Krista M. Pedley, PharmD, MS '00
RDML Pedley has participated in numerous deployments, including Hurricane Katrina, the Presidential Inauguration in 2005, and Hurricanes Frances, Ivan and Isabel. RDML Pedley was also a Contributor on the Report to the Surgeon General on Clinical Pharmacy and Co-Author on PHS Pharmacy Prevention Strategy.
Rear Admiral Krista M. Pedley is the Director of the Office of Special Health Initiatives (OSHI) in the Health Resources and Services Administration (HRSA). OSHI provides a crosscutting focal point for HRSA to deliver on population health and Secretarial priorities, especially those that may be more clinical in nature. Specifically, OSHI coordinates and collaborates with components in the Department of Health and Human Services (HHS) that align with the work of OSHI; coordinates HRSA’s work on Long COVID, climate change and environmental justice; serves as the principal advisor within HRSA on global health issues and the President’s Emergency Plan for AIDS Relief (PEPFAR); provides agency-wide leader-ship and policy development in the administration of the 340B Drug Pricing Program to promote access to clinically and cost effective pharmacy services to the country’s most vulnerable patient populations; serves as the lead on behavioral health issues that span HRSA; provides cross-cutting leadership on HRSA oral health programs; and oversees HRSA’s Commissioned Corps Affairs. She previously served as the Director of the Office of Pharmacy Affairs (OPA) for over eleven years where she led the administration of the 340B Drug Pricing Program, where over 700 drug manufacturers provide discounted outpatient drugs to safety-net clinics and hospitals that purchase approximately $44 billion in 340B drugs annually. The 340B Program spans HHS and focuses on drug pricing transparency and reducing the cost of medications for the country’s most vulnerable safety-net patient populations.
RDML Pedley began her career as a pharmacist with the United States Public Health Service in May 2000. She was assigned to the Food and Drug Administration, Office of Generic Drugs, as a Project Manager for Bioequivalence and then as Medical Affairs Coordinator reviewing topical drug protocol design. After five years, RDML Pedley transferred to HRSA and then the Office of the Secretary of Health and Human Services, where she served as Senior Public Health Analyst for the National Bioterrorism Hospital Preparedness Program (NBHPP). In 2007, RDML Pedley began working with OPA, where she led a national collaborative that focused on integrating clinical pharmacy services into primary care to improve the health of patients with multiple chronic conditions. She then became the Director of OPA in July 2010 and was promoted to Rear Admiral and Assistant Surgeon General in February 2020.
RDML Pedley received her Doctor of Pharmacy degree at the University of Pittsburgh in 2000 and her Master of Science in Engineering Management and Systems Engineering, with a Concentration in Crisis, Emergency and Risk Management, from The George Washington University in 2008. She is also a 2011 graduate of the Public Health Leadership Institute (PHLI) Scholar Program.
RDML Pedley is the recipient of numerous awards, including an Exceptional Promotion to Captain in 2015, the Meritorious Service Medal in 2018, the PHS Commendation Medal in 2012, 2009, 2005, and the APhA Foundation Pinnacle Award in 2016 and 2011.
Dr. Lisa Rohan '95
Dr. Rohan is a Professor in the Department of Pharmaceutical Sciences in the School of Pharmacy. She also holds appointments in the Department of Obstetrics, Gynecology, and Reproductive Sciences in the School of Medicine and the Clinical Translational Science Institute at the University of Pittsburgh. Additionally, she is an Investigator at the Magee Womens Research Institute. Dr. Rohan serves as co-principal investigator for the Microbicide Trials Network Laboratory, an HIV/AIDS clinical trials network established by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). This network encompasses an international team of investigators and community and industry partners from seven countries and three continents. She obtained a Bachelor of Science in Chemical Engineering from West Virginia University and a Ph.D. in Pharmaceutics from the University of Pittsburgh School of Pharmacy. After completion of her Ph.D. work Dr. Rohan completed a Postdoctoral Fellowship in the Department of Obstetrics, Gynecology, and Reproductive Sciences in the area of Mucosal Immunology at the University of Pittsburgh.
The basis of Dr. Rohan’s research lies in the area of drug delivery. Her lab has a major focus in the design of mucosal drug delivery systems including vaginal and cervical drug delivery as applied in the areas of infectious disease and gynecologic oncology. Particular interests are in studying the role of chemical, physical, and biological properties of mucosal tissues and fluids in pharmaceutical product development. The group has developed a number of biologically relevant dissolution methods which can assist in predicting product functionality in vivo. An additional focus of the lab lies in generating a better understanding of drug transport and metabolism in the female lower reproductive tract and other mucosal tissues.
The Rohan Pharmaceutics Laboratory is involved in a number of stages of product development including preclinical drug candidate evaluation, formulation development, preclinical formulation assessment, scale-up, and introduction to early clinical trials. The lab has developed a number of products which have been advanced through IND to Phase I clinical testing including several topical pre-exposure prophylactic products for use against Sexually Transmitted Diseases and HIV. The work by her research team has also generated optimized imaging techniques for sentinel node identification in cervical cancer as well as novel delivery systems for chemotherapeutic agents.
Virginia (Ginny) Schmith ‘89
Virginia (Ginny) Schmith received her B.S. Pharmacy (1984) and Ph.D. in the Clinical Pharmaceutical Scientist program (1989) from the University of Pittsburgh School of Pharmacy. She worked for GSK (and predecessor companies) for 26 years doing clinical pharmacology and pharmacometrics for investigational drugs throughout drug development. After leaving GSK in 2015, Ginny began consulting at Nuventra Pharma Sciences for almost 7 years and eventually semi-retired in December 2021. She continues to consult part-time with small companies within her own company (Schmith PK/PD Consulting LLC). Over 33+ years, she has actively contributed to clinical strategy across all phases of drug development across numerous therapeutic areas: anesthesia, cardiovascular, pulmonary, gastrointestinal, central nervous system, dermatology, cancer, inflammation, antibiotics, antivirals, and rare diseases, and has actively contributed to the approval of 15+ drugs. Dr. Schmith has been an Adjunct Professor at UNC-CH Eshelman School of Pharmacy since 1989 and recently become a Courtesy Clinical Professor at the University of Florida School of Pharmacy. Ginny has published 50 peer-reviewed articles and reviews in international scientific journals in addition to over 70 published abstracts; she has authored 5 patents; and is an active member of the American Society of Clinical Pharmacology and the International Society of Pharmacometrics. Ginny has maintained her pharmacy license and volunteered with the COVID vaccine effort in Florida.
Mehul Mehta ‘86
Dr. Mehta is the Director, DNP (Division of Neuropsychiatric Pharmacology), OCP (Office of Clinical Pharmacology), in CDER (Center for Drug Evaluation and Research), FDA. With a current staff of about 28 PhDs, his division is responsible for reviewing the clinical pharmacology aspects of the Neurological, Psychiatric, Analgesic, Anesthetic, and Addiction drug products from pre-IND (Investigational New Drug) to post-NDA (New Drug Application) stages. He obtained his M.Sc. from University of Bombay in Synthetic Organic Chemistry in 1979, M.S. from University of Houston in Medicinal Chemistry in 1981, and his Ph.D. in Pharmacokinetics from the University of Pittsburgh in 1986 and joined FDA as a reviewer the same year. He has been in his current position for last 22 years over which period he has contributed significantly to the approval of hundreds of NDAs. In addition to his review oversight, administrative, and management responsibilities, he continues to play a significant role in broad based regulatory needs. For example, he represented the agency as the FDA Lead Expert on the ICH M9 EWG for BCS (Biopharmaceutics Classification System) based biowaivers guideline that was finalized in 2021; co-chair of the CDER NTI (Narrow Therapeutic Index) WG; founding co-chair and current member of the CDER BCS Committee; member of the CDER Lifecycle Management Board; co-chair of the FDA-EUFEPS-AAPS sponsored GBHI (Global Bioequivalence Harmonization Initiative) workshop; member of the FIP BCS SIG, etc. Current regulatory research interests include potential of biomarkers as confirmatory efficacy evidence for therapeutics to treat major unmet needs like Alzheimer’s disease, ALS, etc.; therapeutic equivalence of complex modified release products; NTI designation of drug products; adult to pediatric efficacy extrapolation in various indications; possible extension of BCS based biowaivers, and the CDER MIDD (Model Informed Drug Development) initiative. He has authored numerous publications and book chapters, has led WGs for the FDA ‘Hepatic Impairment’ guidance and SUPAC MR guidance, and has been a key member for several more guidance WGs. He is a charter member of AAPS and was recognized as AAPS Fellow in 2012.
Robert Monte ‘79
A Supervisory Program Specialist in the Office of Healthcare Transformation (OHT) in Veterans Affairs Central Office. He was previously Director of the Veterans Engineering Resource Center (VERC) at the VA Pittsburgh Healthcare System and the Acting National VERC Director. He developed the grant that supported the Pittsburgh VERC and was one of four centers selected in a competitive review process among applications from 23 VA Medical Centers across the country.
He graduated from the University of Pittsburgh School of Pharmacy in 1979 with a Bachelor of Science Degree in Pharmacy and the University of Pittsburgh Katz Graduate School of Business in 1992 with a Master of Business Administration (MBA). His pharmacy career includes staff, supervisory, and clinical pharmacist positions over the past 43 years in professional clinical settings including inpatient and outpatient hospital pharmacy, retail, and specialty mail order pharmacy.
Mr. Monte developed the Pharmacology Curriculum for Chatham University Physician Assistant and Doctor of Physical Therapy programs and taught there for 17 years as an Adjunct Professor of Pharmacology. He is also Program Director for the University of Pittsburgh Health School of Engineering Systems Engineering Course and guest lecturer in the School of Pharmacy Healthcare Innovations Course.
His 38-year VA career includes work as a Supervisory Pharmacist, Manager Medical Specialty Service Line, Advanced Clinical Access and Systems Redesign Coordinator, Network Telemedicine Coordinator, and his current position. Mr. Monte has lead Systems Redesign teams, presented, and served as faculty at the local, Network and National level in the Veterans Healthcare System. He has worked part time as a specialty pharmacist at CVS Specialty for 25 years.
His current interest is in improving healthcare processes using simulation, technology, project management, data analytics and Lean. He has developed game-based learning programs to teach a wide variety of content across VHA. He led the VERC effort in developing a lung nodule tracking tool for the VHA National Lung Cancer Screening trial and Prostate Cancer Tracking Tool. He led the VERC effort in the VHA National My VA Access Program from Fiscal Year 2015-17 and is currently working to implement the PACT Act in VHA as a Senior FAC-PPM Project Manager.
James Steck ’72
James was born in Pittsburgh in a working-class family and grew up in North Huntingdon Township, graduating from Norwin High School in 1967. After high school, he went to the University of Pittsburgh and did two years of pre-pharmacy at the Greensburg campus. He was the first in his family to attend college. Upon graduation from Pitt’s School of Pharmacy and becoming licensed in 1972, he worked for 2 years in retail at an independent pharmacy in Butler, PA. In 1974, he enrolled in a Drug Information Program at Case Western Reserve University’s School of Library Science. After getting a master’s degree, he moved to the Chicago area and was employed by a number of different pharmaceutical companies. He worked in several different functional areas including medical Information/medical writing, clinical research and clinical project management, regulatory affairs, and scientific assessment of licensing opportunities. At the end of his career he held the position of Director of Regulatory Affairs at Abbott Laboratories (now Abbvie), with responsibilities for Humira rheumatology submissions to the Food and Drug Administration, resulting in approvals for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.