50+ industry speakers driving innovation at the premier ... · 50+ industry speakers driving...

September 17-19, 2014Hyatt Regency Mission

Bay Spa and Marina

San Diego, CA

50+ Industry Speakers Driving Innovation at the Premier Medical Affairs Meeting!

SPONSORS

ATTENDEE BENEFITS ■ Implement metrics and per-formance management in Medical Affairs, MSL teams and IIT planning to increase operational effi ciency

■ Enhance communication between internal and external teams to provide value add

■ Optimize MSLs to ensure timely completion of IIT programs

■ Explore strategies to identify and strategically interact with KOLs to achieve your organiza-tion’s goals

■ Learn to effectively disseminate a products economic valueto internal and external stakeholders

SUZANA GIFFINExecutive Director, Scientifi c Affairs, Head of Global Medical Information, AMGEN

OSCAR SEGURADOChief Medical Offi cerCRESCENDO BIOSCIENCE/ MYRIAD GENETICS

DENNIS KIMVP, Head Global Medical Affairs, SPECTRUM PHARMACEUTICALS

MARIA KOULLICKSenior Director of Healthcare Economics, ST. JUDE MEDICAL

RICHEY NEUMAN VP, Head of North America Medical Affairs,TEVA PHARMACEUTICALS

Customize Your ExperienceTHREE STREAMS:

■ Medical Affairs Executive Forum

■ Medical Science Liaison Best Practices

■ Investigator-Initiated Trials

ADDITIONAL AREAS OF FOCUS:

■ KEY OPINION LEADER INTERACTIONS

■ HEALTH ECONOMICS OUTCOMES RESEARCH

FEATURED SPEAKERS

STREAMS CHAIRED BYBOB NUMEROFDirector, Global Medical Affairs, BAXTER HEALTHCARE

SURABHI SHARMAAssociate Director, Clinical Research,NOVARTIS CONSUMER HEALTHCARE

JASON ROTHAERMELRegional Manager, Medical Science Liaisons, Oncology, Global Medical Affairs,ABBVIE ONCOLOGY

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Dear Colleague,

As the healthcare landscape continues to change, Life Science organizations are being forced to quickly adapt. With the increasing need to support internal goals, the com-munication of medical, scientifi c and economic information is at the forefront of every organization. These responsibilities fall on Medical Affairs professionals who are tasked with developing strategic platforms and utilizing both internal and external teams to maximize outreach. Additionally, these professionals play an instrumental role in effectively managing Investigator Initiated Trials, which provide great value to an organization by discovering the full potential of their marketed products.

The Medical Affairs Strategic Summit West is the industry’s leading forum to discuss new ideas with your Medical Affairs, Medical Science Liaison, Clinical Research and Health Economics Outcomes Research colleagues to improve the performance and operational effi ciency of your internal and external teams. This year’s event is comprised of fi ve educational areas including:

■ Medical Affairs Executive Forum: focuses on enhancing your Medical Affairs structure that ensures compliant Medical and Scientifi c communication to key internal and external stakeholders

■ Medical Science Liaison Best Practices: discusses ways to build high performance teams that provide value to internal colleagues, investigator-initiated trials, key opinion leaders and multiple functions within an organization

■ Investigator Initiated Trials: examines strategies to enhance the value of investigator sponsored studies by decreasing start up time, improving outcomes with the shift towards personalized medicine and integrating post approval development plans while remaining compliant with FDA regulations

■ Health Economics Outcomes Research: demonstrate the value of your product by enhancing the communication of economic and pricing data to all stakeholders

■ Key Opinion Leader Interactions: explores ways to strategically interact with key thought leaders to maximize the benefi ts of interactions and provide value to multiple areas within an organization

As the Life Science and Healthcare industries continue to grow and evolve, this is the ideal summit to learn these innovative ideas to improve the performance of you Medical Affairs and Medical Science Liaison teams while maximizing the benefi ts of successful Investigator Initiated Trials, Health Economics Outcomes Research and Key Opinion Leader Interactions.

Sincerely,

Nicole deVoe Scott GrossmanConference Director Production Team Lead Medical Affairs Strategic Summit Series

W E L C O M E T O

AT T E N D E E P R O F I L E

H O T E L I N F O R M AT I O N

HYATT REGENCY MISSIONBAY SPA AND MARINA1441 Quivira Road, San Diego, CA 92109

To make reservations please call 1-888-421-1442 and request the negotiated rate for ExL’s MASS West. You may also make reservations online using the following weblink: https://resweb.passkey.com/go/EXLPharmaSeptember. The group rate is available until August 26, 2014. Please book your room early as rooms available at this rate are limited.

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AGENDA DAY WEDNESDAY, SEPTEMBER 17, 20141W O R K S H O P Master Classes

WORKSHOP DDifferent, But In the Same Way: How Medical Affairs Organizations Across Various Life Science Industry Sectors Compare, Contrast, and Can Learn From Each Other

■ Learn both similarities and differences between fi eld medical affairs (MSL) organizations from different parts of the life science industry (biopharma, device, diagnostic)

■ Understand common MSL behaviors across the industry MSL groups

■ Gather “pearls” regarding best practices

■ Ascertain common platforms that inform a mutual value proposition

■ Garner insights on creative approaches to adding value with your own fi eld medical teams

DAVID A. JENCEN, PhD, Principal, JENCEN FIELD MEDICAL CONSULTING LLC

WORKSHOP EGlobal IIT Management and Approaches to Working with Worldwide Investigators

■ Strategies to effectively to work with investigators from other countries

■ Understand necessary criteria to run global IITs

■ Regulatory, legal and compliance issues that need to be considered when con-ducting national and international IITs

■ Proposal review and approval process

ALEXANDER KOSTEK, Senior Director, External Medical Communications, PFIZER

WORKSHOP FImpact of Off-Label Discussions on Medical Affairs and Medical Science Liaisons

■ Discuss the current status of off-label discussions and their impact of Medical Affairs and Medical Science Liaisons

■ Review the court, Department of Justice and FDA’s interpretations of the “gray area” of scientifi c discussion

■ Understand FDA guidances on off-label discussions and understand their current status

■ Apply the gray areas of off-label discussions and evaluate their impact on digital and in-person communications

DARSHAN KULKARNI, PharmD, MS, Esq., Life Science Compliance and Regulatory Attorney, THE KULKARNI LAW FIRM

PAUL YEUNG, MD, Senior Medical Director, TEVA PHARMACEUTICALS

LUNCHEON FOR AM WORKSHOP ATTENDEES ONLY

DAY ONE CONCLUDES

9:00

12:00

1:30

4:30

WORKSHOP AEstablish Global Medical Science Liaison Teams to Maximize Communication

■ Explore the current global presence of MSLs through a global survey

■ Evaluate factors to determine when a global MSL team is essential

■ Evaluate how a MSL team is developed to support global needs with regional implementation considerations

■ Discuss challenges of assessing outcomes for these teams

LYNN BASS, Director, Global Medical Affairs,JAZZ PHARMACEUTICALS

REBECCA VERMEULEN, Senior Director, Medical Science Liaisons, BioOncology, GENENTECH

WORKSHOP BObligations and Compliance. How Can/Should Industry Help

■ Understand how the industry partner should maintain an arm’s length while offering necessary support and regula-tory guidance

■ Discuss if the industry partner should offer training for the sponsor-investigator or investigator

■ Review how the industry partner should effectively and compliantly execute this training

■ Demonstrate examples of non-compli-ance relating to IND/IDE fi ling, IRB review, and defi ning intellectual property owner-ship and discuss strategies to overcome these issues

HARVEY M. ARBIT, PharmD, MBA, RAC, CCRP, ARBIT CONSULTING

KEVIN WEATHERWAX, Manager Investigator Assistance Program, UNIVERSITY OF MICHIGAN

WORKSHOP CThe Impact of a Medical Affairs Department in Large Pharma versus Small Biotech

■ Review the fundamental core aspects of a Medical Affairs organization regard-less of the company structure

■ Understand changes in Medical Affairs over past 20 years to prepare for the next 20 years

■ Leadership challenges and opportunities for the next generation of Medical Affairs leaders

RANDALL KAYE, Former Chief Medical Offi cer, AVANIR

TO REGISTER C ALL: 866-207-6528 OR VIS IT WEST.EXL-MASS.COM 3

AGENDA DAY THURSDAY, SEPTEMBER 18, 20142

9:00 Impact of the Affordable Care Act on Effective Communication of Medical and Scientifi c Information to Maximize Operational Effi ciency and Provide Value to All Stakeholders

■ Increase effectiveness of MSL communication with KOLs and HCPs to provide more value add from interactions

■ Utilize internal and external Medical Affairs teams to effectively communicate medical and scientifi c communication to all stakeholders

■ Impact of the Sunshine Act on how Physicians and Industry interacts

■ Effectively disseminate HEOR data to demonstrate product value to key stakeholders

■ Utilize publications to communicate IIT results

JEFF HERSH, MD, Chief Medical Offi cer, GENERAL ELECTRIC HEALTHCARE

NANCY RUIZ, MD, FACP, FIDSA, Chief Medical Offi cer, MEDA PHARMACEUTICALS

OSCAR SEGURADO, MD, PhD, Chief Medical Offi cer, CRESCENDO BIOSCIENCE / MYRIAD GENETICS

MICHAEL MONTGOMERY, MD, Executive Medical Director, Medical Affairs, INCYTE

9:30 Navigate the Legal Risks of Medical Affairs Communications in the Digital Age

■ In what ways may FDA’s Draft “Guidance for Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media” impact Medical Affairs communications

■ Impact of the recent 1st Amendment case law on Medical Affairs communications now or in the future

■ Enable email, text and digital communications for Medical Liaisons

■ Challenges with addressing product-related misinformation in social medial and with healthcare professionals who use social media

GRETCHEN FRITZ, Senior Director, Associate General Counsel, Commercial Brands and Legal Affairs Department, DAIICHI SANKYO

10:00 Leverage Big Data to Infl uence Scientifi c Communities

■ Understand why comprehensive and objective data is increasingly important

■ What data is available today and what’s required to make it useful

■ What rigorous analytics can tell you

■ How to leverage data inside your organization

TONY PAGE, CEO, VOXX ANALYTICS

M A I N C O N F E R E N C E Plenary Sessions

8:00 REGISTRATION OPENS AND CONTINENTAL BREAKFAST

8:45 Opening Remarks

WHAT YOUR COLLEAGUES ARE SAYING ABOUT MASS“Outstanding presentations from a very robust speaking faculty” Sr. Director, Medical Affairs, Infi nity Pharmaceuticals

“Very interesting and engaging talks given by knowledgeable speakers” Clinical Project Manager, Genentech

“Great Medical Affairs meeting that touched on a number of key topics for my whole team” Associate Director, Intermune

“Very good presentations and great group discussions” Senior Operations, Medical Affairs, Biomarin

“Great meeting, the group provided many educational conversations” Senior Manager, Teva Pharmaceuticals

“Perfect meeting that provided a great learning environment” Associate Director, Bristol-Myers Squibb

“Very dynamic summit. I was able to take a lot of knowledge back to my department”Senior Director, Medical Affairs, Abbott

“One of the best Medical Affairs meetings I have attended” Medical Affairs, LifeScan, A Johnson & Johnson Company

4 TO REGISTER C ALL: 866-207-6528 OR VIS IT WEST.EXL-MASS.COM

AGENDA DAY THURSDAY, SEPTEMBER 18, 20142 M

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Chairperson’s Opening Remarks

BOB NUMEROF, Director, Global Medical Affairs, BAXTER HEALTHCARE


JASON ROTHAERMEL,Regional Manager, Medical Science Liaisons, Oncology, Global Medical Affairs,ABBVIE ONCOLOGY


SURABHI SHARMA,Associate Director, Clinical Research, NOVARTIS CONSUMER HEALTHCARE

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Medical Science Liaison Collaboration with Internal Colleagues to Provide Value Add

■ Strategies for effective knowledge sharing obtained in KOL engagements

■ Effectively disseminate information for cross functional use

KEVIN APPARETI, Senior Director, Global Medical Science Liaison, PHILLIPS HEALTHCARE

Strategies to Build and Deploy a Contract Medical Science Liaison Team

■ Identify your organizations needs in regards to a MSL team

■ Understand benefi ts and pitfalls when building a team internally versus outsourcing one

■ Strategies to identify which vendoris best suited for your organization

GAIL ROSEN SPAHN, PharmD, Sr. Director, Medical Sciences, XENOPORT

Report on the Value of Your Investigator Initiated Study Program

■ Strategies to report value of IST program to senior leadership

■ Identify the commonly requested metrics and the best way to display them

■ Examine operational metrics around day-to-day functioning of a biotech IST program

CHRISTIAN WADE, Ph.D., Associate Director, Medical Affairs Scientifi c Alliances and Operations, SEATTLE GENETICS

Integrate Investigator Initiated Studies Into Post-Approval Development Plans

■ Understand the need to integrate post-approval studies into your investigator initiated research portfolio

■ Understand the need for post-approval evidence-based data

■ Utilize investigators to fi ll the needs of post-approval trials

■ Oversight and management of approved investigator research

■ Overview of required post-approval studies

DENNIS DECKTOR, PhD, MBA, Senior Medical Director,REGENERON PHARMACEUTICALS

Establish Medical Affairs Partnerships with Clinical Development and Commercial Departments

■ Maximize the value of Medical Affairs by supporting clinical development, investigator initiated studies and commercial

■ Assist commercial colleagues in partnerships with patient communities

■ Methodology in supporting clinical development through Medical Affairs functions

■ Develop and execute cross team strategies while assisting other depart-ments in meeting their un-met goals

DENNIS KIM, VP, Head Global Medical Affairs, SPECTRUM PHARMACEUTICALS

Increase the Utilization of Technology to Enhance Engagement Strategiesfor Thought Leaders

■ Understanding the needs to develop a centralized platform for data

■ Utilizing data mapping capabilities to increase records management on KOL

■ Enhancing a centralized data collection system to increase identifi cation platforms

PETER GANNON, CEO, WITHIN3

10:45 11:30 11:45 12:15


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Build a High Performance Medical Science Liaison Team by Identifying Key Strategic Drivers

■ Characteristics for a successful MSL team in the current regulatory environment

■ Build meaningful and compliant strategic initiatives that provide the most value to internal and external stakeholders

■ Find the balance between reactive and proactive MSL activities

JASON ROTHAERMEL, RN., BSN., MBA., Regional Manager, Medical Science Liaisons, Oncology, Global Medical Affairs, ABBVIE ONCOLOGY

Scientifi c Information Sharing Throughout a Product’s Complete Life Cycle

■ Strategies for building and implementing a communication plan throughout a product’s life cycle

■ Explore different ways to disseminate information at different point in the life cycle

■ Understand information to focus on at different parts in the life cycle

BOB NUMEROF, Director, Global Medical Affairs, BAXTER HEALTHCARE

Role of Investigator Initiated Trials in Evidence Generation Supporting Personalized Medicine

■ Identify the drivers of shifts to value-based and personalized medicine

■ Research approaches in personalized medicine

■ Understand the value of personalized medicine in clinical research

KIUMARS Q VADIEI, Medical Affairs Scientifi c Director, GLAXOSMITHKLINE

Information Sharing and Key Opinion Leader Meeting Preparation in a Mobile World

■ Understand the challenges and opportunities for effectively engaging with and responding to KOLs

■ The rationale for leveraging mobile in Medical Affairs and related fi eld functions

■ Best practices in accessing and sharing information while maintaining compliance

■ Advantages of integrating mobile offi ce platforms to streamline information exchange and dissemination

SHARON BENZENO, Senior Director, Portfolio Marketing, ELSEVIER, INC.

Operational Effi ciency of Medical Affairs through Planning and Performance Metrics

■ Identify key areas requiring planning and performance metrics

■ Improve resourcing and budgeting in your organization

■ Strategize to improve organizational effi ciency and processes

OSCAR SEGURADO, MD, PhD, Chief Medical Offi cer, CRESCENDO BIOSCIENCE / MYRIAD GENETICS

Implement Organizational Readiness Platforms in Investigator Initiated Trials

■ Strategies to implement a change management platform in IIT programs

■ Effectively collaborate with investigators to ensure timely change management

■ Best practices for effective handling of protocol deviation

KATHRYN SHANTZ, Operations Leader, External Scientifi c Research, ASTRAZENECA

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Examine the Role of Medical Affairs in Advertising and Promotion

■ Discuss strategies to engage commercial teams; when is the appropriate time to collaborate with medical

■ Examine specifi c examples where a medical perspective my have prevented an untitled warning letter

■ Role of medical in pre launch and launch related promotional materials

MICHAEL UJHELYI, Director of Medical Affairs and Sciences, MEDTRONIC

Develop a Global Process for Scientifi c Communication

■ Understand the important aspects to consider when standardizing scientifi c content

■ Analyze fi nancial impact through cost avoidance and survey analysis

■ Best practices for implementing a scientifi c communication platform on a global scale

TIM FISH, Director of Medical Affairs, BAXTER BIOSCIENCE

Increase the Impact of Your Brand by Implementing a Global Medical Science Liaison Team

■ Identify strategies to maximize communication in a global MSL community

■ Understand and overcome common pitfalls associated with implementing a global MSL team

■ Ensure effective reporting for seamless sharing of knowledge globally

IF YOU ARE INTERESTED IN LEADING THIS SESSION, PLEASE CONTACT STEVE DECKER AT [email protected] OR 212-400-6234

International Case Study: Using Surveys to Strengthen Medical Science Liaisons’ Relationships with Thought Leaders in Emerging Markets

■ Regulatory changes that make Pharma strengthen and expand the role of MSLs/Medical Advisors

■ Implementation of 2 arm survey approach to assess the quality of thought leaders’ interactions and reveal the gaps in Medical Affairs functioning

■ Conclusions and recommendations to realign industry efforts to match thought leaders’ needs with internal objectives.

ALEXANDER TOLMACHEV, Senior Manager for Medical and Regulatory Projects, TAKEDA PHARMACEUTICALS

Develop International Investigator Initiated Study Research Programs to Determine What Model Works Best

■ Determine key factors to consider in program design

■ Key functional groups and their role in IISR programs

■ Learn to balance oversight with country level consideration

SUSAN BURRISS, Clinical Development Scientist, GLAXOSMITHKLINE

Optimize Medical Science Liaisons to Decrease Study Start Up Time

■ Identify areas where a MSL can add value to clinical development functions

■ Develop and leverage relationships with investigators when selecting sites

■ Utilize MSL presence to keep processes on track

DEBRA WALKER, Associate Director, Medical Science Liaison, BOEHRINGER INGELHEIM

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AGENDA DAY FRIDAY, SEPTEMBER 19, 20143C

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Understand the Evolution of Medical Information to Adapt to the Dynamic External Landscape

■ Review current trends and how Medical Information departments have adapted to a dynamic external landscape

■ Review survey fi ndings and key components to the globalization of Medical Information

■ Discuss how Medical Information departments have applied technologically innovative solutions to advance its capabilities

SUZANA GIFFIN, Executive Director, Scientifi c Affairs, AMGEN

FDA Draft Guidance on Unsolicited Requests

■ Review FDA guidance on unsolicited requests

■ Strategies to effectively handle unsolicited requests on social media

■ Best practices to educate your organization to compliantly handle off-label requests

MONICA KWARCINSKI, PharmD, Executive Director, Medical Services, PURDUE PHARMA

Implement Analytics in Medical Affairs for Real Time Data Capture in a New Product Launch

■ Understand what analytics to implement for effective data capture

■ Utilize metrics to allocate resources and drive business improvement


Understand the Role of the Mid-Level Providers in Medical Science Liaison Interactions

■ Understand the value of the mid level provider

■ Strategies to ensure valuable MSL interactions with mid-level providers

■ Ensure compliant interactions when interacting with mid level providers

NATALIA KUJDYCH, Clinical Science Liaison, GENZYME

Metrics to Determine Operational Effectiveness of your Medical Science Liaison Team

■ Identify appropriate metrics to implement and gauge effectiveness of your MSL team

■ Demonstrate the impact of a MSL organization and how metrics can serve as a basis for supporting MSL resourcing

CHAD SCHROER, VP MSLs, EMD SERONO

Examine the Growing Function of the Medical Science Liaison Role and the Impact on Multiple Functions throughout an Organization

■ Explore the key functions of a MSL, including fi eld and internal functions

■ Understand the adaptation of a MSL team and understand the future MSL will like

■ Manage core fi eld responsibilities with the emergence of MSLs of internal projects

WILLIAM SYPULA, PharmD, Senior Medical Science Liaison, LEO PHARMACEUTICALS

Support Investigator Initiated Research in a Global Environment

■ Explore how industry is looking at IITs from a global perspective

■ How patients and industry benefi t from international trials

■ Understand the differences between IIT programs between USA and EMEA

■ Understand which stakeholders benefi t from international IITs

KIRAN BHIRANGI, Head of Global Medical Affairs, Europe, SHIRE

Investigator Initiated Trials and Research Collaborations: Differences and Similarities

■ Explain the difference between an IIT grand and research collaboration

■ Discuss when it is viable and appropriate to support them

■ Explore operational effi ciencies that the two entail

ALEXANDER KOSTEK, Senior Director, External Medical Communications, PFIZER

Navigate the Changing Regulatory Landscape for Successful and Compliant Investigator Initiated Trials

■ Understand the need for an IIT strategy managing system

■ Strategies to mitigate risks and control costs while remaining pursuant to FDA guidelines

■ Effectively obtain trial data to ensure compliant trial disclosure

■ Maintain support for audit requirements and documentations

JENNIFER LILL, VP of Medical Affairs, DENDREON

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8:00 9:15 9:30 10:00 10:45 11:15


AGENDA DAY FRIDAY, SEPTEMBER 19, 20143 Strategies for Strategic Global Publication Planning

■ Identify specifi c needs of global affi liates with respect to the publication plan

■ Identify function needs of different stakeholders and local opportunities

■ Discuss design and scope of a global publication plan

■ Understand the role geography plays in a publication plan

NANCY RUIZ, MD, FACP, FIDSA, Chief Medical Offi cer, MEDA PHARMACEUTICALS

Career Architecture in Global Medical Affairs: Building Pathways for Mobility and Success

■ GMA roles in the context of GMA ‘job families’

■ The importance of GMA Talent Assessment

■ Potential pathways for GMA career growth and development

■ Over There: GMA and expatriate experiences

RICHEY NEUMAN, MD, MPH, VP, Head or North American Medical Affairs, TEVA PHARMACEUTICALS

Impact of Payer and Managed Care on the Medical Science Liaison Role

■ Analyze shifting role of MSL to include payer and managed care responsibilities

■ Leverage MSL teams to engage consumers in market access discussions

■ Understand the value of a payer and managed care liaison to internal and external stakeholders

DANA EVANS, Director Medical Affairs Payer Support, GENENTECH

PANEL SESSION: Determine Strategies to Best Utilize Technology to Strengthen Virtual Connections While Satisfying the HCP’s Information Needs

■ Identify the needs of your organizations to determine the appropriate technology

■ Effectively implement technology both internally and externally

■ Ensure the implemented technology is palatable to healthcare practitioners

ERIC ZHAO, PharmD, Medical Science Liaison, Oncology, TEVA

SHEEN KAPLAN, National Director, Payer & Health Outcomes, ALLERGAN

CHAD SCHROER, VP MSLs, EMD SERONO

Implement Publication Plan for Successful Dissemination of Study Results

■ Strategies for timely study data capture and dissemination

■ Benefi ts of building an internal publication team

■ Benefi ts and pitfalls of outsourcing IIT publication teams


FDA Requirements and Legal Liability Associated with Investigator Initiated INDs

■ FDA requirements for Investigator Initiated INDs

■ IRB review and oversight responsibilities

■ Strategies to minimize regulatory risk and legal liability

ERNEST PRENTICE, Ph.D., Vice Chancellor for Academic Affairs, UNIVERSITY OF NEBRASKA

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Strategies to Identify and Strategically Interact with Key Opinion Leaders to Achieve Your Goals

■ Understand internal and external resources for identifying the appropriate thought leader for your project

■ Successfully articulate your needs to thought leaders for effi cient interactions

JULIAN BLUMENFELD, MD, Chief Medical Science Liaison, ROEHR PHARMACEUTICALS

The Evolving Role of Imaging and Its Health Economic Impact

■ Discuss the wide range of possible ways a Medical Device can have benefi cial economic value

■ Discuss the different lenses of the stake-holders, including payers, and how they may view this economic impact

■ Discuss the possible timing of the collection of health economic data

JEFF HERSH, MD, Chief Medical Offi cer, GENERAL ELECTRIC HEALTHCARE SYSTEMS

Build Effective Support for Clinical Trials with a Medical Science Liaison Team

■ Organizational scheme for early involvement of MSLs in clinical trials

■ Determine supportive clinical functions for MSLs during the pre-trial period

■ Create value added clinical supportive activities from trial initiation to closure

DEENA KEGLER-EBO, Regional Scientifi c Manager, ACORDA THERAPEUTICS

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Understand the Value of the Medical Science Liaison for the Key Opinion Leader

■ Understand KOL vs. industry expectations from an MSL

■ Maximizing interactions that provide value for both parties

■ Novel/untraditional MSL engagement strategies

■ Redefi ning measures of success

JESSA FORD DEPEW, PharmD, MBA, Medical Science Director, INTERMUNE

Maximize the Effi ciency of HEOR Data Throughout Medical Affairs, R&D and Commercial Teams to Support the Field Based Communications of Therapy/Intervention

■ Enable cross functional communication

■ Develop a team to collect, decipher and communicate data to internal and external stakeholders

■ Support key stakeholders in a value driven healthcare landscape through HEOR messaging

JULIA GAEBLER, Senior Director, Global Medical Outcomes Strategy, BIOGEN IDEC

Pharmaceutical Company’s Perspective to Ensure Successful Investigator Initiated Trials

■ Understand the numerous regulatory responsibilities involved in an IIT

■ Review 21 CFR 312 and 812 guidelines for IITs

■ Discuss how industry can support IITs when they are not sponsoring from a regulatory perspective

SURABHI SHARMA, M.S., MBA, CCRC, Associate Director- Clinical Research, NOVARTIS CONSUMER HEALTHCARE

Defi ne Organizational Goals to Engage and Maximize Key Opinion Leader Relationships

■ Understand the defi nition ofa KOL

■ Defi ne organizational strategies to engage KOLs

■ Maximize relationships between KOLs and MSLs

■ Measure the success of KOL/MSL interactions

SCOTT CONRY, West Field Diretor, Hemostasi Medical Science Liaisons, NOVO NORDISK

Strategies for Industry to Best Engage Key Opinion Leaders

■ How KOLs want to be engaged

■ What type of industry interactions bring value to KOLs

■ What data and information thought leaders are looking for from industry

BEN CADIEUX, Director, Medical Affairs, RAPTOR PHARMACEUTICALS

The Changing role of Key Opinion Leaders in the Context of US Healthcare Reform

■ Transparency created by performance metrics for hospitals and physicians

■ KOL qualifi cations necessary to support clinical as well as health economic & reimbursement strategies

■ Leveraging KOLs to infl uence economic stakeholders

MARIA KOULLICK, Senior Director of Healthcare Economics, ST. JUDE MEDICAL

CASE STUDY: Enhance the Economic Value of a Product to Internal and External Stakeholders

■ Display how a comprehensive real-world data analysis can inform the value proposition of a drug for important stakeholders

■ Illustrate the design of a classic retrospective analysis, its development over the drug’s life cycle, its inferred outcomes and its impact of formulary decision making and its limitations

RUSSELL L KNOTH, Ph.D., Director, Health Economics and Outcomes Research, EISAI

PANEL SESSION: Investigator Perspective for Successful Investigator Initiated Trial Programs

■ Strategies for industry to effectively interact with investigators

■ Understand needs of investigators for study completion

■ Best practices to lower study overhead

■ Review critical aspects of an IIT for timely and successful completion

■ Understand aspects of IITs that are commonly forgotten until after the grant has been made to ensure study success

ERNEST PRENTICE, Ph.D., Vice Chancellor for Academic Affairs, UNIVERSITY OF NEBRASKA

RUDOLF SCHOPF, MD, Professor of Medicine, JOHANNES GUTENBERG UNIVERSITY OF MEDICINE

KEVIN WEATHERWAX, Manager Investigator Assistance Program, UNIVERSITY OF MICHIGAN

JAKE VINSON, Director, Research Programs Manager, MEMORIAL SLOAN KETTERING CANCER CENTER

CHRISTY GILCHRIST, PhD, CRA, Director of Cancer Research Institute, SAINT VINCENT HOSPITAL

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