Day 1 - Thursday, January 28, 2010

7:00

Registration & Breakfast

7:55

Welcome and Opening Remarks

Kathleen B. Drennan, President, TrialAdvance

DISTINGUISHED FEATURED PRESENTATION

8:00

How a Robust “Lessons Learned" Process Can Help Global Clinical Development Teams Successfully Meet Today's Drug Development Challenges

Global project teams are faced with many challenges as they implement their clinical programs. How global teams execute on their global clinical study plan is key if the team is expected to meet timelines, ensure data quality and meet budget expectations. A team’s success is determined by how well the team members work together, address issues and make timely decisions. This is true whether it is an internal team, an outsourced team or a mix of internal and external resources. How a team effectively addresses these study challenges is dependent upon team members building trust with each other and applying on-going lesson learned to avoid repeating previous mistakes so team performance is optimized. A lessons learned process will be presented that enables a team to capture feedback in a confidential non-threatening way so the real lessons learned can be identified and discussed with the ultimate goal to move a team to a high level of performance. High performing teams are more flexible, effectively deal with project crisis when they arise (and they do!!) and in the end have a greater likelihood of project success, i.e. meeting timelines. Specific examples on the use of a lessons learned process to maximize team performance will be presented.

8:45

Going Global, the Race to Run Clinical Trials Faster and More Efficiently is Getting Longer

Session I - Clinical Trials and the New Environment
Moderator: Kathleen B. Drennan, President, TrialAdvance

9:15

Clinical Development in Asia Pacific and Japan

Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer

The global R&D environment is increasingly characterized by global competition, a rise in costs of development and a decrease in productivity. In the near future most clinical trials of the top pharmaceutical companies will be conducted outside of U.S. For Bayer this trend for off-shoring of clinical research into emerging markets has materialized particularly in the Asia-Pacific region.
Access to a large number of patients and to treatment naive patients is attractive along with economic advantages. Shorter development time, earlier access to the Asian markets, more development projects within the same resource frame, and an increased probability of regulatory success are potential advantages of this development strategy.
However, there are limits to regional externalization of R&D related to ethnicity and global acceptance of data.

Attendees can be expected to gain insights including:

• the trend of off-shoring of clinical research into emerging markets
• lead times needed to start studies in Asian countries
• efforts made by Bayer to significantly build global R&D resources into the Asia Pacific region.

9:45

Refreshment Break and Networking

10:15

Clinical Trials in the New Environment with a Patient-Centered Approach

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

The environment we operate in is continually changing. The complexities of science and medicine are impacted by a myriad of factors, including medical needs and expectations, public concerns, and regulatory changes. In general, development of new medicines is taking longer and costing more. “Personalized medicine” has become a key word in conversation, and has also become an avenue in which new medications will play a role. This presentation will discuss patient-centered opportunities and challenges in this new era of pharmaceutical development, using examples of tailored therapeutic opportunities with biomarkers, pharmacogenomics, and adaptive designs.

10:45

Leveraging Biometrics and Niche Global Expertise to Mitigate Risk, and Increase the Efficiency of Clinical Development

Suleman Verjee, Ph.D., President and CEO, Versante International, LLC

In today’s economy, it is important for companies to maximize the use of their resources. Whether large or small, pharmaceutical and biotechnology companies face time constraints and financial pressures. They need to move through the regulatory review process of key agencies quickly and successfully. One mistake can lead to months of unnecessary delays, inability to secure a late-stage development partner or funding entity, or worse, the failure to bring a good drug to market.

Key components of any efficient development process include clinical plans that minimize development time and satisfy regulatory requirements. In addition, proper execution of the clinical plan is paramount to the success of the program. We will present several topics that are particularly relevant in today’s environment when conducting global clinical trials. These topics are associated with management and scientific issues, as well as execution of the clinical program:

• The acceptance of current medical practice for indications with limited treatment alternatives sometimes makes it more difficult for novel therapeutics to be developed, e.g. immunotherapies. Flexibility and innovative designs may provide a solution.
• Use of Electronic Data Capture Systems to mitigate risk.
• Recognition of the lack of in-house expertise and competence, including the need for ongoing statistical expertise and effective trial management during the entire development process.
• Development paradigm for the management and execution of global programs. One stop shopping may not be the best solution for emerging pharmaceutical and biotech companies.

11:15

Lunch

12:50

Advancing Clinical Trials: It’s About the People, Are You Ready?

Kathleen B. Drennan, President, TrialAdvance

Much headway has been made in the last decade with scientific innovation leading to breakthrough drug therapies. Although a key focus has been on efficiencies, metrics, and processes, we remain stuck in innovating better ways to strategically plan and execute clinical trials leading to faster trials. Efficient clinical trial completion continues to lag behind scientific and technological innovation due to entrenched protocol designs, challenging patient enrollment, slow time to completion, and inadequate site performance. Looking forward, what will change this paradigm?

This presentation will address the future of clinical trials, focusing on and understanding the most critical component of the trials themselves, the people involved, and their influence on the success or failure of clinical trials.

Session II - Designing Trials to Optimize Site Selection & Patient Recruitment
Moderator: Kathleen B. Drennan, President, TrialAdvance

1:20

Using Social Media to Recruit the Right Trial Participants

David S. Williams III , Chief Marketing Officer, PatientsLikeMe

Companies across all industries are trying to learn how to harness the power of social media (using sites like Facebook, Twitter and YouTube) to get in front of their target audiences. For healthcare organizations, it is more crucial than ever to know how to effectively target and recruit patients to inform the research being done to improve their quality of life. PatientsLikeMe combines the power of social media and real-world patient data to generate higher quality interest with a more engaged patient population, and partners throughout the healthcare industry are learning how to maximize that value.

This workshop addresses the following:

• Why are patients sharing real-world health data to create new knowledge?
• How is real-world data informing the clinical trial world?
• Clinical trial awareness:
o How to define and target a highly engaged patient audience?
o How to accelerate the delivery of important new medicines by reaching your clinical trial enrollment goals faster?

Session III - Essential Innovation for the Acceleration of Clinical Trials
Moderator: Kathleen B. Drennan, President, TrialAdvance

1:50

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
 

2:20

Refreshment Break and Networking

2:50

Predict or Perish

Cosimo Spera, Head of Advanced Mathematics and Predictive Analytics, Decision View Company

Session IV - The Unique Needs of Pediatric Clinical Trials
Moderator: Kathleen B. Drennan, President, TrialAdvance

3:20

Ethical Considerations in Global Pediatric Psychopharmacology Trials

Albert J. Allen, M.D., Ph.D., Sr. Medical Director, Neuroscience Development, Eli Lilly & Co.

This presentation will discuss ethical considerations in global pediatric trials. Historical documents and ethical guidelines regarding pediatric research will be reviewed. Major applicable laws and/or guidelines will be reviewed from a global perspective to illustrate points raised by case studies. Important ethical considerations as they apply to pediatric drug development research will be highlighted and discussed. During the last half of the talk case studies will be presented that illustrate specific questions and implementation issues as they apply to global pediatric clinical trials.

Benefits: After attending the talk audience members will:
1. Have a better understanding of international laws, regulations and guidelines that apply to global pediatric trials,
2. Know factors of importance to IRBs that review pediatric studies,
3. Be aware of some common topics that may arise in pediatric clinical trials and have ethical implications, and
4. Have a list of resources to consult for additional information on ethics and pediatric clinical trials.

3:50

Decreasing the Time to Activate Clinical Trials: Initial Data from the Multiple Myeloma Research Consortium MMRC Model

Sandra Wear, R.N., Associate Director of Operations, Multiple Myeloma Research Consortium

Activation of oncology trials is a lengthy and complex process. Recent literature has identified numerous opportunities to improve activation timelines1, 2. The Multiple Myeloma Research Consortium MMRC has implemented several processes to identify and overcome myeloma clinical trial activation barriers within the consortium network of 14 North American cancer centers. Methods/Results: 12 MMRC-facilitated trials had sufficient trial data available for review within the study period of May 2006 to March 2009. Activation time was defined as the time from a center's receipt of the final clinical trial protocol from the sponsor, to the time the first patient was enrolled into a trial at any MMRC participating center. The earlier group EG of MMRC trials n=7 required a mean of 257 calendar days for activation, comparable to the mean published data of 251 calendar days1. The more recent group RG of MMRC trials n=5 required a mean of 158 calendar days for activation, representing a 38% shortening of activation time. Additionally, implementation of standardized processes and rigorous project management resulted in a reduction in activation times for all MMRC centers in a given trial from a mean of 7.5 months to a mean of 5.1 months. Improving the mean time of several specific steps in the process including time to initial protocol review submission from receipt EG=37 vs. RG=19 days, scientific review committee time EG=98 vs. RG=55 days, and the time from trial opening to first patient dosed EG=74 vs. RG=27 days contributed to the overall decrease in activation times. The EG metrics data are comparable to published data1 for each process step. Conclusion: The MMRC member institutions have seen substantial improvements in trial activation times and are in the process of implementing additional processes to further improve protocol development and trial conduct metrics. With increasing numbers of new oncology agents to be evaluated and greater pressure on trial sponsors to introduce efficiencies into trial timelines, overcoming such barriers is of critical importance.

4:20

Interactive Roundtable Discussions

5:20

Networking Reception and Poster Session 

Day 2 - Friday, January 29, 2010

Top of Page

7:30

Continental Breakfast

7:55

Review of Day One

Kathleen B. Drennan, President, TrialAdvance

Session V - Outsourcing Issues and Solutions for Clinical Trials
Moderator: Kathleen B. Drennan, President, TrialAdvance

8:00

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

8:30

 Increasing Growth of Networks and Virtualization of Pharma

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

9:00

Refreshment Break and Networking

9:30

Ensuring Patient Safety in Clinical Trials

Gregory J. Fiore, M.D., Senior Director, Head, North American Region, Global Pharmacovigilance, Schering-Plough

10:00

Conference Concludes

Luncheon Provided at 11:25 PM