The Technical Forums at the CRS 2026 AM&E offer a unique opportunity for companies to showcase their innovative ideas and products to the entire CRS network. These forums foster valuable conversations, allowing participants to ask questions and share insights that are driving the progress of delivery science.
Tuesday, July 7, 2026
Technical Forums I
9:00 AM TO 10:00 AM |
Combining Physics-Based and Machine Learning Approaches to Accelerate Pharmaceutical Formulations Design and Development
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| Room: Auditorium 6 The successful translation of an active pharmaceutical ingredient (API) into a viable clinical therapy hinges critically on the development of an optimal drug formulation. Engineering a formulation that balances bioavailability, stability, and targeted delivery often presents a complex physicochemical challenge. With advances in machine learning, physics-based simulation and compute hardware, modeling is emerging as a valuable source of information to complement experimental characterization and guide decisions in formulation development. In this talk, we showcase how the tools from the Schrödinger platform can be applied to modeling formulations across a diverse set of therapeutic modalities, ranging from small molecules to peptides to biologics. The talk will feature case studies on crystalline solid formulations, demonstrating the use of crystal structure prediction to map polymorph landscapes and machine learning approaches for optimal co-former selection for co-crystals. Furthermore, we will explore amorphous solid dispersions, showcasing how physics-based simulations can help predict formulation stability and understand the drug release mechanism. Finally, we will discuss methods to analyze those complex, dynamic structures that are typical of formulations in the fluid state, such as lipid-based formulations for nucleic acid delivery and excipient-protein interactions in injectables. Speaker: Irene Bechis, PhD, Schrödinger |
Enabling Drug Development with Innovative Solubilization Technologies
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Room: Auditorium 7 Advances in drug discovery have increased the number of poorly soluble compounds, driving the need for effective solubilizers across drug development stages and administration routes (oral, parenteral). This presentation reviews novel and established solubilizers for approved or experimental drug molecules, emphasizing formulation parameters, screening methods, in vitro and animal data, and regulatory considerations. Select case studies will illustrate the use of Apisolex™ polymer - a polyaminoacid based ingredient - to enhance the solubility of hydrophobic drugs in injectable formulations and of Apinovex™ - a polyacrylic based excipient - to stabilize active pharmaceutical ingredients as amorphous solid dispersions for oral use. The benefits of those excipients have been evaluated by pharmaceutical companies through in-vitro and animal studies, and phase I clinical trials. Recommendations will be offered for excipient selection to support progression from early trials to late-stage clinical development towards drug approval. Speaker: Pawel Balcerzak, PhD, Lubrizol Life Science Elena Draganoiu, PhD, Lubrizol Life Science |
Long-Acting Injectables: AI and Robotics Driven Formulation |
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Room: Auditorium 8 Poly(lactic‑co‑glycolic acid) (PLGA) remains the benchmark material for long‑acting injectable (LAI) drug delivery, supported by decades of clinical use and multiple approved products. As the only biodegradable polymer platform built entirely from regulatory‑accepted building blocks, PLGA offers unmatched tunability in composition, molecular weight, and architecture. However, LAI performance is not defined by the polymer alone. Release behavior and depot performance emerge from an integrated interaction between polymer properties, formulation strategy, and manufacturing process—an interplay that is often underestimated. For particle‑based systems and emerging in situ forming depots, this complexity creates an expansive design space that is difficult to navigate using conventional approaches. The Intrepid platform addresses this challenge through automated formulation development, combining robotics and artificial intelligence to accelerate experimentation and efficiently explore polymer, formulation, and process relationships. We will demonstrate how this approach enables highly tunable release profiles and robust depot performance targeting multiple formulation objectives simultaneously, saving time and costs for development. Together with Corbion’s leadership in PLGA supply and developments, these capabilities open renewed opportunities for faster and customizable, next‑generation LAI development. Speakers: Brigitte Lamers, PhD, Corbion Biomaterials Christine Allen, PhD, Intrepid Labs |
Rational Formulation Strategies for High Concentration Subcutaneous Biologics: From Innovative Excipients to Spray Dried Drug Product Suspensions |
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Room: Auditorium 3/4 The pharmaceutical industry is undergoing a clear transition from intravenous (IV) administration toward subcutaneous (SC) delivery of biologics, driven by strong patient preference, reduced healthcare burden, and the opportunity for at home administration. This shift places significant challenges on formulation and manufacturing, particularly for high dose biologics. High drug concentrations required for SC delivery frequently lead to excessive viscosity, reduced syringeability, aggregation risk, and limited stability, while conventional formulation and dosage forms often prove insufficient. As a result, enabling the IV to SC transition increasingly depends on innovative excipient strategies and alternative drug product presentations. This 1 hour session brings together two complementary presentations addressing how advanced formulation science and particle engineering can mitigate formulation risks, expand delivery options, and accelerate the transition from IV to patient centric SC biologic therapies. The first presentation will focus on novel, nature inspired synthetic sugar excipients designed to stabilize proteins and reduce viscosity in highly concentrated liquid formulations. Leveraging on computational and experimental screening, this library of excipients expand the formulation design space, enabling higher concentrations, improved injectability, and enhanced long term stability for SC delivery. The second presentation will explore spray drying as an enabling technology for biologics, highlighting its role in generating stable solid state drug products and ultra high concentration non aqueous systems. Using examples across immunoglobulins and monoclonal antibodies, this talk will discuss formulation design, particle engineering, and aseptic processing de risking strategies, to support clinical and commercial manufacturing. Speakers: Joana Cristovão, Hovione FarmaCiencia Inês Matos, Hovione FarmaCiencia |
Technical Forums II
1:30 PM to 2:30 PM |
Innovative Solutions Supporting Long Acting Therapy Development: An Industry Approach |
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Room: Auditorium 3/4 Long-acting injectables (LAIs) promise transformative dosing convenience, but their development is often slowed by limited, slow, or low‑resolution ways to predict how a drug depot forms, releases drug, and interacts with surrounding tissue. In this session, speakers will describe how Gilead Sciences is advancing LAI development by combining AI/ML-enabled image analysis with mechanistic, physics‑based modeling to create “digital twins” of injected depots that support faster, more informative decisions early in development. The session will also highlight leveraging human skin models that accelerate understanding of the mechanism behind injection‑site reactions, by leveraging traditional histology as well as multiplex cytokine secretions. This session will provide a snapshot of how Gilead Sciences is hoping to better understand the complexity of LAI injections and improve the efficiency of bringing these therapies to the clinic. Innovative Solutions Supporting Long Acting Therapy Development: An Industry Approach Speakers: Robert C.H Gresham, PhD, Gilead Sciences Preethi Raghavan, PhD, Gilead Sciences Brie Falkard, PhD, Gilead Sciences |
Wednesday, July 8, 2026Technical Forums III9:00 AM TO 10:00 AM |
Breaking the Injection Barrier Using Innovative Technologies for Oral Delivery of Midsize and Macromolecules |
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Room: Auditorium 6 Oral delivery of macromolecules such as peptides and proteins remains a major challenge due to enzymatic degradation, poor permeability and instability in the gastrointestinal tract. Despite these barriers, oral administration offers clear advantages in patient convenience, adherence and cost reduction. This presentation explores formulation and delivery strategies used to enhance oral bioavailability of macromolecules, with emphasis on lipid-based formulations, enteric softgels and sublingual/buccal routes. Mechanistic considerations including protection from gastric degradation, promotion of solubilization and modulation of intestinal absorption pathways will be discussed. By aligning molecular properties with appropriate formulation and delivery strategies, oral administration may be achievable for a specific range of peptides and biologics, supporting patient-centric product design and lifecycle differentiation. Speaker: Karunakar Sukuru, RPh, PhD, Catalent |
Enabling Innovation in Polymer Therapeutics Through Scientific Alliance |
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Room: Auditorium 2 Innovation in polymeric drug delivery systems sits at the intersection of polymer chemistry, biology, and analytical science. No single discipline or organization can address this complexity alone. This session brings together experts from academia and industry - Dr Maria Jesus Vicent (CIPF), Dr Sergio Esteban (Curapath), and Dr Snežana Đorđević (Tosoh Bioscience) to discuss how collaborative approaches to physico‑chemical characterization can accelerate understanding and innovation in polymer therapeutics. We will also highlight the importance of detailed characterization and analytical mindset in the development of polymer-based drug delivery systems and how any advancement in science including the rapidly growing drug delivery field, needs to be followed by the advancement in analytical technology. Chair & Speaker: Jonas Wege, MSc, Tosoh Bioscience GmbH Speakers: Maria J. Vicent, PhD, Polymer Therapeutics Lab, CIPF (Spain) Snežana Đorđević, PhD, Tosoh Bioscience GmbH Sergio Esteban, PhD, Curapath |
Hyaluronic Acid Nanogel (Sonanos™): A Next-Generation Pharmaceutical Excipient for Injectable Formulations as a Sustained Release Agent and Solubilizer |
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Room: Auditorium 3/4 This presentation introduces a next-generation pharmaceutical excipient for injectable formulations—hyaluronic acid nanogel (Sonanos™)—currently awaiting first-in-human trials. Sonanos™ functions as both a sustained release agent and a solubilizer. Sonanos™ consists of nano-sized hydrogel particles (20–100 nm) that encapsulate a wide range of APIs without the use of organic solvents or harsh processing conditions, enabling the following applications: - Sustained Release Agent for Biologics: Sonanos™ PG (Sustained Release Grade) suppresses burst release and enables prolonged drug release via in situ depot formation. It is applicable to long-acting peptides, poorly water-soluble peptides, and proteins without inducing denaturation. - Solubilizer for Higher-Molecular-Weight Modalities: Sonanos™ DS (Solubility Enhancement Grade) markedly enhances the solubility of poorly water-soluble APIs, including higher-molecular-weight modalities such as peptides. In certain cases, solubility increases exceeding 100,000-fold have been observed, achieved by simple addition of API powder to a Sonanos™ DS solution. Asahi Kasei Corporation has established proprietary industrial-scale manufacturing technology for Sonanos™ and is planning GMP manufacturing in compliance with IPEC‑PQG guideline. We welcome collaboration with pharmaceutical industry partners to develop innovative injectable formulations using Sonanos™. Speaker: Yoshiyuki Nakagawa, PhD, Asahi Kasei Corporation |
Learning to Deliver: Machine Learning–Guided Lipid Nanoparticles Enabled by High-Throughput Fabrication for Efficient RNA Transport Using Dionamix NanoStation Platform |
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Room: Auditorium 7 Efficient intracellular delivery of RNA therapeutics remains a major challenge due to endosomal sequestration and rapid recycling of lipid nanoparticles (LNPs). In this seminar, I will present our recent work on innovating LNP formulations to improve RNA delivery efficiency by increasing intracellular retention and promoting endosomal release. Our strategies include incorporating a pH-sensitive polymer into LNPs to facilitate endosomal escape and a lipid component that inhibits endosomal recycling, effectively rewiring intracellular trafficking pathways. To accelerate discovery, we leverage high-throughput automated LNP library fabrication using Dionamix NanoStation, enabling rapid generation and screening of diverse nanoparticle formulations. Coupled with machine learning–guided optimization, this platform allows systematic exploration of structure–function relationships and identification of high-performance LNP candidates. These engineered LNPs demonstrate superior RNA delivery in both in vitro and in vivo models. I will discuss mechanistic insights, formulation design principles, and translational potential, highlighting our findings from three recent studies and unpublished work. The Dionamix NanoStation platform enables precise, reproducible LNP formulation through controlled flow rates and user-defined volumetric lipid mixing, eliminating manual pipetting. This control supports systematic optimization of particle size, composition, and encapsulation efficiency. Integrated automation and scalability enable rapid iteration and consistent LNP library generation for high-throughput workflows. Speakers: Shyh-Dar Li, PhD, University of British Columbia Reyhaneh Jafarirad, MSc, Dionamix Scientific inc. |
Thursday, July 9, 2026Technical Forums IV9:00 AM TO 10:00 AM |
Scale Up Challenges in LNP Drug Product Development |
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Room: Auditorium 6 This session will cover the integrated activities of novel lipid design, chemistry and quality attributes, along with key considerations for their use in LNPs including scale up challenges for drug product production. The effect of raw material attributes on LNP formulation properties during different parts of the manufacturing process will also be addressed. Speakers: Michael Parr, Evonik Canada Inc. Sophie Hammer, Evonik Operations GmbH |
Thursday, July 9Industry Roundtable8:00 am to 9:30 am |
Industry Insights in the Future of Controlled Release |
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Room: Auditorium 3/4 Presentations by industry leaders and experts in the world of controlled release, providing insight into the future challenges from a commercialization lens. Followed by a panel discussions and Q&A with the audience. Speakers: Tyler Novak, PhD, Gilead Sciences Seth P. Forster. PhD, Merck & Co. Inc |
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