Provides key market questions, analysis tools, timeline and checklist to successfully commercialize and launch a biotech innovation.

1. June 2011 BIO International Convention
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2. As a guest of BIO blogger Betsy Raymond Stevenson, reporting
in RSS Snapshot, I am offering a practical market intelligence
checklist and tips to bring an innovation forward to launch.
These guidelines, a reminder to some, tie into the themes
crossing a number of the sessions on how to ensure enough
innovation reaches the marketplace. To achieve success we
must effectively create and communicate value at early stages of
development, across a broad enough audience and range of
customers (e.g., patients, regulators, investors, payors/clinical
effectiveness councils). With intensified financial, regulatory and
– Sara Misch reimbursement pressures, demonstrating economic value within
a defined population is essential (e.g., companion diagnostics, sub-populations). At the
same time, audiences and patients are expecting greater transparency and dialogue
from manufacturers, so as an industry we need to widen communication channels and
continue investigating alternative formats to reach customers (e.g., social media).
What is Your Perspective?
I would like to hear about the various approaches you are
using to reach customers at earlier stages of development,
and what market analytic tools are valuable or essential
within your companies for successful commercialization.
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2011
BIO
International
Convention
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3. – June
2011
BIO
International
Convention
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4. To know your competition you must first know
your customers – across all types/segments
• What are the important unmet needs in
diagnosing or treating the disease/condition?
• What are the strengths vs weaknesses of the
current options and approaches?
• Which brands are most likely to close the needs
gap and why?
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2011
BIO
International
Convention
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5. Secondary Assess Treatment Landscape
Research + (Common Attitudes and Practices)
Some Primary
Primary +
Map Diagnostic and Treatment Pathway
Secondary
Research
Primary Research Strengths + Weaknesses Attribute
Assessment Across All Brands
w/Customers
Analysis/ Insights Gap Analysis: Treatment Pathway
vs Brand Strengths
from Customer Input
Competitive Brand
Mapping:
Which brands have
Analysis/ Insights – strengths vs your
Matrix Tools weaknesses?
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2011
BIO
International
Convention
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6. Establish Context – Understand Entire
Market Landscape
• Thoroughly assess current diagnostic and
treatment environment
– What is the current set of treatments or approaches
for the condition or disease
– Consider and include behavioral, cognitive,
nutritional, homeopathic and clinical observation in
addition to the traditional hematologic, imaging,
surgical and pharmacologic approaches
– Identify meaningful gaps in existing approaches
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2011
BIO
International
Convention
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7. Gather Resources for Landscape
Assessment
• Accessible Secondary Sources: Industry reports, analyst reports,
patient associations, advocacy groups, government sites for epi +
treatment data (CDC, NIH-NCI, WHO), university sites (http://
www.epibiostat.ucsf.edu/epidem/epidem.html)
• Primary Research: Talk to and learn from a wide range of
customers types (not just experts)!! Use treatment pathway as
guide for asking the right questions
– Regulators
– Payors / National or Regional HTA Councils/ Hospital and pharmacy boards
– Patients/Families/ Care-givers
– Providers/Technicians
– Medical Experts/ investigators
– June
2011
BIO
International
Convention
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8. Use Tools To Analyze Market Data and
Customer Insights
• Diagnostic and Treatment Pathway/
Patient Flow
• Competitive Matrix
– Strengths/Weaknesses by Brand (SWOT)
• Benefit Ladder Tool
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2011
BIO
International
Convention
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9. Treatment What is the relevant disease/condition population base? How do these patients first
Population/ access the HC system for the relevant condition/ disease (routine or referral office
Entry Point visit, ER, hospital)
Evaluation/ Who makes the diagnosis vs treats condition and what standardized methods vs
Diagnosis clinical guidelines are used (i.e.lab values, imaging, surgery + pathology-staging).
What lifestyle/demographics, clinical factors (including stage of disease, prior
Treatment treatment), genetic factors, or diagnostic results impact treatment decision– and
Choice how? How do treatment protocol or standards change based on disease
progression?
What particular brands/ products/ services/ equipment is used to treat or diagnose.
What are the major influences on brand choice, i.e. access to suppliers, pricing
Brand Choice advantages, existing long term relationships/ contracts, standard of care/ clinical
protocols, economic data (superiority) + conditions?
Fulfillment/ How is the brand accessed, used, purchased by end user (patient, tech, HCP) ?
Fulfillment Cycle How long is purchasing cycle and what impacts cycle timeline? Do end users
Timeline change brands-when and why?
– June
2011
BIO
International
Convention
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10. Complete for each brand in market and compare
Strengths (+)
+ 4 months
1-yr survival
survival data
data (=SoC)
(16 mo) vs SoC
Important/ Important +
Non-differentiating Differentiating
Grade 4
Grade 3 fever
neutropenia
Weaknesses (-)
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2011
BIO
International
Convention
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11. – Emotional /
Self-Expressive
Benefits • Translate product attributes/
features into distinct advantages
vs competition
End-use
Benefits • Tool is populated from customer
insights and competitor
assessment
Functional
Benefits • This provides foundation for the
product positioning
Product
Attributes
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2011
BIO
International
Convention
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12. Clinical Milestones
Lead
Phase II Phase II Regulatory
Phase III Country
(Safety) (Efficacy) Filings
Approval
Qualitative, external Qualitative, external Competitive brand Qualitative MR:
feedback on target feedback on adjusted matrix assessment/ fine tune
product profile (TPP) TPP from PII efficacy: SWOT positioning as
early brand positioning needed
Early qualitative Benefit Laddering, Qual Iterative promotional
landscape assessment Reconfirm Treatment Research: Develop Brand message development,
+ unmet needs eval landscape, unmet needs Value Messages: Convert including e-message
Attributes to benefits strategy
Situational / Iterative qual MR to
Environment Analysis develop positioning
Key Customer input to Evaluate full dx +tx
Phase IIII endpoints, Economic benefit / Test promo materials +
pathway: secondary trade-off analysis delivery formats
including health sources / data +
economics (qual study +/- quant) (e-formats)
systematic, qualitative
research w/ HCPs,
patients
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2011
BIO
International
Convention
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13. Does your product offer a meaningful,
differentiating clinical benefit for a
definable patient group?
Can you communicate the clinical
benefit successfully to all customer
groups?
Are enough customers willing to pay
for the benefit…and do you know which
products/approaches will be displaced?
– June
2011
BIO
International
Convention
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14. smisch@smrsolutionsplus.com
Office: 978-254-5098
Mobile: 908-327-5924
http://www.linkedin.com/pub/sara-misch/8/694/22
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