Non-Profit Biotech Model

 

The Institute has adopted a non-profit biotech model, which is a unique approach that differs from other non-profit foundations that advocate for specific patient groups. Established non-profit private foundations typically raise private donations to support their programs by:

 

1. Support basic research in academia to advance new knowledge.

 

2. Provide educational information and marketing material for patients.

 

3. Politically advocate and lobby for patients.

 

However, this model has several shortcomings. First, these foundations devote a small percentage of their budget to medical research. Second, they do not place a primary emphasis on drug discovery, product development, and eliminating or reducing the high risk of drug development during the regulatory process. Third, it is difficult to identify clear metrics by which these foundations facilitate new treatments and cures for the patients that they advocate for.

 

In contrast, the Institute has adopted a non-profit biotech model in which our primary goal is to devote a high percentage of our budget to develop new diagnostic and treatment regimens for patients. We focus our efforts in conducting research that ultimately will result in a Food and Drug Administration (FDA) approved Investigational New Drug (IND) application to initiate clinical research. The Institute serves as a catalyst to accelerate drug development. The Institute mobilizes the private practice sector to accelerate drug development by eliminating significant red tape and bureaucracy that typically plagues government and academia. By using a cooperative model between the private sector, industry, academia and government the Institute can facilitate finding treatments and cures for patients in the fastest and most cost-effective manner.

 

The Institute's research operation is illustrated in the following discussion.

Over the past several years, the pharmaceutical industry has undergone major restructuring by downsizing and outsourcing research and development programs. This trend has decreased their own internal drug development program. Often they acquire new drugs once the drug has achieved a critical level of regulatory success. There is a major gap in infrastructure between the discovery science stage and clinical trial stage (see below figure). This gap typically has a historical high failure rate. The Institute has positioned itself in this gap to create stem cells to screen drug libraries that other institutions have created or the Institute will create. The purpose of drug screening is to identify the best lead drug that can graduate towards an FDA-approved IND. Once approved, the Institute will license the drug to the pharmaceutical industry for payment. Revenue received for such license and any future milestone payments are then reinvested back to the Institute to support and expand its chief mission of finding cures.

 

Thus, the Institute proposes to use the following metrics to judge its success:

 

1. The number of IND-approved drugs.

 

2. The number of patients enrolled in clinical trials.

 

3. The number of patients that receive compassionate use of an experimental drug.

 

4. The cost and time of getting an approved IND.

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