Successfully Marketing Clinical Trial Results Winning in the Healthcare Business - PDF

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					 Call for Abstracts                                           CLINICAL TRIAL DISCLOSURE
“Emeralds of Experience”
     presentations                                            learning the landscape and
 DUE BY     SEPTEMBER 17, 2007                                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
Associate Director, Publication Coordination
                                                              regulations for public disclosure of clinical trial information. Individuals delivering
and Transparency Compliance Exploratory
Development Communications, Novartis                          this conference work inside the industry ensuring company compliance with laws
Pharmaceuticals Corporation                                   and regulations governing the public disclosure of clinical trial information.
PAMELA ROSE, RN, BSN, ASQ-CMQOE                               Knowledge gained from industry-driven experience cannot be overstated.
Director, Clinical Trial Information Registries,
TAP Pharmaceutical Products Inc.

PROGRAM COMMITTEE                                                              This Event is Co-located with 4 other DIA Conferences
TRACY BECK, PhD                                                                     for Added Networking Opportunities!
Global Medical Business Office Consultant; CTR
Results Gatekeeper, Eli Lilly and Company                                                Publication Writing and Building Partnerships
                                                              cated                      DIA Outsourcing Summit
                                                         Co-lo ts
Global Leader of J & J Clinical Registry,                                                PMI Pharmaceutical SIG/DIA PM SIAC Joint Conference: The Future of
Johnson & Johnson Pharmaceutical Research                  Even                          Pharmaceutical Project Management – Is a Paradigm Shift Needed?
& Development, LLC
                                                                                         Winning Strategies for Achieving a Quality EDC Clinical Trial Process:
MARY KUSKIN, RPh                                                                         Sponsor/CRO, Investigator, IRB Approver and IT/IS
Director, Regulatory Affairs
Pharmalink Consulting Inc.

Global Manager, AstraZeneca Clinical Trials
Website, AstraZeneca                                           WHO SHOULD ATTEND
JOHN C. McKENNEY, Sr.                                          Those who will benefit from attending this program include:
President & CEO, SEC Associates Inc.
ROBERT PAARLBERG, MS                                             Clinical trial sponsors                                Pharmaceutical industry and academic
Director, Global Regulatory Policy and Intelligence,             Independent investigators                              clinical researchers
UCB, Inc.                                                        Biotechnology researchers                              Clinical research and development departments
                                                                 Investigator site personnel                            Investigational review boards/ethics
Senior Director, Global Medical Research                         Regulatory affairs personnel
and Registration, Abbott Laboratories                                                                                   Clinical quality assurance professionals
                                                                 Medical communications groups
Associate Medical Business Operations Consultant;
CTR Initiated Gatekeeper,
Eli Lilly and Company

PATRICIA TEDEN, MBA                                                         See page 5 for Suggested Abstract Topics and
Independent Consultant                                                            Abstract Submission Guidelines
Medical Director/CEO, Comac Medical Ltd.

                                                              THIS PROGRAM WAS DEVELOPED BY THE GOOD CLINICAL PRACTICES
                                                              AND QUALITY ASSURANCE CLINICAL TRIAL DISCLOSURE WORKING
                                                              G R O U P A N D T H E C L I N I C A L R E S E A R C H , R E G U L AT O RY A F FA I R S , A N D
For further information, contact                              MEDICAL WRITING SPECIAL INTEREST AREA COMMUNITIES
Ellen Diegel, Program Manager
Phone +1.215.442.6158 / Fax +1.215.442.6199
                                                                                             COMPLETE SCHEDULE OF EVENTS!
                                                                 VISIT WWW.DIAHOME.ORG FOR A %                               DIA, 800 Enterprise Road, Suite 200, Horsham, PA 19044, USA tel: +1-215-442-6100 fax: +1-215-442-6199 email:
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 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 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 !
                         MONDAY • NOVEMBER 12                                                with the role of the market in health care delivery, contractors
                                                                                             as customers, and the very large amounts spent on R&D.
  4:00-6:00   PM         REGISTRATION                                                        Outsourced costs such as CRO contracts and clinical grants
                                                                                             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
  7:30-8:15   AM        REGISTRATION AND                                                     play, in the entire process, as well as how the major actors
                        CONTINENTAL BREAKFAST                                                involved need to interact with one another.
                                                                                             Professor Harold E. Glass has more than twenty-five years’ international
                                                                                             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!
  Shared refreshment breaks, luncheons, and networking reception                             Dr. Glass holds a MSc (Econ.) from the London School of Economics and a
                                                                                             PhD from the University of North Carolina. He has served on the faculties
  allow for extensive multidisciplinary networking opportunities
                                                                                             of the University of North Carolina and University of Zurich, and has pub-
  among attendees
                                                                                             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
                                                                                             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

Program Agenda for Clinical Trial Disclosure
   10:15-10:30     AM    WELCOME FROM PROGRAM CHAIRPERSONS                                                          Pamela Rose, RN, BSN, ASQ-CMQOE
                         Barbara Godlew, RN                                                                         Director
                         Associate Director, Publication                                                            Clinical Trial Information Registries
                         Coordination and Transparency Compliance                                                   TAP Pharmaceutical Products Inc.
                         Exploratory Development Communications
                         Novartis Pharmaceuticals Corporation

10:30 AM-12:00 PM SESSION 1                                                        UNDERSTANDING A NEW STREET MAP: FDA REVITALIZATION
                                                                                   ACT AND CLINICAL TRIAL DISCLOSURE FROM A LEGISLATURE'S
CLINICAL TRIAL LANDSCAPE AND LIFECYCLE:                                            POINT OF VIEW
THE RELATIONSHIP BETWEEN DISCLOSURE AND                    THE                     Speaker Invited
CHAIRPERSONS                                                                   3:00-3:30   PM      REFRESHMENT BREAK
Barbara Godlew, RN
Robert Paarlberg, MS                                                           3:30-5:00   PM      SESSION 3
Director, Global Regulatory Policy and Intelligence, UCB, Inc.
                                                                               AFTER THE TRIAL IS COMPLETED: WHAT, WHEN,
The relationship between clinical trial disclosure and the publication         WHERE, AND HOW TO POST TRIAL RESULTS
plan for congress abstracts/posters and completed study manuscript             CHAIRPERSONS
are closely intertwined. This session will examine some of the aspects
                                                                               Tracy Beck, PhD
clinical teams should consider when writing a study protocol as well           Global Medical Business Office Consultant; CTR Results
as identifying key stakeholders to include in the publication planning         Gatekeeper, Eli Lilly and Company
process. Attendees will also gain knowledge on how the patients,
                                                                               Milen Vrabevski, MD
families, and advocates view public disclosure of clinical trial proto-        Medical Director/CEO, Comac Medical Ltd.
cols and results and how public disclosure may impact publication
planning.                                                                      The biopharmaceutical industry has used clinical trial registries and
                                                                               results databases as one way to increase clinical trial transparency
    FROM     THE   EDITOR’S DESK: HOW MUCH        IS   TOO MUCH?               and public trust. Up until recently, the emphasis has been on reg-
    Paul W. Ladenson, MD                                                       istering trials at initiation, but now the focus has shifted towards dis-
    Editor-in-Chief, The Journal of Clinical Endocrinology &                   closing results. This session will examine external stakeholders who
    Metabolism, The Endocrine Society                                          are shaping the landscape of trial disclosure and what potholes to
                                                                               look out for. Attendees will learn what, when, and how to post
    LANDSCAPES AND LIFECYCLES: FROM         THE   PERSPECTIVE    OF THE        results summaries, as well as how to avoid risks of off-label promo-
    PUBLICATION PLAN                                                           tion when creating the summaries for public disclosure.
    Barbara Godlew, RN
    Robert Paarlberg, MS                                                           BRIEF OVERVIEW     OF   CURRENT REQUIREMENTS      FOR   POSTING
    THE PATH TOWARDS ACCESS AND TRANSPARENCY:                                      Pamela Rose, RN, BSN, ASQ-CMQOE
    THE PATIENTS’ POINT OF VIEW                                                    WHAT, WHERE,      AND   HOW   TO   POST RESULTS
    Pat Furlong                                                                    Tracy Beck, PhD
    President, Parent Project Muscular Dystrophy
                                                                                   HOW TO AVOID THE RISKS        OF   OFF-LABEL PROMOTION      IN
                                                                                   RESULTS SUMMARIES
12:00-1:30   PM       LUNCHEON
                                                                                   Bob Naidus, JD
                                                                                   Senior Pharmaceutical Counsel, Novartis Pharmaceuticals
1:30-3:00   PM        SESSION 2                                                    Corporation
                                                                               5:30-6:45   PM      NETWORKING RECEPTION
                                                                                                   SPONSORED BY THE GOOD CLINICAL PRACTICES
                                                                                                   AND QUALITY ASSURANCE CLINICAL TRIAL
Gerard Lynch                                                                                       DISCLOSURE WORKING GROUP AND THE
Global Manager, AstraZeneca Clinical Trials Website
                                                                                                   CLINICAL RESEARCH, REGULATORY AFFAIRS AND
Michael Rubison, PhD                                                                               MEDICAL WRITING SPECIAL INTEREST AREA
Senior Director, Global Medical Research and Registration,
Abbott Laboratories
This session provides an introduction to the major themes of the con-
ference and provides an overview of the laws and policies associated                               WEDNESDAY • NOVEMBER 14
with transparency of clinical trial registration and results disclosure.
This overview will include US federal and state legislation, interna-          7:30-8:30   AM      REGISTRATION AND
tional policies and institutional agreements for both required and                                 CONTINENTAL BREAKFAST
voluntary compliance, and the key issues that have driven clinical
trial transparency. The international research and regulatory commu-           8:30-10:00 AM       SESSION 4
nity has responded with a large array of databases and database
standards proposed by international, national, regional healthcare             READING AND FOLLOWING THE ROAD MAP: PUBLIC
and regulatory groups, pharmaceutical companies, academic institu-             REGISTRATION OF CLINICAL PROTOCOL INFORMATION
tions, professional societies, patient advocate and therapeutic                CHAIRPERSONS
specialty groups.                                                              Barbara Godlew, RN
                                                                               Maureen Strange
                                                                               Associate Medical Business Operations Consultant; CTR Initiated
    CLINICAL TRIAL DISCLOSURE                                                  Gatekeeper, Eli Lilly and Company
    Gerard Lynch
    Michael Rubison, Phd                                                       Passed, pending, and proposed clinical trial registry legislation pro-
                                                                               vides an array of confusing and sometimes conflicting articles and

 requirements for both the end users and the registry administrators.                  Pamela Rose, RN, BSN, ASQ-CMQOE
 This session will provide attendees with clarity on recent develop-
                                                                                       State of Maine regulations require that publicly disclosed clinical
 ments in federal legislation and challenges the staff at the National
                                                                                       trial information must be “reliable, accurate and true.” The FDA
 Library of Medicine face in complying with the requirements.
                                                                                       Revitalization Act bill currently pending in Congress declares that clin-
 Attendees will also gain knowledge in the functional use of
                                                                                       ical trial registry and results database information “shall not be false as we build a record in the registry, step-by-step,
                                                                                       or misleading in any particular.” Finally, the IFPMA statement on
 and answer audience questions during this process.
                                                                                       clinical trial disclosure calls for companies to “establish a process of
      FINDING AND UNFOLDING THE MAP: LEGISLATION                                       verification” and to “make public how they will adhere to” the stan-
      SURROUNDING CLINICALTRIALS.GOV                                                   dards defined in the statement. Collectively, these statements build a
      Rebecca Williams, PharmD                                                         compelling argument for instituting a robust audit program to assess
      Assistant Director,, National Library                         your organization’s trial disclosures. This session includes an overview
      of Medicine                                                                      of the key components 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 disclosures. Attendees are invited
      YOU HOW !!!
                                                                                       to come armed with their most pressing questions to pose to our
      Annice Bergeris
      Information Research Specialist, National Library of Medicine                    panelists on this timely and critical topic. Participants will leave this
      (assistance provided by Barbara Godlew and Maureen Strange)                      session with increased understanding and appreciation of how to
                                                                                       prepare for, and what to expect during, a clinical disclosure audit.
 10:00-10:30      AM   REFRESHMENT BREAK
 10:30 AM-12:00 PM SESSION 5                                                                   Auditee Perspective
                                                                                               Shawn M. Pelletier
                                                                                               Associate Director R&D Operations
 COMPANY PROCESS FOR PUBLIC DISCLOSURE                                                         Bristol-Myers Squibb Company
                                                                                               Valerie V. Phillips, MA
 Margaret M. Cobb, MD, PhD                                                                     Manager Clinical Trial Disclosure
 Global Leader of J & J Clinical Registry, Johnson & Johnson                                   Pfizer Inc
 Pharmaceutical Research & Development, LLC
 Patricia Teden, MBA                                                                           Auditor Perspective
 Independent Consultant                                                                        John C. McKenney, Sr.
                                                                                               Beat E. Widler, PhD
 Creating a business process that is accurate, predictable, and capable of
                                                                                               Global Head of Clinical Quality Assurance
 meeting the changing needs for disclosing information about clinical trials
                                                                                               F. Hoffmann-La Roche
 in multiple study registries and results databases is difficult. Companies
 need to leverage their current clinical trial process, determine if the disclo-
 sure steps will be centralized or decentralized, determine how much to                3:00-3:30   PM        REFRESHMENT BREAK
 leverage technology, and decide whether, and how, to use outside
 resources. During this session, we will hear how a large pharma, a small              3:30-5:00   PM        SESSION 7
 biopharmaceutical company, and a device company developed their clini-
 cal trial disclosure business process.
                                                                                       “EMERALDS        OF   EXPERIENCE”
      HERDING BIG PHARMA CATS …                                                        AVOIDING ACCIDENTS: CLINICAL TRIAL DISCLOSURE
      Margaret M. Cobb, MD, PhD                                                        LESSONS LEARNED
      Anthony K. Taylor, Sr.                                                           Mary Kuskin, RPh
      Clinical Operations Coordinator, Targanta Therapeutics                           Director, Regulatory Affairs, Pharmalink Consulting Inc.
      Corporation                                                                      The field of clinical trial disclosure has expanded dramatically in
                                                                                       the last ten years. There has been a steady increase in the reach
      Lisa Griffin Vincent, PhD, MA                                                    of stakeholders, regulations and experience on a global scale. The
      Senior Director, Corporate Clinical Research & Development,                      strategy for posting and maintaining clinical trial information finds a
      Medtronic Inc.                                                                   place in the overall development and lifecycle strategy for biophar-
                                                                                       maceutical and medical device companies. This session will highlight
 12:00-1:30   PM       LUNCHEON                                                        individuals’ experiences along this path to share the practical aspects
                                                                                       of balancing regulation compliance with presentation of meaningful
 1:30-3:00   PM        SESSION 6                                                       information on clinical trial databases.
 CHAIRPERSONS                                                                          5:00   PM             CONFERENCE ADJOURNED
 John C. McKenney, Sr.
 President & CEO, SEC Associates Inc.

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.
  “Emeralds of Experience” Information
The Drug Information Association (DIA) is offering a unique opportunity for presenters at                 The Clinical Trial Disclosure “Emeralds of Experience” session is sched-
the DIA Clinical Trial Disclosure conference in Weston, FL.                                               uled for Wednesday, November 14, 2007 at 3:30 pm.
A podium session will provide those in the clinical trial disclosure field an opportunity to              Those interested in participating in the 15-minute podium presentation
share their successes, challenges, and “Emeralds of Experience” on various topics with                    session should submit an abstract on the topic and information that
their DIA Clinical Trial Disclosure colleagues. Participants can share their experiences and              will be presented. Due to the limited time available for podium presen-
“emeralds” by developing a 15-minute presentation.                                                        tations, only 4 (four) “Emeralds” will be accepted. A subset of the
Suggested Abstract Topics:                                                                                program committee will review and select from the topics submitted,
                                                                                                          if necessary. For those interested in submitting a poster, authors
   Stakeholder Street Maps: A Worldwide Overview to Clinical Trial Disclosure Law
                                                                                                          should submit an abstract according to the Guidelines for Abstract
   Reading and Following the Road Map: Public Registration of Clinical Protocol
                                                                                                          Submission below.
   After the Trial is Completed: What, When, Where, and How to Post Trial Results                         DEADLINE FOR SUBMISSIONS IS SEPTEMBER 17, 2007.
   Clinical Trial Landscape and Lifecycle: The Relationship between Registration and
   the Trial Publication Plan                                                                             ALL ENTRIES MUST BE SUBMITTED ONLINE.
   Herding Cats through Canyons: Developing a Company Process for Public Disclosure             
   Are You Ready? Preparing for Audit of Public Disclosure Processes                                      AbstractSubmissionLauncher.aspx

  Guidelines for Abstract Submission
All abstracts must be received by September 17, 2007. Authors of selected abstracts                       1. At time of electronic submission of abstracts, all speakers must
will be notified by September 28, 2007. Please provide the following information                             complete the speaker disclosure section of the electronic submission
using the online abstract form:                                                                              form.
                                                                                                          2. Preference will be given to submitted abstracts that address real-life
                                                                                                             applications and case studies.
SPEAKER NAME (Degrees, job title)                                                                         3. Final PowerPoint presentation for all accepted abstracts will be due
AFFILIATION (Mailing address, phone number, fax number, eMail)                                               to DIA by October 23, 2007 to be reviewed by the committee and
                                                                                                             included in the attendee registration packet. Should you choose to
PRESENTATION TITLE                                                                                           submit an abstract for consideration, please mark your calendars
SUMMARY (approximately 2-3 sentences) suitable for inclusion in preliminary program,                         with this deadline.
if selected                                                                                               4. Final PowerPoint presentations for all accepted abstracts may have
LEARNING OBJECTIVES (Please provide two learning objectives to inform the learner                            a company logo on slide number one. Any company logo appearing
of what he/she should be able to do after attending your session.                                            on any other slides will be removed by DIA.
                                                                                                          5. Time allotted for individual presentations will be approximately
ABSTRACT (300 words or less)                                                                                 15-20 minutes. Final timing will be determined by the session chair
                                                                                                             and based on the number of presentations selected for the session.
DISCLOSURE INFORMATION                                                                                    6. DIA will provide complimentary conference attendance for the
All speakers must disclose any significant financial interest or other relationship                          selected presenter.
with the manufacturer(s) of any commercial product(s) and/or providers of commercial                      7. Please note: Only one presenter per presentation will be allowed.
services discussed in an educational presentation, as well as any discussion of                              Any exceptions to this policy must be discussed with the DIA office
unlabeled or unapproved drugs or devices.                                                                    in advance.

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         Drug Information Association                                                                                                                                 

CLINICAL TRIAL DISCLOSURE                                                                                                                                             CALL FOR ABSTRACTS
                                                                                                                                                             “Emeralds of Experience” presentations
learning the landscape and                                                                                                                                          DUE BY SEPTEMBER 17

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