Enhancing Sales Effectiveness Through Field Based Monitoring Wendy Heckelman, PhD – President, WLH Consulting , Inc. Kerry Clem – Vice President of Sales, Acorda Therapeutics

Session Objectives ► Clarify the Goals and Key Elements of Field Based Monitoring ► Assess the Current State of Field Based Compliance Monitoring in Pharma ► Identify the Challenges Associated with Field Based Monitoring ► Discuss Strategies to Enhance Sales Effectiveness through Field Based Monitoring ► Share Acorda Therapeutic’s Experience with FBM 2

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Recent Corporate Integrity Agreements (CIA) Requirements for Field Force Monitoring Field Force Monitoring has become a regular CIA requirement and is becoming the new benchmark Sample Language: “…establish a comprehensive Field Force Monitoring Program to evaluate and monitor its sales representatives' interactions with HCPs and HCIs” “…a formalized process designed to directly and indirectly observe… interactions with HCPs and HCIs and to identify potential off-label promotional activities or other improper conduct.” Company Board Members have to certify that they have evaluated the effectiveness of the Compliance Program to meet Federal health care program requirements, FDA requirements, and the obligations of the CIA.

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Common Goals of Field Based Monitoring ► Apply a risk-based approach to monitoring ► Proactively identify potential issues ► Maximize compliant sales effectiveness ► Report and escalate findings internally/externally, as appropriate ► Inform internal compliance protocols

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Elements of Effective Field Based Monitoring Clearly Defined Salesforce Performance Expectations

Conducted on an Ongoing Basis

Monitoring Practices Based on Sound Risk Mitigation Strategy

Integrated into the Overall Plans of Marketing, Sales, Compliance, and Training

Automated Monitoring and Reporting Tools

Continuous flow of insights to close the loop and ensure behavior change

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Common Challenges of Field Based Monitoring

Field Force and Sales Effectiveness

Process Issues ► Assign appropriate responsibility for FBM

► Communicate and clarify the purpose for FBM

► Decide when to conduct FBM

► Determine how to integrate with field coaching ► Mitigate fear in the field force

► Determine how FBM should be done

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Strategies to Enhance Sales Effectiveness through Field Based Monitoring 7

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Field Based Monitoring for Sales Effectiveness TO GET STARTED: I.

Determine compliant sales messages and performance expectations

II.

Design compliance training to produce behavior change

III.

Institute Field Based Monitoring Program

IV.

Create reporting system to track individual and group performance

V.

Develop change management and communications plan 8

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Determine Compliant Sales Messages ► Create partnerships between sales, marketing, medical, regulatory, and compliance to develop compelling sales messages ► Determine what sales professionals can and cannot say ► Combine sales and compliance training efforts to help sales professionals handle questions and situations 9

Set compliance standards for behavioral monitoring

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Design Compliance training to produce behavioral change ► Focus on behavioral skill; include opportunities for practice ► Allow time for feedback and ongoing coaching to ensure learning is retained ► Heighten awareness on how to make good decisions for compliant sales practices ► Provide targeted training to all levels of the organization to build a culture of compliance 10

Enables overall program success by bridging the gap between policy and conduct © 2010, 2011, 2012, 2013, 2014, 2015 WLH Consulting, Inc. Patent pending.

Institute Field Based Monitoring Program ► Work with stakeholders to establish process for FBM (e.g., frequency, roles) ► Determine how FBM fits with the company culture, external marketplace and regulatory environment ► Share the FBM purpose and process with the sales force with upfront positioning from Sales leadership ► Encourage sales effectiveness within the boundaries Clarify the purpose and the process for FBM to minimize of compliant behavior fear and misinformation 11

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Create reporting system to document observations Connect reporting systems to coaching and ongoing development efforts: ► Individual, regional, or product reports enable targeted improvement efforts ► Real time reporting means faster implementation of training or development ► Time based action plans to close the loop ► Make compliance part of selling effectiveness

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Field reporting enables confident certification that compliance efforts are effective © 2010, 2011, 2012, 2013, 2014, 2015 WLH Consulting, Inc. Patent pending.

Develop change management and communications plan ► Instill an understanding of compliance goals and expectations ► Provide training to reinforce, “What Good Looks Like” ► Establish a supportive, proactive compliance environment ► Identify champions in leadership and the field force whose behaviors support compliance ► Recognize and communicate the positive impact compliance has had in the organization 13

A comprehensive change management plan enables cultural adoption © 2010, 2011, 2012, 2013, 2014, 2015 WLH Consulting, Inc. Patent pending.

The Acorda Therapeutics FBM Experience ► Implemented “Field Shield” to monitor compliance field sales activity in 2011 ► Program evolution ► Key benefits

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Tips for FBM Implementation = Getting Started ►Engage all relevant stakeholders in the development of the process ►Clarify purpose and expectations with field ►Weave FBM into regular field coaching activity ►Ensure Ensure training, monitoring, and reporting is ongoing and interconnected ►Customize compliance program based on company and product-specific risks and issues

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Questions

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Contact Information Partial Client List

www.wlhconsulting.com

Dr. Wendy Heckelman [email protected] 954-385-0770

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