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Wednesday, December 8, 2010
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7:00 am Registration and Morning Coffee
7:45 Barnett Welcome and Chairperson’s Opening Remarks
8:00 Are You a "C" Level CPM WORKSHOP
9:30-9:45 Networking Coffee Break
11:00 End of Workshop
CASE STUDY
11:00 am Challenges in Patient Recruitment: Considerations, Strategies, and a Case Study
David Parker, Senior Director, Clinical Operations, MacroGenics
Helen West, Vice President, Strategic Development, MMG
The drug development process grows more complex, costly, and time-consuming each year. The commonly attributed factors for this include increasingly sophisticated science and study design, greater regulatory scrutiny, and more challenging operational hurdles. The most significant and costly of these operational challenges is subject recruitment and retention. In this session, we will:
- Provide an overview of the various recruitment tactics, from traditional to novel and emerging
- Outline an approach to tailoring the best suited recruitment strategy for your specific study
- Review a case study of a particularly challenging study, the approach we took, and the lessons we learned
CASE STUDY
11:40 Effective Planning and Execution of Patient Recruitment and Retention Strategies is Vital to a Successful Clinical Trial
Nancy Widener, Executive Director, Central Clinical Operations, Bristol-Myers Squibb
Industry data tells us that many (most) clinical trials do not end on time, according to the original timeline plan. Not finishing a study “on time” can translate into spending more money, using more resources, and losing revenue because the drug is delayed getting to market. Not being able to recruit patients into a trial can cause the trial to run long. Not retaining enough patients in a clinical trial can result in data loss that puts the statistical power at risk. Learn how to use data to develop effective plans and to track progress against a plan. Listen to case studies that describe recruitment challenges and hear ideas for overcoming these challenges. See how effective decision making can align a team around development and execution of contingency plans.
12:20 pm Luncheon Presentation (Sponsorship Available) or Lunch on Your Own
1:30 Leveraging eRecruitment for Clinical Trial Enrollment
Scott Connor, Vice President, Marketing, AcurianSponsored by
With Web 2.0 and social media continuing to gain mindshare with consumers and marketers alike, the focus surrounding its effectiveness in recruiting patients for clinical trials has increased dramatically in recent months. Your speaker will provide insight into the pitfalls and possibilities of eRecruitment as a patient enrollment strategy, including performance metrics from recent trials. Topics include how to recruit online, the critical success factors of an online campaign, and a case study.
2:10 The Advantages of Using Data Analytics to Accelerate Patient Enrollment, Strengthen Sponsor-Investigator Relationships, and Drive Results
Kathleen Colatrella, President, Research and Development, LINEA System, LLC
Joseph G. Oliveto, M.B.A., Vice President, Operations, Chelsea Therapeutics
The scenario is always the same: complex clinical trial design, urgency to complete trial faster, delayed patient enrollment due to nonperforming sites, lack of resources, and increased costs. Clinical teams need to rethink their approach to managing all aspects of clinical trials, particularly patient enrollment. Accelerating patient enrollment represents one of the largest opportunities for pharmaceutical companies to reduce trial time and cost. The use of analytics to gain meaningful insight on site performance will enable teams to make informed decisions with selecting sites that can produce the patients required to fulfill the enrollment target. Furthermore, converting and establishing partnerships with research sites will create mutual benefits and encourage a win-win situation that would yield better quality overall.
- Formulate questions and assessments beyond standard feasibility to create relevant data to help identify the right investigators for their trials
- Generate and interpret data to identify the right physicians having large patient populations matching their protocol criteria
- Use information about sites to foster a deeper and more predictable relationship with their investigators to impact enrollment
- Gain insight on the components required from the site perspective that will engage the investigator in a true partnership that will benefit both parties
2:50 Networking Refreshment Break and Exhibit Viewing
3:20 Understanding the Unique Challenges and Opportunities in Recruiting and Retaining Hispanic and Latino Populations in Clinical Trials
Sara Tylosky, M.B.A., Director, Consulting, Farma Consulting
Hispanic and Latino populations represent the fastest growing segment in the U.S. population. Consequently, more pharmaceutical and biotech companies seek to include a significant portion of Hispanics/Latinos in their clinical trials, particularly in the areas of type 2 diabetes, hypertension, HIV/AIDS, glaucoma, breast cancer, and kidney disease. Most previous recruitment methods have focused on traditional methods of community-based recruitment, such as public databases, mass media advertising, or community health screening. However, these methods offer limited success for this population group. This presentation summarizes the cultural barriers and opportunities of this population group to help sponsors and CROs create appropriate recruitment strategies.
4:00 Strategies for the Effective Management of Global Clinical Trials
Vanessa Salomao, Senior Project Lead, PAREXEL International
A Global Lead will face many challenges such as limited face-to-face time, different cultures, several locations, and various time zones when dealing with global projects. It is important to use technology and stay visible to your people in order to be aligned with practical decisions, provide clear direction, and implement effective plans in a complex international environment. A Global Lead should be able to communicate, inspire, and involve across barriers of language, culture, and communications technology. Being from South America, the challenges of managing global studies is even greater as people do not see us as trustable managers. For this reason we have to create stronger relations with clients and internal teams. This presentation will offer a different perspective and creative management style. Attendees will come away with the knowledge of how to manage projects creatively and adapt to different cultures and scenarios.
4:40 International Clinical Development Partner Collaboration
Colin Scott, M.D., Senior Director, Clinical Development, Respiratory Franchise, Forest Research Institute, Inc.
The complexity of project managing a clinical development program is vastly increased when a foreign partner is involved. This presentation will outline the additional obstacles which have to be overcome when an international dimension is added to a clinical development program, including physical barriers (e.g., time zone, F2F meetings), cultural differences (e.g., communication style, language barriers), regulatory requirements (e.g., timing, documentation, approval requirements), and study differences (e.g., medical practice, integration of data). Benefits will also be addressed including globalization, expanding indications, and global dossier production. Tools to minimize inconvenience will be discussed including communication matrix development, “safety valve” identification, and information exchange schedules. Kenneth Kaitin, director of Tufts CSDD best summed up the future stating, “Moving forward no company... will develop new drugs entirely alone.” Due to the weakness of many companies’ development pipelines, there is an increasing emphasis on partnering which, of necessity, leads to international collaborations. The goal of this presentation is to develop an awareness in the audience that specific accommodations have to be accepted when dealing with a foreign partner. There are specific tools which can facilitate the process which must be supplemented by cultural awareness.
5:20 Optimizing Trial Performance for Asia Clinical Studies through Effective Project Management 
Albert Kuo, Deputy General Manager, New Drug Development Services, Protech Pharmaservices Corporation
Due to growing demand of conducting clinical studies in Asia, the traditional project management approach is not enough. A flexible project management operational model is more suitable and generates better performance for the study. Decentralized project personnel in regional and local areas following a global guiding principle create more motivation and positive results to clinical studies. The session will introduce the Asia clinical studies experience with “Starfish” & “Satellite” models implemented. As heavy demand in conducting clinical studies outside the US grows, a flexible project management operational mode is a must for the future success of a clinical study.
6:00 Wrap-Up and Close of Day One
6:00 - 7:00 Reception and Exhibit Viewing (Sponsorship Opportunities Available, Contact Angela Parsons: 781-972-5467, aparsons@healthtech.com)