To Register Call 866-207-6528 or visit us at www.exlpharma.com

PROUDLY PRESENTS

6th Clinical Data Disclosure Summit

March 1-2, 2011Crowne Plaza Philadelphia Downtown · Philadelphia, PA

ImplementIng and maIntaInIng ComplIant trIal regIstrIes and results databases for drugs, bIologICs & medICal devICes

FEATURED SESSIONS:

Determining the Latest EudraCT and European Registry DevelopmentsDetlef Niese, Head Global Development External Affairs, NOVARTIS

Developing Flexible Global Disclosure PoliciesSusan Kobza, Senior Manager, Clinical Trials Registry, ASTELLASRosemary Wagner, Global Operations Lead, Clinical RegistryJOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT

What is the Impact of Sponsor and Affiliate Relationships when Posting Initiatives Are Not Fully in Sync?Kristi Whiteside, Clinical Trial Disclosure, CELGENERobin Smith, Director Clinical Trial Registries, ALLERGAN

Sounding the Alarm: Making Senior Management Understand the Risks of Data Discrepency and the Impact on Financial and Public StakeholdersThomas Wicks, Product Manager, PharmaCM, INTRASPHERE TECHNOLOGIES Assessing the Unique Challenges Consumer ProductsJoyce Hauze, MBA, CCRA, Senior Specialist, Clinical Research Operations, JOHNSON & JOHNSON CONSUMER PRODUCTS

Evaluating Key Developments in International Transparency Requirements and RegistriesJohn C. McKenney, President, SEC ASSOCIATES

Defining the Impact of Transparency on the Generics IndustryHoward Rutman, Vice President, Medical Director, TARO PHARMACEUTICALS

Achieving Cross-Regional Registry CongruencyChristopher Dedels, Global Product Manager – Clinical Trial Disclosure Solutions, VIRTIFY

Implementing a Successful Results Posting ProcessJacqueline Sayers, Quality Projects Manager, ROCHE PRODUCTS

Streamlinining the Results Tabulation Process to Align Reporting Data Beyond the Project LevelTania Walton, Principal Programmer, CIS Programming, ASTRAZENECA

FACUlTy INClUDES:AllerganAstellasAstrazenecaCelgeneJohnson & JohnsonNovartisRoche ProductsTaro Pharmaceuticals

SPONSORS AND ExhIbITORS:

FEATURED WORkShOP:Leveraging Processes and Systems that Streamline Trial and Results Transparency Initiatives

RegisteR by JANUARy 14Th foR Reduced PRicing

Dear Colleague,

How can your organization support data disclosure compliance statements when posting requirements and processes form a highly non-congruent posting environment? What steps can be taken to form a consistent global approach to data disclosure, while keeping internal and external stakeholders in sync to the information in the public domain?

Pharmaceutical, biologic and device companies are continually challenged in keeping up with the nuances of trial registration and results posting require-ments. Consumer Product groups and the generics industry are both caught in ever-changing policy decisions on if and how they are compliant to the changes FDAAA has made.

Now in it’s 6th year, ExL Pharma’s 6th Clinical Data Disclosure conference works to unravel the complexities of posting trial and results information - keeping com-pliant with the myriad of regulatory requirements while keeping your organiza-tion’s communication strategies in sync. Join leading experts and influencers as we take a hard look at the implications and present real strategies for complying with transparency issues today.

We look forward to seeing you in Philadelphia.

Sincerely,

Terry di Paolo Kristen hunterConference Producer Team Leader, Production

Venue Information

Who Should Attend?

Professionals from Pharmaceutical, Biotechnology and Medical Device companies with responsibilities in the following areas:

• Clinical Trial Registration

• Trial Results Disclosure

• Quality Assurance/Regulatory Affairs

• Clinical Development/Compliance

• Medical Affairs/Communications

• Consumer Products

This event is also of interest to:

• Technology solutions for clinical data management

• Consultants in Regulatory and Compliance

• CROs with Registry Posting Services

• Medical Translation Services

• Market Intelligence Services

RooM RESERvATIoNSIf you require overnight accommodations, please contact the Crowne Plaza Philadelphia Downtown at 215-561-7500 to book your room. ExL has reserved a block of rooms at a dis-counted rate for conference participants. Please mention ExL Pharma and the conference name to take advantage of the discount. You must book your room by Monday, February 7, 2011 to be eligible for the discounted rate. Please book your room early, as the rooms available at this rate are limited.

For reservations please call 215-561-7500Discounts enD on MonDay, February 7, 2011

crowne plaza philaDelphia Downtown

1800 Market streetphiladelphia, pa 19103 215-561-7500www.cpphiladelphia.com

To Register Call 866-207-6528 or visit us at www.exlpharma.com

PRE-CONFERENCE WORkShOP · Tuesday, March 1, 2011

MAIN CONFERENCE · DAY ONE · Tuesday, March 1, 201112:00 Main Conference Registration Begins1:00 Chair’s Welcome and opening Remarks

1:15 NIh RUlEMAkINgCurrent Advancements in NIh Rulemaking and Its Impact on the Expansion of ClinicalTrials.gov• Providing results for unapproved products from last patient last visitin Phase II trials• Evaluate the challenges in providing non-technical summaries on trial results• Addressing the impact of providing a copy of full protocol in results disclosure• Should the industry report results on discontinued products?

Scott Cunningham, Partner, CovINGToN & BURLING LLP

1:45 EU REgUlATORyDetermining the Latest EudraCT and European Registry Developments – Implementing Processes to Ensure Compliance• Evaluating the effect EudraCT v8 and pending v9 in ensuring compliance • Assessing how local amendments form unique challenges in the ability to post consistent and uniform information• Taking a closer look at Pediatric trials, PIPs and disclosure for studies run inside and out of the European Union

Detlef Niese, head Global Development External AffairsNovARTIS

2:45 Networking and Refreshment Break

3:15 SENIOR MANAgEMENTSounding the Alarm: Making Senior Management Understand the Risks of Data Discrepency and the Impact on Financial and Public Stakeholders• Understanding what information senior management needs to be presented with to better understand the risks of data discrepancy inherent in posting trial and result information• Evaluating the ramifications of noncompliance of Form 3674s when published articles and registry posting information is seeming inconsistent• Communicating specific gaps in disclosure protocols that require management attention and direction and providing an course of action

Thomas Wicks, Product Manager, PharmaCMINTRASPhERE TEChNoLoGIES

4:00 PANEl DISCUSSION: SPONSORS AND CROSWhat is the Impact of Sponsor and Affiliate Relationships when Posting Initiatives Are Not Fully in Sync?• Clarifying the liability present when CROs and affiliates are not fully in sync with existing and emerging SOPs • Examining strategies for disseminating posting strategies and requirements when dealing with multi-national clinical trials• Ensuring that external partner contracts are clear in determining responsibilities in posting, notifying and maintaining of information

Moderator:Kristi Whiteside, Clinical Trial Disclosure, CELGENEPanelists:Robin Smith, Director Clinical Trial Registries, ALLERGAN

Additional panelist to be announced

4:45 glObAl REgISTRIESEvaluating Key Developments in International Transparency Requirements and RegistriesKeeping up with the rapid pace of change is a significant challenge for sponsors and investigators who need to know about newly emerging disclosure requirements in order to remain compliant. This session will help by providing critical information, such as:• Which countries/regions are most active recently in pushing new requirements• Which registries have been recently launched or are expected soon• Which countries/registries have lost momentum

John C. McKenney, PresidentSEC ASSoCIATES

5:30 Close of Day One

Leveraging Processes and Systems that Streamline Trial and Results Transparency Initiatives

• Establishingandre-evaluatingSOPstobetteradjusttothegrowingcomplexityofdisclosurerequirements» Identifying internal and external stakeholders and determining their responsibilities to the gathering, posting and timing of transparency initiatives

• Determiningthetriggersthatinitiatedisclosureactions» What communications strategy is in place to update trial and site start and status data?» How can we align affiliates, CROs and external partners appropriately?

• Examiningthedifferncesintrialpostingandresultsposting• Formingprocessesthatbestutilizereuseofinformationalcomponents• OrganizingRFPmeetingsandsourcingstakeholderinputtoensurefullunderstandingofprocessrequirementsRobin Smith, Director Clinical Trial Registries, ALLERGANAdditional Workshop Leader to be announced

8:00 Workshop Registration and Breakfast 9:00 Workshop Begin10:30 Networking Break12:00 Luncheon for Workshop Attendees

MAIN CONFERENCE · DAY TWO · Wednesday, March 2, 2011

8:00 Continental Breakfast9:00 Chairperson opening Remarks and Roundtable Recaps

9:05 RESUlTS DISClOSUREProactive Strategies in Implementing a Successful Results Posting Process that Can Anticipate Future Regulatory and Functional Challenges• Aligning stakeholders and incorporating them into a robust results posting process• Identifyingtheimpactonthewiderorganizationandimplementinganeffective communications strategy• Anticipating future regulatory changes and the impact that may have on your process

Jacqueline Sayers, Quality Projects ManagerRoChE PRoDUCTS

9:50 RESUlTS TAbUlATIONStreamlinining the Results Tabulation Process to Align Reporting Data Beyond the Project Level• Formingsystemsthatincorporatetheintracitiesinproject-specificstudydata• EvaluatingthetabulationprocessutilizingSASmacros• Overcoming non-specific study level information, such as reasons for discontinuation and free text study data• Developingoversightprotocolsthatareaccurateandconsistentacrossprojectswithinthesame therapeutic areas

Tania Walton, Principal Programmer, CIS Programming, ASTRAZENECA

10:30 Networking and Refreshment Break

11:00 REgISTRy CONgRUENCyAchieving Cross-Regional Registry Congruency in Trial and Results Posted Data• Challenges in achieving cross-registry congruency• Systematic approaches to auditing posting data across registries• Synchronizingregistrydataandovercomingchallengesofregistrynuancesandlanguagebarriers• Examining  and evaluating systems that manage trial registration for multiple registries

Christopher Dedels, Global Product Manager – Clinical Trial Disclosure Solutions, vIRTIFy

11:45 gENERICS INDUSTRyDefining the Impact of Transparency on the Generics Industry and The Unique Challenges to Implementing Trial and Result Policies • Defining the types of trials within the generics community that lead to a trigger of disclosure requirements• Examining the impact of trial result posting in the highly competitive generics industry

» Does posting undermine competitive advantages?• Determining best practices in posting data within the generics industry

howard Rutman, vice President, Medical DirectorTARo PhARMACEUTICALS

12:30 Luncheon for Conference Participants

1:30 glObAl bEST PRACTICESDeveloping Flexible Global Disclosure Policies that Form Consistent Approaches to handling Changing Regulatory Requirements • Forming global policies that combine regulatory, stakeholder and internal policy of disclosure• Developing global policies that mitigate local, regional and country-specific regulatory changes• Structuring dynamic communications and clear decision paths to ensure specific issues (regitry rejections,clarifications)arehandledefficiently

ASTELLAS CASE STUDY

Susan Kobza, Senior Manager, Clinical Trials RegistryASTELLASJOHNSON & JOHNSON CASE STUDY

Rosemary Wagner, Global operations Lead, Clinical RegistryJohNSoN & JohNSoN PhARMACEUTICAL RESEARCh & DEvELoPMENT

3:15 J&J CASE STUDy CONSUMER PRODUCTSAssessing the Unique Challenges Consumer Products Face in Determining Eligibility, Aligning Stakeholder’s and Posting Trial and Result Information • Evaluating the scope of consumer products and their potential classifications into drug or device categories• What IS an applicible clinical trial?

» Under which regulation is the trial being conducted? * Under21CFR§812,312,314?Under402(j)ofthePHSAct?Undera510(k)?* IsitGenerallyRecognizedasSafeandEffective(GRASE)underaMonograph(21CFR§330‐358)

» Thecomplexitiesforbioequivalencetrials(21CFR§320) » What is meant by “with health outcomes”

• AdaptingSOPstoobjectivelyassessaconsumerproductsrequirementtotransparencyand forming appropriate timing strategies that meet all regulatory and stakeholder requirements• Examining the unique challenges in posting consumer product trial information in an Rx environment

Joyce hauze, MBA, CCRASenior Specialist, Clinical Research operations Contracted withJohNSoN & JohNSoN CoNSUMER AND PERSoNAL PRoDUCTS

4:00 PANEl: COMPETITIVE INTEllIgENCEAssessing how Trial Information Impacts Competitive Intelligence Initiatives and Stakeholder Relations• Implications of results disclosure on pipeline development and wider corporate analysis• Assessing how data, especially results data, can and will be used by other interested parties

» Financial analysts looking to leverage stock spreads » Competitive groups looking to gather information on unapproved products

• Evaluating how secondary market services are leveraging posted information through data mining of ClinicalTrials.gov and reselling to competitors• Defining predictive analytics and its potential on pipeline development

Moderator :

Robert Paarlberg, Principal, PAARLBERG & ASSoCIATESPanelists:

Jacqueline Sayers, Quality Projects Manager, RoChE PRoDUCTShoward Rutman, vice President, Medical Director, TARo PhARMACEUTICALS

4:45 Closing Remarks

Media Partners

Sponsorship and Exhibiting Opportunitiesdo you want to spread the word about your organization’s solutions and services to potential clients who will be attending this event? take advantage of the opportunity to exhibit, present an educational session, host a networking event, or distribute promotional items to attendees. exl Pharma will work closely with you to customize a package that will suit all of your needs. to learn more about these opportunities, please contact:

Steve DeckerBusiness Development Manager(212) 400-6234, sdecker@exlpharma.com

Registration Fees for Attending Exl Pharma’s 6th Clinical Data Disclosure Summit:

early birD pricinGregister by friday, January 14, 2011 to take advantage of early-bird pricing:Conference + Workshop $1995Conference only $1695

stanDarD pricinGregister after friday, January 14, 2011: Conference + Workshop $2195Conference only $1895

onsite pricinGConference + Workshop $2295Conference only $1995

Group Discount proGraM: discounts cannot be combined; early Bird rates do not apply

Save 25% per person when Registering Four For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register 4 at one time). this is a savings of 25% per person.

Save 15% per person when Registering Three Can only send three? You can still save 15% off of every registration. to find out more on how you can take advantage of these group discounts, please call 866-207-6528.

MakecheckspayabletoExLEvents, Inc.andwritecodeP1610onyourcheck.YoumayalsouseVisa,MasterCard,DiscoverorAmerican Express. Payments must be received in full prior to the commencement of the conference.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: Afullrefund(minusa$95processingfee),oravouchertoanotherExLeventvalidfortwoyearsfromthevoucher issue date.Four weeks or Less: A voucher to another ExL event valid for two years from the voucher issue date.Toreceivearefundorvoucher,pleasefaxyourrequestto888-221-6750.Please Note: Conference registrations may be transferred to other colleagues in the event you are unable to attend. There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague occurring within five business days of any ExL conference.

Please notify ExL Pharma, info@exlpharma.com, prior to the event with the name and contact information of the replacement attendee.PleaseNote:Speakersandagendaaresubjecttochangewithoutnotice.Intheeventofaspeakercancellation,everyefforttofindasuitablereplacementwill be made.

*The opinions of this faculty do not necessarily reflect those of the companies they represent nor ExL Events, Inc.*

Five Ways to Registerfax: 888-221-6750

mail: exl events, Inc.

555 8th ave, ste 310

new York, nY 10018

phone: 866-207-6528

online: www.exlpharma.com

email: register@exlpharma.com

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