Presentations
ON DEMAND
· Prologue: "Grades" of Ancillary, Raw and Starting Materials and Excipients
Prologue Speaker: @Allison Radwick – USP
· Prologue: Breaking Barriers for bRo5 Molecules: Formulation Strategies for Next-Generation Therapeutics
Prologue Speaker: @Ketankumar Patel – St. John's University
· Prologue: Excipients: It's Complicated
Prologue Speaker: Chris Moreton, PhD (he/him/his) – FinnBritt Consulting
· Prologue: Preformulation and Biopharmaceutical Support for Drug Delivery
Prologue Speaker: @Andrei Blasko – Clearview Pharma Solutions LLC
Monday, October 23, 2023
Formulation and Delivery
· 9:00 AM – 10:00 AM ET Overcome Capping Challenges and Increase Tableting Speed in Direct Compression
Location:360 Stage #1 Exhibit Hall West A4-B3
Partner Presentation Speaker: @Talles Ernica – Roquette America Inc.
· 10:00 AM – 10:30 AM ET Novel Analytical Imaging and Dissolution Modeling
Location:208 AB West
Speaker: @Shawn Zhang – DigiM Solution LLC
· 10:00 AM – 10:30 AM ET Particle Engineering for High Concentration Protein Suspensions
Location:209 AB West
Speaker: @Erica Schlesinger – Seran Biosciences, LLC
· 9:00 AM – 9:30 AM ETAPI Co-Processing for Enhanced Solid Oral Dosages
Location:205 AB West
Speaker: @Rajesh Dave – NJIT
· 12:30 PM – 1:30 PM ET The Viscosity Reduction Platform: Enabling High-concentration and Low-viscosity Protein Formulations
Location:360 Stage #2 Exhibit Hall West A4-B3
Partner Presentation Speaker: Can Araman, PhD – MilliporeSigma
· 3:00 PM – 3:15 PM ET The Potential for a Ban on TiO2 (E171) Use in Pharmaceuticals and the Impact on Patients and the Industry
Location:208 AB West
Rapid Fire Speaker: @David Schoneker. – Black Diamond Regulatory Consulting/IPEC-Americas
· 3:45 PM – 4:00 PM ET Novel Strategies for Process-Related Impurity Clearance during Biologics Manufacturing
Location:205 AB West
Rapid Fire Speaker: @Aba Acquaah – Merck Research Laboratories
Manufacturing & Analytical Characterization
· 9:00 AM – 9:30 AM ET Impact of Raw Materials Variation On Continuous Feeders Performance
Location:206 AB West
Speaker: @Sara Fathollahi – DFE Pharma
· 12:30 PM – 1:15 PM ET Calcium Carbonate as Alternative to Titanium Dioxide in Coatings
Location: Spotlight Stage C Exhibit Hall West A4-B3
Chalk Talk Presenter: @Giovanni Raspantini – MilliporeSigma a Business of Merck KGaA
Tuesday, October 24, 2023
Manufacturing & Analytical Characterization
· 9:00 AM – 9:30 AM ET Small Molecule Drug In Silico Crystal Structure and Property Predictions
Location:205 AB West
Speaker: @John Shelley – Schrodinger, LLC
· 10:00 AM – 10:30 AM ET Next Generation Lab-Scale Transport Validation: Fluid Behavior and Quality Impacts
Location:205 AB West
Speaker: @Florian Rosenthal – F. Hoffman - La Roche Ltd.
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Formulation and Delivery
9:00 AM – 11:00 AM ET Symposium: Enabling Excipients and Approaches for Advancing Formulation and Delivery 1
Location:208 AB West
Moderator: @Anette Mullertz – University of Copenhagen
· 9:00 AM – 9:30 AM ET Enabling Oral Absorption of Peptides By Self-Nanoemulsifying Drug Delivery Systems
Location:208 AB West
Speaker: @Anette Mullertz – University of Copenhagen
· 9:30 AM – 10:00 AM ET Environmentally-Responsive Hydrogel Excipient Broadly Enhances Oral Bioavailability of Insoluble Drugs
Location:208 AB West
Speaker: @Doug Godfrin – VeraMorph
· 10:00 AM – 10:30 AM ET High-Throughput Screening Workflow for Amorphous Solubility and Excipient Performance
Location:208 AB West
Speaker: @Yuchen Fan – Genentech Inc.
· 10:30 AM – 11:00 AM ET Understanding Surfactant-Protein Interactions in Mitigating Interface Induced Protein Particle Formation in Biotherapeutic Solutions Subjected to Interfacial Stresses
Location:208 AB West
Speaker: @Prajnaparamita Dhar – The University of Kansas
· 9:00 AM – 11:00 AM ET Symposium: Enabling Excipients and Approaches for Advancing Formulation and Delivery 2
Location:209 AB West
Moderator: @Haichen Nie – Teva Pharmaceuticals
o 9:00 AM – 9:30 AM ET Strategic Overview of Complex Excipients in US Pharmacopeia With a Focus on Polysorbates and LG Polymer
Speaker: @Otilia Koo – Bristol Myers Squibb
o 9:30 AM – 10:00 AM ET Mechanistic Insights on Fogging in Lyophilized Formulations
Speaker: @Navpreet Kaur – Sanofi
o 10:00 AM – 10:30 AM ET Revisiting the Crucial Role of Amino Acids as Excipients in Protein-Based Drug Product Development
Speaker: @Haichen Nie – Teva Pharmaceuticals
o 10:30 AM – 11:00 AM ET Role of Excipients in Frozen and Freeze-Dried Protein Formulations
Speaker: @Raj Suryanarayanan – College of Pharmacy/University of Minnesota
· 10:30 AM – 11:30 AM ETNew Generation of Digital Self-Serve Platforms Boost R&D Productivity
Location:360 Stage #1 Exhibit Hall West A4-B3
Partner Presentation Speaker: @Shahrzad Missaghi – Colorcon
· 12:30 PM – 1:15 PM ET Designing Pharmaceutical Materials for Extrusion Enabled Continuous Manufacturing
Location: Spotlight Stage A Exhibit Hall West A4-B3
Chalk Talk Presenter: @Thomas Durig – Ashland
· 1:30 PM – 2:30 PM ET Keynote: Excipient Taxonomy for the 21st Century: A Grand Challenge for the Pharmaceutical Sciences Community
Location:209 AB West
Keynote Speaker: @Bruno Hancock – Pfizer Inc.
· 1:30 PM – 2:30 PM ET Strategies to Reduce Nitrosamine Contamination of Drug Products
Location:360 Stage #1 Exhibit Hall West A4-B3
Partner Presentation Speaker: @Andreas Sauer – Shin-Etsu
· 2:30 PM – 3:30 PM ET Speaker Spotlight: The Value of USP Standards for Excipients Used in Medicines: Current and Future State
Location: Spotlight Stage C Exhibit Hall West A4-B3
Spotlight Speaker: @Catherine Sheehan – U.S. Pharmacopeia (USP)
· 2:30 PM – 3:30 PM ET Special Poster Collection
Location: Poster Forum #7; Exhibit Hall West A4-B3
Poster Collection Host: @Carl Allenspach
· 3:00 PM – 4:00 PM ET Rapid Fires: Enabling Excipients and Approaches for Advancing Formulation and Delivery 1
Location:208 AB West
Rapid Fire Moderator: Tzichi Ju, Ph.D. – AbbVie Inc.
· 3:00 PM – 3:15 PM ETORODS: a Novel Expandable Platform for in situ Drug Delivery
Location:208 AB West
Rapid Fire Speaker: @Matteo Cerea – Universita' degli Studi di Milano
· 3:15 PM – 3:30 PM ET Novel Artemisinin-Containing Nanodrug for Leukemia Treatment
Location:208 AB West
Rapid Fire Speaker: @Noha Ghonim – University of Maryland Baltimore
· 3:30 PM – 3:45 PM ET Exploring Role of Lipidic and Phospholipidic Excipients for Dry-Powder Inhalers
Location:208 AB West
Rapid Fire Speaker: Nivedita Shetty, PhD (she/her/hers) – Genentech
· 3:45 PM – 4:00 PM ET Amorphous Dispersion Speciation: Impact of Polymer Chemistry and Molecular Weight
Location:208 AB West
Rapid Fire Speaker: @Wesley Tatum – Serán Bioscience
· 3:00 PM – 4:00 PM ET Rapid Fires: Enabling Excipients and Approaches for Advancing Formulation and Delivery 2
Location:209 AB West
Rapid Fire Moderator: @Michael Danquah– Chicago State University College of Pharmacy
· 3:00 PM – 3:15 PM ET Impact of Pneumatic Tube System Transportation on Biopharmaceutical Product Quality
Location:209 AB West
Rapid Fire Speaker: @Kashappa Goud Desai
· 3:15 PM – 3:30 PM ET Long-Acting Biodurable Implants: Fundamental Transport Properties to Complex Release Mechanisms
Location:209 AB West
Rapid Fire Speaker: @Angela Ren – University of Texas At Austin
· 3:30 PM – 3:45 PM ET Formulating Biologics for Oral Delivery – Considerations and Challenges
Location:209 AB West
Rapid Fire Speaker: @True Rogers
· 3:45 PM – 4:00 PM ET The Role of Saccharide Excipient Chemistry on Protein Particle Engineering
Location:209 AB West
Rapid Fire Speaker: @Amrit Paudel
· 4:00 PM – 5:00 PM ET AAPS Excipients Community Membership Meeting
Location: Spotlight Stage A Exhibit Hall West A4-B3
Community Leader: @Haichen Nie @Jin Zhao @Ketaki Patwardhan @Allison Radwick
· 5:00 PM – 6:00 PM ET Handbook of Pharmaceutical Excipients: Next Grand Challenges Continued (Invited guests only)
Location: Challenger 41-42, Hyatt Regency Orlando
Wednesday, October 25, 2023
Formulation and Delivery
· 10:30 AM – 11:00 AM ET Application of Asymmetric Flow Field-Flow Fractionation (AFFF) and Capillary Electrophoresis (CE) for the Characterization of Liposomal Formulations
Location:206 AB West
Speaker: @Thilak Mudalige
· 3:00 PM – 4:00 PM ET Hot Topic: Novel Excipients in Biopharma: Balancing Innovation, Risk, and Need
Location:308 AB West
Hot Topic Speaker: @Joshua Katz
Hot Topic Speaker: @Mary Krause
Hot Topic Moderator: @Joshua Katz
Hot Topic Speaker: @Andrea Hawe
Hot Topic Speaker: Can Araman, PhD – MilliporeSigma
· 3:15 PM – 3:30 PM ET Hierarchical Approach to Raw Material Variability in Drug Product Lifecycle
Location:205 AB West
Rapid Fire Speaker: @David Goldfarb
· 3:15 PM – 3:30 PM ET Characterization of Inhalation Drug Products Containing Spray-Dried Phospholipid Porous Particles
Location:208 AB West
Rapid Fire Speaker: @Yang Yang
· 3:45 PM – 4:00 PM ET Putting Lipids on the Map of 3D-Printable Filaments!
Location:208 AB West
Rapid Fire Speaker: @Moaaz Abdelhamid
Manufacturing & Analytical Characterization
· 10:00 AM – 11:00 AM ET Development of Multiarticulate Formulations Using Innovative Excipients Through Algorithm-Based Tools
Location: Spotlight Stage C Exhibit Hall West A4-B3
Chalk Talk Presenter: @Nitin Swarnakar
Chalk Talk Presenter: @Ramesh Muttavarapu
· 12:30 PM – 1:30 PM ET Special Poster Collection
Location: Poster Forum #7; Exhibit Hall West A4-B3
Poster Collection Host: @Carsten Ehrhardt
· 3:30 PM – 3:45 PM ET USP's Iterative Approach on Modern Analytical Methods for Polymeric Excipients
Location:205 AB West
Rapid Fire Speaker: @Peng Zhang
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
Rockville MD
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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