Medical Affairs teams face persistent challenges to be the interface between their company, product, KOL external experts, and prescribers. Evolving restrictions for compliance and limited commercial resources have placed greater emphasis onto Medical Affairs teams. BioPharma has greatly restricted resources and must rely greatly on these teams to communicate medical information and promote value. This summit focuses on strategies for engagement and success for medical affairs organizations to meet current and future organization needs.

1. S av e $ 2 0 0 o r m o re b y reg i ster i n g b y Octo ber 1 7 , 2 0 1 4 !
World Congress Presents the Third Medical Affairs Summit
BioPharma Medical
December 10-11, 2014
Affairs Congress, West Coast
Ensure Value, Compliance, Success, and Growth by Doing More with Less
H i lt on San D i e g o R esort & S pa • San D i ego, C A
With vastly limited resources, BioPharma is faced with the challenge
to excel in a restricted environment. This summit offers a uniquely-dedicated
forum for BioPharma Medical and Clinical Affairs
executives to convene and benchmark strategies for success.
Establish a medical
affairs organization
Msl lifecycle
management
Go global
Msl roles and
evolution
Communicate real
world evidence
Define
compliance
barrier
Specifically
designed for
emerging and
Growing Biotech
companies!
Target
External
outreach
Engagement
The evolving role
of medical affairs
Communication
Cultivate
Outreach
Develop
Internal obstacles
Innovation research
collaboration
Demonstrate Value to
Internal stakeholders
Enhance the impact of
medical affairs with
limited resources
Build high value
medical affairs teams
MSL quality Metrics:
determine Value
KOL
development
External scientific
collaboration
Dennis Decktor,
PhD, MBA
Senior Medical
Director, Lead
Medical Affairs
REGENERON
Kelly Hogan,
PharmD
Medical Director,
Immunology
GRIFOLS
Peter Lee, JD, LLM
Senior Director,
Healthcare
Compliance
PHARMACYCLICS
Nicole H.
Longwell, PhD
National Director,
Medical Science
Liaisons,
Autoimmune
and Rare
Diseases Business
Mallinckrodt
Jeffrey
McCombs, PhD
Director of
Graduate Studies
Schaeffer
Center
for Health
Policy and
Economics, USC
William
Soliman, PhD
Medical Director,
Metabolic
Diseases, Specialty
Care, Medical
Affairs Group
Eisai, Inc.
FEATURED facult y perspecti ves:
Partners: Workshop Organized by:
Sponsor: @wrldhealthcare
#biomsl
To register, please visit www.worldcongress.com/biomsl • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com

2. World Congress Presents the Third Medical Affairs Summit
BioPharma Medical
December 10-11, 2014
Affairs Congress, West Coast
Ensure Value, Compliance, Success, and Growth by Doing More with Less
H i lt on San D i e g o R esort & S pa • San D i ego, C A
Who Should Attend
Heads of Medical Affairs departments
and MSL Directors from small, medium,
and large Biotech manufacturers will
greatly benefit from this uniquely
dedicated summit. Vice Presidents,
Heads, Directors, and Managers from the
following sectors will be in attendance:
• Medical Affairs
• Clinical and Scientific Affairs
• Medical Science Liaison Directors
• Medical Directors
• Chief Medical Officers
• Therapeutic Area Leads
• KOL Development
• Medical Communications
• Medical Information
• Medical Science Liaisons
• HOPE Liaisons
• Clinical Science Liaisons
• Managed Care Liaisons
BioPharma is faced with the challenge to do more
with less at the best value — This is especially true
when it comes to developing and growing successful
Medical Affairs operations. Medical Affairs teams
face persistent challenges to be the interface between
their company, product, KOL external experts, and
prescribers. Evolving restrictions for compliance
and limited commercial resources have placed greater
emphasis onto Medical Affairs teams. Biotech
companies have greatly restricted resources and
must rely greatly on these teams to communicate
medical information and promote value. This summit
focuses on strategies for engagement and success for
biotech medical affairs organizations to meet current
and future organization needs.
WHY YOU SHOULD SPONSOR
POSITION
your company
as a leading
solutions and
service provider
MEET
your market
SHOWCASE
new technology
innovations
INCREASE
brand awareness
GENERATE
leads and new
business
DEVELOP
new and
current client
relationships
Benefit from one-on-one meetings, corporate branding and relationship
building by participating as an active corporate supporter and sponsor.
To inquire about sponsorship and executive networking opportunities, contact:
David Capobianco, Vice President, Business Development, World Congress
781-939-2635 | David.Capobianco@worldcongress.com
To register, please visit www.worldcongress.com/biomsl • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com

3. Day One – Wednesday, December 10, 2014
7:30 am –
8:30 am Workshop Registration and Morning Coffee
Pre- Summit workshops
8:30 am –
11:45 am Workshop: Establish A Medical Affairs Organization —
Set up for Success by Determining When and How to Develop an MSL Team for Deployment
Medical Affairs organizations have critical demands on clinical data deadlines, internal staffing architecture of medical field teams,
and necessity of proper outreach with restricted budgets and resources. This interactive workshop examines critical factors to
identify and methods to establish an ideal action plan for optimal field team recruitment, training, and deployment that best serves
the product lifecycle:
• Establish a timeline that coincides with drug development, product launch, and commercialization
• Work with clinical investigators to disperse data to the scientific community
• Determine the timing of MSL outreach readiness by assessing drug development phases
Workshop Facilitator:
Nicole H. Longwell, PhD
National Director, Medical Science Liaisons,
Autoimmune and Rare Diseases Business
Mallinckrodt
David Jencen, PhD
Principal
Jencen Field Medical Consulting
Workshop Sponsor:
11:45 am –
1:00 pm Lunch on your own / Main Summit Registration
Main Summit
1:00 pm –
1:15 pm Chairperson’s Welcome and Opening Remarks
Sean Turbeville, PhD
Senior Director, Medical and Scientific Affairs
Sunesis (Tentative)
1:15 pm –
2:00 pm Opening Keynote:
The Evolving Role of Medical Affairs in Engagement, Outreach, and Communication
Health care reform has a vast impact on the balance of compliance, engagement, and communication as conducted by medical affairs
teams. Understand the developments and implications on Medical Affairs in the new landscape:
• Understand the commercial and medical implications of reform
• Set up for success by leveraging field advancements and opportunities
• Address quality and payer requirements and effects on medical affairs teams
• Assess benefits of conducting comparative effective research with institutions for enhanced reach
Jeffrey McCombs, PhD
Associate Professor, Director of Graduate Studies, Clinical Pharmacy and Pharmaceutical Economics & Policy
Leonard D. Schaeffer Center for Health Policy & Economics, University of Southern California
2:00 pm –
2:45 pm Enhance External Outreach of Medical Affairs for Maximum Uptake
Biotech companies face similar industry limitations as large pharma, coupled with the need to excel in a vastly changing market.
Examine obstacles and opportunities for success including enhanced product promotion, communication, engagement, and uptake.
• Elevate disease state education to external experts, prescribers, advocacy groups, and patients
• Develop Key Opinion Leader (KOL) programs, investigator-initiated trials (IITs), and advocacy initiatives
• Allocate resources for CMEs, posters, abstracts, and medical publications
Thought Leader TBA
Acclaim from the 2nd Annual Summit:
“Excellent framework for strategic planning and education of my company stakeholders. Important content to
bring back to my company.”
- Vice President, Medical Scientific Affairs, Ironwood Pharmaceuticals
To register, please visit www.worldcongress.com/biomsl • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com

4. Day One – Wednesday, December 10, 2014 (continued)
2:45 pm –
3:45 pm Open Forum:
Overcome Internal Obstacles and Restricted Resources to Excel in a Saturated Environment
Budget, personnel, and logistics for small to mid-size biotech companies have the potential to restrict scope and impact of medical affairs
organizations. Discuss challenges and opportunities to enhance operations in this open forum. Key topic areas include:
• Evaluate how to develop and grow the Medical Affairs organization to the necessary capacity
• Determine scope of MSL teams and division of field outreach
• Predict and manage field team interactions throughout product lifecycle
• Clearly define roles and responsibilities
• Understand how to operate with KOLs when access is limited
• Manage a remote team successfully
• Communicate and report on the value the team provides
• Understand company expectations on ROI, scientific communication, and education demands
Facilitator:
Kelly Hogan, PharmD
Medical Director, Immunology
Grifols
3:45 pm –
4:15 pm Networking and Refreshment Break
4:15 pm –
5:00 pm Panel DISCUSSION:
Evaluate Quality Metrics to Prove Value to Internal Stakeholders
Medical Affairs organizations have the continuous obstacle of assessing, measuring, and communicating department value to internal
stakeholders. Discuss methods and opportunities to assess value:
• Educate senior management and internal stakeholders
• Increase cross-company communication and collaboration
• Align the Medical Affairs organization to maximize the contribution and benefit to the company
• Position Medical Affairs and field teams in the context of company strategy for a heightened perceived value
Nicole H. Longwell, PhD
National Director, Medical Science Liaisons, Autoimmune and Rare Diseases Business
Mallinckrodt
Additional Panelists TBA
5:00 pm –
5:45 pm Benchmark KOL Development Opportunities in a Restricted Environment
With a delicate balancing act between access, reach, and impact of external experts, medical affairs organizations can maximize outreach
by focusing on their ability to:
• Identify external experts and touchpoints at a local, regional, and global level
• Translate field information internally to be leveraged for success
• Grow a network of KOLs through alliances and relationship development
Thomas Hitchcock, PhD
Associate Director, Department of Clinical and Medical Affairs
Ulthera, Inc.
Noam Frey, MD, MBA
Vice President, North American Medical Affairs
InterMune (Tentative)
5:45 pm –
6:45 pm Cocktail and Networking Reception
Acclaim from the 2nd Annual Summit:
“The conference was a great mix of ideas and topics. The attendees were engaged and that led to great
discussions all around. World Congress conferences are always well thought out and include very dynamic
speakers. I always walk away from the conference having learned so much more than I expected.”
- Director of Operations, Cutting Edge Information
To register, please visit www.worldcongress.com/biomsl • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com

5. Day Two – Thursday, December 11, 2014
8:00 am –
8:30 am Morning Coffee
8:30 am –
8:45 am Chairperson’s Welcome and Review of Day One
Sean Turbeville, PhD
Senior Director, Medical and Scientific Affairs
Sunesis (Tentative)
8:45 am –
9:30 am Accelerate Access through Advanced Health Outcomes Strategy and Innovation
• Leverage outcomes to demonstrate how products can deliver value to patients with unmet medical needs
• Identify metrics, transformative processes, and technology applications to drive delivery and acceleration of therapy to leverage
technology for accelerated development
• Assess the evolving roles of the MSL — Health Outcome and PharmacoEconomic (HOPE) Liaisons, Clinical Trial Liaisons, HEOR
Liaisons, and Managed Care Liaisons
Stuart H. Levine, MD, MHA
Executive Vice President, Heritage Provider Network
Assistant Professor, Internal Medicine and Psychiatry, David Geffen School of Medicine, UCLA
9:30 am –
10:15 am Go Global — Develop a Global Medical Affairs Presence
Making the determination to expand a global field force and presence requires a needs and capabilities assessment. In this session:
• Evaluate timeline impact to determine the right opportunities and environments to expand a global field force
• Examine when to place field teams abroad and assess timing of engagement
• Determine engagement with European MSLs, KOLs, and stakeholders
• Assess needs for a European partner for success and promotion
Richey Neuman, MD, MPH
Vice President, Medical Affairs
Hyperion Therapeutics
10:15 am –
10:45 am Networking and Refreshment Break
10:45 am –
11:30 am Case Study: MSL Lifecycle Management for an Orphan Drug
Assess the role the medical affairs organization plays in product development, clinical trials, and commercialization. Hear a real-world
example for success, including how to:
• Alter the medical affairs model to have a long-term focus on innovation while delivering value to patients with unmet medical needs
• Adhere to the drug development cycle for orphan and innovative therapies while identifying possible early access opportunities
• Incorporate patient-centric focus on product for realistic forecast
Dennis L. Decktor, PhD MBA
Senior Medical Director, Sarilumab
Lead, Medical Affairs, Regeneron
11:30 am –
12:15 pm Roundtable discussion: Medical Affairs Planning through the Product Lifecycle
Determine the level of internal and external engagement needed during each phase. Benchmark where others are focusing their teams
during development. Discuss:
• Reporting structure and methodology
• Scope and capacity of reach for Medical Affairs teams
• Commercial access to product on market
• Compliance limitations and regulations
Facilitator:
William Soliman, PhD
Medical Director, Metabolic Diseases, Specialty Care, Medical Affairs Group
Eisai, Inc.
12:15 pm –
1:30 pm Luncheon
To register, please visit www.worldcongress.com/biomsl • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com

6. Day Two – Thursday, December 11, 2014 (continued)
1:30 pm –
2:15 pm Ensure Compliance with Scientific Exchange and Off-Label Promotion when Partnering
with External Partners
• Meet compliance regulations when partnering with a company subject to differing restrictions
• Understand the boundaries of compliance issues when working in orphan indications
• Evaluate when to rely on compendia listing for drug usage
• Leverage disease state education to identify opportunities and limitations with partner
Peter Lee, JD, LLM
Senior Director, Health Care Compliance
Pharmacyclics
2:15 pm –
3:00 pm How to Pick a Partner — Best Practices for External Scientific Collaboration
With declining availability of federal funds, biotech companies are increasing their outreach to partner with larger firms and research
universities. Assess medical affairs’ role in the relationship to collaborate and share funding with academia:
• Assess the scientific expertise of the potential external partners
• Align quality metrics to meet institution needs for reducing readmissions
• Determine appropriate relationship guidelines when partnering with investigators
• Sync up clinical development timelines to ensure success in operating under different government structures, data review processes,
and decision making deadlines
• Balance needs, demands, and intellectual property rights to ensure a successful business model
Thought Leader TBA
3:00 pm Close of Summit
WHY YOU SHOULD SPONSOR
POSITION
your company
as a leading
solutions and
service provider
MEET
your market
SHOWCASE
new technology
innovations
INCREASE
brand awareness
GENERATE
leads and new
business
DEVELOP
new and
current client
relationships
Benefit from one-on-one meetings, corporate branding and relationship
building by participating as an active corporate supporter and sponsor.
To inquire about sponsorship and executive networking opportunities, contact:
David Capobianco, Vice President, Business Development, World Congress
781-939-2635 | David.Capobianco@worldcongress.com
To register, please visit www.worldcongress.com/biomsl • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com

7. Space is limited – Register today to secure the best possible rate!
Call: 800-767-9499 | Email: wcreg@worldcongress.com | Visit: www.worldcongress.com/biomsl
Venue:
Hilton San Diego Resort & Spa
1775 E Mission Bay Drive, San Diego, CA 92109
619-276-4010
sandiegohilton.com
Discounted Room Rate: $149
Please mention WC Research/World Congress
when registering to receive this special rate!
World Congress
500 West Cummings Park, Suite 5200
Woburn, MA 01801
PB14020
wcreg@worldcongress.com
PHONE
800-767-9499
781-939-2400 outside the U.S.
ATTN Mail Room: If undeliverable please forward to Medical and Clinical
Affairs Departments
@wrldhealthcare
#biomsl
PRSRT STD
U.S. Postage
PAID
Gallery
Registration Fee: Register By
PHARMA / BIOTECH / 9/26/2014
12/10/2014
device
Conference $1595.00 $1695.00 $1895.00
Conference + Workshop $1895.00 $1995.00 $2195.00
STANDARD
Conference $1895.00 $1995.00 $2195.00
Conference + Workshop $2195.00 $2295.00 $2495.00
Fee for conference includes welcome coffee, lunch, reception,
refreshments, and web-based conference documentation available
pre- and post-event, accessible through password-protected website.
Checks in U.S. funds drawn from U.S. bank payable to: WC Research Inc.
No personal checks accepted. Verification may be required for rate
approvals. Please contact us should you have any special needs.
SPECIAL TEAM DISCOUNTS: Your organization may
send ONE executive FREE for every three delegates
registered. All registrations must be made at the same
time to qualify. To register your team, contact us at 800-767-9499.
Participant Substitution and Cancellations:
Your registration may be transferred to a member of your organization
up to 24 hours in advance of the conference. Cancellations received
in writing on or before 30 days prior to the start of the event will be
refunded, less a $395 administrative charge. No refunds will be
made after this date; however, the registration fee less the $395
administrative charge can be credited to another World Congress
conference if you register within 6 months from the date of this
conference. In case of conference cancellation, World Congress’
liability is limited to refund of the conference registration fee only.
World Congress reserves the right to alter this program without
prior notice.
Satisfaction guaranteed: World Congress stands behind
the quality of its conferences. If you are not satisfied with the
quality of the conference, a credit will be awarded towards
a comparable World Congress conference of your choice.
Register By
10/17/2014
Register By
Register Now! E-MAIL
WEBSITE
WorldCongress.com/
BioMSL
Best Value
S av e $ 2 0 0 o r m o re b y reg i ster i n g b y Octo ber 1 7 , 2 0 1 4 !
BioPharma World Congress Presents the Third Medical Medical Affairs Summit Affairs
Congress, West Coast
December 10-11, 2014
Ensure Va l u e, Compliance, S u ccess , a n d Growth by Doing More w i t h Less
H i lt o n S an D i e g o R eso rt & S pa • S an D i e g o , C A
Establish a medical
affairs organization
Build high value
medical affairs teams
Msl lifecycle
management
Go global
Msl roles and
evolution
Communicate real
world evidence
Define
compliance
barrier
Target
Demonstrate Value to
Internal stakeholders
MSL quality Metrics:
determine Value
Internal obstacles
development
Enhance the impact of
medical affairs with
limited resources
External
outreach
Engagement
Outreach
The evolving role
of medical affairs
Communication
KOL
Cultivate
Develop
Innovation research
collaboration
External scientific
collaboration
To register, please visit www.worldcongress.com/biomsl • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com