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High-Level Strategies for Managing and Executing Practice Issues and Challenges Hear from Medical Affairs, MSL and related Professionals Representing: AUXILIUM PHARMACEUTICALS AVANIR PHARMACEUTICALS BAYER HEALTHCARE PHARMACEUTICALS BOEHRINGER-INGELHEIM BRISTOL-MYERS SQUIBB CENTOCOR ORTHO BIOTECH CEPHALON DAIICHI SANKYO ELI LILLY INTERMUNE GENZYME JOHNSON & JOHNSON OTSUKA AMERICA PHARMACEUTICAL RS MEDICAL TALECRIS PHARMACEUTICALS VERTEX PHARMACEUTICALS Featured Presentations Addressing: Medical Affairs in Today’s Environment Demonstrating Medical Affairs Value REMS Programs Aligning Medical Affairs and Marketing The Current and Future Role of Registries Effectively Communicating Safety Risk Information Future Role of MSD/MSLs Publication Planning Update for Medical Affairs Medical Device Issues and Challenges Plus! – Strategic Outlook Panel Group Discussing What Universal Challenges Lie Ahead TO REGISTER CALL 866-207-6529 or visit us at www.exlpharma.com/medaffairsforum Sponsors & Exhibitors: MEDICAL AFFAIRS Presents REGISTER BY February 25th, 2011 FOR THE BEST SAVINGS Tri-Located with the 8th Annual MSL Best Practices and 13th Investigator Initiated Trials Conferences! MAXIMIZE YOUR NETWORKING! April 14-15, 2011 • Dolce Basking Ridge • Basking Ridge, NJ

Medical Affairs Executive Forum, April 2011, Basking Ridge, NJ

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High-Level Strategies for Managing and Executing Practice Issues and Challenges

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Page 1: Medical Affairs Executive Forum, April 2011, Basking Ridge, NJ

Hig h-Level St r ateg ies for Ma na g ing a nd Execut ing Pract ice Issues a nd Cha l leng es

H e a r f r o m M e d i c a l A f f a i r s , M S L a n d r e l a t e d P r o f e s s i o n a l s R e p r e s e n t i n g :• AUXILIUMPHARMACEUTICALS• AVANIRPHARMACEUTICALS• BAYERHEALTHCAREPHARMACEUTICALS• BOEHRINGER-INGELHEIM• BRISTOL-MYERSSQUIBB• CENTOCORORTHOBIOTECH• CEPHALON• DAIICHISANKYO

• ELILILLY• INTERMUNE• GENZYME• JOHNSON&JOHNSON• OTSUKAAMERICAPHARMACEUTICAL• RSMEDICAL• TALECRISPHARMACEUTICALS• VERTEXPHARMACEUTICALS

F e a t u r e d P r e s e n t a t i o n s A d d r e s s i n g :• MedicalAffairsinToday’sEnvironment• DemonstratingMedicalAffairsValue• REMSPrograms• AligningMedicalAffairsandMarketing• TheCurrentandFutureRoleofRegistries

• EffectivelyCommunicatingSafetyRiskInformation• FutureRoleofMSD/MSLs• PublicationPlanningUpdateforMedicalAffairs• MedicalDeviceIssuesandChallenges

P l u s ! – S t r a t e g i c Ou t l o o k Pa n e l G r o u p Di s c u s s i n g Wh a t Un i ve r s a l Ch a l l e n g e s Li e A h e a d

TO R EGI S TE R CA LL 866- 207- 6529 o r v i s i t u s a t w w w.e x l p h a r m a .c o m /m e d a f fa i r s fo r u m

S p o nso r s & Exhib ito r s:

EXECUTIVE FORUM

M E D I C A L A F F A I R S

P r e s e n t s

R EGI S T ER B Y Fe b r u a r y 2 5 t h , 2 0 1 1 FOR T HE B ES T S AV I NGS

Tri-Located with the 8th Annual MSL Best Practices and 13th Investigator Initiated Trials Conferences!

MaxiMize your NetworkiNg!

A p r i l 1 4 - 1 5 , 2 0 1 1 • D o l c e B a s k i n g R i d g e • B a s k i n g R i d g e , N J

Page 2: Medical Affairs Executive Forum, April 2011, Basking Ridge, NJ

Medical Affairs/Field Medical AffairsMedical Science LiaisonsMedical Directors/StrategyResearch & DevelopmentScientific Affairs

Medical EducationInvestigator Initiated/Sponsored TrialsClinical Research AssociatesPost-Marketing Studies/Phase IVProject Management

Basking Ridge300 North Maple AveBasking Ridge, NJ 07920 USAPhone: 800.953.8033Reservations: 800.953.8033Fax: 908.953.3105

Dolce Basking Ridge combines a retreat-like setting with over 20,000 square feet of IACC approved function space. The award-winning Dolce Basking Ridge is the Tri-state region’s setting of choice for business and pleasure. We are less than an hour west of Manhattan from Interstate 287, 78 and 80. Newark Liberty Airport is a 30-minute drive, while LaGuardia and JFK Airports are just an hour away.

If you require overnight accommodations, please contact reservations directly at 800.953.8033 to book your room. ExL has reserved a block of rooms at a discounted rate for conference participants. Please mention ExL Pharma and the conference name to take advantage of this discount. You must book your room by Wednesday, March 23, 2011 to be eligible for the discounted rate. Please book your room as early as possible as the rooms available at this rate are limited.

Shuttle Information: We offer Complimentary shuttle service within a 6 mile radius which would include to Basking Ridge Train Station.

Airport Information: Newark International Airport is approximately 30 minutes away.

Sponsorship & 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

sponsor, underwrite 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 suits all your needs. To learn

more about these opportunities, please

contact the Steve Decker at 212-400-6234,

or [email protected].

Who Should Attend: Pharmaceutical, Biotechnology, Specialty, Medical Device, CRO and Service Providers with responsibilities in:

Testimonials from Recent ExL Events:

Yes, the event met my expectations – very good. - Giselle Crosa, Sr. Manager, Vertex Pharmaceuticals

Thorough and entertaining - really engaging, Linda Barr, Senior Director, Clinical Development & Regulatory Affairs,” Accera, Inc.

Very good information and discussions, - Ylva Sjoquist, Research Manager, Ikaria

Very good in every respect, excellent presentation, Robert E. Kristofco, Director, Medical Education Group, Pfizer

Great content – well-designed agenda! - Holli Tirabasso, Medical Education Manager, Allergan

Very good practical info, - Christine Berger, Manager Scientific Education, Celgene

TO R E GI S TE R CA LL 866- 207- 6529 o r v i s i t u s a t w w w.e x l p h a r m a .c o m /m e d a f fa i r s fo r u m

Page 3: Medical Affairs Executive Forum, April 2011, Basking Ridge, NJ

Day One ~ April 14, 20118:00 Continental Breakfast & Conference Registration

CONFERENCE COMMENCES

9:00 Conference Welcome and Chairperson’s Opening Remarks Michael O. Montgomery, MD,CPI,Director,Worldwide MedicalAffairsImmunologyResearch,MedicalAffairs, CentocorOrthoBiotechServices,LLC

9:15 Medical Affairs in Today’s Environment• Roles,activitiesandfunctionsofacontemporary medicalaffairsdepartmentintoday’senvironment• Whattraditionalrolesofcommercializationhave medicalaffairstakenover?• Whatmaystilllieahead?

Jeffrey Spears, Director,MedicalAffairs, TalecrisBioTherapeutics

10:00 Demonstrating Medical Affairs Value• Overviewofkeyvaluedriversandproductivity• Adheringtoresearchwhilealigningwithcommercialgoals• Increasingrelianceoncomplianceandglobalization• ChangingrolesofRoleofteammembersMedDirectors/MSLs• Activitiesnotlinkedtofinancialreturn

Leo Plouffe, Jr., MD CM FACOG, VicePresident,Women’s HealthCareMedicalAffairs,BayerHealthCarePharmaceuticals

10:45 30-Minute Networking and Refreshment Break

11:15 Aligning Medical Affairs and Marketing • Theimportanceofintegratingthetwoareas• Exampleswhenyoucan’tcollaborateforethicalor compliancereasons• DevelopingMedicalActionPlans• Marketablevs.Non-MarketableProducts

Craig S. Conoscenti, MD, FCCP, MedicalAffairs, BoehringerIngelheimPharmaceuticals

12:00 Addressing the Current and Future Role of Registries

• Findinganswerstounansweredquestions• Developingevidence-baseddiseasemanagement• Generatingdatatosupportmarketaccess• Buildingcommunitiesofphysiciansandpatients

John Yee, MD, MPH, VicePresident,GlobalMedicalAffairs, GenzymeCorporation

12:45 Luncheon

2:00 Examining the Role of Medical Affairs in Medical Education

• Understandingthekeyissues• DoesMedicalAffairshavearole?• Maintainingscientificobjectivity• WhatpotentialcontributionscanMAmake

Shahin Gharakhanian, MD, DPH, VP,Strategic MedicalEducation&Publications,Dept.ofMedicalAffairs, MedicinesDevelopmentGroup(MDG)GlobalR&D,Vertex Pharmaceuticals

2:45 Effectively Communicating Safety Risk Information

• Whatisindustry’srole?• Targetingphysicians,healthcareadvocatesandpatients• WhatistheamountofriskconsideringadventofREMSprograms• Addressingsafetyriskcommunicationsasinformationismore availabletopatientnetworks,proprietarynetworks,medical educationandpayororganizations• Navigatinginformation/resources

Rebecca Vermeulen, SeniorDirector,GlobalMedical CustomerSolutions,EliLilly

3:30 Networking and Refreshment Break

4:00 Realizing the Importance of REMS Programs• AnticipatingaproperREMSprogram• ManagingHCPslackofexperienceandunfamiliarity• Recognizethevaluetopatientsintermsofassuringsafety andeffectiveness• LegalandComplianceconsiderations

Gail Rosen Spahn, PharmD, SeniorDirector,MedicalAffairs, AuxiliumPharmaceuticals

4:45 INTERACTIVE ROUNDTABLE DISCUSSIONS Choose your preferred topic and discuss in an intimate, break-out style, setting.

• MedicalAffairsValue• FocusingonREMS• RoleinMedicalEducation• CommunicatingSafetyRiskInformation• AligningMedicalAffairs&Marketing• Current&FutureRoleofRegistries• Tools&Technologies• OpenTable

If you would like to suggest a roundtable discussion topic, please email Program Director, Ethan Denkensohn at [email protected]

5:00 Cocktail Reception Network with 8th MSL Best Practices, and 13th Investigator Initiated Trials Attendees.

5:45 Day One Concludes

TO R E GI S TE R CA LL 866- 207- 6529 o r v i s i t u s a t w w w.e x l p h a r m a .c o m /m e d a f fa i r s fo r u m

Page 4: Medical Affairs Executive Forum, April 2011, Basking Ridge, NJ

DAY TWO ~ April 15, 2011

8:50 Chairperson’s Recap of Day One Michael O. Montgomery, M.D., C.P.I.,Director,Worldwide MedicalAffairsImmunologyResearch,MedicalAffairs, CentocorOrthoBiotechServices,LLC

9:00 The Role of the CMO and How it Impacts Medical Affairs

• Increasingmedicalandscientificcredibility• Providingleadershipbeyondorganizationalresponsibilities• Commitmenttopatientsafetyandoutcomes

Randall Kaye, MD, ChiefMedicalOfficer, AvanirPharmaceuticals

9:45 Medical Affairs in the 21st Century - Responding to Dynamic Industry Trends

• TheChangingHealthcareEnvironment-TheFutureofMSLs andMSDs• USPopulationandHCPTrends-WhatTheyMeanand HowtoRespond• HealthcareReform-ImpactonBiotechandPharma• PersonalizedMedicineandPharma’sResponse• ChangingandGrowingRole&ImportanceofMedicalAffairs intheFuture

Alan Cohen, MD, FAAP, FCCP, FAAAAI, FACAAI, SeniorVicePresident,MedicalAffairs,InterMune

10:30 Networking and Refreshment Break

11:00 Medical Affairs Plan Design and Implementation for Product Support

• AdvocacyPlan• InvestigatorInitiatedStudies• MedicalInformationPlan• PhaseIV• PublicationPlanning• SalesTraining

Campbell Alliance

11:45 Medical Device Focus - Challenges, Issues, Opportunities, and Strategies for Success

• NewChallenges• Opportunities• CriticalIssuestoAddress• StrategiesforSuccess• Caseexamples

Dominic J. F. Tong, MD, VP,MedicalandClinicalAffairs, RSMedical

12:30 Luncheon

1:30 Publication Planning Update for Medical Affairs

• Recentchangesintheindustry •publicationsplans:past,presentandfuture •institutionalpolicies •Authorship• Lexicon:isthisjustsemantics?• Documentation

•Publicationspolicies •Investigatoragreements •Authoragreements

Mina Patel, PhD, SeniorDirector,MedicalCommunications, Cephalon

2:15 How MSLs work Successfully with Medical Affairs

• ManagingKOLs• AdBoardsandSpeakersManagement• FieldSupport• BizDevelopment• FutureRolesandResponsibilitiesforMSLs

Josh Cirulli, PharmD, MedicalScienceLiasion,Otsuka AmericaPharmaceutical

3:15 Closing Panel Discussion: Five-Year Strategic Outlook

• WhatUniversalChallengesLieAhead?• ImportanceofExpandingResources• Globalwaysofworking• Caseexamples

Jeffrey S. Humphrey, MD, VP,OncologyMedicalStrategy, Bristol-MyersSquibb(moderator)

Michael O. Montgomery, M.D., C.P.I., Director, WorldwideMedicalAffairsImmunologyResearch,MedicalAffairs, CentocorOrthoBiotechServices,LLC

Suku Nagendran, MD, ExecutiveMedicalDirector, MultiTAHead,MedicalAffairs,DaiichiSankyo

4:00 Chairperson’s Closing Conference Concludes

DAY ONE & ROUNDTABLES RE-CAP

TRI-LOCATED with the 8th Annual MSL Best Practices and 13th Investigator Initiated Trial Conferences

Maximize your Networking Opportunities with Shared Networking Breaks and Luncheon! Stay Connected & Interact with us Online!

TO R E GI S TE R CA LL 866- 207- 6529 o r v i s i t u s a t w w w.e x l p h a r m a .c o m /m e d a f fa i r s fo r u m

Page 5: Medical Affairs Executive Forum, April 2011, Basking Ridge, NJ

FIVE WAYS TO REGISTER

Registration Fees for Attending ExL’s Executive Medical Affairs ForumPRICINGRegister by February 25th to take Advantage of Early-Bird Pricing. Standard Rates begin on February 26th and please note that On-Site rates take effect on April 14thEarly-Bird Rates $1795 Standard Rates $1995 On-Site $2195

CEU – Please check with an applicable professional association and/or licensing board that accept Continuing Education hours.

Save 25% per person when Registering FourFor every three simultaneous registrations from your company you will receive a fourth complimentary registration (must register 4 at one time). Please call 866-207-6528.

Save 15% per person when Registering ThreeCan only send three? You can still save 15% off every registration. To take advantage, please call 866-207-6528.

Make checks payable to ExL Events, Inc. and write code P323 on your check. You may also use Visa, MasterCard, Discover or American 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: A full refund (minus a $95 processing fee), or a voucher to another ExL event valid for two years from the voucher issue date.

One to Four weeks: A 50% refund, or a voucher to another ExL event valid for two years from the voucher issue date.

Within the Last Week: A voucher to another ExL event valid for two years from the voucher issue date.

To receive a refund or voucher, please fax your request to 888-221-6750.

Please Note: Conference registrations may be transferred to other colleagues in the event you are unable to attend. Please notify ExL Pharma, [email protected], prior to the

event with the name and contact information of the replacement attendee.

Please 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.

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.

*The opinions of the speakers and attendees do not necessarily reflect those of the companies they represent or ExL Events, Inc.*

Media Partners

Fax: 888-221-6750Mail: ExLEvents,Inc. 5558thAve.,Ste.310 NewYork,NY10018

Phone: 866-207-6528Online: www.exlpharma.com/medaffairsforumEmail: [email protected]

36OPMTHE FULL SPECTRUM OF PRODUCT MANAGEMENT

36O

Page 6: Medical Affairs Executive Forum, April 2011, Basking Ridge, NJ

R EGI S T ER B Y Fe b r u a r y 2 5 t h , 2 0 1 1 FOR T HE B E S T S AV I NGS

To Register:ExL Events, Inc.555 8th Avenue, Suite 310New York, NY 10018

866-207-6528

888-221-6750

[email protected]

www.exlpharma.com/medaffairsforum

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Questions? Comments?Contact Ethan Denkenohn at [email protected]

EXECUTIVE FORUM

M E D I C A L A F F A I R S

A p r i l 1 4 - 1 5 , 2 0 1 1 • D o l c e B a s k i n g R i d g e • B a s k i n g R i d g e , N J

AUXILIUMPHARMACEUTICALSAVANIRPHARMACEUTICALS

BAYERHEALTHCAREPHARMACEUTICALSBOEHRINGER-INGELHEIMBRISTOL-MYERSSQUIBB

CENTOCORORTHOBIOTECH

CEPHALONDAIICHISANKYO

ELILILLYINTERMUNEGENZYME

JOHNSON&JOHNSONOTSUKAAMERICAPHARMACEUTICAL

RSMEDICALTALECRISPHARMACEUTICALSVERTEXPHARMACEUTICALS

P r e s e n t s

TO R EGI S TE R CA LL 866- 207- 6529 o r v i s i t u s a t w w w.e x l p h a r m a .c o m /m e d a f fa i r s fo r u m

Thanks to Our Sponsors: H e a r f r o m M e d i c a l A f f a i r s , M S L a n d r e l a t e d P r o f e s s i o n a l s R e p r e s e n t i n g :