Doctoral Dissertations – USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences

Dr. Susan Bain	“Regulatory” Due Diligence: A Survey Investigation of Best Practices in the Medical Products Industry
Dr. Tony Chan	Implementation of Risk Management in Medical Device Companies: A Survey Analysis of Current Practices
Dr. Grant Dagliyan	Implementation of Good Manufacturing Practice Regulations for Positron Emission Tomography Radiopharmaceuticals: Challenges and Opportunities Perceived by Imaging Thought Leaders
Dr. Michael Jamieson	The Role of Universities in the Commercialization of Medical Products: A Survey of Industry Views
Dr. William Leitner	FDA Influence on Advisory Committees through Documentation: A Content Analysis and Survey of Industry Views
Dr. Duane Mauzey	Current Practices in Pharmaceutical Container Closure Development
Dr. JoAnn Pfeiffer	Current Practices of U.S. Investigators in the Management of the Clinical Trial Agreement: A Survey of Knowledge, Attitudes, Perceptions, and Engagement.
Dr. Taranjit Singh Samra	Software Risk Management: An Exploration of Software Life Cycle Methodologies, Best Practices and Tools for their Application to Medical Device Software Risk Management
Dr. Martin Solberg	A Survey Analysis of Transparency in Three Asian Regulatory Agencies Responsible for Medical Products
Dr. Ellen Whalen	Clinical Trials Driven by Investigator-Sponsors: GCP Compliance With or Without Previous Industry Sponsorship

Dr. Lilit Aladadyan	Implementation of Tobacco Regulatory Science Competencies in the Tobacco Centers of Regulatory Science (TCORS): Stakeholder Views
Dr. Kwabena Dankwah	Promotion of Regulated Products Using Social Media: An Industry View
Dr. Patrick Dimapindan	An Integrated Framework to Evaluate Customer Service Delivery: A Study of Electronic Systems at FDA’s Los Angeles Import Operations Branch
Dr. Clare Elser	Validation Master Plans: Progress of Implementation within the Pharmaceutical Industry
Dr. David Locke	Reprocessing of Single-use Medical Devices: A Survey Investigation Comparing the Views of Three Unheard Stakeholders
Dr. Richard McCall	Risk Approaches and Standards Used in Hospitals: A Survey of Industry Views
Dr. Susan Ramsey	The Impact of Incomplete Monographs on the OTC Drug Industry: A Survey Investigation of Industry Views
Dr. Chin-Wei Soo	Convergence of United States Regulatory and Reimbursement Policies Impacting Patient Access to Humanitarian Use Devices (HUD)
Dr. Neal Storm	Regulatory Dissonance in the Global Development of Drug Therapies: A Case Study of Drug Development in Postmenopausal Osteoporosis
Dr. Simone Turnbull	Regulating Cosmeceuticals in the United States: A Cosmetic Industry View

Dr. Donatus Ako-Arrey	Effect of GDUFA Legislation on the Development and Approval of Generic Drugs: A Survey of Industry Views and Experiences
Dr. Terry Church	Continuity Management in Biobank Operations: A Survey of Biobank Professionals
Dr. Alicia M. McDowell	Challenges in the Implementation of Risk Evaluation Mitigation Strategies (REMS): A Survey of Industry Views
Dr. Aimee Greco	Implementation of Unique Device Identification in the Medical Device Industry: A Survey of the Change Management Experience
Dr. Grant Griffin	Sharing the Results Of Clinical Trials: Industry Views On Disclosure Of Data From Industry-Sponsored Clinical Research
Dr. Martha Kamrow	Organizational Communication of Regulatory Intelligence: A Survey of the Medical Device Industry
Dr. Cesar Medina	Incentivizing Quality in the Manufacture of Pharmaceuticals: Manufacturers’ Views on Quality Ratings
Dr. Caroline Mosessian	Value Based Purchasing: Decision-Making Processes Underlying Hospital Acquisitions of Orthopedic Devices
Dr. Vada Perkins	A Survey of Regulatory Data Management Practices Within the Pharmaceutical Industry
Dr. Nancy Pire-Smerkanich	Benefits-Risks Frameworks: Implementation by Industry
Dr. Susan Pusek	IRB Capabilities to Oversee New Technology: Social Media as a Case Study
Dr. Ali Rejaei	Establishing Clinical Efficacy of Botanical Products: A Survey of Industry Views
Dr. Catherine Sheehan	Views on Global Harmonization of Pharmacopeial Standards: A Survey of Key Stakeholders
Dr. Alexa Smith	Use of Natural Colors: Experience and Views in Pharmaceutical and Dietary Supplement Industries

Dr. Sunita Babbar	Challenges to Implementation of Alternative Methods to Animal Testing for Drug Safety Assessment in North America
Dr. Victor Gangi	Examining the Regulatory Framework for Drug Compounding: Industry Views and Experiences
Dr. John Hartigan	Computerized Simulation in Clinical Trials: A Survey Analysis of Industry Progress
Dr. Nami Migita	Regulatory Programs to Foster Medical Product Development: User Experience in the United States and Japan
Dr. Penny Ng	Regulation of Pediatric Cancer Drug Development: An Industry Perspective
Raina Olexa	Real World Evidence for Regulatory Decision Making
Dr. Darin Oppenheimer	Risk Management and Recalls: A Survey of Medical Device Manufacturers
Dr. Katherine St. Martin	Examining the Cord Blood Industry Views on the Biologic License Application Regulatory Framework
Dr. Curtis Truesdale	Regulatory Team Development in Post-Merger Integration: A Survey of Views from Medical Product Companies
Dr. Jennifer Wiley	Experience with Breakthrough Therapy Designation: An Industry Survey

Monique Carter	Global Expedited Regulatory Drug Development Pathway Utilization and Impact
Dr. Jeanne Greenwald	U.S. Veterinary Drug Shortages: Industry Views on Potential Changes to Regulatory Policy
Virginia Hill	The Evolving Regulatory Landscape of Dietary Supplements: An Industry Survey
Terence Hogan	Sustaining Clinical Trial Transparency While Preventing the Re-Identification of Subjects
Dr. Martinus Koning-Bastiaan	Institutional review board implementation of the single IRB model for multicenter clinical trials
Dr. Laura Beth Kupsch	Contract research organizations: a survey of industry views and outsourcing practices
Dr. Wendi Lau	A Survey of US Industry Views on Implementation of Decentralized Clinical Trials
Geoffrey Okelo	Assessing Critical Elements for “First-Time Right” Submission Leading to Regulatory Acceptance and Approval Action: A Survey of Stakeholders on Abbreviated New Drug Application (ANDA)
Dr. Mary Wilhelm	Regulatory Agreements for Drug Development Collaborations: Practices in the Medical Products Industry
Dr. Carolyn Wright	Using Telemetry to Ensure Safe and Reliable Medical Device Operation: Experience with Defibrillators and Infusion Pumps
Dr. Michael Yartzoff	Current Practices in Biocompatibility Assessment of Medical Devices

Dr. Lori Alquier	Regulatory Harmonization in a Resource-Limited Setting: The World Health Organization Collaborative Procedure for Accelerated Registration
Dr. Mladen Bozic	The Impact of FDA Patient Focused Drug Development (PFDD) on US Drug Development Strategies: A Survey of Views from Pharmaceutical Product Companies
Wendy Clark	Patient Focused Recall Strategy and Communication for Implantable Medical Devices: A Survey of the Medical Device Industry Views and Practices
Dr. Kerry Cobb	Surveying Stakeholder Views on the Current Good Laboratory Practices (GLP) Regulations and their Proposed Revisions.
Wenying Du	China’s Role in Global Drug Development
Dr. Cheryl Hergert	Use of Electronic Health Record Data for Generating Clinical Evidence: A Summary of Medical Device Industry Views
Ronald Lillie	Implementation of GVP IX for Postmarketing Signal Management in the Bio-Pharmaceutical Industry
Dr. Hai Luong	Regulatory CMC Strategies for Gene and Cell Therapies During Mergers and Acquisitions: A Survey of Industry Views
Dr. Lequina Myles	An Industry Survey of Implementation Strategies for Clinical Supply Chain Management of Cell and Gene Therapies
Nozomi Yagi	US Regulatory Policy for Human Factors Engineering: A Survey of Policy Impact on Current Practices

Dr. Eugene Babcock	Evaluation of FDA-Sponsor Formal Meetings on Development of Cellular and Gene Therapies: A Survey of Industry Views
Lisa Crockett
Mary Ann Del Fiorentino
Brian Green	Assessing Organization Knowledge and Readiness for Developing Value and Access Strategies During Drug Development: An Industry Survey
Dr. Anjali Malhotra	21 CFR Part 11 Compliance for Digital Health Technologies in Clinical Trials
Sonali Namiranian	The Current State of Patient Focused Drug Development (PFDD) in the United States: Perspectives from Patient Advocacy Organizations (PAO)
Tayler Renshaw
Katy Rudnick
Bridget Walton	Impact of Drug Regulations on the Medicalization of Psychedelic Compounds: Survey of Key Stakeholders
Dr. Colleen Watson	Design Control for Software as a Medical Device: An Industry Survey of Views and Experiences

Olufunke Bidemi Bundo
Adam Scott Cargill
Elaine Lynn Freeman	Evaluating the FDA’s Direct Food INGREDIENT Program: A Focus on GRAS Regulation, Industry Compliance, and Regulatory Outcomes from an Industry Perspective
Viktoria Magyar	Regulatory Landscape Analysis of Botulinum Neurotoxins in the Americas: A Comparative Review
Holly McCaleb	Pathways to Convergence in AAV GTx Import Testing Requirements: Insights from Industry Stakeholders on the Benefits of Regulatory Reliance and Global Alignment
Scott Charles Stirn	Factors Influencing the Selection of Phase 1 First-In-Human Clinical Study Sites for Novel Molecular Therapies: A Survey of Industry Views
James Patrick Wabby	The Evolution of Regulatory Strategies for Combination Products: A Survey of Views from Combination Product Drug Delivery Companies
Shaojun Sean Zhu	Navigating the U.S. Regulatory Landscape for Radiopharmaceutical Clinical Trials: A Survey of Views and Best Practices from Radiopharmaceutical Sponsors and Clinical Sites

Erika Fernandez
Wendy Fong
Yi Gao
Denise Holliday
Vivien Hua
Anuschka Merson
Sabrina Nicolich
Isaac Nyarko
Nicholas O. Sarif