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

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Component Type: Poster Presentation




Speakers
HA

Heba Abdullah

Global Safety Medical Director, Amgen Inc.
JA

Joshua Ainsley

Data Scientist, Fino Consulting
HA

Hyun-Kyung An

Korea Institute of Drug Safety & Risk Management
TA

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
ED

E. Dennis Bashaw

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

Jessica Chou

Section Chief, TCDE
EC

Eunhee Chung

Director, Global Clinical Development, SOUSEIKAI Global Clinical Research Center
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 VP of Clinical Research at Anesiva. Most recently, he has been involved in evaluating Artificial Intelligence solutions in Pharmacovigilance.
AC

Alisha Couto

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

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 of Regulatory Affairs and Pharmacovigilance at AnGes, Inc. a small biotechnology company focused on a Phase 3 gene therapy product for Critical Limb Ischemia. Colleen... Read More →
DD

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 and NOSCAR® Olympus Medical Systems Research Award by the American Society for Gastrointestinal Endoscopy (ASGE) and Society of American Gastrointestinal... 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 melanoma. Joe earned his PharmD from the University of Pittsburgh and is a registered pharmacist in the state of New Jersey. He completed his fellowship training at... Read More →
BG

Beverly Gow

Director of Pharmacovigilance Support Services, PrimeVigilance
KH

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 in operations, business development, and quality management functions._x000D_ | _x000D_ | Nick holds a Ph.D. in Cognitive Science from the University of... 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 degree from Purdue University. He has dedicated his career to the development of software solutions for various industries including manufacturing, life science... Read More →
MH

Michelle Hoiseth

Vice President, PAREXEL Access, PAREXEL
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 and thorough market assessment capabilities to produce highly differentiated products with strong customer appeal.
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 expert counsel on the most efficient electronic patient reported outcome trial designs and works to improve Almac’s ePRO service offering.
RH

Rebecca Hummel

Quality Manager, CNS Healthcare
GK

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 trials and global CROs to explore in this newly emerged clinical research country.
LK

Laura Khurana

Scientific Advisor, ERT
CL

Camilla Lau

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

Lawrence Liberti

Executive Director, Centre For Innovation In Regulatory Science (CIRS)
For the past 36 years, Mr Liberti has worked in the fields of regulatory affairs and clinical R&D. Since 2009 he has served as the Executive Director of CIRS (formerly the CMR International Institute for Regulatory Science), an independent, division of Thomson Reuters. He is pursuing his Doctorate through the WHO Collaborating Centre for Pharmaceutical Policy and Regulation at Utrecht University, researching expedited regulatory pathways with... 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 mobile COE to ensure quality delivery. Her breath of knowledge across Clinical Operations in her past experience as a CRA allows her to identify key focus areas across... Read More →
RM

Richard Macaulay

Senior Consultant, PAREXEL Access Consulting
RM

Ramya Mathew

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

Dan McDonald

Director, Business Development, Imperial
EM

Eric Morrie

Director, Product Operations, ClinCapture
MN

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 a preceptor for PharmD rotation students. He earned his PharmD from the Philadelphia College of Pharmacy and is a registered pharmacist in the State of Pennsylvania and... 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 tools for Submissions Planning and Portfolio Management, delivery of an authoritative source for submission milestone tracking and management to align and drive... 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. Jennifer has a Master of Science in Statistics and a Master of Philosophy in Education in Psychometrics from University of Pennsylvania, where she has taught... Read More →
MS

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 2 years, I have worked at Quintiles in the global feasibility department with a focus on pediatrics, cardiovascular medicine, and general medicine in close... Read More →
JS

Jui Shah

Health Scientist Administrator, NIAID, Clinical Research Resources Branch, National Institutes of Health (NIH)
CS

Carrie Shults

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

Tai Wai Shun

Medical Reviewer, TCDE
FS

Fenan Solomon

Regulatory Affairs, Rutgers University
avatar for Stella Stergiopoulos

Stella Stergiopoulos

Senior Project Manager, Tufts Center for the Study of Drug Development
Ms. Stella Stergiopoulos manages multi-sponsored and grant funded 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, resource management, and protocol design. She has also been a speaker at conferences and has published articles in peer-reviewed and trade... Read More →
avatar for Michelle Thompson

Michelle Thompson

Vice President, FDA Quality and Regulatory Consultants, LLC
Mrs. (Holbrook) Thompson is a well respected business leader and Quality Assurance (QA) professional. She has been working in QA for over ten years and joined FDA Quality and Regulatory Consulting (FDAQRC) in 2015. She has been a Registered Quality Assurance Professional in good clinical practices (RQAP-GCP) since 2007 and an active member in the Society of Quality Assurance (SQA) and the North Carolina SQA chapter. She has two dogs and is an... Read More →
LV

Lucie Vu

Postdoctoral Fellow, MCPHS University
avatar for Chris Watson

Chris Watson

Director of Product Strategy, Exco InTouch
Chris has a PhD in Behavioural Neuropharmacology and is an experienced product strategist with over 17 years’ experience in the delivery of innovative business and consumer solutions. Chris’ career started in the financial services and for the last 8 years, Chris have been translating his commercial experience into the clinical technology industry. With an extensive knowledge of product and software development processes he is responsible for... Read More →
DW

Diane Webb

President, BizInt Solutions, Inc.
KY

Kun Yang

Post-Doctoral Fellow, Biogen, MCPHS University
JZ

Joshua Zhang

Senior Medical Director, Celldex
RZ

Rafal Ziecina

Medical Director, Quintiles


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