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Oh, Brave New World: Launching New Products & Competing Successfully in Specialty Care Markets

Presented by Chris Bogan,

Chief Executive Officer

Is Your Company Ready?

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What Do Game of Thrones, Biologic Immunity and Specialty

Care Markets Have in Common?

Image Sources: http://crisprtx.com/our-programs/crispr-cas9-gene-editing.php ;

http://www.hindustantimes.com/tv/watch-game-of-thrones-6-teaser-sets-a-grim-and-creepy-

mood/story-uLb9vsRq5iM9Vh23VA6b9K.html; and www.clipart.com

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100% of the Largest Pharma Brands in 2015 Were Specialty Care

Medicines

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The Shift From Primary Care To Specialty Care Medicine Has

Dramatically Changed Go-To-Market Strategies & Tactics. . .

FDCs

Deeper

Science

Specialists

Power

MOA

ACO’s IDN

Influence

Patient

Influence

HCP

Influence

Pricing

Sales

Force

Size

LCM

Have Your Operating

Systems Evolved To Keep

Pace With The New

Reality?

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Biologics & Targeted

Therapeutics

MOAs Cross

Therapeutic Areas

Lifecycle

Management

Evolves

Portfolio

Management

Evolves

Accelerated

Lifecycles

The Revolution in Biologics Is Rapidly Changing Required

Skills to Compete in Specialty Care Markets 1

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Case History: The Birth Story of Humira Humbles & Inspires

Current Indications

Humira

+$14

Billion

Rheuma-

toid

arthritis

(RA) Psoriatic

arthritis

(PsA)

Juvenile

Crohn’s

disease

(CS)

Adult

hidradenitis

suppurativa

(HS)

Crohn’s

disease

(CS) Ulcerative

colitis

(UC)

Plaque

psoriasis

(PS)

Juvenile

idiopathic

arthritis

(HS)

Ankylosing

spondylitis

(AS)

New

Formul

ation

EU

Uveitis

New

Formul

ation

US

$780

Million

Peak Year

Sales

Forecast

2012

1993

2000

2015

2016

9 Indications across

Rheum, Derm, GI. . .

adalimumab (Humira)

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THOUGHT LEADER

SEGMENTS

PRE-

CLINICAL

PHASE

II

PHASE

III LAUNCH LIFECYCLE PHASE

I

Segmentation & Targeting Take On Greater Nuance &

Impact In The New World of Specialty Care

Local KOLs

IDN Thought Leaders

Payer Influencers

Global Thought Leaders

Regional Thought Leaders

Grow Product Shape Product Educate Market

2

Patient Advocacy Leaders

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TL’s Patient

Demographic

TL’s Expertise

TL’s Influence

Network

Therapeutic Area

Product

Qualifications

TL’s Scientific

Publications

Regional

Diversity

Behavioral

Segmentation

Pre-Launch Post-Launch

TL’s Experience

Company’s Relationship

with the TL

“Creating a cross-functional plan for TL development before launch is a role that Medical Affairs can play

successfully. TL management planning has to start way in advance because Medical Affairs need times to

prepare the market for disease awareness, understand key decision makers’ needs and create a value-based

launch strategy for products.”

- Interviewed VP, Medical Affairs (Company B)

Timing of Strategies Used for Thought-Leader (TL) Tiering

Thought Leader Segmentation Criteria Evolve Over Time

Source: Best Practices, LLC Field Benchmarking Studies – 2016

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Case: Failure To Understand Behavioral Differences Among

Segments Can Lead To Flawed Positioning and Launch Havoc

Situation: Pfizer sought to be the first

company to introduce an inhaled insulin into

the US diabetes market.

Response: Pfizer created Exubera, an

inhaled form of powdered insulin, which was

the first product of its kind. The launch

failed; the product was withdrawn from

market only a year after launch – rejected

by physicians and achieving only a few

million dollars in total sales.

Lessons Learned: The product launch

team failed to appreciate behavioral

differences among distinct KOL segments

(Endos & Pulmonologists) that proved

critical to market reaction. The perspectives

of pulmonologists and endocrinologists

conflicted. Safety concerns are critical to

address & delivery systems matter. Source: Best Practices, LLC Analysis

Case Analysis

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300 204 200

63

565

366 450

93

75th Percentile Average Median 25th Percentile

Number of Thought Leaders Targeted

Setting Thought Leader Strategy Is A Mix of Science + Art +

Execution

N=7

Source: Best Practices, LLC Field Benchmarking Studies – 2016

28

19 25

10

35 28 30

15

75th Percentile Average Median 25th Percentile

Number of TLs per MSLs Pre-Launch Post-Launch

+47%

14 11 10 9

16 15 15 11

75th Percentile Average Median 25th Percentile

Number of MSLs Employed

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asd asd There Is A Seismic Change In How Thought Leaders are Selected –

But Many Co.’s Are Still Using Approaches From A Decade Ago

Launch Years Before

2012

83%

80%

71%

Company’s relationship with

Thought Leader

Product type

Therapeutic area

Segmentation criteria was based on company’s or

the product’s perspective

Launch Year After

2012

75%

75%

73%

TL’s patient demographic

TL’s expertise

TL’s influence network

Thought leaders are at the center of the

segmentation process

Top Three TL Selection Criteria Used by Benchmark Class before and after 2012

Source: Best Practices, LLC Field Benchmarking Studies – 2016

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Earlier

Outcomes

HEOR & Launch

Differentiating

Your Product

Competition HEOR for HCPs,

Payers, IDNS &

Patients

Outcomes

Higher Specialty Pricing Makes Medicines Targets For Political

Attacks, Brutal Competition & Innovative Adaptation

Low Price,

High Volume

Primary Care

Hi Price, Low

Volume

Specialty

Accept Oncology &

Rare Disease

Payers

3

Pricing Trauma

on HCV

Payers

Attacks on

Biopharma

Payers

Pay for Performance

Models

Pricing Innovation

Speed to Price

Cuts

Discounting

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Field Resources & Tactics Have Been Transformed To A

More Science-driven Specialty Focus

Specialty Field Resource Evolution

Smaller Science-Driven Sales Forces Rise

Medical Science Liaisons Grow

Large Primary Care Sales Forces Retreat

Outcomes Liaisons Grow

IDN / ACO Specialists Evolve

Field-based Policy Specialists & Liaisons

Technology Enables Smaller Specialist

Field Forces

4

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Innovative

Outcomes

Research is

Increasing in 6 of

10 companies

next 24 months

Patient-reported

Outcomes

Research is

Increasing in 5

of 10

companies

next 24 months

Outcomes Research Is Growing Across Multiple Fronts

Effective

Outcomes

Research is

Increasing in

7 of 10

companies in

next 24

months

Different Stakeholders Demand Different Types Health Outcomes Data

Patients Payers & HC Providers Increasing Use

Inc

rea

sin

g U

se

Analysis of safety Workplace

productivity

Resource use

Cost Analysis

Analysis of efficacy

Economic analysis

Quality of

life

Burden of

illness

Type of HO Data

Mostly Used with

Payers and Patients

Type of HO Data

Mostly Used with

Payers and Providers

Type of HO Data

Mostly Used with

HC Providers

Payers

Health Outcomes Are A Required Proof of Differentiation Much

Earlier, Deeper and More Diverse Than Ever Before 5

Source: Best Practices, LLC 2015 Field Benchmarks on Health Outcomes

P1 P2 P3 Launch PC OLD HEOR

HO Studies & SciCom

HO Strategy

Diseases Burden, Epidemiology

PRO Landscape + HO Research

Comparative Effectiveness

Data & Label Gap

Assessment

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“Frenemies” May Become the Norm In A Specialty World Of

Fixed Dose Combinations & Multi-drug Therapies 6

FDCs for Hepatitis C

sovaldi

Ladispavir

/ ledipasvir Elbasvir &

grazoprevir

ombitasvir

daclatasvir dasabuvir, ombitasvir, paritaprevir,

and ritonavir

elbasavi

What Is Best Practice For Selecting Alliance

Partners in a Fixed Dose Combination Universe?

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• Fixed Dose Combinations

Create Portfolio Challenges

• Higher Prices Enrich Niches Creating Competition

• Global Pricing Creates High-Low Price

Bands & Cross Border Patient Flows

• Indications Planning Creates Timing Challenges

• Biologics Slower

Uptake Curves

• Planned Obsolescence As Strategy

• Partner Selection Is Key

• Pricing Complexity

Across TAs and FDCs

• Accelerated Life

cycles Are Common

Specialty Lifecycles Can Accelerate and Compress in

Challenging New Ways 7

Image source: http://assets3.bigthink.com/system/idea_thumbnails/44897/primary/black%20hole%20new%20SS.jpg?1340209673

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Key Insights & Takeaways: 7 Fronts Where The Market Is Compelling

Biopharma Companies To Evolve and Adapt . . .Are You Keeping Pace?

1. The Revolution in Biologics Is Changing

Required Skills to Compete in Specialty Markets

2. Segmentation & Targeting Take On Greater

Nuance & Impact In The New World

3. Higher Specialty Pricing Makes Medicines

Targets For Brutal Attacks, High Competition &

Innovative Adaptation

4. Field Resources Have Been Transformed To A

More Science-driven Specialty Focus

5. Health Outcomes – The Proof of Differentiation

– Are Required Earlier, Must Go Deeper and

Become More Diverse Than Ever Before

6. “Frenemies” May Become the Norm In A World

Of Fixed Dose Combinations & Multi-drug

Therapies

7. Specialty Lifecycles Accelerate and Compress

in Challenging New Ways

P1

P2

P3

Launch

PC

Mkt.

Leader

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About The Speaker Chris Bogan is founder & CEO of Best Practices, LLC, a global thought leader in the field

of best practice performance improvement for companies in the bio-pharmaceutical. medical device and healthcare sector.

#1 On Amazon.Com

Reader Ratings –

Customer Satisfaction

PHARMA-

CEUTICALS

BIOTECH

CRO’s

COMMER-

CIAL / R&D

HOSPITALS

MEDICAL

DEVICE

GROUP

PROBLEM

SOLVING

Client Sectors

E-mail: cbogan@best-in-class.com

(Phone) 919-767-9228

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Learn More About Our Company

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provide research, consulting, benchmark database, publishing and advisory services to the

biopharmaceutical and medical device sectors. We work closely with business intelligence groups. Our work

is based on the simple yet profound principle that organizations can chart a course to superior economic

performance by leveraging the best business practices, operating tactics and winning strategies of world-

class companies.

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Phone: (919) 403-0251