C568-MASS-Web

NEW FOR 2015MEDICAL AFFAIRS EXECUTIVE FORUM:

PLENARY SESSIONS with valuable insights from CHIEF MEDICAL OFFICERS AND EXECUTIVE LEADERS on how to ensure the value of scientific, commercial and legal communications

12+ unique perspectives on the role that medical affairs plays in R&D, commercialization, product launches, and market access and reimbursement

MSL PROFESSIONALS exploring KOL engagement, relationships with CROs and clinical teams and HEOR projects

INDUSTRY PROFESSIONALS AND INVESTIGATORS discussing ways that strong collaborations can lead to new therapeutic candidates, improved therapies and the discovery of new drug indications through investigator-initiated trials and research collaboration projects

7 PANEL SESSIONS that foster interactive group discussions and complement a robust learning experience

3 WORKSHOPS tailored specifically to the needs of medical affairs’ current role, medical science liaisons career progression, and investigator-initiated trials and research collaborations

FEATURED SPEAKERS

DAVID BIONDI

JANSSEN

GREGORY P. GILMET

UPSHER-SMITH LABORATORIES

ROBERT NUMEROF

BAXTER HEALTHCARE

KEVIN APPARETI

PHILIPS HEALTHTECH

VANESSA JOHNSON

BAYER HEALTHCARE

MEDICAL SCIENCE LIAISON BEST PRACTICES CONGRESS

VINCENT BASEHART

UCLA RADIATION ONCOLOGY

CHRISTY GILCHRISTST. VINCENT

HOSPITAL

INVESTIGATOR-INITIATED TRIALS & RESEARCH COLLABORATIONS SYMPOSIUM

ASHLEYWILLS

TESARO

MEDICAL AFFAIRS STRATEGIC SUMMIT

APRIL 15-17, 2015THE WESTIN GOVERNOR MORRIS

MORRISTOWN, NJ

EAST 3 CONFERENCES

1 LOCATION

ALL ACCESS


8th Medical Affairs Executive Forum16th Medical Science Liaison Best Practices Congress21st Investigator-Initiated Trials and Research Collaborations Symposium

COLLEEN BAIRD

ABBOTT VASCULAR

SPONSORS

C O M P L I A N C E

IMPLEMENTATION SERVICES

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For more information visit www.exlevents.com/MASS

DEAR COLLEAGUE,

The Medical Affairs Strategic Summit East is the original and leading summit

designed to optimize medical affairs teams and discuss new ideas, trends and

ways of collaborating with your MSLs and clinical research colleagues. The

unique summit combines three key functions in life sciences companies to

optimize education, networking and collaboration. Additionally, this event will

help you improve the performance and operational efficiency of your internal and

external teams while maintaining regulatory compliance, achieving successful

product launches, exploring new drug indications and building strong, long-lasting

relationships with key opinion leaders.

As the main communication channel between a company and the scientific

community, medical affairs teams provide brand and therapeutic area expertise

to a wide range of functional areas across the company, including manufacturing,

quality, regulatory affairs, drug safety, R&D, and marketing. They are also

responsible for supporting product launches and postmarket communication and

publication activities. Once a product reaches the market, there are many limitations

in the interactions between sales representatives and healthcare providers

due to regulatory restrictions. To circumvent these constraints, medical affairs

teams utilize medical science liaisons (MSLs) to disseminate information to key

opinion leaders (KOLs) that not only answers essential medical questions but also

strengthens product placement and regulatory compliance.

Additionally, with the constant evolution of clinical research and the potential for

finding new drug indications and the effectiveness of new drug combinations,

investigator-initiated trials (IITs) and research collaborations (sponsored research)

have become crucial for research and development. Medical affairs professionals,

MSLs, clinical operations and external research work closely with investigators to

achieve successful trials that can lead to new milestones in drug development.

This collaboration between medical affairs, MSLs and clinical research teams is the

backbone for successfully cultivating and communicating the value of treatments.

For more than a decade, ExL’s Medical Affairs, MSL and IIT events have helped

you navigate rapidly changing medical affairs and regulatory landscapes. We look

forward to continue providing you with exceptional standalone sessions, innovative

case study presentations, and thought-provoking panel sessions in a unique

educational format to meet all your company’s needs.

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

Katerina LeonKaterina LeonConference Production [email protected]

SPONSORSWELCOME TO MASS EAST 2015

VENUEThe Westin Governor Morris2 Whippany RoadMorristown, NJ 07960

To make reservations please call 973-539-7300 and request the negotiated rate for ExL’s MASS East. You may also make reservations online using the following weblink: http://bit.ly/1vJUAsm. The group rate is available until March 25, 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].

Scott GrossmanScott GrossmanDivision Head, Conference [email protected]

C O M P L I A N C E


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ExL’s MASS event is the ideal platform to showcase your organization to your target market over three days in one intimate 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 customized package please contact Eric Morrin at [email protected] or 212-400-6228.


WELCOME TO MASS EAST 2015

UNIQUE CONFERENCE FORMAT The Medical Affairs Strategic Summit East 2015 provides a unique blend of learning formats, giving you access to a number of different types of content across three conferences. We created a BRING-YOUR-TEAM ENVIRONMENT that provides you with the ability to tailor your agenda and choose sessions that will help you meet your objectives.

MULTI CONFERENCEMASS East features three conferences, which allows you to create a learning experience tailored to your needs

¡ 8th Medical Affairs Executive Forum ¡ 16th Medical Science Liaison Best Practices Congress ¡ 21st Investigator-Initiated Trials and Research Collaborations Symposium

MASTER CLASS WORKSHOPSReceive executive-level training in three-hour workshops that allow for interactions, discussions and hands-on activities with your peers

CASE STUDY PRESENTATIONSThese select sessions will allow you to hear firsthand perspectives on how organizations achieved objectives and successfully overcame challenges

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 55+ 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 conference participants to meet with colleagues from each of the three events 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 14 hours of networking.

APRIL 15TH Workshop Networking Break

APRIL 16THMain Conference Continental Opening BreakfastNetworking LunchCocktail Reception

APRIL 17THContinental Networking BreakfastNetworking LunchTwo Networking Breaks

ATTENDEE PROFILE

TITLE

ORGANIZATIONS

○ 25% Vice Presidents, Heads, Senior Directors

○ 19% Directors

○ 23% Managers

○ 20% Medical Science Liaisons

○ 13% Academics, Investigators, KOLs

25%

19%

13% 23%

20%

14%

27%

12%5%

42%

○ 5% Academic

○ 42% Pharmaceutical

○ 14% Biotechnology

○ 27% Medical Device

○ 12% Service Provider

For more information visit www.exlevents.com/MASSFor more information visit www.exlevents.com/MASS

1:30 Optimize the Impact of a High-Performing Medical Affairs TeamMedical affairs teams have multiple functions in implementing medical and communication strategies for different products and subsequently ensuring market success. High-performing medical affairs teams collaborate with different internal teams to successfully bridge the gap between clinical, commercial and legal. This workshop explores the way high-performing medical affairs teams can achieve operational effi ciency and work together to increase brand impact and streamline processes.

• Understand how regulations shaped medical affairs teams and processes• Increase collaboration with industry colleagues • Review ways to demonstrate value to internal and external stakeholders while adapting to the evolving role of medical affairs • Examine medical affairs’ impact on commercial objectives• Learn tools to overcome resourcing, communication and fi nancial challenges

William Soliman Ph.D, Global Director, Medical Cloud Strategy, VEEVA SYSTEMS 2:30-300 Networking and Refreshment Break

4:30 Workshop Concludes

1:30 Fundamentals, Challenges, and Opportunities – A Workshop for Medical Science Liaisons Medical science liaisons (MSLs) are vital for relationship management and the effective communication of product information to healthcare providers, payers, academic centers and regulators. With a great array of obligations, MSLs require the best tools to be successful and maximize the outcomes of their interactions. This workshop is especially designed for MSLs with minimal experience to gain tools and valuable insights that will allow them to increase their effi ciencies and improve outcomes.

• Explain the fundamentals of the Medical Science Liaison (MSL) role• Recognize how the MSL role is infl uenced by a company’s focus• Describe career opportunities beyond the MSL entry level role

Lynn Bass, Director, Medical Affairs and Global Grants Manager, JAZZ PHARMACEUTICALS Elizabeth Kupferer, Ph.D, WHNP-BC, Medical Science Liaison III, BAYER HEALTHCARE

2:30-300 Networking and Refreshment Break


1:30 Foster Innovation in Medical Research and Optimize Operational Effi ciencies Through Research Collaborations and Investigator- Initiated Trials (IITs)

Post-approval studies are playing a vital role in the discovery of new drug indications and treatment of unmet medical needs. The growing collaboration between industry and academic investigators has led to increased funding and opened the doors to achieving promising clinical outcomes. Nevertheless, there are a number of different ways industry and investigators can collaborate. This workshop addresses the similarities and differences between research collaborations and IITs and when it is viable and appropriate to support these trials.

• Delve into how to manage expectations when working with investigator-initiated trials vs. research collaborations• Review considerations regarding supporting investigator-initiated trials vs. research collaborations and the impact on funding, compliance

and resources• Explore the benefi ts for each party involved in both types of studies and the impact on intellectual property ownership, royalties and

publication rights Alexander Kostek, Senior Director/Team Leader, Global PFIZER Non-Sponsored Research, PFIZER, ACRP’s Investigator Research Interest Group Leadership Team Member

2:30-300 Networking and Refreshment Break


8:00 Main Conference Registration and Continental Opening Breakfast

8:30 Chairperson’s Opening Remarks

Natalia Borinshteyn, M.D., Ph.D, Vice President, HCV Launch Team, Global Medical Affairs, ABBVIE

8:45 EXECUTIVE PANEL Ensure Value in All Dissemination of Scientifi c, Medical, Commercial and Legal Communications to Strengthen Relationships with Stakeholders

Chief medical offi cers and executive leaders have a great responsibility concerning the success of clinical trials, effective postmarket responses and the dissemination of key information, and they must provide strategic leadership and credibility. This panel session addresses the tools, challenges and skills needed to effi ciently strengthen relationships with stakeholders through effective value-added communication.

• Bridge the gap between legal, commercial and medical teams through accurate data and information dissemination

• Build transparent relationships with internal teams, regulatory authorities, investors and advisory committee members

• Manage internal teams and effi ciently communicate corporate decisions to keep business continuity

• Learn about fi eld medical intelligence to collect, aggregate and disseminate fi eld information

Denisa Hurtukova, M.D., Vice President and Head of North America Medical Affairs, Therapeutic Groups, TEVA PHARMACEUTICALSMark Monane, Chief Medical Offi cer, CARDIODXRichey Neuman, M.D., MPH, FACP, Vice President, Head of Medical Affairs, HYPERION THERAPEUTICS

Nancy M. Ruiz, M.D., FACP, FIDSA, Chief Medical Offi cer, MEDA PHARMACEUTICALS Trudy F. Vanhove, M.D., Ph.D, MBA, Vice President, Medical Affairs, JAZZ PHARMACEUTICALS

9:30 The Synergistic Work of Industry and Key Opinion Leaders (KOLs) to Achieve the Best Impact on Patient Outcomes and Treat Unmet Medical Needs

• Discuss the KOL perspective on working with industry and ways in which both parties can overcome obstacles and optimize industry/medical community relationships

• Learn about the benefi ts of integrating KOLs in every phase of drug development to leverage key drivers in healthcare and patient care

• Analyze the impact of the Sunshine Act in the interactions between KOLs and industry

• Understand what KOLs want from pharma and how to provide them the most valuable information

Douglas Dieterich, Professor of Medicine at Icahn School of Medicine, MOUNT SINAI

10:00 Explore the Technology Revolution in Personal Healthcare Monitoring and Hear About Working with KOLs to Make Sense and Gain Value

• Learn about new, cutting-edge health monitoring technology and its impact on patient perception of health

• Hear about key developments in specifi c disease areas using personal health monitoring technology

• Understand strategy and tactics for working with KOLs to enhance the description of medication benefi ts using these new technologies

William C. Maier, Chief Scientifi c Offi cer, VP of Epidemiology and Risk Management, Real World Evidence, MAPI

WORKSHOP DAY WEDNESDAY, APRIL 15, 2015 W

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MAIN CONFERENCE PLENARY SESSIONS THURSDAY, APRIL 16, 2015

8th 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 teams, 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 vs. mature products or is undergoing a merger and/or acquisition.

Among many key topics, the 8th Medical Affairs Executive Forum addresses how medical affairs departments are affected by the current pharmaceutical landscape, including 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

✓ 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

✓ Medical Science Liaisons

8:00 Main Conference Registration and Continental Breakfast

8:30 Plenary Sessions10:45 Networking Break

11:05 Chairperson’s Opening Remarks William C. Maier, MPH, Ph.D, Chief Scientifi c Offi cer, Vice President of Epidemiology and Risk Management, Real World Evidence, MAPI

11:15 Leverage Big Data to Better Engage and Impact Disease Communities

• Learn why comprehensive and objective data is becoming increasingly important to better understand the landscape of disease communities

• Discuss what data is available today and what is required to make it useful in the life sciences industry

• Hear about what rigorous analytics can tell you and how to leverage them inside your organization

Anthony Page, CEO, VOXX ANALYTICS

12:00 The Types of Key Performance Indicators that Can Be Put in Place to Demonstrate the Value of Health Economics and Outcomes Research (HEOR) to Payers

• Explore the changing landscape of the interactions between industry and payers and the infl uence of ACOs and integrated delivery networks

• Assess the impact on industry’s approach to payers through data generation focused on effectiveness and quality

• Review similarities and differences in the data and outcomes presented to regulatory authorities and payers

• Learn about key performance indicators that will improve interactions and streamline processes with payers

Gregory P. Gilmet, M.D., MPH, Senior Medical Director, Head Medical Affairs, UPSHER-SMITH LABORATORIES, INC. 12:45 Luncheon

2:00 Strengthen Relationships Between Medical Affairs, Legal Teams and Healthcare Providers in the Aggregate Spend Landscape

• Discuss ways to collect data and include it in physician fi nancial transparency reports

• Learn about the type of information that needs to be collected post-aggregate spend and the way it will be distributed

• Hear how to effectively communicate to HCPs the information that will be distributed and how they can be ready for questions by providing context for the reported items

• Enhance the way legal and medical teams act in silos and provide transparency to involved parties

Regina Alvarado, Senior Manager, Compliance & Ethics, COMPLIANCE IMPLEMENTATION SERVICES (CIS)

2:30 PANEL Explore Medical Affairs’ Role in Market Access and Reimbursement in Order to Build Strong Payer Relationships

• Learn how medical affairs can play a role in securing reimbursement through the integration of HEOR, MSLs, and Market Access and Reimbursement (MA&R) early in product development

• Discuss the way conversations with payers are documented to achieve regulatory compliance

• Explore why it is important to integrate economic benefi ts, patient outcome data and clinical evidence supporting a product when having conversations with payers

Gregory P. Gilmet, M.D., MPH, Senior Medical Director, Head Medical Affairs, UPSHER-SMITH LABORATORIES, INC.

AGENDADAY TWO: THURSDAY, APRIL 16, 2015

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

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

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Sean Turbeville, Senior Director, Medical and Scientifi c Affairs, SUNESIS PHARMACEUTICALS David M. Biondi, D.O., Therapeutic Area Lead, Neuroscience Insights & Innovation, Scientifi c Affairs, US Medical Affairs, JANSSEN SCIENTIFIC AFFAIRS

3:15 Networking Break

3:45 Plan for a Successful Product Launch to Achieve Market Dominance, Promotional Effectiveness and Opportunity Maximization

• Hear about the expanding role of medical affairs for new product launches through planning and execution excellence at all stages

• Learn about strategic processes that can be put in place to build excitement and create demand for your product before it is available to buyers

• Consider the importance of timely data dissemination and the publication and drafting of the key product message

• Uncover the reasons for product launch failure

4:30 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 vs. 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

Lance Hill, Chief Executive Offi cer, WITHIN 3

5:15 Cocktail Reception

6:15 Day Two Concludes

8:00 Registration Opens and Continental Breakfast

8:45 Chairperson’s Opening Remarks William C. Maier, MPH, Ph.D, Chief Scientifi c Offi cer, VP of Epidemiology and Risk Management, Real World Evidence, MAPI

9:00 PANEL Establish a Successful Medical Affairs Launch Readiness Plan

• Create a successful medical affairs launch readiness plan that supports your global medical affairs teams within each therapeutic area

• Discuss the tools needed to develop and integrate launch road maps across all verticals, including marketing, payers and clinical

• Explore life cycle strategic planning from phase II to launch to ensure resources and medical affairs’ capabilities are readily available and used properly throughout the product’s life cycle

Panelists: Michelle Youngers, President and COO, SCIENCEMEDIA Natalia Borinshteyn, M.D., Ph.D. Vice President, HCV Launch Team, Global Medical Affairs, ABBVIE Mehul Patel, Director, Medical Affairs, ACTAVIS

9:45 Go Beyond Scientifi c Expertise to Understand the Expanding Model of Global Medical Affairs for Small Biopharma

• Hear about drug distribution as a new partner for global medical affairs

• Learn about Managed Access Programs and the expectations from regulatory agencies and industry

• Explore the use of medical information call centers in emerging markets and novel ways to utilize an undervalued service

Sean Turbeville, Senior Director, Medical and Scientifi c Affairs, SUNESIS PHARMACEUTICALS


11:00 Guarantee Transparent Healthcare Decisions Independent from Product Promotion Through the Effective Separation of Commercial and Medical Affairs Functions

• Hear about misconduct activities that lead to criminal fi nes such as the use of MSLs to promote off-label prescribing, excessive payment to HCPs, failure to disclose negative results from studies, promotion of unapproved uses, etc.

• Discuss regulatory expectations for medical affairs teams and ways to avoid unlawful interactions between commercial and medical teams and HCPs

• Hear about the types of policies and SOPs that need to be put in place on how to document and respond to off-label questions from HCPs, including “gray” areas in unsolicited requests and off-label conversations

• Explore the role of corporate integrity agreements (CIAs) in strengthening compliance around medical information activities of the medical affairs function

Peter Lee, Senior Director, Healthcare Compliance, PHARMACYCLICS

11:45 Luncheon

12:45 PANEL Examine the Current Role of Medical Affairs in the Changing Environment of Pharma and How to Support Internal Goals

• Discuss the impact that product launches, drug approvals and regulatory obstacles have on the structure and functions of medical affairs departments

• Learn ways to optimize effi ciencies when dealing with restructuring and fi nancial constraints

• Explore the impact of mergers and acquisitions in the roles and responsibilities of medical affairs professionals

Robert Numerof, Senior Director, Global Medical Affairs, BAXTER HEALTHCARE

1:30 Real World Evidence (RWE) and Its Impact on Medical Affairs’ Research Strategies and Competencies

• Understand what comprises RWE, its perceived advantages, and current challenges associated with its generation and implementation

• Discuss how the growing interest in RWE impacts the research strategies and competencies needed by medical affairs organizations

• Examine how RWE is being used by payers and clinicians in their decision-making processes, and how its use might evolve in the future

David M. Biondi, D.O., Therapeutic Area Lead, Neuroscience Insights & Innovation, Scientifi c Affairs, US Medical Affairs, JANSSEN SCIENTIFIC AFFAIRS

2:15 PANEL The Role of Global Medical Affairs Teams from Clinical Development to Commercialization

• Examine the role of medical affairs in clinical development teams, in phase I-III studies, and in integrated teams — IIS/IIT and commercialization teams

• Understand life cycle management and compound development from launch preparation to postlaunch activities

• Develop ways to position a molecule to maximize budget and achieve a competitive advantage before patent expiration

• Achieve clinical optimization through the deep understanding of clinical issues and the discovery of new indications

• Discuss publication planning strategies to support clinical studies Richey Neuman, M.D., MPH, FACP, Vice President, Head of Medical Affairs, HYPERION THERAPEUTICS Robert Numerof, Senior Director, Global Medical Affairs, BAXTER HEALTHCARE Mehul Patel, Associate Director, Medical Affairs, ACTAVIS William Soliman Ph.D, Global Director, Medical Cloud Strategy, VEEVA SYSTEMS

3:00 Closing Remarks

3:15 Summit Concludes

MEDICAL AFFAIRS EXECUTIVE FORUM

AGENDADAY THREE: FRIDAY, APRIL 17, 2015

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16TH 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 16th Medical Science Liaisons 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, how 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 how to prioritize and maintain 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 Directors

✓ Medical Science

✓ Medical Strategy

✓ Scientific Communication

✓ Medical Education

✓ Key Opinion Leadership/Thought Leadership/Opinion Leader Relationships


8:30 Plenary Sessions


11:05 Chairperson’s Opening Remarks Vanessa Johnson, M.S., Regional Director, Medical Science Liaisons, US Medical Affairs, BAYER HEALTHCARE

11:15 Grow Valuable Relationships with Key Thought Leaders (KTLs) Through Strategic Engagement Programs and Sustained Relationship Management

• Discuss tools to create value and engage with key thought leaders to make sure you grow valuable relationships

• Learn about thought leader segmentation and engagement modeling

• Explore the use of a thought leader database registry as an important tool for managing KTLs

• Examine ways to overcome challenges that arise when engaging with KTLs

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

12:00 Shift from Field Work to Account Management and Other Responsibilities While Exploring the Impact on the Evolution of the MSL Role

• Hear the ramifi cations of the traditional MSL role evolving to include other responsibilities like compliance training, account management, and increased involvement in R&D

• Explore ways to cover as much ground in the fi eld as possible while successfully fulfi lling other responsibilities

• Discuss the impact of therapeutic area and product mergers on training, time management and overall effi ciencies

Vanessa Johnson, M.S., Regional Director, Medical Science Liaisons, US Medical Affairs, BAYER HEALTHCARE

12:45 Luncheon

2:00 Manage Relationships with CROs and the Close Interactions with Clinical Research Teams

• Explore the support/oversight provided by MSLs to clinical research teams and CROs in research and development

• Discuss the best ways to incorporate the value of CROs into the roles and responsibilities of MSLs

• Examine how to maximize the role of the MSL to increase the productivity of CROs and clinical research teams during pre and postmarket phases

Jay Elliott, Deputy Director, Medical Affairs Strategist Liaison, BAYER HEALTHCARE

2:30 Align Medical Affairs’ Functions with MSL Responsibilities in Order to Strengthen Communication and Field Operations

• Discuss strategies to ensure alignment between medical affairs and MSLs

• Hear examples of effective communication between in-house and fi eld-based medical affairs functions and tips for facilitation

• Develop successful MSL training and career progression programs that will strengthen your medical affairs department

Brandi Howard, Ph.D, Senior Director and Head of US Field Medical Affairs, TEVA PHARMACEUTICALS


“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



3:45 PANEL Different Types of Performance Metrics Used in Companies of All Sizes to Demonstrate the Value of MSLs

• Discuss ways different companies are approaching performance metrics, including the reporting of meaningful outcomes and quality events

• Explore the assessment of different activities with the potential to impact businesses and their relationships to performance metrics

• Determine objectives to determine the quality of TL engagements Panelists: Eric Jozefi ak Director, Hematology-East MSLs, CELGENE CORPORATIONDeena Kegler-Ebo, Ph.D, MBA, Senior Medical Science Liaison, Southeast USA & Puerto Rico, ACORDA THERAPEUTICSMargaret Levy, Director and Therapeutic Area Head, Nephrology Regional Medical Liaisons, AMGEN INC.Rebecca Persinger, RD, Ph.D, Medical Science Liaison II, Team Lead, GRIFOLS

4:30 PANEL The Impact of Compliance and Risk Mitigation on the Evolution of the MSL Role

• Identify high-compliance risk areas for MSLs • Review the impact of compliance and risk mitigation on the

evolution of the MSL role • Ensure MSLs are compliant with what medical and scientifi c

information can and cannot be shared Panelists: Colleen Baird, National Manager, Medical Science/Medical Affairs,ABBOTT VASCULARLynn Bass, Director, Medical Affairs and Global Grants Manager, JAZZ PHARMACEUTICALS Margaret Levy, Director and Therapeutic Area Head, Nephrology Regional Medical Liaisons, AMGEN INC.




8:45 Chairperson’s Opening RemarksVanessa Johnson, M.S., Regional Director, Medical Science Liaisons, US Medical Affairs, BAYER HEALTHCARE

9:00 PANEL Optimize MSL-Physician Interactions Through a Clear Understanding of the Role, Impact and Value of MSLs

• Discuss ways to help physicians understand the role of the MSL and the value of new clinical studies

• Discover tools to educate physicians to understand the importance of the MSL role and the main differences with commercial teams

• Learn how to properly manage off-label discussions and proactive/reactive discussions through effective MSL training

Panelists: Susan Barlow, Associate Director, Medical Affairs, Field Medical Affairs, VALERITAS INC.Rebecca Persinger, RD, Ph.D, Medical Science Liaison II, Team Lead, GRIFOLSTayo Fakunle, Ph.D, Medical Science Liaison, VERICELDonna Cronin, Director, Field Based Medicine East, ACORDA THERAPEUTICS

9:45 Fostering a Robust and Cross-Functional MSL Team• Discuss ways to maximize opportunities and talents of a diverse

MSL team• Review collaboration and skill sharing opportunities with internal

cross-functional departments• Explore a case study of a MSL- Clinical Operations Liaison

Elaine Nadeau, Medical Science Liaison, Neurology, ACORDA THERAPEUTICSDonna Cronin, Director, Field Based Medicine East, ACORDA THERAPEUTICS


11:00 A Novel Approach to Performance Metrics in the Roles and Responsibilities of Medical Science Liaisons

• Learn about the reporting of substantial quality events and meaningful outcomes as effective performance metrics for MSLs

• Discuss innovative approaches to communicate the value of MSLs to multiple stakeholders

• Identify ways to incorporate qualitative and quantitative metrics into performance evaluations

• Discuss the importance of networking with internal stakeholders Frank Ragone, Senior Medical Science Liaison, GENZYME

11:45 Luncheon

12:45 Facilitate Growing Cross-Functional Projects Between the US Medical Science Teams, In-House Clinical Research Leaders and HEOR

• Address the importance of strategic goals, building processes and strong communication plans to achieve clinical and business objectives

• Hear about strategic planning, fi nancial management, personnel management, professional development, training and support to achieve cross-functional projects between teams

• Discuss how to overcome communication challenges when working with multiple teams while staying aligned with business objectives

Colleen Baird, National Manager, Medical Science/Medical Affairs, ABBOTT VASCULAR

1:30 Examine Thought Leader Access of Community vs. Academic KOLs and Discuss Ways to Bring Value

• Understand the barriers and clinical data discussion points for KOL engagement

• Explore the opportunities that MSLs have when interacting with academic KOLs and understand their research programs to reach collaboration outside of IITs

• Overcome community KOL access barriers by understanding what they need from MSLs to fi nd value in the interaction

• Optimize the interactions between KOLs, sales representatives and MSLs to foster communications and reduce redundancy

Muriel Siadak, Former Director, Scientifi c Partnerships, ONYX PHARMACEUTICALS

2:15 Case Study: Medical Affairs’ Responsibility to Bring a Biotechnology Product from Clinical Development to Commercialization

• Hear about the strategies to develop plans and presentations in order to bring a cell-based product for cartilage repair to market

• Understand what a company relies on in order to bring a product to market and how to optimize the work of MSL teams in the fi eld

• Analyze the challenges and opportunities biotechnology companies face regarding medical affairs as opposed to those faced by pharmaceutical companies

Tayo Fakunle, Ph.D, Medical Science Liaison, VERICEL




MSL BEST PRACTICES CONGRESSPA

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21ST INVESTIGATOR-INITIATED TRIALS & RESEARCH COLLABORATIONS SYMPOSIUM

Investigator-initiated research plays a big role in working with industry 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 the IIT portfolio management taking into consideration financial, logistical and regulatory/legal aspects. Although investigator-initi-ated 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 21st 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 vs. multicenter trials, best practices for understanding and fulfilling the expec-tations of industry and sponsors, structured data, analytics and systems management impact 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 publica-tion 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


8:30 Plenary Sessions


11:05 Chairperson’s Opening RemarksMary Voehl Hirsch, Senior Director, SANOFI ACRP’s Investigator Research Interest Group Leadership Team Member

11:15 Compliance Considerations when Evaluating IIT Studies — What Sponsor-Investigators Might Not Think About

• Hear ways of evaluating compliance areas when outsourcing for trial execution (EDC, medical writing, investigational product handling, reporting, staffi ng)

• Discuss the impact of the Sunshine Act, state laws and EU transparency requirements on IITs

• Learn suggested best practices for common scenarios (case studies) arising in IITs such as confl icts of interest, organizational structures, scope changes, etc.

Kari K. Loeser, Senior Director & Senior Compliance Counsel, JAZZ PHARMACEUTICALS

12:00 Best Practices for Understanding and Fulfi lling the Expectations of Industry and Sponsors when Running Investigator-Initiated Trials

• Determine ways to ensure quality outcomes through the understanding of feasibility, goals and resources

• Discuss how one-way vs. two-way agreements work and how to manage compliance expectations, intellectual property ownership and funding

• Explore ways to overcome challenges when expectations are not set properly and the terms of the agreement are misunderstood

• Maximize the ROI for each party involved in IITs and identify the main drivers involved

Damon Michaels, Director - Clinical Trials Research, VANDERBILT UNIVERSITY

12:45 Luncheon

2:00 PANEL Drive Post-Approval Research and Publicly Communicate the Need for IITs in Specifi c Therapeutic Areas

• Discuss the ways organizations are publicly exposing the needs for investigator-initiated trials in different therapeutic areas while maintaining regulatory compliance and the nature of unsolicited requests

• Examine what can and cannot be done to inform investigators and any interested parties about the need for IITs and hear about the different legal perspectives within companies

Panelists:

Mary Voehl Hirsch, Senior Director, SANOFI, ACRP’s Investigator Research Interest Group Leadership Team Member

Alexander Kostek, Senior Director/Team Leader, Global PFIZER Non-Sponsored Research, PFIZER, ACRP’s Investigator Research Interest Group Leadership Team Member


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

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2:30 CASE STUDY: Investigator-Initiated Trial of a Pediatric Device for Pancreatic Disease

• Hear about protocol design, funding and the publication of results using preliminary data from an IIT designed to test the artifi cial pancreas (AP) in adolescents with type 1 diabetes

• Address challenges and considerations for future trials and how to secure external funding from industry and government institutions

• Learn strategies to successfully publish study results Daniel Cherñavvsky, M.D., Assistant ProfessorCenter for Diabetes Technology, UNIVERSITY OF VIRGINIA


3:45 Investigator-Initiated Trials Optimization at the NIH Heart, Lung and Blood Institute (NHLBI) Through the Use of Performance Measures

• Learn how the NHLBI is improving the performance of investigator- initiated trials from enrollment to publication, through the use of performance measures, in an environment of increasing fi scal austerity and a need for accountability for public funds

• Hear about NHLBI priorities for clinical trials and key messages the Institute would like to share with investigators, hospitals, academic centers and industry

Monica R. Shah, M.D., FACC, Deputy Chief, Heart Failure and Arrhythmias Branch, NATIONAL INSTITUTES OF HEALTH

4:30 Integrate Investigators, MSLs and Other Departments to Become Cross Functional and Optimize IITs

• Hear best practices to optimize the review process of an IIT and provide proper oversight after approval

• Discuss considerations to determine the type of operations that need to be outsourced and the roles and responsibilities of the parties involved to achieve regulatory compliance and meet clinical endpoints

• Learn why being cross functional can reduce the cost of your IIT and optimize effi ciencies and communication

Deena Kegler-Ebo, Ph.D, MBA, Senior Medical Science Liaison, Southeast USA & Puerto Rico, ACORDA THERAPEUTICS




8:45 Chairperson’s Opening RemarksMary Voehl Hirsch, Senior Director, Investigator-Sponsored Trials, SANOFI

9:00 Effi ciently Negotiate Contracts in IITs and Research Collaborations• Explore the differences and similarities in the grant application

process for IITs and research collaborations in order to achieve fi nancial transparency

• Discuss how to determine ownership of the research, patent implications and subsequent publication rights in each type of collaboration

• Hear best practices for effi ciently negotiating contracts, including managing timelines and safety reporting

Lori Barrentine, Director Clinical and Scientifi c Affairs, PAMLAB

9:45 Informed Decision-Making in Investigator-Sponsored Research Through Structured Data, Analytics and Systems Management

• Explore the evaluation of risk and determine strategic priorities • Estimate IIT support and ways to manage internal resource

constraints• Identify process gaps to address ineffi ciencies and achieve process

improvement in IITsAshley Wills, Senior Manager, Medical Affairs Research - IST, TESARO


11:00 Foster Compliance and Strengthen IIT Studies for Newer Sponsor- Investigators

• Understand the pharmaceutical and sponsor-investigator perspectives and needs throughout the IIT grant cycle

• Identify and manage risk and compliance issues for newer sponsor-investigators

• Work with community-based investigators and understand their experience, skill set and framework

• Evaluate resources and their implications for fostering compliance• Learn strategies for overcoming bumps along the way

Christy Gilchrist, Director, Cancer Research Institute, ST. VINCENT HOSPITALAhmad Naim, Senior Medical Director, INCYTE CORPORATION

11:45 Luncheon

12:45 Best Practices for Running Single vs. Multicenter Investigator- Initiated Clinical Studies

• Discuss the different regulatory requirements and interactions with the IRB when conducting single vs. multicentered IITs

• Learn how to effi ciently secure fi nancing, ensure study to start-up time, train and monitor multicentered IITs, minimize risk, and promote the accuracy and quality of the data collected

• Hear logistic considerations for running multi-center vs. single site IITs and how to plan for the unexpected

• Examine regulatory considerations when searching for an external research site

Vincent Basehart, Director, Clinical Trials, UCLA RADIATION ONCOLOGY

1:30 Development of a Strong Publication Plan for Study Results of Investigator-Initiated Trials

• Hear ways to develop strategies for successful dissemination of study results so they are published in a timely/accurate manner

• Discuss pharmaceutical publication responsibilities, challenges and opportunities when dealing with publications from IITs

• Explore the roles and responsibilities of publication service providers and their impact on global publication plans for IITs

Nicole H. Longwell, Ph.D, National Director, Medical Science Liaisons Autoimmune and Rare Diseases Business, MALLINCKRODT PHARMACEUTICALS

2:15 How to Prepare for Audits and Inspections of Investigator-Initiated Trials

• Hear how to provide proper IIT oversight and prepare for FDA inspections

• Understand investigators’ regulatory obligations with the IRB and the FDA to achieve compliance and good clinical practice

• Discuss how to implement and document robust internal audit programs that will ensure compliance and reduce inspection fi ndings

• Examine how to effectively manage the risks of IITs and ensure adequate safety reporting and the integrity of the data

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IIT & RESEARCH COLLABORATIONS SYMPOSIUM

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8th Medical Affairs Executive Forum16th Medical Science Liaison Best Practices Congress21st Investigator-Initiated Trials and Research Collaborations Symposium

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