Donna Rivera

University of Maryland School of Pharmacy, Department of Pharmaceutical Health Services Research

Director, Oncology Real World Evidence Program Lead, Oncology AI Program Lead, Project Pragmatica •Built the Oncology Real World Evidence [RWE] Program to enhance patient-centered regulatory decision-making in oncology. • Lead the cross functional epidemiology team responsible for regulatory review of oncology real world data (RWD) containing submissions of Investigational New Drug (IND) Applications, New Drug Applications (NDA), Biologics License Applications (BLA), Investigational Device Exemption (IDE) applications, Premarket Approval (PMA) applications, for drugs, evaluation of Automatic Class III Designations (De Novo requests), Premarket Notification (510(k)) Submissions across drugs (CDER), biologics (CBER), and devices (CDRH) in accordance with regulatory requirements. • Developed educational initiatives and multidisciplinary training programs to elevate awareness of oncology RWE across the agency, resulting in improved regulatory science engagement. • Manage an international oncology RWD Research Portfolio to optimize the regulatory use of RWD and RWE through centralized strategy, organization, and funding to ensure maximal observational study efficiency, transparency, and impact. • Guidance development for all FDA RWE Guidance policy documents • Evaluate the methodological approaches to integration of clinical trials and real-world routine clinical practice through appropriate use of pragmatic design elements and generation of learning health systems.

Using a strategic framework, I led an initiative to evaluate, design, and facilitate large scale heterogenous data linkages with SEER cancer registry data. Novel linkages enhance the availability of longitudinal treatment-related data by elucidating key components of the patient trajectory to better understand individual patient and population level health outcomes. I was responsible for developing collaborative partnerships across several federal agencies (current scientific collaborations with the VA, CDC, FDA, and DOE),as well as academic institutions and commercial entities to advance precision cancer surveillance. Within the current portfolio I managed partnerships with a myriad of clinical health data vendors across 12 clinical data types. Real World Evidence: Leading novel data collaborations, linkages, and analytic strategy within SEER to enhance data for precision cancer surveillance. Pharmacy Data Expertise: Global picture of medication utilization within the healthcare system for data acquisition and longitudinal treatment evaluation. Cancer Pharmacoepidemiology: Evaluating oncology medication utilization and outcomes using SEER and SEER-Medicare data. Research tools to standardize observational research include serving as the Clinical Developer of the Cancer Medication Enquiry Database (CanMED): https://seer.cancer.gov/oncologytoolbox/ Fellowship Director, Pharmacy Fellowship in Cancer Surveillance and Clinical Data Science: https://surveillance.cancer.gov/jobs/pharmacy.html

Individualized training as clinician epidemiologist with leadership on pharmacoepidemiology studies and pharmacogenetic survey development to advance cancer control and population sciences methods.

PHA 5226 Evidence-Based Pharmacy Course Facilitator (2013), TA (2012) PHA 5742C Professional Communication in Pharmacy Lead TA (2014), TA (2013) Delivered the weekly course lectures and recorded lectures for distance students Created presentations and educational materials for teaching Planning and curriculum development with TAs and faculty Graded projects and assignments and provided productive feedback (150+ students)

Clinical trial protocol and study document development Developed a Phase I Clinical Trial Protocol Integrated PK data into clinical software Develop FDA submission documents (e.g. IND, aNDA) Organized weekly team meetings to ensure a successful preclinical development plan Liaison between clinical trial center and GSK Interacted with required contributors to the drug development process in industry including regulatory, formulation, and value teams