i-Disclose.com The Independent Payment Clearinghouse for Full and Transparent Disclosure of Financial Relationships Between Independent Researchers and Pharmaceutical Companies Copyright 2006 - Robert T Cooper Last updated: September 6, 2006 Contact: Bob Cooper – 610-724-1118

The Independent Payment Clearinghouse for Full and Transparent Disclosure of Financial Relationships Between Independent Researchers and Pharmaceutical Companies

The Situation Pharmaceutical companies need to work with independent researchers and key opinion leaders (KOLs) to provide: Clinical research on new and established products Absolutely necessary – the pharmaceutical research pipeline can not function without 3 rd party researchers and study authors Medical Education for other physicians An important part of keeping physicians’ knowledge and expertise current Consulting, advisory boards, etc. A controversial yet integral part of pharmaceutical marketing These researchers/KOLs need to be paid for their efforts Copyright 2006 - Robert T Cooper

Pharmaceutical companies need to work with independent researchers and key opinion leaders (KOLs) to provide:

Clinical research on new and established products

Absolutely necessary – the pharmaceutical research pipeline can not function without 3 rd party researchers and study authors

Medical Education for other physicians

An important part of keeping physicians’ knowledge and expertise current

Consulting, advisory boards, etc.

A controversial yet integral part of pharmaceutical marketing

These researchers/KOLs need to be paid for their efforts

The Situation (continued) Researchers want to publish the results of their studies in peer-reviewed medical journals, with publishing credits adding to their own expertise. (“Publish or perish.”) Pharmaceutical companies want to publish the results of the clinical trials that show outcomes for their products. Medical journals want to provide leading edge scientific discoveries. Copyright 2006 - Robert T Cooper

Researchers want to publish the results of their studies in peer-reviewed medical journals, with publishing credits adding to their own expertise. (“Publish or perish.”)

Pharmaceutical companies want to publish the results of the clinical trials that show outcomes for their products.

Medical journals want to provide leading edge scientific discoveries.

The Situation (continued) According to industry trade organization PhRMA, U.S. pharmaceutical companies spent over $51 billion on R&D in 2005 6.5% increase over 2004 spending R&D represents over 19.2% of domestic sales About 40% of that - $20 billion – is spent on external researchers and institutions Copyright 2006 - Robert T Cooper

According to industry trade organization PhRMA, U.S. pharmaceutical companies spent over $51 billion on R&D in 2005

6.5% increase over 2004 spending

R&D represents over 19.2% of domestic sales

About 40% of that - $20 billion – is spent on external researchers and institutions

The Problem Real (or even perceived) conflicts of interest due to financial ties call the results of clinical trials into question. This takes the focus off the science and creates a contentious relationship between: Pharmaceutical companies Researchers/KOLs Medical Journals Government agencies such as the FDA Most importantly, it causes a huge public perception problem for the pharmaceutical companies who are ultimately held responsible for this problem. This problem is getting very high profile news coverage Legislators and both the Wall Street Journal and New York Times agree that a solution is required Copyright 2006 - Robert T Cooper

Real (or even perceived) conflicts of interest due to financial ties call the results of clinical trials into question.

This takes the focus off the science and creates a contentious relationship between:

Pharmaceutical companies

Researchers/KOLs

Medical Journals

Government agencies such as the FDA

Most importantly, it causes a huge public perception problem for the pharmaceutical companies who are ultimately held responsible for this problem.

This problem is getting very high profile news coverage

Legislators and both the Wall Street Journal and New York Times agree that a solution is required

The Solution What is required is full and transparent disclosure of all relationships and monies received by researchers/KOLs from funding sources (typically pharmaceutical companies.) Most observers and medical societies place the responsibility on the researchers/KOLs to disclose their ties, but they often: Forget to disclose Choose not to disclose Don’t disclose because they don’t think it is relevant in a particular case Copyright 2006 - Robert T Cooper

What is required is full and transparent disclosure of all relationships and monies received by researchers/KOLs from funding sources (typically pharmaceutical companies.)

Most observers and medical societies place the responsibility on the researchers/KOLs to disclose their ties, but they often:

Forget to disclose

Choose not to disclose

Don’t disclose because they don’t think it is relevant in a particular case

Our Solution i-Disclose.com is an independent, 3 rd party clearinghouse through which all research sponsors and/or pharmaceutical companies can pay (or report payments to) researchers / key opinion leaders. Each payment is documented and a detailed profile and history is created for each researcher/KOL Detailed reports are available to qualified medical journals, participating pharmaceutical companies and federal agencies such as the FDA Individual researchers/KOLs have access to their own reports as well 3 rd parties would have access to details only if authorized by both payor and payee. Copyright 2006 - Robert T Cooper

i-Disclose.com is an independent, 3 rd party clearinghouse through which all research sponsors and/or pharmaceutical companies can pay (or report payments to) researchers / key opinion leaders.

Each payment is documented and a detailed profile and history is created for each researcher/KOL

Detailed reports are available to qualified medical journals, participating pharmaceutical companies and federal agencies such as the FDA

Individual researchers/KOLs have access to their own reports as well

3 rd parties would have access to details only if authorized by both payor and payee.

Copyright 2006 - Robert T Cooper $ Payment Payment Details $ Payment Payment Details i-Disclose.com Payment Tracking & Reporting Pharmaceutical Company A Researcher / KOL 1 Researcher / KOL 2 Accounts Payable Pharmaceutical Company B Accounts Payable Medical Journals Institution On-Demand Reporting

Our Solution To be most effective, the solution to this problem must ultimately be industry-wide since researchers/KOLs work with multiple pharmaceutical companies and publish in a variety of medical journals. Each of these players needs to be able to cross-check each other on a level playing field. There is greater benefit to all stakeholders in being part of i-Disclose.com than not being part of it. Copyright 2006 - Robert T Cooper

To be most effective, the solution to this problem must ultimately be industry-wide since researchers/KOLs work with multiple pharmaceutical companies and publish in a variety of medical journals.

Each of these players needs to be able to cross-check each other on a level playing field.

There is greater benefit to all stakeholders in being part of i-Disclose.com than not being part of it.

Business model Members pay an annual subscription fee based on membership type Sponsor Researcher Journal Institution / Association In exchange for data management, reporting and audit services, i-Disclose.com makes a small transaction fee on each payment it tracks. Copyright 2006 - Robert T Cooper

Members pay an annual subscription fee based on membership type

Sponsor

Researcher

Journal

Institution / Association

In exchange for data management, reporting and audit services, i-Disclose.com makes a small transaction fee on each payment it tracks.

Similar Models in Other Industries Insurance sector Choicepoint’s “CLUE” system (Comprehensive Loss Underwriting Exchange) which tracks all property claims by individuals among all insurance carriers thus providing a valuable underwriting metric for all insurance carriers. Competitors cooperating to compete more effectively Financial sector SWIFT (Society of Worldwide Interbank Financial Telecommunication) which was recently in the news, a pan-European banking clearinghouse that helped the FBI track financial ties to terrorist organizations in Europe Copyright 2006 - Robert T Cooper

Insurance sector

Choicepoint’s “CLUE” system (Comprehensive Loss Underwriting Exchange) which tracks all property claims by individuals among all insurance carriers thus providing a valuable underwriting metric for all insurance carriers.

Competitors cooperating to compete more effectively

Financial sector

SWIFT (Society of Worldwide Interbank Financial Telecommunication) which was recently in the news, a pan-European banking clearinghouse that helped the FBI track financial ties to terrorist organizations in Europe

Business Process Research sponsors generate a digital file that details payments made to researchers/KOLs Transmitted record data includes: Payor ID Researcher/KOL AMA ID number (if applicable) Clinicaltrials.gov ID number (if applicable) and/or description of research/service provided Product or compound affiliation Date of payment Amount of payment Real-time account reports are available online to both payors and payees, as well as to registered medical journals and academic institutions. Copyright 2006 - Robert T Cooper

Research sponsors generate a digital file that details payments made to researchers/KOLs

Transmitted record data includes:

Payor ID

Researcher/KOL AMA ID number (if applicable)

Clinicaltrials.gov ID number (if applicable) and/or description of research/service provided

Product or compound affiliation

Date of payment

Amount of payment

Real-time account reports are available online to both payors and payees, as well as to registered medical journals and academic institutions.

Underlying technology Secure, Web-based system provides encryption of transmitted data SAS-70 certified hosting environment High security with 99.999% reliability for power, bandwidth, storage, etc. API integration modules available for major accounts payable systems i.e. SAP, Oracle, Microsoft, Lawson, etc. Secure, password protected portal site for real-time reporting Copyright 2006 - Robert T Cooper

Secure, Web-based system provides encryption of transmitted data

SAS-70 certified hosting environment

High security with 99.999% reliability for power, bandwidth, storage, etc.

API integration modules available for major accounts payable systems i.e. SAP, Oracle, Microsoft, Lawson, etc.

Secure, password protected portal site for real-time reporting

Marketing and sales approach Get endorsement from key stakeholder groups: medical journals, industry groups (i.e. PhRMA, AMA, etc.) high-profile researchers/KOLs thought leaders (i.e. Center for Bioethics). Get i-Disclose incorporated into disclosure policies of medical journals, academic institutions, and pharma research grants. Will only accept submission or pay researchers/KOLs that are registered with i-Disclose.com. Get buy-in from top pharmaceutical manufacturers. Use public relations to become the industry thought leader in full and transparent disclosure. Provide I-Disclose certification via “seal of approval” Copyright 2006 - Robert T Cooper

Get endorsement from key stakeholder groups:

medical journals,

industry groups (i.e. PhRMA, AMA, etc.)

high-profile researchers/KOLs

thought leaders (i.e. Center for Bioethics).

Get i-Disclose incorporated into disclosure policies of medical journals, academic institutions, and pharma research grants.

Will only accept submission or pay researchers/KOLs that are registered with i-Disclose.com.

Get buy-in from top pharmaceutical manufacturers.

Use public relations to become the industry thought leader in full and transparent disclosure.

Provide I-Disclose certification via “seal of approval”

Competition To date there is no competition. Suggested solutions keep pointing back to the responsibility of the researcher/KOL to disclose. But often they don’t because They forget They don’t think it is relative They don’t want others to know This is an unworkable solution to this problem. Copyright 2006 - Robert T Cooper

To date there is no competition.

Suggested solutions keep pointing back to the responsibility of the researcher/KOL to disclose. But often they don’t because

They forget

They don’t think it is relative

They don’t want others to know

This is an unworkable solution to this problem.

Summary This is a big and growing problem that CANNOT be solved by: The FDA Individual pharmaceutical companies Individual researchers / KOLs A third party clearinghouse is needed with a simple and secure solution for the entire pharmaceutical industry… i-Disclose.com is that solution Copyright 2006 - Robert T Cooper

This is a big and growing problem that CANNOT be solved by:

The FDA

Individual pharmaceutical companies

Individual researchers / KOLs

A third party clearinghouse is needed with a simple and secure solution for the entire pharmaceutical industry…

i-Disclose.com is that solution