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Minyan Mailbag: Personalized Medicine



Note: Our goal in Minyanville is to remove intimidation from the financial markets and encourage an interactive dialogue among the Minyanship. We share this next discussion with that very intent.

David -

I was told by a company executive that personalized oncologic drugs (specifically, personalized vaccines) were going to have a problematic development environment with the FDA. I wonder how that plays into your overall drug development thesis on personalized medicines? I believe you are right, but believe the FDA and the drug industry are not yet on that page.

Minyan JD

The executive you spoke with is correct, but perhaps paints things with too broad of a brush. The FDA will have a problem with personalized vaccines where the production process requires a portion of the patient's tumor (like the vaccines shelved by Cell Genesys (CEGE) today). Very few, if any, of these processes are manageable within the context of strict FDA manufacturing guidelines. Most have manufacturing success rates below 85% and the wait time between diagnosis and therapy can be as long as six weeks. That wait time gives the tumors too much of a head start and the poor manufacturing success rate means 15 of every hundred people will never receive the drug.

The FDA told manufacturers of drugs requiring some personal component that they needed to be able to characterize each dose produced in a way that could guarantee similar content and potency. This is an extraordinarily difficult challenge to meet for any drug requiring whole tumor as a starting point. Those companies who use a standardized antigen where the patient's only contribution is dendritic cells have a much easier time of it.

Even if whole-tumor-based vaccine manufacturing is successful, I remain unconvinced a whole-tumor approach can generate an immune response proportionally specific to the patient's cancer. For a refresher on why I believe this to be the case, read this story I wrote about a year ago.

When I speak about personalized cancer therapies, my intent is to look beyond therapies that need a piece of the tumor. I am partial to single-antigen immunotherapy, where the only thing needed from the patient is their dendritic cells (see Dendreon's (DNDN) Provenge, in which I own a position). But the therapy could be a simple oral pill, too. The personalization I wrote about (and spoke about at MIM-1) comes more from the point of view of an exacting analysis of the patient's disease than whether the therapy requires the individual to contribute something.

Under this view of personalized therapy, the doctor starts with a detailed analysis showing which markers of disease the patient has. The doctor then consults her "toolbox" to find drugs effective against the specified disease markers. She then administers those targeted drugs to the patient. Because of the exquisite specificity of the process where specific markers are found and treated with drugs specific to those markers, increased efficacy and lower side effects should be the result.

I hope that answers the question.


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