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Tuesday, June 17
 

11:30am EDT

Professional Poster Session II
Tuesday June 17, 2025 11:30am - 1:30pm EDT
EH
Component Type: Session

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.

Speakers
avatar for Meha Ahmed

Meha Ahmed

ORISE Research FELLOW, FDA, United States
An epidemiologist with expertise in pharmacoepidemiology, risk management, and pharmacovigilance. Meha Ahmed holds a Master of Health Science degree in Epidemiology from Johns Hopkins Bloomberg School of Public Health. She currently serves as an ORISE Research Fellow at the FDA, where... Read More →
AA

Abdulaziz Alageel

Senior Alert and Monitoring Expert, Saudi Food and Drug Authority, Saudi Arabia
avatar for Saeed Alshahrani

Saeed Alshahrani

Alarm & Control Expert, Saudi Food & Drug Authority, Saudi Arabia
avatar for Vasanti Anand

Vasanti Anand

Regulatory Writer, BMS, United States
Have a doctorate in Molecular Biology and Biochemistry and completed a prestigious postdoctoral fellowship as a Michael J. Fox Fellow in Neuroscience. With over 11 years of experience as a scientific and regulatory writer, I have developed a diverse skill set in both publication and... Read More →
avatar for Troy Astorino

Troy Astorino

CTO, PicnicHealth, United States
Troy Astorino, co-founder and Chief Technology Officer of PicnicHealth, holds degrees in Aerospace Engineering and Physics from MIT. At PicnicHealth, Troy spearheads the development of technologies transforming unstructured medical records into research datasets. His team has pioneered... Read More →
avatar for Maree Beare

Maree Beare

Founder and CEO, Clinials, Australia
avatar for Amanda Kirby Bowles

Amanda Kirby Bowles

Managing Director, Deloitte, United States
Amanda helps organizations transform their business by innovating in process and technology to help protect patients, manage risk, and drive value. Amanda has in-depth experience in patient safety, pharmacovigilance, and regulatory affairs -- including operations strategy, global... Read More →
avatar for Maryann Chapin

Maryann Chapin

ORISE Fellow, Food and Drug Administration, United States
Maryann is a current postdoctoral ORISE fellow at the Food and Drug Administration (FDA) within the Division of Pharmacovigilance (DPV), focusing on the characterization of newly identified safety signals (NISS). Prior to her FDA fellowship, she completed a 2-year fellowship at the... Read More →
JC

Joan Cheung

Senior Consultant, NNIT, United States
Joan Cheung is a Senior Consultant at NNIT where she leverages new technologies for digital transformations in the life sciences. Since her Doctor of Pharmacy from St. John’s University, she gained technical project and product management skills in Regulatory Affairs with projects... Read More →
EC

Eunmi Choi

Manager, Korea Institute of Drug Safety & Risk Management, Korea, Republic of
Eunmi Choi, MPH, PhD Manager, Office of Drug Safety Information Department of Drug Safety Information Korea Institute of Drug Safety and Risk Management (KIDS) Republic of Korea ----------------------------------------------------------------------------- Since 2011, I have been engaged... Read More →
avatar for Pamela Concepcion

Pamela Concepcion

Patient Safety Scientist, Astrazeneca, United States
AC

Ana Corona

Translator, University of Utah, United States
SD

Sahith Doppalapudi

Associate Director, PV Analytics Analytics Center of Excellence, Bristol-Myers Squibb Company, United States
Sahith Doppalapudi holds a master's degree in Chemical Engineering from Oklahoma State University and has accumulated over 14 years of experience in the pharmaceutical industry. Throughout his career, he has served in different roles including Quality Analyst, Validation Lead, and... Read More →
avatar for Heidi Grabenstatter

Heidi Grabenstatter

Scientific Director, RDCA-DAP, Critical Path Institute, United States
Heidi Grabenstatter, Ph.D., is the Scientific Director of the Rare Disease Cures Accelerator- Data Analytics Platform (RDCA-DAP). In this role, she leads neutral convenings of clinician experts, data scientists, industry partners, and patient advocacy leaders to identify disease-specific... Read More →
avatar for Hannah Graunke

Hannah Graunke

Senior Policy Analyst, Duke-Margolis Institute For Health Policy, United States
Hannah Graunke, MPP is a Senior Policy Analyst with the Biomedical Innovation team at the Duke-Margolis Institute for Health Policy. Her research focuses on coverage and access for novel medical technologies, medical product payment, and condition-based models. She is a former Peace... Read More →
avatar for Tarek Hammad

Tarek Hammad

Vice President, Head of Medical Safety, Marketed Products & Plasma-Derived Thera, Takeda, United States
Dr. Tarek Hammad, VP & Head of Medical Safety for Marketed Products at Takeda Pharmaceuticals, is a renowned expert in drug safety, benefit-risk assessment, and pharmacoepidemiology. With extensive experience at major pharmaceutical companies like Sanofi and Merck, as well as a distinguished... Read More →
avatar for Eimy Honda

Eimy Honda

Pharmacovigilance Specialist, University of São Paulo, MBA USP/Esalq, Brazil
Eimy is a Pharmacist with a Bachelor's degree from the Federal University of São Paulo (Unifesp) and an MBA in Business Management from USP/Esalq. She currently works as a Pharmacovigilance Specialist, with a strong focus on implementing technology solutions such as RPA and AI. With... Read More →
avatar for Alice Hsu

Alice Hsu

Director Integrated Signal Management, Amgen Inc., United States
Alice Hsu currently leads the Integrated Signal Management team within Global Patient Safety at Amgen. In this role, she is the business process owner for safety signal detection, signal management, and safety governance. She leads a team of signal management scientists, data scientists... Read More →
avatar for Angela Hu

Angela Hu

VP, PAREXEL International Inc., Taiwan
Angela Hu is an accomplished Biostatistics professional with extensive experience in the global pharmaceutical industry. Her career has been marked by a consistent focus on operating at the highest levels of the organization, ensuring that robust and insightful input is provided to... Read More →
avatar for Aarthi Iyer

Aarthi Iyer

Corporate Counsel, Cogent Biosciences, Inc., United States
Aarthi B. Iyer is a Senior Regulatory Attorney & Managing Director for Kinetiq, a consulting and technology division of Quorum Review IRB. Aarthi provides guidance and regulatory analysis on issues related to human subjects research including informed consent, privacy, data use, and... Read More →
avatar for MIDHUN RAJ K

MIDHUN RAJ K

Manager, Signal Management, IQVIA, India
Pharmacovigilance professional, with bachelor's in pharmacy and master's in data sciences with 15+ years of working experience in drug safety surveillance industry with a special focus on its quality management aspects. Worked with number of pharmaceutical, biological and medical... Read More →
avatar for Dipti Kalra

Dipti Kalra

Team Leader, Office of Scientific Investigations, OC, CDER, FDA, United States
CDR Dipti Kalra is a Team Leader of the Risk Evaluation and Mitigation Strategies (REMS) Compliance team in the Office of Scientific Investigations, Office of Compliance at the Food and Drug Administration (FDA). She is a commander with the United States Public Health Service. She... Read More →
avatar for Terry Katz

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →
avatar for Yoon Jeon (Jamey) Kim

Yoon Jeon (Jamey) Kim

Director, Cluster Pharmacovigilance Lead, Merck & Co., Inc., Rahway, NJ, USA, Panama
Yoon Jeon (Jamey) Kim, the Director and North Cluster PV lead for Latin America at MSD, has 23 years of experience with the company. She provides strategic leadership for cluster countries (Colombia, Ecuador, Venezuela, Central America, and the Caribbean), with an extensive background... Read More →
avatar for Ray Kirchmier

Ray Kirchmier

Manager, Deloitte, United States
Ray Kirchmier, B.S. Biological Sciences, PMP - Manager, Deloitte - Ray has over 9 years of experience in the pharmaceutical industry. Before joining Deloitte, he was a Scientist and Quality Assurance Specialist at Patheon–Thermo Fisher Scientific. In 2018, he brought his pharmaceutical... Read More →
avatar for Toshitatsu Kobayashi

Toshitatsu Kobayashi

Senior Regulatory Expert, Otsuka Pharmaceutical Co., Ltd., Japan
After completing a Ph.D. and postdoctoral research, the speaker joined their current pharmaceutical company in 2007, beginning a career in drug development. He spent six years conducting nonclinical pharmacokinetics research on biologics before transitioning to the regulatory affairs... Read More →
avatar for Daisuke Koide

Daisuke Koide

Project Professor, Department of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo, Japan
Dr. Daisuke Koide is Project Professor at the Department of Biostatistics and Bioinformatics at Graduate School of Medicine, the University of Tokyo. He is also head of safety management division at clinical research promotion center in the University of Tokyo Hospital. He holds a... Read More →
SL

Sue Lee

Director, Global Patient Safety Signal Management and Innovation, Takeda, United States
ML

Marie Liles-Burden

Director, Pharmacovigilance Risk Management, Takeda, United States
Marie A. Liles-Burden, MPH, is a seasoned expert in pharmacovigilance and epidemiology. She obtained a Bachelor of Science from the Massachusetts College of Pharmacy and Health Sciences and a Master of Public Health from Boston University. Currently, Marie serves as the Director of... Read More →
avatar for Anran Liu

Anran Liu

ORISE Postdoctoral Fellow, U.S. Food and Drug Administration, United States
Anran is a postdoctoral fellow at the U.S. FDA, CDER Office of Surveillance and Epidemiology, conducting research in pharmacovigilance and drug safety surveillance. She earned her PhD in Biostatistics from SUNY Buffalo in August 2024, where she developed approaches for adverse event... Read More →
avatar for Niamh McGuinness

Niamh McGuinness

Director of Pharma Solutions, Applied AI Science Team, IQVIA, United States
Niamh McGuinness is Director of Pharma Solutions with the Applied AI Science Team in IQVIA. Niamh leads a diverse group of experts who build AI solutions and utilize a suite of award-winning technology to help pharma customers protect participant privacy and surface critical insights... Read More →
AM

Amanda McMannis

Associate Director, Clinical Operations, The Prostate Cancer Clinical Trials Consortium, United States
Amanda McMannis is the Associate Director of Clinical Operations at the Prostate Cancer Clinical Trials Consortium within Memorial Sloan Kettering Cancer Center. She manages the late phase clinical trials and registry studies within the company’s portfolio.
GM

Greeshma Mundayat

Solution Owner, Maxisit, United States
avatar for Lindsey Murray

Lindsey Murray

Executive Director, Rare Disease COA Consortium, Critical Path Institute, United States
Lindsey Murray, PhD, is the Associate Director for Rare Diseases at the Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium. Dr. Murray has more than 14 years of experience in clinical and health outcomes research, specializing in quantifying the patient’s... Read More →
EO

Evon Okidi

Senior Data Scientist, Medidata Solutions, A Dassault Systemes Company, United States
Evon Okidi is senior data scientist at Medidata AI, where she builds models that leverage machine learning, deep learning and statistical methods to predict and forecast clinical trial activities. In her early career, she worked as a Biostatistician focusing on HIV/AIDS research and... Read More →
avatar for Feisal Othman

Feisal Othman

Benefit Risk Assessment Lead, Bristol Myers Squibb, United States
Feisal Othman is a drug safety and risk management professional with over 16 years of experience in various roles in healthcare and medication safety, currently serving as a Benefit-Risk Assessment Lead at Bristol Myers Squibb. His background includes developing and overseeing global... Read More →
MR

Mohit Raizada

Director - Signal Management Services, IQVIA, India
Dr. Mohit Raizada is the Director and Head of Signal Management Services in the Lifecycle Safety department at IQVIA, India. He is an expert in signal management and has successfully onboarded, led, executed, and completed complex signal management projects for various companies... Read More →
PR

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 →
avatar for Andrea Russell

Andrea Russell

Assistant Professor, Northwestern University Feinberg School of Medicine, United States
I am an Assistant Professor of Medicine in the Department of Psychiatry & Behavioral Sciences and the Division of General Internal Medicine at Northwestern Feinberg School of Medicine. In addition, I am faculty within the Center for Applied Health Research on Aging (CAHRA) with expertise... Read More →
MS

Molly Shields

Policy Research Assistant, Duke-Margolis Institute For Health Policy, United States
Molly Shields is a Policy Research Assistant on the Biomedical Innovation team at Duke-Margolis, supporting work under U.S. Food and Drug Administration grants and the Institute’s collaboration with Highlander Health to optimize clinical research. She has experience working on health... Read More →
CS

Cristiano Silva

Data Manager, Albert Einstein Israelite Hospital, Brazil
avatar for Margaret Studzinska

Margaret Studzinska

Senior Director, Regulatory and Medical Writing, MMS Holdings, United States
Margaret Studzinska, MBA is a Senior Director in Regulatory and Medical Writing, with over 15 years of experience in medical and regulatory writing for the clinical research and pharmaceutical industries. She has supported multiple regulatory submissions to global health authorities... Read More →
JT

Julie Tripp

Senior Director of Toxicology, Mind Medicine Inc., United States
RV

Rishi Verma

Medical Director, Roche & Stethy, Australia
DW

Doug Weatherhead

Chief Commercial Officer, ESPERO, United States
avatar for Benjamin Worley

Benjamin Worley

Senior Director, Sustainability and ESG, Labconnect, United States
avatar for Takayuki Yasuda

Takayuki Yasuda

Statistical Programmer, Chugai Pharmaceutical Co., Ltd., Japan
Takayuki Yasuda has been serving as a Statistical Programmer in the Biometrics department at Chugai Pharmaceutical Co., Ltd. since 2020. He worked in the CRO industry from 2014 to 2020. Since 2024, he has been leading an initiative on implementing generative AI in the clinical development... Read More →
TZ

Teresa Zhang

Safety Scientist, Beigene, United States
Teresa is a Safety Scientist at BeOne Medicines (formerly BeiGene). She has over 5 years of experience in pharmacovigilance at biotech companies in the oncology space. In her current role, she is also exploring the application of artificial intelligence in signal detection and case... Read More →
CZ

Chenan Zhang

Director, Epidemiology, Pfizer, United States
avatar for Andrea Zuleta

Andrea Zuleta

Manager, Office of Health Literacy, Abbvie, United States
Tuesday June 17, 2025 11:30am - 1:30pm EDT
EH Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
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  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
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  • Level
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  • Advanced Analytics
  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
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  • Regulatory Reliance
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