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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 her PharmD degree at The University of North Carolina-Chapel Hill in 2003.
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
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 and in cloud environments, in Europe and in US. Romuald is holding the degree of Master of Drug Regulatory Affairs in addition to diploma in Data Technology.
avatar for David Bristol

David Bristol

President, Statistical Consulting Services, Inc.
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 background includes knowledge and understanding of FDA, EU and Global drug and medical device regulations. She is continually developing her technical expertise by... 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 research experience in clinical trials design and measurement error. Dr. Dong has won several FDA awards and is the author of more than 20 scientific journal articles.
avatar for Dinah Duarte

Dinah Duarte

Head, Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
Head of Scientific Evaluation Unit at INFARMED, I.P. Portuguese regulatory authority for medicines; Committee for Orphan Medicinal Products member at European Medicines Agency; Associate Professor (Lisbon University); member of European Network of Centres for Pharmacoepidemiology & Pharmacovigilance; former Committee for Medicinal Products for Human Use member. MSc in Regulatory Affairs & Evaluation of Medicines and Specialist in Regulatory... 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 she had specialized in Chinese Studies. She has more than 10 years of experience in the pharmaceutical and CRO industry for roles in Communications and Patient... 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 programmes, to develop the most effective country and site strategies. Bhavish has experience in a wide variety of areas and include project management investigating... Read More →
JM

Julie Massicotte

Director, Clinical Pharmacology and Regulatory Affairs, Algorithme Pharma
SM

Steve Mayall

Principal Consultant, Pope Woodhead & Associates Ltd
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

Head of US PV and Clinical safety Operations, APCER Life Sciences
Sanjeev is an MD in Internal Medicine and has more than 14 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 pharmacovigilance, medical writing, medical affairs, clinical research and operations, and project management. Sanjeev was also Senior Resident in the Cardiology and... 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. The book “Medical Imaging in Clinical Trials” published by Springer in 2014 was the third one he had co-authored. He has over 70 publications in the medical... 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 a deep interest in eCOA and direct to patient technologies and analytics. After developing and managing VIASYS´ eCOA products for 5 years, he now is Head of... Read More →
avatar for Saumya Nayak

Saumya Nayak

Manager, Patient and Site Services, SPN, Asia Pacific, Quintiles
Saumya Nayak is Manager with Quintiles Site and Patient Networks and also the capability lead of the Site and Patient Network Operations and Project Delivery function in Asia-Pacific. Saumya holds a masters degree in Biotechnology. She has more than 10 years of experience in the CRO industry. In her current role as operations lead, she manages end-to-end execution of patient recruitment and retention strategies/programs. In addition, she... Read More →
NP

Nihar Parikh

Healthcare Consultant, CitiusTech Inc.
avatar for Mark Perrott

Mark Perrott

Head of Development Consulting, Pope Woodhead and Associates Ltd.
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 site relationships and partnerships through the team of Prime Site Managers and working closely with Quintiles preferred sites. Prior to joining Quintiles... 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 programs. Dr. Sashidharan is currently is responsible for Medical Affairs activities for the Asia Pacific region at Pharm-Olam International.
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 performance measures, and ClinROs, across a range of CNS therapeutic areas. Dr. Saxby obtained his PhD at Newcastle University and has published 30+ papers... 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. She has contributed clinical content to 4 successful NDA and sNDA submissions and functions as the project manager for publication planning.
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® software testing analyst where he ensured the integrity for efficient implementation of software amendments. Kevin has a Bachelor of Science in Mathematics from... 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. Natalia has been leading IPHARMA since 2012.
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 of Medicines.
avatar for Robin Whitsell

Robin Whitsell

President, Whitsell Innovations, Inc.
Robin Whitsell is the president and founder of Whitsell Innovations, Inc.(WI). WI is a full-service medical and scientific writing firm established in 2006 and headquartered in Chapel Hill, NC, focusing on the needs of pharmaceutical, device, and biotech clients. Prior to founding WI, she was the assistant director of preclinical and clinical programs at a start-up pharmaceutical company and led one program from pre-IND through NDA. She has 18... 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 Development department at Schering-Plough. In 2011, I joined Regulatory Dossier Development group at J&J.



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