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PROUDLY PRESENTS rd Annual
Sponsors: Association Partner:
January 14-15, 2008Sheraton Crystal City
Arlington, VA
Clinical Data Disclosure Summit
3
Featured Presentations: GSK CASE STUDYThe Impact of Data Disclosure: GSK’s Experience with Clinical Research TransparencyCraig A. Metz, PhD, Vice President, CEDD Regulatory Affairs, GLAXOSMITHKLINE
FEDERAL LEGISLATIONThe Impact of the FDA Amendments Act and Understanding the Consequences of ViolationBret Koplow, PhD, JD, Partner, PATTON BOGGS
DO YOU COMPLY?Strategies for Measuring Clinical Trial Registration and Results Database Compliance on a Global Scale Mike Rubison, PhD, Senior Director, Global Medical Research & Registration, ABBOTT LABORATORIES
Implementing and Maintaining Compliant Trial Registries and Results Databases for Drugs, Biologics and Medical Devices
Highly Interactive Sessions:PRE-CONFERENCE WORKSHOPA Scalable Approach to Trial Registration and Results Disclosure: A Practical Primer on Preparing Your Company for Affordable and Compliant Data Disclosure
ASK THE NIH An Interactive Presentation on ClinicalTrials.gov - Current and Planned Features and Requirements
Keynote PresentationPUBLICATION PERSPECTIVE Understanding and Remaining Compliant with the ICMJE’s Data Disclosure Requirements Christine Laine, MD, MPH, Senior Deputy Editor, ANNALS OF INTERNAL MEDICINE, ICJME Secretariat
Dynamic Panel Discussions Answer the Following QuestionsWhat is the Purpose of the Data Disclosure Initiative? Are we Achieving It?
How to Leverage Technology to Support your Clinical Data Disclosure Solutions?
CALL 866-207-6529 OR VISIT US AT WWW.EXLPHARMA.COMPRICES INCREASE AFTER NOVEMBER 30TH
JANUARY 14-15, 2008 · ARLINGTON VA
3rd Annual Clinical Data Disclosure Summit
CALL 866-207-6529 OR VISIT US AT WWW.EXLPHARMA.COM
Who Should Attend?
Heads, Vice Presidents, Directors, & Managers from the following departments:- Clinical Trial Registries/Data Disclosure/Trial Registration - Regulatory Affairs / Compliance / Development - Medical Writing- Medical Information / Knowledge Management- Medical Communication - Medical Affairs- Clinical Trial Information - Clinical Operations - Clinical R&D / Clinical Research / Clinical Development - Clinical Affairs - Clinical Quality Assurance
This conference is also of interest to:- CROs - Trial Registries and Results Hosting Companies - Technology Vendors to Facilitate Clinical Data Disclosure - Independent Investigators- Investigator Site Personnel - Investigational Review Boards / Ethics Committees
Dear Colleague
Kristen Hunter, ExL Pharma, [email protected]
Hotel InformationSheraton Crystal City1800 Jefferson Davis Highway · Arlington, VA 22202 · (703) 486-1111
This boutique-style hotel is nestled in the heart of Crystal City adja-cent to the Crystal City Metro, minutes from Reagan National Airport, Washington DC and Alexandria, VA. The Sheraton Crystal City offers a complimentary shuttle to and from Reagan National Airport. Please contact the hotel directly for more information.
Room ReservationsIf you require overnight accommodations, please contact the Sheraton Crystal City at 703-486-1111 to book your room. ExL has reserved a block of rooms at a discounted rate for conference participants. Please men-tion ExL Pharma and the conference name to take advantage of this discount. You must book your room BEFORE FRIDAY DECEMBER 21st to be eligible for the discounted rate. Please book your room early as the rooms available at this rate are limited.
Sponsorship and Exhibiting Opportunities
Showcase your organization’s products and services to the senior-level audience
at this event. Our experienced sales representatives will work closely with you to
custom-design a package to suit all of your company’s needs. To take advantage of
these branding opportunities and learn more about how to most effectively pitch
your specific product to this audience of potential clients, please contact Sales
Director, Tom McDonough at 212-400-6242 or [email protected].
In 2007 the pressure to disclose clinical data for drug, biologic and medical device companies reached an all-time high. Clinical data disclosure requirements and recommendations have been issued by federal and state governments, international regulatory authori-ties, WHO and journal editors. In addition, several high profile cases and reports bringing into question drug safety have surfaced, fuel-ing the argument for fully transparent trials.
Responding to the increased regulations a significant portion of ExL Pharma’s 3rd Clinical Data Disclosure Summit is dedicated to un-derstanding the various regulations and requirements, both nation-ally and internationally, and strategies for determining whether your company is in compliance. The remainder of the conference features case study presentations from large and small pharma as well as de-vice companies showcasing how they’ve handled data disclosure.
For two years ExL’s Clinical Data Disclosure Summit has success-fully brought together industry executives to discuss various strate-gies for publicizing clinical data while exploring the positive and negative ramifications. Following a year of much media attention and increased requirements for data disclosure, our third event promises to be our best yet.
I look forward to seeing you in January.Sincerely,
Conference Agenda• Identifying the Act’s implications and the potential consequences of non-compliance• Recognizing the Act’s impact on State-level clinical trial registry and results database requirements
Country Specific Requirements1:45 Identifying the Required, Proposed and Voluntary Clinical Trial Disclosure Specifications in Various Countries • Making sense of the inconstancies in international requirements · Which countries have mandatory data disclosure laws with enforced consequences for non-compliance · Countries with pending legislation · Recent important changes in regulations• Optimizing international regulatory intelligence gathering • Locations where ethics committees/IRBs act as registration enforcers
Do You Comply?2:15 Strategies for Measuring Clinical Trial Registration and Results Database Compliance on a Global Scale Mike Rubison, PhD, Senior Director, Global Medical Research & Registration, ABBOTT LABORATORIES
• What elements are measured to determine level of compliance?• Is it possible to be compliant with all the regulations? Is that ideal? Is it practical? • Identifying the challenges when measuring degree of compliance • Assigning responsibility for measuring and maintaining compliance • Conducting internal audits of registry compliance
3:00 NetworkiNg & refreshmeNt Break
Ask The NIH 3:30 An Interactive Presentation on ClinicalTrials.gov - Current and Planned Features and Requirements Nicholas Ide, Chief Architect, clinicaltrials.gov, NATIONAL INSTITUTES OF HEALTH
• Understanding trial registration • The impact of FDARA on the registry• Handling of trial results as mandated by FDARA
Panel Discussion4:15 Utilizing Technology to Create Clinical Data Disclosure Solutions moderator:
Rick Ward, Vice President, Business Development, VERITAS PaNelists:
Joseph P. Brennan, Director, Medical Knowledge Management Technical Services, JOHNSON & JOHNSON John McKenney, President & CEO, SEC ASSOCIATES, INC.Scott Moore, Associate Director, Development eSubmissions, GENENTECH
• Various technology implementation options that support data disclosure process · Implementing an enterprise-wide system automating registry and results posting · Integrating patient-response mechanisms with developed internal system• Strategies for utilizing technology to define and increase compliance
Monday, January 14th
8:00 registratioN aNd Breakfast for workshoP PartiCiPaNts
9:00 A Scalable Approach to Trial Registration and Results Disclosure: A Practical Primer on Preparing Your Company for Affordable and Compliant Data Disclosure John McKenney, President & CEO, SEC ASSOCIATES, INC. Mike Rubison, PhD, Senior Director, Global Medical Research & Registration, ABBOTT LABORATORIES Pat Teden, MBA, INDEpENDENT CONSULTANT
• What needs to be done? What are the requirements and regulations?• Trial registration · Where is the data to register? · When and where should this occur? · What infrastructure and operational process do I need in place? · How can I be sure no trials are ‘falling through the cracks’? Advice for handling studies for newly acquired/merged companies, and for partnership-sponsored studies.• Results databases · What are the requirements? What are my options? · How do I ensure/enforce consistency? · How do I handle proprietary information and avoid promotional language? · How does results disclosure impact publication?• Developing a deployment strategy: Centralized or decentralized operations? Manual or technology-enabled process? Insource or outsource operations? Internal audit and/or external audit? • How do I stay current with the evolving regulations and expectations?• Useful tools and templates will be provided to workshop participants
10:45 NetworkiNg & refreshmeNt Break
12:00 luNCh for workshoP atteNdees
Main Conference Begins 12:00 registratioN oPeNs for maiN CoNfereNCe
1:00 Chairperson’s Welcome Pamela Rose, RN, BSN, Director, Clinical Trial Information Registries,
TAp pHARMACEUTICAL pRODUCTS, INC.
The Newly Enacted Federal Legislation1:05 Understanding the New Regulatory Requirements for Drug, Biologic and Medical Device Clinical Trial Regis-tration and Results Data Banks and the Potential Liability for Non-ComplianceBret Koplow, PhD, JD, Partner, pATTON BOGGS
• Anticipating the statutory and regulatory mandates under the Food and Drug Administration Amendments Act of 2007• The products and studies covered, procedures required, and timelines for implementation
Interactive Workshop
Implementing & Maintaining Compliant Trial Registries & Results Databases for Drugs, Biologics & Medical Devices3rd Annual Clinical Data Disclosure Summit
5:00 ROUNDTABLES Each attendee chooses their preferred topic to discuss in an intimate set-ting. Attendance per table is limited. Roundtable moderators summarize discussion points to entire group the following morning.
1. How does clinical data disclosure impact patient recruitment? 2. What value does inclusion of Phase I information provide and to whom? 3. What is going to happen with the pending and current state regulations over the next three years? 4. What will the impact of the new results database legislation have on pub lishing clinical trial manuscripts?5. What is the impact of the new legislation on nonIND trials?6. What are the positive long-term outcomes of FDARA?
6:00 CoNClusioN of day oNe
8:00 Breakfast & Coffee
9:00 Chairperson’s Introduction Pamela Rose, RN, BSN, Director, Clinical Trial Information Registries,
TAp pHARMACEUTICAL pRODUCTS, INC.
9:05 Key Points from Roundtable Discussions Each roundtable moderator share the key elements from the previous day’s discussion
Competitive Intelligence9:45 Utilizing Competitor’s Registries & Results Databases to Benchmark Performance, Influence Trial Design and Better Position the ProductShacker Mourad, RPh, MBA, Director, Strategy Analysis and Intelligence ASTRAZENECA
• Determining what information must be disclosed and what is competi- tive information • How to identify recruitment competition and determine best location• Strategies for utilizing registries and results databases to benchmark against your competition • How information from competitor’s registries and results databases influences · Trial design · Product positioning · Licensing opportunities · Development timelines · Identifying low-cost locales · Product life-cycle management strategies • What counter-intelligence measures can be built into registries and results databases • How are litigation attorneys using this information?
GlaxoSmithKline Case Study10:15 The Impact of Data Disclosure: GSK’s Experience with Clinical Research Transparency Craig A. Metz, PhD, Vice President, CEDD Regulatory Affairs, GLAXOSMITHKLINE
Tuesday, January 15th
10:45 NetworkiNg & refreshmeNt Break
Genentech Case Study11:15 From 0 to 60: Evolution of a System to Address Clinical Trial Registration and Disclosure NeedsScott Moore, Associate Director, Development eSubmissions, GENENTECH
• Identifying the sources of data elements needed for clinical trial registration • Developing an immediate solution/system for posting study records to ClinicalTrials.gov and posting study results• Taking a patched-together solution and building a validated system for maintaining study records for upload to ClinicalTrials.gov• Next steps in evolving the system to take more advantage of feeds from our CTMS and other systems to minimize duplication of metadata
Novo Nordisk Case Study11:45 Leveraging Technology to Generate Structure and De fine Standard Procedures for Trial Data Disclosure Merete Jørgensen, MSc MBA, Project Director, Public Access to Clinical Trials, NOVO NORDISK A/S
• Utilizing technology to build and maintain compliant data disclosure • An example of how the IT infrastructure for trial registration, results and publication disclosure are be built into one integrated system • How the infrastructure supports the underlying process of trials registra- tion/results postings, from data collection through approval and ensur- ing maintenance of the information• How the backend IT system PURE manages the information flow from the internal clinical trials system IMPACT through the trial registry and internal publication database to the external Novo Nordisk clinical trials portal and to www.clincialtrials.gov
12:30 luNCh
Medical Device1:45 Identifying the Unique Device Issues that Impact Trial Registration and Results DisclosureLisa Griffin Vincent, PhD, MA, Senior Director, Corporate Clinical Research & Development, MEDTRONIC
• Unique challenges associated with medical device trial data disclosure · High frequency of changes to the product • Registration and results requirements for both significant and non- significant medical devices• How the competitive nature of device industry does not lend itself to same registration and results disclosure as drugs and biologics • Analyzing the public health benefit of device registries
Keynote Presentation. Publication Perspective2:15 Understanding and Remaining Compliant with the ICMJE’s Data Disclosure Requirements Christine Laine, MD, MPH, Senior Deputy Editor, ANNALS OF INTERNAL MEDICINE, ICJME SECRETARIAT
• Overview of registration progress since initial ICMJE requirements were unveiled and enforced • Analysis of the increased requirements on all trials beginning enrollment after January 1, 2008 · Rationale behind inclusion of Phase I trials in updated requirements · For-profit v. non-profit registers: Is there evidence of bias? • Avoiding synopsis posting results that can preclude publication · Understanding the criteria for previous publication
Panel Discussion3:00 What is the Purpose of the Data Disclosure Initiative? Are we Achieving It? moderator:
Barbara Godlew, RN, President & Principal Analyst, THE FAIRE COMpANY, LLC
PaNelists:
• Alan Goldhammer, PhD, Vice President, Scientific & Regulatory Affairs, PHRMA • Lisa Griffin Vincent, PhD, MA, Senior Director, Corporate Clinical Research & Development, MEDTRONIC• Christine Laine, MD, MPH, Senior Deputy Editor, ANNALS OF INTERNAL MEDICINE, ICJME SECRETARIAT
• Has public perception of the industry been impacted positively or negatively since ICJME released requirements for publication?• Who is benefiting from data disclosure?• Have drugs, biologics & devices become safer since disclosure initiative began? · Does disclosure threaten or promote innovation?• Does publicly disclosed data take some responsibility off of the FDA to ensure drug safety? · Whose responsibility then does it become? The patient? Curious physicians?• Are patients able to more easily find and enroll in trials since the data disclosure initiative?• What is the impact of data disclosure on patients and patient groups?• To what degree are ethics committees/IRBs making use of the registered information?
4:00 CoNfereNCe CoNCludes
Implementing & Maintaining Compliant Trial Registries & Results Databases for Drugs, Biologics & Medical Devices
Questions? Comments?Please contact Program Director Kristen Hunter,
212-400-6241, [email protected]
Five Ways to Register:Fax: 888-221-6750Mail: ExL Events, Inc. 555 8th Ave, Ste 1703 New York, NY 10018Phone: 866-207-6528Online: www.exlpharma.com Email: [email protected]
Registration Fees for Attending ExL’s 3rd Clinical Data Disclosure Summit:EARLY BIRD PRICINGRegister by Friday, November 30th, 2007 to Take Advantage of Early Bird Pricing: Conference + Workshop $1995Conference Only $1695
STANDARD PRICINGRegister After Friday, November 30th: Conference + Workshop $2195Conference Only $1895
ONSITE PRICINGConference + Workshop $2295Conference Only $1995
Group Discount ProgramFor every 3 simultaneous registrations at the standard price
from your company you will receive a 4th registration for FREE! To take advantage, please call 866-207-6528
Make checks payable to ExL Events, Inc. and write code P418 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received by January 11th, 2008.
Cancellations: If you need to cancel your registration for an upcoming ExL conference, please note the following policies derived from the Start Date of the event:Four weeks or more: A full refund (minus a $95 processing fee), or a voucher to another ExL event valid for two years from the voucher issue dateOne to Four weeks: A 50% refund, or a voucher to another ExL event valid for two years from the voucher issue dateWithin the Last Week: A voucher to another ExL event valid for two years from the voucher issue dateTo receive a refund or voucher, please fax your request to 888-221-6750Conference registrations may be transferred to other colleagues in the event you are un-able to attend. Please notify the ExL Pharma, [email protected], prior to the event with the name and contact information of the replacement attendeePlease Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, every effort to find a suitable replacement will be made.
*The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL Events, Inc.*
Media Partners
Association Partner
Society of Clinical Data Management
The Society for Clinical Data Management is a premier clinical data management organiza-tion. Membership includes over 2,000 domestic and international professionals from the biotechnology, medical device, and pharmaceutical industries; the academic, regulatory, and scientific research communities; and third-party organizations including CROs, consul-tants, vendors, and placement firms.
Learn more about SCDM’s annual Fall Conference, Leadership Forum, Certified Clinical Data Manager (CCDM) Program, award-winning Good Clinical Data Management Practices (GCD-MP) Document and many educational opportunities at www.scdm.org.
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PROUDLY PRESENTS rd Annual January 14-15, 2008
Sheraton Crystal CityArlington, VA
Clinical Data Disclosure Summit
Implementing and Maintaining Compliant Trial Registries and Results Databases for Drugs, Biologics and Medical Devices
3
Sponsors:Keynote PresentationPUBLICATION PERSPECTIVE Understanding and Remaining Compliant with the ICMJE’s Data Disclosure Requirements Christine Laine, MD, MPH, Senior Deputy Editor, ANNALS OF INTERNAL MEDICINE, ICJME Secretariat
Association Partner:
CALL 866-207-6529 OR VISIT US AT WWW.EXLPHARMA.COMPRICES INCREASE AFTER NOVEMBER 30TH
Do You Comply with
the Newly Enacted
Federal Legislation?
