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Professional Poster Session II
Session Chair(s)
Representative Invited
DIA, United States
Professional 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 : To identify industry best practices in safety signaling and gain clarity on future state capabilities that organizations are prioritizing to navigate the rapidly evolving PV landscape.
Speaker(s)
Safety Signaling Industry Benchmarking
Amanda Bowles, MS
Deloitte, United States
Managing Director
Characterization of Newly Identified Safety Signals for Marketed Drugs by the US Food and Drug Administration, 2020-2024
Maryann Rose Chapin, PHARMD, RPH
Food and Drug Administration, United States
ORISE Fellow
Evidence-based Design of Prescription Medication Information: An Updated Scoping Review
Andrea Russell, PHD
Northwestern University Feinberg School of Medicine, United States
Assistant Professor
Automating Pharmacovigilance Workflows through AI to Improve Patient Safety Outcomes
Rishi Verma, MD, MS
Roche & Stethy, Australia
Medical Director
Early Severe Adverse Event Warning Mechanism
Sahith Doppalapudi, MS
Bristol-Myers Squibb Company, United States
Associate Director, PV Analytics Analytics Center of Excellence
Evaluation of Different Search Strategies to Identify Cases of Anaphylaxis in the FDA Adverse Event Reporting System
Anran Liu, PHD
U.S. Food and Drug Administration, United States
ORISE Postdoctoral Fellow
Implementing a Structured Benefit-Risk Assessment (SBRA) Framework: A Case Study
Feisal Othman, PHARMD, RPH
Bristol Myers Squibb, United States
Benefit Risk Assessment Lead
Quantitative Signal Detection for Small and Specialized Safety Database
Mohit Raizada, DDS
IQVIA, India
Director - Signal Management Services
Signal Management (SM) Activities using Real-World Evidence (RWE)
MIDHUN RAJ K, MS, RPH
IQVIA, India
Manager, Signal Management
Development of a Safety Toolkit to Influence Inclusion Barriers for Adolescents and Young Adults in Adult Clinical Trials
Pamela Concepcion, PHARMD
Astrazeneca, United States
Patient Safety Scientist
Sue Lee
Takeda, United States
Director, Global Patient Safety Signal Management and Innovation
AI Automating Multimodal Evidence Integration for Drug Safety Signal Causality Assessment
Tarek Hammad, MD, PHD, MS, MSC, FISPE
Takeda Pharmaceuticals, United States
Vice President, Global Head of Medical Safety, Marketed Products and PDT, PSPV
Effective Communication of Drug Benefit-Risk Profiles through Automation for High-Quality Regulatory Documentation
Vasanti Anand, PHD
BMS, United States
Regulatory Writer
Streamlining Global Post-Approval Safety Monitoring Programs: A Standardized Framework
Yoon Jeon (Jamey) Kim, MSC, RPH
Merck & Co., Inc., Rahway, NJ, USA, Panama
Director, Cluster Pharmacovigilance Lead
Transforming Pharmacovigilance with AI: Revolutionizing Safety Monitoring for Better Patient Outcomes
Teresa Zhang, PHARMD
Beone Medicines, United States
Safety Scientist
Use of HLA-B*58:01 Genotyping to Prevent Allopurinol-Induced Severe Cutaneous Adverse Reactions in Korea
Sohyeon Park, RPH
KIDS, Korea, Republic of
pharmacist
Regional Pharmacovigilance Centers: A Cornerstone of Drug Safety Information Development in Korea
HYUN JOO JUNG, PHARMD, PHD
Korea Institute of Drug Safety & Risk Management, Korea, Republic of
Department of Drug Safety Information
Bayesian Confidence Propagation Neural Network for Signal Detection: Comparing Traditional Disproportionality Methods
Alice Hsu, MPH
Amgen Inc., United States
TA Safety
Patient and Prescriber Engagement in Recombinant ADAMTS13 Additional Risk Minimization Measures (aRMM)
Marie Liles-Burden, MPH
Takeda, United States
Director, Pharmacovigilance Risk Management
Consumer Perspectives on Post-marketing Drug Surveillance in Brazil
Eimy Honda, MBA
University of São Paulo, MBA USP/Esalq, Brazil
Pharmacovigilance Specialist
Characterization of Drugs with REMS Elements to Assure Safe Use (ETASU)
Meha Ahmed, MS
U.S. Food and Drug Administration, United States
ORISE Research Fellow
Assessment of Risk Factors for Myocarditis in the United States Using Integrated Electronic Health Records and Claims Data
Claudia Ana Ianos, MD
Pfizer Inc, United States
Senior Director, Safety Risk Management Lead
MM120 (LSD) Demonstrates No Evidence of Abuse Potential in Rodent Preclinical Studies
Julie Tripp, MS
Mind Medicine Inc., United States
Senior Director of Toxicology
Safety Profile of SARS-CoV-2 RNA Vaccines based on Adverse Event Reports in Japan
Daisuke Koide, PHD, RPH
Graduate School of Medicine, The University of Tokyo, Japan
Project Professor, Department of Biostatistics and Bioinformatics
In AI Do We Trust: Workforce Perspectives on AI Readiness and Integration in Clinical Trials
Aarthi Iyer, JD, MPH
Cogent Biosciences, Inc., United States
Senior Corporate Counsel
Patient-Centered Design for Device Risk Communication in Informed Consents: A User Testing Validation Study
Andrea Mariana Zuleta, MS
Abbvie, United States
Manager, Office of Health Literacy
Supporting Quality, Relevance, and Reliability Upon EHR-Sourced Data Accrual
Patrick Rodriguez, MA
Duke-Margolis Institute For Health Policy, United States
Policy Analyst
Sustainable Clinical Trials: Advancing Health Equity and Environmental Stewardship
Benjamin Worley, MPA
LabConnect, United States
Senior Director, Sustainability & ESG
Leveraging Oncology Innovations for Advancements in Neurology, Infectious Disease, Rare Disease Clinical Trials and Research
Margaret Studzinska, MBA
MMS Holdings, United States
Senior Director, Regulatory and Medical Writing
Comparison of Clinical Trial Recruitment to Incidence and Prevalence of Disease in Certain Demographic Populations
Evon Okidi, MSC
Medidata Solutions, A Dassault Systemes Company, United States
Senior Data Scientist
Advancing Drug Development for Rare Diseases: An Update on the Rare Disease Clinical Outcome Assessment Consortium
Lindsey Murray, PHD, MPH
Critical Path Institute, United States
Executive Director, Rare Disease COA Consortium
Risk-Based Quality Management in Rare Disease Trials: An Observational Perspective on Data Integrity
Julien Nunes Goncalves, MSC
Cyntegrity, South Africa
Head of Growth
Does a Dedicated Research Language Services Team Increase Enrollment and Retention of Spanish Speaking Participants?
Ana Corona
University of Utah, United States
Medical Research Translator
Learned Lessons from a US-wide outreach program to expand enrollment to the decentralized PROMISE Registry
Amanda McMannis, PHD
The Prostate Cancer Clinical Trials Consortium, United States
Associate Director, Clinical Operations
Ensuring Success in MRCTs with Optimal Sample Sizes for Global Drug Development
Angela Hu, MED, MS
Parexel, United States
VP, Biostatistics
Integrating RBQM (Risk Based Quality Management) into CRF (Case Report Form) Design
Johann Proeve, PHD
Cyntegrity, Germany
Chief Scientific Officer
Impact of ICH E6(R3) on Data Managers: Changes in Risk-Based Quality Management for Clinical Trials
Cristiano Rocha Silva, PHD
Albert Einstein Israelite Hospital, Brazil
Data Manager
Leveraging Remote Data Capture to Generate Real-World Evidence for Clinical Transformation
Troy Astorino
PicnicHealth, United States
CTO
Building a Holistic Patient View Through High Quality Source Data Collection and Linkage
Molly Shields
Duke-Margolis Institute For Health Policy, United States
Policy Research Assistant
A Generative AI Tool for Searching and Generating Responses to Regulatory Authority Inquiries on Clinical Trial Notifications
Takayuki Yasuda
Chugai Pharmaceutical Co., Ltd., Japan
Statistical Programmer
Creating a Framework for Developing Fit-For-Purpose Studies that Can Support Coverage
Hannah Graunke, MA
Duke-Margolis Institute For Health Policy, United States
Senior Policy Analyst
Streamlining Change Impact Assessment with Digital Workflow Solutions
Toshitatsu Kobayashi, PHD
Otsuka Pharmaceutical Co., Ltd., Japan
Senior Regulatory Expert
Automated Extraction of Chemistry, Manufacturing, and Controls (CMC) Change Information from Unstructured Reports
Ray Kirchmier, PMP
Deloitte, United States
Manager
Multimodal Digital Remote Patient Monitoring (RPM): The Development of Solutions for Adverse Events of Special Interest
Michael Trulli, MBA
Evinova, United States
Associate Director, Science Capability and Delivery
Innovations in Therapy Development for Rare Diseases through the Rare Disease Cures Accelerator –Data and Analytics Platform
Heidi Grabenstatter, PHD
Critical Path Institute, United States
Scientific Director, RDCA-DAP
Digital Adoption Platforms: Enhancing Compliance, Data Integrity, and Efficiency in Life Sciences
Joan Cheung, PHARMD, RPH
NNIT, United States
Senior Consultant
Assessing the Impact of Quality Issues on Vocabulary Mappings in Downstream Data
Niamh Catherine McGuinness, PHD
IQVIA, United States
Director, Pharma Solutions, IQVIA Applied AI Science
The Impact of Data Standards and Digital Data Flow (DDF) on Operational Efficiency
Kimberly Tableman, MSC
Espero, United States
Founder & CEO
Revolutionizing Computer System Validation (CSV) with Artificial Intelligence: A Risk-Based Approach for Quality Assurance
Terry Katz, MS
Daiichi Sankyo, United States
Senior Director, Biostatistics and DM Planning and Functional Excellence
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