New Research Model to Accelerate Drug Development

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Online webinar was held on March 25, 2010.

As I was preparing to attend this call I remembered an article that appeared in Pharmaceutical Executive by Emmanuel Le Poul (November 18, 2009) entitled: “Rising to the Challenge in R&D.” So while the country was in the midst of discussing healthcare, the article started off by describing, that the pharmaceutical industry has not been able to improve the number of new molecule entities (NMEs) approved by the FDA. With the debate on healthcare focused solely on costs. The bigger issue is around productivity and innovation and why is it that we have not been able to improve the success rate for new NMEs? Many of you are well aware of the billions of dollars invested and countless clinical trials being performed each year. Is there a better model for drug development?

I had expected this webinar to focus on the ‘science’ aspects of drug development. Instead the focus was on improving the ‘process’ and for me that was truly enlightening. The presentation highlighted the growing ‘disconnect’ between academia and the pharmaceutical industry. We are well aware of the pending patent issues within the industry. The investment costs of $50 billion per year being spent on R&D, and the lack of ROI in terms of new products. The speakers covered the history for how we got to this point, and introduced the Accelerated Research Collaboration (ARC) model developed by the Myelin Repair Foundation (MRF). http://www.myelinrepair.org/research_model/

The ARC model is a holistic approach that spans the entire drug discovery and development value chain. This offers Pharma the means to make decisions when to license the discovery. I see it as improving the odds for success by closing the gap shown in the graphic on the right.

I’ll summarize the model as follows:

  • The first step is target discovery. This is the basic science conducted in university laboratories. For the most part, the NIH and other disease research organizations simply fund basic science that results in the publication of results in peer review journals. The result is hundreds of thousands of such articles published each year. The ARC model identifies the best scientists, requires them to share data in real time, manages the scientific process to a strategic research plan designed to discover therapeutically relevant targets, and then file patent applications on their discoveries.
  • The second link in the value chain is target validation. The ARC model establishes and manages a network of contract research organizations, better known as CROs, tasked with validating the basic science from the MRF labs to industry standards.
  • The third step in crossing “the valley of death” is drug discovery. The ARC model identifies and engages commercial partners to conduct drug discovery research. The MRF accomplishes this step in the process by entering into partnerships with multiple pharmaceutical partners, each established to move multiple targets through drug discovery and clinical trials.

The sports equivalent of the ARC model is to achieve as many shots on goal as possible, and thus overcome the high attrition rates inherent in getting a treatment approved and available to patients. An essential component of the ARC model is coordinating and being involved with all the players and participants in the value chain, from the academics, other non-profits, patients, physicians and various government agencies, like the NIH and the FDA. The MRF invests and is involved in every step of the process.

If better treatments can be found using this model then we will have achieved success. We have spent too much attention on the cost of healthcare rather than focusing on the patient and developing new treatments through process innovations like the ARC model. I would recommend visiting their site to learn more about this model and the success they have had so far.

For more information on the webinar including the transcripts and slides these can be found on: http://myelinrepair.org/myelincures/

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