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Monday, June 16
 

12:00pm EDT

Student Poster Session I
Monday June 16, 2025 12:00pm - 2:00pm EDT
EH
Component Type: Session

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
avatar for Xianwen Chen

Xianwen Chen

Student, University of Macau, Macao
Chen Xianwen is currently a PhD candidate in the Institute of Chinese Medical Sciences at the University of Macau. Her research interests include drug regulatory science and drug policy. In 2020–2022 she obtained her Master’s degree at University of Macau, then she worked as an... Read More →
avatar for Constance Chisha

Constance Chisha

PhD Student, University of the Witwatersrand, South Africa
Constance Sakala Chisha is a doctoral candidate pursuing a PhD at the University of the Witwatersrand. She holds a Bachelor’s degree in Pharmacy from the University of Zambia and a Master’s degree in Pharmaceutical Services and Medicines Control from the University of Bradford... Read More →
KD

Kimberly Dayato

Full Time Student, Mount St Mary's University, United States
avatar for Tanvi Gupte

Tanvi Gupte

Student, University of Maryland, United States
JH

Jackson Hanf

Student, University of Southern California, United States
avatar for Md Rashedul Islam

Md Rashedul Islam

Undergraduate Research Scholar, Queensborough Community College, United States
Md Rashedul Islam is an undergraduate researcher at Queensborough Community College, City University of New York, majoring in Computer Science & Information Security. As a 2024–2025 CUNY Research Scholars Program scholar, he conducts research in medical & radiation physics, focusing... Read More →
NJ

Nabeela Jahangeer

Student, University of Southern California, United States
avatar for Patricia Jumelle

Patricia Jumelle

Student, University of Southern California, United States
LL

Lauren Le

Student, Butler University, United States
avatar for Jeremiah Lee

Jeremiah Lee

Research Ambassador, University of Southern California, United States
Jeremiah Lee (they/them) is a budding queer health researcher with an emphasis in inclusive clinical practice. As a M.S. student in Clinical Trial Management at USC Mann and Research Ambassador for the SC CTSI Regulatory Science Research Team, they explore how and why clinical trials... Read More →
RM

Ritika Malik

Student, Temple University, United States
TM

Taraneh Mousavi

PhD Student, University of Maryland, Baltimore, United States
SN

SRIVIDYA NARAYANAN

Student, Northeastern University, United States
Srividya Narayanan is a dedicated regulatory affairs professional with a background in dentistry, now specializing in medical devices and AI integration in health systems. She currently works with Culture Care Collective, contributing to an AI-driven platform to enhance community... Read More →
avatar for Ebere Okpara

Ebere Okpara

Research Assitant, University of Illinois Chicago, United States
Ebere Okpara is a PhD Candidate in Pharmacy Systems, Outcomes, and Policy at the University of Illinois Chicago. Her research focuses on real-world evidence generation in chronic diseases, including oncology and respiratory conditions. She also applies mixed methods to evaluate health... Read More →
avatar for Mercy Owusu-Asante

Mercy Owusu-Asante

Graduate Student, School of Life and Medical Sciences, University of Hertfordshire, United Kingdom
Mrs Mercy Owusu-Asante is a pharmacist with an MSc in Pharmaceutical Services and Medicines Control obtained from the University of Bradford, UK. In the area of personal professional development, Mercy is pursuing a PhD in Regulatory Science at the University of Herfordshire, UK... Read More →
avatar for Ruonan Peng

Ruonan Peng

Graduate Research Assistant, University of California, Riverside, United States
Ruonan Peng is a Ph.D. candidate in Chemical Engineering at University of California, Riverside, specializing in CRISPR-based diagnostics and microfluidic platforms for infectious disease detection. She previously worked as a Regulatory Affairs Specialist at Ferring Pharmaceuticals... Read More →
avatar for Yen Phan

Yen Phan

Student, University of Oxford, Ireland
Yen Phan has completed an MSc in Medical Statistics at the University of Oxford and is currently pursuing a Doctor of Health Science (DHSc) in Leadership in Clinical Practice and Education at The George Washington University School of Medicine and Health Sciences. She works as a Clinical... Read More →
avatar for Ran Tu

Ran Tu

Phd Student, Georgetown University, United States
My name is Ran Tu, and I am a Ph.D. candidate in Biostatistics at Georgetown University. I got my Bachelor’s degree in Mathematics from Wuhan University and my Master’s degree in Biostatistics from Yale University. Currently, under the mentorship of Professors Ming Tan and Ao... Read More →
avatar for Alice Vanneste

Alice Vanneste

PhD Student, KU Leuven, Belgium
Alice Vanneste is a PhD researcher at the Department of Pharmaceutical and Pharmacological Sciences at KU Leuven. Her PhD research focusses on the systematic implementation of patients' perspectives across the medical drug life cycle. By collecting more patient-based evidence derived... Read More →
avatar for Jenna Wildeman

Jenna Wildeman

PharmD Candidate, University of Washington, United States
Jenna Wildeman is a PharmD candidate at the University of Washington School of Pharmacy with a strong interest in real-world evidence and health outcomes research. Jenna is passionate about improving care through data-driven insights and aspires to contribute to evidence-based policy... Read More →
avatar for Siqian Zheng

Siqian Zheng

Doctor of Biomedical sciences, University of Macau, China
Zheng Siqian obtained her Bachelor of Engineering degree in Pharmaceutical Engineering from the School of Pharmacy at Shandong University. She continued her academic journey and earned a Master of Science in Pharmaceutical Management from the University of Macau, where she was awarded... Read More →
Monday June 16, 2025 12:00pm - 2:00pm EDT
EH Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  17: Posters, Session
 
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
MA

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
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
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 →
EH

Eimy Honda

University of São Paulo - USP, Brazil
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 →
MR

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 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 →
TK

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 →
SL

Sue Lee

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

Marie Liles-Burden

Director, PhV Risk Management, Takeda, United States
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
EO

Evon Okidi

Senior Data Scientist, Medidata Solutions, A Dassault Systemes Company, United States
FO

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 →
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 →
MS

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
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
  17: Posters, Session
 
Wednesday, June 18
 

11:30am EDT

Professional Poster Session III
Wednesday June 18, 2025 11:30am - 1:30pm EDT
EH
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
ZA

Zinah Alabdulkarim

Senior Scientific Evaluation Expert, SFDA, Saudi Arabia
NA

Nicolai Ayasse

Clinical Outcome Assessment Scientist, Critical Path Institute, United States
Cole Ayasse is a quantitative researcher with expertise in statistics, psychometrics, and research design. Dr. Ayasse has experience working in multiple therapeutic areas, including rare diseases and oncology, but with an emphasis on and particular interest in neurological disorders... Read More →
MB

Maria Baier

Data Scientist, Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany
avatar for Anna-Marika Bauer

Anna-Marika Bauer

Regulatory Specialist, 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 →
AB

Andrea Bell-Vlasov

Science Policy Analyst, U.S. Food & Drug Administration, United States
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 →
SC

Susan Chong

Senior Manager, Global Regulatory Policy and Intelligence, Amgen Inc., 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 →
avatar for Lorraine Danks

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 →
MF

Motoki Fujii

Senior Professional, EPS Corporation, 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 →
DF

Denise Fulton

Vice President, Research & Content Strategy, RAPS, United States
Denise Fulton, Vice President for Research & Content Strategy, leads the Regulatory Focus, journals, books, and research teams at the Regulatory Affairs Professionals Society. She joined RAPS in early 2020 after 20 years of leading newsrooms for MDedge/Medscape, a company dedicated... Read More →
avatar for Katharina Goldner

Katharina Goldner

Regional Regulatory Affairs Manager, Bayer AG, Germany
Katharina is a biologist with an M.Sc. who has been making waves at Bayer since 2016. Starting as a CMC Manager for herbal medicinal products in Consumer Health, she transitioned in 2020 to become Regional Regulatory Affairs Manager for Eastern Europe, the Middle East, and Africa... Read More →
avatar for Fadhilah Hasbullah

Fadhilah Hasbullah

GCP Inspector, National Pharmaceutical Regulatory Agency (NPRA) Malaysia, Malaysia
She completed her Master of Science (MSc) in Clinical Research from The University of Sheffield, United Kingdom, in 2014 and her Bachelor of Pharmacy (Hons) from the International Islamic University Malaysia in 2007. She started to working at the National Pharmaceutical Regulatory... Read More →
avatar for Nicole Herk

Nicole Herk

Analytics Director, Medtronic, United States
Nicole Herk, M.S., is an Advanced Analytics Program Director and manages the Employee Listening Program at Medtronic. She joined Medtronic in 2018 and is responsible for the enterprise engagement survey and other active and passive listening solutions throughout the organization designed... Read More →
avatar for Li Huang

Li Huang

Principal Biostatistician, Phastar, United States
Li Huang is a Principal Biostatistician at PHASTAR. She holds a Doctor of Dental Surgery (DDS) degree from Hubei Medical University (China), a Master of Science in Dentistry from the National University of Singapore (NUS), and a Master of Science in Applied Statistics from California... Read More →
avatar for Tse-Yin Huang

Tse-Yin Huang

Reviewer, Center for Drug Evaluation, Taiwan, Taiwan
Tse Yin Huang received a Doctor of Philosophy degree from China Medical University. He has been working as a reviewer at the Center for Drug Evaluation (CDE) in Taiwan for over two years, responsible for reviewing the clinical pharmacology sections of new drug applications. In his... Read More →
avatar for Timothy Kline

Timothy Kline

Senior Director, Global Regulatory Affairs, GSK, United States
Programmed to change the trajectory of patient lives by harnessing 10 years of strategic regulatory design and execution in oncology, rare diseases both BLA (cell & gene therapy) and NDA (oncology & neurological disorders) with successful Health Authority track record in complex innovative... Read More →
HK

Hema Kothari

Scientific Writer II, Bristol Myers Squibb, United States
avatar for Catherine Lee

Catherine Lee

Associate Director - US Policy and Intelligence, Johnson and Johnson, United States
Catherine Lee, DrPH is currently Associate Director, Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the policy work on Real-World Evidence, Pediatrics and Immunology Therapeutic Area, Janssen Pharmaceutical Companies of Johnson & Johnson. Before joining... Read More →
IL

Iyn-Hyang Lee

Professor, College of Pharmacy, Yeungnam University, Korea, Republic of
avatar for Tyler Ludlow

Tyler Ludlow

Founder and Chief Decision Scientist, Decision Skills Institute, United States
Tyler helps people turn their decision burdens into opportunities for growth. After earning a degree in applied math and an MBA, he studied decision science at Stanford. He then spent 15 years helping leaders at global 500 firms (including 18 of the top 20 pharma companies), make... Read More →
avatar for Yuki Miyatake

Yuki Miyatake

Sr Manager, Eli Lilly Japan, Japan
Yuki Miyatake is a Senior Manager of Regulatory Policy 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 enables individuals... Read More →
avatar for Toru Morishita

Toru Morishita

Manager, Global Regulatory Affairs, GlaxoSmithKline, United States
avatar for Katie Moy

Katie Moy

Associate Director, Medical Information & Review, Acadia Pharmaceuticals, United States
Katie Moy currently serves as Associate Director in Medical Information and Review at Acadia Pharmaceuticals Inc. She has supported 7 product launches in her career, globalized Medical Information workstreams, and led Medical Communications and Information content creation across... Read More →
NN

Nancy Ngum

Public Health Officer, AUDA-NEPAD, South Africa
MO

Miyako Okayama

Regulatory Expert, Regulatory Technology & Operations Office, Regulatory Affairs, Otsuka Pharmaceutical, Co., Ltd., Japan
VP

Valerie Parker

Assistant Research Director, Duke Margolis Institute For Health Policy, United States
avatar for Jaymin Patel

Jaymin Patel

HEOR, AESARA, United States
Jaymin Patel is an Associate Director in the Value & Evidence team at AESARA, where he focuses on both pre- and post-approval strategy, patient experience data, and clinical outcome assessments for Phase 2 and 3 studies. His work emphasizes aligning endpoints and PROs with what matters... Read More →
AR

Allison Radwick

Senior Regulatory and Policy Communications Manager, U.S. Pharmacopeia, United States
Allison is accomplished in combining communications, regulatory affairs, policy and science with demonstrated success driving public engagement initiatives, implementing integrated outreach plans and liaising across executive and functional levels. Skills include building awareness... Read More →
AR

Aysha Rana

Regulatory Affairs Specialist, Spectra Medical/Northeastern Universitu, United States
SR

Sarah Roberge

IBC Chair, IBC Services, WCG Clinical, United States
I am currently an Institutional Biosafety Committee (IBC) Chair at WCG, working with research sites, sponsors, and CROs to ensure that human gene transfer clinical trials are conducted safely. Prior to joining WCG in early 2019, I worked at Seattle Cancer Care Alliance, BloodworksNW... Read More →
avatar for Cynthia Rothblum-Oviatt

Cynthia Rothblum-Oviatt

Science Policy Analyst, Rare Disease Team, OND, CDER, FDA, United States
Dr. Cynthia Rothblum-Oviatt serves as the External Engagement Lead for the FDA’s Center for Drug Evaluation and Research (CDER) Rare Diseases Team within the Office of New Drugs. Prior to joining FDA, Dr. Rothblum-Oviatt spent approximately 20 years in the non-profit rare disease... Read More →
avatar for Cecilia Speck

Cecilia Speck

Post-Doctoral Fellow, Novartis, United States
Cecilia is a recent graduate of the Raabe College of Pharmacy at Ohio Northern University. She is currently a post-doctoral fellow at Novartis through the Rutgers Pharmaceutical Industry Fellowship Program. Her 2-year fellowship is in US Publications and Medical Content, Strategy... Read More →
avatar for Yu Fa Su

Yu Fa Su

Project Manager, Taiwan Center For Drug Evaluation, Taiwan
As a Project Manager at the Center for Drug Evaluation (CDE), Taiwan, in the Division of Consultation, I manage drug consultation applications across all stages of development and review cases involving cell therapy technologies. My responsibilities include developing project plans... Read More →
avatar for Toru Suzuki

Toru Suzuki

Head, Regulatory and Development policy, Novartis Pharma, Japan
Toru Suzuki is the Head of Development and Regulatory Policy, Regulatory Affairs Japan at Novartis Pharma K.K. in Tokyo. In this role, he leads the policy team and oversees the analysis of the regulatory environment using both external and internal data. His responsibilities include... Read More →
ST

Sarah Tanios

FDA, United States
ST

Sarah Tanios

Fellow, Purdue University, United States
avatar for Jayashree Tikhe

Jayashree Tikhe

Senior Product Marketing Manager, Dassault Systemes, United States
Jaya Tikhe has extensive experience and deep knowledge in early drug discovery and project management. As a medicinal and organic chemist, she has a proven track record of successful delivery of candidate quality molecules on programs in CNS, immunology, inflammation and oncology... Read More →
JV

Jacqueline Vanderpuye-Orgle

Vice President, Parexel, United States
KW

Kim Wilkinson

Associate Director, Medical Writing, Alexion RDU, Astrazeneca, United States
Kim Wilkinson, Associate Director of Medical Writing at Alexion's Rare Disease Unit, AstraZeneca, brings over a decade of expertise in clinical regulatory documentation. With a Ph.D. in Immunology and Cell Biology, Kim has leveraged their strong scientific background to excel in the... Read More →
BY

Baiyu Yang

Principal Quantitative Scientist, Roche Molecular Systems, United States
Wednesday June 18, 2025 11:30am - 1:30pm EDT
EH Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  17: Posters, Session
 
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Thursday, June 12
Sunday, June 15
Monday, June 16
Tuesday, June 17
Wednesday, June 18
Thursday, June 19
EH
TBD
Virtual
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 20: Short-Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Keyword
  • 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
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming