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Provides key market questions, analysis tools, timeline and checklist to successfully commercialize and launch a biotech innovation.
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June 2011 BIO International Convention
– 2 – June 2011 BIO International Convention
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 reimbursement pressures, demonstrating economic value within – Sara Misch
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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• 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?
To know your competition you must first know your customers – across all types/segments
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Assess Treatment Landscape (Common Attitudes and Practices)
Map Diagnostic and Treatment Pathway
Secondary Research + Some Primary
Primary + Secondary Research
Strengths + Weaknesses Attribute Assessment Across All Brands Primary Research
w/Customers
Gap Analysis: Treatment Pathway vs Brand Strengths Analysis/ Insights
from Customer Input
Competitive Brand Mapping:
Which brands have strengths vs your
weaknesses? Analysis/ Insights –Matrix Tools
– 6 – June 2011 BIO International Convention
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
– 7 – June 2011 BIO International Convention
• 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
Gather Resources for Landscape Assessment
– 8 – June 2011 BIO International Convention
• Diagnostic and Treatment Pathway/ Patient Flow
• Competitive Matrix – Strengths/Weaknesses by Brand (SWOT)
• Benefit Ladder Tool
Use Tools To Analyze Market Data and Customer Insights
– 9 – June 2011 BIO International Convention
Treatment Population/ Entry Point
What is the relevant disease/condition population base? How do these patients first access the HC system for the relevant condition/ disease (routine or referral office visit, ER, hospital)
Evaluation/ Diagnosis
Who makes the diagnosis vs treats condition and what standardized methods vs clinical guidelines are used (i.e.lab values, imaging, surgery + pathology-staging).
Treatment Choice
What lifestyle/demographics, clinical factors (including stage of disease, prior treatment), genetic factors, or diagnostic results impact treatment decision– and how? How do treatment protocol or standards change based on disease progression?
Brand Choice 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 advantages, existing long term relationships/ contracts, standard of care/ clinical protocols, economic data (superiority) + conditions?
Fulfillment/ Fulfillment Cycle
Timeline
How is the brand accessed, used, purchased by end user (patient, tech, HCP) ? How long is purchasing cycle and what impacts cycle timeline? Do end users change brands-when and why?
– 10 – June 2011 BIO International Convention
Complete for each brand in market and compare Strengths (+)
Weaknesses (-)
Important + Differentiating
Important/ Non-differentiating
+ 4 months survival data
(16 mo) vs SoC 1-yr survival data (=SoC)
Grade 4 neutropenia Grade 3 fever
– 11 – June 2011 BIO International Convention
– Emotional / Self-Expressive
Benefits
End-use Benefits
FunctionalBenefits
Product Attributes
• Translate product attributes/features into distinct advantages vs competition
• Tool is populated from customer insights and competitor assessment
• This provides foundation for the product positioning
– 12 – June 2011 BIO International Convention
Clinical Milestones
Phase II (Safety) Phase III
Lead Country Approval
Regulatory Filings
Qualitative, external feedback on target
product profile (TPP)
Early qualitative landscape assessment
+ unmet needs eval
Phase II (Efficacy)
Key Customer input to Phase IIII endpoints,
including health economics
Qualitative, external feedback on adjusted TPP from PII efficacy: early brand positioning
Reconfirm Treatment landscape, unmet needs
Evaluate full dx +tx pathway: secondary
sources / data + systematic, qualitative
research w/ HCPs, patients
Competitive brand matrix assessment/
SWOT
Iterative qual MR to develop positioning
Benefit Laddering, Qual Research: Develop Brand Value Messages: Convert
Attributes to benefits
Situational / Environment Analysis
Iterative promotional message development,
including e-message strategy
Qualitative MR: fine tune
positioning as needed
Economic benefit / trade-off analysis
(qual study +/- quant)
Test promo materials + delivery formats
(e-formats)
– 13 – June 2011 BIO International Convention
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?
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[email protected] Office: 978-254-5098 Mobile: 908-327-5924 http://www.linkedin.com/pub/sara-misch/8/694/22