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

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

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  • 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. 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. 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. 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. Is This How You See Patient Advocacy Groups?
  • 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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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