2024 Program Themes
Theme 1: “Emerging Novel Technologies in the Bioanalytical Field”
Keywords: LC-MS, LBA, Gyros, Biomarkers, ADCs, Novel Modalities, Cell Therapy, Gene Therapy, ADA Isotyping, Spectral Flow, Elispot, Lumipulse, Isoplexis, O-Link, HR-LCMS Proteomics, Nano LCMS, CyToF, Microsampling, VAMS, AI/ML, Immunogenicity, Predictive Models, Organoid, ProTacs/TPDs, NGS
Description: Drug development has continued to advance, accompanied by the development of technologies that facilitate new bioanalytical strategies employed for characterization. Numerous emerging technologies have been applied to address bioanalytical inquiries in the domains of biomarkers and fit-for-purpose discovery. Some are gradually transitioning into the regulated bioanalytical arena. For example, the enumeration of various cell populations by flow cytometry as well as global gene expression profiling by RNA-Seq can serve as key or exploratory biomarkers. The difficulties associated with obtaining high-quality whole blood samples from terminally ill and pediatric populations have prompted advancements in sampling techniques. This theme offers a platform to exchange insights on the application of novel technologies in order to effectively address distinctive bioanalytical questions.
Theme 2: “Bioanalytical Strategies for New Modalities”
Keywords: Critical Reagents for Novel Modalities, Microsampling Advancements, ddPCR, HRMS, Innate Immunity, Expamers, Bioanalytical Strategies, Preclinical ADA testing, Peptide BA strategy, ADC, instrument validation, LBA, Hybrid LC-MS, FDA guidance, Dose formulation, Protein Degraders, CAR-T, Cell/Gene therapy, Antibody-siRNA conjugate, Automation, Data Analysis, qPCR
Description: New modalities are calling for comprehensive bioanalytical strategies that use innovative approaches to effectively characterize and assess the safety, efficacy, pharmacokinetics, and pharmacodynamics. These modalities, including but not limited to gene therapies, cell-based therapies, RNA-based therapeutics, and antibody-drug conjugates, pose unique challenges due to their complex structures and mechanisms of action. Bioanalytical strategies for new modalities encompass a broad range of methodologies, such as advanced mass spectrometry, next-generation sequencing, flow cytometry, and ligand-binding assays, among others. These strategies aim to enable robust characterization of new modalities, facilitating their translation into clinical development and regulatory approval.
Pharmaceutical Analysis Track
Theme 1: Analytical Methods for Complex and Novel Formulations
Keywords: Parenterals, Analytical Methods, Multicomponent Drugs, Combination Drugs
Description: Advances in formulation sciences have expanded the application of novel therapies for human diseases. This, however, has led to more complex formulations, posing new challenges for analytical scientists. From multicomponents to targeted delivery formulations, innovative analytical methods are necessary to ensure quality products. This session features experts discussing innovative approaches for characterizing complex formulations. Gain valuable insights into the latest advancements in analytical methods for multicomponent systems, lipid nanoparticle delivery, parenteral formulations, and more.
Theme 2: Stuck in the Middle - Methodologies for oligonucleotides, peptides, and other medium-sized molecules
Keywords: Oligonucleotides, Medium-Sized Molecules, Peptides, Analytical Methods, Analytical Characterization
Description: This scientific session covers into the current challenges encountered in the development of analytical methods for oligonucleotides, peptides, and other medium-sized molecules. These molecules possess structural complexity, making their accurate characterization, impurity separation and structure elucidation a challenge. The session addresses the difficulties related to specifications, sensitivity, detection, and the scarcity of suitable reference materials. Experts in the field discuss innovative approaches and techniques employed to overcome these challenges in analyzing these diverse molecules. Gain valuable insights into the latest advancements in analytical methods for these “in between” molecules.
Theme 3: Challenges in Analytical Method Validations and Transfers
Keywords: Analytical Method Transfer, Analytical Method Validation, Risk Management, ICH Q2, Technology Transfer, Lab Qualification, USP <1224>
Description: Method validation and transfer are foundational processes in analytical method lifecycle. Validation is carried out by an originating lab to demonstrate a method is suitable for its intended purpose and consistently produces reliable results. Transfer is done to demonstrate the ability of the receiving lab to conduct the method. Sometimes validation and transfer occur nearly, or in parallel. Accelerated timelines, geographical distance, new technologies, and other factors can make these processes challenging. Proactive communication and collaborative planning are necessary to facilitate knowledge transfer and ensure lab readiness for a successful outcome. Risk assessment can help provide structure to this endeavor to help build lab capability and ensure regulatory and quality compliance. This session presents strategies, tools, and case studies of validation/transfers along with discussions on joint risk assessments and technical troubleshooting before, during and after transfer.
Theme 4: Nitrosamine Analysis and Control
Keywords: Nitrosamine Analysis, Mutagenic Impurities, Impurity Quantitation, Carcinogenic Potency Categorization Approach
Description: Nitrosamine impurities have recently received significant attention and scrutiny as scientists and health agencies strive to develop scientific understanding while ensuring patient safety. Improved characterization and mitigation of nitrosamine risk requires sensitive analytical methods capable of quantitation at very low levels combined with end-to-end assessment of factors contributing to nitrosamine formation. This theme focuses on the analytical methodologies and approaches used to establish control of these challenging impurities, as well as recent changes in the associated regulatory landscape.