DRSc Dissertations

2008 Cohort

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

2010 Cohort

Hesham Abdullah Challenges in the Co-Development of Molecular Biomarkers and Targeted Oncology Therapeutics
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

2012 Cohort

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. McDowel 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
Vada Perkins Industry Views on IDMP Implementation
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

2014 Cohort

Sunita Babbar  Future of Reproductive Developmental and Juvenile Toxicity Testing
Victor Gangi Examining the Regulatory Framework for Drug Compounding Outsourcing Facilities: Industry Views and Experiences
Dr. John Hartigan Computerized Simulation in Clinical Trials: A Survey Analysis of Industry Progress
Michelle McGuinness  Investigating in Orphan Drug Development: An Analysis of the Impact of Orphan Drug Incentive Programs in the United States
Nami Migita Governmental programs to foster medical product development in small enterprise: A survey comparison of 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
Curtis Truesdale Regulatory Governance in Post-Merger Integration Environments of Medical Product Companies: A Survey of Industry.
James Turner IT /RA linkages
Dr. Jennifer Wiley Experience with Breakthrough Therapy Designation: An Industry Survey

2016 Cohort

Monique Carter Global  Expedited Regulatory Drug Development Pathway Utilization and Impact
Jeanne Greenwald United States Veterinary Drug Shortages
Virginia Hill Substantiating Structure Function Claims
Terence Hogan Sustaining Clinical Trial Transparency While Preventing the Re-Identification of Subjects
Martinus Koning-Bastiaan Single IRB Review: Implementation by IRBs
Laura Kupsch Inter-IRB transparencey
Dr. Wendi Lau A Survey of US Industry Views on Implementation of Decentralized Clinical Trials
Geoffrey Okelo Exploring Critical Elements of First Time Approval:  Generic Tool for Effective High-Quality ANDA Submission
Mary Wilhelm Regulatory Agreements for Joint Development Programs: Practices Within the Pharmaceutical Industry
Carolyn Wright The Use of Telemetry to Ensure Safe and Reliable Medical Device Operation
Michael Yartzoff Current Practices in Biocompatibility Assessment of Medical Devices

2018 Cohort

Lori Alquier An Assessment of the World Health Organization Collaborative Process for Accelerated Registration
Mladen Bozic
Wendy Clark
Kerry Cobb
Wenying Du
Cheryl Hergert
Ronald Lillie
Luong Hai
Lequina Myles From Discovery to Patient to Public: A Survey of Clinical Supply Chain Management and Distribution of Advanced Therapies
Nozomi Yagi