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Clinical Project Management

Forum 2010The Premier Event for Clinical Project Managers

December 8-9, 2010Crowne Plaza Philadelphia DowntownPhiladelphia, PA

Barnett International/ Cambridge Healthtech Institute’s Inaugural

Coverage Includes:

Optimizing Project Performance and Mitigating Risk

Global Considerations: Strategies, Challenges, and Opportunities

Optimizing Site Performance: Sponsor and Site Perspectives

Ensuring Data Quality, Ensuring Success

And! Building Better Clinical Project Managers

Plus! An Interactive Workshop: Are You a “C” Level CPM?

Organized by:Cambridge Healthtech Institute healthtech.com/cpm

Final Agenda

Corporate Sponsors:

Wednesday, December 8, 20107:00 am Registration and Morning Coffee7:45 Barnett Welcome and Chairperson’s Opening Remarks

8:00-11:00 am WORKSHOP

Are You a “C” Level CPM?According to a PhRMA (Pharmaceutical Research and Manufacturers of America) annual survey, pharmaceutical companies sink 45% of their total R&D budget solely into clinical trials. With spiraling costs, time constraints, high failure rates, and an increased globalization of trials, sponsors face significant pressure to find new efficiencies. In achieving this goal, the Clinical Project Manager plays a critical role, like a “C” level executive. What does it take to be a “C” level CPM? It requires mastering critical thinking skills as different as conflict resolution and root cause analysis.

This workshop will enable you to explore the critical skills required to perform at a “C” level. We will practice some of them on selected life sciences case studies. A “C” level CPM has learned to master the art of decision-making, the 5-step coaching model, how to create a performance system that supports the desired behaviors, and how to systematically identify the root cause of deviations. No amount of tools or systems can replace these critical thinking skills. Strive to be a “C” level CPM.

During this session, you will learn how to:

•  Create a performance environment that rewards the behaviors you want, whether the performer reports to you or not

•  Rationally assess the root cause of mechanical or human performance deviation

•  Select the best well-balanced corrective action to permanently address any identified root cause

•  Identify and master each team member’s “personal drivers”•  Recognize the ideal degree of involvement required by each

project situation•  Develop your own development plan toward a “C” level CPM,

which means mastering four separate sets of skills

All these skills will be practiced on clinical trials related case studies. You will receive feedback from the instructor on your performance working on the case studies.9:30-9:45 Networking Coffee Break11:00 Close of Workshop

About Your Workshop Leader:Eric Morfin, M.B.A., P.M.P., is a sought after speaker and frequently published author with over twenty years’ experience as a project manager. Over the course of his career, Mr. Morfin has worked with GlaxoSmithKline, Aventis, Novartis, Bristol-Myers Squibb, AstraZeneca, and

Merck Frosst, to name only a few. He is currently the co-author of several Project Management in Pharmaceuticals books. He is an active member of several professional societies, and has developed several unique seminars on Project Management in Drug Development. Mr. Morfin founded and remains a volunteer with the leading non-profit organization for Project Management in Life Sciences, BioPharmaPM (www.biopharmapm.org). BioPharmaPM has local groups around the world, more than 8000 members and is a registered PMI education provider.

Mr. Morfin is a partner with Critical Skills, Inc., whose mission is to increase organizational effectiveness through the establishment of Superior Thinking Skills as a company’s most sustainable competitive advantage. Critical Skills, Inc.’s primary focus is in applying project management best practices to the Pharmaceutical/Biotech/Life Sciences industries.

MANAGING ENROLLMENT AND OPERATIONAL CHALLENGES IN PATIENT RECRUITMENT AND RETENTIONCASE STUDY11:00 Challenges in Patient Recruitment: Considerations, Strategies, and a Case StudyDavid Parker, Senior Director, Clinical Operations, MacroGenicsHelen West, VP, Strategic Development, MMGThe 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 STUDY11:40 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 SquibbIndustry 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 Opportunity Available) or Lunch on Your Own1:30 Leveraging eRecruitment for Sponsored by Clinical Trial Enrollment

Scott Connor, Vice President, Marketing, AcurianWith 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, LLCJoseph G. Oliveto, M.B.A., Vice President, Operations, Chelsea TherapeuticsThe 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

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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 Viewing3:20 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 ConsultingHispanic 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.

GLOBAL CONSIDERATIONS: STRATEGIES, CHALLENGES, AND OPPORTUNITIES4:00 Strategies for the Effective Management of Global Clinical Trials

Vanessa Salomao, Senior Project Lead, PAREXEL InternationalA 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 CollaborationColin 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 Building Better Clinical Project Managers: A Seven-Module CurriculumHolly 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 Wrap-Up and Close of Day One6:00 - 7:00 pm Reception and Exhibit Viewing (Sponsorship Opportunities Available, Contact Angela Parsons: 781-972-5467, aparsons@healthtech.com)

Thursday, December 9, 20107:00 am Sponsored Breakfast (Sponsorship Opportunity Available) or Morning Coffee8:00 Chairperson’s Day Two Welcome

OPTIMIZING PROJECT PERFORMANCE AND MITIGATING RISK8:05 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 STUDY8:45 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

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9:25 Measure and Deliver Maximum Performance of Your Clinical Trial Methodology

Yan Cardineau, Program Director, PDP & PMO, R&D & Clinical Research, Medtronic CardiovascularHistory 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 Viewing10:25 Variable Billing vs. Fixed-Price Models – How Does Your Clinical Trial Stand to Gain?

Chris Porter, COO, Clinipace WorldwideThe 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

OPTIMIZING SITE PERFORMANCE: SPONSOR AND SITE PERSPECTIVES11:05 Enhancing Workflow Processes between Sponsor and Site: The Site Perspective

Howard Waxman, Ph.D., Director of Research, Belmont Center for Comprehensive TreatmentClinical 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 StartupDarlene Panzitta, President, DSP Clinical ResearchStudy 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 STUDY1:40 Strategies for Optimizing Materials Management and Reducing Opportunity Costs for Clinical Trial Project ManagersGloria Alley, Director, Clinical Ancillaries Management, Thermo Fisher ScientificThis 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 VascularThoughtful 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

sponsors3:00 Networking Refreshment Break and Exhibit Viewing

ENSURING DATA QUALITY, ENSURING SUCCESS3:20 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 GroupA 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

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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 quality4:40 Maximizing the Evaluability of Your Clinical Trial Data

Adam Ruskin, Ph.D., D.V.M., M.P.H., Director, Clinical Operations, Emergent BiosolutionsThe 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.6:00 Close of Conference

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Sponsorship InformationConference Hotel:

Crowne Plaza Philadelphia Downtown1800 Market StreetPhiladelphia, PA 19103Phone: (215) 561-7500 • Fax: (215) 561-2556

Room Rate: $159 s/dReservation Cut-off: November 16, 2010

To reserve your hotel room, call the hotel directly to make your room reservation. Identify yourself as a Cambridge Healthtech Institute conference attendee to receive the reduced room rate. Reservations made after the cut-off date or after the group room block has been filled (whichever comes first) will be accepted on a space-and-rate-availability basis. Rooms are limited, so please book early.

Flight Discounts:To receive a 5% or greater discount on all American Airline flights, please use one of the following methods:

• Call 1-800-433-1790 (authorization code A12DOAJ).

•  Go online at www.aa.com (enter A12DOAJ in  Promotion discount box).

•  Contact Wendy Levine, Great International Travel  1-800-336-5248 ext. 137.

Car Rental Discounts:Special discount rentals have been established with Hertz for this conference. Call Hertz directly at 800-654-3131 and reference our Discount Number 04KL0001

Hotel & Travel InformationBecome a Sponsor:

Brand your company as a thought leader in clinical project management by participating as an active Sponsor. Presenting your solutions or services directly to our delegates can significantly impact their purchasing and collaboration decisions and help you achieve your sales and business development objectives.

Opportunities include Breakfast or Luncheon Presentations, or you may pre-select and gain access to your highest level prospects through an Invitation-only VIP Dinner or function (limited availability).

CHI will support your Sponsorship and brand your Company with strong marketing programs before, during and after the event. The earlier you secure your Sponsorship, the more opportunity for exposure.

To discuss your objectives and participation options, please contact:

Arnie WolfsonManager of Business DevelopmentPhone: 781-972-5431E-mail: awolfson@healthtech.com

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Cambridge Healthtech Institute 250 First Avenue, Suite 300, Needham, Massachusetts 02494

T: 781-972-5400 or toll-free in the U.S. 888-999-6288F: 781-972-5425 • www.healthtech.com

HOW TO REGISTER: Online:

healthtech.com/cpmEmail: reg@healthtech.com

Phone: 781-972-5400Fax: 781-972-5425

Each registration includes all conference sessions, posters and exhibits, food functions, and a copy of the conference proceedings link.

Register 3 - 4th is Free! Individuals must register for the same conference or conference combination and submit completed registration forms together for discount to apply. Please repro-duce this registration form as needed.

Handicapped Equal AccessIn accordance with the ADA, Cambridge Healthtech Institute is pleased to arrange special accommodations for attendees with special needs. All requests for such assistance must be submitted in writing to CHI at least 30 days prior to the start of the meeting.

Substitution/Cancellation PolicyIn the event that you need to cancel a registration, you may: •  Transfer your registration to a colleague within your organization. •  Credit your registration to another Cambridge Healthtech

Institute program.•  Request a refund minus a $100 processing fee per conference.•  Request a refund minus the cost ($350) of ordering a copy of the CD.

NOTE: Cancellations will only be accepted up to two weeks prior to the conference. Program and speakers are subject to change.Video and or audio recording of any kind is prohibited onsite at all CHI events.

The latest industry news, commentary and highlights from Bio•IT World

CHI Insight Pharma ReportsA series of diverse reports designed to keep life science professionals informed of the salient trends in pharmaceutical technology, business, clinical development, and therapeutic disease markets. For a detailed list of reports, visit InsightPharmaReports.com, or contact Rose LaRaia at rlaraia@healthtech.com, 781-972-5444.

Barnett Educational ServicesBarnett is a recognized leader in clinical education, training, and reference guides for life science professionals involved in the drug development process. For more information, visit www.barnettinternational.com.

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Clinical Project Management Forum 2010The Premier Event for Clinical Project Managers

December 8-9, 2010 Crowne Plaza Philadelphia Downtown • Philadelphia, PA