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Wednesday, June 18
 

11:30am EDT

#POS 3: 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, Germany
Maria is a Data Scientist at Boehringer Ingelheim, where she leverages her expertise to drive innovation and data-driven decision-making in the realm of Quality Management. Her background in mathematics and consulting has equipped her with strong analytical acumen and a diverse perspective... Read More →
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
avatar for Jason Casavant

Jason Casavant

Executive Director, Medical Writing, Synterex, Inc., United States
Jason Casavant is a 25-year veteran in the industry and is the current head of medical and regulatory writing at Synterex, Inc. Over his career, he has held various positions in medical and regulatory writing, QA/QC, operations, training, and site monitoring.
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 →
avatar for Susan Chong

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 →
SD

Saurabh Das

Associate Consultant, Tata Consultancy Services Ltd, India
avatar for Motoki Fujii

Motoki Fujii

Senior 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 →
avatar for Denise Fulton

Denise Fulton

Vice President, Research & Content Strategy, Regulatory Affairs Professionals Society (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 Lincy George

Lincy George

Vice President, Oncology Global Regulatory Affairs, Sanofi, United States
Lincy Thomas George has more than 20 years of experience in global pharmaceutical companies working in regulatory affairs across early development and late stage assets. (Novartis, BMS, now Global Oncology Regulatory Head at Sanofi)
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 Stephen Karpen

Stephen Karpen

Senior Director, Regulatory Affairs, Breakthrough T1D, United States
Stephen Karpen, PharmD joined Breakthrough T1D in 2023 and is the Senior Director for Regulatory Affairs. Dr. Karpen is responsible for implementing Breakthrough T1D’s regulatory strategy and works to accelerate the development of T1D therapies by implementing solutions to challenges... 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 →
avatar for Hema Kothari

Hema Kothari

Scientific Writer II, Bristol Myers Squibb, United States
Hema Kothari is a Scientific Writer II at Bristol Myers Squibb, specializing in the development of scientific and regulatory documents. With a strong foundation in scientific communication and as a subject matter expert in Investigator's Brochure, Hema brings expertise in synthesizing... 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 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 →
avatar for Nancy Ngum

Nancy Ngum

Public Health Officer, AUDA-NEPAD, South Africa
avatar for Miyako Okayama

Miyako Okayama

Regulatory Expert, Regulatory Technology & Operations Office, Regulatory Affairs, Otsuka Pharmaceutical, Co., Ltd., Japan
Miyako Okayama is a Regulatory Expert, Regulatory Technology & Operations Office, Regulatory Affairs Department at Otsuka Pharmaceutical, Co., Ltd., where she leads eCTD publishing and management of the global regulatory systems. Prior to joining Otsuka, she served as the Event Manager... Read More →
avatar for Valerie Parker

Valerie Parker

Assistant Research Director, Duke-Margolis Institute For Health Policy, United States
Valerie J. Parker is an Assistant Research Director at the Duke-Margolis Institute for Health Policy. Valerie manages one of the institute’s cooperative agreements with the US FDA as well as oversees a core workstream of the institute’s Real-World Evidence Collaborative, where... Read More →
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 →
avatar for Aysha Rana

Aysha Rana

Regulatory Affairs Specialist, Spectra Medical/Northeastern University, United States
Aysha Rana, PharmD, MS is a Regulatory Affairs professional with 7+ years of global experience spanning pharmaceuticals, biologics, and medical devices. A recent graduate of Northeastern University’s Master’s in Regulatory Affairs program, she has led regulatory strategy, eCTD... Read More →
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 Sandeep Singh

Sandeep Singh

Associate Director, Global Medical Information, Genmab, United States
I'm Sandeep Singh, PharmD, currently working as Associate Director of Global Medical Information at Genmab. Since earning my Doctorate of Pharmacy in 2017, I’ve had the opportunity to support multiple medical communication strategies across both pharmaceutical companies and agencies... 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

Pharmacovigilance and Medication Safety Fellow, Purdue University, United States
Sarah Tanios, PharmD, is a Regulatory Pharmaceutical Fellow in Medication Safety with Purdue University, AbbVie, and the FDA. She earned her PharmD from Midwestern University’s Chicago College of Pharmacy. Prior to her current role in drug safety and pharmacovigilance, she gained... Read More →
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
Dr. Jackie Vanderpuye-Orgle is a health economist with over 20 years of progressive experience in the application of econometric principles and statistical analysis to patient data. At Parexel, Jackie is responsible for providing technical expertise on network meta-analysis, advanced... Read More →
avatar for Stuart Walker

Stuart Walker

Professor and Consultant, Centre for Innovation In Regulatory Science (CIRS), United Kingdom
Professor Stuart Walker, BSC, PhD (London), MFPM, FRSC, FiBiol, FRCPath, is an independent Consultant in Pharmaceutical Medicine and Founder of both the Centre for Medicines Research (CMR) International and the Centre for Innovation in Regulatory Science (CIRS). UK
avatar for Kim Wilkinson

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 →
avatar for Baiyu Yang

Baiyu Yang

Principal Quantitative Scientist, Roche Molecular Systems, United States
Baiyu Yang, PhD, is a Principal Quantitative Scientist at Roche Molecular Systems. She is a seasoned epidemiologist with 10+ years of experience leading large observational studies and 40+ manuscript publications. For the past seven years, she has been leading Real-World Data (RWD... 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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