Nancy Pire-Smerkanich, DRSc, MS is an Assistant Professor, Department of Regulatory and Quality Sciences in the School of Pharmacy at the University of Southern California (USC). Dr. Smerkanich received her faculty appointment after successfully completing her Doctoral Dissertation on “Benefits Risk Frameworks – Implementation in Industry” in 2015. In addition to teaching in courses related to drug development and clinical trials, she continues to provide regulatory guidance to industry peers. Nancy brings many years of practical regulatory knowledge and experience from industry to academia where she participated in all regulatory aspects of product development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas. Known for her dedication to education and mentoring across industry, Nancy continues to be recognized for her ability to provide accurate, relevant and dynamic instruction on both the technical and strategic aspects of global regulatory affairs and for her service to professional organizations such as the Drug Information Association (DIA) and The Organization for Professionals in Regulatory Affairs (TOPRA).
Areas of Expertise (3)
Regulatory Filing Strategy
Clinical Regulatory Guidance
Outstanding Volunteer Service Award, DIA
USC: M.S. and DRSc, Regulatory Science
University of Connecticut: B.S., Biology
University of Connecticut: B.A., Russian
Selected Articles (3)
Pooja Singh, Kaylene Okada, Amelia Spinrad, Nancy Pire-Smerkanich, Eunjoo Pacifici
Since 1971, Naloxone has been the only FDA approved opioid antagonist indicated for use after opioid overdose. New formulations of Naloxone have been introduced into the market, including an injectable, auto-injector, and nasal spray. However, Naloxone is short-acting and as such often requires multiple doses and may induce severe withdrawal symptoms. This study examines the regulatory framework to understand the evolution of products indicated to treat opioid overdose and the landscape of therapies in development. Furthermore, this study examines how the Food and Drug Administration (FDA) and other government agencies have approached the opioid crisis.
Jacqueline Chen, Kaitlyn Park, Sun Young Uhm, Amelia Spinrad, Apurva Uniya, Nancy Pire-Smerkanich, Eunjoo Pacifici
Clinical trials (CTs) play an important role in developing new treatments, expanding or refining treatments that are already available, and/or identifying behavioral changes that can prolong or improve the lives of subjects. CTs are also conducted to understand normal human physiology, pathophysiology, and factors associated with health outcomes. Results from CTs are then used to determine the safety and efficacy of medications or treatment. CT participants should reflect the diversity of those receiving the treatments because, exclusion of specific populations in CTs may potentially result in knowledge gaps for clinicians and regulators. Historically, women and geriatrics have been underrepresented as CT participants. For women, this is the result of Food and Drug Administration (FDA) action in 1977 which restricted women with childbearing potential from participating in phase I and early phase II CTs after thousands of birth defects resulted from thalidomide usage during pregnancy. While the U.S. Government Accountability Office’s 1992 and 2001 reports documented an increased female inclusion in later stages of CTs, earlier phases of CTs were still lacking. Likewise, older adults and geriatrics have been excluded in CTs arbitrarily or to avoid adverse events associated with drug-drug interactions and comorbidities. Over the past few decades, the FDA has worked to address this issue and increase diversity and transparency in CTs. In 2015, the FDA’s Action Plan for Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 called for improved CT inclusion and reporting of demographic subgroups (sex, age, race, and ethnicity), highlighting three priority areas: quality, participation, and transparency. This research examines the current state of female inclusion in phase I and II CTs (2016 to 2017) and geriatric inclusion in phase III CTs (2010 to 2017).
Amelia Spinrad, Nancy Pire-Smerkanich, Eunjoo Pacifici, Apurva Uniyal, Annie Xie, Annie Ly, Advaita Chandramohan
Because clinical trial results are instrumental in the approval of a new drug or changes to the practice of medicine, ensuring the accuracy and validity of collected data is critical in the clinical trial process. This function, routinely carried out by clinical trial monitors in industry-sponsored trials, is often lacking in investigator-initiated trials (IITs) conducted in academia. To address this challenge, we have developed a self-study module that can be used to cross-train academic researchers in essential concepts and practical approaches to monitoring. Furthermore, we are applying a framework drawn from implementation science in the development and launch of this initiative. This framework, as used in other educational programs, is employed here to close the gap between initiative and practice, thereby effectively disseminating this training would improve the quality of clinical trials in academia.