Tracks and Themes Track 1: Advances in Discovery, Formulation, and Delivery of New Modalities A tremendous rise in the biologics market has driven significant interest in their discovery and in using novel drug delivery systems to enable drug delivery via different routes. This track focuses on aspects of the discovery and development of biologics and new modalities. Submissions are invited on topics related to multi-specific antibodies, oligonucleotides, proteins, nanobodies, genes, RNA, peptides, cell-free manufactured proteins, vaccines, cells, and allogenic and synthetic cells. Discussions are encouraged on diverse strategies for the discovery, formulation, and delivery of these modalities to address unmet medical needs. Theme 1: Preformulation and Formulation Approaches for Biologics and New ModalitiesKeywords: Preformulation, Formulation, Stability, CMC, Excipient, Impurities, BiologicsExplore the challenges associated with preformulation and formulation development of biologics and new modalities. In addition to the modalities mentioned above under Track 1, submissions related to screening and excipients selection, the impact of excipients on pharmacokinetics/pharmacodynamics (PK/PD), and stability are welcome. Discussions of Chemistry, Manufacturing, and Controls (CMC) issues related to the development of these modalities are encouraged.Theme 2: Drug Delivery for New Modalities and TherapiesKeywords: Drug Delivery, Gene Delivery, Vaccines, Cell Therapy, Personalized MedicineThis theme focuses on different strategies and challenges involved in the design of drug delivery systems, the delivery of biologics, and manufacturing challenges in the development of novel drug delivery systems. Topics such as nanoparticles, liposomes, hydrogels, Antibody-Drug Conjugates (ADCs), nanobots and devices, personalized medicines, cell-based therapies, and viral and non-viral gene delivery are the primary focus. Submissions on advances in the delivery of genes, vaccines, and biotherapeutics via non-parenteral routes of administration (e.g., oral, topical, intravitreal, nasal, and inhalation) are encouraged. Theme 3: AI/ML in Drug Discovery and DevelopmentKeywords: Artificial Intelligence, Synthetic Biology, Gene Editing, CRISPR, DiscoveryThis track explores how Artificial Intelligence/Machine Learning (AI/ML) and big data are transforming the landscape of drug development and reducing discovery time and cost. Submissions are welcome on novel biotherapeutics developed using AI; AI-enabled gene-editing drugs; and the combination of AI, synthetic biology, and cell manufacturing as well as their impact on new drugs, novel design, and manufacturing processes. Topics to be covered include: CMC and regulatory issues; the use of AI in CMC and process development; decentralized manufacturing, risks, and benefits associated with using AI in drug discovery and development; and data integrity concerns. Track 2: Novel Strategies to Advance Biotherapeutic Development Advances in therapeutic development for targeted delivery, platform technology, high-content bioanalysis, and data science. Theme 1: Development Strategy for Novel Targeted Therapeutic DeliveryKeywords: Targeted Delivery, Bioanalysis, PharmacokineticsAs the field of targeted drug delivery advances with new modalities such as lipid nanoparticles, cell therapies, and gene therapeutics, science is also gaining ground in the design of protein therapeutics tailored to deliver to specific tissues (examples: eye, tumor, or brain) and methods for bioanalysis. Discuss how pharmacokinetics, pharmacodynamics, and immunogenicity bioanalysis and data for tissue-targeted therapeutics can inform and advance therapeutic development.Theme 2: Advances in Analytical and Bioanalytical Platform TechnologyKeywords: Instrumentation Platforms, Flow Cytometry, Multiplexing, Imaging, Data Science The field of analytical platform technology is racing to keep pace with the emergence of new modalities such as oligonucleotides and cell and gene therapies, as well as the increasing need for more informative analytical evaluation of traditional therapeutics such as monoclonal antibodies and antibody drug conjugates. Discuss high-resolution instrumentation techniques, multiplexing, flow cytometry, imaging platforms, and other technological advancements. Submissions are also welcome related to the associated developments in data science that add increased information to biodistribution, pharmacokinetics, immunogenicity, and pharmacodynamics analyses. Theme 3: High Content BioanalysisKeywords: MAPPS, In-Silico Prediction, Immunogenicity Prediction, Artificial Intelligence, Machine Learning, personalized medicine, OmicsHigh Content Bioanalysis in genomics, proteomics, metabolomics, and lipidomics, along with technologies to identify and measure biomarkers at the single cell level, combined with advances in data sciences (artificial intelligence) are exponentially evolving. Discuss case studies and platforms for high content bioanalysis for personalized medicine, novel -omic approaches, immunogenicity prediction, immunogenicity risk assessments, and digital biomarkers. Submissions are also welcome that explore evolving data science and artificial intelligence methodologies for analysis of large data sets.