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MEDICAL AFFAIRS STRATEGIC SUMMIT

3 CONFERENCES 1 LOCATION ALL ACCESS

11th MEDICAL AFFAIRS EXECUTIVE FORUM FEATURED SPEAKERS

Ornah T. Levine- Dolberg, M.D. TEVA PHARMACEUTICALS

CHAIRPERSONDavid Cram CORCEPT THERAPEUTICS

Kari Loeser JAZZ PHARMACEUTICALS

Jeffrey D. Pollard, M.D. 23ANDME

19th MEDICAL SCIENCE LIAISON BEST PRACTICES CONGRESS FEATURED SPEAKERS

24th RESEARCH COLLABORATIONS & IITs SYMPOSIUM FEATURED SPEAKERS

CHAIRPERSONDannis Chang GENENTECH

Jamie Tobitt VERTEX PHARMACEUTICALS

Alison Martens MEDA PHARMACEUTICALS

Sarah Henry KARYOPHARM THERAPEUTICS, INC.

CHAIRPERSONKatie Wozniak SAGE PRODUCTS

Michael Ujhelyi MINNEAPOLIS HEART INSTITUTE FOUNDATION

Alena V. Pechonkina, MD, MBA GILEAD SCIENCES CENTER

FEATURING PRESENTATIONS, PANEL DISCUSSIONS AND CASE STUDIES ON: MEDICAL AFFAIRS The Role of Medical Affairs in the Emerging Field of Biosimilars

PANEL: Commercial and Clinical Communication Challenges Throughout the Product Development Life Cycle

CASE STUDY: The Intricacies of Medical Affairs Management in an Orphan Drug Organization

FEATURING 3 MASTER CLASS WORKSHOPS:Medical Affairs Compliance Training Methods that Yield High-Value Results for Advisory Boards

SPONSORS

Georgea Pasedis NEW HAVEN PHARMACEUTICALS

WEST

SEPTEMBER 14-16, 2016 HARD ROCK HOTEL SAN DIEGO

SAN DIEGO, CAWays to Ensure Compliant MSL and Sales Interactions and Establish Appropriate SOPs

An Introduction to Research Collaborations and Roundtable Challenge Analysis

MSL BEST PRACTICESA Field-Based Perspective on Demonstrating Value to Medical Affairs Leadership

PANEL: MSL Rising Stars in the Life Science Industry

CASE STUDY: The Utilization of Experienced Clinical Personnel in an MSL Role and Subsequent Recruitment Techniques

RESEARCH COLLABORATIONS & IITs Operational Oversight of Investigator-Initiated Trials on a Global Basis

PANEL: Strategies to Increase Sponsor and Site Collaboration

CASE STUDY: Techniques to Become an Industry Partner for Investigator-Initiated Studies

50+ INDUSTRY SPEAKERS DRIVING INNOVATION AT

THE PREMIER MEDICAL AFFAIRS MEETING!

Dear Colleague,

Compliant, efficient and streamlined communications, whether shared internally or externally, are vital to a life science organization’s product development life cycle. Similarly, information exchange for clinical and commercial goals must adhere to regulatory standards and research best practices. Medical communication professionals, whether they are crafting operating procedures, engaging thought leaders or conducting oversight during a clinical trial, all require retraining and must fine-tune their daily functions in order to succeed in the ever-expanding and technologically advanced healthcare marketplace.

ExL Events’ Medical Affairs Strategic Summit (MASS) West 2016, September 14-16 at the Hard Rock Hotel San Diego, provides a meeting place and educational forum for life science professionals, researchers and healthcare providers to convene and collaborate on challenges facing medical communications. This three-day event features an expert speaking faculty from leading life science organizations, as well as innovative researchers, ready to share their perspectives on a multitude of topics in a three-track format:

¡ The 11th Medical Affairs Executive Forum highlights communication issues between commercial and clinical entities, while analyzing the expanded scope of medical affairs departments into the prelaunch and postmarketing phases.

¡ The 19th Medical Science Liaison Best Practices Congress showcases a number of panel discussions with representatives from all levels of experience and responsibility to truly dissect the growth of the MSL role, as evidenced by its presence in IITs and its recruitment of personnel with advanced degrees.

¡ The 24th Research Collaborations & IITs Symposium explores how to enhance clinical research by examining operational aspects, such as sponsor and site communication, central management of IITs, and the establishment of an IST workflow.

The summit begins with a day of intensive master class workshops that provide strategies and techniques to navigate compliance, communication and research issues. In addition, a morning of plenary sessions will examine topical subjects in an interactive environment.

MASS West also builds in hours of designated networking time for attendees to collaborate on common challenges and build mutually beneficial partnerships.

With three days of advanced learnings and ample relationship building, MASS West is a can’t-miss event for life science professionals.

WHO SHOULD ATTEND

207 Fifth Ave | San Diego, CA 92101

There’s something electric about being in the middle of it all. Hard Rock Hotel San Diego puts you in the limelight with chic accommodations just steps from downtown and the famed nightlife of the Gaslamp Quarter. Whether you’re here to catch a game at PETCO Park (located just one block away) or attend a corporate event at the San Diego Convention Center (right across the street), we’ll take you there.

If you require overnight hotel accommodations, please contact the hotel. ExL Events has reserved a block of rooms at a group rate for participants. To make reservations guests can call 877-344-ROCK (7625) and request the group rate for ExL’s MASS WEST Meeting. The group rate is available until August 23, 2016. Please book your room early as rooms available at this rate are limited.

*ExL Events, Inc. is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or 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 info@exlevents.com. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL’s reserved guest room block using the details provided.

HARD ROCK HOTEL SAN DIEGO

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

• Marketing and Commercial

• Research and Development

• Medical Education

• Medical Communications

• Investigator-Initiated/Sponsored Trials (IIT/IST)

• Key Opinion Leadership/Thought Leadership/Opinion Leader Relationships

• Publication Planning

• Postmarketing/Phase IV Studies

• Scientific Communication

• Program/Product Management

• Health Economics

• Quality Assurance

• Investigator Studies

• Scientific Engagements

• Medical/Scientific Information

• Compliance/Legal

• Account Management

This conference is also designed for:

• KOL and Thought Leader Mapping Organizations

• Data Management Vendors

• Clinical Trial Service Providers

• Scientific and Technology Solutions Providers

• Medical Affairs Service Organizations

• Medical and Scientific Communication Vendors

• Talent Acquisition Service Providers

1:00 WORKSHOP REGISTRATION 1:30 Medical Affairs Compliance Training Methods that Yield High-Value Results for Advisory Boards

A top priority of medical affairs teams is proving the value of a product to internal stakeholders and to key opinion leaders, in order to gain their guidance. However, compliance in these interactions must be maintained, despite how this may impact timelines or budgets.

• Pinpoint how medical and compliance departments can collaborate on compliance challenges when developing an advisory board• Discuss how to maintain compliance while balancing timely and cost-effective outcomes for long-term value• Determine how to transmit compliance standards to functional leaders and develop a checklist to ensure success

Peter Lee, Vice President, Compliance, HERON THERAPEUTICSKevin Appareti, Senior Director, Global Medical Science Liaison, Office of Medical Affairs, PHILIPS HEALTHCARE

1:30 Ways to Ensure Compliant MSL and Sales Interactions and Establish Appropriate SOPsA major issue facing MSLs and their managers is the separation of commercial and clinical operations. While sales and marketing teams require appropriate and accurate information to sell a product, there are compliance restrictions between the two entities and new MSLs are prone to violations.

• Learn the most frequent compliance violations in relation to information transmission and develop a risk mitigation strategy• Analyze sample communications to understand compliant transmission and dissemination of medical and scientific communication, while citing violations• Utilize internal legal and compliance teams as resources for guiding new MSLs and account managers prior to their interactions with thought leaders

Alison Martens, RN, BSN, CCRP, Medical Science Liaison, Northeast Region and Team Lead, MEDA PHARMACEUTICALS

1:30 An Introduction to Research Collaborations and Roundtable Challenge AnalysisResearch collaborations involve the management of multiple channels of communication, compliance, information and budgets. This workshop will feature two themes: understanding the management of research collaborations and providing a forum for those in attendance to present and collaborate on issues they are currently facing at their respective organizations.

• Gain intensive training on research collaboration compliance, procurement, budgeting and communication challenges plaguing those new to sponsored trials• Collaborate with fellow attendees, leading investigators and sponsors on issues currently faced in research operations• Develop strategies and checklists for ensuring compliance and streamlined communications throughout the research life cycle

Alexander Kostek, Senior Director/Team Leader, Innovative Research Collaborations, PFIZERPriscilla Hsue, M.D., Professor, Department of Medicine, UNIVERSITY OF CALIFORNIA SAN FRANCISCOThomas J.R. Beveridge, M.Sc., Ph.D., Associate Director, Clinical Sciences, Medical Affairs, FERRING PHARMACEUTICALS

2:30-3:00 NETWORKING BREAK

4:30 WORKSHOPS CONCLUDE

DAY ONE PRE-CONFERENCE WORKSHOPS SEPTEMBER 14, 2016W

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7:45 MAIN CONFERENCE REGISTRATION AND CONTINENTAL BREAKFAST

8:15 Chairperson’s Opening RemarksMarither Chuidian, M.D., Senior Medical Director, AVANIR PHARMACEUTICALS

8:20 PANEL: The Value of a Medical Strategy Throughout a Product Life Cycle: Ensuring the Alignment of Corporate, Clinical, Regulatory and Commercial Objectives

• Hear how a Medical Director can bridge the gap between commercial and clinical entities in a life science organization

• Understand the relationship between the product life cycle and a brand, and how to best navigate the scientific and business landscape

• Develop a culture of collaboration with open communications within cross-functional teams to allow for efficient channel management and information flow

• Align MSLs and sales teams with organizational expectations and compliance adherence

Panelists:Marither Chuidian, M.D., Senior Medical Director, AVANIR PHARMACEUTICALSDavid Tworek, Regional Director, Medical Affairs, LUNDBECKSnehal Naik, Director, Clinical Development and Medical Affairs, PROMETHEUS LABORATORIESKari Loeser, Senior Director and Senior Compliance Counsel, JAZZ PHARMACEUTICALS

9:00 Operations and Excellence as a Core Strategic Advantage for Medical Affairs

• Discuss how the absence of firmly embedded unique operating models, strategic medical functions and tools that drive value can often hinder the success of medical affairs as a strategic partner

• Discover the process to address this issue from a medical and operational perspective

• Examine the formation of the Medical Operations and Excellence unit and the value that this function has proven to have with the final goal of placing medical affairs as a strategic value provider

Ornah T. Levine-Dolberg, M.D., Vice President and Head of Medical Affairs, Growth Markets, TEVA PHARMACEUTICALSMoshe Cykert, Senior Director, Head of Operations and Medical Excellence, Growth Markets, TEVA PHARMACEUTICALS

9:45 Optimize Your Engagement Strategy with Intelligent Data Use• Discover how engagements can more effectively drive business

objectives when based on solid intelligence• Use data to frame community thinking on key topics• Learn how to build peer networks that support local, regional and

national territory objectivesTony Page, CEO, VOXX ANALYTICS

10:15 NETWORKING BREAK

DAY TWO PLENARY SESSIONS SEPTEMBER 15, 2016

11th ANNUAL

11TH MEDICAL AFFAIRS EXECUTIVE FORUM DAY TWO: SEPTEMBER 15, 201611:00 Chairperson’s Opening Remarks

David Cram, Director, Medical Affairs, CORCEPT THERAPEUTICS

11:15 The Effects of Company Size on the Establishment of an Advisory Board Benchmark

• Understand the financial challenges of compensating a KOL for advisory board participation in a smaller pharmaceutical or biotechnology organization

• Determine the appropriate structure, medium and participants for an advisory board in relation to a company’s size

• Learn best practices for advisory board facilitation that serve business goals

Lisa Stepp, Ph.D., Senior Director Medical Affairs, PEREGRINE PHARMACEUTICALS

12:00 PANEL: Commercial and Clinical Communication Challenges Throughout the Product Development Life Cycle

• Hear perspectives from MSLs and account managers on how medical affairs can better regulate communication channels

• Assess the use of firewalls and what compliance issues have arisen• Pinpoint how commercial and clinical teams can collaborate on the

engagement of KOLs Panelists: Jonas Hylton, Pharm.D., Associate Director, Medical Affairs — Medical Science Liaisons, MEDIVATION

12:45 LUNCHEON

1:45 PANEL: The Establishment of Internal Firewalls to Avoid Compliance Violations Between Commercial and Medical Affairs Teams

• Assess why compliance and overregulation are concerning issues for medical affairs leadership, as evidenced by recent surveys

• Discuss the use of firewalls and the challenges they present for MSLs and sales teams in their communication with therapeutic area experts

• Determine how intense a firewall should be to allow for efficient communication while simultaneously maintaining compliance

Panelists: Scott McConnell, Senior Director, Medical Affairs, CHIASMA Bob Numerof, MSL Field Team Leader, U.S. Medical Affairs, CSL BEHRING

2:30 The Role of Medical Affairs in the Emerging Field of Biosimilars• Review the current status of biosimilars in the U.S.• Consider the similarities and differences between the roles medical

affairs professionals play supporting biosimilars versus reference biologics

• Analyze the implications of a new drug category on the establishment of medical affairs benchmarks

• Communicate best practices from other therapeutic areas that can be applied to the biosimilars arena

Jonathan Uy, M.D., Head, Immunology Medical Affairs, SANDOZ

3:15 NETWORKING BREAK

3:45 Leverage Technology for Optimal Stakeholder Engagement• Identify the logistical and resource barriers to domestic and global

stakeholder engagement• Learn about the innovative communication solutions that leading

organizations utilize to overcome these challenges• Discuss how to use these solutions to deliver improved engagement

outcomes while remaining compliant Lance Hill, CEO, WITHIN3

4:30 CASE STUDY: Best Practices for Risk Mitigation and Collaboration While Maintaining Compliance

• Identify how to proactively partner with Compliance/Legal teams for effective risk mitigation in medical affairs  

• Examine and share strategies for current topics in medical affairs, such as the roles of MSLs and internal stakeholders and the use of cross-functional projects 

• Cite the roles of legal and compliance throughout the product life cycle Kari Loeser, Senior Director and Senior Compliance Counsel, JAZZ PHARMACEUTICALS

5:15 NETWORKING RECEPTION

6:15 DAY TWO CONCLUDES

DAY THREE: SEPTEMBER 16, 2016

8:00 CONTINENTAL BREAKFAST

9:00 Chairperson’s Recap of Day Two David Cram, Director, Medical Affairs, CORCEPT THERAPEUTICS

9:15 Development, Disruption, Adoption: A Medical Affairs Perspective

• Get comfortable with new health technology and out-of-the-box ideas and find true north in your organization via strategies for cross-functional alignment and collaboration

• Address the power of disruption: Disrupting healthcare is a good thing, right? Work through new and existing regulatory barriers 

• Incorporate KOL engagement — into your process early and often; information, education and in/outbound communication strategies are essential

Jeffrey D. Pollard, M.D., Director of Medical Affairs, 23andMe

10:00 CASE STUDY: The Intricacies of Medical Affairs Management in an Orphan Drug Organization

• Cite differences in the structure and scope of medical affairs departments for orphan drugs

• Review the challenges that come with a lack of traditional opinion leaders, and how to leverage information and guidance for drug development

• Understand how MSLs can play a role in the commercial process and patient relations

David Cram, Director, Medical Affairs, CORCEPT THERAPEUTICS

10:45 NETWORKING BREAK

11:15 The MSL Training Dilemma: Identifying Opinion Leader ‘Need’ Segments

• Discuss the research conducted on medical affairs managers, MSLs and KOLs and the best ways to provide therapeutic area thought leaders with the most valuable scientific expertise

• Understand your target KOL population by identifying and sizing their distinct need segments

• Examine the benefits of going beyond medical consultation and providing information to KOLs on corporate programs such as clinical trials, speakers bureaus and advisory boards

Gary Kaplan, M.A., Vice President, Medical Affairs Research, CLINICAL SCORE

12:00 LUNCHEON

1:00 PANEL: Medical Affairs’ Expanding Reach into Postmarketing Studies

• Explore organizational structures where postmarketing studies fall under medical affairs’ responsibilities in comparison to clinical development and market access

• Compare the priorities of the three potential governing departments and their relationship to postmarketing studies

• Optimize postmarketing timelines by taking advantage of medical affairs’ experience in planning and organization

Panelists: Heith Durrence, Ph.D., Medical Science Director, PERNIX THERAPEUTICS Peter Krein, Ph.D., Senior Director, Medical and Scientific Affairs, QIAGEN

1:45 The Critical Role of Medical Affairs Throughout Product Launch• Describe medical affairs’ level of involvement in pivotal data

dissemination, publications, continuing medical education, medical information and training

• Understand how to pinpoint appropriate thought leaders and subsequent relationship management, including MSL activities and scientific advisory boards

• Compare the current versus traditional medical affairs role Matt Bryant, Pharm.D., Associate Director, Medical Affairs, THERAVANCE BIOPHARMA

2:30 NETWORKING BREAK

3:00 PANEL: The Use of Medical Affairs Teams in Patient Centricity Efforts

• Expand the scope of traditional stakeholders to include the patient perspective

• Coordinate with patient advocacy groups to rebuild patient trust in the life sciences industry

• Account for patients being more educated with greater access to information

Panelists: Asha Das, Vice President, Clinical Development and Medical Affairs, TOCAGEN

3:45 Closing Remarks David Cram, Director, Medical Affairs, CORCEPT THERAPEUTICS

4:00 SUMMIT CONCLUDES

11th ANNUAL

19TH MSL BEST PRACTICES CONGRESS DAY TWO: SEPTEMBER 15, 2016

11:00 Chairperson’s Opening Remarks Dannis Chang, Medical Science Director, GENENTECH

11:15 A Field-Based Perspective on Demonstrating Value to Medical Affairs Leadership

• Pinpoint the metrics used by chief medical and scientific officers when evaluating MSL performance and interactions and where they differ with that of medical affairs leadership

• Balance the use of qualitative and quantitative analysis for MSL and medical affairs operations

• Demonstrate value for both clinical and commercial goals within an organization

Georgea Pasedis, Pharm.D., Senior Medical Science Liaison, NEW HAVEN PHARMACEUTICALS

12:00 Deliver Value to Healthcare Providers Through a Collaborative Approach Between Medical Information and Medical Science Liaisons

• Define the Medical Information and MSL roles and review the similarities and differences

• Review what the “art of medical communications” entails from business and legal points of view

• Assess the results of a survey evaluating the current relationship and collaboration efforts between Medical Information and MSLs across various pharmaceutical companies

• Delve into the importance of collaboration and identify ways to improve customer service and patient care through a collaborative approach among in-house and field medical affairs professionals to deliver value for HCPs

Dannis Chang, Medical Science Director, GENENTECH

12:45 LUNCHEON

1:45 Technology Utilization to Maximize the Expanding MSL Role• Understand the value of virtually managing and evaluating MSLs • Learn about communication and engagement tracking technology used

in thought leader relationships• Maintain compliance in the dissemination of information using third-

party tools Paul Minne, Director, Medical Science Liaisons, BIOGEN

2:30 CASE STUDY: The Utilization of Experienced Clinical Personnel in an MSL Role and Subsequent Recruitment Techniques

• Discuss scientific professionals with Pharm.D., Ph.D. and M.D. degrees transitioning to MSL roles

• Recognize the therapeutic areas that demand a higher education certification, as well as a more experienced background

• Determine how MSL team leads can effectively recruit and retrain new MSLs with therapeutic-area expertise

Fely Canorea-Vega, M.D., Medical Sciences Manager, ABBOTT VASCULAR

3:15 NETWORKING BREAK

3:45 The Development of a Multifunctional MSL Team with Growth Capabilities

• Highlight the methods, roles and responsibilities of larger pharmaceutical and biotechnology medical affairs teams and discuss how and when they can be replicated within a smaller field model

• Assign MSL team members cross-functional workstreams that can be efficiently executed

• Identify communication channel issues that arise in large medical affairs teams and increase collaboration between field MSL and in-house teams

Melanie Olesky, Senior Director, Medical Information, TETRAPHASE PHARMACEUTICALS

4:30 Implement and Utilize Key Performance Indicators to Evaluate an MSL

• Study the recent industry shift from quantitative analysis of performance to qualitative metrics

• Analyze which metrics are most vital to senior leadership’s measuring of MSL-KOL interactions

• Develop a strategy for how an MSL can best showcase their value Sunil Mehta, Pharm.D., MSL Regional Director, ALEXION PHARMACEUTICALS Brian Tumminello, Senior Medical Science Liaison, ALEXION PHARMACEUTICALS

5:15 NETWORKING RECEPTION

6:15 DAY TWO CONCLUDES

DAY THREE: SEPTEMBER 16, 20168:00 CONTINENTAL BREAKFAST 9:00 Chairperson’s Recap of Day Two

Dannis Chang, Medical Science Director, GENENTECH

9:15 PANEL: MSL Rising Stars in the Life Science Industry• Hear from a group of new MSLs, nominated by experienced leadership

from their respective organizations• Assess the challenges faced by these MSLs and how they are navigating

the life science industry• Forecast the growth of MSLs and how they can advance

Panelists: Beth Lakey, Medical Science Liaison, ADVANCED ACCELERATOR APPLICATIONS

10:00 Microlearning for the MSL• Recognize the need to provide learner-driven training to benefit just-in-

time performance support• Evaluate design elements that make microlearning impactful for overall

knowledge retention• Discover and share best practices for making training accessible for MSLs• Review case study highlights

Michelle A. Youngers, President and COO, SCIENCEMEDIA

10:45 NETWORKING BREAK

11:15 Globalize MSL Teams to Prepare for Emerging Healthcare Areas• Pinpoint previously unattended territories and their therapeutic areas of

focus that now require an MSL presence• Dissect the relationship between an MSL presence, healthcare infrastructure

and patient population• Navigate common language, legal and cultural barriers that prevent MSL

integration Katherine Presto, Independent Pharmaceutical Consultant

12:00 LUNCHEON

1:00 MSL Presentations to Managed Care Organizations• Differentiate presentation styles and tactics used for managed care

stakeholders versus traditional KOLs• Understand how to demonstrate value and assess what metrics are the

most important to health plans and other managed care groups• Learn what is required internally to train MSLs on managed care

presentations Jamie Tobitt, Pharm.D., Senior Medical Science Liaison, VERTEX PHARMACEUTICALS

1:45 The Role of the MSL in Company and Investigator-Initiated Trials• Review the specific roles of investigators versus pharmaceutical company

staff in different study settings• Analyze MSL-specific skills that IIT managers rely on throughout the life

cycle of different study designs• Establish potential compliance concerns with IIR studies• Examine the functions of the MSL on an IIT review committee and

maximize their participation Lynn Bass, Director, Medical Affairs and Global Grants Manager, JAZZ PHARMACEUTICALS

2:30 NETWORKING BREAK

3:00 The Organizational Value of Internal Mentoring for New MSLs and Leadership

• Quantify the value of involving experienced MSLs and medical affairs managers in the development of new personnel

• Evaluate virtual and in-person tools for successful meetings and reviews• Develop one-to-one and group mentoring strategies

Lori Peters, Medical Science Liaison, DEPOMED

3:45 Closing Remarks Dannis Chang, Medical Science Director, GENENTECH

4:00 SUMMIT CONCLUDES

"Great conference. I learned a lot and am definitely looking forward

to next year's meeting."Associate Medical Director, ABBVIE

11th ANNUAL

24TH RESEARCH COLLABORATIONS & IITs

DAY TWO: SEPTEMBER 15, 2016 11:00 Chairperson’s Opening Remarks

Katie Wozniak, Senior Manager, Clinical Research, SAGE PRODUCTS

11:15 PANEL: Strategies to Increase Sponsor and Site Collaboration• Learn about specific challenges at sites/centers from those creating and

conducting IITs, and about the role of good communication in successful projects

• Understand how to work with the site and reduce key barriers that can threaten project success

• Highlight how a poor understanding of logistics (e.g., a sponsor-center disconnect) can adversely affect protocol design, budget and schedule for a clinical trial

Panelists: Michael Ujhelyi, Vice President, Research and Scientific Affairs, MINNEAPOLIS HEART INSTITUTE FOUNDATION Joseph Cosico, Director, Clinical Research Operations, CEDARS- SINAI MEDICAL CENTER

12:00 CASE STUDY: The Establishment of an Investigator-Sponsored Trial Workflow Within a Small Pharmaceutical Company

• Discover how organizations new to ISTs can transition from basic, in-house software to tailored, therapeutic-specific tools

• Create a review committee to vote on submitted concepts• Develop SOPs that meet business needs while adhering to IST compliance

Sarah Henry, Senior Clinical Project Manager, KARYOPHARM THERAPEUTICS INC.

12:45 LUNCHEON

1:45 The Effects of an Organization’s Brand and Business Strategy on IIS Selection

• Account for a company’s portfolio when reviewing IIS submissions • Compare an IIS budget and the number of studies approved and rejected

versus the timeline of the approval process • Assess the cost of venturing into a new product line and how submissions

will be reviewed Elizabeth Mena, Associate Director, Medical Sciences, PHARMACYCLICS

2:30 The Increase in the Utilization of CRO Presence for Clinical Trials• Analyze specific tasks associated with clinical trials and assess why

specific activities, such as medical communications, are kept in-house• Utilize CROs for their therapeutic-area expertise when a host organization

makes a new venture• Hypothesize the future use of CROs for trial planning and weigh the

benefitsIf you are interested in leading this session, please contact Eric Morrin at emorrin@exlevents.com.

3:15 NETWORKING BREAK

3:45 CASE STUDY: Techniques to Become an Industry Partner for Investigator-Initiated Studies

• Learn how to incentivize investigator-initiated studies and provide efficient support

• Brainstorm ways companies can publicly communicate the needs for IITs in different therapeutic areas

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

• Leverage MSLs and other internal teams to increase support for IITs Alexander Kostek, Senior Director/Team Leader, Innovative Research Collaborations, PFIZER

4:30 CASE STUDY: The Creation of a Hybrid Role to Bridge the Gap Between Medical Affairs and Clinical Development

• Observe how medical affairs and clinical divisions are closely aligned when a dedicated IIT program is not present

• Cite how medical affairs can become involved in study design and operations

• Determine the best practices and processes used to connect both entities Alix Bennett, Ph.D., Associate Director, Medical Affairs, PROMIUS PHARMA

5:15 NETWORKING RECEPTION

6:15 DAY TWO CONCLUDES

DAY THREE: SEPTEMBER 16, 20168:00 CONTINENTAL BREAKFAST

9:00 Chairperson’s Recap of Day Two Katie Wozniak, Senior Manager, Clinical Research, SAGE PRODUCTS

9:15 PANEL: IST Operations Across the Life Science Industry• Hear from senior operation managers from biotechnology, medical

device and pharmaceutical organizations regarding the similarities and differences in how their respective industries approach research collaborations

• Highlight regulatory and compliance issues and compare them across industries

• Discuss the use of MSLs throughout the research collaboration processPanelists:

Katie Wozniak, Senior Manager, Clinical Research, SAGE PRODUCTS Sarah Henry, Senior Clinical Project Manager, KARYOPHARM THERAPEUTICS, INC. Elizabeth Mena, Associate Director, Medical Sciences, PHARMACYCLICS

10:00 Innovative Technologies and Initiatives for Monitoring and Tracking Investigator-Initiated Trials

• Hear about specific programs and their abilities to track IITs• Discuss the international regulatory differences for IITs and how to

establish a global standard• Consider the affects of the NIH funding decrease on IIT innovation

Christy Gilchrist, Ph.D., CRA, Director, Cancer Research Institute, SAINT VINCENT HOSPITAL

10:45 NETWORKING BREAK

11:15 Dynamic Management Models for IIS Team Leadership• Ponder the use of a matrix environment to manage research team

members• Analyze the use of dedicated study team managers versus

multifunctional leaders• Compare global and regional leadership, as well as team structure, based

on their therapeutic area Kasmin Delgado, Senior Medical Science Liaison, Women’s Health Division, VALEANT PHARMACEUTICAL

12:00 LUNCHEON1:00 Operational Oversight of Investigator-Initiated Trials on a Global Basis

• Assess how a growing organization effectively manages differences in geographies, therapies and strategies

• Determine where study management resides: Is it with clinical operations or medical affairs?

• Outline how to align medical affairs, medical science liaisons, clinical operations, contracting and clinical pricing

Alena V. Pechonkina, M.D., MBA, Associate Director, Clinical Operations, GILEAD SCIENCES  W. Marshall Cool, Associate Director, Clinical Operations, GILEAD SCIENCES  Julie Doostzadeh, Ph.D., Senior Clinical Program Manager, Clinical Operations, GILEAD SCIENCES  Daniel Park, Manager, Clinical Contracts and Finance, GILEAD SCIENCES  Selin Hall, M.D., Senior Clinical Trial Manager, GILEAD SCIENCES Terry Burton, Manager, Clinical Contracts and Finance, GILEAD SCIENCES

2:30 NETWORKING BREAK

3:00 Use of Cross-Functional Study Evaluation Committees• Decide the makeup of an evaluation committee to assess how roles

should be allocated• Examine the use of voting and non-voting committee members and how

they participate• Scrutinize the presence of marketing on evaluation committees and the

potential of compliance violations

3:45 Closing Remarks Katie Wozniak, Senior Manager, Clinical Research, SAGE PRODUCTS

4:00 SUMMIT CONCLUDES

“This was a great learning experience! I met a lot of new contacts and am excited to go back to work to share what I have learned with my colleagues.”

Principle Clinical Trials Associate, CELGENE

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**Please Note: There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague within five business days of any ExL conference.**

CANCELLATION AND REFUND POLICY: If you cancel your registration for an upcoming ExL event, the following policies apply, derived from the Start Date of the event:

- Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another ExL event valid for 12 months from the voucher issue date.

- Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher issue date. - Five days or less: A voucher (minus a $395 processing and documentation fee) to another ExL event valid for

12 months from the voucher issue date.

To receive a refund or voucher, please email cancel@exlevents.com or fax your request to 888-221-6750.

CREDIT VOUCHERS: Credit vouchers are valid for 12 months from date of issue. Credit vouchers are valid toward one (1) ExL event of equal or lesser value. If the full amount of said voucher is not used at time of registration, any remaining balance is not applicable now or in the future. Once a credit voucher has been applied toward a future event, changes cannot be made. In the event of cancellation on the attendees’ behalf, the credit voucher will no longer be valid.

ExL Events, Inc. does not and is not obligated to provide a credit voucher to registered attendee(s) who do not attend the event they registered for unless written notice of intent to cancel is received and confirmed prior to the commencement of the event.

SUBSTITUTION CHARGES: There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference.

ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare‚ hotel or any other expenses incurred by registrants.

ExL Events’ liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date‚ content‚ speakers and/or venue.

*The opinions of ExL’s conference speakers do not necessarily reflect those of the companies they represent, nor ExL Events, Inc.

Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL’s designated speakers and is designed for informational purposes for its attendees. It is NOT INTENDED for purposes of copywriting or redistribution to other outlets without the express written permission of ExL’s designated speaking parties. Neither ExL nor its content providers and/ or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS, INC. EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of, or endorse the views or opinions given by any third-party content provider. ExL presentations may point to other websites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.

Please make checks payable to: “PMA"

contact our offices at (201) 871-0474.

contact our offices at (201) 871-0474.