CLINICAL TRIAL DISCLOSURE Learning the Landscape and Reading the Roadmap

One of Five Co-located DIA Events!

CLINICAL TRIAL DISCLOSURE learning the landscape and reading the roadmap

November 13-14, 2007 Hyatt Regency Bonaventure Conference Center and Spa, Weston, FL, USA

PROGRAM CHAIRS This conference will provide practical, pharmaceutical and biotech company-based BARBARA GODLEW, RN experience/advice and a hands-on conference venue for complying with worldwide President and Principal Analyst regulations for public disclosure of clinical trial information. Individuals delivering The FAIRE Company, LLC this conference work inside the industry ensuring company compliance with laws PAMELA ROSE, RN, BSN, ASQ-CMQOE and regulations governing the public disclosure of clinical trial information. Director, Clinical Trial Information Registries, TAP Pharmaceutical Products Inc. Knowledge gained from industry-driven experience cannot be overstated.

PROGRAM COMMITTEE TRACY BECK, PhD This Event is Co-located with 4 other DIA Conferences Global Medical Business Office Consultant; CTR for Added Networking Opportunities! Results Gatekeeper, Eli Lilly and Company MARGARET M. COBB, MD 5 Publication Writing and Building Partnerships Global Leader of J & J Clinical Registry, DIA Outsourcing Summit Johnson & Johnson Pharmaceutical Research Co-located & Development, LLC Events PMI Pharmaceutical SIG/DIA PM SIAC Joint Conference: The Future of Pharmaceutical Project Management – Is a Paradigm Shift Needed? MARY KUSKIN, RPh Director, Regulatory Affairs Winning Strategies for Achieving a Quality EDC Clinical Trial Process: Pharmalink Consulting Inc. Sponsor/CRO, Investigator, IRB Approver and IT/IS GERARD LYNCH Global Manager, AstraZeneca Clinical Trials Website, AstraZeneca JOHN C. McKENNEY, Sr. President & CEO, SEC Associates Inc. WHO SHOULD ATTEND ROBERT PAARLBERG, MS Director, Global Regulatory Policy and Intelligence, Those who will benefit from attending this program include: UCB, Inc. Clinical trial sponsors Pharmaceutical industry and academic MICHAEL RUBISON clinical researchers Senior Director, Global Medical Research Independent investigators Clinical research and development \ and Registration, Abbott Laboratories Biotechnology researchers departments MAUREEN STRANGE Investigator site personnel Investigational review boards/ethics Associate Medical Business Operations Consultant; Regulatory affairs personnel committees CTR Initiated Gatekeeper, Eli Lilly and Company Medical communications groups Clinical quality assurance professionals PATRICIA TEDEN, MBA Independent Consultant MILEN VRABEVSKI, MD Medical Director/CEO, Comac Medical Ltd. THIS PROGRAM WAS DEVELOPED BY THE GOOD CLINICAL PRACTICES AND QUALITY ASSURANCE CLINICAL TRIAL DISCLOSURE WORKING GROUP AND THE CLINICAL RESEARCH, REGULATORY AFFAIRS, AND MEDICAL WRITING SPECIAL INTEREST AREA COMMUNITIES For further information, contact Ellen Diegel, Program Manager Phone +1.215.442.6158 / Fax +1.215.442.6199 VISIT WWW.DIAHOME.ORG FOR% A COMPLETE SCHEDULE OF EVENTS [email protected] DIA, 800 Enterprise Road, Suite 200, Horsham, PA 19044, USA tel: +1-215-442-6100 fax: +1-215-442-6199 email: dia@diahom Continuing Education

The Drug Information Association (DIA) has been reviewed and approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1620 I Street, NW, Suite 615, Washington, DC 20006. The DIA has awarded up to 1.1 continuing education units (CEUs) to participants who successfully complete this program. To receive a statement of credit, please visit www.diahome.org. Detailed instructions on how to complete your credit request and download your certifi- cate will be provided onsite. Disclosure Policy: It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosure will be included in the course materials. Learning Objectives: At the conclusion of this conference, participants should be able to: Name the major stakeholders influencing policymaking regarding the disclo- Discuss the required, proposed and voluntary requirements for clinical sure of clinical trial information trial registration in the United States and other countries described in the Apply for a ClinicalTrials.gov protocol registration account workshop Describe how, where, and when to publicly register a clinical trial and to post Describe the clinical trial lifecycle and the relevance to clinical trial clinical trial results disclosure Plan a clinical trial disclosure process appropriate for their company use Explain the relationship between registration and the trial publication plan Differentiate relevant differences between major regulations, recommenda- Describe processes for ensuring the company is prepared for audit tions, and guidelines worldwide

Special 5-in-1 Plenary Session! with the role of the market in health care delivery, contractors MONDAY • NOVEMBER 12 as customers, and the very large amounts spent on R&D. Outsourced costs such as CRO contracts and clinical grants 4:00-6:00 PM REGISTRATION represent a very large portion of all drug development spending. Pharmaceutical professionals involved in outsourced activities TUESDAY • NOVEMBER 13 need to understand the role that business plays, and does not play, in the entire process, as well as how the major actors 7:30-8:15 AM REGISTRATION AND involved need to interact with one another. CONTINENTAL BREAKFAST Professor Harold E. Glass has more than twenty-five years’ international 8:15-8:30 AM WELCOME AND OPENING REMARKS experience in business and in the pharmaceutical industry. He is professor of health policy at the University of the Sciences in Philadelphia (USP). USP 8:30-9:15 AM Plenary Session has a long legacy in the pharmaceutical industry dating back to University’s Join your colleagues from all 5 conferences during this special founding in 1821, counting among its distinguished graduates such indus- plenary session featuring keynote speaker Harold Glass, PhD, try giants as Lilly, Wyeth, Rorer, Smith, Kline, Burroughs, Wellcome, followed by a spirited Q&A session. Warner, Lambert, McNeil and many others. He is also senior research fel- low at the Centre for Evidence Based Policy at Queen Mary, University of Added Feature! London. Shared refreshment breaks, luncheons, and networking reception Dr. Glass holds a MSc (Econ.) from the London School of Economics and a allow for extensive multidisciplinary networking opportunities PhD from the University of North Carolina. He has served on the faculties among attendees. of the University of North Carolina and University of Zurich, and has pub- lished widely in the areas of business strategy and drug development. Keynote Address Professor Glass is the founder of DataEdge, LLC, which he sold in 2001 to DRUG DEVELOPMENT AS A BUSINESS: THE ROLE OF IMS Health. DataEdge was a company focusing on drug development and OUTSOURCING pharmaceutical marketing. Harold Glass, PhD, Professor, Health Policy, University of the Sciences in Philadelphia; President, TTC, LLC 9:15-9:45 AM Q&A Session with Keynote Speaker Pharmaceutical drug development is part of a distinctive global

business, distinguished by: the interaction of health care equity 9:45-10:15 AM REFRESHMENT BREAK

Statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of information, in any type of media, is prohibited at all DIA events without prior written consent from DIA.

2 Program Agenda for Clinical Trial Disclosure

10:15-10:30 AM WELCOME FROM with transparency of clinical trial registration and results disclosure. PROGRAM CHAIRPERSONS This overview will include US federal and state legislation, interna- Barbara Godlew, RN tional policies and institutional agreements for both required and vol- President and Principal Analyst untary compliance, and the key issues that have driven clinical trial The FAIRE Company, LLC transparency. The international research and regulatory community Pamela Rose, RN, BSN, ASQ-CMQOE has responded with a large array of databases and database stan- Director, Clinical Trial Information Registries dards proposed by international, national, regional healthcare and TAP Pharmaceutical Products Inc. regulatory groups, pharmaceutical companies, academic institutions, professional societies, patient advocate and therapeutic specialty groups. 10:30 AM-12:00 PM SESSION 1 KEY MILESTONES AND ISSUES: A CHRONOLOGICAL HISTORY OF CLINICAL TRIAL LANDSCAPE AND LIFECYCLE: CLINICAL TRIAL DISCLOSURE THE RELATIONSHIP BETWEEN DISCLOSURE AND THE Gerard Lynch TRIAL PUBLICATION PLAN Michael Rubison, PhD CHAIRPERSONS Barbara Godlew, RN Robert Paarlberg, MS 3:00-3:30 PM REFRESHMENT BREAK Director, Global Regulatory Policy and Intelligence, UCB, Inc.

The relationship between clinical trial disclosure and the publication 3:30-5:00 PM SESSION 3 plan for congress abstracts/posters and completed study manuscript are closely intertwined. This session will examine some of the aspects AFTER THE TRIAL IS COMPLETED: WHAT, WHEN, clinical teams should consider when writing a study protocol as well WHERE, AND HOW TO POST TRIAL RESULTS as identifying key stakeholders to include in the publication planning CHAIRPERSONS process. Attendees will also gain knowledge on how the patients, Tracy Beck, PhD families, and advocates view public disclosure of clinical trial proto- Global Medical Business Office Consultant; CTR Results cols and results and how public disclosure may impact publication Gatekeeper, Eli Lilly and Company planning. Milen Vrabevski, MD Medical Director/CEO, Comac Medical Ltd. FROM THE EDITOR’S DESK: HOW MUCH IS TOO MUCH? The biopharmaceutical industry has used clinical trial registries and Paul W. Ladenson, MD Editor-in-Chief, The Journal of Clinical Endocrinology & results databases as one way to increase clinical trial transparency and Metabolism, The Endocrine Society public trust. Up until recently, the emphasis has been on registering trials at initiation, but now the focus has shifted towards disclosing LANDSCAPES AND LIFECYCLES: FROM THE PERSPECTIVE OF THE results. This session will examine external stakeholders who are shap- PUBLICATION PLAN ing the landscape of trial disclosure and what potholes to look out Barbara Godlew, RN for. Attendees will learn what, when, and how to post results sum- Robert Paarlberg, MS maries, as well as how to avoid risks of off-label promotion when creating the summaries for public disclosure. THE PATH TOWARDS ACCESS AND TRANSPARENCY: THE PATIENTS’ POINT OF VIEW BRIEF OVERVIEW OF CURRENT REQUIREMENTS FOR POSTING Pat Furlong RESULTS President, Parent Project Muscular Dystrophy Pamela Rose, RN, BSN, ASQ-CMQOE

WHAT, WHERE, AND HOW TO POST RESULTS 12:00-1:30 PM LUNCHEON Tracy Beck, PhD

HOW TO AVOID THE RISKS OF OFF-LABEL PROMOTION IN RESULTS SUMMARIES 1:30-3:00 PM SESSION 2 Bob Naidus, JD STAKEHOLDER STREET MAPS: A WORLDWIDE OVERVIEW Senior Pharmaceutical Counsel, Novartis Pharmaceuticals TO CLINICAL TRIAL DISCLOSURE Corporation CHAIRPERSONS Gerard Lynch 5:30-6:45 PM NETWORKING RECEPTION Global Manager, AstraZeneca Clinical Trials Website SPONSORED BY THE GOOD CLINICAL PRACTICES Michael Rubison, PhD AND QUALITY ASSURANCE CLINICAL TRIAL Senior Director, Global Medical Research and Registration, Abbott Laboratories DISCLOSURE WORKING GROUP AND THE CLINICAL RESEARCH, REGULATORY AFFAIRS AND This session provides an introduction to the major themes of the con- MEDICAL WRITING SPECIAL INTEREST AREA ference and provides an overview of the laws and policies associated COMMUNITIES

3 WEDNESDAY • NOVEMBER 14 biopharmaceutical company, and a device company developed their clinical trial disclosure business process.

7:30-8:30 AM REGISTRATION AND HERDING BIG PHARMA CATS … CONTINENTAL BREAKFAST Margaret M. Cobb, MD, PhD

SMALL PHARMA: THE CATS WITH MANY HATS 8:30-10:00 AM SESSION 4 Anthony K. Taylor, Sr. READING AND FOLLOWING THE ROAD MAP: PUBLIC Clinical Operations Coordinator, Targanta Therapeutics Corporation REGISTRATION OF CLINICAL PROTOCOL INFORMATION CHAIRPERSONS A DEVICE COMPANY AND COMBINATION PRODUCTS Tracy Hegarty PERSPECTIVE External Affairs Operations Manager, Novartis Pharmaceuticals Lisa Griffin Vincent, PhD, MA Company Senior Director, Corporate Clinical Research & Development, Maureen Strange Medtronic Inc. Associate Medical Business Operations Consultant; CTR Initiated Gatekeeper, Eli Lilly and Company

Passed, pending, and proposed clinical trial registry legislation pro- 12:00-1:30 PM LUNCHEON vides an array of confusing and sometimes conflicting articles and requirements for both the end users and the registry administrators. This session will provide attendees with clarity on recent develop- 1:30-3:00 PM SESSION 6 ments in federal legislation and challenges the staff at the National ARE YOU READY? PREPARING FOR AUDIT OF CLINICAL Library of Medicine face in complying with the requirements. TRIAL DISCLOSURES Attendees will also gain knowledge in the functional use of CHAIRPERSONS ClinicalTrials.gov as we build a record in the registry, step-by-step, and John C. McKenney, Sr. answer audience questions during this process. President & CEO, SEC Associates Inc. Pamela Rose, RN, BSN, ASQ-CMQOE FINDING AND UNFOLDING THE MAP: LEGISLATION SURROUNDING CLINICALTRIALS.GOV State of Maine regulations require that publicly disclosed clinical Rebecca Williams, PharmD trial information must be “reliable, accurate and true.” The FDA Assistant Director, ClinicalTrials.gov, National Library Revitalization Act bill currently pending in Congress declares that clinical of Medicine trial registry and results database information “shall not be false or misleading in any particular.” Finally, the IFPMA statement on clinical YES! YOU CAN REGISTER A TRIAL TO CLINICALTRIALS.GOV trial disclosure calls for companies to “establish a process of verification” WITHOUT A GLOBAL POSITIONING SYSTEM AND WE’LL SHOW and to “make public how they will adhere to” the standards defined YOU HOW!!! Nick Ide in the statement. Collectively, these statements build a compelling argu- Technical Lead and Chief Architect of ClinicalTrials.gov, ment for instituting a robust audit program to assess your organization’s National Library of Medicine trial disclosures. This session includes an overview of the key components (assistance provided by Tracy Hegarty and Maureen Strange) comprising a sound clinical trial disclosure audit. The highlight of the session consists of a panel discussion featuring industry professionals who have been audited or have conducted audits of clinical trial dis-

10:00-10:30 AM REFRESHMENT BREAK closures. Attendees are invited to come armed with their most pressing questions to pose to our panelists on this timely and critical topic. Participants will leave this session with increased understanding and

10:30 AM-12:00 PM SESSION 5 appreciation of how to prepare for, and what to expect during, a clinical disclosure audit. HERDING CATS THROUGH CANYONS: DEVELOPING A COMPANY PROCESS FOR PUBLIC DISCLOSURE PANELISTS CHAIRPERSONS Margaret M. Cobb, MD, PhD Auditee Perspective Global Leader of J & J Clinical Registry, Johnson & Johnson Shawn M. Pelletier Pharmaceutical Research & Development, LLC Associate Director R&D Operations, Patricia Teden, MBA Bristol-Myers Squibb Company Independent Consultant Valerie V. Phillips, MA Manager Clinical Trial Disclosure, Pfizer Inc Creating a business process that is accurate, predictable, and capable of meeting the changing needs for disclosing information about clinical trials Auditor Perspective in multiple study registries and results databases is difficult. Companies John C. McKenney, Sr. need to leverage their current clinical trial process, determine if the disclo- Beat E. Widler, PhD sure steps will be centralized or decentralized, determine how much to Global Head of Clinical Quality Assurance leverage technology, and decide whether, and how, to use outside F. Hoffmann-La Roche resources. During this session, we will hear how a large pharma, a small

4 3:00-3:30 PM REFRESHMENT BREAK individuals’ experiences along this path to share the practical aspects of balancing regulation compliance with presentation of meaningful information on clinical trial databases. 3:30-4:30 PM SESSION 7 ARE WE MEETING THE NEEDS OF PATIENT GROUPS? MERALDS OF XPERIENCE “E E ” Jacqueline Sayers, MBA, PhD Global Head of Quality Products, Pharma Development AVOIDING ACCIDENTS: CLINICAL TRIAL DISCLOSURE Roche Products Ltd LESSONS LEARNED CHAIRPERSON THE PROPOSED PUBLIC CLINICAL TRIAL DATABASE IN FRANCE Mary Kuskin, RPh Mary Kushkin, RPh Director, Regulatory Affairs, Pharmalink Consulting Inc. Director, Regulatory Affairs Pharmalink Consulting Inc. The field of clinical trial disclosure has expanded dramatically in the last ten years. There has been a steady increase in the reach of stakeholders, regulations and experience on a global scale. The 4:30 PM CONFERENCE ADJOURNED strategy for posting and maintaining clinical trial information finds a place in the overall development and lifecycle strategy for biopharmaceutical and medical device companies. This session will highlight

TRAVEL AND HOTEL The most convenient airport is Fort Lauderdale/Hollywood UNITED AIRLINES & US AIRWAYS International Airport and attendees should make airline reservations as early as Save through Area Pricing and Discount Fees possible to ensure availability. The Hyatt Regency Bonaventure Conference Center and Spa is holding a block of rooms at the reduced rate below until To obtain schedule information and the best fares, call United Airlines’s October 22, 2007, for the DIA event attendees. Room availability at this rate Specialized Meeting Reservations Center at 1-800-521-4041. Make sure you is guaranteed only until this date or until the block is filled. refer to Meeting ID Number 571AK. Dedicated reservationists are on duty 7 days a week from 8:00 AM to 10:00 PM EST. Single $189 Double $214 This special offer applies to travel on domestic segments of all United Airlines, Please contact the Conference Center by telephone at +1-954-616-1234 or United Express, PED, and United code share flights (UA*, operated by US +1-800-233-1234 and mention the DIA event. The hotel is located at 250 Airways, US Airways Express and Air Canada). Racquet Club Road, Weston, FL 33326, USA.

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5 Drug Information Association www.diahome.org CLINICALCLINICAL TRIAL TRIAL DISCLOSURE DISCLOSURE learning the landscape and reading the roadmap

Hyatt Regency Bonaventure Conference 5 Co-located Events for Added Networking Opportunities! Center and Spa, Weston, FL, USA DIA Outsourcing Summit NOVEMBER 13-14, 2007 | Event ID #07039 Publication Writing and Building Partnerships PMI Pharmaceutical SIG/DIA PM SIAC Joint Conference: The Future of Pharmaceutical Project Management – Is a Paradigm Shift Needed? Winning Strategies for Achieving a Quality EDC Clinical Trial Process

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GROUP DISCOUNTS (not available online or on already discounted fees) Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. See page 5 for complete details.

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