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Professional Poster Session 2
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 : Health inequities among underserved US populations are complex and related to unequal access to quality healthcare. Our objective was to identify healthcare professionals who, based on their expertise and areas of impact, can be considered potential partners in addressing healthcare disparities.
Speaker(s)
Health Equity and Inclusive Research Experts Profiling: Identifying Healthcare Professionals to Address Health Disparities
Daniel Alvarez, MD, MS
Principal Medical Director, Health Equity and Inclusive Research (HEIR), Genentech, A Member of the Roche Group, United States
Dental Adverse Events with Transmucosal Buprenorphine Used to Treat Opioid Use Disorder and Pain: A Case Series
Samantha Cotter, PharmD
Safety Evaluator, FDA, United States
Characteristics of Opioid-Induced Hyperalgesia Occurring with Short and Long-Term Opioid Use
Sarah E Kang, PharmD, MS
Safety Evaluator, FDA, United States
Working with Patient Councils to Mitigate Drug-Related Risks
Raphael Elmadjian Pareschi, PharmD, MBA
Patient Safety Lead/ Head of Pharmacovigilance Brazil, Roche, Brazil
Using Historical RCT Controls Cohort to Contextualize Serious Adverse Events for ongoing RCTs
Chris Schneiderman, MPH
Director, Data & Digital Convergence Catalyst, Abbvie, United States
Comparing Safety Between Generic and Brand Drugs of Statins Marketed in Japan: A Cohort Study
Hotaka Maruyama, MPharm
Division of PharmacoEpidemiology, Office of Pharmacovigilance ?, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Comparison of US FDA and EMA Risk Minimization Strategies for Products with Eliminated REMS with ETASU and EU aRMMs
Tiffany Dominic, PharmD
Risk Management Fellow, Pfizer, United States
The Long-Term Safety of Tofacitinib as a Treatment for Moderate-to-Severe Ulcerative Colitis Based on Korean National Data
Sung Hoon Jung, DrMed, AHIP
Professor, The Catholic University of Korea, Korea, Republic of
A First-in-Human Study Evaluating Safety and Pharmacokinetics in Healthy Participants of the Heavy Metal Chelator HOPO 14-1
Laura Magda, MD, MSc
Director of Clinical Trials, SRI International, United States
Comprehensive Analysis of Pharmacovigilance Inspection Practices in the Pharmaceutical Industry in Saudi Arabia
Malak Almutairi, MSc, RPh
Researcher , Saudi Food and Drug Authority, Saudi Arabia
Drug Shortages in Saudi Arabia: A Cross-Sectional Study
Majdi Al Gharsan, PharmD
Director, Director of Medical Services, Ministry of Defence, Saudi Arabia
Effectiveness of the Additional Risk Minimization Measures for Luspatercept Among Healthcare Professionals in Europe
Samuel Ewusie, PharmD, MS, RPh
Associate Director, Safety Evidence and Science, Bristol-Myers Squibb Company, United States
Pioneering Use of a Decentralized Clinical Trial Model Leading to Faster Patient Recruitment in a Rare Cancer Study in Japan
Hiroya Taniguchi, MD
Head Physician, Department of Clinical Oncology, Aichi Cancer Center Hospital, Japan
Leveraging Real-World Data for a Culture of Learning in Health Systems: A Landscape Assessment
Matt D'Ambrosio
Policy Analyst, Duke-Margolis Institute For Health Policy, United States
The ACT ON Trial: Assisted Cascade Testing through Outreach and Navigation
Emily Epstein
Clinical Behavioral Health Specialist , Weill Cornell Medicine, United States
Implementing Clinical Trial to Real-World Data (RWD) Linkage
Mehdi Najafzadeh, PhD
Senior Director, Medidata Solutions, United States
EFFECT: An Epidemiological Framework For Equitable Representation of Racial and Ethnic Populations in Clinical Trials
Andrew R Marley
Senior Epidemiologist, Parexel, Spain
Pharmacist Training for Advanced Therapeutic use in a First in Human Study (FIH): Delivery of AAV9 CRISPR/Cas9 in Aviremic HIV Participants
Samantha Seepersad, MS
AD, Excision Biotherapeutics, United States
Identifying Novel Endpoints in Rare Disease Studies Using Real-World Evidence: A Regulatory Science Perspective
Christina Mack, MPH
CSO RWE and SVP AAIS, IQVIA, United States
Decentralized Clinical Trials Platform Construction for Implementation in Ultra-Rare Cancer Clinical Trial in Japan
Hisahiro Ito, PhD, MS
Head of Project Management Office, National Cancer Center Japan, Japan
Important Tool in our Rare Disease Toolbox: Hybrid Retrospective-Prospective Natural History Studies as External Comparators
Gerd Rippin, PhD
Senior Director, Biostatistics, Real-World Solutions, IQVIA, Germany
Innovation in Times of Uncertainty: The OPTIMAL Trials Experience Conducting a Large-Scale Clinical Trial after COVID-19
Bruna Sampaio
Manager, Data management, Hospital Israelita Albert Einstein, Brazil
Context and Comparative Effectiveness of Covid-19 Treatments: Predicting mortality, Rehospitalization, and Activities of Daily Living (ADLs) Across Covid-19 Variants and Treatments
Brittin Wagner, PhD, MA
Senior Research Scientist, PointClickCare, Canada
Optimizing Site and Country Selection for Clinical Trial Planning: a Mixed Integer Linear Programming Approach
Alexandru Socolov, MSc
Senior Data Scientist, Medidata Solutions, United States
Clinical Biomarkers: Implementing the Principles of Context-Of-Use for Biomarker Bioanalysis in Support of Drug Development
Sam Willcox
Section Manager - Large Molecule Bioanalysis , ACM Global Laboratories, United Kingdom
Development of Data and Artificial Intelligence (AI) Ethics Principles within a Pharmaceutical and Diagnostics Company
Timothe Menard, PharmD, MSc
Global Head, Quality Excellence Digital | Bioethics Ambassador, F. Hoffmann-La Roche Ltd, Switzerland
Using Structured Clinical Trial Information from the National Cancer Institute to Improve Cancer Clinical Trials Search
Rebecca Williams, PharmD, MPH
Senior Clinical Trials Subject Matter Expert, Essex Management, Part of Emmes Group, United States
The Use of Decentralized Research Technologies for the Continuity of Participant Follow Up during the COVID-19 Pandemic
Izabela Chaves Pedro, AHIP
Clinical Research Associate, Hospital Israelita Albert Einstein, Brazil
Professionals’ Perceptions on Differences Between RCT and EHR Data by Literature Review and on the Use of EHR Data by Survey
Cheryl Hergert, DRSc, MPH
, University of Southern California, United States
From Dreams to Implementation: The Realities of Incorporating GenAI in Life Sciences and Healthcare
Matt Wampole, PhD, MA
Director, Solution Consulting, Clarivate, United States
Journey to the Center of Plain Language Summaries (PLS): A Retrospective analysis of Audience Engagement Measures
Ayush Sood, PharmD
Post-Doctoral Fellow, MASC, Clinical Development and Medical Affairs, Boehringer-Ingelheim Pharmaceuticals, Inc. , United States
Regulatory Updates: New Therapeutic Possibilities for the Brazilian Population
Renata Costa, MSc
Specialist, Libbs Farmaceutica, Brazil
Hereditary Transthyretin-Related Amyloidosis Ongoing Clinical Study: A Baseline Report of the First 3,167 Participants
Pierre Engel, PhD, MPharm
Senior Director Business Development , Centogene Gmbh, Germany
Optimization of Content Retrieval for Medical Information Scientific Responses by the Addition of Medical Conference Evidence
Joseph Laudano
Medical Director, IQVIA, United States
Optimization of Content Retrieval for Medical Information Scientific Responses by the Addition of Medical Conference Evidence
Jennifer Riggins, PharmD
Director, Membership and Strategic Collaborations, phactMI, United States
Choosing the Right Design: A Guiding Framework for Using Direct-to-Patient, Hybrid and Conventional Site-Based Study Designs
Mui Van Zandt
VP/Global Head, Data Strategy, Access and Enablement, IQVIA, United States
Taiwan's Pediatric or Rare Severe Disease Priority Review Voucher Program: Enhancing Novel Drug Accessibility
Cheng Chi Chen, MSc
Clinical Reviewer, Center For Drug Evaluation, Taiwan
Update on a Biopharmaceutical Bioethics Consultation Service: 16-Year Descriptive Characteristics
Susan Watson, PhD
Associate Director, Bioethics, Eli Lilly and Company, United States
14 Day Continuous Purification Process Achieves Acceptable Bioburden and Product Quality
Celeste Lee Amadei
Product Manager, PAK Biosolutions, United States
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