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June 2011 BIO International Convention




                    – 1
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.



– June	
  2011	
  BIO	
  International	
  Convention	
     – 2
– June	
  2011	
  BIO	
  International	
  Convention	
     – 3
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?



– June	
  2011	
  BIO	
  International	
  Convention	
     – 4
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?




– June	
  2011	
  BIO	
  International	
  Convention	
               – 5
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
– June	
  2011	
  BIO	
  International	
  Convention	
     – 6
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	
     – 7
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




– June	
  2011	
  BIO	
  International	
  Convention	
     – 8
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	
                 – 9
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 (-)
– June	
  2011	
  BIO	
  International	
  Convention	
           – 10
– 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


– June	
  2011	
  BIO	
  International	
  Convention	
           – 11
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

– June	
  2011	
  BIO	
  International	
  Convention	
               – 12
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	
     – 13
smisch@smrsolutionsplus.com
Office: 978-254-5098
Mobile: 908-327-5924
http://www.linkedin.com/pub/sara-misch/8/694/22




                       – 14

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How to Build and Leverage Market Intelligence to Launch Successful Innovations

  • 1. June 2011 BIO International Convention – 1
  • 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. – June  2011  BIO  International  Convention   – 2
  • 3. – June  2011  BIO  International  Convention   – 3
  • 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? – June  2011  BIO  International  Convention   – 4
  • 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? – June  2011  BIO  International  Convention   – 5
  • 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 – June  2011  BIO  International  Convention   – 6
  • 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   – 7
  • 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 – June  2011  BIO  International  Convention   – 8
  • 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   – 9
  • 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 (-) – June  2011  BIO  International  Convention   – 10
  • 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 – June  2011  BIO  International  Convention   – 11
  • 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 – June  2011  BIO  International  Convention   – 12
  • 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   – 13

Editor's Notes

  1. Slide 2 - This is supposed to be a blog-like “chatty” intro to attract the next slides– any ideas on how to make it more interesting?
  2. Whatever you can do to spruce this up as a title slide? Also let me know as a separate line item what your fee would be to create a ppt template using my logo colors.Thanks!
  3. Can you make this more 3-day and shade the segments? Needs to be more lively.. Probably easier to do over??
  4. Tried to change the website address to the standard royal blue color, but somehow format was not accepted. Do you prefer the title line separator in the teal or navy color? (see slide 6)
  5. Can we make this more interesting with shading and color?
  6. This should go immediately AFTER the brand matrix tool slide. Ladder could use enhancement – and of course the ghastly color would change .
  7. This will now follow both the Brand Matrix and new benefit ladder slide- right before the Market Readiness Checklist. The text boxes need some nice borders.
  8. Use Check Marks as bullets?
  9. FINAL SLIDE