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Wednesday, June 29 • 9:00am - 4:00pm
Professional Poster Session 2.

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Component Type: Poster Presentation




Speakers
avatar for Laurie Anderson

Laurie Anderson

Safety Evaluation and Risk Management Scientist, GlaxoSmithKline
Manager-Safety Evaluation and Risk Management | Laurie joined GlaxoSmithKline in 2009 as a Medical Information Scientist. Prior to GSK Laurie worked as a clinical pharmacist at The University of California-San Francisco Medical Center and Duke University Medical Center. She earned... Read More →
JA

Julie Appel

Clinical Data Surveillance Specialist, Novo Nordisk A/S
MB

Marielle Bassel

Research Scientist II, UBC: An Express Scripts Company
AB

Amanda Bowles

Specialist Leader, Deloitte Consulting LLP
Amanda has over 14 years of life sciences experience including over 11 years specializing as a pharmacovigilance and drug safety subject matter advisor. Her experience spans drug safety and regulatory affairs, including extensive experience in PV operations strategy consulting, global... Read More →
avatar for Romuald Braun

Romuald Braun

Managing Director, uanotau gmbh
Since 1992 Romuald has been working in roles related to Compliance, Document Management, Content Management in Life Sciences industry. He played roles on client side and in consulting, in delivery and in sales, in project roles and in line responsibility. He worked in client server... Read More →
avatar for David Bristol

David Bristol

President, Statistical Consulting Services, Inc.
David Bristol has been a statistical consultant for more than 10 years, currently as Statistical Consulting Services. Prior to consulting, he was a statistician in the pharmaceutical industry for more than twenty years in several therapeutic areas at six different companies. He has... Read More →
avatar for Jennifer Chapman

Jennifer Chapman

Associate Director, REMS Training and Technology, Celgene Corporation
PD

Pina D'Angelo

Senior Director, Scientific Affairs, Novum Pharmaceutical Research Services
avatar for Rashmi Dodia

Rashmi Dodia

Regulatory Operations Specialist II, MMS Holdings, Inc.
Rashmi is a Regulatory Operations Specialist at MMS Holdings Inc., a CRO based in Michigan. She holds a Masters in Regulatory Science from the Johns Hopkins University, Baltimore and a BSc (Hons) in Biomedical Science from the University of Central Lancashire, UK. Her strong regulatory... Read More →
CD

Cassie Dong

Mathematical Statistician, Division of Biometrics VI, OTS, CDER, FDA
Cassie is a Statistics Reviewer in CMC Review Team at office of Biostatistics, FDA and holds a Masters in Chemistry and PhD in Statistics. She joined FDA in 2012. Her primary review work concentrates on the analytical similarity assessment and product quality control. She also has... Read More →
avatar for Dinah Duarte

Dinah Duarte

Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →
CE

Celeste Elash

Scientist, Consulting, ERT
ME

Manon Exposito

Pharmacist Project Manager, Universal Medica
DF

Daphne Farrington

Clinical Research Scientist, Eli Lilly and Company
BF

Bella Feng

Statistical Programming Manager, Amgen Inc
avatar for Joseph Fulginiti

Joseph Fulginiti

Post-Doctoral Fellow, Clinical Development and Medical Affairs, Rutgers, The State University of New Jersey
avatar for Qing Gu

Qing Gu

Sr. Study and Publication Manager, Medical Strategy and Operations Team, Pfizer Investment Co., Ltd
YI

Yumi Inoue

Manager, SOUSEIKAI Global Clinical Research Center
MI

Masanori Ito

Senior Biostatistics Manager, Astellas Pharma Global Development, Inc.
LK

Laura Khurana

Scientific Advisor, ERT
avatar for Jessie Lee

Jessie Lee

Associate Director, Site and Patient Networks, Quintiles
Jessie Lee is Associate Director with Quintiles’ Site & Patient Networks and also the capability lead of the Patient Engagement and Recruitment Strategies function in Asia-Pacific. Jessie graduated from the National University of Singapore with a Master’s degree in Arts where... Read More →
avatar for Bhavish Lekh

Bhavish Lekh

Associate Global Feasibility Lead, Quintiles
Bhavish Lekh is continually developing his expertise and over the past 8 years has been building on academic and industry knowledge within biochemistry, health Care and clinical research. In his current role he provides expert feasibility guidance to clinical research studies and... Read More →
JM

Julie Massicotte

Director, Clinical Pharmacology and Regulatory Affairs, Algorithme Pharma
avatar for Steve Mayall

Steve Mayall

Principal Consultant, Pope Woodhead & Associates Ltd
Steve Mayall is a Principal Consultant in Pope Woodhead’s Development Consulting Practice. He has advised a wide variety of global pharmaceutical and biotech companies on benefit-risk management during the past 15 years. Key areas have included developing risk management plans... Read More →
MM

Maureen McGee

Senior Scientist, Merck & Co., Inc.
LM

Lubna Merchant

Associate Director, Div of Medication Error Prevention and Analysis, OSE, CDER, FDA
avatar for Sanjeev Miglani

Sanjeev Miglani

Vice President-PV and Clinical Safety North America and Global Medical Affairs, APCER Life Sciences
Sanjeev is an MD in Internal Medicine and has more than 16 years’ experience in the field of Medicine, Pharmacovigilance and Clinical Research. He has held executive leadership positions in pharmaceutical companies and business process outsourcing firms with responsibilities for... Read More →
avatar for Colin Miller

Colin Miller

CEO, BrackenData
Colin was employed at Syntex and Procter & Gamble before moving to the USA in 1994 and starting Bona Fide Ltd which was sold to BioClinica in 1999. Colin joined BioClinica as Vice President and later Senior Vice President and helped grow the company from 35 to more than 1200 employees... Read More →
avatar for Willie Muehlhausen

Willie Muehlhausen

Head of Innovation, ICON
Willie Muehlhausen started his career as a Veterinary Surgeon in Berlin, Germany, before he joined PAREXEL in 1998. After two tenures in the UK and US, having moved to PAREXEL´s eClinical group, Willie joined invivodata to head up their BD team in Europe. During this time he acquired... Read More →
avatar for Saumya Nayak

Saumya Nayak

Associate Director, Patient Recruitment Programs, Asia Pacific, QuintilesIMS
Saumya has 10 yrs. of clinical research experience including tenures at QuintilesIMS & Parexel. In her current role, she is leading the operations team responsible for optimal delivery of recruitment campaigns. She has hands-on experience developing best-in-class recruitment strategy... Read More →
NP

Nihar Parikh

Healthcare Consultant, CitiusTech Inc.
avatar for Mark Perrott

Mark Perrott

Head of Development Consulting, Pope Woodhead
Mark is Head of Development Consulting at PopeWoodhead where he leads a team of Benefit-Risk and Risk Minimisation professionals. He joined PW in November 2016 and his 20 year pharma career has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI and Foresight... Read More →
avatar for Srinivas Pai Raikar

Srinivas Pai Raikar

Director, Quintiles East Asia Pte Ltd
Srinivas Guiri Pai Raikar is the Director of Site and Patient Networks at Quintiles based out of Singapore. He has 24 years of combined global biopharmaceutical and Clinical Research experience. He is currently heading the Prime Site Program, leading the initiatives focused on building... Read More →
avatar for Nithin Sashidharan

Nithin Sashidharan

Senior Medical Advisor, Pharm-Olam International
Dr. Nithin Sashidharan is a Pharmaceutical Physician with more than 9 years of clinical and industry experience. Dr. Sashidharan previously worked as Senior Medical Advisor for Immunology and Nephrology at Biocon where he closely worked with innovator biologics and biosimilar development... Read More →
avatar for Brian Saxby

Brian Saxby

Vice President, Business Development, Neurocog Trials Inc.
Dr. Saxby leads the strategic development of new products and services, drawing on a strong scientific background in clinical trials and computerized cognitive testing. NeuroCog Trials provides rater training, in-study data quality services and surveillance for all cognitive and functional... Read More →
TS

Tulin Shekar

Associate Principle Statistician, Merck & Co., Inc.
CS

Claire Sheridan

Manager, Clinical Operations, Iroko Pharmaceuticals, LLC
Claire Sheridan, PhD is a Manager of Clinical Operations at Iroko Pharmaceuticals, LLC (a global specialty pharmaceutical company dedicated to advancing the science of analgesia). Claire has led several Phase 1 through Phase 3 clinical trials, including PK/PD and pediatric trials... Read More →
avatar for Oliver Steck

Oliver Steck

Principal, Navitas Inc.
He has been a business consultant for more than 14 years. Since joining WCI, he has helped global pharmaceutical clients to optimize their processes in regards of content management, different compliance related issues, risk management and Pharmacovigilance.
PT

Pelin Tanyeri

Associate Professor, Department of Medical Pharmacology, Sakarya University
RT

Ron Taylor

Director, Clinical Trial Management, Seattle Genetics, Inc.
ST

Suneela Thatte

Vice President, Global Operations, Quintiles Research Pvt Ltd
avatar for Kevin Venner

Kevin Venner

Biostatistician II, Almac Clinical Technologies
Kevin Venner is a member of the Almac Clinical Technologies Biostatistics Group, where he provides statistical consultancy on randomization methodology, IXRS® implementation, and randomization simulation services for clinical trials. Prior to his Biostatistics role, he was an IXRS... Read More →
NV

Natalia Vostokova

Chief Operating Officer, IPHARMA LLC
Natalia Vostokova is a Chief Operating Officer of IPHARMA LLC (CRO in Russia and EEU). She obtained her PharmD degree from Moscow Medical Academy n.a. Sechenov in 2004. She has been in clinical research for more than 10 years including clinical operations, commercial, and management... Read More →
SW

Stuart Walker

Founder, Centre For Innovation In Regulatory Science (CIRS)
During his research career, Professor Walker has supervised over twenty-five PhD programmes, co-authored 250 research papers and co-edited twenty-four books in the fields of toxicology, drug discovery, clinical development, Regulatory policies & more recently in the Benefit/Risk Assessment... Read More →
avatar for Robin Whitsell

Robin Whitsell

President, Whitsell Innovations, Inc
Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, she has 20 years’ experience, specializing in medical writing and regulatory submission strategies. Prior to founding WI, Ms. Whitsell was the assistant director of preclinical... Read More →
GZ

Gregory Zak

Director, Product Innovation, ICON
avatar for Eli Zavialov

Eli Zavialov

Associate Director, Regulatory CMC Dossier Development and Operations, Johnson & Johnson
Graduated Moscow State University with a B.S. degree in Chemistry in 1994, and University of Southern California with a Ph.D. degree in Organic and Biochemistry in 1998. Started my professional career at Merck Technical Operations where I spent 2 years before moving on to join Chemical... Read More →



Wednesday June 29, 2016 9:00am - 4:00pm
TBD Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA