Day One Wednesday 21 March 2012

Day One Wednesday 21 March 2012 ›

Day Two Thursday 22 March 2012 ›

last modified: 28 March '12

Please enable javascript to see more information on speakers

8am

Registration & coffee

9am

Opening remarks

Maria Harrison at Late Phase Drug Development World Americas 2012

› Maria Harrison, Vice President of Late Phase Services, PRA Late Phase Services

STRATEGIC CHALLENGES IN LATE PHASE DRUG DEVELOPMENT

9.10am

Demonstration of Differential Medical Value and Real-World Evidence

Todd Michael at Late Phase Drug Development World Americas 2012

› Todd Michael, Senior Director, Evidence Translation, Sanofi

9.40am

Phase IV Clinical Studies – How flexible can these be?

Vipin Arora

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...

more..

› Vipin Arora, Director, Statistics, Abbott

10.10am

Regulatory-mandated post-marketing studies

Kathleen (Kushner) Mandziuk

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...

more..

• History and current trends in post-marketing requirements from regulatory agencies
• Common challenges to the planning and execution of postmarketing research
• Stakeholder involvement and value of post-approval study participation
• Utilizing data to drive the management of post-marketing research

› Kathleen (Kushner) Mandziuk, Senior Scientific Affairs Director, PRA Late Phase Services

10.40am

Speed networking followed by morning refreshments

Fun, high speed breaks in the conference day for making new contacts and exchanging details. Bring plenty of business cards!

CONDUCTING POST-APPROVAL STUDIES

11.40am

Case Study: Thyroid cancer development program – case study from vandetanib (Zactima)

• Development in a rare cancer, predictive biomarkers, risk/ benefit assessment
• Interactions with FDA/EMA

12.10pm

Case study: Peri-approval strategy trials during evolving combination therapy standards of care: Learnings from HIV and PAH

Alex Dusek at Late Phase Drug Development World Americas 2012

• Providing evidence to support product claims and develop data in expanded populations of patients
• Clinical program design to evaluate real-world outcomes
• Addressing the challenges of US and EU regulatory requirements

› Alex Dusek, Global Brand Strategy Leader, Bayer

12.40pm

Lunch

DEMONSTRATING VALUE IN LATE PHASE

1.40pm

Leveraging Clinical Technologies to Conduct Late Phase Research

Patrick Chassaigne

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...

more..

• Address common challenges and provide solutions for designing Phase IV studies and registries
• Discuss practical approaches to gain efficiencies in implementing and managing large global studies
• Hear several case studies and resulting key takeaways around site satisfaction and patient retention.

› Patrick Chassaigne, Director, Late Phase Solutions, Medidata Solutions Worldwide

2.10pm

Getting the right evidence from your late stage activities: the importance of planning ahead

Lynn J Okamoto

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...

more..

• Predict late phase considerations earlier in the life cycle
• Fill evidence gaps within and alongside the clinical development program
• Prioritize activities that need to be done in the peri-approval period

› Lynn J Okamoto, SVP & Sr Research Scientist, Health Economics, United BioSource Corporation

2.40pm

Panel session: Approaches for collecting real-world evidence and demonstrating value

Jay Bae at Late Phase Drug Development World Americas 2012

Shrividya Iyer at Late Phase Drug Development World Americas 2012

Russel Knoth at Late Phase Drug Development World Americas 2012

› Jay Bae, Global Health Outcomes, Eli Lilly
› Shrividya Iyer, Director, Global Outcomes Research, Pfizer
› Russel Knoth, Director, US Health Economics & Outcomes Research, Eisai, Inc
› Todd Michael, Senior Director, Evidence Translation, Sanofi

3.10pm

Afternoon refreshments

3.40pm

Demonstrating value in late phase – Payer Perspective

Mark J Cziraky at Late Phase Drug Development World Americas 2012

- How health care decision-makers assess the real-world value of pharmaceutical products

› Mark J Cziraky, Vice President, Industry Sponsored Research, HealthCore

LATE PHASE CLINICAL TRIAL DESIGN

4.10pm

Drug Development and Diverse Patients in Clinical Trials

Coleman Obasaju

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...

more..

› Coleman Obasaju, Senior Medical Director, Oncology, Eli Lilly

4.40pm

Pragmatic Clinical Trials (PCTs) - Considerations in Late Phase Research

Jean Siebenaler at Late Phase Drug Development World Americas 2012

Learning Objectives:

1. Will be able to summarize the key reasons for designing a pragmatic trial versus an explanatory randomized trial or observational study design
2. Will be able to identify the key pragmatic clinical trial design and reporting elements

This brief presentation on pragmatic clinical trials (PCT) will highlight the role and the value of these increasingly popular study designs in Late Phase and Outcomes research. Differences between PCTs, explanatory RCTs and observational designs will be reviewed, and the important key design and reporting elements of PCTs will be discussed in detail.