BEGIN:VCALENDAR
VERSION:2.0
X-WR-CALNAME:2026crbesummiteastinnovatio
X-WR-CALDESC:Event Calendar
METHOD:PUBLISH
CALSCALE:GREGORIAN
PRODID:-//Sched.com 2026 CRBE Summit East - Innovations in Controlled Release, Bioavailability Enhan//EN
X-WR-TIMEZONE:UTC
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T120000Z
DTEND:20260512T130000Z
SUMMARY:Registration Opens & Continental Breakfast for Attendees
DESCRIPTION:
CATEGORIES:MORNING NETWORKING BREAK
LOCATION:Hyatt Regency New Brunswick\, New Brunswick\, NJ
SEQUENCE:0
UID:456ae148fbb2a300cebb79304d135bf7
URL:http://2026crbesummiteastinnovatio.sched.com/event/456ae148fbb2a300cebb79304d135bf7
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T125500Z
DTEND:20260512T130000Z
SUMMARY:Welcome and Chairperson’s Introduction & Opening Remarks
DESCRIPTION:
CATEGORIES:
LOCATION:Hyatt Regency New Brunswick\, New Brunswick\, NJ
SEQUENCE:0
UID:67b2a53dea87a6e9c94cf09536ae6c54
URL:http://2026crbesummiteastinnovatio.sched.com/event/67b2a53dea87a6e9c94cf09536ae6c54
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T130000Z
DTEND:20260512T134000Z
SUMMARY:From Formulation to Function: Engineering Drug Product Quality to Maximize Therapeutic Performance
DESCRIPTION:For drug product scientists and formulators\, the ultimate measure of success lies not just in developing a stable formulation\, but in ensuring that a drug product consistently delivers its intended therapeutic effect. In this keynote\, Mansoor Khan will explore how a deeper scientific understanding of drug product quality—through critical quality attributes (CQAs)\, advanced analytical characterization\, and mechanistic insights into formulation–process–performance relationships—can be leveraged to engineer medicines that perform reliably in patients. The session will highlight emerging strategies that integrate formulation science\, materials characterization\, and predictive modeling to strengthen product robustness\, enhance bioavailability\, and reduce variability. By connecting drug product design with real-world therapeutic performance\, this keynote will provide a forward-looking perspective on how product quality research can drive the next generation of high-performing pharmaceutical products.
CATEGORIES:KEYNOTE
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:7ccdc73b0b778ef6137dc57fa22bd341
URL:http://2026crbesummiteastinnovatio.sched.com/event/7ccdc73b0b778ef6137dc57fa22bd341
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T134000Z
DTEND:20260512T141000Z
SUMMARY:Amorphous Solid Dispersions and Crystallinity
DESCRIPTION:The presentation will cover the industrial perspectivefor managing risk of crystallinity in amorphous soliddispersions\, covering three key areas:\n• Manufacturability\n• Stability\n• Bioavailability\n\nLearning Objectives\n•&nbsp\;Norm on basics of solid dispersions\n• Establish understanding of failure modes for soliddispersion based on manufacturing technology\n• Develop appreciation for environmental controlswith respect to crystallinity\n• Grow understanding of crystallinity impact on PKperformance
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:434993ded3a660a2017533bec6e73764
URL:http://2026crbesummiteastinnovatio.sched.com/event/434993ded3a660a2017533bec6e73764
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T141000Z
DTEND:20260512T144000Z
SUMMARY:Innovating Oral Drug Delivery: Enabling Small and Macromolecule Therapies
DESCRIPTION:The oral administration of macromolecules such as peptides and proteins continues to be limited by harsh gastrointestinal conditions\, rapid enzymatic degradation\, and poor membrane permeability. Novel delivery technologies—such as sophisticated lipid-based systems\, delayed-release softgel platforms\, and buccal or sublingual approaches—are emerging to overcome these barriers. By protecting sensitive compounds\, directing site-specific release in the intestine\, and leveraging lymphatic transport pathways\, these solutions aim to enhance systemic exposure. This presentation will highlight the scientific rationale and data demonstrating how these innovations are advancing the clinical feasibility of oral macromolecule delivery. The current state of macromolecule delivery and recent advances in this space will be discussed.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:3a6a98d162870cd1a6680474d14c73bf
URL:http://2026crbesummiteastinnovatio.sched.com/event/3a6a98d162870cd1a6680474d14c73bf
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T144000Z
DTEND:20260512T151000Z
SUMMARY:Morning Networking Break in Exhibit Hall
DESCRIPTION:
CATEGORIES:MORNING NETWORKING BREAK
LOCATION:Hyatt Regency New Brunswick\, New Brunswick\, NJ
SEQUENCE:0
UID:9ce8f25a318c278761096f4801fe787f
URL:http://2026crbesummiteastinnovatio.sched.com/event/9ce8f25a318c278761096f4801fe787f
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T151000Z
DTEND:20260512T154000Z
SUMMARY:Breaking the Dose Barrier for Subcutaneous Drug Delivery: Advancing High-Concentration Biologics Through Smart Device Design and Patient-Centered Innovation
DESCRIPTION:Amorphous solid dispersions (ASDs) are supersaturating formulations that enhance both the\nHigh-dose biologic drug products have become increasingly prevalent for treating chronic diseases across diverse therapeutic areas\, with subcutaneous (SC) self-administration emerging as the preferred delivery route driven by patient and healthcare provider demand. However\, developing these products presents unique complexities requiring careful strategic planning and robust development strategies. This presentation provides a comprehensive analysis of SC combination drug product development\, focusing on the critical interplay between high-concentration formulation design\, delivery device selection\, and biopharmaceutical attributes that collectively minimize clinical risk factors. Key developmental challenges addressed include formulation strategies for achieving therapeutic doses\, large-volume delivery through optimized drug-device combinations\, pharmacokinetic (PK) bridging risk assessment\, and patient tolerability considerations. By integrating formulation science\, device engineering\, and clinical bridging strategies\, this presentation offers guidance for successfully navigating the complex development pathway of high-dose SC biologics from concept to commercialization.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:9be1f9808be5285620c861862438b18d
URL:http://2026crbesummiteastinnovatio.sched.com/event/9be1f9808be5285620c861862438b18d
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T154000Z
DTEND:20260512T161000Z
SUMMARY:Beyond Solubility - A New Pharmaceutical Classification Guiding Enabled Formulations in the Modern Molecular Landscape
DESCRIPTION:Modern drug development faces a significant challenge as over 70% of new pharmaceutical compounds struggle with low solubility. A novel classification framework is introduced to improve the design of enabled formulations\, specifically focusing on amorphous solid dispersions. This system moves past basic solubility issues to evaluate how and when to consider the impact of dissolution and diffusion as rate limiting steps to absorption. By categorizing these complex molecular properties\, the framework helps researchers determine how to optimize their amorphous formulation for optimal performance. Ultimately\, this approach provides a sophisticated strategy for optimizing bioavailability in an increasingly complex chemical landscape.\n&nbsp\;\nWith over 70% of new drugs being solubility-limited\, rising molecular complexity requires advanced bioavailability enhancement strategies.Amorphous solid dispersions (ASDs) remain a leading solution\, yet their application must evolve alongside modern chemical properties.A new classification system guides formulation design by identifying when to optimize beyond basic solubility to consider dissolution rate\, the formation of solubilized species\, or to consider the addition of permeation enhancers.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:d50afccd835c66bd368f5589360c5ceb
URL:http://2026crbesummiteastinnovatio.sched.com/event/d50afccd835c66bd368f5589360c5ceb
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T161000Z
DTEND:20260512T164000Z
SUMMARY:Lifecycle Management and Reformulation Opportunities for Peptides and Challenging Small Molecules
DESCRIPTION:As pharmaceutical pipelines increasingly yield complex APIs—including poorly permeable small molecules and peptides—first-generation drug products often fall short of the ideal Target Product Profile. Sub-optimal bioavailability\, positive food effects\, and reliance on parenteral administration present significant hurdles to patient compliance and market success.\nThis presentation explores how lipid-based formulations provide a proven\, low-risk toolkit for strategic lifecycle management and 505(b)(2) reformulations. By leveraging IID-listed lipid excipients\, formulators can mitigate absorption challenges for small molecules\, develop specialized dosage forms\, and even achieve the “holy grail” of patient-centricity—oral peptide delivery.\nHighlighting real-world case studies and future-facing formulation approaches\, this session will demonstrate how lipid excipients enable value-added reformulations that bring new life to existing assets.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:7d5674d61a2cdbae4314315bb379c2a5
URL:http://2026crbesummiteastinnovatio.sched.com/event/7d5674d61a2cdbae4314315bb379c2a5
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T164000Z
DTEND:20260512T174000Z
SUMMARY:Networking Lunch
DESCRIPTION:
CATEGORIES:MORNING NETWORKING BREAK
LOCATION:Hyatt Regency New Brunswick\, New Brunswick\, NJ
SEQUENCE:0
UID:5f75574c0a4ab5802f3d65ad90b2ab50
URL:http://2026crbesummiteastinnovatio.sched.com/event/5f75574c0a4ab5802f3d65ad90b2ab50
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T174000Z
DTEND:20260512T181000Z
SUMMARY:Combining Extended Release with Bioavailability Enhancement
DESCRIPTION:A growing proportion of modern small-molecule drug candidates are challenged by oral absorption limitations arising from poor solubility\, poor permeability\, or both. For compounds that also require prolonged exposure\, formulation strategy becomes more complex\, particularly when once-daily dosing is desirable for chronic therapy\, patient convenience\, adherence\, or competitive product positioning. In these cases\, conventional immediate-release or standard modified-release approaches may be insufficient to achieve the desired pharmacokinetic and therapeutic profile.\n\nThis presentation will discuss emerging oral formulation strategies that combine amorphous solid dispersions with extended-release design to address both bioavailability and duration of exposure in a single dosage form. By pairing supersaturation-enabling systems with controlled-release architectures\, these hybrid approaches offer a path to improve absorption while maintaining targeted release kinetics. Using a series of case studies\, we will show how such strategies can be used to better match in vivo pharmacokinetic performance to therapeutic goals and program requirements. The discussion will focus on practical formulation considerations and lessons learned in applying these integrated platforms to next-generation oral medicines.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:13c02beb6bad8a74b80674cf201f8f66
URL:http://2026crbesummiteastinnovatio.sched.com/event/13c02beb6bad8a74b80674cf201f8f66
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T181000Z
DTEND:20260512T184000Z
SUMMARY:Engineering Solubility: Modern Approaches in OSD Formulation
DESCRIPTION:Poor solubility continues to limit the performance of many oral drug candidates. This session explores how strategic formulation design in oral solid dosage (OSD) development can enhance solubility and drive better bioavailability outcomes. From enabling technologies to rational design principles\, attendees will gain practical insights into approaches that improve drug performance while supporting efficient and scalable development.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:be45474a84f31f32d18b60190e1125ee
URL:http://2026crbesummiteastinnovatio.sched.com/event/be45474a84f31f32d18b60190e1125ee
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T183500Z
DTEND:20260512T185000Z
SUMMARY:Safe by Design: Benefit-Risk Assessment Based Pediatric Excipient Selection
DESCRIPTION:The dilemma to select appropriate excipients for paediatric products can be resolved by applying systematic benefit-risk assessment process\, by using the newly developed “Paediatric Excipient Risk Assessment (PERA)” framework and tool which will be presented and demonstrated by case studies in this session. Attendees will gain insights into how to balance functionality with safety to support the development of effective pediatric patient centric medicines.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:8a16d7fe14e4a73e6e96d8ba6a04a5c0
URL:http://2026crbesummiteastinnovatio.sched.com/event/8a16d7fe14e4a73e6e96d8ba6a04a5c0
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T190000Z
DTEND:20260512T193000Z
SUMMARY:Afternoon Networking Break in Exhibit Hall
DESCRIPTION:
CATEGORIES:MORNING NETWORKING BREAK
LOCATION:Hyatt Regency New Brunswick\, New Brunswick\, NJ
SEQUENCE:0
UID:9ad5721dacf213168721144b502dc870
URL:http://2026crbesummiteastinnovatio.sched.com/event/9ad5721dacf213168721144b502dc870
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T193000Z
DTEND:20260512T200000Z
SUMMARY:Right Platform\, Right Time: A Decision Framework for Solubility Challenges
DESCRIPTION:\n
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:1f1a5cfa41f29ca059a372dda7030c3e
URL:http://2026crbesummiteastinnovatio.sched.com/event/1f1a5cfa41f29ca059a372dda7030c3e
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T200000Z
DTEND:20260512T203000Z
SUMMARY:Precision PK by Design: KinetiSol™- Enabled BAE and Controlled Release
DESCRIPTION:Precisely controlling exposure is critical to maximizing efficacy and minimizing risk. This session explores how KinetiSol™-enabled bioavailability enhancement (BAE) and controlled-release (CR) design enable next-generation PK optimization. Learn how high-energy amorphous processing and formulation tuning can rapidly shape exposure profiles—improving absorption\, extending duration\, and aligning PK with therapeutic intent for challenging APIs.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:9e3b8f5f676f90c858fe263ba49852d5
URL:http://2026crbesummiteastinnovatio.sched.com/event/9e3b8f5f676f90c858fe263ba49852d5
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T203000Z
DTEND:20260512T210000Z
SUMMARY:The Hidden Secrets of Designing a Robust Oral Controlled Release Formulation
DESCRIPTION:Designing robust oral controlled release formulations requires more than extending drug release—it demands a deep understanding of formulation\, physiology\, and performance variability.\n This session uncovers the often-overlooked factors that impact success\, from material selection and release mechanisms to in vivo predictability and scalability. Gain practical insights into avoiding common pitfalls and building formulations that deliver consistent\, reliable performance from development through commercialization.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:6f2c36617facbc84b5480ee62c1d72cd
URL:http://2026crbesummiteastinnovatio.sched.com/event/6f2c36617facbc84b5480ee62c1d72cd
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T210000Z
DTEND:20260512T213000Z
SUMMARY:Developing Drug Products for Oral Delivery of Challenging Molecules: Formulation Design and Biopharmaceutical Considerations
DESCRIPTION:Small molecules that belong to BCS II and IV classes pose developability challenges and require formulation strategies to enhance oral bioavailability. This talk will discuss various strategies to overcome this problem. 1) Amorphous solid dispersions (ASDs)- This section will focus on dissolution mechanism of ASDs and strategies (surfactants\, pH modifiers) to increase drug load in ASD without comprising dissolution performance. 2) Prodrugs- Considerations for developing prodrugs for rapidly crystallizing compound and impact of pro-moeity selection on prodrug performance will be discussed. 3) Permeation enhancers (PEs) for BCS IV- Utilizing PEs for enhancing oral bioavailability of BCS IV compound and impact of solid form and formulation strategy on performance of the PE will be discussed.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:a81f15d9b4094285cb517bf06beb9874
URL:http://2026crbesummiteastinnovatio.sched.com/event/a81f15d9b4094285cb517bf06beb9874
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260512T213000Z
DTEND:20260512T223000Z
SUMMARY:Chair’s Closing Remarks\, Drinks Reception in Exhibit Hall and End of Day One
DESCRIPTION:\n
CATEGORIES:MORNING NETWORKING BREAK
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:324ade6b141ebf43ca1e027a637f3239
URL:http://2026crbesummiteastinnovatio.sched.com/event/324ade6b141ebf43ca1e027a637f3239
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T130000Z
DTEND:20260513T130500Z
SUMMARY:Chairperson’s Welcome & Opening Remarks
DESCRIPTION:
CATEGORIES:
LOCATION:Hyatt Regency New Brunswick\, New Brunswick\, NJ
SEQUENCE:0
UID:dbcb653129ecdf209c461ed676522d27
URL:http://2026crbesummiteastinnovatio.sched.com/event/dbcb653129ecdf209c461ed676522d27
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T130000Z
DTEND:20260513T133500Z
SUMMARY:KEYNOTE: Cellular Nanoparticles: Design\, Fabrication\, and Biomedical Applications
DESCRIPTION:The pharmaceutical industry is undergoing a profound transformation\, shifting from traditional batch processes to continuous manufacturing. This evolution is partly propelled by advances in Process Analytical Technology (PAT) and the foundational principles of Quality by Design (QbD). Transitioning to a SMART factory mode of operation\, however\, requires technological innovation\, significant professional development\, and the maturity of regulatory and management systems. The issue of data integrity breaches (BAD-I)\, with its historical implications and current prevalence\, serves as a critical backdrop for understanding how to balance technological progress with the necessary professional and systemic maturity. This balance is essential to ensure the successful guidance of pharmaceutical manufacturing through this revolutionary phase. In this presentation\, we will introduce a SMART framework designed to provide a common-sense foundation for navigating the complexities of pharmaceutical manufacturing’s evolution. This framework will offer ways to ensure that data integrity\, technological advancements\, and professional maturity move in concert toward a more efficient and compliant future.\n\n\n\n
CATEGORIES:KEYNOTE
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:c0c9407b074a7022c712160a6f680bb8
URL:http://2026crbesummiteastinnovatio.sched.com/event/c0c9407b074a7022c712160a6f680bb8
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T133500Z
DTEND:20260513T140000Z
SUMMARY:Eudracap®: Ready-to-Fill Capsules Enhance Functional Performance
DESCRIPTION:Eudracap® capsules leverage functional polymer technology to deliver enteric and site-specific release without additional coating steps. These systems enable robust performance\, reduced process complexity\, and improved scalability. This session will examine formulation considerations\, performance data\, and applications across modified release strategies.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:fbd84ff1f9ce48f268243e7eca07da73
URL:http://2026crbesummiteastinnovatio.sched.com/event/fbd84ff1f9ce48f268243e7eca07da73
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T140000Z
DTEND:20260513T142500Z
SUMMARY:Room-Temperature Aerosol Dehydration: A Continuous\, Scalable Platform for Thermostable Formulations of Biologics with Enhanced Delivery Performance
DESCRIPTION:Room-Temperature Aerosol Dehydration (RTAD) is an emerging continuous drug product formulation platform that converts liquid biologics and vaccines into shelf-stable\, bioactive powders without cold chain dependency. Developed at Princeton University and commercialized by Inaedis\, Inc.\, this scalable cGMP-compatible process gently generates aerosols of sub-20 µm droplets that flash-evaporate at room-temperature conditions — preserving biomaterial potency while eliminating the harmful thermophysical and dehydration stresses inherent toconventional spray drying and lyophilization.From a formulation standpoint\, RTAD uniquely bridges enabling thermal stability\, controlled release and bioavailability enhancement for biologics. Technology allows precise control over particle morphology\, size distribution\, and excipient composition to tune drug release profiles and improve the bioavailability of high-molecular-weight therapeutics across multiple delivery routes. RTAD supports diverse therapeutic platforms including proteins\, monoclonal antibodies\, viral vectors\, mRNA-lipid nanoparticles\, live-attenuated vaccines\, bacteriophages\, and subunit formulations. Additionally\, RTAD enables ultra-concentrated formulations of biologics\, e.g.\, mAbs with &gt\;400 mg/mL\, compatible with prefilled syringes and autoinjectors — reducing dose volumes and facilitating multi-antigen delivery with favorable pharmacokinetic profiles.RTAD-produced thermostable powders accommodate versatile delivery systems aligned with the controlled release landscape: subcutaneous administration\, inhalation via dry powder inhalers and nebulizers\, transdermal administration\, and. The continuous\, scalable nature of theaerosol dehydration process offers a promising alternative to batch lyophilization\, opening new pathways for continuous biopharmaceutical manufacturing of thermostable solid-dose biologics.This formulation platform addresses critical stability and manufacturability challenges across oncology\, autoimmune diseases\, gene therapy\, and vaccination\, while expanding therapeutic access through flexible\, cold-chain-free delivery strategies that improve patient compliance andenabling equitable global distribution of next-generation biologic therapies.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:96aad696e2ebc465d66ef86ebbe82e93
URL:http://2026crbesummiteastinnovatio.sched.com/event/96aad696e2ebc465d66ef86ebbe82e93
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T142500Z
DTEND:20260513T145000Z
SUMMARY:Lets Break this Down: Lipid Digestion & its Significance in in-vitro Permeation Models for Emulsion Systems
DESCRIPTION:Lipid-based emulsions are increasingly used to enhance drug delivery\, yet the impact of lipid digestion on permeation outcomes is often overlooked. This session examines how enzymatic digestion transforms emulsions into dynamic colloidal structures—such as mixed micelles and vesicles—that directly influence drug solubilization and transport across biological barriers. We will discuss why conventional in-vitro permeation models\, when applied without accounting for digestion processes\, may fail to predict in-vivo performance. Key factors including lipid composition\, droplet size\, bile interactions\, and digestion kinetics will be highlighted. Attendees will gain practical insight into designing more biorelevant in-vitro permeation models that better reflect physiological conditions and support informed formulation development.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:18824c70cbbe9cd06cec895b1db0877f
URL:http://2026crbesummiteastinnovatio.sched.com/event/18824c70cbbe9cd06cec895b1db0877f
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T145000Z
DTEND:20260513T152000Z
SUMMARY:Morning Networking Break in Exhibit Hall
DESCRIPTION:\n
CATEGORIES:MORNING NETWORKING BREAK
LOCATION:Hyatt Regency New Brunswick\, New Brunswick\, NJ
SEQUENCE:0
UID:01402892533e1b353e0a980800df76f2
URL:http://2026crbesummiteastinnovatio.sched.com/event/01402892533e1b353e0a980800df76f2
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T152000Z
DTEND:20260513T154500Z
SUMMARY:Designing a Universal Nasal Drug Delivery Platform to Enhance Bioavailability of Challenging Small Molecules
DESCRIPTION:Nasal drug delivery is emerging as a powerful alternative for small molecules limited by poor bioavailability. This session explores the design of a universal nasal delivery platform engineered to overcome solubility\, permeability\, and stability challenges. Discover how smart formulation and device strategies can unlock rapid absorption\, consistent exposure\, and new therapeutic potential for molecules once considered undeliverable.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:dbe4c5bd0d9f65ac9915e90be54c459e
URL:http://2026crbesummiteastinnovatio.sched.com/event/dbe4c5bd0d9f65ac9915e90be54c459e
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T154500Z
DTEND:20260513T161000Z
SUMMARY:Amorphous Solid Dispersion Development for Straightforward to Challenging Compounds
DESCRIPTION:This session explores practical strategies for ASD development&nbsp\;and manufacturing&nbsp\;across a spectrum of molecule complexity\, from straightforward to highly challenging.&nbsp\;Formulation\, scale-up\, and manufacturing approaches will be discussed with case studies for a range of selected compounds. A case study including development of an extended release tablet for an ASD intermediate will be presented.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:f009eefe5e2e5f8a1d4b9e280dc0aa6c
URL:http://2026crbesummiteastinnovatio.sched.com/event/f009eefe5e2e5f8a1d4b9e280dc0aa6c
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T161000Z
DTEND:20260513T163500Z
SUMMARY:Overview of the Current Landscape of Long Acting Injectable (LAI) Drug Product Development
DESCRIPTION:Long acting injectables offer a powerful approach to improve patient care and reduce global healthcare costs through reduced dose frequency and better medication adherence. &nbsp\;However\, LAI product design requires a deep understanding of chemistry\, manufacturing\, and controls (CMC) aspects\, including material properties\, formulation\, processing\, and device characteristics. This session will review various formulation strategies that have been successfully applied to commercial LAI products and selection of an appropriate formulation technology guided by drug properties and the desired product profile.\n\nAttendees will gain insights into the value proposition for LAIs in the pharmaceutical industry\, different types of LAI dosage forms\, and the technical challenges impacting formulation development and manufacture.\n\n
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:ad4796219e0c6b5cd1e6e05b77320403
URL:http://2026crbesummiteastinnovatio.sched.com/event/ad4796219e0c6b5cd1e6e05b77320403
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T163500Z
DTEND:20260513T170000Z
SUMMARY:The Severed Loop: We Are Formulating for Patients We Have Never Met
DESCRIPTION:\n
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:eb24b81e3740894f03688e602ae317a7
URL:http://2026crbesummiteastinnovatio.sched.com/event/eb24b81e3740894f03688e602ae317a7
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T170000Z
DTEND:20260513T180000Z
SUMMARY:Networking Lunch
DESCRIPTION:\n
CATEGORIES:MORNING NETWORKING BREAK
LOCATION:Hyatt Regency New Brunswick\, New Brunswick\, NJ
SEQUENCE:0
UID:5476c001d80d929f373f9012f388679f
URL:http://2026crbesummiteastinnovatio.sched.com/event/5476c001d80d929f373f9012f388679f
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T180000Z
DTEND:20260513T182500Z
SUMMARY:Assessing the Facts Concerning Excipient Safety and Misinformation: From Nitrosamines to Talc\, Titanium Dioxide and Colorants
DESCRIPTION:Excipient safety has become a growing focus for regulators\, industry\, and the public\, particularly around topics such as nitrosamines\, talc\, titanium dioxide\, and pharmaceutical colorants. This session will review the current scientific evidence and regulatory perspectives surrounding these widely discussed materials. By separating data-driven risk assessments from common misconceptions\, the presentation will provide a clear overview of how excipient safety is evaluated and communicated in today’s evolving regulatory and public landscape.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:5b2d0b2dc3404a2ba6432e35296a1259
URL:http://2026crbesummiteastinnovatio.sched.com/event/5b2d0b2dc3404a2ba6432e35296a1259
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T182500Z
DTEND:20260513T185000Z
SUMMARY:Physiologically Based Biopharmaceutics Modeling (PBBM) Applications in Drug Development
DESCRIPTION:PBBM and PBPK modeling are increasingly central to mechanistic understanding of drug absorption and systemic exposure. By linking critical material attributes\, process parameters\, and physiological variables\, these approaches enable quantitative prediction of in vivo performance\, virtual bioequivalence\, and biowaiver strategies. This session will highlight recent advances in model-informed drug development (MIDD)\, including applications in complex formulations\, nonlinear absorption\, and regulatory decision-making.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:4938e4ca2e703772d8e1760f03fd7fcf
URL:http://2026crbesummiteastinnovatio.sched.com/event/4938e4ca2e703772d8e1760f03fd7fcf
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T185000Z
DTEND:20260513T191000Z
SUMMARY:Afternoon Networking Break in Exhibit Hall
DESCRIPTION:\n
CATEGORIES:MORNING NETWORKING BREAK
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:ca59fba89fc888d4d7597170a0a69a7a
URL:http://2026crbesummiteastinnovatio.sched.com/event/ca59fba89fc888d4d7597170a0a69a7a
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T191000Z
DTEND:20260513T193500Z
SUMMARY:Optimizing Regional and Systemic Pharmacokinetics with Lipid-based Drug Products
DESCRIPTION:Lipid nanoparticles (LNPs) have emerged as a transformative platform for drug delivery\, yet optimizing their design remains complex. This session will explore how formulation strategies\, lipid selection\, and process parameters can be fine-tuned to improve stability\, targeting\, and delivery efficiency. Attendees will gain practical insights into overcoming key development challenges and unlocking the full potential of LNPs across a growing range of therapeutic applications.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:3c4b1ac09e3e8b7b8c3c631b841276f8
URL:http://2026crbesummiteastinnovatio.sched.com/event/3c4b1ac09e3e8b7b8c3c631b841276f8
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T193500Z
DTEND:20260513T201000Z
SUMMARY:Agglomerated Crystalline Sodium Caprate: Enabling Better Tablet Performance
DESCRIPTION:Overcoming the Challenge of Processing Permeation Enhancers into Robust Drug Product.
CATEGORIES:GENERAL SESSION
LOCATION:Crowne Plaza Princeton - Conference Center by IHG\, 900 Scudders Mill Rd\, Plainsboro Township\, NJ 08536\, USA
SEQUENCE:0
UID:8ecb21f983e6a4dd24cceadb284a9a82
URL:http://2026crbesummiteastinnovatio.sched.com/event/8ecb21f983e6a4dd24cceadb284a9a82
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260515T133027Z
DTSTART:20260513T201000Z
DTEND:20260513T201500Z
SUMMARY:Chair’s Closing Remarks and End of Day Two
DESCRIPTION:\n
CATEGORIES:MORNING NETWORKING BREAK
LOCATION:Hyatt Regency New Brunswick\, New Brunswick\, NJ
SEQUENCE:0
UID:31a3bd73e492d87bc4096a6ca42c21a7
URL:http://2026crbesummiteastinnovatio.sched.com/event/31a3bd73e492d87bc4096a6ca42c21a7
END:VEVENT
END:VCALENDAR