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5th www.exlevents.com/KOL KOL Relationship Summit Advisory Board & Speaker Bureau Management 6th Conference EXECUTIVE SUMMARY

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5th

www.exlevents.com/KOL

KOL Relationship Summit

Advisory Board & Speaker Bureau Management

6th

Conference

EXECUTIVE SUMMARY

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INTRODUCTION 3

2014 SESSION SUMMARIES 5

RESOURCES FOR INFORMATION AND DISCUSSION 10

RECOMMENDED SERVICE PROVIDERS 11

CONTENTS

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6TH KOL ENGAGEMENT AND ADVISORY BOARDS SUMMIT

If you weren’t able to join us in 2014, here is what you missed at these two great events, which will

join together for one action-packed conference in 2015.

ExL Pharma’s 6th Advisory Board & Speaker Bureau Management Conference, designed to help

attendees recruit, engage and optimize advisory boards and speaker bureaus with limited resources in

a post-Sunshine Act era, was held June 24-25, 2014 in Philadelphia. The 5th annual KOL Relationship

Summit, which focused on cross-functional collaborative strategies to identify, engage and grow

thought leader networks in a highly regulated environment, was held at the same time. In 2015, these

two great events will become one robust conference with more speakers, more topics and more

networking than ever before.

Each event featured many noteworthy faculty members.

5TH KOL RELATIONSHIP SUMMIT SPEAKERS INCLUDED:

Kathryn Presto, Roche

Victor Miranda, GE Healthcare

Ben Cadieux, Raptor Pharmaceuticals

Rafael Fonseca, Mayo Clinic in Arizona

Paul Meade, Thought Leader Select

Alice Chung, Genentech

Faith Yao, Acorda Therapeutics

Nikki Frederickson, Boston Scientific

Lance Hill, Within3

B. Gabriel Smolarz, AstraZeneca

Yifat Guy, Ph.D., Senior Medical Science Liaison, Ikaria

Ed O. Idriss, Noven Therapeutics, Inc.

John Sears, Janssen Global Services

Bruce Freundlich, Antares Pharmaceuticals

Kasmin Delgado, Assurex

Peter Fitzgerald, Stanford University

Alexander Tolmachev, Takeda Pharmaceuticals

INTRODUCTION

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6TH ADVISORY BOARD & SPEAKER BUREAU MANAGEMENT CONFERENCE SPEAKERS INCLUDED:

Kevin Appareti, Philips Healthcare

Maureen Cawley, Genentech

David Stauffer, Eli Lilly and Company

Peter Fitzgerald, Stanford University

Kimberly Berger, Healthstar Communications

Louis Greco, Pharmawrite

Alexandra Langendorfer, Merck

Kathryn Presto, Roche

Alexander Tolmachev, Takeda Pharmaceuticals

Lance Hill, Within3

Testimonials included the following:

“Fantastic, useful tools that will have immediate professional impact!”

—Director, External Expert Engagement, Teva Pharmaceuticals

“Excellent and practical presentations.”

—Medical Alliance Manager, Vertex

“Wonderful speakers, fast-paced presentations and an uplifting view of the future of healthcare.”

—Executive Director, Global Marketing, Merck

The following session summaries and highlights will give you an idea of what you may have missed.

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Ben Cadieux of Raptor Pharmaceuticals focused his session on how to “Ensure

Cross-Functional KOL Engagements and Activities that Are Compliant in

the Context of Regulatory Change.” Key opinion leaders are often chosen for

their clinical knowledge, academic standings/location, research experience and

publication record, contributions to treatment guidelines, active roles as speakers at

national events, and high prescribing habits. They typically drive the development

and appropriate use of new medicines/devices and are integral partners to pharma/

biotech. To mitigate risk and enhance cross-functional collaborations, Cadieux

recommended the following: holding annual compliance training with a focus on

code of conduct, giving clear guidance to fi eld staff regarding the use of medical

information, adhering to a set MA grants review process, holding advisory board/

roundtable discussions, and taking other key steps. Additionally, Cadieux pointed

out that off-label promotion is the reason for a majority of recent Corporate Integrity

Agreements.

Faith Yao of Acorda Therapeutics advised attendees on ways

to “Create a Cross-Functional Collaborative Framework for

KOL Engagement to Advance Successful New Products.”

She defi ned a strong collaborative framework as who and

what (cross-functional partners and what they bring to the

table), communication (methods, frequency, fl exibility and

overall attitude), and shared corporate goals (and the steps

taken to reach those goals). It is important to match KOL

interests and priorities with internal stakeholders and to

develop SOPs for interactions with thought leaders across

multiple departments to ensure consistency. This promotes

continuous interaction as well as internal engagement.

A  Strong  Collabora1ve  Founda1on  

Who  &  What  

Shared  Corporate  Goal(s)  

Communication  

MLR  198  AMP   3  

SESSION SUMMARIES

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B. Gabriel Smolarz of AstraZeneca offered a few case studies

on how to “Formulate a Strategic Global KOL Insight Plan.”

Smolarz highlighted a few key questions to ask: What do we

need to know? When do we need to know it (at what stages

of this process)? Which divisions of the organization are

asking the questions? Lastly, whom do we need to know it

from? He also pointed out that it is important to determine

what insights are being sought out. Furthermore, there are

worldwide KOLs, regional and country KOLs, and local KOLs,

all with overlapping insights when it comes to strategic

planning, products and growth. When they come together,

medical and marketing KOLs can help companies achieve

the success they are looking for.

Kathryn Presto of Roche offered a workshop titled “From Legislation to Practice:

Overcome Challenging Situations with KOLs Post-Sunshine Act.” The goals for any

company working with thought leaders are consistency (strategic identifi cation,

segmentation, planning, maintaining and tracking activities with KOLs); coordination,

prioritization and collaboration (execution across multiple functions and across

local and global functions); and transparency across the organization (Commercial,

Medical Affairs, Research and Development, and Regulatory teams). Communication

is key and, since different thought leaders want different things, it is critical to

examine internal and external audiences and determine their specifi c needs.

For internal audiences, expectations include knowledge transfer, engagement

transparency and compliant engagements, reporting, and transparency. External

groups are looking for the “four Ps” of interaction: participatory, proprietary,

proactive and professional. When all stakeholders are aware of the plan and manage

accordingly, a tremendous amount of unnecessary time and effort is eliminated.

When departments meet regularly to give status updates or change course on

specifi c initiatives, everyone benefi ts from the interchange. Preparation involves an

advisory planning process.

SESSION SUMMARIES

Case Presentation #2 Medical Device EXL989

KOL Insight Overlaps

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“Transforming KOL Engagement: Look for the Bubbles”

from conference chairperson David Stauffer of Eli Lilly and

Company encouraged attendees to ask themselves two

questions: “Why do we collaborate with thought leaders?”

and “Why do they want to collaborate with us?” Changing

objectives may create a notable thought leader gap that

needs to be addressed. Stauffer also asked companies to

examine their current strategies to determine if they are

truly the best they can be and to take a closer look at how

the KOL approach might need to change in the future. All of

this involves rethinking a number of key elements, including

purpose, collaboration, focus, method, influence and

convention.

Kevin Appareti of Philips Healthcare shared tips on how to

“Build upon Intelligent Insights from Thought Leaders and

Share Knowledge Within a Corporation.” Per Appareti, the

corporate landscape today involves changing drivers and

shifting power as we continue to see the transformation

of healthcare. Likewise, the definition of a KOL is also

changing. Engagement entails identifying key stakeholders,

mapping gaps/issues/topics, prioritizing and selecting

topics, engaging KOLs and stakeholders, and planning

events. Drivers of engagement include forming relationships,

building trust, sharing insights and providing feedback, and

listening and communicating, among others. After gathering insights, companies

should also socialize their knowledge by developing a structured and systemized

approach to delivering information internally and externally. Finally, Appareti advised

that using metrics to measure work will make it more impactful.

SESSION SUMMARIES

Changing  objec:ves  may  create  a  Thought  Leader  gap  

•  Build strong relationships •  Develop trust •  Clinical and scientific exchange •  Share insights •  Touch points for ongoing collaborations •  Opportunity for peer-to-peer networking •  Focus on broad set of topics •  Provide feedback •  Create diversity of interactions •  Solve problems together •  Meaningful work •  Listen •  Communicate

Engagement: drivers of engagement

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In “New Technology and Innovation in Medicine: A Global Approach,” Peter

Fitzgerald of Stanford University spoke about the challenges of healthcare

and the medical technology industry. Fitzgerald predicted that, in the coming

years, life science and information technology will continue to collide. Medical

technology startup success is a three-ring circus, including invention, innovation

and execution on a global level. The process/integration of technology may

have a local component, but companies should watch out for reverse innovation.

Furthermore, digital socialization can have a profound impact on behavior. New

challenges in clinical and cost effectiveness in medicine recognize that the focus

is no longer on solo devices, gizmos or gadgets — it is now on reducing hospital

stays and decreasing complications. Facilitating conversations, lowering the rate of

readmissions and improving patient compliance are also key areas to focus on. The

next horizon in healthcare involves variability, robotic control and mobile/connected

health. Finally, reduced variation in healthcare will help deliver more cost-effective

and effi cient care to patients while reducing hospital stays.

Maureen Cawley of Genentech offered insights on how to

“Streamline Effi ciencies and Improve Technologies to

Moderate Advisory Boards.” Presently, there is a widespread

lack of communication about and understanding of the role

and purpose of a thought leader moderator, and moderators

have a lack of appreciation for compliance requirements.

Advisors also have misperceptions regarding advisory

boards and thought leader moderators. Effective advisory

boards create business impact and improve compliance.

Thought leaders need to leverage the skills of an effective

moderator, be able to lead successful dialogue by using

clinical expertise to lead dynamic discussions while engaging the audience, foster

the robust exchange of information and encourage critical inquiry. Setting clear

expectations helps clarify roles and defi ne advisory board success. To become

successful, Crawley suggests that advisory boards: ensure compliance with company

policies, frame the session at the outset of the meeting, actively facilitate discussion

and engage each advisor, encourage critical inquiry, and clearly summarize group

insights.

CONFIDENTIAL-FOR GENENTECH INTERNAL TRAINING PURPOSES ONLY-NOT TO BE SHARED OR DISTRIBUTED 5  

FASCINATING DIALOGUE

A

C

AAA B

COMPANY BUSINESS

OBJECTIVES

QUALIFIED ADVISORS

A

C

AAA B REFLECTIONS ON

FASCINATING DIALOGUE

TAKE ACTION MOVE BUSINESS

FORWARD

OBJECTIVES

A

C

AAA B

ACTIONABLE INSIGHT

RECOMMENDATIONS

✔ ✔ ✔

Effective Advisory Boards Create Business Impact and Improve Compliance

✗ ✗ ✗

AD BOARD SPONSOR

SESSION SUMMARIES

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“Methodology to Efficiently Build and Run Global Advisory Boards,” delivered

by Alexandra Langendorfer of Merck, started with a question: “Why do you need

an advisory board meeting?” The answer: Because you need ongoing expert

advice. Global strategy offers a cost-effective solution. Document goals, consider

experts to invite, determine the chairperson and the budget, and make sure the list

includes diversity and the right dynamics. Remember that there is no right answer

when it comes to fair compensation. Then, set standards for travel guidelines as

well as accommodation and meals — and consider factors such as whether any

attendees will have jet lag. A good meeting includes goals that are addressed with

clear feedback, an enjoyable intellectual experience, participation from all board

members and a program on budget. A bad meeting results in unclear next steps,

board members that aren’t engaged and a program that is over budget. Maintaining

a strong board entails establishing preset meeting goals, creating good intellectual

experiences for members, letting the board know you are moving forward with

recommendations and restructuring as needed.

SESSION SUMMARIES

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RESOURCES FOR INFORMATION AND DISCUSSION

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RECOMMENDED SERVICE PROVIDERS