Tuesday, June 25 • 9:00am - 4:00pm
Professional Poster Session 1

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Component Type: Poster Presentation

avatar for Lien-Cheng Chang

Lien-Cheng Chang

Section Chief, Division of Medicinal Products, TFDA
Lien-Cheng (Eric) Chang received his PhD degree from the Institute of Biopharmaceutical Sciences at Yang Ming University. Previously, he worked in Taichung Hospital and NTU Hospital in Clinical Pharmacy Services and also served in the former Bureau of Pharmaceutical Affairs for six... Read More →

Elisa Conrad

Clinical Science Advisor, ERT
Ms. Conrad is a licensed clinician with more than 12 years of experience with patients across many CNS (Neurology and Psychiatry/Psychology) indications. In addition to being an experienced sub-investigator and site rater, she has extensive expertise in the development and delivery... Read More →

Christina Cantrell

Senior Patient Insights Leader, Genentech, A Member of the Roche Group
Christina has worked for over 15 years in clinical research, always with a focus on the patient’s experience and primarily in outcomes research and insights gathering. She has worked at both large and community hospitals, health technology vendors, and she currently works at Roche... Read More →

Teresa Curto

Associate Director, Biostatistics, Cytel
avatar for Anthony Davidson

Anthony Davidson

Associate Consultant Scientific Writing, Eli Lilly and Company
Anthony is a medical writer within the Design Hub which is part of the Clinical Design, Delivery, and Analytics organization at Lilly. He is responsible for the writing of oncology clinical trials. Anthony has been at Lilly for 6 years and has worked in clinical research for 14 y... Read More →
avatar for Hunter Davis

Hunter Davis

Medical Affairs / Medical Science Liaison Fellow, Genentech, Rutgers University, Ernest Mario School of Pharmacy
Hunter Davis is a recent graduate from the University of California, San Francisco School of Pharmacy. He is currently a Medical Affairs and Medical Science Liaison Post Doctoral fellow at Genentech with an adjunct faculty appointment at Rutgers University, Ernest Mario School of... Read More →

Ye Jin Eun

Senior Data Scientist, Janssen
avatar for Andre Ghetti

Andre Ghetti

Chief Executive Officer, AnaBios
Andre Ghetti, PhD, is our Chief Executive Officer. During the last several years, Dr. Ghetti focused on the creation of new tools and strategies to advance biomedical sciences, with special emphasis on enabling the direct study of human biology and pharmacology to accelerate the rate... Read More →
avatar for Daphne Guinn

Daphne Guinn

ORISE Post-Doctoral Fellow, FDA
Daphne Guinn is currently a Post-Doctoral Policy Fellow in the Office of Clinical Pharmacology. Prior to joining FDA, Daphne completed a post-doctoral fellowship in regulatory science at Georgetown University. She used the training opportunity to pursue her interest in innovative... Read More →

Adam Hamm

Director, Biostatistics, Cytel
avatar for Joanne Hathaway

Joanne Hathaway

Manager, Global Regulatory Affairs, Promotion Compliance, Otsuka Pharmaceutical Commercialization & Development
Joanne Hathaway joined Otsuka Development & Commercialization (OPDC) as Senior Analyst, Document Management in 2016. In this role, she was responsible for managing promotional materials for all marketed products that required submission to the Office of Prescription Drug Promotion... Read More →

Lauren Holmes

Global Trial Manager, Rutgers University/Ernest Mario School of Pharmacy
Lauren is currently a post-doctoral fellow with the Rutgers Pharmaceutical Industry Fellowship Program. Her fellowship is in global development and trial management at Novartis Pharmaceuticals where she is about to begin her second year in the program.

Chin-Fu Hsiao

Investigator, National Health Research Institutes
Chin-Fu Hsiao received his Ph.D. degree from Department of Statistics at University of Wisconsin-Madison. His research interests include Bayes decision theory, sequential analysis, clinical trials and genetic study. His current research focuses on the design and evaluation of multi-regional... Read More →

Shu-Mei Hsu

HTA Researcher, TFDA/Center for Drug Evaluation
MPH. in Global Health Systems, Tulane University, USA. MSc. in Preventive Medicine, National Taiwan University, Taiwan. BSM. in Veterinary Medicine, National Chung-Hsing University, Taiwan

Dalong Huang

Mathematical Statisitician, CDER, FDA
Dr. Huang has served as a statistical reviewer to provide statistical expertise regarding QT issues since he jointed FDA in 2015. He is active in regulatory science research, and has several publications and presentations in ICH E14 related research area in particular. Prior to joining... Read More →
avatar for Toshiko Ishibashi

Toshiko Ishibashi

Clinical Operation I, JAPAN, Clinical Operation, Ono Pharmaceutical Co., Ltd.
Toshiko Ishibashi, PhD, serves in Clinical Operations at Ono Pharmaceutical Co. Ltd. She has more than 16 years of clinical research experience as a Clinical Research Coordinator at Kumamoto University Hospital and St Luke’s International Hospital. Dr. Ishibashi previously served... Read More →

Mohit Juneja

Co-Founder, Lyfescience
avatar for Miah Jung

Miah Jung

Pharmacologist, FDA
Miah Jung is a Pharmacologist in the Compliance Enforcement Branch, Office of Scientific Investigations, Center for Drug Evaluation and Research (CDER), FDA. She has been with FDA for six years, and serves as a subject matter expert in Good Clinical Practice (GCP) inspections to evaluate... Read More →

Oksana Karavaeva

ClinOps Director, IPHARMA LLC
avatar for Andrea Keyter

Andrea Keyter

Deputy Director, Medical Devices, South African Health Products Regulatory Authority
Andrea is a pharmacist and has 10 years of experience within the field of regulatory affairs, quality assurance, quality risk management, pharmaceutical production, complementary medicines manufacture and risk-based inspection planning. In her current role, Andrea is responsible for... Read More →

Namita Kothary

Consumer Safety Officer, FDA
Namita Kothary is a Consumer Safety Officer on the Postmarketing Adverse Drug Experience Compliance Team in CDER’s Office of Compliance. As a Consumer Safety Officer, Dr. Kothary monitors and assesses industry compliance with postmarketing adverse drug experience statutory requirements... Read More →

Tetsuya Kusakabe

Professor, Osaka City University, Graduate School of Medicine
Tetsuya KUSAKABE is a Professor at the Osaka City University, Graduate School of Medicine, since July 2017. Prior to this, he was a Director at the Ministry of Health, Labour and Welfare (MHLW) from November 1996 to July 2017. He was involved in pharmaceutical regulations, research... Read More →

Samir Lababidi

Statistician, FDA

Connie Langer

Regulatory Scientist, Pfizer Inc.
Connie Langer is an Associate Director at Pfizer in Groton, CT, where she is accountable to manage and provide global strategy and submissions for investigational studies, new commercial registrations and maintenance of product licenses. She had the unique opportunity to work closely... Read More →

Xin (Joy) Li

Mathematic Statistician, Office of Translational Science, CDER, FDA
avatar for Neil McAuslane

Neil McAuslane

Director, Centre For Innovation In Regulatory Science (CIRS)
Neil McAuslane is Director of the Centre for Innovation in Regulatory Science (CIRS, previously CMR International) and works in the area of regulatory and HTA strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology... Read More →
avatar for Masaki Mihaila

Masaki Mihaila

Programming Lead, Manager, Pfizer
Ms. Mihaila is a SAS programmer who analyzes data from clinical trials mostly for Regulatory Agencies and publications. She has been working in the Pharmaceutical industry for 13 years and for most of her career, she has been working on Oncology data. With her current position at... Read More →
avatar for Juliane Mills

Juliane Mills

Director Scientific Affairs, Real World Solutions, PRA Health Sciences
Juliane Mills, Director of Scientific Affairs, has a comprehensive understanding of drug development from the laboratory to the patient’s bedside from over 20 years of experience in various scientific roles in academic institutions and industry. She has extensive experience in the... Read More →

Tomoko Minamiguchi

Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA)
Tomoko Minamiguchi is a reviewer at Pharmaceuticals and Medical Devices Agency (PMDA) since 2012. She is involved in the review of blood products. She is a member of Orphan Drug Working Group in PMDA.
avatar for Nipa Parikh

Nipa Parikh

Senior Director, PV Operations, Global Head Aggregate Reports/RMPs, Otsuka Pharmaceutical Development and Commercialization Inc.
Nipa Parikh is a Senior Director in Global Pharmacovigilance at Otsuka Development & Commercialization (OPDC). She has experience in pharmacovigilance for the past 16 years, but has specialized in aggregate reporting and risk management plans for the past 10 years. Nipa received her... Read More →
avatar for Yannick Pouliot

Yannick Pouliot

Sr. Computational Biologist, Unlearn.AI
Computational biologist and software developer with deep expertise in data mining and modeling, including meta-analysis, data cleansing, metadata encoding, and visualization.

Susan Pusek

Director, Education Programs (Clinical/Translational Research), University of North Carolina Chapel Hill
Susan Pusek is the Director of Education Program at the North Carolina Translational and Clinical Sciences Institute. She is also a doctoral student in Regulatory Science at the University of Southern California. Ms. Pusek has over 25 years of experience within the clinical research... Read More →

George Quartey

Scientific Enablement Leader, Genentech, A Member of the Roche Group
"George joined Roche/Genentech in January 2009 as an Expert Statistician, responsible for developing, Driving and Embedding Innovative Statistical Methods for the Analysis and Reporting of Safety, and Epidemiological Data. George previously worked for GSK and Cambridge University... Read More →

Caroline Seo

Senior Analyst, Patient-Centered Outcomes, Pharmerit International
Caroline Seo is a senior research analyst within the patient-centered outcomes group at Pharmerit International. With a background in mixed-method research, Caroline conducts patient journey studies and develops/validates patient-reported outcome measures in various therapeutic areas... Read More →

Jit Sheth

Postdoctoral Medical Affairs Fellow, Alnylam Pharmaceuticals and Northeastern University

Landon Shupe

Pst-Doctoral Fellow, Rutgers University/Ernest Mario School of Pharmacy

Manfred Stapff

CMO, Trinetx

Meng Ting Tsai

Project Manager, Center For Drug Evaluation (CDE)
Meng Ting Tsai is a Project Manager in Division of Regulatory Affairs and Compliance of CDE Taiwan for more than 3 years. Meng Ting Tsai holds a Master of Life Science from National Taiwan University and is Project Management Professional (PMP) certification holder.

Hanming Tu

Vice President, IT, Frontage Laboratories, Inc.
* MS, MCRP * VP, Clinical IT & Database Administration (DBA) at Frontage * Manager, DBA in Accenture Life Science Cloud * Director, Clinical IT in Octagon Research * Over 18 years of pharmaceutical and clinical IT experience * Oracle Certified Professional (OCP) and DBA Master from... Read More →

Brian Ung

Manager, U.S. Health Economics & Outcomes Research (HEOR), Celgene Corporate

Christopher Varghese

Post Doctoral Fellow, Global Scientific Engagement, Johnson & Johnson, Rutgers University
Post-doctoral fellow at Johnson & Johnson through Rutgers University. Have experience in community, hospital and industry settings. Interests lie in developing novel drug therapies, consumer behaviors, and creating a healthier world for future generations.

Renee Willmon

Manager, Behaviour Science, Self Care Catalysts

Denise Meade

Director, Product Management, IBM Watson Health
Denise Meade, Director of Product Management at IBM Watson Health, oversees the development of new offerings using real-world evidence for access, value, and commercial needs. In addition, she chairs the Innovation Council on Value-Based Purchasing and manages strategic collaborations... Read More →
avatar for Danielle Abatemarco

Danielle Abatemarco

Senior Innovation Specialist, Celgene
Danielle is a Sr. Pharmacovigilance Innovation Specialist at Celgene, where she has worked for five years. Her research focuses on the application of artificial intelligence in pharmacovigilance. Her background is in Neuroscience and Nursing. She is currently pursuing an Executive... Read More →

Bruno Assuncao

Associate Director Pharmacovigilance Innovation, Celgene

Tuesday June 25, 2019 9:00am - 4:00pm
Posters Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA