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Professional and Student Poster Session 1
Session Chair(s)
Representative Invited
DIA, United States
Professional and Student Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.
Learning Objective : Biomarkers that can predict clinical benefit are often used as efficacy endpoints, and they are especially beneficial for rare disease drug development. In this study, we examined biomarkers that supported the approval of novel drugs for non-oncologic rare diseases in the U.S. over a decade.
Speaker(s)
Poster Session
, United States
FDA’s Approach to Fulfilling PDUFA VII Commitments Related to Use of Digital Health Technologies to Support Drug Development
Kayla Garvin, MPH
Sr Regulatory Health Project Manager, FDA, United States
Call for Representative Oncology Trials: FDA Racial & Ethnic Diversity Postmarket Requirements Sep 2022 - Aug 2023
Scarlett Yang, PhD
Manager, Regulatory Affairs, Gilead Sciences, United States
Evaluation of the Economic Impact of Reliance Review: A SAHPRA Case Study
Stuart Russel Walker, PhD
Professor and Consultant, Centre for Innovation In Regulatory Science (CIRS), United Kingdom
Protection of Non-subjects in Clinical Trials Involving Human Gene Transfer: Data and Best Practices from a Central IRB
Christopher Doyle, PhD
Senior Director, IBC Services, WCG, United States
Assessing the Use of Risk-Based Approaches in Four Major Agencies – What is their Impact on the Approval of New Medicines?
Juan Lara
Senior Research Analyst, Centre For Innovation In Regulatory Science (CIRS), Mexico
Understanding of Drug Approval/Disapproval Decisions and Accountability - Development and Results of a Training Program
Toshiko Ishibashi, PhD, RN
Oncology Medical Science Department, Medical Affairs Division, Daiichi Sankyo Co., Ltd., Japan
ChatGPT: A Reliable Tool to Identify Regulatory Precedents?
Paul Bolot, PharmD, MSc
Global Regulatory Strategist, Bayer, Switzerland
Exploring Regulatory Trends and Precedents with an Internal Database of FDA-Approved Companion Diagnostics (CDx) in Oncology
Namosha Mohite, PharmD, RPh
Assistant Director, US Regulatory Affairs, Bayer, United States
Evaluation of PMR/Cs for Assessing Data in Racial and Ethnic Populations Underrepresented in Premarket Clinical Trials
Grace Collins
Manager, Regulatory & Data Insights, Friends of Cancer Research, United States
Risk Evaluation and Mitigation Strategy (REMS) Standardization of Assessment Plan Metrics
Zarnab Jillani, PharmD
Medication Error Pharmacovigilance and Risk Management Fellow, FDA, United States
Confirmatory Evidence of Effectiveness Used to Support Non-Oncologic Rare Disease Novel Drug Marketing Application Approvals
Bridget Nugent, PhD
Science Policy Analyst, FDA, United States
Assessing Feasibility of Using RWD to Support Biosimilar Development: Rituximab use in US Patients with Follicular Lymphoma
Jeanine Flanigan, PharmD, MS
HEOR specialist, Sandoz, United States
Achieving IDMP Compliance with Digital Regulatory Information Management and SPOR Data Synchronization Solutions
Joan Cheung, PharmD, RPh
Principal Consultant, Epista Life Science, United States
Improving Patient Subgroup Representation with Real-World Data
Nora Emmott, MPH
Senior Policy Analyst, Duke Margolis Institute For Health Policy, United States
Electronic Product Information (ePI) Pilots Across LATAM: A Sponsor’s Digital Transformation Study
Jorge Azar
Senior Area Regulatory Director for Latin America, AstraZeneca, United States
Biopharmaceutics Evaluation for Approval of Parenteral Formulations: Biowaiver versus Establishing a Clinical Bridge
Tapash Ghosh, PhD
TL, FDA, United States
Health Canada Regulatory Requirements for Clinical Trials with Cannabis and Psychedelic-Assisted Psychotherapy
Neda Gharavi, PhD
Senior Director Medical Writing & Regulatory Affairs , BioPharma Services, Canada
Facilitating the Accessibility of Orphan Drugs: Analysis of Orphan Drug Cases from 2018 to 2023 in Taiwan
Yueh-Wen Lan, MS
Senior Project Manager, Center for Drug Evaluation, Taiwan
Analysis of Approval Regulations of Colorectal Cancer Drugs in the United States: Twenty-Year Retrospective Study
Salman Alharthi, PhD
, Security Forces Hospital, Saudi Arabia
Clinical Outcome Assessment (COA) Qualification Program Analysis
Felix Yang, PharmD
Manager, Regulatory Advertising and Promotion, Moderna, United States
Adapting Real-World Data (RWD) into CDISC Submission Standards: Updates from a Case Study
James Browning, MPH
Director of Biostatistical Programming, Center for Observational Research, Amgen, United States
Development, Alignment, and Maintenance of Safety-informing Regulatory Documentation
Bhavana Tallavajhula, MS, RPh
Director, Bristol Myers Squibb, United States
Regulatory CMC Trends in Bispecific Antibody Development
Jessica Miller, PharmD
1st-Year Fellow, Global Regulatory Affairs CMC, GlaxoSmithKline, United States
Interactive Data Driven Platform for Detecting, Extracting, and Adjudicating Secondary Primary Malignancies in Safety Database
Sahith Doppalapudi, MS
Associate Director, PV Analytics Analytics Center of Excellence, Bristol Myers Squibb, United States
Impact of Lost to Follow-Up on Power and Study Results in Randomized Controlled Studies with Time-to-Event Endpoints
Jiewei Zeng, PhD
Associate Director, Abbvie, United States
Extracting Lab Value Reference Ranges from Real World Neonatal ICU Data
Nick Henscheid, PhD
Senior Scientist, Critical Path Institute, United States
Statistical Methodology for Safety Study using Real-World Data (RWD)
Li Huang, DMD, MS
Principal Biostatistician, Phastar, United States
Artificial Intelligence/Machine Learning advances in Real World Data Analytics
Jacqueline Vanderpuye-Orgle, PhD, MSc
Vice President, Parexel, United States
Harnessing the Synergistic Effect of Commercial Software and R to Build and Power a Larger Clinical Design Space Exploration
Sydney Ringold, MBA
Customer Success Manager, Cytel, Inc., United States
Associations between Social Determinants of Health and Initiation of Wegovy, Ozempic, and Mounjaro
Ashwin Anand, MPH
Engagement Manager , Forian, United States
Cultivating Global Competencies Through Cross-Cultural Exchange (CCE) Programs for Pharmaceutical Professionals
Ashley Ogawa-Wong, PhD
Associate Director, Regulatory Liaison, Merck Sharp & Dohme LLC, United States
Comparison of the Regulatory Performance of NMRAs in Africa with WHO Maturity Level-3 Status: Identifying Best Practices
Mercy Acquaye Owusu-Asante, MSc
Graduate Student, School of Life and Medical Sciences, University of Hertfordshire, United Kingdom
Evaluation of Good Review Practices in member agencies of the East African Medicines Regulatory Harmonisation Initiative
Nancy Biyeah Yang Ngum, MPH
Student, University of Hertfordshire, United Kingdom
Assessment of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Opportunities and Challenges
Constance Sakala Chisha, PhD
PhD Student, University of the Witwatersrand, South Africa
Phototoxicity Testing of Emerging Fluorescence Imaging Products: Reactive Oxygen Species Generation and Photocytotoxicity
Shruti Vig, PhD
Graduate Student, University of Maryland, College Park, United States
Risk of Neutropenia with the Use of Ceftaroline: A Review
Tuiana Brown
PharmD Candidate 2025, Chicago State University, United States
Remaining Hurdles and Potential Solutions in Realizing the Therapeutic Promise of iPSC - An Overview of Patent and Clinical Data
Liyang Lyu, MSc
Student, University of Macau, Macao
Analysis of Quality of Life Patient-Reported Outcomes in Clinical Trials for Huntington’s Disease
James Kim
Undergraduate Student Researcher, University of Southern California, United States
Evaluation of Time-To-Event-Endpoints in Oncology Biosimilar Trials
Jan-Georg Bohlken
Student, University of Bremen, Germany
Survey on the Mental Health Status of COVID-19 Recovered Patients in Macao: A Cross-Sectional Study
Representative Invited
student, University of Macau, Macao
Exploring Risk Factors, Life style modification Unveiling the Comparative Efficacy of Metformin and Glimepiride
Rajashekhar Ittedi, MS
Lead Clinical Research Coordinator, Axentrabio, United States
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