Aprecia and CMIC, a Leading CDMO in Japan, have established an agreement to bring 3DP pharmaceutical products to Japan

Multi-omics approaches integrate multiple omics data generated from cancer patients to better understand the molecular and clinical features of cancer. Multi-omics technologies, including genomics, proteomics, and metabolomics, have also been included in clinical trials to understand the response to immunotherapy and the mechanisms of drug resistance.

Gene therapy has made tremendous strides over the past decade or so. The first approved drugs are on the market, and literally hundreds of trials are underway offering unprecedented hope to patients with rare, debilitating genetic disorders. Nevertheless, safety issues continue to swirl around the field as adverse events are reported in trials involving both lentivirus and AAV vectors. Pricing and manufacturing pose additional hurdles that could significantly challenge the field.

Genomic analyses are yielding a host of new information on the multiple genetic abnormalities associated with specific types of cancer. A comprehensive description of cancer-associated genetic abnormalities can improve our ability to classify tumors into clinically relevant subgroups and sometimes identify drivers. However, the functional significance of cancer-associated mutations is often difficult to discern. Forward genetic screens provide a powerful tool to identify genes or genetic networks that contribute to specific biological phenotypes or diseases and therefore hold great potential for elucidating gene function and revealing therapeutic targets for diseases. The advent of CRISPR-Cas technology has revolutionized genome editing in higher eukaryotes and enables efficient gene manipulation in mammalian cells. CRISPR guide-RNA libraries allow facile generation of a pool of genetically perturbed cells and its application in genetic screens has marked a major breakthrough for functional genomics in mammalian cells.

Implementation of biobanking best practices and analytical platform standardization are two important components for any data generation associated with state of the art biobanks that support precision medicine applications. Sample collection, pre analytical variables, controlled environment storage and sample processing can often have a large impact on the quality of biomaterials. This roundtable will describe how to standardize biobanking efforts in a manner commensurate with both academic and industrial partnerships. Data will be presented on the governance of biosample collections, standardization efforts, and quality control harmonization for biosamples as well as global best practices for the regulatory oversight of national and commercial biobank resources. Finally, a review of several international programs will illustrate how collaborative efforts are helping advance integrated biobanking precision medicine across many research and clinical areas.