MEDICAL AFFAIRS STRATEGIC SUMMIT WEST 3 1 ALLinfo.exlevents.com/rs/195-NER-971/images/C593-MassWestBrochure.pdf · Medical Affairs Strategic Summit ... A medical science liaison’s

MEDICAL AFFAIRS STRATEGIC SUMMIT

3 CONFERENCES

1 LOCATION

ALL ACCESS

9th Medical Affairs Executive Forum

17th Medical Science Liaison Best Practices Congress

22nd Investigator-Initiated Trials & Research Collaborations Symposium

WESTSEPTEMBER 30 - OCTOBER 2, 2015Hyatt Regency Mission

Bay Spa and MarinaSan Diego, CA


Suzana Giffi n AMGEN

FEATURED SPEAKERSRiccardo Perfetti SANOFI

Enrique Carrazana ACORDA

Tehseen SalimiASTRAZENECA

KEY TAKEAWAYS Leverage ways medical affairs teams can support market access and achieve multi-disciplinary conversations with payers

Uncover HEOR team structures, roles and responsibilities in companies of all sizes

Discuss how medical affairs can engage with guideline bodies, medical societies and associations

Examine how to launch products in different therapeutic areas with different target audiences


Fely Canorea-VegaABBOTT VASCULAR

Kathleen GuindonGENENTECH

Paul Minne BIOGEN

LaGenia Bailey SUNOVION

22nd Investigator-Initiated Trials and Research Collaborations Symposium

Stuart KellerELI LILLY AND COMPANY

Jonas HyltonMEDIVATION

Alexander KostekPFIZER

Stephanie deRijkeEMORY UNIVERSITY

KEY TAKEAWAYS Optimize regulatory reporting of IITS while managing the risks

Hear about considerations for running IITs for products in early versus late-stage development

Discover the differences and similarities between investigator-initiated trials and research collaborations

Implement ways to become an industry partner of choice for sponsor-investigators

FEATURED SPEAKERS

FEATURED SPEAKERS

KEY TAKEAWAYS Identify ways to optimize the role of MSLs in medical device and pharma companies

Hear about the role of MSLs across geographies (Europe, the Middle East, Africa and the US)

Explore the different types of hybrid roles that MSLs can have across companies

Learn when MSLs can get involved to support clinical development

SPONSORS

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For more information visit www.exlevents.com/MASSWEST

WELCOME TO MASS WEST 2015

Scott GrossmanDivision Head, Conference [email protected] | 917-258-5152

DEAR COLLEAGUE,

For life sciences companies, communication to internal stakeholders and the scientific community is key because it provides brand and therapeutic information and properly informs KOLs. At the forefront of communications is a high-performing medical affairs team that ensures regulatory compliance, working with MSL professionals to enhance communication to KOLs. Medical affairs is instrumental in investigator-initiated trials and research collaborations.

The healthcare landscape is changing, and organizations must alter the way they interact with key stakeholders. As the need for big data utilization, HEOR awareness, market access and reimbursement support increases, medical affairs leaders are creating strategic platforms to meet these demands while engaging with new thought leaders.

Medical Affairs Strategic Summit (MASS) West is designed as a three-day educational platform for medical affairs teams to discuss challenges and trends and improve collaborations with MSLs and clinical research colleagues.

The first day of the summit serves as an intensive workshop, where attendees will learn from those implementing excellence in one of the three components of the conference theme.

MASS West features three educational tracks:

¡ The 9th Medical Affairs Executive Forum will address the importance of scientific communications for global regulations and launch readiness commercialization, ways to optimize medical affairs’ role in drug development, and how to maintain the integrity of medical affairs functions when facing increasing commercial pressures.

¡ The 17th Medical Science Liaison Best Practices Congress will provide with you tools to strengthen field operations, achieve work-life balance and adapt to a rapidly changing landscape in a high-level learning atmosphere.

¡ The 22nd Investigator-Initiated Trials & Research Collaborations Symposium will explore best practices for engaging with investigators, assisting in trial design, utilizing fair market value, developing CAPAs, and handling noncompliance and research misconduct. It will also address important considerations for successful research from proposal to publication, ways to be a preferred industry partner for an investigator, and the criteria for the early termination of trials.

Before these in-depth tracks begin, there will be a plenary kickoff highlighting essential issues relevant to the scope of the conference, such as the need for strategic leadership to support market access and reimbursement, KOL engagement, and the future of innovation within medical affairs. Premier individuals who function as leaders within their respective branches of medical affairs will deliver these talks.

If you’re looking to navigate the rapidly changing medical affairs and regulatory landscape, you cannot afford to miss the exceptional standalone sessions, innovative case study presentations and thought-provoking panels MASS West has to offer.

We look forward to joining you at this premier industry event this September!

Derek O’ConnorConference Production Director494 8th Avenue, 4th Floor, New York, NY [email protected] | 212-400-6233

SPONSORS

VENUEHyatt Regency Mission Bay Spa and Marina1441 Quivira RoadSan Diego, CA 92109

To make reservations please call 1-888-421-1442 and request the group rate for ExL’s MASS West 2015. The group rate is available until September 9, 2015. Please book your room early as rooms available at this rate are limited.

ExL Events, Inc. is not a� liated with any third-party booking agencies,

housing bureaus, or travel and events companies. In the event that an outside

party contacts you for any type of hotel or travel arrangements, please

disregard these solicitations and kindly email us at [email protected].

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ExL’s MASS event is the ideal platform to showcase your organization’s technology or services to your target market over three days in one location. Take advantage of this opportunity to exhibit, showcase your subject matter expertise, host a networking event, and/or distribute promotional items to attendees. ExL’s customized packages will maximize your ROI. For more information on a package tailored to your needs, please contact Eric Morrin at [email protected] or 212-400-6228.


A UNIQUE CONFERENCE FORMAT The Medical Affairs Strategic Summit West 2015 provides a unique blend of learning formats, giving you access to a number of different types of content across three conferences. The summit covers a wide range of topics that can help you meet everyday goals. We created a BRING-YOUR-TEAM ENVIRONMENT that provides you with the ability to tailor your agenda and choose sessions that fit your interests.

MULTIPLE CONFERENCESMASS West features three conferences, which allows you to customize your learning experience to your needs:

¡ 9th Medical Affairs Executive Forum ¡ 17th Medical Science Liaison Best Practices Congress ¡ 22nd Investigator-Initiated Trials & Research Collaborations Symposium

MASTER CLASS WORKSHOPSChoose one of three engaging workshops designed for medical affairs teams, MSL leaders and professionals involved in research collaborations

CASE STUDY PRESENTATIONSThese sessions give you the opportunity to benefit from firsthand perspectives on ways organizations successfully overcame challenges to achieve business objectives

INTERACTIVE PANELSHave the opportunity to listen to a myriad of industry professionals engage in group discussions and debates on regulatory updates and many hot button topics in medical affairs and clinical research

SPEAKING FACULTYHear perspectives from 40+ industry experts, including vice presidents of medical affairs, MSL team leaders, professionals involved in investigator-initiated trials and research collaborations, KOLs, and investigators

PLENARY SESSIONSListen to executive leaders, global KOLs and industry partners during shared sessions that allow attendees to meet with colleagues from each of the three conferences and foster interaction and networking opportunities

POWER NETWORKING The Medical Affairs Strategic Summit agenda provides all delegates a number of networking opportunities throughout this event. These activities help build peer-to-peer relationships and facilitate thought-provoking conversations through six hours of networking.

SEPT 30 Workshop Networking Break

OCT 1Continental BreakfastTwo Networking BreaksNetworking LunchNetworking Reception

OCT 2Continental BreakfastTwo Networking BreaksNetworking Lunch

ATTENDEE PROFILE

TITLE

ORGANIZATIONS

○ 27% Vice Presidents, Heads, Senior Directors

○ 17% Directors

○ 24% Managers

○ 20% Medical Science Liaisons

○ 12% Academics, Investigators, KOLs

27%

17%

12% 24%

20%

18%

23%

12%6%

41%

○ 6% Academic

○ 41% Pharmaceutical

○ 18% Biotechnology

○ 23% Medical Device

○ 12% Service Provider

WELCOME TO MASS WEST 2015

For more information visit www.exlevents.com/MASSWESTFor more information visit www.exlevents.com/MASSWEST

1:00 Workshop Registration

1:30 OPTIMIZING THE MEDICAL AFFAIRS VALUE PROPOSITION As the business model evolves for life sciences manufacturers, Medical Affairs (MA) departments are increasingly relied upon to provide “value beyond the pill” across a diverse spectrum of stakeholders. While generation, analysis and communication of product data remains the primary responsibility, Medical Affairs 2.0 has focused on new(er) offerings such as strategic payer engagements, outcomes, data analytics, REM systems and patient-centric programming. Gathering from MA experts across the industry, this workshop will explore how departments continue to deliver value in the context of signifi cant industry and societal changes while simultaneously increasing effi ciencies of core MA functions.

• Identify methods to increase collaborations with internal stakeholders• Generate ideas for establishing valuable professional relationships with an increasingly diverse set of external customers• Identify methods for improving MA operational effi ciencies at all stages of the product life cycle• Learn about novel metrics that quantitatively and qualitatively demonstrate Medical Affairs value, both internally and externally

David Jencen, Ph.D., Principal, JENCEN FIELD MEDICAL CONSULTING LLCCraig Sponseller, Vice President Medical Affairs, KOWA PHARMACEUTICALS AMERICA Paul Cavanaugh, PhD, Director, Global Medical Publications, SANOFI

2:30 Networking Break

4:30 Workshop Concludes

1:30 FUNDAMENTALS, CHALLENGES AND OPPORTUNITIES FOR NEW MSLs A medical science liaison’s (MSL’s) main responsibilities are to support the dissemination of information to key opinion leaders (KOLs), answer important medical questions and strengthen product placement while maintaining regulatory compliance. They are essential for supporting relationships with healthcare providers, payers, academic centers and regulators. Nevertheless, there are many variations of the MSL role and ways in which MSLs can maximize their career paths and interactions. This workshop is specially designed for MSLs with minimal experience to gain a better understanding of MSL functions and ways to increase their success in this unique role.

• Recognize how the MSL role is infl uenced by a company’s focus and what drives goals for a fi eld team • Describe career opportunities beyond the MSL entry-level role• Explore the different types of MSLs (therapeutic, health outcomes, diagnostic, device, MSL management, thought leader liaison) and how to optimize

interactions • Hear about the current regulatory landscape and ways to be prepared

Kevin Appareti, Senior Director, Global Medical Science Liaison, PHILIPS HEALTHCARE



1:30 DRIVE SCIENTIFIC RESEARCH AND OPTIMIZE THE IMPACT OF RESEARCH COLLABORATIONS AND INVESTIGATOR-INITIATED TRIALS Investigator-initiated research is a crucial part of how life sciences companies and external partners in academia and government institutions work together to run trials that can address unmet medical needs and lead to new therapeutic candidates and improved therapies. In addition, investigator-initiated research allows companies to achieve a greater understanding of the safety and effi cacy data of their products. In the journey of data generation, life sciences companies also partner with these institutions in research collaborations by participating in a more active way in these post-approval studies. This workshop will address the main considerations supporting each type of collaboration and optimizing the impact, depending on your company’s needs.

• Hear about the main drivers to conduct IIT programs versus research collaborations• Isolate key aspects of both types of studies and determine which type of collaboration is better suited for your organization• Learn about the main challenges you’ll face and ways to overcome them to achieve operational effi ciency• Develop approaches to optimize post-approval studies from proposal to publication

Alexander Kostek, Senior Director/Team Leader, Innovative Research Collaborations, PFIZER INC



8:00 Registration and Continental Breakfast

8:30 CHAIRPERSON’S OPENING REMARKSMark Monane, Chief Medical Offi cer, CARDIODX

8:45 EXECUTIVE PANEL STRATEGIC LEADERSHIP TO SUPPORT MARKET ACCESS AND REIMBURSEMENT

• Determine the impact of a company’s organizational structure on supporting market access

• Assess what launch medical affairs teams can do to support market access and achieve multi-disciplinary conversations with payers

• Review best practices for working with KOLs and payers to ensure market access and product reimbursement

• Analyze the way conversations with payers occur to achieve payer coverage, and how these conversations are held within regulatory compliance

Panelists:Riccardo Perfetti, Senior Medical Offi cer, Vice President Global Medical Affairs, Diabetes Division, SANOFI Mark Monane, Chief Medical Offi cer, CARDIODXSuzana Giffi n, Executive Director, Scientifi c Affairs, AMGEN Elizabeth Faust, Ph.D, Head of Medical Affairs, PHARMACYCLICSJamey Skillings, M.D., Senior Vice President and Chief Medical Offi cer, TOCAGEN INC

9:30 GAIN INSIGHTS INTO HEALTHCARE CULTURE TO SPUR (OR EXPAND?) INNOVATIONS IN RELATIONSHIP MANAGEMENT IN COMPLEX ADAPTIVE SYSTEMS

• Understand the new/new defi nition of culture and how culture can predict outcomes in safety, quality and experience of both patients and employees

• Learn how awareness of culture helps manage complex relationships that are built through systems, process and procedures.

• Learn what cultural components are best suited for complex adaptive systems (such as healthcare) and how this information can strengthen relationships both within and outside of the system

Julie Kennedy Oehlert DNP BSN RN, Chief Administrative Offi cer Ambulatory Services, Associate Chief Experience Offi cer, UC SAN DIEGO HEALTH SYSTEM

10:00 ACHIEVE EARLY INVOLVEMENT OF MSLS IN CLINICAL TRIALS TO OPTIMIZE RESULTS AND REDUCE STUDY TIME

• Hear about the advantages of early involvement of MSLs in clinical trials and why it is important to develop enduring relationships with investigators

• Discuss ways in which the early involvement of MSLs can enhance recruitment, reduce study time and strengthen relationships withCROs

• Learn about success metrics that can be put in place when involving MSLs in clinical research

• Maximize the impact of MSLs’ involvement through the product life cycle while balancing other functions

Kathleen Guindon, Senior Medical Science Liaison, GENENTECH

10:30 Plenary Sessions Conclude and Networking Break

PRE-CONFERENCE WORKSHOPS WEDNESDAY, SEPTEMBER 30, 2015 W

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MAIN CONFERENCE PLENARY SESSIONS THURSDAY, OCTOBER 1, 2015

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9th ANNUAL

MEDICAL AFFAIRS EXECUTIVE FORUM

Medical affairs teams are important for achieving regulatory compliance and maximizing productivity and communication by providing accurate disease information to internal departments, consumers and HCPs. Additionally, they help maintain relationships with KOLs and work with clinical and commercial groups to ensure clinical data is understood and used accurately in commercial operations. Essentially, they constitute the backbone for successful product launches and postmarket activities. Nevertheless, medical affairs’ roles and responsibilities can vary greatly depending on the company’s life cycle and whether a company has prelaunch or mature products, or is undergoing a merger and/or acquisition.

Among many key topics, the 9th Medical Affairs Executive Forum addresses how medical affairs departments are affected by the current pharmaceutical landscape. Areas of focus include the impact of a company’s product life cycle on medical affairs functions, ways to use innovation in medical affairs to overcome challenges and move from R&D to commercialization, how to demonstrate the value of HEOR to payers, strategies to successfully establish a medical affairs launch readiness plan, and — most importantly — how to strengthen and optimize the role of medical affairs across all company verticals.

This conference is designed for representatives from pharmaceutical, biotechnology and medical device organizations with responsibilities in the following areas:

✓ Medical Affairs/Field Medical Affairs

✓ Medical Science and Field Medical Science Liaisons

✓ Clinical/Scientific Affairs

✓ Medical Strategy/Communications

✓ Key Opinion Leadership/Thought Leadership/Opinion LeaderRelationships

✓ Research and Development

✓ Medical Education

✓ Publication Planning

✓ Scientific Communication

✓ Program Management

✓ Quality Assurance

✓ Scientific Engagements

11:15 CHAIRPERSON’S OPENING REMARKS Suzana Giffi n, Executive Director, Scientifi c Affairs, AMGEN

11:30 POST-REGISTRATION CLINICAL ACTIVITIES AIMED AT CHARACTERIZING THE FULL PRODUCT VALUE FOR PATIENTS, PHYSICIANS AND PAYERS

• Identify the limitations of clinical development program(s)• Assess whether critical stakeholders have been involved and

develop an engagement plan• Defi ne strategies to address the evidence gap and lack of patient

insights and cost comparison evaluations• Address product value in the context of new treatment strategies

versus standard of care Riccardo Perfetti, Senior Medical Offi cer, Vice President Global Medical Affairs, Diabetes Division, SANOFI

12:15 PANEL THE IMPORTANCE OF SCIENTIFIC COMMUNICATIONS FOR GLOBAL LAUNCH READINESS AND COMMERCIALIZATION

• Identify methods for developing a strategic communications plan• Uncover ways to translate strategies into an actionable tactical plan• Examine global launch readiness across the whole range of

capabilities• Address resource and budgetary planning• Hear about the application of innovative technologies for scientifi c

exchange Panelists: Suzana Giffi n, Executive Director, Scientifi c Affairs, AMGEN Elizabeth Faust, PhD, Head of Medical Affairs, PHARMACYCLICS Carrie Rabbitt, Attorney, NOVO NORDISK

1:00 Networking Luncheon

2:15 PANEL OPTIMIZE MEDICAL AFFAIRS’ ROLE IN DRUG DEVELOPMENT AND ACHIEVE ROBUST CLINICAL OUTCOMES

• Study ways in which medical affairs leadership can work with internal teams to achieve successful clinical trial outcomes

• Explore medical affairs’ role in the discovery of new drug indications• Discover how to effectively participate in drug development and

discovery programs, including local and international committees• Review strategies in which medical affairs can work cross-

functionally to move from R&D to commercialization Panelists: Enrique Carrazana, Chief Medical Offi cer, ACORDA THERAPEUTICS Dennis Kim, Principal and Chief Medical Offi cer, PANTHERA LIFE SCIENCES Paul Rowe, Senior Medical Director, Medical Research and Strategy, DAIICHI SANKYO


AGENDADAY TWO: OCTOBER 1, 2015

“Great meeting; discussions were very valuable and very relevant!” Global Director, Medical Affairs, BAXTER

“Excellent presentations and discussions.” Senior Vice President, Medical Affairs, INVENTIV THERAPEUTICS INSTITUTE


3:30 ESTABLISH A SUCCESSFUL TRAINING STRATEGY TO SUPPORT PRODUCT LAUNCHES

• How to plan a strategy to prioritize and distribute medical-science content throughout a product life cycle.

• Consider reuse of scientifi c training materials for commercial preparation to create both time and cost effi ciencies.

• Case Study: How Daiichi Sankyo internal teams collaborated to build a successful launch plan.

• Align the different scientifi c, legal and commercial teams to create a cohesive launch training plan

• Examine best practices and optimal timelines to prepare for a launch

Panelists: Michelle Youngers, President and COO, SCIENCEMEDIA Shawn Furniss, Director, Field Medical Affairs, DAIICHI SANKYO

4:15 EVOLVING ROLE IN MEDICAL AFFAIRS IN ENHANCING PATIENT ACCESS

• Hear best practices to execute and develop pharmacoeconomics and outcomes research studies across products in collaboration with payer and provider organizations

• Discuss ways to anticipate and prepare for changes in the evolving U.S. healthcare delivery system, including the Patient Protection and Affordable Care Act (PPACA)

• Design a successful pharmacoeconomic strategy and establish consensus across internal stakeholders

• Learn about the impact of different HEOR structures in companies of all sizes on the interactions with external organizations

Shailja Dixit, Head of Health Economics and Outcomes Research, ALLERGAN

5:00 Networking Reception

6:00 Day Two Concludes


8:30 CHAIRPERSON’S RECAP OF DAY TWO Suzana Giffi n, Executive Director, Scientifi c Affairs, AMGEN

8:45 PANEL THE USE OF BIG DATA AND HEALTHCARE ANALYTICS TO GET THE BEST TREATMENTS IN FRONT OF PATIENTS

• Leverage real-world data and predictive analytics to help identify the best targets for clinical trials

• Discuss the use of fi eld medical technology and its impact on documenting meaningful interactions to provide additional profi ling of HCPs and institutions

• Study ways to integrate internal and external data in order to drive decisions in clinical, medical and commercial operations

Panelists: Chris Cestaro, Vice President of Marketing and Corporate Development, ZEPHYR HEALTH Blake A. Morrison, PharmD Principal, VENN5 BIOCONSULTING

9:30 OPTIMIZE KOL ENGAGEMENT• Understand the evolving role and growing importance of Medical

Affairs in biopharma• Explore how several leading companies are optimizing KOL

engagement• Review specifi c strategies, tactics and practical tools to support KOL

engagement Daniel Hawkins, Founder and Managing Director, CLARION HEALTHCARE

10:00 THE IMPLEMENTATION OF A KOL MANAGEMENT AND DEVELOPMENT PROGRAM IN A MEDIUM-SIZED BIOTECH COMPANY

• Explore how KOL engagement positively impacted the implementation of diagnostic tools and the commercialization of products for a medium-sized biotech company

• Address the benefi ts and challenges faced when embarking in a KOL management program, and how to effi ciently plan for success

• Hear about ways to track KOL interactions internally and avoid mismanaged relationships

• Learn the importance of educating MSL teams to get their engagement in the program

Frank Courjal, Director, Scientifi c Affairs, THE BINDING SITE


11:00 THE IMPORTANCE OF INNOVATION AND EXPLORING THE ROLE OF MEDICAL AFFAIRS IN EFFECTIVE LIFE CYCLE MANAGEMENT AND SUCCESSFUL PRODUCT DEVELOPMENT

• Protect and foster innovation in the development process and product management, from concept to commercialization, while effectively partnering with R&D, clinical and commercial teams

• Determine ways to better align medical affairs’ KPIs with other internal partner and stakeholder goals, and how to translate them into actionable objectives

• Assess how to maximize opportunities by recommending strategic investments that can drive product growth

• Explore ways to work with business development teams and other internal stakeholders to optimize life cycle management and product placement

Paul Rowe, Senior Medical Director, Medical Research and Strategy, DAIICHI SANKYO


12:45 BEST PRACTICES FOR MAXIMIZING KOL INSIGHTS AND ENGAGEMENT IN VIRTUAL ADVISORY BOARD AND STEERING COMMITTEE MEETINGS

• Discuss best practices for engaging KOLs virtually and the advantages of doing so versus using live advisory boards and steering committee meetings

• Hear about online engagement venue types, tips and techniques for maximizing the value of both medical affairs and KOLs when engaging in discussion forum-style virtual meetings

• Learn about the analysis and measurement of key success factors for virtual advisory boards and steering committee meetings

Michael Kirby, Vice President, Business Partnerships, WITHIN 3

1:30 MAINTAIN THE INTEGRITY OF MEDICAL AFFAIRS FUNCTIONS WHEN FACING INCREASING COMMERCIAL PRESSURES

• Defi ne the main differences in the functions of medical affairs andcommercial teams, and how to achieve successful interactions in ahealthcare compliance environment

• Guarantee transparent healthcare decisions independent of product promotions

• Discuss ways to communicate regulatory expectations to medicalaffairs and commercial teams and avoid unlawful interactions

• Hear about compliant medical affairs product launch (andprelaunch) strategies that complement commercial activities

Carrie Rabbitt, Attorney, NOVO NORDISK

2:15 CREATE AND REINFORCE THE VALUE OF MEDICAL AFFAIRS TO SENIOR MANAGEMENT TO DRIVE COMMUNICATION AND DECISION- MAKING

• Discuss ways to demonstrate the value of medical affairs functions to key internal stakeholders and the types of performance metrics that can be put in place

• Maximize the types of initiatives that can reinforce the value of medical affairs operations throughout an organization

• Identify commonly faced challenges and ways to overcome them• Hear how to optimize the role of medical affairs in order to go

beyond being the intersection between scientifi c and commercial aspects

Elizabeth Faust, Ph.D., Head of Medical Affairs, PHARMACYCLICS

3:00 CLOSING REMARKS Suzana Giffi n, Executive Director, Scientifi c Affairs, AMGEN

3:15 Summit Concludes

MEDICAL AFFAIRS EXECUTIVE FORUM

AGENDADAY THREE: OCTOBER 2, 2015 CA

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17TH MEDICAL SCIENCE LIAISON BEST PRACTICES CONGRESS

Medical Science Liaisons (MSLs) are crucial for maintaining relationships with KOLs and serving as medical and scientific experts when it comes to understanding and discussing product characteristics and clinical data. In recent years, the role of MSLs has evolved to include account management, greater interactions with clinical teams/CROs and other strategic roles. With the evolution of the MSL role and the need for maintaining regulatory compliance in all medical affairs functions, there is a demand to support, train and prepare MSL teams to be successful in every aspect of their job. This will allow fruitful interactions with community physicians, academic centers, hospitals, insurance companies and internal stakeholders.

The 17th Medical Science Liaison Best Practices Congress addresses the evolving role of the MSL in the current pharmaceutical landscape, including the impact of compliance and risk mitigation, novel approaches to performance metrics, methods to overcome communication challenges when working with multiple teams, ways to maximize the role of the MSL to increase the productivity of CROs and clinical research teams, and the prioritization and maintenance of relationships with KOLs and other fundamental stakeholders. Additionally, it will equip you with tools to develop successful MSL training and career progression programs that will optimize MSLs’ jobs and help MSL leadership work toward achieving higher retention of MSL teams.

This conference is designed for representatives from pharmaceutical, biotechnology and medical device companies with responsibilities in the following areas:

✓ Medical Science Liaisons

✓ Medical Science

✓ Medical Strategy

✓ Scientific Communication

✓ Medical Education

✓ Key Opinion Leadership/Thought Leadership/Opinion Leader Relationships

11:15 CHAIRPERSON’S OPENING REMARKSKathleen Guindon, Senior Medical Science Liaison, GENENTECH

11:30 NAVIGATE MSL-HCP INTERACTIONS IN A HIGHLY REGULATED HEALTHCARE COMPLIANCE LANDSCAPE

• Hear about the types of joint interactions than can occur between MSLs and commercial teams, and how to maintain regulatory compliance

• Discuss preapproval and postlaunch communication activities that can occur between MSLs and KOLs

• Assess how to utilize the healthcare compliance team within your company to strengthen MSL interactions with internal and external stakeholders

Peter Lee, COMPLIANCE ATTORNEY

12:15 EXPLORE THE ROLES AND RESPONSIBILITES OF MSLs IN DIFFERENT GEOGRAPHIES (THE US, EUROPE, THE MIDDLE EAST AND AFRICA)

• Review the specifi c/unique forms of physician interactions and KOL engagement in different geographies

• Understand the impact of local regulatory landscapes on fi eld medical operations

• Evaluate the interactions between internal and external teams that occur due to diverse organizational structures in different regions

• Establish ways in which MSLs can collaborate and work together in a global medical affairs landscape

Fely Canorea-Vega, M.D., Regional Medical Science Manager, MidAmerica, ABBOTT VASCULAR


2:15 MAXIMIZE WORK-LIFE BALANCE IN A FAST-PACED AND RAPIDLY EVOLVING MSL ROLE

• Discuss ways to overcome challenges that can arise in fi eld work and how to manage intensive travel

• Master different tactics that can help with optimizing MSL-physician interactions and time management to achieve a greater work-life balance

• Examine techniques that can be done on the go to help keep a work-life balance and improve wellness in a constantly evolving MSL role

LaGenia Bailey, Director, MSL-Great Lakes, SUNOVION PHARMACEUTICALS


3:30 VIRTUAL MSL AS AN ALTERNATE CHANNEL TO IMPROVE MSL PRODUCTIVITY

• Discover environmental and industry trends on virtual means of communication

• Hear scenarios for a virtual MSL• Identify performance metrics relevant to virtual MSLs• Assess critical factors for successful implementation of virtual

MSLs• Maximize the impact of MSLs’ involvement through the product life

cycle while balancing other functions Sandeep Gantotti, Associate Director, Extended Medical Enterprise, INDEGENE


“Great setup! Thank you so much for a well-organized event! Great forum for gaining insight from different perspectives and networking at the same time.“Medical Science Liaison, LEO PHARMA

“Great speakers, networking and information on how others are managing!”Director, ACORDA THERAPEUTICS


4:15 PANEL DIFFERENCES AND SIMILARITIES BETWEEN MSLs IN PHARMACEUTICAL VERSUS MEDICAL DEVICE COMPANIES AND WAYS TO PROMOTE COLLABORATION

• Understand the unique and specifi c roles and responsibilities of MSLs in pharma and device companies

• Examine differences in KOL engagement and fi eld work when working in both industries and strategize how to learn from each other

• Learn about the specifi c challenges faced by each type of MSL and ways to overcome them

• Determine ways for MSLs to transition from one industry to the other

Panelists:Kathleen Guindon, Sr. Medical Science Liaison, GENENTECHFely Canorea-Vega, M.D., Regional Medical Science Manager, MidAmerica, ABBOTT VASCULARKasmin Delgado, MSL, ASSUREX HEALTHIlene Pedroso, PhD, Medical Science Liaison, MALLINCKRODT PHARMACEUTICALS


6:00 Day Two Concludes


8:45 CHAIRPERSON’S RECAP OF DAY TWOKathleen Guindon, Senior Medical Science Liaison, GENENTECH

9:00 STRATEGIES FOR MSL OPERATIONAL IMPROVEMENT AND TEAM RETENTION

• Hear best practices to manage a team of MSLs and effectively communicate goals, compliance expectations and limitations

• Explore different corporate initiatives to motivate and achieve higher retention of MSLs

• Learn about the most common mistakes made when managing fi eld teams and how to improve communication with MSLs

Lisa Stepp, Senior Director Medical Affairs, PEREGRINE PHARMACEUTICALS, INC.

9:45 THE IMPACT OF HEALTHCARE TRANSFORMATION ON THE MSL ROLE AND KOL ENGAGEMENT

• Hear how the transformation of healthcare is driving new behaviors by providers, payers, patients and vendors

• Learn how MSLs must adapt how they behave and how they interact with an evolving stakeholder landscape

• Understand the focus on the Triple Aim of Experience of Care, Population Health and Per Capita Cost to improve healthcare delivery and patient outcomes

• Pinpoint who holds the risk in care and costs• Review MSL strategies, which include proactive engagement,

partnerships, co-creation, the new defi nition of value, and a balanced view of clinical/economic/operational issues

Kevin Appareti, Senior Director, Global Medical Science Liaison, PHILIPS HEALTHCARE


11:00 PANEL KOL ACCESS AND MSL ROLES AND RESPONSIBILITIES IN DIFFERENT THERAPEUTIC AREAS (ORPHAN VERSUS WIDESPREAD DISEASES)

• Explore how performance metrics and KOL interactions vary when working with different therapeutic areas (rare versus widespread diseases)

• Hear about the differences between MSLs in the orphan drug space (larger territories, less competition to access KOLs) versus MSLs that face more competition for KOL access

• Identify ways in which each type of MSL can optimize the time and quality of KOL interactions

Panelists:Kevin Appareti, Senior Director, Global Medical Science Liaison, PHILIPS HEALTHCAREKasmin Delgado, MSL, ASSUREX HEALTHEric Churchill, Senior MSL, MILLENIUM PHARMACEUTICALS


12:45 QUALITATIVE AND QUANTITATIVE PERFORMANCE METRICS TO DEMONSTRATE THE VALUE OF FIELD OPERATIONS

• Learn how to report metrics and collect “meaningful insights” and accomplishments

• Determine what different tools, dashboards and internal reports can help visualize/track performance metrics

• Examine how to collect information from a strategic standpoint when you can’t rely on quantitative data

• Establish ways to achieve sustainable performance metricsBrian Tumminello, Senior MSL, ALEXIONBrad Tumminello, Senior MSL, ALEXION

1:30 HEAR ABOUT HYBRID MSL ROLES AND HOW TO EFFECTIVELY SUPPORT INTERNAL GOALS

• Discuss how MSLs can act as product medical leads and support/perform medical director functions

• Hear about the different functions of a hybrid role including how to manage budget, create business plans and answer questions from other departments

• Learn ways to effi ciently perform MSL hybrid functions while covering as much time in the fi eld

Ilene Pedroso, PhD, Medical Science Liaison, MALLINCKRODT PHARMACEUTICALS

2:15 AN UPDATE ON THE FDA 2015 PUBLIC MEETING ON OFF-LABEL COMMUNICATIONS

• Discuss key points of the FDA’s 2015 public meeting on off-label communications

• Hear about important status updates and the implications on the distribution of off-label information, including unsolicited requests, the distribution of scientifi c medical information on unapproved new uses, and manufacturer discussions

David Jacobs, Assistant General Counsel, Commercial Brands, Legal Affairs, DAIICHI SANKYO

3:00 CLOSING REMARKSKathleen Guindon, Senior Medical Science Liaison, GENENTECH


AGENDADAY THREE: OCTOBER 2, 2015

MSL BEST PRACTICES CONGRESS

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22ND INVESTIGATOR-INITIATED TRIALS & RESEARCH COLLABORATIONS SYMPOSIUM

Investigator-initiated research plays a big role in working with industry organizations to run trials that address unmet therapeutic needs that can lead to new therapeutic candidates, improved therapies and the discovery of new drug indications. With the increasing number of investigator-initiated trial (IIT) requests coming into life science organizations, there is also a higher demand to optimize IIT portfolio management, taking into consideration financial, logistical and regulatory/legal aspects. Although investigator-initiated research provides a strong avenue for achieving scientific benchmarks, sponsored research — also called research collaborations — is another type of joint effort in which investigators and industry work together to run trials and share responsibility and ownership of trial designs and outcomes.

The 22nd Investigator-Initiated Trials and Research Collaborations Symposium covers all aspects of IITs, including the use of performance measures to optimize trials, considerations for running single versusmulticenter trials, best practices for understanding and fulfilling industry and sponsor expectations, structured data, the impact of analytics and systems on IITs, and ways to foster compliance and strengthen studies for newer sponsor-investigators. In addition, this summit speaks to the similarities and differences between research collaborations and IITs, including responsibilities; ownership of the research, royalties and publication rights; and, most crucially, when it’s viable and appropriate to support each type of collaboration.

This conference is designed for representatives from academic institutions; hospitals; and pharmaceutical, biotechnology and medical device companies whose responsibilities involve:

✓ Investigator-Initiated Research

✓ Investigator-Initiated Studies

✓ Investigator-Initiated Trials

✓ Investigator-Sponsored Trials

✓ Research Collaborations

✓ Medical Affairs/Global Medical Affairs

✓ Medical/Clinical Operations

✓ Clinical Project Management

✓ Clinical Medical Affairs

✓ Clinical Trial Monitoring

✓ Research Grants

✓ Clinical Outcomes and Publications

✓ Regulatory Affairs

11:15 CHAIRPERSON’S OPENING REMARKSAlexander Kostek, Senior Director/Team Leader, Innovative Research Collaborations, PFIZER INC

11:30 CORRECTIVE AND PREVENTIVE ACTION (CAPA) DEVELOPMENT IN INVESTIGATOR-INITIATED TRIALS

• Describe small-scale RCA and CAPA processes for single sites• Explore ways to engage the PI and study team in order to improve

trial quality and meet expectations • Analyze the implications of institutional review board (IRB) reports

and institutional involvementStephanie deRijke, Director, Clinical Trials Audit and Compliance, EMORY UNIVERSITY

12:15 PANEL BEST PRACTICES FOR RUNNING INVESTIGATOR-INITIATED TRIALS

• Hear about best practices for running IITs and establishing performance metrics that will contribute to trial success

• Discover ways to set expectations and work with industry to achieve trial support and funding outside NIH grants

• Discuss how to establish a high-performing relationship that ensures effective communication between sponsors and investigators, including managing internal and external communications

• Uncover ways to proactively identify risks • Learn about MSL roles and responsibilities within an IIT program

Panelists:Jonas Hylton, Regional Director, Medical Affairs, MEDIVATION Alexander Kostek, Senior Director/Team Leader, Innovative Research Collaborations, PFIZER INC Stephanie deRijke, Director, Clinical Trials Audit and Compliance, EMORY UNIVERSITY


2:15 THE REGULATORY AND LEGAL PERILS OF RESEARCH MISCONDUCT DURING AN INVESTIGATOR-RUN TRIAL

• Explain non-compliance versus research misconduct• Defi ne research misconduct and explain the three classifi cations of

misconduct• Describe how to deal with an allegation of research misconduct

using due processErnest Prentice, Associate Vice Chancellor, UNIVERSITY OF NEBRASKA MEDICAL CENTER



“Very informative with real takeaways!”Senior Manager Operations, BAXTER

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3:30 IMPORTANT CONSIDERATIONS FOR SUCCESSFUL INVESTIGATOR- INITIATED RESEARCH FROM PROPOSAL TO PUBLICATION

• Determine what sponsor investigators should consider in order to effectively execute their programs and develop a positive track record with the industry

• Learn about the resources that investigators can use before starting a trial

• Review some of the major challenges faced by investigators and ways to effectively partner with the industry to overcome them

Victoria Anderson, MPH, CCRP, CCRC, Research Projects Coordinator, ROCKY MOUNTAIN POISON & DRUG CENTER (RMPDC) A DIVISION OF DENVER HEALTH

4:15 WHEN TO SUPPORT RESEARCH COLLABORATIONS VERSUS INVESTIGATOR-INITIATED TRIALS

• Identify the main differentiators for each kind of collaboration and ways to determine whether something is truly investigator-initiated or a research collaboration

• Explore the differences and similarities in the grant application process for IITs and research collaborations to better achieve fi nancial transparency

• Evaluate the implications for ownership of the research, royalties and publications

Angela Ran Shen, Operations Manager, Global Medical Affairs, SHIRE




8:45 CHAIRPERSON’S RECAP OF DAY TWOAlexander Kostek, Senior Director/Team Leader, Innovative Research Collaborations, PFIZER INC

9:00 ACHIEVE A CLEAR UNDERSTANDING OF THE CRITERIA FOR EARLY TERMINATION OF INVESTIGATOR-INITIATED TRIALS

• Discuss how to achieve a clear understanding between the PI and industry on the expectations of the trial

• Examine the different factors that comprise a trial that may not succeed

• Utilize metrics to drive discussions and decisions on trial health • Review how to use the entire medical team (medical affairs and fi eld

medical) to communicate similar messages to investigators • Address why the termination of a trial should not mean the

termination of a relationship between investigators and industry Stuart Keller, RPh, Clinical Research Scientist, Cardiovascular Medical Affairs, ELI LILLY AND COMPANY

9:45 EXAMINE WAYS TO BE A PREFERRED INDUSTRY PARTNER FOR A SPONSOR-INVESTIGATOR

• Recognize the different things industry organizations can do to incentivize investigator-initiated trials and provide effi cient support

• Analyze ways companies can publicly communicate the needs for IITs in different therapeutic areas and get proposals for IITs

• Examine the different types of support the industry can provide and which ones ensure higher trial success

• Leverage MSLs and other teams to increase support of IITs


11:00 THE USE OF PERFORMANCE METRICS TO COLLECT AND REPORT THE VALUE OF IITs

• Discuss the types of performance metrics that companies should measure to track IIT effi ciency and program value

• Gain tools to strengthen relationships between MSLs, investigators and other stakeholders in order to effectively demonstrate the value of IITs

• Gauge which performance metrics to implement in IITs according to company size and region

Alexander Kostek, Senior Director/Team Leader, InnovativeResearch Collaborations, PFIZER INC


12:45 MANAGEMENT OF INVESTIGATOR-INITIATED TRIALS FOR PRODUCTS IN EARLY STAGE DEVELOPMENT VERSUS MARKETED PRODUCTS

• Realize the implications of running IITs before a product achieves marketing authorization

• Hear about the similarities and differences in the grants application process in premarket and postmarket IITs

• Examine the difference in the type of support that can be provided to sponsors/investigators when having preapproved and approved products versus when applying for an IIT in each type of category

Damon R. Michaels, CCRP Director, Clinical Trials Research, VANDERBILT UNIVERSITY MEDICAL CENTER

1:30 HOW TO SUCCESSFULLY INTEGRATE A QUALITY COMPONENT INTO IITs

• Defi ne roles and responsibilities in a quality program to be established upon inception

• Learn metrics and benchmarks to determine quality standards and how they are evolving

• Hear examples of IITs being helped by the use of quality components and how failed IITs could have been saved

John Schenkel, Program Manager, Global Investigator Initiated Research, PFIZER INC

2:15 INFRASTRUCTURE REQUIREMENTS TO RUN IITs IN ACADEMIC INSTITUTIONS OF DIFFERENT SIZES

• Discuss the different implications of running IITs in a network setting compared to a smaller institution

• Craft strategies to get funding for IITs coming from small and bigger academic institutions

• Determine how to ensure proper safety monitoring and trial oversight without the support of a bigger institution and a network setting

• Learn about what infrastructure is required to run IITs when coming from a small versus a big academic institution

.

3:00 CLOSING REMARKS Alexander Kostek, Senior Director/Team Leader, Innovative Research Collaborations, PFIZER INC


AGENDADAY THREE: OCTOBER 2, 2015

IIT & RESEARCH COLLABORATIONS SYMPOSIUM CA

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IIT & RESEARCH COLLABORATIONS SYMPOSIUM

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MEDICAL AFFAIRS STRATEGIC SUMMIT

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22nd Investigator-Initiated Trials & Research Collaborations Symposium

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MEDICAL AFFAIRS STRATEGIC SUMMIT WEST 3 1 ALLinfo.exlevents.com/rs/195-NER-971/images/C593-MassWestBrochure.pdf · Medical Affairs Strategic Summit ... A medical science liaison’s