Invent@SC Clinical Pharmacology of Biotherapeutics - Enter the text here that is the new abstract information for your application. This section must be no longer than 30 lines of text. The Invent@SC T32 training program aspires to educate the next generation of exceptional physician-scientists to become global leaders in the clinical pharmacology of biotherapeutics. Biotherapeutics comprised 40% of FDA new drug approvals in 2022, up from approximately 25% in prior years. The principles of clinical pharmacology apply to every therapeutic that is administered to humans, yet a yawning gap exists between the current practice and the ideal application of clinical pharmacology input at critical points of biotherapeutic discovery and development. Unfortunately, lessons in the clinical pharmacology of biotherapeutics often come in the late stages of expensive clinical trials. We hypothesize that late-stage failures can be dramatically reduced if sound clinical pharmacology principles guide each earlier stage. Toward that goal, the Seattle Children’s Research Institute (SCRI), the University of Washington (UW) School of Medicine, UW College of Engineering, and the Fred Hutchinson Cancer Center (FHCC) propose a training program focused on the clinical pharmacology of biotherapeutics. Physician-scientists from more than 25 ACGME-accredited fellowship programs in the SCRI/UW/FHCC systems will be admitted into the program based on merit, their expertise, and their passion for discovering novel therapeutics. Each scholar’s research will focus on a “discovered here” therapeutic candidate that has the potential to benefit children and adults. Each scholar will select laboratory, clinical, and biotech mentors to ensure that they have expert advice from each discipline. Courses entitled “Clinical Pharmacology of Biotherapeutics,” “Pharmacology of Clinical Trial Failures and Successes,” “Responsible Conduct in Biomedical Research,” and “Enhancing Reproducibility through Rigor & Transparency” are required to complete the program. Elective courses are also offered. This T32 training program for postdoctoral clinicians is built on the foundation of the existing Invent@SC Postdoctoral Scholars Program, which was established in 2022. The Invent@SC program has recruited two cohorts of postdoctoral scholars, who were selected based on their accomplishments, natural curiosity, and passion for pediatric therapeutic discovery. We continue to admit approximately 10 PhD postdocs per year. The T32-supported scholars will benefit from the infrastructure and camaraderie of the existing Invent@SC program. In addition, the Washington Research Foundation has committed over $5 million for Invent@SC scholars from both programs to apply for and manage Technology Commercialization Grants that cover costs not typically covered by laboratory mentors’ academic grants. The existing cohort of over 30 top-tier biotech mentors are available not only for 1:1 mentoring but also for roundtables on career development and clinical pharmacology impact discussions. The exceptional recruiting programs that we have built for the existing Invent@SC program will be leveraged to ensure recruitment of exceptional T32-supported Invent@SC Clinical Pharmacology of Biotherapeutics scholars.
