MAY 2
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Schedule at a Glance

Download the Preliminary Schedule of Events
 
 Monday, May 2
 
9:00 AM - 12:00 PM    Key new IPEC Papers and Guides: What you need to know!
This workshop will focus on a review of recently published and impending IPEC Position Papers and Guides. The interactive workshop will be designed with breakout sessions to facilitate audience participation and feedback. It will also include group discussion on ideas for future improvements and/or needs.
Workshop Room 1 (Tallahassee 1-3)
 
9:00 AM - 12:00 PM    Elemental Impurities Implementation Status - Outcomes from PQRI Workshop and Phase 2 Collaborative Study
This workshop will summarize and update information presented at the 4th PQRI Workshop on Elemental Impurities including the current status of global implementation of the ICH Q3D Guideline and the results and implications of a PQRI Collaborative Study which investigated a number of the analytical challenges related to EI testing.
Workshop Room 2 (Sanibel 1-3)
 
1:00 PM - 4:00 PM    Unlock the Benefit/Risk Approach Metrics for Selecting Excipients for Paediatrics
A workshop/session to strengthen the use of excipients for paediatrics through sharing of regulatory and formulation experiences, risk assessment and testing the application of Benefit/Risk Approach Metrics developed to select excipients for pediatric dosage form using patient, dosage form, and excipient attributes.
Workshop Room 2 (Sanibel 1-3)
 
1:00 PM - 4:00 PM    An Overview of Excipient Regulations and Requirements in Key Regions and Countries
This workshop will provide an overview of excipient regulations and requirements in key regions and countries outside of the US such as Europe, Canada, India, Brazil/other LATAM countries, China and a few other Asian countries. This information is often difficult to find since few countries have regulations specific to excipients.
Workshop Room 1 (Tallahassee 1-3)
 
5:00 PM - 7:00 PM    NETWORKING: Welcome Reception
Reconnect with colleagues and friends over drinks and appetizers at the Welcome Reception!  All Excipient World Conference & Expo registrants welcome. (Included in registration.)
Castillo Fort
 
 Tuesday, May 3
 
9:00 AM - 9:45 AM    Setting the Course for Novel Excipients – Round Table (Recorded)

Join us in the theater & lounge to view a recording of IPEC-Americas experts discussing how essential novel excipients are to drug development and why the FDA Novel Excipient Pilot Program is so important to spur innovation across the industry.

Exhibit Hall Theater & Lounge (Sun Ballroom)
 
9:45 AM - 10:30 AM    Impact and Far Reaching Consequences of European Microplastics Regulations on Excipients and Medicinal Products
The European Chemicals Agency (ECHA) is moving forward with proposed restrictions on the use of microplastics in products used in various market segments – including medicinal products. ECHA’s proposed regulations may lead to far reaching future impacts if industry does not act now. Attend this talk to learn more!
Session Room 2 (Sun 4-6)
 
9:45 AM - 10:30 AM    Medical silicone film former technology enabling novel topical solutions for drug delivery
The aim of this presentation is to discuss silicone film forming technology in topical applications including drug delivery and demonstrate the results of recent in-vitro studies where the benefits of DuPont Liveo silicone film former technologies on key parameters of topical forms e.g. substantivity skin permeation are discussed.
Session Room 1 (Sun 1-3)
 
10:35 AM - 11:00 AM    Role of Excipients in Enhancing the Structural Complexity of Topical Products Containing Microparticles
The presentation will focus on the unique complexities of topical semi-solid products containing microparticles and describe the impact of polymers (and other excipients) on the products’ structural complexity which in turn impacts bioavailability, and thereby creates potential challenges with the development of bioequivalence (BE) approaches for such products.
(RECORDING)
Exhibit Hall Theater & Lounge (Sun Ballroom)
 
11:00 AM - 11:20 AM    USP’s updates on developing NF LG polymer monograph specifications: Highlights and Key Challenges
This presentation will provide an overview of USP's development work of LG polymer monographs and highlight challenges with characterization of LG polymer excipients and development of appropriate compendial specifications of these excipients.
Exhibit Hall Theater & Lounge (Sun Ballroom)
 
11:00 AM - 11:45 AM    Viscosity Reducing Agents in Protein Formulation
When proteins are concentrated to high concentrations, the formulation’s viscosity may increase significantly prohibiting some routes of application. We are developing an excipient platform, allowing the use of excipient combinations, that can reduce protein viscosity to a greater extent while maintaining protein stability.
Session Room 1 (Sun 1-3)
 
11:25 AM - 11:45 AM    Purification of Excipients: How Sustainable CO2 Technology is Changing the Conversation

Greener. Faster. Cheaper. Upcycled, inexpensive CO2 can be used for various processing and manufacturing applications, supplanting toxic, expensive solvents that necessitate ethical storage, disposal, and/or remediation. This presentation highlights how to use supercritical CO2 for the purification of excipients including mRNA applications, terpenes, polymeric cleanup, and antioxidants.

Exhibit Hall Theater & Lounge (Sun Ballroom)
 
1:00 PM - 1:20 PM    Impact of the EU E171 Ban on Pharmaceuticals - IPEC & Industry Response
Titanium Dioxide (also known as E171) has recently been banned for use in foods and dietary supplements in Europe.  A three-year period has been granted for the EMA and the pharmaceutical industry to assess the impact of a potential ban in pharmaceuticals.  See what IPEC is doing to address this!
Exhibit Hall Theater & Lounge (Sun Ballroom)
 
1:00 PM - 1:45 PM    Where does oxidative stability lie? The Excipients vs The Formulation System
This presentation highlights the fallout of reactions if oxidation is allowed to progress unchecked and the strategies that can help bring oxidative change under control by various means, including the use of antioxidants.
Session Room 1 (Sun 1-3)
 
1:20 PM - 1:40 PM    Atypical Actives - déjà vu What can be done about new regulatory concerns?
Regulatory agencies are issuing deficiencies and rejecting sponsors' drug applications that use excipients as atypical actives.  Why, what are the issues, what can industry do?
Exhibit Hall Theater & Lounge (Sun Ballroom)
 
1:40 PM - 2:00 PM    Sustainability -What does it mean for pharmaceutical excipients?
Sustainability is in the news everywhere, we hear about “transitioning to a carbon net zero world” which will impact all industry sectors.  Join us in an interactive discussion on sustainability and what we as can do as excipient suppliers and users.
Exhibit Hall Theater & Lounge (Sun Ballroom)
 
2:15 PM - 3:00 PM    Role of Excipient Properties on Content Uniformity for Batch and Continuous Mixing
This presentation is focused on the impact of excipient properties and API concentration on content uniformity in batch and continuous mixing processes. It is shown that continuous mixing could be beneficial for achieving good content uniformity and that less process optimization is required to ensure homogeneous mixtures.
Session Room 2 (Sun 4-6)
 
2:15 PM - 3:00 PM    Technical Qualification of Alternate Source Excipients in Commercialized Drug Products
This presentation seeks to highlight the complexity of the evaluation and qualification of alternate sources of excipients in already commercialized drug products, which requires much more than comparing specifications.
Session Room 1 (Sun 1-3)
 
3:00 PM - 3:30 PM    Comparative Characterization of Polymers for Ritonavir Amorphous Solid Dispersions
Join Dr. Oktay for an oral presentation discussing the research on her poster followed by Q&A.
The objective of this study was to employ a drug-polymer interaction calculations and small-scale experimental characterization to screen polymers for potential ASDs of poorly soluble drugs for improved bioavailability.
Exhibit Hall Theater & Lounge (Sun Ballroom)
 
3:30 PM - 4:30 PM    Bottle of Lies: The Inside Story of the Generic Drug Boom
In a vivid and detailed talk, Katherine Eban will take the audience into the hidden world of endemic fraud and perilous conditions in the overseas manufacturing plants that make America's low-cost drugs and drug ingredients.
General Session Room (Sun B)
 
4:30 PM - 5:30 PM    NETWORKING: Booking Signing with Katherine Eban
Katherine Eban will be signing copies of her bestselling book "Bottle of Lies: The Inside Story of the Generic Drug Boom" in the Exhibit Hall Theater immediately following her keynote presentation.

Paperback copies of "Bottle of Lies: The Inside Story of the Generic Drug Boom" can be purchased for $12 during registration. (Retail price: $19.99)
Exhibit Hall Theater & Lounge (Sun Ballroom)
 
5:30 PM - 9:30 PM    NETWORKING: IPEC-Americas 30th Anniversary Celebration

Celebrate 30 years by joining us as we recreate the wine & cheese reception that started it all! (Access is included with your registration.)
5:30 Cocktails & Apps
6:15 Dinner
6:45 Awards & Concert featuring Prime Time

NEW LOCATION: Emerald Bay Plaza
 
 Wednesday, May 4
 
8:00 AM - 9:00 AM    Update on FDA’s Inactive Ingredient Database
The FDA's IID is used in drug development decisions by industry and application assessment decisions by FDA. In the year 2020 the IID changed. How will these changes affect excipient suppliers and drug product applicants? Find out what's changing in 2022 and how you can be prepared.
General Session Room (Sun B)
 
9:30 AM - 10:15 AM    Animal Health Perspectives on Excipients
So, you want to source or supply raw materials for use in animal health products? This presentation is designed to set expectations, define CVM's (Center for Veterinary Medicine) regulatory requirements, and demonstrate how we as an animal health industry are different and in need of suitable suppliers.
Session Room 2 (Sun 4-6)
 
9:30 AM - 10:15 AM    Digital Assistant to Support Drug Product Development
Formulation development is currently based on empirical methods; the process can be time-intensive, costly, and has a high risk of failure. This presentation will take a deep dive into the science behind how formulation prediction systems enable formulators to develop robust drug formulations.
Session Room 1 (Sun 1-3)
 
10:15 AM - 10:45 AM    Excipient Regulations and Requirements in Key Regions Workshop - Extended Q&A
Did you go to the Excipient Regulations and Requirements in Key Regions workshop and think of more questions to ask? Join the workshop presenters for an extended Q&A... and keep the conversation going!
Exhibit Hall Theater & Lounge (Sun Ballroom)
 
10:15 AM - 10:45 AM    IPEC Papers and Guides Workshop - Extended Q&A
Did you go to the IPEC Papers and Guides workshop and think of more questions to ask?
Join the workshop presenters for an extended Q&A... and keep the conversation going!
Exhibit Hall Theater & Lounge (Sun Ballroom)
 
10:45 AM - 11:45 AM    Novel Excipient Discussion Panel
Join us for a lively discussion about novel excipients.  Our panelists will share insights on both the industry need for novel excipients as well as their thoughts on the FDA's Novel Excipient Review Pilot Program.
General Session Room (Sun B)
 
1:00 PM - 1:45 PM    Supply Chain Security and its Relationship to Pharmaceutical Quality
Increase your understanding of the importance of Supply Chain Integrity and Quality of Materials. During COVID-19 supply chain integrity have come to the forefront more than ever. Learn more about strategies to help you protect yourself against an adverse event and become a champion for patient safety.
Session Room 2 (Sun 4-6)
 
1:00 PM - 1:45 PM    Turning Lipids into Tablets: The High Functionality Solution to Poor API Dissolution
JRS has developed a new co-processed, high-functionality adsorbent binder. This presentation demonstrates how this new excipient can adsorb oily APIs and / or APIs dissolved in oil, and result in a free-flowing powder that can be compressed into tablets or filled into capsules. It can also enhance the dissolution of poorly soluble compounds.
Session Room 1 (Sun 1-3)
 
1:50 PM - 2:10 PM    Challenges in the Development of Novel Lipid Excipients for mRNA Lipid Nanoparticle Drug Products: A COVID-19 Vaccine Case Study
Novel lipid excipients were used to encapsulate RNA within lipid nanoparticles forming the delivery technology behind the Covid-19 vaccine developed by Pfizer and BioNTech called Comirnaty®. Multiple challenges were faced during their development and these challenges along with success factors will be discussed in the presentation.
Session Room 1 (Sun 1-3)
 
1:50 PM - 2:10 PM    Improved Supply Chain Security for Distributors of Closed-Pack Pharmaceutical Excipients
Third-party GDP certification of pharmaceutical excipient distributors has been available since 2012. A new, innovative, third-party GDP standard will soon be available to improve the safety and security of pharma excipient supply worldwide. It was designed by industry supply chain security experts specifically for distributors of closed-pack pack pharmaceutical excipients.
Session Room 2 (Sun 4-6)
 
2:30 PM - 3:15 PM    Hygroscopicity Classification of Pharmaceutical Ingredients and Impact on Supply Chain
Hygroscopicity of raw materials must be properly classified to define the proper handling, sampling and storage of these materials throughout the end-to-end supply chain management to ensure product quality.
Session Room 2 (Sun 4-6)
 
2:30 PM - 3:15 PM    Improving Excipient Performance Through Particle Engineering
Excipient particle engineering enhances functional performance and improves pharmaceutical formulations when done effectively and can include singular or individual ingredients whereas co-processed excipient composition and morphology requires proper particle engineering for optimal performance.
Session Room 1 (Sun 1-3)
 
3:30 PM - 4:30 PM    The Future of Pharmaceutical Supply Chain
An interactive discussion including representatives from the US Department of Justice (DOJ) about how the re-invention of supply chains, the execution of real-time decisions, and driving commercial growth models, creates potential for increased ant-trust crimes.
General Session Room (Sun B)
 
4:30 PM - 5:00 PM    Closing Remarks
Join us for closing remarks by Joe Zeleznik, IPEC-Americas Chair-Elect.
General Session Room (Sun B)
 
5:00 PM - 7:00 PM    NETWORKING: Thank You Happy Hour
Join us for a casual happy hour to reflect on this year's event and start dreaming about recovening in DC in 2023!
Sun Ballroom Foyer