Patient Advocacy Groups Benefits To Oncology Commercialization []

THE IMPORTANCE OF PATIENT

ADVOCACY GROUPS IN

ONCOLOGY COMMERCIALIZATION

Oncology USA 2010 – Boston, MA 03.23.10biomedwoRx

Michael W. Young

Principal,

biomedwoRx: Life Sciences Consulting

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

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

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

Is This How You See

Patient Advocacy Groups?

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.

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

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

Rich Market Research Territory

Can readily help outline and characterize the unmet

clinical and patient needs

Can make dramatic impact on design of:

Clinical trials

Drug administration protocol

Design of product

Dosing regimen

Opportunities to understand and promote

improvements to patient Quality of Life

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

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

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

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

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.

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?

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

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?

Additional Points of Beneficial

Interaction with Advocacy Groups

Patient Registries

Opportunities to support and review pooled data

Online Presence

Educational Website collaboration

CME / Patient Education links

Therapy Webinars for patients and caregivers

Convention / Symposia Support

Support for co-sponsored disease state presentations

Collaborative KOL gatherings

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