THE IMPORTANCE OF PATIENT
 ADVOCACY GROUPS IN
 ONCOLOGY COMMERCIALIZATION
 Michael W. Young
 Principal,
 biomedwoRx: Life ...
Relevant Background
   Board of Directors – Cutaneous Lymphoma
    Foundation, the only non-profit patient advocacy
    g...
Patient Advocacy Groups


   In one form or another have been in the US for over
    a hundred years
     March of Dimes...
Patient Advocacy Groups in Oncology

There are over 200 advocacy groups in the
  solid and hematology space alone:
   Can...
Is This How You See
Patient Advocacy Groups?
Growing in Potential Importance
   Patient-centric healthcare and promotion is now the
    essential thrust of many pharm...
Advocacy Groups As Partners
   Encourage you to look at Patient Advocate Groups
    as commercial and development partner...
KOL Development Partners

   Medical Advisory Boards and Boards of Directors are often
    the Who’s Who in Disease Manag...
Rich Market Research Territory
   Can readily help outline and characterize the unmet
    clinical and patient needs
   ...
Benefit Scope and Speed of
Commercial Initiatives
   Approval Process
     Work  with Patient Education Coordinators
   ...
Benefit Scope and Speed of
Commercial Initiatives
   Launch Resource
     Spokespeople    for public relations activitie...
Benefit Scope and Speed of
Commercial Initiatives
   New Indication Expansion
     Credible  source to explain the unmet...
Abundant Source of Competitive Intelligence

   Often involved in recruitment for clinical trials
     What  trials can ...
Healthcare Reform in 2010


   Dependent children will be allowed to remain
    on their parents' health insurance up to ...
Healthcare Reform in 2010
   Steps will be taken to fix the doughnut hole; in the first year,
    those who hit the dough...
Rapidly Build Effective Linkage
   Through Advocacy Washington Offices
   Many Advocacy Groups have:
     Washington   ...
Patient Assistance Programs
   There are currently over 1000 prescription drug patient
    assistance programs available ...
Additional Points of Beneficial
    Interaction with Advocacy Groups

   Patient Registries
     Opportunities   to supp...
Recommendations for Successful
Interaction with Advocate Groups
   Establish a Professional / Patient Advocate
    Capabi...
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Patient Advocacy Groups Benefits To Oncology Commercialization [www.BiomedwoRx.Com]

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An overview of patient advocacy fundamentals in the oncology space which support commercialization, approval, launch, and later.

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Patient Advocacy Groups Benefits To Oncology Commercialization [www.BiomedwoRx.Com]

  1. 1. THE IMPORTANCE OF PATIENT ADVOCACY GROUPS IN ONCOLOGY COMMERCIALIZATION Michael W. Young Principal, biomedwoRx: Life Sciences Consulting biomedwoRx Oncology USA 2010 – Boston, MA 03.23.10
  2. 2. Relevant Background  Board of Directors – Cutaneous Lymphoma Foundation, the only non-profit patient advocacy group devoted to this orphan cancer  Head of Professional and Patient Advocacy for Ligand Pharmaceuticals in oncology, dermatology, and pain management sectors  Professional Relations manager for Burroughs Wellcome Co. in the HIV / Antiviral franchise working with over 60 patient and professional groups
  3. 3. Patient Advocacy Groups  In one form or another have been in the US for over a hundred years  March of Dimes 1938 – polio  American Lung Association 1904 - tuberculosis  Major growth coincided with major epidemics including the AIDS epidemic  Breast Cancer movement  Non-Profit vs. For-Profit Patient Advocacy Groups
  4. 4. Patient Advocacy Groups in Oncology There are over 200 advocacy groups in the solid and hematology space alone:  Cancer Care, Inc.  Lymphoma Research Foundation  American Cancer Society  Leukemia and Lymphoma Society  Pancreatic Cancer Action Network  Susan G. Komen Foundation  Cutaneous Lymphoma Foundation  Y-Me National Breast Cancer Organization  American Brain Tumor Association
  5. 5. Is This How You See Patient Advocacy Groups?
  6. 6. Growing in Potential Importance  Patient-centric healthcare and promotion is now the essential thrust of many pharma, biotech, and device marketers  The rapid evolution of “personalized medicine” and the dramatic growth of genomic sequencing capabilities (eg. Illumina, Life Technologies, Sequenom)  The impact of consumerism on therapy and quality of life tradeoff choices makes interaction with patients a mandate.
  7. 7. Advocacy Groups As Partners  Encourage you to look at Patient Advocate Groups as commercial and development partners  To recognize the fertile relationship ground which with careful planting and cultivation can yield more productive “crops” of products  To bring to light benefits for both:  Smaller companies developing products  Larger companies marketing products
  8. 8. KOL Development Partners  Medical Advisory Boards and Boards of Directors are often the Who’s Who in Disease Management  Opportunities for Market Research, Focus Groups, and Roundtable discussions  Speaker Bureau resource  Opportunities to build lasting, trusting KOL relationships  Opportunities to create additional publications and augment publication planning  Chance to understand local and regional referral patterns  Regional and National influence mapping
  9. 9. Rich Market Research Territory  Can readily help outline and characterize the unmet clinical and patient needs  Can make dramatic impact on design of:  Clinicaltrials  Drug administration protocol  Design of product  Dosing regimen  Opportunities to understand and promote improvements to patient Quality of Life
  10. 10. Benefit Scope and Speed of Commercial Initiatives  Approval Process  Work with Patient Education Coordinators  Support Public Hearings with ODAC and other FDA convocations  Provide additional appropriate lobby for new therapies  Ready source of patient success or patient unmet need examples who are compelling and credible
  11. 11. Benefit Scope and Speed of Commercial Initiatives  Launch Resource  Spokespeople for public relations activities, media tours, online presence  Press release focus and coordinated “buzz” development  Sales training resource (in disease awareness and impact on patients and healthcare delivery)  Keynote roles for launch sales meeting  Referral point for new patients
  12. 12. Benefit Scope and Speed of Commercial Initiatives  New Indication Expansion  Credible source to explain the unmet clinical need  Opportunity to facilitate rapid information dissemination through existing patient base  Excellent first-line feedback on side effect management
  13. 13. Abundant Source of Competitive Intelligence  Often involved in recruitment for clinical trials  What trials can you share?  What trials are your competitors mounting?  Are your competitors funding specific patient initiatives?  What do you know about the advocacy group Medical Advisory Boards?  Source of Medical Opinion to ODAC  Position or Guideline paper development  May share complications encountered by competitor products
  14. 14. Healthcare Reform in 2010  Dependent children will be allowed to remain on their parents' health insurance up to age 26.  Existing insurance plans will be barred from imposing lifetime caps on coverage.  Insurers will be prevented from canceling insurance retroactively, except for fraud.  Insurance plans cannot exclude coverage for pre-existing medical conditions for children under age 19.
  15. 15. Healthcare Reform in 2010  Steps will be taken to fix the doughnut hole; in the first year, those who hit the doughnut hole will receive a $250 rebate. Next year, the cost of drugs in the doughnut hole will go down by 50 percent.  Prevention care will be available to Medicare beneficiaries without co-payments or deductibles beginning in 2010.  People with medical conditions that make them uninsurable may be able to get coverage through a federally subsidized health insurance program, to be established within 90 days. The legislation limits spending for this program to $5 billion  What will all this mean to your business and how can patient advocate groups help?
  16. 16. Rapidly Build Effective Linkage  Through Advocacy Washington Offices  Many Advocacy Groups have:  Washington representatives working the Hill  Internal policy experts monitoring healthcare reform impacts on their patient populations  Membership or appointments to key government advisory committees  Dedicated interaction with FDA, DEA, NIH, NCI, etc.  Insurance Industry interaction and knowledge
  17. 17. Patient Assistance Programs  There are currently over 1000 prescription drug patient assistance programs available to uninsured patients and many advocacy groups support resource databases for patients.  The majority of these programs are pharmaceutical industry sponsored  Many advocacy organizations serve a clearinghouse function or provide modest support for ancillary needs (eg. transportation to care sites).  How will these change under the new Healthcare Plan?
  18. 18. Additional Points of Beneficial Interaction with Advocacy Groups  Patient Registries  Opportunities to support and review pooled data  Online Presence  EducationalWebsite collaboration  CME / Patient Education links  Therapy Webinars for patients and caregivers  Convention / Symposia Support  Support for co-sponsored disease state presentations  Collaborative KOL gatherings
  19. 19. Recommendations for Successful Interaction with Advocate Groups  Establish a Professional / Patient Advocate Capability  Provide necessary training  Compliance / Grants  Clinical  Product  Alliance Management  Do Your Homework – Not all groups are valuable to your commercial effort  Establish one point of contact for each organization
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