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