Day 1 | Day 2 | Download Brochure
Thursday, December 9, 2010
|
7:00 am Sponsored Breakfast (Sponsorship Opportunity Available) or Morning Coffee
8:00 Chairperson’s Day Two Welcome
8:05 Critical Chain Concepts for Optimizing Clinical Trials
Andreas Scherer, Ph.D., General Manager, ProChain Solutions, Inc.
Dr. Scherer will first cover the key principles of the Critical Chain methodology as well as the basics of buffer management. He will review the usage of Critical Chain on the team level. Towards the end of this element we will discuss some advanced topics (executive sponsorship, sustainability, scalability, and change management). Second, Dr. Scherer will present how Critical Chain can improve the execution of projects managing clinical study teams. Third and finally, there will be a Q&A session. Participants will be given the opportunity to have a more in-depth dialog with the speaker.
CASE STUDY
8:45 From Chaos to Clockwork:Sponsored by
Managing Your Way to Clinical Success in the Drug Development Process 
Greg Kain, Manager, Project Planning & Execution, Integrated Project Management Company, Inc.
Facing the complexity of a clinical trial can be daunting. Activities such as site selection, patient recruitment, data collection, and regulatory submission necessitate the highest degree of accuracy under a tight timeframe. Not only must you coordinate all players and activities across the drug development process and problem-solving as you go, you must build in contingency planning to buttress against potential risks. This session will use a case study focusing on a fledgling biotech firm, to illustrate the challenges of and techniques for managing a constellation of activities, resulting in a successful NDA submission. As companies build in contingency plans to guard against potential risks, it is important to consider:
- Maximizing limited resources
- Anticipating risks across the project teams
- Facilitating project execution effectively
- Forecasting project completion and total costs
9:25 Measure and Deliver Maximum Performance of Your Clinical Trial Methodology
Yan Cardineau, Program Director, PDP & PMO, R&D & Clinical Research, Medtronic Cardiovascular 
History suggests that most trials will be late and over budget. How do you create a system that improves your likelihood of success? How do you apply the body of knowledge from other industries to the unique environment of clinical trials? Success relies on the Clinical Trial Methodology and Framework. It is a collection of proven techniques for delivering improved project performance, including pipeline management and project management. It is important for executives and clinical leaders to understand and recognize the importance of governance and disciplined execution. It is also important to properly scale the methodology to the size and complexity of the trials you run. The audience will get a practical of perspectives and tools for improving performance and their bottom line.
10:05 Networking Coffee Break and Exhibit Viewing
10:25 Variable Billing vs. Fixed-Price Models – How Does Your Clinical Trial Stand to Gain?
Chris Porter, COO, Clinipace Worldwide
The same economic pressures that have been forcing many professional industries such as legal, accounting, and consultancy to alter their billing practices are bearing down on CROs as well. The dynamics of billing by the hour are now proving to be counterproductive to the achievement of mutual goals by CROs and research sponsors. In this session, we’ll examine some of the drivers that are pushing aside traditional ways of billing. More often than not, the primary selection driver for many large CROs lacking differentiation is price. When the best price is all that is required to win a deal, there is an added incentive to bid low to win the job. And when a low bid is truly unrealistic, it opens the door to future scope changes and change fees. Emerging companies are looking for innovative ways to stretch their budgets, gain some stability in uncertain economic times, and mitigate risk. Many are turning to CROs that actively embrace new ways of doing business, such as incorporating electronic data capture, just-in-time monitoring, and strategic partnering. These innovative approaches are making it possible to swing the billing pendulum in the other direction — to a fixed price model. In this session, we’ll examine some of the drivers that are pushing aside traditional ways of billing, including:
- The recognition that hourly billing is excessive in difficult economic times
- A gnawing feeling that clients are poorly served by hourly billing and the bidding practices that it engenders
- A shift toward building strategic relationships between CROs and sponsors
- The desire to mitigate risk and contain budget
- Adoption of integrated technology platforms
11:05 Enhancing Workflow Processes between Sponsor and Site: The Site Perspective
Howard Waxman, Ph.D., Director of Research, Belmont Center for Comprehensive Treatment
Clinical trial operations can be enhanced by understanding basic barriers to start-up, enrollment, and completion. This presentation from a site perspective addresses several key issues including regulatory review, recruitment, and compliance. Audience dialogue is encouraged to bring obstacles to the surface. Often asked to give a “site perspective” on key issues at pharmaceutical conferences, your speaker will present information based on real-world reactions received at previous forums. This talk will raise key points where there is recognition by sponsors that problems can be addressed. Attendees will come away with a greater understanding of what they can do to enhance clinical trials operations.
11:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:00 pm Avoiding the Five Top Mistakes at Study Startup
Darlene Panzitta, President, DSP Clinical Research
Study sponsors often face budget and time constraints during study startup which can lead to poor decisions that ultimately will affect the study long after the startup phase. Your speaker will identify the five common mistakes sponsors make during study startup and how these mistakes can be avoided. As clinical trials and study protocols become increasingly complex, it’s essential that sponsors and CROs work together to guarantee that clinical studies use the best strategies and tactics to run smoothly, from startup to closeout. This talk will offer actionable advice and proven strategies to avoid mistakes and conduct a smooth clinical trial. Participants will learn how to avoid these top mistakes:
1. Not starting with a final protocol
2. Not having sites initiated in a timely manner
3. Underestimating timelines
4. Poor CRF design and not implementing full, correct UAT (User Acceptance Testing)
5. Not having a “Plan B” (or C and D) in place for slow recruitment
CASE STUDY
1:40 Strategies for Optimizing Materials Management and Reducing Opportunity Costs for Clinical Trial Project Managers 
Andrew MacKnight, Vice President, Clinical Ancillaries Management, Thermo Fisher Scientific
This presentation will address the growing complexity of managing clinical ancillary materials for global trials. Case studies will be reviewed showing how efficient sourcing, aggregation, and site distribution can alleviate what is currently a significant burden on clinical project management professionals. This session tackles a key reason why trials don’t start on time and run smoothly. Highly relevant to clinical project managers, we will cover the current issues of sponsor risk associated with clinical materials and equipment deployed at investigator sites. Attendees will come away with an understanding of new potential project management approaches to ancillary trial materials.
2:20 Effective Site Corrective Action Plans
Vicki Gashwiler, RN, BSN, CCRP, Senior Clinical Research Associate, Clinical Research Operations, Abbott Vascular
Thoughtful and effective corrective action plan development and implementation is a powerful compliance tool. Sites and sponsor must collaborate as a team to understand both the root cause(s) and the most effective methods of preventing recurrent non-compliance. Many times sponsors leave sites with the burden of root cause assessment and corrective action plan development – giving little advice or direction to research coordinators and investigators. Audience members will gain insight on CAP implementation from both the sponsor and site perspective. Understanding will be gained on what works best and why it works. In this session, we will review:
- Effective CAP tools (for both sponsors and sites)
- Examples of both effective and ineffective CAPs
- CAP education tips & ideas – getting sites on the same page as sponsors
3:00 Networking Refreshment Break and Exhibit Viewing
3:20 Strategies for Ensuring High Quality Data Results for Your Trials
Jan Kosmyna, RN, MS, CCRP, Program Manager, Cleveland Clinic Vascular Surgery ARO, Vascular Surgery, Cleveland Clinic
Lori Vivian, RN, BSN, CCRP, RAC, Director of Clinical Research Operations, The Ouriel Group
A clinical trial will only result in high quality data with proper planning and with the right people involved throughout the entire process. In this session, your presenters will share from a project management perspective, what the necessary steps are to implement throughout the length of the study, as well as what members of your team should be involved at each step, to ensure high quality data results. Additionally, they will share lessons they’ve learned through their combined 20+ years of research experience. They will also discuss strategies they have found effective to ensure the result every clinical trial strives for: high quality data results.
4:00 EDC and Ancillary eTool Solutions in Clinical Trials
Musa Mutyaba, CCRA, Senior CRA, Infinity Pharmaceuticals, Inc.
Cost pressures on clinical development often demand timelines that can overwhelm an underprepared and poorly planned trial, even with sound protocol design. It is paramount in this scenario (which is becoming common given the current economic climate) therefore to have solutions that can ensure high quality of this data is obtained in a timely and efficient manner, from input to output, no matter the date source (investigator site or vendor). Source verification is vital to ensuring the integrity of data, whether at 100% (as required by GCP) or by a risk-based approach (for milestones such as interim analyses). The level of quality of the data in question depends on the efficiencies of data entry, data verification, and data output, areas which can be greatly improved by source documents, EDC systems with collaborative features, and ancillary eTools. In this session, we will:
- Discuss strategies that can be used to improve source document verification (both 100% as well as risk-based) and data analysis
- Outline tools available that are most valuable for leveraging EDC solutions
- Review cases that demonstrate the use of EDC and ancillary solutions in improving data quality
4:40 Maximizing the Evaluability of Your Clinical Trial Data
Adam Ruskin, Ph.D., D.V.M., M.P.H., Director, Clinical Operations, Emergent Biosolutions
The role of the Clinical Project Manager is to provide a clean, locked database in a timely and cost-effective manner. While most managers focus on the operational part of this role which involves timeliness and efficiency, the best project managers understand what is necessary to ensure high quality, highly evaluable data. This presentation will focus on techniques and strategies that all Clinical Project Managers should be employing during the set-up and conduct of a clinical trial to minimize non-evaluable subjects and data. Real-life examples will be presented that illustrate the impact of disregarding the quality aspect of data on effects of entire investigational product lines. This will be useful, practical information that the audience should be able to immediately take back, present, and apply. As there are a significant number of trials that fail simply due to poor data quality, the clinical project manager needs to know how to prevent this from occurring in their studies and how to maintain consistent, high quality data throughout the course of their studies. Practical techniques that they can implement to help with their daily responsibilities of trial management will be presented.
5:20 Building Better Clinical Project Managers: A Seven-Module Curriculum
Holly V. Malin, Associate Director, Clinical Business Operations, Millennium: The Takeda Oncology Company
Tina D. Forrister, Senior Consultant, Halloran Consulting Group, Inc.
Clinical project management is challenging, even for seasoned professionals. Gaining and maintaining the skills you need to be effective can be almost as challenging. This presentation will review the curriculum designed for and currently being implemented at Millennium Pharmaceuticals, the Takeda Oncology Company. Seven course modules, based on Project Management fundamentals and covering topics such as “Managing People and Leading the Team” and “Scope and Time: Managing What and When,” are delivered over approximately 40 hours. Each module includes interactive workshops such as small-group work, individual exercises, skits, and role plays. The content and rationale for the curriculum design plus learner and manager feedback will be presented.
6:00 Close of Conference