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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

              Presents




MEDIC AL
A FFA IR S
 EXECUTIVE FORUM

         Apr il 14-15, 2011 • Dolce Basking Ridge • Basking Ridge, NJ
      Hig h-Level St r a te g ies for Ma na g ing a nd Execut ing Pr a ct ice Issues a nd Cha lleng es
      Hear from Medical Affairs, MSL and related Professionals Representing:
 •	    AUXILIUM	PHARMACEUTICALS                                     •	   ELI	LILLY
 •	    AVANIR	PHARMACEUTICALS                                       •	   INTERMUNE
 •	    BAYER	HEALTHCARE	PHARMACEUTICALS                             •	   GENZYME
 •	    BOEHRINGER-INGELHEIM                                         •	   JOHNSON	&	JOHNSON
 •	    BRISTOL-MYERS	SQUIBB                                         •	   OTSUKA	AMERICA	PHARMACEUTICAL
 •	    CENTOCOR	ORTHO	BIOTECH                                       •	   RS	MEDICAL
 •	    CEPHALON                                                     •	   TALECRIS	PHARMACEUTICALS
 •	    DAIICHI	SANKYO                                               •	   VERTEX	PHARMACEUTICALS
 Fe a t u re d P re s e n t a t io n s A ddre ss in g :
 •	    Medical	Affairs	in	Today’s	Environment                       •	   Effectively	Communicating	Safety	Risk	Information
 •	    Demonstrating	Medical	Affairs	Value                          •	   Future	Role	of	MSD/MSLs
 •	    REMS	Programs                                                •	   Publication	Planning	Update	for	Medical	Affairs
 •	    Aligning	Medical	Affairs	and	Marketing                       •	   Medical	Device	Issues	and	Challenges
 •	    The	Current	and	Future	Role	of	Registries
       Plu s! – S t ra te g ic Ou t lo o k Pa n e l Gro u p Di s c u ss in g Wha t Un ive r s a l Cha lle n g e s Lie A he a d
       MaxiMize your                                   Tri-Located with the 8th Annual MSL Best Practices and
        NetworkiNg!                                    13th Investigator Initiated Trials Conferences!
Sp o nso rs & Exhibito rs:

      TO REGI S TER CA LL 866-207-6529 o r v i s i t u s a t w w w.e xlp ha r m a .c o m /m e d a ffa ir s fo r u m
Who Should Attend:
  Pharmaceutical, Biotechnology, Specialty, Medical Device, CRO and Service Providers with responsibilities in:
             Medical Affairs/Field Medical Affairs                                                                     Medical Education
             Medical Science Liaisons                                                                                  Investigator Initiated/Sponsored Trials
             Medical Directors/Strategy                                                                                Clinical Research Associates
             Research & Development                                                                                    Post-Marketing Studies/Phase IV
             Scientific Affairs                                                                                        Project Management


 Testimonials from Recent ExL Events:

    Yes, the event met my expectations                                       Very good information and                                   Great content – well-designed
  – very good. - Giselle Crosa, Sr. Manager,                              discussions, - Ylva Sjoquist, Research                       agenda! - Holli Tirabasso, Medical Education
 Vertex Pharmaceuticals                                                   Manager, Ikaria                                              Manager, Allergan



    Thorough and entertaining - really                                       Very good in every respect, excellent                         Very good practical info,
 engaging, Linda Barr, Senior Director, Clinical                          presentation, Robert E. Kristofco, Director,                 - Christine Berger, Manager Scientific Education,
 Development & Regulatory Affairs,” Accera, Inc.                          Medical Education Group, Pfizer                              Celgene




                                                                                                                                Sponsorship &
                                                                                                                                Exhibiting Opportunities
                                                                                                                                Do you want to spread the word about your
                                                                                                                                organization’s     solutions       and     services        to
Basking Ridge                                                                                                                   potential clients who will be attending this
300 North Maple Ave
Basking Ridge, NJ 07920 USA                                                                                                     event? Take advantage of the opportunity to
Phone: 800.953.8033
                                                                                                                                sponsor, underwrite an educational session,
Reservations: 800.953.8033
Fax: 908.953.3105                                                                                                               host   a   networking         event,     or    distribute

Dolce Basking Ridge combines a retreat-like setting with over 20,000 square feet of IACC approved function space. The
                                                                                                                                promotional items to attendees. ExL Pharma
award-winning Dolce Basking Ridge is the Tri-state region’s setting of choice for business and pleasure. We are less than       will work closely with you to customize a
an hour west of Manhattan from Interstate 287, 78 and 80. Newark Liberty Airport is a 30-minute drive, while LaGuardia          package that suits all your needs. To learn
and JFK Airports are just an hour away.
                                                                                                                                more about these opportunities, please
If you require overnight accommodations, please contact reservations directly at 800.953.8033 to book your room. ExL
                                                                                                                                contact the Steve Decker at 212-400-6234,
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                  or sdecker@exlpharma.com.
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.

    TO R EGI S TER CA LL 866-207-6529 o r v i s i t u s a t w w w.e xlp h a r m a .c o m /m e d a ffa ir s fo r u m
Day One ~ April 14, 2011
8:00      Continental Breakfast &                                         2:00   Examining the Role of Medical Affairs in
          Conference Registration                                                Medical Education
                                                                                 •	 Understanding	the	key	issues
                                                                                 •	 Does	Medical	Affairs	have	a	role?
CONFERENCE COMMENCES                                                             •	 Maintaining	scientific	objectivity
                                                                                 •	 What	potential	contributions	can	MA	make
                                                                                 Shahin Gharakhanian, MD, DPH, VP,	Strategic	
9:00      Conference Welcome and Chairperson’s                            	      Medical	Education	&	Publications,	Dept.	of	Medical	Affairs,	
          Opening Remarks                                                 	      Medicines	Development	Group	(MDG)		Global	R&D,	Vertex	
	         Michael O. Montgomery, MD,	CPI,	Director,	Worldwide		           	      Pharmaceuticals
	         Medical	Affairs	Immunology	Research,	Medical	Affairs,
	         Centocor	Ortho	Biotech	Services,	LLC                            2:45   Effectively Communicating Safety Risk
                                                                                 Information
9:15      Medical Affairs in Today’s Environment                                 •	 What	is	industry’s	role?
          •	 Roles,	activities	and	functions	of	a	contemporary		                 •	 Targeting	physicians,	healthcare	advocates	and	patients
          	 medical	affairs	department	in	today’s	environment	                   •	 What	is	the	amount	of	risk	considering	advent	of	REMS	programs
          •	 What	traditional	roles	of	commercialization	have		                  •	 Addressing	safety	risk	communications	as	information	is	more		
          	 medical	affairs	taken	over?		                                        	 available	to	patient	networks,	proprietary	networks,	medical		
          •	 What	may	still	lie	ahead?		                                         	 education	and	payor	organizations
                                                                                 •	 Navigating	information/resources
          Jeffrey Spears, Director,	Medical	Affairs,	
	         Talecris	BioTherapeutics                                               Rebecca Vermeulen, Senior	Director,	Global	Medical	
                                                                          	      Customer	Solutions,	Eli	Lilly
10:00 Demonstrating Medical Affairs Value
          •	 Overview	of	key	value	drivers	and	productivity               3:30   Networking and Refreshment Break
          •	 Adhering	to	research	while	aligning	with	commercial	goals
          •	 Increasing	reliance	on	compliance	and	globalization          4:00   Realizing the Importance of REMS Programs
          •	 Changing	roles	of	Role	of	team	members	Med	Directors/MSLs           •	 Anticipating	a	proper	REMS	program
          •	 Activities	not	linked	to	financial	return                           •	 Managing	HCPs	lack	of	experience	and	unfamiliarity		
                                                                                 •	 Recognize	the	value	to	patients	in	terms	of	assuring	safety		
          Leo Plouffe, Jr., MD CM FACOG, Vice	President,	Women’s	                	 and	effectiveness	
	         Health	Care	Medical	Affairs,	Bayer	HealthCare	Pharmaceuticals          •	 Legal	and	Compliance	considerations

10:45 30-Minute Networking and Refreshment Break                                 Gail Rosen Spahn, PharmD, Senior	Director,	Medical	Affairs,	
                                                                          	      Auxilium	Pharmaceuticals
11:15 Aligning Medical Affairs and Marketing
          •	 The	importance	of	integrating	the	two	areas                  4:45   INTERACTIVE ROUNDTABLE DISCUSSIONS
          •	 Examples	when	you	can’t	collaborate	for	ethical	or		                Choose your preferred topic and discuss in an
          	 compliance	reasons                                                   intimate, break-out style, setting.
          •	 Developing	Medical	Action	Plans                                     •	 Medical	Affairs	Value
          •	 Marketable	vs.	Non-Marketable	Products                              •	 Focusing	on	REMS
          Craig S. Conoscenti, MD, FCCP, Medical	Affairs,	                       •	 Role	in	Medical	Education
	         Boehringer	Ingelheim	Pharmaceuticals                                   •	 Communicating	Safety	Risk	Information
                                                                                 •	 Aligning	Medical	Affairs	&	Marketing
12:00 Addressing the Current and Future Role                                     •	 Current	&	Future	Role	of	Registries
      of Registries                                                              •	 Tools	&	Technologies
          •	 Finding	answers	to	unanswered	questions                             •	 Open	Table	
          •	 Developing	evidence-based	disease	management                        If you would like to suggest a roundtable discussion
          •	 Generating	data	to	support	market	access
                                                                                 topic, please email Program Director, Ethan
          •	 Building	communities	of	physicians	and	patients
                                                                                 Denkensohn at edenkensohn@exlpharma.com
          John Yee, MD, MPH, Vice	President,	Global	Medical	Affairs,	
	         Genzyme	Corporation

12:45 Luncheon                                                            5:00                       Cocktail Reception
                                                                                                     Network with 8th MSL Best Practices,
                                                                                                     and 13th Investigator Initiated Trials
                                                                                                     Attendees.

                                                                          5:45   Day One Concludes

       TO R EGI S TER CA LL 866-207-6529 o r v i s i t u s a t w w w.e xlp h a r m a .c o m /m e d a ffa ir s fo r u m
DAY TWO ~ April 15, 2011
DAY ONE & ROUNDTABLES RE-CAP
8:50   Chairperson’s Recap of Day One                                           	 	    •	Publications	policies	
       Michael O. Montgomery, M.D., C.P.I.,	Director,	Worldwide                 	 	    •	Investigator	agreements	
	      Medical	Affairs	Immunology	Research,	Medical	Affairs,		                  	 	    •	Author	agreements
	      Centocor	Ortho	Biotech	Services,	LLC                                     Mina Patel, PhD, Senior	Director,	Medical	Communications,
                                                                        	       Cephalon
9:00   The Role of the CMO and How it
       Impacts Medical Affairs                                          2:15    How MSLs work Successfully with
       •	 Increasing	medical	and	scientific	credibility                         Medical Affairs
       •	 Providing	leadership	beyond	organizational	responsibilities           •	 Managing	KOLs
       •	 Commitment	to	patient	safety	and	outcomes                             •	 Ad	Boards	and	Speakers	Management	
                                                                                •	 Field	Support
       Randall Kaye, MD, Chief	Medical	Officer,	                                •	 Biz	Development
	      Avanir	Pharmaceuticals	
                                                                                •	 Future	Roles	and	Responsibilities	for	MSLs
9:45   Medical Affairs in the 21st Century -                                    Josh Cirulli, PharmD, Medical	Science	Liasion,	Otsuka	
       Responding to Dynamic Industry Trends                            	       America	Pharmaceutical
       •	 The	Changing	Healthcare	Environment	-	The	Future	of	MSLs		
       	 and	MSDs                                                       3:15    Closing Panel Discussion: Five-Year
       •	 US	Population	and	HCP	Trends	-	What	They	Mean	and		                   Strategic Outlook
       	 How	to	Respond                                                         •	 What	Universal	Challenges	Lie	Ahead?
       •	 Healthcare	Reform	-	Impact	on	Biotech	and	Pharma                      •	 Importance	of	Expanding	Resources
       •	 Personalized	Medicine	and	Pharma’s	Response                           •	 Global	ways	of	working
       •	 Changing	and	Growing	Role	&	Importance	of	Medical	Affairs		           •	 Case	examples
       	 in	the	Future                                                          Jeffrey S. Humphrey, MD, VP,	Oncology	Medical	Strategy,	
       Alan Cohen, MD, FAAP, FCCP, FAAAAI, FACAAI,                      	       Bristol-Myers	Squibb	(moderator)
	      Senior	Vice	President,	Medical	Affairs,	InterMune                        Michael O. Montgomery, M.D., C.P.I., Director,	
                                                                        	       Worldwide	Medical	Affairs	Immunology	Research,	Medical	Affairs,	
10:30 Networking and Refreshment Break                                  	       Centocor	Ortho	Biotech	Services,	LLC

11:00 Medical Affairs Plan Design and                                           Suku Nagendran, MD, Executive	Medical	Director,	
      Implementation for Product Support                                	       Multi	TA	Head,	Medical	Affairs,	Daiichi	Sankyo
       •	 Advocacy	Plan
       •	 Investigator	Initiated	Studies                                4:00    Chairperson’s Closing
       •	 Medical	Information	Plan                                              Conference Concludes
       •	 Phase	IV
       •	 Publication	Planning
       •	 Sales	Training
       Campbell Alliance

11:45 Medical Device Focus - Challenges, Issues,
      Opportunities, and Strategies for Success
       •	 New	Challenges                                                    TRI-LOCATED with the 8th Annual
       •	 Opportunities                                                     MSL Best Practices and 13th Investigator
       •	 Critical	Issues	to	Address
       •	 Strategies	for	Success                                            Initiated Trial Conferences
       •	 Case	examples
       Dominic J. F. Tong, MD, VP,	Medical	and	Clinical	Affairs,	           Maximize your
	      RS	Medical
                                                                            Networking Opportunities
12:30 Luncheon                                                              with Shared Networking Breaks
1:30   Publication Planning Update for                                      and Luncheon!
       Medical Affairs                                                      Stay Connected & Interact with us Online!
       •	 Recent	changes	in	the	industry	
       	 	     •	publications	plans:	past,	present	and	future	
       	 	     •	institutional	policies	
       	 	     •	Authorship
       •	 Lexicon:	is	this	just	semantics?
       •	 Documentation	

           TO R EGI S TER CA LL 866-207-6529 o r v i s i t u s a t w w w.e xlp h a r m a .c o m /m e d a ffa i r s fo r u m
Media Partners


                                                                                                                                                                    PM               36O
                                                                                                                                                                    THE FULL SPECTRUM OF PRODUCT MANAGEMENT




 FIVE WAYS TO REGISTER

      Fax:	    		   888-221-6750                                                                   Phone:		       866-207-6528
      Mail:	   	    ExL	Events,	Inc.                                                               Online:		      www.exlpharma.com/medaffairsforum
      	        	    555	8th	Ave.,	Ste.	310                                                         Email:	 	      registration@exlpharma.com
      	        	    New	York,	NY	10018


 Registration Fees for Attending ExL’s Executive Medical Affairs Forum
 PRICING
 Register 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 14th
 Early-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 Four
 For 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 Three
 Can 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, info@exlpharma.com, 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.*
To Register:
                     ExL Events, Inc.                             866-207-6528                         Method of Payment:                  Check Credit Card
                     555 8th Avenue, Suite 310                                                                                            Make checks payable to ExL Events, Inc.
                                                                  888-221-6750
                     New York, NY 10018                                                                Card Type:                         MasterCard  Visa  Discover Amex
                                                                  registration@exlpharma.com
                                                                                                       Card Number:                                            Exp. Date:
                     www.exlpharma.com/medaffairsforum
                                                                                                       Name on Card:
          Yes!    Register me for the conference:
   Please contact me:                                                                                  Signature:
    I’m interested in marketing opportunities at this event
    I wish to receive email updates on ExL Pharma’s upcoming events                                                      555 8th Avenue, Suite 310
                                                                                                                          New York, NY 10018
   Name:                                            Title:                                                                Priority Code: P323DM

   Company:

   Dept.:

   Address:

   City:                                            State:                 Zip:

   Email:

   Telephone:                                       Fax:


   Questions? Comments?
   Contact Ethan Denkenohn at edenkensohn@exlpharma.com

                                                                                               R E GI S T E R B Y Fe b r u a r y 2 5 t h , 2 0 1 1 F OR T H E B E S T S AV I NGS

                  Presents




                MEDIC AL
                A FFA IR S
                  EXECUTIVE FORUM
      April 14-15, 2011 • Dolce Basking Ridge • Basking Ridge, NJ
Thanks to Our Sponsors:                                      Hear from Medical Affairs, MSL and related Professionals Representing:
                                                               AUXILIUM	PHARMACEUTICALS                               CEPHALON                              JOHNSON	&	JOHNSON
                                                                AVANIR	PHARMACEUTICALS                              DAIICHI	SANKYO                    OTSUKA	AMERICA	PHARMACEUTICAL
                                                           BAYER	HEALTHCARE	PHARMACEUTICALS                             ELI	LILLY                                RS	MEDICAL
                                                                  BOEHRINGER-INGELHEIM                               INTERMUNE                           TALECRIS	PHARMACEUTICALS
                                                                   BRISTOL-MYERS	SQUIBB                               GENZYME                             VERTEX	PHARMACEUTICALS
                                                                CENTOCOR	ORTHO	BIOTECH




            TO REGI S TER CA LL 866-207-6529 o r v i s i t u s a t w w w.e xlp ha r m a .c o m /m e d a ffa ir s fo r u m

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

  • 1. 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 Presents MEDIC AL A FFA IR S EXECUTIVE FORUM Apr il 14-15, 2011 • Dolce Basking Ridge • Basking Ridge, NJ Hig h-Level St r a te g ies for Ma na g ing a nd Execut ing Pr a ct ice Issues a nd Cha lleng es Hear from Medical Affairs, MSL and related Professionals Representing: • AUXILIUM PHARMACEUTICALS • ELI LILLY • AVANIR PHARMACEUTICALS • INTERMUNE • BAYER HEALTHCARE PHARMACEUTICALS • GENZYME • BOEHRINGER-INGELHEIM • JOHNSON & JOHNSON • BRISTOL-MYERS SQUIBB • OTSUKA AMERICA PHARMACEUTICAL • CENTOCOR ORTHO BIOTECH • RS MEDICAL • CEPHALON • TALECRIS PHARMACEUTICALS • DAIICHI SANKYO • VERTEX PHARMACEUTICALS Fe a t u re d P re s e n t a t io n s A ddre ss in g : • Medical Affairs in Today’s Environment • Effectively Communicating Safety Risk Information • Demonstrating Medical Affairs Value • Future Role of MSD/MSLs • REMS Programs • Publication Planning Update for Medical Affairs • Aligning Medical Affairs and Marketing • Medical Device Issues and Challenges • The Current and Future Role of Registries Plu s! – S t ra te g ic Ou t lo o k Pa n e l Gro u p Di s c u ss in g Wha t Un ive r s a l Cha lle n g e s Lie A he a d MaxiMize your Tri-Located with the 8th Annual MSL Best Practices and NetworkiNg! 13th Investigator Initiated Trials Conferences! Sp o nso rs & Exhibito rs: TO REGI S TER CA LL 866-207-6529 o r v i s i t u s a t w w w.e xlp ha r m a .c o m /m e d a ffa ir s fo r u m
  • 2. Who Should Attend: Pharmaceutical, Biotechnology, Specialty, Medical Device, CRO and Service Providers with responsibilities in: Medical Affairs/Field Medical Affairs Medical Education Medical Science Liaisons Investigator Initiated/Sponsored Trials Medical Directors/Strategy Clinical Research Associates Research & Development Post-Marketing Studies/Phase IV Scientific Affairs Project Management Testimonials from Recent ExL Events: Yes, the event met my expectations Very good information and Great content – well-designed – very good. - Giselle Crosa, Sr. Manager, discussions, - Ylva Sjoquist, Research agenda! - Holli Tirabasso, Medical Education Vertex Pharmaceuticals Manager, Ikaria Manager, Allergan Thorough and entertaining - really Very good in every respect, excellent Very good practical info, engaging, Linda Barr, Senior Director, Clinical presentation, Robert E. Kristofco, Director, - Christine Berger, Manager Scientific Education, Development & Regulatory Affairs,” Accera, Inc. Medical Education Group, Pfizer Celgene Sponsorship & Exhibiting Opportunities Do you want to spread the word about your organization’s solutions and services to Basking Ridge potential clients who will be attending this 300 North Maple Ave Basking Ridge, NJ 07920 USA event? Take advantage of the opportunity to Phone: 800.953.8033 sponsor, underwrite an educational session, Reservations: 800.953.8033 Fax: 908.953.3105 host a networking event, or distribute Dolce Basking Ridge combines a retreat-like setting with over 20,000 square feet of IACC approved function space. The promotional items to attendees. ExL Pharma award-winning Dolce Basking Ridge is the Tri-state region’s setting of choice for business and pleasure. We are less than will work closely with you to customize a an hour west of Manhattan from Interstate 287, 78 and 80. Newark Liberty Airport is a 30-minute drive, while LaGuardia package that suits all your needs. To learn and JFK Airports are just an hour away. more about these opportunities, please If you require overnight accommodations, please contact reservations directly at 800.953.8033 to book your room. ExL contact the Steve Decker at 212-400-6234, 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 or sdecker@exlpharma.com. 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. TO R EGI S TER CA LL 866-207-6529 o r v i s i t u s a t w w w.e xlp h a r m a .c o m /m e d a ffa ir s fo r u m
  • 3. Day One ~ April 14, 2011 8:00 Continental Breakfast & 2:00 Examining the Role of Medical Affairs in Conference Registration Medical Education • Understanding the key issues • Does Medical Affairs have a role? CONFERENCE COMMENCES • Maintaining scientific objectivity • What potential contributions can MA make Shahin Gharakhanian, MD, DPH, VP, Strategic 9:00 Conference Welcome and Chairperson’s Medical Education & Publications, Dept. of Medical Affairs, Opening Remarks Medicines Development Group (MDG) Global R&D, Vertex Michael O. Montgomery, MD, CPI, Director, Worldwide Pharmaceuticals Medical Affairs Immunology Research, Medical Affairs, Centocor Ortho Biotech Services, LLC 2:45 Effectively Communicating Safety Risk Information 9:15 Medical Affairs in Today’s Environment • What is industry’s role? • Roles, activities and functions of a contemporary • Targeting physicians, healthcare advocates and patients medical affairs department in today’s environment • What is the amount of risk considering advent of REMS programs • What traditional roles of commercialization have • Addressing safety risk communications as information is more medical affairs taken over? available to patient networks, proprietary networks, medical • What may still lie ahead? education and payor organizations • Navigating information/resources Jeffrey Spears, Director, Medical Affairs, Talecris BioTherapeutics Rebecca Vermeulen, Senior Director, Global Medical Customer Solutions, Eli Lilly 10:00 Demonstrating Medical Affairs Value • Overview of key value drivers and productivity 3:30 Networking and Refreshment Break • Adhering to research while aligning with commercial goals • Increasing reliance on compliance and globalization 4:00 Realizing the Importance of REMS Programs • Changing roles of Role of team members Med Directors/MSLs • Anticipating a proper REMS program • Activities not linked to financial return • Managing HCPs lack of experience and unfamiliarity • Recognize the value to patients in terms of assuring safety Leo Plouffe, Jr., MD CM FACOG, Vice President, Women’s and effectiveness Health Care Medical Affairs, Bayer HealthCare Pharmaceuticals • Legal and Compliance considerations 10:45 30-Minute Networking and Refreshment Break Gail Rosen Spahn, PharmD, Senior Director, Medical Affairs, Auxilium Pharmaceuticals 11:15 Aligning Medical Affairs and Marketing • The importance of integrating the two areas 4:45 INTERACTIVE ROUNDTABLE DISCUSSIONS • Examples when you can’t collaborate for ethical or Choose your preferred topic and discuss in an compliance reasons intimate, break-out style, setting. • Developing Medical Action Plans • Medical Affairs Value • Marketable vs. Non-Marketable Products • Focusing on REMS Craig S. Conoscenti, MD, FCCP, Medical Affairs, • Role in Medical Education Boehringer Ingelheim Pharmaceuticals • Communicating Safety Risk Information • Aligning Medical Affairs & Marketing 12:00 Addressing the Current and Future Role • Current & Future Role of Registries of Registries • Tools & Technologies • Finding answers to unanswered questions • Open Table • Developing evidence-based disease management If you would like to suggest a roundtable discussion • Generating data to support market access topic, please email Program Director, Ethan • Building communities of physicians and patients Denkensohn at edenkensohn@exlpharma.com John Yee, MD, MPH, Vice President, Global Medical Affairs, Genzyme Corporation 12:45 Luncheon 5:00 Cocktail Reception Network with 8th MSL Best Practices, and 13th Investigator Initiated Trials Attendees. 5:45 Day One Concludes TO R EGI S TER CA LL 866-207-6529 o r v i s i t u s a t w w w.e xlp h a r m a .c o m /m e d a ffa ir s fo r u m
  • 4. DAY TWO ~ April 15, 2011 DAY ONE & ROUNDTABLES RE-CAP 8:50 Chairperson’s Recap of Day One • Publications policies Michael O. Montgomery, M.D., C.P.I., Director, Worldwide • Investigator agreements Medical Affairs Immunology Research, Medical Affairs, • Author agreements Centocor Ortho Biotech Services, LLC Mina Patel, PhD, Senior Director, Medical Communications, Cephalon 9:00 The Role of the CMO and How it Impacts Medical Affairs 2:15 How MSLs work Successfully with • Increasing medical and scientific credibility Medical Affairs • Providing leadership beyond organizational responsibilities • Managing KOLs • Commitment to patient safety and outcomes • Ad Boards and Speakers Management • Field Support Randall Kaye, MD, Chief Medical Officer, • Biz Development Avanir Pharmaceuticals • Future Roles and Responsibilities for MSLs 9:45 Medical Affairs in the 21st Century - Josh Cirulli, PharmD, Medical Science Liasion, Otsuka Responding to Dynamic Industry Trends America Pharmaceutical • The Changing Healthcare Environment - The Future of MSLs and MSDs 3:15 Closing Panel Discussion: Five-Year • US Population and HCP Trends - What They Mean and Strategic Outlook How to Respond • What Universal Challenges Lie Ahead? • Healthcare Reform - Impact on Biotech and Pharma • Importance of Expanding Resources • Personalized Medicine and Pharma’s Response • Global ways of working • Changing and Growing Role & Importance of Medical Affairs • Case examples in the Future Jeffrey S. Humphrey, MD, VP, Oncology Medical Strategy, Alan Cohen, MD, FAAP, FCCP, FAAAAI, FACAAI, Bristol-Myers Squibb (moderator) Senior Vice President, Medical Affairs, InterMune Michael O. Montgomery, M.D., C.P.I., Director, Worldwide Medical Affairs Immunology Research, Medical Affairs, 10:30 Networking and Refreshment Break Centocor Ortho Biotech Services, LLC 11:00 Medical Affairs Plan Design and Suku Nagendran, MD, Executive Medical Director, Implementation for Product Support Multi TA Head, Medical Affairs, Daiichi Sankyo • Advocacy Plan • Investigator Initiated Studies 4:00 Chairperson’s Closing • Medical Information Plan Conference Concludes • Phase IV • Publication Planning • Sales Training Campbell Alliance 11:45 Medical Device Focus - Challenges, Issues, Opportunities, and Strategies for Success • New Challenges TRI-LOCATED with the 8th Annual • Opportunities MSL Best Practices and 13th Investigator • Critical Issues to Address • Strategies for Success Initiated Trial Conferences • Case examples Dominic J. F. Tong, MD, VP, Medical and Clinical Affairs, Maximize your RS Medical Networking Opportunities 12:30 Luncheon with Shared Networking Breaks 1:30 Publication Planning Update for and Luncheon! Medical Affairs Stay Connected & Interact with us Online! • Recent changes in the industry • publications plans: past, present and future • institutional policies • Authorship • Lexicon: is this just semantics? • Documentation TO R EGI S TER CA LL 866-207-6529 o r v i s i t u s a t w w w.e xlp h a r m a .c o m /m e d a ffa i r s fo r u m
  • 5. Media Partners PM 36O THE FULL SPECTRUM OF PRODUCT MANAGEMENT FIVE WAYS TO REGISTER Fax: 888-221-6750 Phone: 866-207-6528 Mail: ExL Events, Inc. Online: www.exlpharma.com/medaffairsforum 555 8th Ave., Ste. 310 Email: registration@exlpharma.com New York, NY 10018 Registration Fees for Attending ExL’s Executive Medical Affairs Forum PRICING Register 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 14th Early-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 Four For 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 Three Can 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, info@exlpharma.com, 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.*
  • 6. To Register: ExL Events, Inc. 866-207-6528 Method of Payment:  Check Credit Card 555 8th Avenue, Suite 310 Make checks payable to ExL Events, Inc. 888-221-6750 New York, NY 10018 Card Type: MasterCard  Visa  Discover Amex registration@exlpharma.com Card Number: Exp. Date: www.exlpharma.com/medaffairsforum Name on Card:  Yes! Register me for the conference: Please contact me: Signature:  I’m interested in marketing opportunities at this event  I wish to receive email updates on ExL Pharma’s upcoming events 555 8th Avenue, Suite 310 New York, NY 10018 Name: Title: Priority Code: P323DM Company: Dept.: Address: City: State: Zip: Email: Telephone: Fax: Questions? Comments? Contact Ethan Denkenohn at edenkensohn@exlpharma.com R E GI S T E R B Y Fe b r u a r y 2 5 t h , 2 0 1 1 F OR T H E B E S T S AV I NGS Presents MEDIC AL A FFA IR S EXECUTIVE FORUM April 14-15, 2011 • Dolce Basking Ridge • Basking Ridge, NJ Thanks to Our Sponsors: Hear from Medical Affairs, MSL and related Professionals Representing: AUXILIUM PHARMACEUTICALS CEPHALON JOHNSON & JOHNSON AVANIR PHARMACEUTICALS DAIICHI SANKYO OTSUKA AMERICA PHARMACEUTICAL BAYER HEALTHCARE PHARMACEUTICALS ELI LILLY RS MEDICAL BOEHRINGER-INGELHEIM INTERMUNE TALECRIS PHARMACEUTICALS BRISTOL-MYERS SQUIBB GENZYME VERTEX PHARMACEUTICALS CENTOCOR ORTHO BIOTECH TO REGI S TER CA LL 866-207-6529 o r v i s i t u s a t w w w.e xlp ha r m a .c o m /m e d a ffa ir s fo r u m