current and future pharmacy practice

In this webinar, the validation of an interactive response technology (IRT) solution built with configurable parameters will be explored. Traditionally, interactive response technology solutions require validation of each study-specific requirement to ensure proper implementation. With the prevalence of configurable interactive response technology solutions where the validation of each configurable parameter occurs within the product, the need for full validation of each requirement within a clinical study has lessened. This webinar will explore how to take advantage of configurations and how to verify them, thereby reducing the effort and timeline required for validation while still maintaining quality within each study.

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians.

Drug delivery via the inhalation route is currently in demand for treatment of various diseases including asthma and chronic obstructive pulmonary disorders.

The field of immuno-oncology has exploded in the clinic, in the press, and on Wall Street, particularly regarding the use of genetically modified immune cells to fight cancer. This “explosion” is largely due to the success of chimeric antigen receptor (CAR) T-cell therapy. The fields of immunology and gene therapy have converged to harness recombinant viruses to deliver “living drugs” with remarkable clinical efficacy, especially for patients with blood cancers. Multiple approaches to engineering immune cells mostly T cells but also other immune cell types make use of CARs, while tumor-specific T-cell receptors continue to gain a foothold in the field, mostly for the treatment of solid tumors. Several genome-editing approaches are now available, including established technologies such as zinc-finger nucleases, and newer modalities like the CRISPR/Cas9 system. These methodologies have recently been applied to augment the antitumor efficacy of adoptively transferred cells in the clinic by knocking out negative regulatory molecules such as PD1.