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Tuesday, June 28 • 9:00am - 5:00pm
Professional Poster Session 1

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Component Type: Poster Presentation


Heba Abdullah

Global Safety Medical Director, Amgen Inc.

Joshua Ainsley

Data Scientist, Fino Consulting

Hyun-Kyung An

Korea Institute of Drug Safety & Risk Management

Hyun-Kyung An

Korea Institute of Drug Safety & Risk Management

Takashi Ando

Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
avatar for Alexandra Atkins

Alexandra Atkins

Senior Scientific Director, NeuroCog Trials

E. Dennis Bashaw

Director, Division of Clinical Pharmacology III, OTS, CDER, FDA

Jessica Chou

Section Chief, TCDE
avatar for Eunhee Chung

Eunhee Chung

Director, SOUSEIKAI Global Clinical Research Center
I am leading the global team here at SOUSEIKAI.My background is in neuropharmacology, but now I feel privileged witnessing and being part of the process of developing new and innovative treatments against human diseases in all therapeutic areas.It would be great to learn more about... Read More →
avatar for Shaun Comfort

Shaun Comfort

Associate Director and Senior Safety Science Leader IIDO, Genentech, A Member of the Roche Group
Dr. Comfort is Associate Director for Risk Management and Sr. Safety Science Leader for Roche-GNE Late Stage Ophthalmology/Hematology Products. He is a Board Certified Neurologist with 13 years combined industry experience including roles as former Medical Reviewer at the US FDA and... Read More →

Alisha Couto

Post Doc Fellow, Bayer HealthCare, Rutgers, The State University of New Jersey

Mabel Crescioni

Director, ePRO Consortium, Critical Path Institute
avatar for Irene Darras

Irene Darras

Global Regulatory Affairs Fellow, Rutgers, The State University of New Jersey
avatar for Colleen Davenport

Colleen Davenport

Director- Global Regulatory Sciences - Oncology, Bristol-Myers Squibb
Over 17 years of experience in the pharmaceutical industry with more than 14 years in regulatory affairs working across multiple therapeutic areas. Colleen has held Regulatory Affairs positions at Sanofi-Aventis, GlaxoSmithKline, and Accenture and is currently the Executive Director... Read More →

Dominique Demolle

CEO, Tools4patient
avatar for Elena Dubcenco

Elena Dubcenco

Associate Medical Director, Robarts Clinical Trials Inc./ University of Western Ontario
Her wide-ranging experience is underscored by numerous scientific publications, including academic and peer-reviewed journal articles; video, oral, and poster presentations; awards and grants including Cook Medical Don Wilson Award by the American Society for Gastrointestinal Endoscopy... Read More →
avatar for Joseph Fiore

Joseph Fiore

Senior Clinical Scientist, Merck & Co., Inc.
Joe Fiore is Sr. Clinical Scientist at Merck & Co., Inc. in Upper Gwynedd, PA within the Clinical Sciences & Study Management group. He supports oncology clinical trials across phase I-III for the anti-PD1 drug pembrolizumab for patients with non-small cell lung cancer and advanced... Read More →

Beverly Gow

Director of Pharmacovigilance Support Services, PrimeVigilance

Kristin Hanson

Scientific Consultant, UBC: An Express Scripts Company
avatar for Nick Hargaden

Nick Hargaden

President, US Operations, Algorics
US operations lead and co-founder at Algorics, a data analytics software and solutions company in the clinical trials space. Nick has been working in the application of software technology in clinical trials since 1998. He has previously held leadership positions with global responsibilities... Read More →
avatar for Rick Hart

Rick Hart

Director of Global Technology Solutions, BioStorage Technologies
Rick has 25 years experience in global technology solutions. Rick leads the effort in the development of ISIDOR®, a transformational and scalable informatics platform which integrates research and sample data to advance bioscience discoveries._x000D_ _x000D_ Rick received his BS... Read More →
avatar for Michelle Hoiseth

Michelle Hoiseth

Chief Data Officer, Parexel, United States
Michelle has been working in the drug and device development industry for 30 years. She has enjoyed a variety of positions that allowed her to create product development plans, run study operations, and support product commercialization objectives. Michelle presently serves Parexel... Read More →
avatar for Kristen Hollingsworth

Kristen Hollingsworth

Global Business Leader, Diagnostics-Oncology, Johnson & Johnson
Seasoned pharmaceutical and diagnostics executive with experience leading cross-functional teams focused on drug development, clinical operations, business development and commercialization. Known for combining strong general management expertise, effective strategic thinking skills... Read More →
avatar for Elisa Holzbaur

Elisa Holzbaur

Manager, ePRO Services, Almac Group
Elisa Holzbaur is Manager, ePRO Services for Almac Clinical Technologies. In this role, she is responsible for creating and maintaining operational procedures to support the delivery of Almac’s ePRO solutions. Working with functional teams across the organization, Elisa provides... Read More →

Rebecca Hummel

Quality Manager, CNS Healthcare

Gaeun Kang

Fellow, Division of Clinical Pharmacology, Chonnam National University Hospital
avatar for Wasif Khan

Wasif Khan

Scientist, icddr,b
I was trained from Johns Hopkins Bloomberg School of Public Health with 26 years of experience in Clinical Trials. My vision is to build the bridge between global CROs and the Key opinion leaders (KOI) so that Bangladesh becomes a potential game changer for international clinical... Read More →

Laura Khurana

Scientific Advisor, ERT

Camilla Lau

Sr. Clinical Trial Manager, Gilead Sciences
avatar for Lawrence Liberti

Lawrence Liberti

Head, Regulatory Collaborations, Centre for Innovation in Regulatory Science (CIRS)
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been... Read More →
avatar for Xiu Wei Lim

Xiu Wei Lim

Regional Clinical Innovation and Operational Excellence Head, Quintiles
Xiu Wei is the Head of Innovation in Quintiles APAC. She leads the idealization, development & execution of mobile initiatives focusing on leveraging mobile technology to increase productivity & quality in Clinical Operations across APAC. Her team also collaborates with Quintiles... Read More →

Richard Macaulay

Senior Director, Parexel Access
Richard Macaulay, PhD, is a senior director with Parexel® Access in London. Richard has specialized for ten years in regulatory and market access strategy, in particular helping obtain regulatory and payer approval for treatments lacking Phase III trial data, with particular expertise... Read More →

Ramya Mathew

Post-Doctoral Fellow, Medical Affairs, Rutgers, The State University of New Jersey

Dan McDonald

Director, Business Development, Imperial

Eric Morrie

Director, Product Operations, ClinCapture

Masahide Nakajima

Manager, Pharmacovigilance Cordination & Administration Department. Ikuyaku., Mitsubishi Tanabe Pharma Corporation
avatar for Samarth Parikh

Samarth Parikh

Postdoctoral Fellow, Janssen Pharmaceutical Companies of Johnson & Johnson
Samarth Parikh is the Post-Doctoral Fellow at Janssen Pharmaceutical Companies of Johnson & Johnson in Global Medical Safety. He is responsible for project managing and preparing safety surveillance reports/responses to internal and external safety queries. In addition, he is also... Read More →
avatar for Matthew Pazdernik

Matthew Pazdernik

Director, Regulatory Submission Planning and Portfolio Management, Merck & Co., Inc.
Matt Pazdernik is the Submission Planning & Portfolio Management Lead for Merck Regulatory Affairs, responsible for the global enterprise system to manage Regulatory Submission Plans, an enterprise-level Portfolio Planning & Project Management capability integrating the process and... Read More →
avatar for Jennifer Ross

Jennifer Ross

Lead Biostatistician, Almac Clinical Technologies
Jennifer Ross is Lead Biostatistician at Almac, where she provides statistical consultancy on randomization methodology, IXRS® implementation and ePRO implementation. She is a member of C-Path’s ePRO Consortium where she is co-Chair of the Publications and Presentations Subcommittee... Read More →

Mikhail Samsonov

Chief Medical Officer, R-Pharm
avatar for Earl Seltzer

Earl Seltzer

Associate Therapeutic Strategy Director, Therapeutic Science and Strategy, Quintiles
I have 10 years of industry experience, starting as a clinical research coordinator and moving to site management and business development oversight for a large mutlispecialty research site in Raleigh, NC that focused on adult and pediatric phase Ib-IV clinical trials. For the past... Read More →
avatar for Earl Seltzer

Earl Seltzer

Associate Therapeutic Strategy Director, Therapeutic Science and Strategy, Quintiles
I have 10 years of industry experience, starting as a clinical research coordinator and moving to site management and business development oversight for a large mutlispecialty research site in Raleigh, NC that focused on adult and pediatric phase Ib-IV clinical trials. For the past... Read More →
avatar for Jui Shah

Jui Shah

Health Scientist Administrator, NIAID, Clinical Research Resources Branch, National Institutes of Health (NIH)
Dr. Shah is a Regulatory Affairs professional with over 18 years of experience ranging from basic research through product development. Dr. Shah's experience as the Regulatory lead is varied and includes clinical trials for drugs and biologics in various therapeutic areas from diabetes... Read More →

Carrie Shults

Development Group Leader, Research Scientist, Lyophilization Technology, Inc.

Tai Wai Shun

Medical Reviewer, TCDE

Fenan Solomon

Regulatory Affairs, Rutgers University
avatar for Stella Stergiopoulos

Stella Stergiopoulos

Research Fellow, Tufts Center for the Study of Drug Development
Ms. Stella Stergiopoulos leads multi-sponsored research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmacovigilance, non-clinical drug development, pharmaceutical outsourcing practices, cycle time metrics... Read More →
avatar for Michelle Thompson

Michelle Thompson

Vice President, FDA Quality and Regulatory Consultants, LLC (FDAQRC)
Mrs. (Holbrook) Thompson has been working in quality assurance for over 15 years and joined FDA Quality and Regulatory Consulting (FDAQRC) in 2015. She completed her Bachelors of Science at North Carolina State University. Mrs. Thompson has been a Registered Quality Assurance Professional... Read More →

Lucie Vu

Postdoctoral Fellow, MCPHS University
avatar for Chris Watson

Chris Watson

Director of Product Strategy - Digital Patient, ERT
Chris has a PhD in Behavioural Neuropharmacology and is an experienced product strategist with over 19 years’ experience in the delivery of innovative business and consumer solutions. Chris’ career started in the financial services and for the last 10 years, Chris has been translating... Read More →

Diane Webb

President, BizInt Solutions, Inc.

Kun Yang

Post-Doctoral Fellow, Biogen, MCPHS University

Joshua Zhang

Senior Medical Director, Celldex

Rafal Ziecina

Medical Director, Quintiles

Tuesday June 28, 2016 9:00am - 5:00pm EDT
TBD Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA