Day Two Thursday 22 March 2012

Day One Wednesday 21 March 2012 ›

Day Two Thursday 22 March 2012 ›

last modified: 28 March '12

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8am

Registration & refreshments

9am

Opening Remarks from the Chair

Toshio Kimura

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...

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› Toshio Kimura, Associate Director, Biostatistics, Biometrics and Data Management, Boehringer Ingelheim

CHALLENGES IN OUTCOME TRIALS

9.10am

Transformational changes in conducting CV outcome trials

Weinong Guo

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...

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• Innovative thinkings to streamline and execute large CV outcome trials
• Managing large outcomes studies to reduced cost and accelerate timelines without compromising study quality and integrity

› Weinong Guo, Senior Director, Program Section Leader, CVM Development Franchise, Novartis

9.40am

Phase IIIb/IV studies in female health care

Marie Foegh

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...

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› Marie Foegh, Chief Medical Officer, Vice President, Clinical Research and Development, Agile Therapeutics

EMPOWERING PATIENTS AND ENABLING TECHNOLOGIES

10.10am

High patient compliance and retention through engaging online data capture

Rauha Tulkki-Wilke

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...

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• Higher scientific value of patient reported outcomes via online tools
• Ways to improve patient compliance and retention in long studies

› Rauha Tulkki-Wilke, Director of Product Management, CRF Health

10.40am

Morning Refreshments

11.10am

Generate Patient Reported and Third Party Observational Data for Late Phase Studies

Scott Dixon at Late Phase Drug Development World Americas 2012

• Mechanisms to collect direct patient outcome data
• Types of measurements that can be collected
• Current trends in data collection methods

› Scott Dixon, Global Strategist, Late Phase and Epro, Oracle

11.40am

Best practices in ePROs in late phase studies

Toshio Kimura

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• How patient-centered online research platforms can give a rich understanding of therapeutics postmarket
• Collecting a broad range of data: prevalence, treatment purpose, evaluations of effectiveness, side effects and burden

› Toshio Kimura, Associate Director, Biostatistics, Biometrics and Data Management, Boehringer Ingelheim

OBSERVATIONAL STUDIES AND REAL WORLD SAFETY SURVEILLANCE

12.10pm

Observational research: areas of consensus and divergence

Ronald E. Weishaar

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...

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• The operational concerns and expectations of sponsors
• Challenges to be addressed to optimise observational research

› Ronald E. Weishaar, Vice President, Observational Research, PharmaNet LLC

12.40pm

Lunch

1.10pm

Opening remarks from the chair

Reinerio Deza

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...

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› Reinerio Deza, Head Global Pharmacovigilance, Cubist Pharmaceuticals, Inc.

1.40pm

Post approval Safety Surveillance-Specific Example of Role of Pharmacoepidemiologic Observational study

Syed s Islam

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...

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• Why observational studies will always be needed in RMP
• How do regulatory bodies interpret results from an observational study
• Our example of presenting the interpretation of a safety observational study to advisory committee/FDA

› Syed s Islam, Medical Director, Pharmacoepidemiology Global Safety and Pharmacoepidemiology GMS, Abbott

2.10pm

Challenges and opportunities in Active Surveillance and lessons learnt as a member of the OMOP Extended Consortium

Xiaofeng Zhou

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...

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• Discuss the key concepts of active surveillance and the potential prospects for wide spread use
• Present an overview of OMOP activities and its value for active surveillance activities at a large pharmaceutical company
• Introduce and discuss other initiatives in the field of active surveillance

› Xiaofeng Zhou, Director of Epidemiology, Pfizer

2.40pm

Registries for evaluating patient outcomes – New initiatives by the AHRQ

Elise Berliner at Late Phase Drug Development World Americas 2012

• Supporting research focused on the outcomes, effectiveness, comparative clinical effectiveness and appropriateness of pharmaceuticals
• Evaluating the success of registries to collect data about patient outcomes

› Elise Berliner, Director of Technology Assessment Programme, Center for Outcomes, AHRQ, AHRQ

3.10pm

Afternoon refreshments

3.40pm

Impact of the US FDA Cardiovascular Assessment Requirements on the Development of Novel Anti-diabetes Drugs

Arie Katz at Late Phase Drug Development World Americas 2012

- Providing robust data to estimate CV risk associated with new therapeutic agents
- Requirements to conduct post-approval CV safety outcomes studies on most (if not all) newly approved drugs

› Arie Katz, Senior Director, Clinical Research, CVGI TA Late Phase Development, AstraZeneca

Role of drug and patient registries

4.10pm

Benefits and challenges of rare disease registries in the drug development process

Emma James at Late Phase Drug Development World Americas 2012

- Highlighting some of the challenges faced both in the clinical and post-marketing setting when trying to establish safety, efficacy and effectiveness (and, therefore, overall value) of a new product for a rare disease

› Emma James, Associate Director, Medical Affairs and Global Registries, Synageva

4.40pm

Optimizing Late Phase & Post Approval Studies - Meeting Multiple Stakeholder Needs

Dr Maria Madison

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...

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