A Two-Day Educational Experience and Pharma Expo with in-depth Workshops & .... of Going Back to the Futureâ (Mode
A Two-Day Educational Experience and Pharma Expo with in-depth Workshops & Education Sessions from Industry’s Top-Excipient Experts DAY 2 - Wednesday, May 11th
DAY 1 - Tuesday, May 10th • • • • • • • •
Keynote Speaker (8:15 - 9AM) Workshops I & II (9AM – 4PM) Educational Sessions – 12 Presentations (9:15AM – 4:15PM) Pharma Expo (9AM – 6PM) Poster Sessions (9AM – 6PM) Lunch + Keynote Speaker (12AM – 1:30PM) Speakers’ Roundtable (4:15 – 5:15PM) ExcipientFest Cocktail (5 –7PM)
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Workshops III & IV (9AM – 4PM) Educational Sessions – 12 Presentations (9:15 AM – 4:15PM) Pharma Expo (9AM – 5PM) Poster Sessions (9AM – 5:15PM Awards) Lunch + Keynote Speaker (12AM – 1:30PM) Speakers’ Round Table (4:15 – 5:15PM) ExcipientFest Cocktail (5 – 7PM)
See who is coming!
Attendance Fees •
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Total Conference Expo: $280 Two-Day admission pass to Expo, Educational Sessions, Lunches, Cocktails & Presentation Book. Total Conference Workshop: $450 Includes all above and participation in one of four th th workshops on May 10 or 11 . Workshop Group Payment Discount: 5 people or more: take $40 off each Total Conference fee (workshops not included). Must register together and have one method of payment.
Hotel Accommodations Renaissance Haborplace Hotel - Baltimore, Maryland Call 1-800-535-1201 and use Group Code: xipxipa ExcipientFest Rates: th th $179 per night from May 7 through May 13 . Deadline: April 9th, 2011 or until rooms last.
Educational Sessions DAY 1 Theme: From 7:00 AM 8:15AM -9AM Baltimore Ballroom
9:15 – 10 AM
10 – 10:45 AM 10:45 – 11:15 AM 11:15 – 12:00 PM
12:00 – 1:30 PM 1:30 – 2:15 PM 2:15 – 3:00 PM
3:00 - 3:30 PM 3:30 P- 4:15 PM 4:15 – 5:15 PM Baltimore Ballroom
(*Invited Speaker)
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Tuesday, May 10 TOTAL COST-OF-OWNERSHIP & SUPPLY CHAIN MANAGEMENT Registration, Coffee & Pastries KEY-NOTE SPEAKER: Component Control; “Changes to 21 CFR 211” Mr. Steve Wolfgang, Team Leader of Data Analysis Team, Division of Manufacturing – FDA (IPEC)
Conference Hall A (Expo Area)
Conference Hall B (Expo Area)
“Lipid Chemistry: Novel Approaches for the pharmaceutical Sciences” Mr. Damon Dalrymple - Abitec “Highly Flowable & Compactible Microcrystaline Cellulose” Mr. Masayuki Kakizawa - Asahi Kasei Coffee & Networking Break “Legislative Update; An Industry Perspective “ Mr. James Willtraut - Buchanan Ingersoll & Rooney (IPEC)
“Understanding the Total Cost of the Extended Materials Supply Chain” Ms. Londa Ritchey* - Pfizer (IPEC) “Got Value? Going beyond TCO in your supplier selection process” Mr. Alex Pena – Warner Chilcot (IPEC)
“The First Aqueous Polymeric Dispersion for Moisture Barrier and Taste Masking Applications” Mr. Nigel Langley - BASF Lunch + Speaker (Baltimore Ball Room) – “Legislative Update on Food Safety” - Congressional Staffer TBD* (IPEC) “Co-Processed Excipients: IPEC Guidelines” “A Superior Excipient for Roller Compaction and Dry Granulation” Mr. Dave Schoneker - Colorcon (IPEC) Mr.Gregory Thoorens - FMC “Co-processing & Modeling Tools for simplifying Modified “Innovative Ready- to-Use Coating Solutions for Taste Masking Applications with Release Formulations” Focus on Process Simplification” Mr. Franz Penz - Meggle Mr. Felix Specht - BioGrund Coffee Break & Networking Break “Microcrystalline Cellulose: 215 to 240, Myth or Reality?" “Isomalt in Pharmaceutical Technologies” Mr. Joseph Zeleznik - JRS Pharma Mr. Bodo Fritzsching - Beneo Palatinit SPEAKERS’ ROUND TABLE: “Continuous Manufacturing; Challenges of Going Back to the Future” (Moderated by Pharmaceutical Technology)
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Speakers from FDA - Mr. Francis Godwin ISP- Dr. Stu Porter, GEA- Mr. Mark Neidlinger, Astra Zeneca- Dr. Albert Alexander, IPEC- Mr. Chris Moreton
5:15 – 7:00 PM
Sponsored by ExcipientFest Cocktail with Live Local Music
DAY 2 Theme:
Wednesday, May 11th EXCIPIENT FUNCTIONALITY & DEVELOPING ISSUES
From 7:00 AM 9:15 – 10 AM 10 – 10:45 AM
10:45 – 11:15 AM 11:15 – 12:00 PM
12:00 – 1:30 PM 1:30 – 2:15 PM 2:15 P- 3:00 PM 3:00 - 3:30 PM 3:30 P- 4:15 PM
4:15 – 5:15 PM Baltimore Ballroom
5:15 – 7:00 PM
Registration, Coffee & Local Pastries
Conference Hall A
Conference Hall B
“Effective Cleaning of Time Release & Color Coatings” Mr. James Sullivan - Dober “USP Excipient Performance Chapter : Excipient QbD for Performance and Functionality” Ms. Catherine Sheehan- USP Coffee Break & Networking Break “Harmonization - PDG Progress” Ms. Susan DeMars - USP
“Third Party Solutions: IPEA and Excipact” Mr. Irwin Silverstein – IPEA & Mr. Dale Carter - Excipact “Characterization and Use of an Excipient in Direct Compression Tableting” Mr. James Farina – Avantor Performance Materials
“Know your Vital Excipients; Recent Developments Beyond Disintegration with Crospovidone” Mr. Wayne Camarco – ISP Pharma Lunch + Speaker (Baltimore Ball Room) – “Excipient Variability and Functionality Testing” - Mr. Steve Hoag* - University of Maryland (IPEC) “Atypical Actives” “Taste Masking and Moisture Protection” Ms. Janeen Skutnik – Pfizer (IPEC) Mr. Abhishek Kathuria - Evonik Polymers “Handling the Overpressure Challenges of Taste-Masked APIs” “Applications of HPMCAS & L-HPC for Pharmaceutical Dosage Forms” Mr. John Tillotson – SPI Pharma Mr. Sakae Obara - Shin-Etsu Coffee Break & Networking Break “FDA Excipient Library “ “Elemental Impurities - Excipient Realities” Ms. Cindy Buhse, Director, Div. Pharmaceutical David Schoneker, Colorcon (IPEC) Analysis, CDER, FDA “Spectroscopic ID Testing (USP)” Alan Potts PhD, USP SPEAKERS’ ROUND TABLE: “Excipient Functionality & Developing Issues (Moderated by Pharmaceutical Technology) Speakers from FDA- Ms. Cindy Buhse, BASF- Mr. Nigel Langley, U. of Duquesne – Mr. Lawrence Block, U. of Maryland-Mr. Steve Hoag, USP- Ms. Catherine Sheehan, IPEC- Mr. Chris Moreton Sponsored by (Academic Poster Awards & Closing Remarks) ExcipientFest Cocktail with Live Music
P.O. Box 373190, Cayey, PR 00737 Ph: (787) 714-3000, Fax: (787) 714-6000 - www.excipientfest.com
Full-Day Workshops Speaker Biographies and detailed workshop outlines available at www.excipientfest.com
9:00 AM – 4:00 PM
May 10th- Tuesday
I
Pharmaceutical Formulation on Tablet Dosage Forms (Conference Room: Homeland) Presented By Emerson Resources: An organization servicing the Pharma and Nutritional Supplement Industries. The company has three areas of focus: Formulation development and technical support, technical training and value added ingredient supply. Work Shop Leaders: Mr. Stephen Levin and Mr. Robert Tuohy - Emerson Resources
II
Functional Excipients for Modified Release and Solubility Enhancement (Conference Room: Federal Hill) Presented By Evonik Polymers: A world leader in the manufacture and supply of functional coatings for the pharmaceutical industry. EUDRAGIT polymers are used for enteric, sustained release, moisture barrier and matrix applications. Work Shop Leaders: Dr. Jian-Xin Lij & Dr. Firouz Asgarzadeh – Evonik Polymers
9:00 AM – 4:00 PM
May 11
III
- Wednesday
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Colorcon Formulation and Coating School for Hydrophilic Matrices (Conference Room: Federal Hill) Presented By Colorcon: A global manufacturer and leader in Film Coating products and Excipients for the Pharma Industry. Work Shop Leaders: Ms. Laura Scattergood and Mr. Gus LaBella – Colorcon (USA)
IV
Supplier Auditing: Qualification, Supply-Chain Security, Incoming Ingredient Approval
(Conference Room: Homeland) Presented By RX360 Work Shop Leaders: Natalie Garrett, Abbott - Director Global TPM/Supplier QA Pharmaceutical Operations
P.O. Box 373190, Cayey, PR 00737 Ph: (787) 714-3000, Fax: (787) 714-6000 - www.excipientfest.com
