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DISTINGUISHED PRESENTERS INCLUDE: PROGRAM OVERVIEW: Clinical research being initiated and conducted by external thought leaders, investigators and key opinion leaders is one area within the pharmaceutical and medical device industries that continues to present considerable challenges for these dynamic organizations. Working to walk an incredibly thin line between sponsored research and investigator research, staying close to results while at arm’s length, and maximizing the investments made in this type of research is a top priority for industry. As product pipelines become increasingly important, and new research leads to potential new indications for therapies and technologies, research being conducted by external parties can often provide a new source of information data and opportunity. This event will provide an opportunity for executives handling external research as well as managing thought leaders and key opinion leaders to gather as one, in order to discuss and debate the many challenges that they face, allowing for a cross-pollination of information, ideas, and knowledge share. 500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com Jason G. Jones, MS, CCRP Global Vice President, Clinical Affairs, Advanced Surgical Devices Division SMITH & NEPHEW Onikepe Adegbola, MD, PhD Chief Medical Officer, Molecular Imaging, Executive Medical Director GE HEALTHCARE Craig Sponseller, MD VP of Medical Affairs KOWA PHARMACEUTICALS Georgia M. Arvanitis, PhD Senior Director, Clinical Sciences & Scientific Fellow LIFECELL Dr. David Turok, MD Vice President and Corporate Medical Director AMERICAN LASER CENTERS Jihong Qu, PhD, MBA Director, Clinical Studies, Atrial Fibrillation Division ST. JUDE MEDICAL John Resman, PharmD Senior Director, Medical Affairs & External Research MEDTRONIC Jasmeet Singh, MD, MPHA Senior Clinical Scientist and Global Medical Safety Reviewer BOSTON SCIENTIFIC Harel Deutsch, MD Assistant Professor of Neurosurgery RUSH UNIVERSITY MEDICAL CENTER Ulf Borg Director, Clinical Affairs COVIDIEN Jodi Akin VP Global Clinical Affairs EDWARDS LIFESCIENCES Robert Galiano, MD Assistant Professor, Director of Research, Deivision of Plastic Surgery NORTHWESTERN UNIVERSITY FEINBERG SCHOOL OF MEDICINE Margaret Tumas, DVM Vice President, Medical & Clinical Affairs Martin Kwende, PhD Director, Clinical Affairs SPIRACUR Kristian Werling Partner MCDERMOTT, WILL & EMERY LLP Blake Morrison, PharmD Senior Director, Medical & Scientific Affairs ONYX PHARMACEUTICALS Meenakshi Datta Partner SIDLEY AUSTIN LLP Deitzah Raby Corporate Counsel & Privacy Officer HILL-ROM HOLDINGS, INC. Nicole Liffrig Molife, Esq. Counsel ARNOLD & PORTER LLP Muriel Siadak Director, Medical Scientific Liaisons SEATTLE GENETICS Ana Stankovic, MD, Ph.D. Worldwide Vice President, Medical Affairs BECTON DICKINSON Bill Oliverson Associate Director of Opinion Leader Relations PFIZER Sabine Teske, Ph.D. Associate Director, Medical Science Liaison DYAX CORPORATION Jesse Weinberger CEO GLOBALCASTMD Cynthia T. Crosby, Ph.D. Vice President, Medical Affairs CAREFUSION Timothy Ayers VP Chief Compliance Officer DENDREON Kevin Appareti Global Director, Medical Science Liaison, Office of Medical & Health Affairs PHILIPS HEALTHCARE Jennifer Lill Senior Director Medical Affairs and Clinical Development, Oncology DENDREON Avi B. Markowitz, MD, FACP Professor, Internal Medicine, Chief, Hematology / Oncology, Bill & Louise Bauer Distinguished Chair, Cancer Research Department, Internal Medicine UNIVERSITY OF TEXAS MEDICAL BRANCH Victor Miranda, MD Vice President, Medical Operations GE HEALTHCARE Donna Merrigan, PharmD Associate Director, Medical Affairs SPECTRUM PHARMACEUTICALS Brian L. Whisler Partner BAKER & MCKENZIE LLP Lance Hill CEO WITHIN3 MEDIA PARTNERS: EVENT SPONSORS:

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Page 1: DISTINGUISHED PRESENTERS INCLUDE - Q1 Productions · distinguished presenters include: ... medical science liaison ... 4:10 exploration of the future of kol relationships in today’s

DISTINGUISHED PRESENTERS INCLUDE:

PROGRAM OVERVIEW:Clinical research being initiated and conducted by external thought leaders, investigators and key opinion leaders is one area within the pharmaceutical and medical device industries that continues to present considerable challenges for these dynamic organizations. Working to walk an incredibly thin line between sponsored research and investigator research, staying close to results while at arm’s length, and maximizing the investments made in this type of research is a top priority for industry. As product pipelines become increasingly important, and new research leads to potential new indications for therapies and technologies, research being conducted by external parties can often provide a new source of information data and opportunity.

This event will provide an opportunity for executives handling external research as well as managing thought leaders and key opinion leaders to gather as one, in order to discuss and debate the many challenges that they face, allowing for a cross-pollination of information, ideas, and knowledge share.

500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com

Jason G. Jones, MS, CCRPGlobal Vice President, Clinical Affairs, Advanced Surgical Devices Division SMITH & NEPHEW

Onikepe Adegbola, MD, PhDChief Medical Officer, Molecular Imaging, Executive Medical DirectorGE HEALTHCARE

Craig Sponseller, MDVP of Medical AffairsKOWA PHARMACEUTICALS

Georgia M. Arvanitis, PhDSenior Director, Clinical Sciences & Scientific Fellow LIFECELL

Dr. David Turok, MDVice President and Corporate Medical DirectorAMERICAN LASER CENTERS

Jihong Qu, PhD, MBADirector, Clinical Studies, Atrial Fibrillation Division ST. JUDE MEDICAL

John Resman, PharmD Senior Director, Medical Affairs & External Research MEDTRONIC

Jasmeet Singh, MD, MPHASenior Clinical Scientist and Global Medical Safety ReviewerBOSTON SCIENTIFIC

Harel Deutsch, MDAssistant Professor of NeurosurgeryRUSH UNIVERSITY MEDICAL CENTER

Ulf BorgDirector, Clinical AffairsCOVIDIEN

Jodi AkinVP Global Clinical AffairsEDWARDS LIFESCIENCES

Robert Galiano, MDAssistant Professor, Director of Research, Deivision of Plastic SurgeryNORTHWESTERN UNIVERSITY FEINBERG SCHOOL OF MEDICINE

Margaret Tumas, DVMVice President, Medical & Clinical Affairs

Martin Kwende, PhDDirector, Clinical AffairsSPIRACUR

Kristian WerlingPartnerMCDERMOTT, WILL & EMERY LLP

Blake Morrison, PharmDSenior Director, Medical & Scientific AffairsONYX PHARMACEUTICALS

Meenakshi DattaPartnerSIDLEY AUSTIN LLP

Deitzah RabyCorporate Counsel & Privacy OfficerHILL-ROM HOLDINGS, INC.

Nicole Liffrig Molife, Esq.CounselARNOLD & PORTER LLP

Muriel SiadakDirector, Medical Scientific LiaisonsSEATTLE GENETICS

Ana Stankovic, MD, Ph.D.Worldwide Vice President, Medical AffairsBECTON DICKINSON

Bill OliversonAssociate Director of Opinion Leader RelationsPFIZER

Sabine Teske, Ph.D.Associate Director, Medical Science LiaisonDYAX CORPORATION

Jesse WeinbergerCEOGLOBALCASTMD

Cynthia T. Crosby, Ph.D.Vice President, Medical AffairsCAREFUSION

Timothy AyersVP Chief Compliance OfficerDENDREON

Kevin ApparetiGlobal Director, Medical Science Liaison, Office of Medical & Health AffairsPHILIPS HEALTHCARE

Jennifer LillSenior Director Medical Affairs and Clinical Development, OncologyDENDREON

Avi B. Markowitz, MD, FACPProfessor, Internal Medicine, Chief, Hematology / Oncology, Bill & Louise Bauer Distinguished Chair, Cancer Research Department, Internal Medicine UNIVERSITY OF TEXAS MEDICAL BRANCH

Victor Miranda, MDVice President, Medical OperationsGE HEALTHCARE

Donna Merrigan, PharmDAssociate Director, Medical AffairsSPECTRUM PHARMACEUTICALS

Brian L. WhislerPartnerBAKER & MCKENZIE LLP

Lance HillCEOWITHIN3

MEDIA PARTNERS:EVENT SPONSORS:

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Pre-Conference Session

500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com

7:20-8:10 IIT OVERVIEW: STRATEGIES FOR INITIATING & IMPLEMENTING SUCCESSFUL PROGRAMS• Developing IIT program and process• Strategies and rationale for review and decision of IIT proposals• Examples of issues and challenges• Case study: Step-by-step implementation of an IIT programJihong Qu, PhD, MBA, Director, Clinical Studies, Atrial Fibrillation DivisionST. JUDE MEDICAL

7:00 REGISTRATION & CONTINENTAL BREAKFAST

10:10 COFFEE & NETWORKING BREAK 10:10 COFFEE & NETWORKING BREAK

8:20 CONFERENCE WELCOME & CHAIRPERSON OPENING REMARKS

12:10 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

8:30 JUSTIFICATION OF INVESTIGATOR INITIATED STUDIES FOR DEVICE COMPANIES• Understanding the reasoning & benefits of implementing IIS programs• Investigator Research to support new indications and new labeling• Implementing investigator led programs for companies of every sizeOnikepe Adegbola, Md, PhDChief Medical Officer, Molecular Imaging, Executive Medical DirectorGE HEALTHCARE

9:20 PRE-STUDY CONSIDERATIONS TO MAXIMIZE INVESTIGATOR RELATIONSHIPS & STUDY EFFICIENCY • Creative deal structures that create a mutually advantageous environment• Key considerations to include in contracts prior to study commencement• Milestone payments tied to results & strategies for timely study completionMartin Kwende, PhDDirector, Clinical AffairsSPIRACUR

10:30 EXPLORING THE ALIGNMENT OF INVESTIGATOR SPONSORED RESEARCH TO MEDICAL & MARKETING STRATEGY • How can manufacturers compliantly generate interest in studies of interest?• Can manufacturers determine direction and value proposition of the IIS?• What strategies may be implemented to align trial and company strategies?Jodi Akin, EDWARDS LIFESCIENCES Jasmeet Singh, MD, MPHA, BOSTON SCIENTIFICMargaret Tumas, DVM

11:20 DEFINING THE ROLES AND RESPONSIBILITIES FOR COMPANY AND SPONSOR INVESTIGATOR• Discussing the complex role of trial “owner”• Undefined roles and responsibilities• Collaborating with other industry organizations for studiesKristian WerlingPartnerMCDERMOTT, WILL & EMERY LLP

8:30 VALIDATING AND SEGMENTING THOUGHT LEADERS THROUGH INFLUENCE MAPPING• Develop a systematic approach to determine champion KOLs • Targeting thought leaders on a global, national, regional and local scale• Create structure through specific KOL targeting and segmentationBill OliversonAssociate Director of Opinion Leader RelationsPFIZER

9:20 DEVELOPING THOUGHT LEADER RELATIONSHIPS WITH RESTRICTED RESOURCES IN TODAY’S ECONOMIC ENVIRONMENT• Factors to consider when determining compensation • Setting the appropriate budget to support thought leader strategy & plans• Creative avenues for opinion leaders to be involved within a companyKevin ApparetiGlobal Dir., MSL, Office of Med. & Health AffairsPHILIPS HEALTHCARE

10:30 GRASPING KOL METRICS: MEASURING THE ROI OF THOUGHT LEADER RELATIONSHIPS• How to measure if KOLs are appropriate and benefiting the company• Structuring thought leader development to maximize productivity & impact• Should thought leader ROI be measured?Jonas Hylton, PharmD, MEDIVATIONKevin Appareti, PHILIPS HEALTHCAREDonna Merrigan, PharmD, SPECTRUM PHARMACEUTICALSJohn Resman, PharmD, MEDTRONIC

11:20 EDUCATING AND TRAINING INVESTIGATORS ON COMPLIANCE CONSIDERATIONS • Impact that Sunshine and new regulations have on trials• Highlighting sponsor compliance resources and tools • IIT research grant compliance Jennifer LillSr Director Medical Affairs & Clinical Development, OncologyDENDREONTimothy AyersVP Chief Compliance OfficerDENDREON

IIT TRACK THOUGHT LEADER TRACK

DAY ONE / THURSDAY, SEPTEMBER 27 2012 / MEDICAL AFFAIRS SUMMIT

PLEASE REFER TO FULL AGENDA(S) FOR MORE INFORMATION ON INDIVIDUAL TRACKED SESSIONS

SPONSORSHIP OPPORTUNITIES:At this time, there are a variety of sponsorship and exhibition opportunities available for companies wishing to increase their visibility and participation in the program, ranging from keynote speaking opportunities through to exhibitor and documentation sponsors. Organizations most suitable for this type of exposure provide services and solutions including:• Clinical Trial Consultants• Clinical Research Organizations• Compliance Consultants• Regulatory Experts• IIT Software & Data Management

• Contract Solutions• KOL Databases• KOL Software Management• Social Network Analysis• Medical Marketing

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500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com

3:00 COFFEE & NETWORKING BREAK 3:00 COFFEE & NETWORKING BREAK

5:00 DAY ONE CONFERENCE CONCLUSION

1:20 FOCUSING ON GLOBAL COMPLIANCE: REVIEW OF THE UK BRIBERY ACT AND FCPA REGULATIONS• Overview of recent UK Bribery Act and of recent FCPA enforcement trends • Enforcement considerations specific to the healthcare/pharma industry• Provisional anti-bribery review for interactions with foreign thought leadersBrian L. WhislerPartnerBAKER & MCKENZIE LLP

1:20 INVESTIGATOR COMMUNICATION & EDUCATION THROUGHOUT THE LIFESPAN OF A STUDY• Compliant and proven communication strategies• Educating investigators on significant risk & IDE submission• Corporate policy and study specific considerationsJasmeet Singh, MD, MPHASr. Clinical Scientist & Global Medical Safety ReviewerBOSTON SCIENTIFIC

2:10 AN INVESTIGATOR PERSPECTIVE ON WORKING WITH INDUSTRY: HURDLES & OPPORTUNITIES FOR SUCCESSFUL IITS• Increasing efficiency of IIT conduct through communication strategies• Common hurdles and successes of IIS from an investigator standpoint• Understanding what attracts investigators to IITs & industry’s roleRobert Galiano, MDNORTHWESTERN UNIVERSITY Harel Deutsch, MDRUSH UNIVERSITY MEDICAL CENTERDr. David Turok, MDAMERICAN LASER CENTERS

2:10 ACCESSING KEY OPINION LEADERS ON A GLOBAL SCALEProfessionals that work within international pharmaceutical and device com-panies understand the importance of “thinking globally” when developing their thought leader strategy and initiatives. Key opinion leaders offer a significant val-ue, authority and credibility on the promotion of a company’s products and are therefore extremely beneficial for a company’s growth and expansion on both a na-tional and international scale. Focusing on one successful company’s best prac-tices, this session will highlight strategies for accessing KOLs and the qualities to look for when searching for thought leaders in specific countries and regions. Jesse Weinberger, CEOGLOBALCASTMD

3:20 OVERCOMING INTERNATIONAL HURDLES TO ENHANCE GLOBAL INVESTIGATOR INITIATED STUDIES • Developing global programs & overcoming common pitfalls• Overview of regulations in Europe and other key markets• Update on the revised ISO 1455 frameworkJodi AkinVice President Global Clinical AffairsEDWARDS LIFESCIENCES

3:20 IDENTIFYING THE APPROPRIATE KOL FOR YOUR COMPANY GIVEN A SMALL POOL OF THOUGHT LEADERS• Accessing KOLs given a small number thought leaders• Thinking outside of the box to attract KOLs and drive innovation• Identify thought leader skills required for company needsSabine Teske, Ph.D.Associate Director, Medical Science LiaisonDYAX CORPORATION

4:10 PANEL ADDRESSING AUDIENCE QUESTIONS: BEST PRACTICES & LESSONS LEARNED FROM MULTIPLE COMPANY PERSPECTIVES• Key components of successful IIT programs from multiple viewpoints• Comparing strategies and procedures implemented at various companies• Tips, best practices and lessons learned for investigator initiated studiesJohn Resman, PharmD, MEDTRONIC Ulf Borg, COVIDIEN

4:10 EXPLORATION OF THE FUTURE OF KOL RELATIONSHIPS IN TODAY’S REGULATORY ENVIRONMENT• Lower costs by implementing virtual communication platforms • Competing for thought leaders in the new regulatory environment• What does the future interaction between industry and KOLs look like?Cynthia T. Crosby, Ph.D.Vice President, Medical AffairsCAREFUSION

DAY ONE / THURSDAY, SEPTEMBER 27 2012 / MEDICAL AFFAIRS SUMMIT

PLEASE REFER TO FULL AGENDA(S) FOR MORE INFORMATION ON INDIVIDUAL TRACKED SESSIONS

IIT TRACK THOUGHT LEADER TRACK

MAXIMIZING OUTCOMES FROM THOUGHT LEADER RELATIONSHIPSWithin the pharmaceutical and device industries, working with key opinion leaders is a critical component of the overall credibility and reputation of an organization’s products. Their participation on scientific programs, speaking at industry and association meetings, their deep connections with hospitals and other physicians, as well as authorship of papers lends products substantial value, authority and credibility that would be otherwise unattainable by the corporation alone. However, the road to the development of these relationships is fraught with challeng-es, from increasingly strict regulatory guidelines, but also a newfound reticence from healthcare professionals unsure of how to balance the need for continued research while maintaining professional neutrality.

INVESTIGATOR INITIATED STUDIESAround the world, pharmaceutical and medical device corporations are being increasingly approached by surgeons and healthcare professionals looking to partner with corporations to investigate new uses for marketed technologies. For the device industry, investigator initiated research pos-es specific challenges as they work to ensure the safety of patients while supporting physicians and surgeons. With increased scrutiny from regula-tory authorities on the safety of medical technologies, risk assessment and management has become a top priority, and one that will certainly be addressed throughout the two-day conference program. Providing a platform specific to IIT research for devices has ensured this program is a must-attend.

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500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com

7:30 CONFERENCE REGISTRATION & MORNING COFFEE

8:00 OPENING REMARKS & DAY TWO WELCOME

8:10 INTERPRETING AND OVERCOMING LEGAL & REGULATORY BARRIERS FOR INVESTIGATOR SPONSORED RESEARCH With such landmark events as Healthcare Reform and the Physician Payment Sun-shine Act including legislation in the Anti-Kickback Statute and the False Claims Acts, device companies have certainly faced heightened attention from regula-tors and consumers alike in recent years. This surveillance has also impacted investigator initiated research as healthcare professionals seek to avoid negative implications and device companies pursue compliance in a complex environment. In order for investigator initiated trials to succeed in a regulatory atmosphere that is under scrutiny, device companies must take proactive measures to not only protect themselves, but also their investigators. • Overview of nomenclature and terminology involved in IITs• Statutes & regulations that apply to IISs & the agencies that enforce them • Exploring consequences of non-compliance• Strategies for protecting the company as well as the investigator Deitzah Raby, HILL-ROM HOLDINGS, INC. Meenakshi Data, SIDLEY AUSTIN LLP

8:10 WORKING AROUND INSTITUTIONAL CAPS TO GENERATE POSITIVE KOL OUTCOMES AND ENGAGEMENTInstitutional caps limiting thought leader involvement with industry is gaining ground now more than ever. Due to the growing emphasis being placed on KOL management as a strategic marketing tool within the healthcare industry, aca-demic institutions are setting guidelines and specific requirements for thought leaders working with industry. Pharmaceutical and medical device companies are challenged with working within these constraints, while still generating posi-tive outcomes from their thought leaders. • Evolve KOL management plans to overcome institutional caps• Review of effective alternate channels to deliver messages to the public• Participate thought leaders in activates based on cap requirementsMuriel Siadak, Director, Medical Scientific LiaisonsSEATTLE GENETICS

9:00 ENSURING TRANSPARENCY: OVERCOMING IMPLICATIONS OF THE PHYSICIAN PAYMENT SUNSHINE ACTThe Physician Payment Sunshine Act of 2009 has elevated regulatory scrutiny within the industry at an all time high. With high profile cases creating frenzy with the media and KOLs becoming increasingly cautious in working with indus-try, manufacturers must begin taking steps to protect their thought leader rela-tionships as well as the public view of their corporate brand. Through discussion, medical affairs executives responsible for continued transparency and interac-tions between industry and thought leaders will find clarification in what is and what is not acceptable regarding transmission of information, compensation, honoraria, travel, coverage, reimbursement, meals and much more. • Communicating the implications of the Sunshine Act to thought leaders• Break down barriers that interfere with transparency and compliance • Adhere to the compliance regulations set forth by the ActNicole Liffrig Molife, Esq., CounselARNOLD & PORTER LLP

10:20 DEVELOPING THOUGHT LEADER RELATIONSHIPS WITH RESTRICTED RESOURCES IN TODAY’S ECONOMIC ENVIRONMENTWithin both small and large pharmaceutical and medical device companies, medical affairs executives are continuously challenged with managing and maintaining successful key opinion leader relationships given restricted re-sources. Often smaller companies are either providing thought leaders with eq-uity stakes, offering them stock options and ownership instructions or delaying payments in order to promote their products to healthcare professionals and patients. As well, larger companies need to develop strategies to be as frugal as possible given their stricter budgets in today’s economic environment. This real-time case study will demonstrate the vital importance for both small and large companies to be mindful of their budgets and develop creative strategies to best ensure efficient and effective thought leader relationships. • Factors to consider when determining thought leader compensation • Setting the appropriate budget to support thought leader strategy & plans• Creative avenues for opinion leaders to be involved within a companyKevin Appareti, Global Dir., Med.Science Liaison, Office of Med. & Health AffairsPHILIPS HEALTHCARE

11:10 PANEL DISCUSSION: GRASPING KOL METRICS: MEASURING THE ROI OF THOUGHT LEADER RELATIONSHIPSThought leaders within the pharmaceutical and medical device space offer an enormous amount of product knowledge, expertise and awareness to both in-dustry as well as patients alike. To a certain extent, medical affairs professionals need to measure the return that thought leaders are providing their company in order to determine the compensation provided is worth the investment. However this controversial topic has physicians, patients and the academic world up in arms questioning the motives of industry; is their priority to their patients or their business? • How to measure if KOLs are appropriate and benefiting the company• Structuring thought leader development to maximize productivity & impact• Should thought leader ROI be measured?Jonas Hylton, PharmD, MEDIVATIONKevin Appareti, PHILIPS HEALTHCAREDonna Merrigan, PharmD, SPECTRUM PHARMACEUTICALSJohn Resman, PharmD, MEDTRONIC

9:00 ASSESSMENT OF IIT PROPOSALS TO ENHANCE RESOURCE ALLOCATION AND MAXIMIZE RETURN ON INVESTMENT As investigator initiated studies are being conducted to a greater extent through-out the healthcare industry, device companies are increasingly approached by ex-ternal investigators for study support. While IITs are often advantageous for device companies, proposals must be stringently examined in order to justify investment and avoid unnecessary risk, as many studies may look promising at first glance, but contain pitfalls that should be avoided. In the current economic environment, it is paramount for device companies to put in place proposal valuation guidelines and processes in order to enhance return on investment of time, resources and support. • Implementing IIS assessment processes and committees • Determining priorities among proposals, allocating resources & headcounts • Maximizing ROI for funding and study support Georgia M. Arvanitis, PhD, LIFECELL Craig Sponseller, M.D., KOWA PHARMACEUTICALS

10:20 MAXIMIZING IITS THROUGH MANAGING INVESTIGATOR RELATIONSHIPS: FROM QUALIFICATION TO EVALUATION Prior to accepting a proposal for an investigator initiated study, device companies must explore and review multiple considerations, not the least of which is the capabilities of the investigator. Whether working with healthcare professionals with whom a company has a longstanding relationship or with new investigators, challenges arise that may delay or derail the research, from restricted enrollment through to lackluster data entry. In order to ensure efficient and effective study completion, device manufacturers must develop and implement strategies for not only qualifying healthcare professionals prior to study commencement, but also for evaluating the investigator throughout the trial. • Importance of analyzing the capabilities of an investigator • Exploring types of criteria for qualifying investigators • Evaluating new investigators vs. HCPs with long term relationships• Assessing investigators throughout and at study completion Ulf Borg, COVIDIEN Blake Morrison, Pharm.D., ONYX PHARMACEUTICALS

11:10 FACILITATING INVESTIGATOR INITIATED PROGRAMS WITHIN THE CURRENT ECONOMIC ATMOSPHERE Within the current economic environment, dwindling funding and restricted budgets are certainly key concerns for executives within every department of a medical device company. With heightened attention surrounding efficient use of resources and capital companywide, the effective management of investigator ini-tiated studies amid restricted resources is a constant consideration. In order to al-locate adequate funding to maximize studies and minimize cost, companies must take proactive steps to develop and implement procedures that take into account such budgetary factors as milestone payments that encourage efficiency, strate-gies for overcoming studies that are not enrolling and unique funding avenues such as company matched grants. Jason G. Jones, MS, CCRP, Global Vice President, Clinical Affairs, Advanced Surgical Devices DivisionSMITH & NEPHEW

9:50 COFFEE & NETWORKING BREAK 9:50 COFFEE & NETWORKING BREAK

IIT TRACK THOUGHT LEADER TRACK7:30 CONFERENCE REGISTRATION & MORNING COFFEE

8:00 OPENING REMARKS & DAY TWO WELCOME

DAY TWO / FRIDAY, SEPTEMBER 28 2012 / MEDICAL AFFAIRS SUMMIT

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1:10 PANEL DISCUSSION: BENCHMARKING INDUSTRY THOUGHT LEADER COMPENSATION AND FMV DETERMINATIONThe Office of Inspector General of the Department of Health and Human Services has declared that the healthcare industry must compensate thought leaders and consultants for their companies at a Fair Market Value in order to avoid the ap-pearance of offering inducements for the promotion of their products. Although the OIG created FMV, they have yet to provide a clear determination of what com-pensation is appropriate for industry to offer thought leaders for their services. This panel discussion will bring together pharmaceutical and medical device com-panies, regulators and physicians to discuss the controversial topic of FMV and provide conference attendees with a framework of thought leader compensation best practices during this time of regulatory uncertainty. • Determining consistent and transparent FMV compensation plans• Bridging the gap between OIG lack of guidance & industry best practices• Discussion of FMV from a legal, industry and physician perspectiveNicole Liffrig Molife, Esq., ARNOLD & PORTER LLPMuriel Siadak, SEATTLE GENETICSAvi B. Markowitz, MD, FACP, UNIVERSITY OF TEXAS MEDICAL BRANCH Deitzah Raby, HILL-ROM HOLDINGS, INC. Meenakshi Datta, SIDLEY AUSTIN LLP

2:10 SHAPING THOUGHT LEADER RELATIONSHIPS ON A GLOBAL BASIS WITHIN KEY INTERNATIONAL MARKETSAreas such as Europe, Japan as well as Brazil, Russia, India and China are all key markets that are ideal for both pharmaceutical and device companies to grow their business and thought leader initiatives. Working with thought leaders in these areas is paramount in accessing and understanding international markets, nevertheless it is not without challenges. Managing communication, understanding cultural dif-ferences and remaining compliant within international regulatory guidelines are all important issues to consider when implementing and reinventing global thought leader plans. • Perspective of thought leader growth in Europe, Japan & BRIC countries• Understanding cultural differences in order to attract international KOLs• Capitalizing on key international markets through KOL collaborationAna Stankovic, MD, Ph.D., Worldwide Vice President, Medical AffairsBECTON DICKINSON

3:00 FOCUSING ON THE EXPECTATIONS OF THOUGHT LEADERS FROM A KOL PERSPECTIVE Pursuing new thought leader relationships within the current healthcare environ-ment can be extremely challenging given the increasing industry regulations and the unruly calendars of physicians and surgeons. Key opinion leaders are self-directed, goal-oriented and they must find relevance in what they are doing. Un-derstanding what KOLs find to be valuable when working with companies is an im-portant factor to consider when organizing and developing strategies for capturing their interests. Through the thought leader perspective, attendees will gain insight on regulatory issues, compensation and what KOLs are looking for in a company before agreeing to work with them. • KOLs on what compensation is appropriate for their time & expertise• Attracting and maintaining the attention of key opinion leaders• What makes a company stand out to thought leaders? Avi B. Markowitz, MD, FACP, Professor, Internal Medicine, Chief, Hematology / Oncology, Bill & Louise Bauer Distinguished Chair, Cancer Research Department, Internal Medicine UNIVERSITY OF TEXAS MEDICAL BRANCH

3:50 CLOSING REMARKS AND CONFERENCE CONCLUSION

500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com

3MAccurayAcorda TherapeuticsActelion PharmaceuticalsAesculapAlcon LaboratoriesAllerganAMAG PharmaceuticalsAmerican Medical SystemsAnimas CorporationArQuleAscent PharmaAstellasAstraZenecaAtos MedicalAtrium Medical CorporationB. Braun MedicalBausch & LombBaxterBecton DickinsonBiocompatiblesBoehringer IngelheimBoston ScientificBristol Myers-SquibbBTG International Canyon PharmaceuticalsCardinal HealthCareFusionCellerationCeloNovaCenter for Clinical Research Solu-tions, Inc.Centocor Ortho-BiotechCephalonCleveland ClinicCodman & ShurtleffColoplastCordis CorporationCovidienCubist PharmaceuticalsCytori TherapeuticsDaiichi Sankyo, Inc.Dana Farber Cancer InstituteDavol Inc.DendreonDePuy SpineDuke Clinical Research InstituteDyaxEdwards LifescienceElektaEli LillyEndo PharmaceuticalsEpsteinBeckerGreenEthicon Endo-SurgeryGE HealthcareGenentechGeorgetown University Medical Center

GlaxoSmithKlineImClone Systems, IncInspire PharmaIntegra LifeSciencesIpsen GroupJohnson & JohnsonKeystone Dental , Inc.Kinetic ConceptsKinetic Concepts, Inc.King & Spalding LLPLanxLifeScanMcGuireWoodsMedicureMedtronicMGH InstituteMillennium PharmaceuticalsMiramar LabsNovaBoneNovo NordiskOrtho McNeil JanssenPathway Medical TechnologiesPfizerPhilips HealthcareRoche DiagnosticsRS MedicalSaul Ewing LLPSeattle GeneticsShireSI-BoneSidley Austin LLPSigma-Tau PharmacueticalsSmith & NephewSomaxon PharmaceuticalsSpectrum PharmaceuticalsSt. Jude MedicalStanford School of MedicineStryker NeurovascularSunovion PharmaceuticalsSysmexTakeda PharmaceuticalsTalecris BiotherapeuticsThe Mayo ClinicThe Medicines CompanyThe Stop ALD FoundationTufts University Medical SchoolUCBUniversity of Arkansas for Medical SciencesUniversity of MichiganUniversity of MinnesotaUS OncologyUTMBValeant PharmaceuticalsVertex PharmaceuticalsVistakon

12:00 LUNCHEON FOR ALL SPEAKERS SPONSORS & ATTENDEES

DAY TWO / FRIDAY, SEPTEMBER 28 PREVIOUS ATTENDEE COMPANIES INCLUDE:

Combined Sessions - IIT & Thought Leader

Executives that will find this program of greatest relevance are those currently working in Inves-tigator Initiated Trials, Investigator Sponsored Research and those currently working to enhance collaborative opinion leader relationships within pharmaceutical, device and diagnostic corpo-rations. Job titles of those executives that will find this program to be most applicable to their job functions include:• Medical Affairs• Medical Science Liaisons• Clinical Affairs• External Research

• Medical Directors• KOL Relationship Management• Opinion Leader Relations• Scientific Affairs

WHO SHOULD ATTEND: