Each track will be split equally between chemical and biomolecule areas, resulting in 10 sub-tracks that will cover many of the areas making the biggest headlines in the pharmaceutical sciences today. -Preclinical Development -Bioanalytics -Clinical Pharmacology -Manufacturing and Bioprocessing -Formulation and QualityBecome a member to receive a discount on PharmSci registration.
BIOMOLECULAR DRUGImmuno-Oncology: Advancement from Infancy to ProductsImmuno-oncology is a rapidly evolving pharmaceutical field with innovative methods of treating cancer, immunotherapies, that either stimulate the activities of specific components of the immune system or counteract immunosuppressive signals produced by cancer cells. New immunotherapy modalities include cellular vaccines, mAbs or alternative scaffold checkpoint inhibitors, as well as CAR-T cells, whose development as pharmaceutical products is unique, challenging, and to date unstandardized. This end-to-end topic will feature 20 symposium presentations that deliver an overview and update on critical aspects of preclinical development, bioanalytics, clinical pharmacology, manufacturing & bioprocessing, as well as formulation and quality, relating to innovative checkpoint inhibitor and CAR-T products.CHEMICAL DRUGRapid and Cost-Effective Delivery of New Drugs to PatientsHigh costs and lengthy timelines continue to impede drug development, affecting patients, prescribers, and payers. Significant contributing factors include manufacturing issues, increasing regulatory expectations, and clinical failures resulting from insufficient efficacy or safety. This end-to-end topic will feature 20 symposium presentations that deliver an update on factors leading to increased development and production burdens, as well as strategies for reducing costs and timelines across drug development with a focus on preclinical development, bioanalytics, clinical pharmacology, manufacturing and bioprocessing, and formulation and quality. Ultimately, innovative approaches in these areas enable drug providers to deliver lifesaving medicines quickly and affordably to patients.
Preclinical DevelopmentPicking the Winning CandidateHow is preclinical data (e.g. ADME, biology, pharmaceutics, and toxicology) used to enable compound selection? Once a target is identified, how do we make the best use of preclinical models, tools, and data to rapidly advance the development of small or large molecules presenting with a high probability of success?Sessions within this theme will cover novel scientific learnings (e.g. in-vitro, in-vivo, and in-silico) and how this information is being applied or could be applied in the preclinical development space.Emerging Research ToolsWe live in an exciting world of new research tools (e.g. organs on chips, transgenic animals, genetically engineered cells, and computational modeling). Sessions within this theme will cover how these tools can be applied to advance either biological system understanding or enable small and large molecule characterization within the preclinical development space.Preclinical to Clinical TranslationHow do we use pre-clinical data to improve confidence in compound success in the clinic? Sessions within this theme will include approaches to overcome drug delivery challenges (e.g. in-silico models to support formulation development); use of modeling and simulations approaches to predict clinical outcome (e.g. PBPK for human dose projections, drug-drug interaction predictions); approaches to identify translational biomarkers (PD or safety); and ways to pre-clinically assess impact of disease state, genetic factors, and ethnic differences in compound efficacy or safety. BioanalyticsNovel Therapeutic ModalitiesThe explosive growth in our understanding of molecular biology has provided a large number of targets to treat and cure diseases. Novel therapeutic modalities are being developed that use new approaches for molecular interactions and new mechanisms to overcome delivery barriers. These modalities may be totally new (e.g. cell therapies), previously little used (e.g. viral gene therapies, siRNA, peptides, millimolecules), combinations and carriers (e.g. tethered molecules, nanoparticles), or next generations of multi-specific antibodies. Each of these modalities present various bioanalytical challenges when measuring exposure (PK), immunogenicity, and pharmacodynamics (PD).These sessions will focus on the challenges bioanalytical scientists face and possible solutions during drug development of these novel therapeutic modalities.New Technology and New Applications of Existing TechnologySensitivity, specificity, accuracy, and precision are some of the characteristics that make robust assays. Recent advances in new technology, as well as the application of existing technology in new areas, are providing tools that enable bioanalysts to deliver more sensitive and reliable assays for PK, PD and immunogenicity measurements.These sessions will bring forward the latest technology and solutions being employed.Emerging Regulations Impacting BioanalysisNational and international regulations for PK, PD, and immunogenicity measurements are advancing at the national, regional, and global level in some cases as concerted efforts, and more frequently as independent and not always aligned endeavors. Compounding the situation for bioanalytical scientists are the various interpretations applied between regulatory bodies, down to differences between individual interpretations of the same statements, which many times ignore the science.These sessions will bring forward the issues faced by bioanalysts, the scientific aspects of the experiments, and regulators who will provide their perspectives on current regulatory issues under consideration. Clinical PharmacologyPBPK Modeling and Clinical Pharmacology in Regulatory Applications & Decision MakingThe ability to accurately predict drug absorption and disposition during drug product development is increasingly relevant today. Modeling and simulation tools and clinical pharmacology techniques provide a quantitative mechanistic framework for predicting and assessing systemic and tissue concentration-time profiles, and can thus provide a valuable resource to support decisions at various stages (early development, late development, post-approval, and lifecycle management) of the drug development process, regulatory interactions, and personalized treatment of patients. A significant step forward for this field is the inclusion of PBPK modeling in submissions to regulatory agencies and acceptance of such models by the agencies to waive and/or supplement clinical studies, and to support labeling.The sessions in this theme will discuss the advances in these areas, current challenges and future applications in regulatory filings and decision making.Non-traditional Approaches to BE and Biosimilars and Application of Clinical Pharmacology to Minimize Barriers to Generic Drug SubstitutionDemonstration of average bioequivalence (BE) is challenging for many molecules including highly variable drugs, narrow therapeutic index drugs, locally acting drugs, fixed-dose combinations, and non-oral routes of delivery. Having the same BE criteria for all classes of drugs and therapeutic areas poses undue technical, resource and logistical burden on the pharmaceutical industry. It also adds to the time and cost of drug development. This theme will focus on novel approaches to BE, which can be acceptable to the regulatory agencies and reduce barriers to generic medications while maintaining safety and efficacy of the drug product. The Biologics Price Competition and Innovation (BPCI) act intended for a more affordable, generic substitutes for biologics, such as biosimilars, and to create an abbreviated approval pathway to help these cheaper biologics reach patients more quickly. Despite approval of the BPCI act, several scientific, legal, regulatory, and post-marketing barriers exist for entry of biosimilars.This theme will explore clinical pharmacology associated challenges and novel opportunities for scientific development, policies, regulations, and commercialization of biosimilars including perspectives from emerging markets.Pharmacogenetics, Big Data, and Population Pharmacokinetics in Personalized Medicine and Special PopulationOne of the primary aims of personalized medicine is individualization of the therapy. Advances in molecular genetics and biomarkers, and the ability to quantify that into a therapeutic regimen, which is tailored to the individual patient, has gained significant attention. Also, the ability to model large datasets and population PK approaches enable a quantitative approach to dose selection and dosing regimen based on individual physiology and pathophysiology. However, individualization of drug therapy also raises numerous challenges such as the development of appropriate diagnostic tools for biomarkers; identification of correct disease targets; cost-effective devices; and developing accurate PK/PD models, among others.In this theme, the personalized medicine’s advances, challenges, and regulatory perspectives will be discussed. Manufacturing and BioprocessingProcess Controls, Manufacturing & Engineering Challenges and Related Strategies The quality requirements of manufacturing processes and materials characterization are increasing continuously. Even if cross-references are possible or even expected by using existing process knowledge from previous product developments, each product presents its own challenges. However, new sensors allow for better in-process controls and process monitoring, or ultimately for parametric release for specific attributes. Through computer modeling, process development, process transfers, and process adjustments can be made smarter and more predictable, if verification or validation succeeds. In the field of biological molecules, including biosimilars, how far through the manufacturing process immunogenicity is affected and what factors are decisive continue to be challenges. Modern strategies to master these process, manufacturing, and engineering challenges for both chemical and biological agents and products are the focus of this theme.Continuous Manufacturing and Connected Processes Supporting End-to-End Approaches and Adapting to the Non-blockbuster EraThe pharmaceutical industry is under tremendous pressure, and patients' expectations are high to provide fast and reliably effective treatment. Simultaneously, the volume per product is predicted to decrease in the post-blockbuster era, which may be commercially compensated by combining products, but not as regards individual batch sizes. New thoughts and concepts are key to overcoming this challenge. Continuous and connected processes, ideally from the raw material to the final product, reduce throughput times and optimize costs. Continuous and connected processes may help to address and overcome the threats to supply chain of marketed products, reduce footprint needs and improve yields. Regarding biologics we will also explore advanced expression systems and recent improvements in purification technologies including glycosylation platform expression systems and analysis systems. Case studies will illustrate the current state of the art but also future plans and vision.Approaches to Master CMC of the Future- CE : Addressing Patients' Needs by Drug Delivery Systems and Future Looking Manufacturing Technologies for Small Molecules- BM: Accelerated Development & Process ContinuumThis track will be thematically separated between chemical and biomolecular drugs. The focus of the chemical side is on state-of-the-art drug delivery systems and their controlled production. Among other topics: oral systems for the administration of poorly soluble molecules; technologies which are material-saving and flexible, such as 3D printing; and technologies and manufacturing processes that have the patient at the center, will be discussed. The biomolecular side will focus on concepts that enable accelerated development, including the underlying strategies. The topic will comprise the setting of criteria for manufacturability in early development; the use of statistical tools for accelerated development and tech transfers/site transfers; as well as a process continuum with realization of continuous process verification, process adaptations, and process learning. Formulation and QualityDevice-Drug CombinationFormulation design and optimization, in recent years, is moving toward more patient-focused and combination considerations to maximize outcomes. This theme is broadly around multiple options to achieve this, including prefilled syringes, auto-injectors, large volume administration options, etc. The development process of these options includes formulation selection, design control, stability and manufacturing considerations. In addition, new developments such as fixed dose combinations of proteins and sustained release of chemical entities will be included.Formulation Development Challenges and StrategiesFormulation design strategies are continually improved, and new strategies continually introduced. Novel formulation technologies are used to overcome low bioavailability, poor solubility, and stability; to create alternative routes of administration; to manage surfactant degradation; and to improve manufacturability of chemical entities. There are also novel formats and administration in biomolecules, including fusion proteins, oligos, intravitreal formulations, high dose, high concentration, etc.This theme will cover the latest advances in formulation development.Quality and Characterization Considerations for Formulation DevelopmentQuality and characterization considerations can significantly influence formulation development considerations. This theme will cover multiple aspects such as polysorbate degradation, (sub)visible particle characterization/quantification methods, peptides technology, and biological consequences. Modeling and simulation approaches that are used to predict critical quality attributes in formulation and process selection will also be discussed. So will regulatory aspects such as impurities profiling, excipients modernization and testing, harmonization, specifications, new drug substance formats (co-crystals, amorphous).
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