Late Phase Drug Development World Americas 2012 - list of speakers 

 
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Kathleen (Kushner) Mandziuk speaking at Late Phase Drug Development World Americas 2012
Kathleen (Kushner) Mandziuk
Senior Scientific Affairs Director
PRA Late Phase Services

Ms. Kushner’s professional research career has almost exclusively been in the area of late phase development. Following her nursing training, she joined the pharmaceutical industry as a Clinical Data Coordinator and enjoyed a variety of management positions in the late phase group of another large CRO. In these roles, she managed the data aspects...

10.10am Day One Wednesday 21 March 2012
Vipin Arora speaking at Late Phase Drug Development World Americas 2012
Vipin Arora
Director, Statistics
Abbott

Vipin Arora has over 17 years of Pharmaceutical Industry experience as lead Statistician, Manager, Group Head and Director in Analytical Sciences. Vipin has experience in developing strategies, in-licensing and out-licensing, pre-submission and follow up activities with Regulatory Agencies in North America, EU, Japan and other regions, approval...

9.40am Day One Wednesday 21 March 2012
Jay Bae speaking at Late Phase Drug Development World Americas 2012
Jay Bae
Global Health Outcomes
Eli Lilly

Elise Berliner speaking at Late Phase Drug Development World Americas 2012
Elise Berliner
Director of Technology Assessment Programme, Center for Outcomes, AHRQ
AHRQ

Patrick Chassaigne speaking at Late Phase Drug Development World Americas 2012
Patrick Chassaigne
Director, Late Phase Solutions
Medidata Solutions Worldwide

As Director of Late Phase Solutions, Patrick assists global pharmaceutical, biotechnology and medical device companies utilize electronic data capture technology to address the challenges of post-approval studies. Prior to joining Medidata, Patrick founded Chassaigne & Associates, a management consulting company with a focus on increasing...

1.40pm Day One Wednesday 21 March 2012
Mark J Cziraky speaking at Late Phase Drug Development World Americas 2012
Mark J Cziraky
Vice President, Industry Sponsored Research
HealthCore

Reinerio Deza speaking at Late Phase Drug Development World Americas 2012
Reinerio Deza
Head Global Pharmacovigilance
Cubist Pharmaceuticals, Inc.

Dr. Reinerio A. Deza, currently Head of Pharmacovigilance at Cubist Pharmaceuticals, has over 20 years of experience in the pharmaceutical industry, primarily in Pharmacovigilance (PV) but has also included Medical Affairs. Most recently, Rene was at Merck (Schering-Plough) as the Sr. Director of Medical Services and the Clinical Risk Management...

1.10pm Day Two Thursday 22 March 2012
Scott Dixon speaking at Late Phase Drug Development World Americas 2012
Scott Dixon
Global Strategist, Late Phase and Epro
Oracle

11.10am Day Two Thursday 22 March 2012
Alex Dusek speaking at Late Phase Drug Development World Americas 2012
Alex Dusek
Global Brand Strategy Leader
Bayer

12.10pm Day One Wednesday 21 March 2012
Marie Foegh speaking at Late Phase Drug Development World Americas 2012
Marie Foegh
Chief Medical Officer, Vice President, Clinical Research and Development
Agile Therapeutics

Dr. Foegh brings to Agile's executive management team more than 20 years of experience in the pharmaceutical and biotechnology industries. She was most recently Vice President of Medical Affairs, Strategy & Development for Female Health Care at Berlex, Inc., where she was responsible for the successful development and regulatory approval of...

9.40am Day Two Thursday 22 March 2012
Weinong Guo speaking at Late Phase Drug Development World Americas 2012
Weinong Guo
Senior Director, Program Section Leader, CVM Development Franchise
Novartis

Dr. Weinong Guo is currently Senior Director & Program Section Leader, Cardiovascular Clinical Science Unit within the CVM Development Franchise at Novartis based in East Hanover, NJ where he is involved in designing and executing later clinical drug development programs targeting atherosclerosis, thrombosis and heart failure, etc. Dr. Guo is a...

9.10am Day Two Thursday 22 March 2012
Maria Harrison speaking at Late Phase Drug Development World Americas 2012
Maria Harrison
Vice President of Late Phase Services
PRA Late Phase Services

Syed s Islam speaking at Late Phase Drug Development World Americas 2012
Syed s Islam
Medical Director, Pharmacoepidemiology Global Safety and Pharmacoepidemiology GMS
Abbott

2010- to date- Medical Director, Global Surveillance and Pharmacoepidemiology, Abbott Laboratories 2009-2010- Director, Epidemiology, Global Safety Surveillance and Epidemiology, Pfizer 2005-to 2009-Director, Epidemiology, Global Safety Surveillance and Epidemiology, Wyeth Pharmaceuticals 2000-2005- Associate Professor and Research...

1.40pm Day Two Thursday 22 March 2012
Shrividya Iyer speaking at Late Phase Drug Development World Americas 2012
Shrividya Iyer
Director, Global Outcomes Research
Pfizer

Emma James speaking at Late Phase Drug Development World Americas 2012
Emma James
Associate Director, Medical Affairs and Global Registries
Synageva

Arie Katz speaking at Late Phase Drug Development World Americas 2012
Arie Katz
Senior Director, Clinical Research, CVGI TA Late Phase Development
AstraZeneca

Toshio Kimura speaking at Late Phase Drug Development World Americas 2012
Toshio Kimura
Associate Director, Biostatistics, Biometrics and Data Management
Boehringer Ingelheim

Toshio Kimura is an Associate Director in Biostatistics at Boehringer Ingelheim Pharmaceuticals. He has worked extensively with PROs and ePROs in particular and has interacted with FDA divisions including the Study Endpoint and Label Development (SEALD). In his most recent NDA submission, ePRO was used to collect the primary endpoint. As part...

9am Day Two Thursday 22 March 2012
11.40am Day Two Thursday 22 March 2012
Russel Knoth speaking at Late Phase Drug Development World Americas 2012
Russel Knoth
Director, US Health Economics & Outcomes Research
Eisai, Inc

Dr Maria Madison speaking at Late Phase Drug Development World Americas 2012
Dr Maria Madison
Director, Global Outcome Surveys
Shire

Dr. Maria Madison has been working in health research since 1983, when she began investigating tropical diseases and health care in rural Zaire. Since then she has worked in industry, government and CROs on a variety of therapeutic areas globally, including infectious, chronic and rare diseases. In 1997 she received her doctorate in Population...

4.40pm Day Two Thursday 22 March 2012
Todd Michael speaking at Late Phase Drug Development World Americas 2012
Todd Michael
Senior Director, Evidence Translation
Sanofi

Coleman Obasaju speaking at Late Phase Drug Development World Americas 2012
Coleman Obasaju
Senior Medical Director, Oncology
Eli Lilly

Coleman K. Obasaju, M.D., Ph.D., senior medical director of Lilly Oncology is responsible for the strategic direction of oncology within the U.S. as well as the global division of oncology. Dr. Obasaju received his medical degree at the University College Hospital, Ibadan, Nigeria and pursued post-graduate training in clinical pharmacology and...

4.10pm Day One Wednesday 21 March 2012
Lynn J Okamoto speaking at Late Phase Drug Development World Americas 2012
Lynn J Okamoto
SVP & Sr Research Scientist, Health Economics
United BioSource Corporation

Lynn J. Okamoto, Pharm.D. is Senior Vice President of Health Economics and a Senior Research Scientist at United BioSource Corporation (UBC) in Lexington, MA. Dr. Okamoto leads the health economic and policy efforts in the US and interfaces with UBC’s European operations on global issues. She has extensive experience in global management, as well...

2.10pm Day One Wednesday 21 March 2012
Jean Siebenaler speaking at Late Phase Drug Development World Americas 2012
Jean Siebenaler
Medical Director
OptumInsight Life Sciences

4.40pm Day One Wednesday 21 March 2012
Rauha Tulkki-Wilke speaking at Late Phase Drug Development World Americas 2012
Rauha Tulkki-Wilke
Director of Product Management
CRF Health

Rauha Tulkki-Wilke works at CRF Health, a company providing ePRO solutions to clinical trials, where she manages the development of new ePRO solutions for the pharmaceutical industry. Rauha has been with CRF Health since it was founded and has more than 10 years of experience with ePRO: developing new, patient-friendly ePRO solutions and...

10.10am Day Two Thursday 22 March 2012
Ronald E. Weishaar speaking at Late Phase Drug Development World Americas 2012
Ronald E. Weishaar
Vice President, Observational Research
PharmaNet LLC

As Vice President – Observational Research in PharmaNet’s Phase IV Development group, Ron has global responsibility for the design and implementation of non-interventional studies and patient registries. Having been involved with all aspects of drug discovery and development for over thirty years, Ron has focused during the past decade on...

12.10pm Day Two Thursday 22 March 2012
Xiaofeng Zhou speaking at Late Phase Drug Development World Americas 2012
Xiaofeng Zhou
Director of Epidemiology
Pfizer

Dr. Xiaofeng Zhou is a director in World Safety Strategy’s Epidemiology group at Pfizer Inc. She has 16 years of working experience with Pfizer in a wide variety of roles including the clinical development operation, post marketing drug safety and pharmacovigilance, clinical safety and risk management, and epidemiology. She has published and...

2.10pm Day Two Thursday 22 March 2012
 
 
 

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Sponsors
Session Facilitators
PRA International at Late Phase Drug Development World Americas 2012
Session presentation sponsor
Medidata Solutions Inc at Late Phase Drug Development World Americas 2012
Session presentation sponsor
OptumInsight at Late Phase Drug Development World Americas 2012
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Oracle Corporation UK Limited at Late Phase Drug Development World Americas 2012
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CRF Health at Late Phase Drug Development World Americas 2012
Session presentation sponsor
PharmaNet/i3 at Late Phase Drug Development World Americas 2012
Session presentation sponsor
United BioSource Corporation at Late Phase Drug Development World Americas 2012