biopharma medical affairs congress, west coast

Establish a mEdical affairs organization

msl lifEcyclE managEmEnt

go global

msl rolEs and Evolution

communicatE rEal world EvidEncE

dEfinE compliancE

barriEr

targEt

ExtErnal outrEach

EngagEmEnt

communication

cultivatE

outrEach

dEvElop

intErnal obstaclEs

innovation rEsEarch collaboration

thE Evolving rolE of mEdical affairs

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

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.

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.

F E AT U R E D FA C U LT y P E R S P E C T i v E S :

To register, please visit www.worldcongress.com/biomsl • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: [email protected]

Organized by:Partners: Workshop Sponsor: @wrldhealthcare

#biomsl

S A v E $ 2 0 0 o R M o R E B y R E g i S T E R i N g B y o C T o B E R 1 7 , 2 0 1 4 !

World Congress Presents the Third Medical Affairs Summit

BioPharma Medical Affairs Congress, West CoastEnsure value, Compliance, Success, and growth by Doing More with Less

H i L T o N S A N D i E g o R E S o R T & S P A • S A N D i E g o , C A

dEcEmbEr 10-11, 2014

Specifically

deSigned for

emerging and

growing Biotech

companieS!

w h y y o u s h o u l d s p o n s o r

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 | [email protected]

World Congress Presents the Third Medical Affairs Summit

BioPharma Medical Affairs Congress, West CoastEnsure value, Compliance, Success, and growth by Doing More with Less




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.

DAy oNE – WEDNESDAy, DECEMBER 10, 20147:30 am – 8:30 am Workshop Registration and Morning Coffee

P R E - S U M M i T W o R K S H o P S8:30 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 DeploymentMedical 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

M A i N S U M M i T1:00 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 CommunicationHealth 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

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 EnvironmentBudget, 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 stakeholdersMedical 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

DAy TWo – THURSDAy, DECEMBER 11, 20148:00 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


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


w h y y o u s h o u l d s p o n s o r

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 | [email protected]

World Congress500 West Cummings Park, Suite 5200Woburn, MA 01801PB14020

PrSrT STDu.S. Postage

PaiDgallery

S A v E $ 2 0 0 o R M o R E B y R E g i S T E R i N g B y o C T o B E R 1 7 , 2 0 1 4 !World Congress Presents the Third Medical Affairs Summit

BioPharma Medical Affairs Congress, West CoastE n s u r e va l u e , C o m p l i a n c e , S u c c e s s , a n d g r ow t h by D o i n g M o r e w i t h L e s s




RegistRation Fee: Register By

9/26/2014

Register By

10/17/2014

Register By

12/10/2014 PHARMA / BIOTECH / dEvICEConference $1595.00 $1695.00 $1895.00Conference + Workshop $1895.00 $1995.00 $2195.00STANdARdConference $1895.00 $1995.00 $2195.00Conference + 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.

WEBSiTEWorldcongress.com/ BioMSL

RegisteR now! [email protected]

Best value

VenUe: Hilton san Diego Resort & spa 1775 E Mission Bay drive, San diego, CA 92109 619-276-4010 sandiegohilton.com Discounted Room Rate: $149

ATTN Mail Room: If undeliverable please forward to Medical and Clinical Affairs Departments

PHONE800-767-9499781-939-2400 outside the U.S.

Please mention WC Research/World Congress when registering to receive this special rate!

SPACE iS LiMiTED – REgiSTER ToDAy To SECURE THE BEST PoSSiBLE RATE!CALL: 800-767-9499 | EMAiL: [email protected] | viSiT: WWW.WoRLDCoNgRESS.CoM/BioMSL

@wrldhealthcare#biomsl

Establish a mEdical affairs organization

msl lifEcyclE managEmEnt

go global

msl rolEs and Evolution

communicatE rEal world EvidEncE

dEfinE compliancE

barriEr

targEt

ExtErnal outrEach

EngagEmEnt

communication

cultivatE

outrEach

dEvElop

intErnal obstaclEs

innovation rEsEarch collaboration

thE Evolving rolE of mEdical affairs

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