30 AM

Coffee Break & Networking Break

Putting the ANSI Standards to Practice Dale Carter (IPEC
Americas)
Traceability in continuous manufacturing paradigm - Brian
Carlin and Michael Sestrick, FMC Corporation

10:30 11:15 AM
11:15 12:00 PM

The application of Kollicoat IR as a 'Zero Peroxide' Binder for Use in Solid Oral Dosage
Forms Nigel Langley, BASF Corporation
EU Guideline: Formalised Risk Assessment for Ascertaining the Appropriate GMP for
Excipients of Medicinal Products for Human Use Kaat Bracquine

12:00 1:30 PM

Lunch and Networking Award Presentation for Academic Posters

1:30 2:15 PM

3:00 3:15 PM

Chemical Screening: The Missing Link in Serialization and

Track & Trace Ravi Kalyanaraman, BMS
Medical Marijuana: Cannabinoid Delivery by a Novel Sublingual
Technology - David Schaible
Coffee Break & Networking Break

3:15 4:00 PM

KEY-NOTE SPEAKER: Excipient Regulatory Strategy for Emerging Dosage Forms - Susan Zuk, FDA & Meera Raghuram. IPEC Americas

4:00 6:00 PM

ExcipientFest Cocktail

2:15 - 3:00 PM

Lubritose Mannitol: A Potentially New Co-Processed Excipient, for Oral Solid Dose - Vivek S.
Dave., Wegmans School of Pharmacy
Practical Applications of the New GMP Standards Ann Van Meter, IPEC Americas

www.excipientfest.com

Half-Day Workshops

Speaker Biographies and Detailed Workshop Outlines Available at www.excipientfest.com

DAY 1 April 25

th

- Monday

Microstructure of topical formulations

9:00 AM 12:00 PM

(Conference Room: Federal Hill)

Presented by BASF Corp.:.
Workshop Leader: Norman Richardson and Amy Ethier
Colorcon Coating School Program

AM Workshops

II

9:00 AM 12:00 PM

(Conference Room: Mt. Washington)

Presented by Colorcon: Colorcon is a world leader in the development, supply and technical support of formulated film coating systems, modified
release technologies, and functional excipients for the pharmaceutical industry.
Workshop Leader: Laura Scattergood and Piyush Patel (Colorcon)
Global Regulatory Perspectives AM

III

9:00 AM 12:00 PM

(Conference Room: Fellspoint)

Presented by IPEC: The industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality
standards for pharmaceutical excipients and excipient delivery systems.
Workshop Leaders: Dale Carter and Janeen Skutnik (IPEC Americas)
Overview/Updates on new or revised IPEC guides recently published or revision in progress
(Conference Room: Guilford)
9:00 AM 12:00 PM

IV

Presented by IPEC: The industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality
standards for pharmaceutical excipients and excipient delivery systems.
Workshop Leader: Bretta Lichtenhan and Heather Sturtevant (IPEC Americas)
Understanding Elemental Impurity Analyses in Preparation for the Upcoming USP <232/2232/233> Transition
(Conference Room: Federal Hill)
1:00 PM 4:00 PM

Presented by Chemical Solutions Ltd.

Workshop Leader: Francine Walker, Technical Director
EU FMD Risk Assessment Are You Ready?

PM Workshops

VI

1:00 PM 4:00 PM

(Conference Room: Fellspoint)

Presented by IPEC: The industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality
standards for pharmaceutical excipients and excipient delivery systems.
Workshop Leaders: Dale Carter and Bretta Lichtenstein (IPEC Europe)
Excipient Supplier Quality Management (Conference Room: Guilford)

VII

1:00 PM 4:00 PM

Presented by IPEC: The industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality
standards for pharmaceutical excipients and excipient delivery systems.
Workshop Leader: Irwin Silverstein (IBS Consulting)

VIII

Global regulatory strategy for excipients (PM)

1:00 PM 4:00 PM

(Conference Room: Fellspoint)

Presented by IPEC: The industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality
standards for pharmaceutical excipients and excipient delivery systems.
Workshop Leader: Meera Raghuram, Kathy Ulman and David Schoneker (IPEC Americas)

Attendance Fees

Total Conference Expo: $390

Two-Day admissions pass to Expo, Educational Sessions,
Lunches and Cocktails.
o
IPEC Anniversary Dinner: $100

Total Conference Workshop: $540

Includes all above and participation in one of several
workshops on April 25th.

Hotel Accommodations
Renaissance Harborplace Hotel, Baltimore, MD
ExcipientFest Rates:
$209 per night from April 26th through May 1st.
Deadline: March 26th or until rooms last.

www.excipientfest.com