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Schedule at a Glance

 Monday, September 27
9:00 AM - 12:00 PM    Elemental Impurities Implementation Status - Outcomes from PQRI Workshop and Phase 2 Collaborative Study Workshop Room 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.
More details coming soon!

Workshop Room 1
12:00 PM - 12:00 PM    NETWORKING: Lunch Riverview North Terrace
1:00 PM - 4:00 PM    Unlock the Benefit/Risk Approach Metrics for Selecting Excipients for Paediatrics
Goals: - To provide guidance in the appropriate risk assessment of excipients for paediatrics, and highlight commonly encountered problems and issues in the field of use of excipients in paediatrics along with considerations for mitigation of risks. - to provide a framework to help formulators think about how to address the challenge of selection of excipients for paediatrics. The workshop will cover: - Topical issues relevant to selection excipients in paediatrics (e.g. safety) and risk assessment (e.g. variability and cumulative exposure) - Underlying principles of chronic and acute risk assessment of excipients - Existing risk assessment approaches - Selection of factors/elements for risk assessment purposes - Framework/ Benefit/Risk Approach Metrics for excipients in paediatrics - Practical Formulation case-scenarios throughout the workshop to illustrate the use of Benefit/Risk Approach Metrics for selection of excipients for paediatrics Objectives: To obtain input from the participants about usability of the benefit/risk-based tool in selecting appropriate excipients for pediatric dosage form and identify opportunities to enhance/optimize the tool. The participants will be asked to provide (i) their perspectives on the potential utility of the framework in the risk assessment of excipients in paediatrics and (ii) their feedback on if and how the framework could be improved. Sub-topics: The session will consist of a mix of presentations (workshop style, using Benefit/Risk Approach Metrics tool for risk assessment) and case studies(e.g. established excipients, novel use, neonatal use) to allow the participants to develop an understanding of the factors that need to be considered when selecting excipients for the range of paediatric patients from neonates through to teenagers and various dosage forms. The delegates will use the tool to devise a best strategy for selection of excipients for paediatric, discuss the selection process in the group and provide appropriate excipients for some example dosage forms in particular age groups. Take Aways: • Participants will learn a new benefit/risk-based tool to select excipients for pediatric dosage form • Participants will test the usability of the tool and provide real time feedback • Based on the feedback the tool can be enhanced/optimized and published in a journal so that it can be readily utilized by formulation scientist and allows use of a consistent approach in selecting excipients for pediatric dosage form across companies globally.
Workshop Room 1
1:00 PM - 4:00 PM    An Overview of Excipient Regulations and Requirements in Key Regions and Countries Workshop Room 2
5:00 PM - 7:00 PM    NETWORKING: Welcome Reception
Reconnect with colleagues and friends over drinks and appetizers at the Welcome Reception!  More details coming soon.
Riverview North Terrace
 Tuesday, September 28
8:00 AM - 8:15 AM    Welcome and Opening Remarks General Session Room
8:15 AM - 9:00 AM    The Critical Impact of Excipients on the Physicochemical and Structural Characteristics of Topical Drug Products General Session Room
9:30 AM - 10:15 AM    Novel or Not? Our Inadvertent Journey Filing a Novel Excipient.
The goal of the presentation is to inform the audience on the inherent complexities to effectively identifying, defining, and characterizing a novel excipient. The presentation will review a first-hand account of: 1) The factors influencing the internal debate 2) The strategies developed to solicit regulatory confirmation 3) The approach to "retrospective" characterization 4) Necessary remediation efforts 5) Hindsight is 20/20, I wish I knew then... 6) Remaining challenges to the effective identification of novel excipients today The attendee will take away a practical example of one company's journey in the perceived "flying blind" process of novel excipient approval and guidance for proactively navigating, if you must. Note: This presentation will be updated with anecdotes relevant to the conversation from the author's experience with COVID vaccine development.
Session Room 1
11:00 AM - 11:45 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 broad definition of microplastics, may impact many excipients and drug products leading to increased labeling and reporting requirements. Based on current information, it is feasible that the regulation will come into force in late 2021 or early 2022. Even though medicinal products and supplements are derogated, there will be reporting obligations which include reporting quantity of microplastics released to the environment, either estimated or measured in the previous year. In addition, data will be required to eliminate certain excipients as microplastics (biodegradable, soluble etc.) in addition to derogation of excipients which are permanently modified and are no longer microplastics in the end use application. All this will require strategy, collaboration and consistency and it is important for the industry sector (excipient manufacturers and drug product manufacturers) to work together and coordinate efforts. Note that ECHA has stated that reporting requirements will stop when microplastics are no longer used and this implies reformulation which is not an optimal or justified approach for medicinal products. Additionally, the talk will also discuss what industry can do in the long term to collect credible data and evaluate longer term strategy for medicinal products.
Session Room 2
11:00 AM - 11:45 AM    Viscosity Reducing Agents in Protein Formulation
Many therapeutic mAbs are currently only available for intravenous administration, while a subcutaneous injection would be more desirable from a patient convenience and health care cost point of view. For this route of administration, a high protein concentration is typically required. Some antibodies, and other proteins, form transient interactions giving rise to a high solution viscosity and thereby causing the requirement for unacceptably high injection forces. As viscosity is fundamentally caused by protein-protein interactions, excipients that are able to reduce viscosity may also be a potential denaturant. Managing high viscosities by using small molecule additives such as excipients has therefore to be balanced with the requirement for protein stability. There are known viscosity modifying excipients, but they may either not perform sufficiently in some cases or they may have undesired effects on proteins, e.g. cause gelation, aggregation, or phase separation. Also, some excipients are not acceptable for certain routes of administrations. This raises the need for new excipients with viscosity modifying properties. Furthermore, a broader excipient selection is required since underlying forces causing protein viscosity are diverse and differ from protein to protein. Additionally, such forces are pH dependent. Upon a change in pH, the hydrophobicity of a protein may remain unchanged however additional charges occurring on the protein surface may cause changes in the way proteins self-interact. When using excipients to manage protein viscosity, it is important to consider their specific properties to evaluate applicability to a specific protein formulation. We have developed an excipient platform able to reduce protein viscosity beyond the common industry standard. We use excipient combinations, which act synergistically on viscosity. Due to the synergistic viscosity reduction, a lower concentration of each excipient can be used, which allows for a better balance of protein viscosity and stability. Thereby, the ratio of the two excipients used offers the opportunity to further optimize the formulation’s viscosity. With this viscosity reducing excipient platform we provide new solutions to manage protein viscosity in a more tailored approach. In this presentation I will discuss the following aspects: • Protein viscosity and the potential underlying structural causes • The effect of single excipients vs. excipient combinations on protein viscosity • Synergy effects arising from the use of excipient combinations • Why pH can be a relevant factor for choosing the appropriate viscosity reducing excipient • The balancing act of protein viscosity versus protein stability • Case Studies highlighting how different protein formulations can be improved by viscosity reducing excipients • Impact of protein viscosity on Downstream Processing (e.g. TFF)
Session Room 1
11:45 AM - 1:00 PM    NETWORKING: Lunch Riverview North Terrace
1:00 PM - 1:45 PM    Role of Excipient Properties on Content Uniformity for Batch and Continuous Mixing
Stimulated by Pharma 4.0, the pharmaceutical industry has recognized that continuous manufacturing has the potential to improve processing and product quality. For the transition from batch-wise to continuous manufacturing, individual processing steps should be re-designed to continuous operation. Powder blending is such a processing step, which is considered to be important because uniform blending of API and excipients is required to ensure accurate dosing of the API. This presentation is focused on the impact of excipient properties and API concentration on content uniformity in batch and continuous blending. The role of material characteristics and behavior in batch and continuous blending is evaluated. Six excipients with variations in particle size, density, flowability and shape are considered. An anhydrous lactose grade, a milled lactose grade, a granulated lactose grade, a spray dried lactose grade, and two MCC grades are evaluated on content uniformity for blending with four different drug loadings. Paracetamol powder with a low bulk density and a small particle size is used as model API in different concentrations. Batch blending is performed for 1, 5, 10, and 30min and is compared to continuous blending in steady state. It is demonstrated that a relationship exists between content uniformity of paracetamol in a batch blended mixture and the particle size, density, flow and morphology of the excipient. It is shown that for batch processes, optimization of process settings is required to ensure homogeneous mixtures. For example, it is shown that excipients with smooth surfaces, high bulk densities and good flow properties result in the most homogeneous blends. These homogeneous blends are already obtained with short mixing times, indicating fast de-agglomeration of the cohesive API. Increased mixing times can result in less homogenous blends, indicating a tendency to segregate due to differences in particle size and bulk density between excipients and API. With larger amounts of API, more time to de-agglomerate and blend the API is required, due to less surface interaction with the available excipient. Excipients with low density and low flow on the other hand, generally show higher relative standard deviation (RSD) for content uniformity. These RSD’s are caused by several individual samples with an abnormal high label claim, indicating the presence of API agglomerates. This is likely due to poor de-agglomeration of the API. Increased blending times improve the de-agglomeration of API and correspondingly the content uniformity of these blends. Blends produced with batch mixing are also compared with blends produced with continuous mixing. It is shown that API-excipient blends prepared using a continuous process generally are more homogeneous, represented by a lower RSD. For all blends of the selected excipients with paracetamol in steady-state, the RSD is below 5% independent of API concentration. Overall, homogeneity of the blend
Session Room 2
1:00 PM - 1:45 PM    Update on Enteric Coating Performance In Vivo

Over the last 70 years many cases of therapeutic failure of enteric coated (EC) formulations have been reported. EC products present a marked slower in vivo dissolution which seems to be the cause for the observed failures. Upon reaching the intestinal lumen, the dosage form is exposed to an environment buffered by bicarbonate at low molarity values. This presentation aims to elucidate the complex interaction between bicarbonate buffer and enteric coating polymers and to showcase a failed bioequivalence study with enteric coated formulations.
An in vitro study investigating the performance of different drug products from the market in both compendial and physiologically relevant bicarbonate buffer will be discussed. The results indicate that the in vitro performance of EC products is more dependent on the ionic composition and molarity of the medium than the bulk pH. Consequently, the generally accepted concept that an enteric coating will rapidly dissolve upon reaching a region of higher pH than its dissolution pH threshold is questionable. Hence, the physiological aspect of bicarbonate buffer should be taken into account during the formulation development process to avoid possible therapeutic failures due to insufficient drug release.
A failed bioequivalence study between enteric coated pantoprazole tablets will be used as a case study to illustrate the application of physiologically relevant dissolution conditions towards improved in vitro - in vivo relationship.

Session Room 1
2:05 PM - 2:25 PM    Novel Lipid Excipients used in Lipid Nanoparticles
Coming soon!
Exhibit Hall Theater
2:30 PM - 2:50 PM    USP’s updates on developing NF PLGA/PLA monograph specifications: Highlights and Key Challenges

PLGA is a polyester made from lactide (or lactic acid) and glycolide (or glycolic acid) monomers, whereas PLA is a polyester made solely from lactide (or lactic acid). PLGA/PLA’s unique characteristics of biodegradation enables controlled release formulations with drug release periods ranging from 1 week to 6 months, which is a game changer in patient's convenience and compliance and allows tailored duration release by modifying polymer composition. PLGA/PLA excipients have been used in more than 20 FDA approved drugs and more than 20 medical devices. However, there are no PLGA/PLA-based generic drug formulations approved. In the excipient workshop held by USP and FDA in 2017, FDA shared they were facing challenges in sameness evaluation of PLGA/PLA. As such, there is an urgent need for developing PLGA/PLA compendial standards.

The development of new monographs for PLGA/PLA is a priority under USP’s excipient science strategy. This presentation will give an overview of USP’s PLGA/PLA monographs development strategy and timeline. It will highlight challenges with the analytical characterization of PLGA/PLA and with the development of appropriate compendial specifications for the PLGA/PLA monographs. USP took efforts to solve these challenges and better understand the various PLGA/PLA compositions through a fellowship program. This presentation will highlight key research from the fellowship program, especially the evaluation of advanced technologies and methodologies for determining the molecular weight of PLGAs and sample variability among manufacturers.

Exhibit Hall Theater
2:55 PM - 3:15 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.
Exhibit Hall Theater
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
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
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!
Riverview North Terrace
 Wednesday, September 29
8:15 AM - 9:00 AM    Digital Assistant to Support Drug Product Development
Currently, drug product development is based on empirical methods; the outcome often depends on the expertise and intuition of the individual formulator. As a result, the development process can be time-intensive, costly, and has a high risk of failure. To lower the risk of failure and reduce the number of time-consuming and costly lab experiments, we have developed a science-based prediction system (ZoomLab™) with an aim of following goals; 1) defining a developability classification of active ingredients into one of the five classes I, IIa, IIb, III or IV based on the solubility in Fasted State Simulating Intestinal Fluid (FaSSIF), the effective intestinal permeability (Peff) and the solubility-limited absorbable dose (SLAD). For each class, factors that may limit the oral bioavailability of the active ingredient are evaluated and recommendations on formulation development options are given. 2) predicting a formulation composition for tablets manufactured by direct compression. To maintain confidentiality, the system does not require the formulator to disclose the identity of the active pharmaceutical ingredient (API). Instead, formulators need to enter ten key properties of the API. In the digital assistant logic, then fourteen different parameters are used to estimate the processability of pharmaceutical powders: d10 value; d50 value; d90 value; distribution span; bulk density; tapped density; compressibility index; Hausner ratio; angle of repose; compaction pressure at a porosity of 0.15; tensile strength at a porosity of 0.15; tensile strength at 100 MPa, 150 MPa and 250 MPa compaction pressure. In the next step, the system predicts the processability of hypothetical API-excipient blends; data characterizing the excipients are stored in a database. Based on the selected dosage form and the defined target product profile, the system predicts an optimal starting formulation. This comprises a list of excipients with the recommended concentrations, as well as manufacturing instructions. This presentation will take a deep dive into the science behind the digital assistant and the concept of its formulation recommendations with practical examples.
Session Room 1
8:15 AM - 9:00 AM    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
9:30 AM - 10:15 AM    Technical Qualification of Alternate Source Excipients in Commercialized Drug Products
Utilization of new (i.e. alternate) sources of excipients after drug product formulation and approval is often required to maintain adequate supply to support commercial drug product manufacturing. When evaluating alternate sources of excipients, excipient users should not assume that all sources meeting the same compendial requirements are interchangeable in all drug product formulations. Confirmation of equivalent functional performance is necessary to confirm interchangeability of the alternate source excipient in the drug product formulation. The regulatory impact of alternate source excipients is mitigated when the specification is the same as that of the currently approved source. However, specification testing alone is not usually sufficient to demonstrate interchangeability of excipients for which the functional performance in the drug product is not well predicted by the specification tests. Evaluation of the critical material attributes of excipients during drug product formulation is not only important for determining the appropriate control strategy; the knowledge is vital for efficient implementation of interchangeable sources of excipients. When excipient critical material attributes are not well understood or are expected to be variable, extensive evaluation of the functional performance of the alternate excipient source in the drug product formulation is required to ensure successful implementation. Following this presentation, the attendee will have a better understanding of the criticality of confirming equivalent functional performance of an alternate source excipient in an already commercialized drug product formulation prior to implementation.
Session Room 1
9:30 AM - 10:15 AM    Update on FDA’s Inactive Ingredient Database
Excipients, the inactive ingredients in pharmaceutical products, are essential drug product components that facilitate drug delivery, promote solubility, improve taste and, in general, allow active pharmaceutical ingredients to be transformed into useable dosage forms. For over 30 years, FDA has published the Inactive Ingredient Database (IID), a publicly available list of the excipients used in FDA approved drug products, as a tool for drug development. Over the years, FDA has made small gradual improvements to the IID in response to requests from industry. But the format and information provided in the IID remained basically the same. In 2019, FDA published a draft guidance for industry on use of the IID. This guidance not only provided advice to industry on how the IID can best be used to develop drug products and prepare applications, but also identified plans for important future IID enhancements that will be made by October 2020. In 2020, the IID will change in some significant and positive ways as FDA fulfills the commitments made to industry under the 2017 reauthorization of the Generic Drug User Fee Amendments (GDUFA II). What will the IID look like when these commitments are fulfilled? How will these changes impact drug applications, especially with respect to qualification of the excipients used in those drug products? What are the advantages of the IID’s new structure? Are there still unaddressed needs? In this presentation, FDA will identify all the changes that have occurred in preparation for fulfilling our GDUFA II commitments for the IID and changes yet to come in 2020. FDA will provide its vision for the IID as an essential tool for drug development.
Session Room 2
10:45 AM - 11:45 AM    Rapid Fire Poster Presentations

This general session will showcase the research of the top 3 academic posters as determined by the conference committee. Each researcher will be given 10 minutes to present their work followed by 5 minutes of Q&A.

An award of $500 will be given to the top academic poster as determined by our academic poster presentation judges. An award of $250 each will be given to the 2nd and 3rd place academic posters. (The awards will be presented during the closing remarks beginning at 4:30 on September 29.)

Exhibit Hall Theater
11:45 AM - 1:00 PM    NETWORKING: Lunch
1:00 PM - 1:45 PM    Improving Excipient Performance Through Particle Engineering
Participants will gain an understanding about how excipient particles are engineered and the dependence on composition and manufacturing process as well as the benefits to formulation development and manufacture that result. Formulators, process engineers and technical services personnel will be provided examples of engineered excipients, their applications, the improvements to product quality and performance. Participants will embark on a journey along the evolution from simple “fit-for-use” ingredients to “designed-for-purposed” high-performance excipients. Throughout the presentation will be an exploration of the numerous ingredients that have been created including the many co-processed technologies developed. An appreciation for balancing co-processed excipient composition in tandem with choosing the appropriate manufacturing process influences co-processed excipient performance will be gained. Not all co-processed excipient combinations or the processes used in manufacture result in high-performance ingredient.
Session Room 1
1:00 PM - 1:45 PM    Sourcing & Supplying Excipients for Animal Health Pharmaceuticals
The animal health industry – live wire or dead weight? If you want to effectively source for, or supply to, the animal health pharmaceutical industry, it’s time to think differently. Bottom line, FDA’s requirements for animal and human health prescription drugs are not written equally. Therefore, you can’t apply the same “rule book” for sourcing and procuring both industries. Attendees will learn where and why the differences exist, the impact of these differences on the supply chain, and why animal health companies are seeking suppliers that understand the nuances we face as an industry. Regardless of drug development stage (formulating, registration, or commercialization), it is essential to consider CVM’s (Center for Veterinary Medicine) requirements for raw materials. Per current expectations, this presentation will define a drug sponsor's responsibility for qualifying a new vendor, discuss the perception of “USP/NF” grade, and provide examples of how supplier’s Certificate of Analysis can cripple animal health development, surge analytical costs, and severely delay time to market. The Generic Animal Drug Alliance (GADA) seeks an opportunity to be transparent about CVM’s expectations. If sourcing & suppliers understand our challenges and are willing to work with drug sponsors to address them, we believe the animal health market has true value and untapped potential. Join our discussion and begin to think differently.
Session Room 2
2:30 PM - 3:15 PM    Hygroscopicity Classification of Pharmaceutical Ingredients and Impact on Supply Chain
Hygroscopicity, the ability of a substance to absorb moisture from the air, can have a significant impact on product quality in drug substance (DS) and drug product (DP) manufacturing. It is well understood that the final DP (i.e. tablet or lyophilized cake) must meet a water specification for release and to maintain stability, but the impact of moisture on the raw materials going into the process is just as important and must be well understood and controlled. A raw material with an out of specification moisture content can cause physical, analytical or chemical challenges (e.g. clumping, imprecise concentrations or inexact pH, respectively). Early engagement and raw material risk assessments (RMRA) identify possible risks associated with each raw material including hygroscopicity. Literature, vendor specifications and pharmacopeia are good sources of information for hygroscopicity, but they can be contradictory or non-specific to the material grade, source or lot in-use. Hygroscopicity may vary between sources and even lot-to-lot if the physical properties, such as crystallinity, crystal form and particle size are not controlled. Therefore, it is best to characterize the specific source of the raw material used in the manufacturing process. At Amgen, ~200 raw materials have been characterized by dynamic vapor sorption (DVS) to classify each material as non-hygroscopic, slightly hygroscopic, hygroscopic or very hygroscopic according to the European Pharmacopeia (25°C/80%RH for 24h). More than half of the materials were classified as hygroscopic or very hygroscopic and of these the majority absorb moisture at what are generally considered ambient conditions (25°C/60%RH) and about a third are absorbing moisture even as low as 25°C/30%RH. Proper handling, sampling and storage procedures are used to mitigate exposure of these materials to high humidity environments throughout the end-to-end supply chain management to ensure product quality.
Session Room 2
2:30 PM - 3:15 PM    Turning Lipids into Tablets: The High Functionality Solution to Poor API Dissolution
Many of the drug compounds currently in development suffer from poor water solubility due to high lipophilicity. The drug dissolution is the rate-limiting step to systemic absorption, leading to low bioavailability that minimizes therapeutic efficacy. For these difficult APIs, formulators use various methods to enhance dissolution, most of which are costly and complex. In response to these challenges, an innovative High Functionality Excipient was developed, enabling the compression of lipids into tablets and enhancing bioavailability. Its capacity for adsorption far exceeds traditional adsorbents while also offering the unique benefits of high functionality excipients. This presentation provides an extensive overview of this revolutionary adsorbent binder, enabling the conversion of soft gel capsules to tablets and enhances dissolution in poorly soluble drugs. Key Learning Objectives: • Challenges of the current methods for Enhancing Drug Solubility • Learn how a new tablet innovation was developed by coprocessing an adsorbent with a high functionality excipient • The functionality and economic benefits of converting softgels capsules into tablets
Session Room 1
3:30 PM - 4:30 PM    The Future of the Pharmaceutical Industry
More information coming soon!
General Session Room
4:30 PM - 5:00 PM    Closing Remarks General Session Room
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 2022!
Riverview North Terrace