Day 1 - Monday, September 21, 2009

7:00

Registration & Breakfast

7:55

Chairman's Opening Remarks

KEYNOTE PRESENTATIONS

8:15 

9:00 

Session I - Clinical Trials and the New Environment

9:45

Carol Robertson-Plouch, Clinical Research Advisor, Eli Lilly & Co.

10:15

Gergana Zlateva, Director, Pfizer

10:45

Refreshment Break and Networking

11:15

John Bolodeoku, Vice President Medical Affairs and Health Economics, Astellas Pharma Europe Limited

Session II - Designing Trials to Optimize Site Selection & Patient Recruitment

11:45

From Instinct to Insight: Delivering Predictable Performance

Alex Lancksweert, Director of Business Performance Analytics, GlaxoSmithKline R&D

Faced with a host of market pressures and manufacturing challenges, today’s pharmaceutical industry is looking to adapt its business models and identify new ways to drive value and greater efficiency. One area ripe for improvement is the planning and execution of clinical trials. According to the Tufts Center for the Study of Drug Development, eliminating one day from a critical path study typically saves $37,000 in out-of-pocket development costs and nets an additional $1.1 million in daily prescription revenue. However, in spite of the efforts of the people involved, most clinical studies fail to meet their enrollment deadlines - 70% of trials fail to complete on-time.
In order to more effectively monitor, manage and mitigate the impact of disruptive events, such as investigator shortfalls, protocol amendments, etc. a more structured approach to recruitment planning, and country & site selection is required. We need to reject the traditional approach to planning clinical trials, that is “Ready, Fire, Aim”, with little forethought given to due diligence, planning or risk management; and adopt a more rigorous process enabled by advanced simulation and visualization tools, we have to shift from planning based on instinct to planning based on insight; and adopt empirical approaches to planning investigator site selection and patient recruitment.
The objective of this presentation is to highlight an approach to reduce variability and accelerate clinical trial execution through the use of enrollment optimization tools; and its impact on our performance.

12:15

Valeri Fedorov, Head of Research Statistics Unit, GlaxoSmithKline

12:45

Lunch

Session III - Essential Innovation for the Acceleration of Clinical Trials

2:15

Drug Access in Clinical Research: One Subject, So Many Interpretations, One Goal - To Improve the Patient's Quality Of Life

Fernando Alfieri Jr., Research and Development Regional Medical Director, Wyeth

Clinical trials have a big importance for countries, patients, institutions and physicians because clinical research promotes scientific development , improve lives and patient quality of life. However, some issues in the protocol approval process have jeopardized the clinical trials implementation. Drug access has been critical and a global issue to implement clinical trials, like Brazil, due to several different interpretations about access which have generated different requests from IRBs, not fully accepted by the sponsors and consequently the final protocol approval has taken long time and determined delays in the site initiation visit to start the trials. Therefore, some aspects like risks involved to the sponsor must be analyzed as well as the local regulations should be understood very well in order to take risks, if there were.

Learning Objectives: Discuss the issue and better understand: what are interpretations and its implications.

2:45

Evaluating Potential Benefits of Dose-Exposure-Response Modeling for Dose Finding

Chyi-Hung Hsu, Senior Expert Statistical Methodologist, Novartis Pharmaceuticals Corporation

Dose selection for confirmatory trials is arguably one of the most difficult and important decisions that need to take place during clinical drug development. Improper dose selection, due to lack of sufficient knowledge of the dose-response (DR) relationship at the end of the learning phase of development, is believed to be one of the key drivers of the high attrition rate currently observed in Phase III.

Designs and methods for improving dose finding in the context of drug development form an active area of research, with proposals having focused primarily on the use of modeling (Bretz, Pinheiro and Branson, 2005), optimal designs (Miller, Dette and Guilbaud, 2007; Dette et al, 2008), adaptive designs (Gaydos et al., 2007), Bayesian methods (Berry et al., 2002) and combinations of these (Krams et al., 2003). A common thread of these contributions is the focus on the estimated dose response relationship, which is used to produce estimates for target doses and to define better allocation of patients to available doses.

The focus of this presentation is on quantifying the potential benefit of exposure-response modeling for dose selection and dose response estimation. Simulations under a unified dose-exposure-response model framework are used to compare dose selection and dose response estimation using dose response vs. exposure response data and modeling.

3:15

Refreshment Break and Networking

3:45

Anastasia Christianson, Senior Director & Global Discipline Leader, AstraZeneca Pharmaceuticals Inc.

4:15

Michael Robbins, Senior Manager, Business Solutions Design and Delivery, Monitoring Systems & Data Flow, Sanofi-Aventis International Clinical Development

4:45

The Expanding eClinical Universe: Streamlining Progress by Changing Current Work Processes and Moving Away from Paper

Alan S. Louie, Ph.D., Research Director, IDC Health Insights

Electronic information management is becoming a key process enabler as companies seek to advance clinical trials and accelerate time to market. Contained under the broad category of eClinical solutions, these commercial products aspire to connect and accelerate clinical development processes, enable greatly improved process efficiencies, and save both time and money over both the near and long term. Electronic processes offer significant capabilities in a number of areas including, reducing data entry errors, eliminating losses due to misplaced research or results, compiling data for regulatory submissions, tracking project progress, and accelerating the review and approval process.

This talk aspires to characterize the overall eClinical landscape as well as highlight technological innovations that are changing traditional drug development processes. Whether its modeling and simulation, electronic data capture, pharmacovigilance, or electronic content compliance, electronic information management solutions are reducing barriers associated with paper, isolated data silos, and versioning. Attendees can be expected to gain new insights including:

• the changing drug development paradigm
• available commercial eClinical solutions that could improve productivity
• changing information management practices from across the industry
• processes to work more effectively in this rapidly changing global ecosystem
 

  5:15

INTERACTIVE ROUNDTABLE DISCUSSIONS

Choose one of these highly specialized roundtable discussions and benefit from focused conversations that provide a comprehensive learning experience in an intimate setting

Please sign up today! Attendance per table is limited. (Full Conference Registration Required)
 

Roundtable A: Conducting Clinical Trials in the Developing World

• What are some of the pros and cons of conducting these clinical trials?
• What are the procedures one should take and what materials are needed?
• How do you deal with the patient’s language barriers?
• How do you fill out paper work/questionnaires?
• What are some of the ethical considerations when conducting these clinical trials

Roundtable B: Pharma Companies and Clinical Experts: How to Effectively Partner for Joint Clinical Development

6:15

Networking Reception and Poster Session

Drinks, Hors D'Oeuvres and Networking!

Day 2 - Tuesday, September 22, 2009

Top of Page

7:30

Continental Breakfast

8:00

Key Points from Roundtable Discussions
Each Roundtable Moderator Shares the Key Points from Previous Day's Discussions

FEATURED PRESENTATIONS

8:20 

8:50 

9:20

Refreshment Break and Networking

Session III - Outsourcing Issues and Solutions for Clinical Trials

9:50

A Proactive Approach to Contracting with Specialty Laboratories

Marion H. Müller-Baer, Manager, Contracts and Outsourcing, Pfizer Inc.

Contracting with vendors that have not had prior experience with working with Big Pharma can be problematic especially if issues are not identified and mitigated prior to start of study. This presentation will outline issues that can occur if thorough due diligence is conducted in advance of contracting with a specialty laboratory. A rigorous evaluation process done at an early stage can help identify issues to be addressed. While doing this at the RFP stage is more expensive as there is always the situation where a lab may not be used, it saves later on in terms of keeping the project on its appointed timeline. The issues that will be addressed include addressing legal and contractual terms, auditing the lab, working with the study team to understand their needs including data basing, reporting results, exporting data to the sponsor, security and capacity at the lab and communications between the lab, sponsor and study sites.

Benefits of this presentation
- Expanding the traditional RFP process with specialty labs to identify the overall capacity, services, skills and systems at the potential vendor at a much earlier stage than is usually done
- Identifying the areas that present the most issues that can impact the contracting and evaluation process
- Proposals for working through areas of concern with specialty labs to avoid impacting the critical timeline for the project
- Establishing a more holistic approach at the Sponsor level in regard to consideration of new potential specialty laboratories

10:20

Diane Stinson, Director Outsourcing, Merck

10:50

Angelina Carvajal, Team Lead, Strategy and Transformation Consulting, Capgemini

11:20

11:40

Mark A. Lanfear, Regional Manager, Roche

12:10

Didier Basseras, Senior Director, Global Clinical Packaging Operations, Sanofi Aventis R&D

12:40

Rudina Odeh-Ramadan, Executive Director, The Clinical Trials Office, Columbia University

Lunch

Session IV - The Unique Needs of Pediatric Clinical Trials

2:10

Kathleen Drennan, Senior Vice President and Managing Director, Iris Global Clinical Trial Solutions

2:40

Nai-Kong V. Cheung, Head, Neuroblastoma Program; Enid A. Haupt Chair in Pediatric Oncology, Memorial Sloan-Kettering Cancer Center; Sloan-Kettering Institute

3:10

Allison Burmeister, Clinical Trial Manager, Elan

3:40

Gary Meininger, Director, Clinical Research, Merck

   4:10

Conference Concludes