Name: #617 POS: Professional Poster Session III
Start: 2026-06-17T11:30:00-0400
End: 2026-06-17T13:30:00-0400

#617 POS: Professional Poster Session III

Wednesday June 17, 2026 11:30am - 1:30pm EDT

Exchange

Component Type: Session

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.

Speakers

Sharad Adekar

Senior Medical Chair, WCG, United States

Sharad Adekar, MD, PhD, CIP, is a Senior Medical Chair at WCG. He is a physician scientist with clinical experience in family practice and pediatrics and research experience in immunology, oncology, cardiovascular diseases, infectious diseases, and neurology. Dr. Adekar has experience... Read More →

Anna-Marika Bauer

Regulatory Specialist II, Critical Path Institute, United States

Anna-Marika Bauer is a regulatory specialist with the Regulatory Science program at the Critical Path Institute (C-Path). She received her undergraduate degree in Neuroscience from Franklin & Marshall College and her Master of Regulatory Affairs from the University of Pennsylvania... Read More →

Priyanka Bobbili

Vice President, Analysis Group, Inc., United States

Dr. Bobbili specializes in the application of statistical methods for the causal analysis of complex longitudinal data. She has a wide range of experience in epidemiology and outcomes research, including studies on causal methods, drug adherence and comparative-effectiveness, particularly... Read More →

Rose Chang

Vice President, Analysis Group, Inc., United States

Dr. Chang is an epidemiologist specializing in outcomes research and the application of advanced methods to generate real-world evidence (RWE) on unmet medical need, treatment patterns, and drug safety and effectiveness. She has experience across therapeutic areas using diverse health... Read More →

Susan Chong

Senior Manager, Global Regulatory Policy and Intelligence, Amgen, United States

Susan Chong is Senior Manager, Global Regulatory Policy and Intelligence at Amgen, where she is responsible for the global regulatory commenting process on draft guidance documents, proposed rules and legislation, and more. Prior to this role, she was a Senior Associate Regulatory... Read More →

Grace Collins

Manager, Regulatory & Data Insights, Friends of Cancer Research, United States

Grace Collins is Manager of Regulatory & Data Insights at Friends of Cancer Research. She leads the development of public data dashboards that track trends in oncology drug development and clinical trials. Her work focuses on analyzing regulatory and policy trends to inform science... Read More →

Lorraine Danks

Senior Program Officer, Gates Foundation, South Africa

After spending 22 years in the pharmaceutical industry in regulatory affairs, QA and PV roles with companies such as Merck KGaA, Boehringer Ingelheim and Merck Sharp & Dohme, Lorraine Danks joined the South African medicines regulator, SAHPRA, in June 2020 to head up the organization’s... Read More →

Mei Sheng Duh

Managing Principal, Analysis Group, Inc., United States

Dr. Mei Sheng Duh, M.P.H., Sc.D., is a Managing Principal and Chief Epidemiologist at Analysis Group. She specializes in decision-grade real-world evidence (RWE) to support product registration, post-approval safety and effectiveness studies, and health technology assessments of pharmaceuticals... Read More →

Motoki Fujii

Exective Professional, EPS Group, Japan

[Expertise] Medical device regulatory consultant Support for the creation of medical device regulatory-related materials Strategy planning and support for face-to-face advice provided by PMDA Correspondence with overseas clients [Career] After joining EPS in 2008, engaged in consulting... Read More →

BI-KAI HSU

Senior Project Manager, Center For Drug Evaluation, Taiwan, Taiwan

I received my Master’s degree in Pharmacology from National Yang-Ming University, Taiwan. I began my career at the Taiwan Food and Drug Administration (TFDA) through alternative military service, where I gained foundational experience in regulatory review. I later worked in the... Read More →

Kaili Kulbacki

Clinical Research Professional, Solaire Solutions, United States

Houshen Kuo

reviewer, Taiwan Food and Drug Administration, Taiwan

Eui-Kyung Lee

Professor, School of Pharmacy, SKKU (sungkyunkwan University), Korea, Republic of

Dr. Eui-Kyung Lee is Professor of Pharmaceutical Policy and Outcomes Research at Sungkyunkwan University, South Korea. She served as Minister of the Ministry of Food and Drug Safety (2019–2020), leading emergency authorizations for COVID-19 diagnostics and fast-track approvals of... Read More →

Carmen Lin

Global Regulatory Affairs Content Strategist Specialist, Roche, Canada

Carmen is a Global Regulatory Content Specialist focusing on regulatory strategy at Roche. A graduate of the University of Toronto’s PharmD program (2023), she maintains her clinical expertise as a registered pharmacist. She has extensive experience in labeling, program management... Read More →

ChiaPing Liu

Senior Technical Specialist, Taiwan Food and Drug Administration, Taiwan

Ms. Liu has received her bachelor degree in pharmacy from Taipei Medical University and later acquired her pharmacist certificate. She has received her master degree in Law from National Cheng Chi University. She has been serving in Taiwan Food and Drug Administration (TFDA) these... Read More →

Arun Mathew

Director, AbbVie, United States

Business process owner for quality risk management in R&D(2.6yrs) Risk Management experience(19 yrs.) Medical devices experience (16yrs). Contributed and reviewed the book Foundations of Quality Risk Management.

Julia Mauro

Project Specialist, DIA, United States

Yuki Miyatake

Sr Group Manager, Eli Lilly and Company, Japan

Yuki Miyatake is a Senior Group Manager of Policy and Excellence at Eli Lilly Japan KK, specializing in regulatory policy strategy and intelligence. Driven by his personal experiences as a former patient, Yuki is passionate about fostering an innovative regulatory environment that... Read More →

Satchell Mede Pacheco

Medical Affairs Strategy Fellow, Rutgers Univerity, United States

Satchell Mede Pacheco, PharmD is a Medical Affairs Strategy professional focused on roles at the intersection of scientific rigor, commercial insight, and patient impact. She is motivated by shaping strategies that expand access to innovation, strengthen evidence generation, and elevate... Read More →

Vihanga Pahalawatta

Director Regulatory Affairs, AbbVie, United States

Vihanga Pahalawatta has over 10 years of industry experience related to In Vitro Diagnostic (IVD) products and Companion Diagnostics (CDx) in Research and Development and Regulatory Affairs. In her current role at AbbVie, Vihanga leads the CDx device regulatory group, guiding teams... Read More →

Jami Peters

Associate Director, Gilead Sciences, United States

I’m a pharmacoepidemiologist with 13 years of experience in the biotechnology industry. My background includes five years in drug safety operations, which continues to strongly inform my current work. I bring hands-on experience with real-world evidence to support pharmacovigilance... Read More →

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States

Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in Real-World Evidence (RWE) Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives... Read More →

Patrick Rodriguez

Policy Analyst, Duke-Margolis Institute For Health Policy, United States

Patrick Rodriguez is a Policy Analyst at the Duke-Margolis Institute for Health Policy on the Biomedical Innovation team. He primarily supports projects under the FDA and Real-World Evidence portfolios. He holds a MA in Bioethics and Science Policy with concentrations in both technology... Read More →

Gargi Roy

Regulatory Affairs Associate, Servier Canada, Canada

I am a Regulatory Affairs Professional with a Bachelor's degree in Pharmacy and a Masters in drug Development specializing in Regulatory Affairs. With over 4 years of experience in Regulatory affairs and previous experience in Quality Assurance, I have expertise in pharmaceutical... Read More →

Harsh Shah

CoFounder and CEO, Clinplex, United States

Harsh Shah is Co-Founder and CEO of Clinplex, an AI regulatory intelligence company focused on continuous compliance assessment for pharmaceutical, biotech, and medical device organizations. He brings 16+ years of pharmaceutical Quality Assurance and Regulatory Affairs experience... Read More →

Jennifer Shelton

Solution Executive, Actalent, United States

Clinical Operations and Solution Executive at Actalent with 16+ years of experience leading global Phase I–IV clinical trials across Oncology, CNS, Rare Disease, vaccines, Infectious and Dermatologic Diseases, CAR-T, Medical Device, and preventive and therapeutic programs. Partners... Read More →

Molly Shields

Policy Analyst, Assistant, Duke-Margolis Institute For Health Policy, United States

Molly Shields is a Policy Analyst, Assistant on the Biomedical Innovation team at Duke-Margolis where she supports the Institute's work on clinical trials, real-world evidence, and U.S. Food and Drug Administration cooperative agreements. During her undergraduate career, she conducted... Read More →

Ayoub Suliman

Regulatory Health Project Manager, FDA, United States

I am a Regulatory Health Project Manager with FDA/CDER's Office of Medical Policy (OMP). In my current role, I support policy development activities for OMP's innovation portfolio including Digital Health Technologies, Real-World Evidence, and Artificial Intelligence programs. I also... Read More →

Amisha Tayal

Regulatory Labeling & Advertising/Promotion Fellow, Pfizer, United States

Amisha Tayal, PharmD, MBA is a Regulatory Labeling and Advertising & Promotion Fellow at Pfizer through the Howard University postdoctoral fellowship program. In her role, she supports cross-functional stakeholders on U.S. labeling strategy, regulatory submissions, and advertising... Read More →

Khim Boon Tee

Senior Principal Assistant Director, National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia, Malaysia

Dr. Tee Khim Boon is a regulatory expert specializing in GCP and BE inspections. She contributes to Malaysia’s NPRA, ensuring data integrity across borders. Between 2014 and 2023, she led oversight missions in India, Taiwan, Thailand, Indonesia, and Romania . Over the past three... Read More →

Katherine Toran

Economist, FDA, United States

Katherine Toran serves as Economist at the Food and Drug Administration, specializing in prescription drugs. Katherine holds a PhD in Economics from University of Kentucky.

Apurva Uniyal

Regulatory Innovation Research Scientist, The DK Kim International Center, Department of Regulatory and Quality Sciences,, United States

Apurva Uniyal, MA, MS, is a Regulatory Innovation Research Scientist at the D.K. Kim International Center for Regulatory Science. With an MS from USC and over 20 years of experience in clinical and regulatory research, she brings both academic and practical expertise to her role... Read More →

Jun-Fon Wang

Senior Clinical Reviewer, The Center For Drug Evaluation (CDE), Taiwan, Taiwan

Multidisciplinary pharmaceutical expert with a solid foundation in clinical pharmacy and extensive experience in regulatory strategy, clinical review, and global drug development. Specialized in benefit–risk assessment of NDA/BLA and IND submissions, post-approval efficacy/safety... Read More →

Mia Williams