Specialty Medicine Revolution - Chris Bogan Keynote ((H2-2016)
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Transcript of Specialty Medicine Revolution - Chris Bogan Keynote ((H2-2016)
Page | 1
Oh, Brave New World: Launching New Products & Competing Successfully in Specialty Care Markets
Presented by Chris Bogan,
Chief Executive Officer
Is Your Company Ready?
Page | 2
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
Page | 3
100% of the Largest Pharma Brands in 2015 Were Specialty Care
Medicines
Page | 4
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?
Page | 5 Page | 5
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
Page | 6 Page | 6
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)
Page | 7
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
Page | 8
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
Page | 9
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
Page | 10
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
Page | 11
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
Page | 12
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
Page | 13
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
Page | 14
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
Page | 15
“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?
Page | 16
• 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
Page | 17
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
Page | 18
Page | 18
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: [email protected]
(Phone) 919-767-9228
Page | 19
Page | 19
Learn More About Our Company
Our company is an internationally recognized thought leader in the field of best practice benchmarking®. We
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.
Best Practices, LLC
6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517
www.best-in-class.com
Phone: (919) 403-0251