Highlights from ExL Pharma's 4th Latin America Clinical Trials
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