Name: Professional Poster Session III
Start: 2025-06-18T11:30:00-0400
End: 2025-06-18T13:30:00-0400

Wednesday June 18, 2025 11:30am - 1:30pm EDT

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

Zinah Alabdulkarim

Senior Scientific Evaluation Expert, SFDA, Saudi Arabia

Nicolai Ayasse

Clinical Outcome Assessment Scientist, Critical Path Institute, United States

Maria Baier

Data Scientist, Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany

Andrea Bell-Vlasov

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

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 →

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Regulatory Policy and Intelligence at Amgen, where she is responsible for the global regulatory commenting process on draft guidance documents, proposed rules and legislation, and more.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 →

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 →

Motoki Fujii

Senior Professional, EPS Corporation, Japan

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 →

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 →

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 →

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 →

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 →

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 →

Nakyung Jeon

Assistant Professor, Pusan National University, Korea, Republic of

Timothy Kline

Senior Director, Global Regulatory Affairs, GSK, United States

Hema Kothari

Scientific Writer II, Bristol Myers Squibb, United States

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 →

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 →

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 →

Toru Morishita

Manager, Global Regulatory Affairs, GlaxoSmithKline, United States

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 →

Nancy Ngum

Public Health Officer, AUDA-NEPAD, South Africa

Miyako Okayama

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

Valerie Parker

Assistant Research Director, Duke Margolis Institute For Health Policy, United States

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 →

Aysha Rana

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

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 →

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 →

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 →

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 →

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 →

Sarah Tanios

FDA, United States

Jayashree Tikhe

Senior Product Marketing Manager, Dassault Systemes, United States

Jacqueline Vanderpuye-Orgle

Vice President, Parexel, United States

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 →

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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