Evolving Commercial Operations in the COVID-19 Era:

Long-term Change or Short-term Solutions?

Saul B. Helman, MD

Justin Zamirowski

Awet Gebrehiiwet-Wilder

Nisha Ninan

John Etchberger

April 21, 2020

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How will the current work environment shape future operations?

1. Evolving commercial operations and decisions in the face of a virtual work

arrangement

2. Maintaining an engaged field force with new and creative activities

1. Ongoing compliance consideration to ensure high standards of ethics are

followed across these new activities

Has your organization taken any of the actions below in

light of the COVID-19 pandemic?

(select all that apply)

• We have delayed a product launch

• We have adjusted our marketing mix and moved to a more digital /

non-personal approach

• We have down-sized our field force

• We have trained our field force remotely / virtually

• We have already done one or more of the above before the pandemic

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Polling Question

[Optional presentation title] 4

Poling Question - Results

The Guidehouse launch excellence team was established in 2011, providing integrated solutions for companies seeking to launch products

Guidehouse Launch

50+Experienced members on

our dedicated, global launch

excellence team

35+Clients engaged across Big

Pharma, Specialty, MedTech,

and BioTech

59Product launches have been

supported over the last 3

years

~25In-line brands currently being

supported by the team

>40Countries of experience,

providing a global perspective

Large~40%

Mid-Sized~26%

Small~34%

Overall Launch Client Mix

(2017-2019)

Sources: 1. STIFEL Weekly Prescription Tracker for Week Ended March 20, 2020; 2. Hynes’ Healthcare Insights March 20, 2020; 3. Hynes’ Healthcare Insights April 6, 2020 6

COVID-19 is disrupting multiple pharma-related industries

COVID-19 Impact Overview

• Pharma companies with upcoming product launches are shifting launches to a

virtual setting or to a later date

• Uncertainly exists with recently launched products and their ability to achieve

short term projected sales targets

• Early in the COVID-19 environment, prescription trends initially have been positively

impacted by an increase in mail order and 90-day prescription fulfillment but overall

recent weeks have show a slight downturn in TRx and NRx 1,2,3

• Healthcare providers are experiencing availability limitations due to closed offices

and shift towards treatment of COVID-related cases

• HCP administered medications may have challenges with utilization due to lack

of access / availability of staff and elective procedures

• Business and personal travel are being restricted due to social distancing policies

• While urgent patients still have access to personal care, non-urgent patients

will largely resort to virtual visits via telehealth where available

COVID-19 is expected to have long-term impacts on the pharma environment,

even after the public health crisis is over and business resumes normal operations

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Guidehouse has observed common operational challenges faced by pharma manufacturers stemming from the impact of COVID-19

Marketing

• Decreased in-person HCP interactions has eliminated need for printed promotional materials, increased

importance of non personal promotions and remote sampling capabilities

• Shift to virtual engagement has increased the need for more digital content and use of newer platforms (e.g.

Zoom, Veeva Engage,…)

• Challenges in obtaining direct HCP interactions drives the need to shift to non-personal promotion-based

strategies

Field-based Roles (Sales, Medical Affairs &

Market Access)

• Due to social distancing restrictions, in-person launch meetings are delayed or moved onto virtual platforms

• Reduced face-to-face access to target accounts drive rep engagement onto online platforms & remote

delivery of lunch and learns

• Due to shifts in provider availability and experience in telehealth capabilities, the current target mix is

dynamic

• Patients’ travel restrictions limit the providers’ ability to distribute samples and administer therapies, thus

requiring alternative free trial options and different approaches to administration of drugs

• Recession is putting pressure on affordability increasing the need for enhanced patient support services

Supply Chain &

Distribution

• Dynamic shift in demand of frequently prescribed therapeutics may lead to product shortages

• Stay-at-home orders drive patients to order from mail order pharmacies rather than brick-and-motors stores

• A prolonged shutdown may strain manufacturing capabilities and product reserves increasing the risk of

experiencing COVID-related interruptions

Guidehouse has been directly engaged with clients to help them navigate several COVID-19 challenges

Guidehouse AdBoard provides

insights to high-priority business

questions from key stakeholders

Our Remote Engagement Solutions

provide a suite of technology-

enabled products to support HCPs,

patients, and providers

Guidehouse Targeting Platform

leverages machine learning to

identify optimal HCP targets

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Commercializing in an Evolving ClimateCreating an in-person experience without extensive travel

National or Regional Meetings

• Traditional model where reps are out of

the field and spend time and resources

traveling to the meeting location

• Highest touch / level of engagement

• Most expensive option ($$$)

Live Broadcast Production

• Off-site studio production

• Limited studio audience

• Real-time, at home engagements

(quizzes, polls, etc.)

• $MM potential savings versus in-person

National Meetings ($$)

Virtual Experience

• Full virtual meeting; all participants

and hosts are at home

• Real-time, at home engagements

(quizzes, polls, etc.)

• Lowest engagement level

• Most cost-effective option ($)

Sales Representative

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Continuing Engagement

• At home efforts to maintain

training and enhance skills

• Virtualize sales materials

• Gamify educational materials

• Use of virtual meeting tools –

Veeva CRM Engage Meeting

Physician

• Certain specialties may have

capacity to focus on CME

• Virtual conference

attendance (ACC, ACSO)

• Market Research

• Virtual speaker programs

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Area of Focus Challenge

Call Documentation

Recording or monitoring HCP

conversations

Data Privacy HCP Access and Consent

Communication Plan Fair Balance, ISI, Medical Info Request

Sample Distribution HCP Access and Authorization

Provision of Meals Kick Back, Transparency

Patient Support Services High Risk Disease States

Sales Representative Interactions Conduct effected by Goal Attainment

Challenges to Assess & Controls to Review

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Field Force Interactions Guidance – Reminders and Considerations

• Communication must

contain a balanced

depiction of efficacy and

safety.

• Never combine scientific

calls by Medical Personnel

with promotional calls

by Commercial Personnel

• Always direct off-label

inquiries and unsolicited

requests to Medical Affairs,

and never respond to off-

label inquiries outside

authorized Medical Affairs

or Clinical channels

• Do not include personal

opinions when

communicating approved

materials to HCPs

• Interact with HCPs to

enhance patient care and

safety

• Never solicit off-label

inquires

• Never offer or provide

anything that can easily be

misunderstood as being

given with improper

intentions

• When discussing an

approved company

product, always provide

fair, balanced, non-

misleading, and factual

information from the PI.

• Respect the relationships

between HCPs and their

patients

• Limit inconvenience to

HCPs’ daily professional

responsibilities

• Never offer anything of

value to HCP or their

employees to influence their

medical judgement or

their purchasing practice

• Provide continued support

of HCPs and Patients

through medical and

consumer education,

resource facilitation and

medical samples.

• Engage in proactive on-

label discussions with

HCPs utilizing

company approved

promotional materials

• Never disguise promotion

• Only distribute promotional

materials to persons you

can reasonably assume to

be in need of such

information or involved in

patient care

• Only use materials

approved by the

company when interacting

with HCPs, and never use

expired or altered

promotional materials.

• Respect Data Privacy Laws

and comply with all HIPAA

rules. We will not

compromise or solict patient

information.

• Always make clear to your

audience which company

you represent and what

your role is.

• Only provide advanced

notification of new potential

products to those

responsible for making

policy decisions and not

those expected to prescribe

through your access and

reimbursement teams.

• Never promote before the

company product has

received market approval

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• Leverage virtual tools such as phone

calls, WebEx, Skype, or Veeva Exchange

to engage with external stakeholders,

ensuring you adhere to the rules of

scientific exchange

• Be sure to adhere to your company's

social media policy and any other

policies and SOPs related to virtual

interactions and scientific exchange

• Especially when interacting virtually, be

sure to make clear to your audience

which company you represent and your

role at the company

• This is a good time to closely partner with

your company's Medical Information

team to ensure healthcare providers

continue to receive the medical

information they need

• Also stay coordinated with your partners

on the sales team – for example, share

any knowledge about the situation of the

healthcare systems in your territory

• Utilize various departments and

aggregate data collected to increase

visibility into potential high risk activities:

• Human Resources

• IT

• Legal

• Internal Audit

• Leverage available data: Hotline reports

• Previous audit & monitoring findings

Resources to Leverage

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How will life after this phase of the COVID-19 Pandemic

alter the commercial model going forward?

Employee testing for

returning to work

Greater demand for

virtual meetings

Continued social distancing

Limited access to

healthcare facilities for non essential

personnel

Increased planning, safety

stocks and alternative suppliers to defend

supply chain from prolonged disruptions

Immediate policy changes

New credentialing requirements

[Optional presentation title] 15

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Contact

©2020 Guidehouse Inc. All rights reserved. This content is for general information purposes only, and should not be used as a substitute for consultation with professional advisors.

Saul B. Helman, MD

Partner

Global Leader - Life Sciences Compliance, Regulatory, Market Access

and International

saul.helman@guidehouse.com

317.294.1228

Awet Gebrehiiwet-Wilder

Associate Director

Life Sciences - Governance, Risk Management and Compliance

awet.gebrehiiwet.wilder@guidehouse.com

213.670.3272

Justin Zamirowski

Director

Life Sciences – Launch Excellence Lead

justin.zamirowski@guidehouse.com

609.896.4055

John Etchberger

Director

Life Sciences – Commercial Strategy

john.etchberger@guidehouse.com

609.219.8721

Nisha Ninan

Managing Consultant

Life Sciences

nisha.ninan@guidehouse.com

215.832.4433