CERSI Writing Competition Winners - Previous Years

2022 Winners:

  • First place: Arnaldo Suba Garcia, "Implementing a Risk-based Regulatory Framework for EHR"
  • Second place: Ramona Wildgoose, "21st Century Regulatory Surveillance: Measuring the Effectiveness of Quality Management Systems"
  • Third place: Herjit Singh Pannu, "The Establishment of Biologics as Biosimilars and "Interchangeables""

2021 Winners:

  • First place: Angela Yu, "An Analysis of the COVID Pandemic Emergency Use Authorization (EUA) and Future Regulatory Strategy Considerations"
  • Second place: Iris Case, "The Regulation of Probiotics"
  • Third place: Laura McGrath, "Regulation of Laboratory-Developed Tests: Decades of Debates Bring the Industry Full Circle"

2020 Winners:

  • First place: West Weiss, "Cutting Through the “Gray Area”: An Analysis of the Regulatory Oversight of Applications of CRISPR Technology in Clinical Research" (Now published in Therapeutic Innovation & Regulatory Science: https://doi.org/10.1007/s43441-021-00294-9)
  • Second place: Chris Chavez, "Assessing the Impact and Prevention Strategies for African Swine Fever"
  • Third place: Katelin Henninger, "Review of the Controversy Surrounding the Use of Ethylene Oxide in Medical Device Sterilization"

2019 Winners:

  • First place: Mark Robberson, "An Empirical Analysis of Innovation in the Pharmaceutical Industry Drug Class: Implications for Regulatory Policy"
  • Second place: John Winnike, "Substantial Evidence of Effectiveness: Considering a More Dynamic Model for Approval of Drugs Addressing Serious Unmet Medical Need"
  • Third place: Jasmine Birlew, "The Financial Risks of Non-Compliant Medical Devices"

2018 Winners:

  • First place: Courtney Turiano, "Basis of Approval and Associated Development Attributes of Drugs Approved by the FDA"
  • Second place: Danielle Jateng, "A Cross-sectional Study of Geriatric Labeling for High Impact Medications Used by Older Americans"
  • Third place: Mitsi McHugh, "Clearly Misunderstood Rules of the Stem Cell Road"

2017 Winners:

  • First place: Dana Wiegand, "Clinical Development Strategies and Regulatory Outcomes of FDA Approved Biological License Applications- Therapeutic Domain Considerations"
  • Second place: Adria Tyndall, "Human Factors Studies in Biologic License Applications for Injectable Device-Biologic Combination Products"
  • Third place: Carrie Voycheck, "The Relationship Between Medical Device Recalls and the Volume of Medical Device Reports (MDRs) Submitted to FDA"

2016 Winners:

  • First place: Lin-Chau Chang, "The Utilization of Standardized MedDRA Queries in Marketing Applications and their Regulatory Reviews."
  • Second place: Renee Harrell, "The Regulatory Implications of Data-mining."
  • Third place: Kelly Waldman, "Challenges of Integrating REMS Elements into Pharmacy Systems."