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How Ebola Drug Trials Today Could Shape Future Drug Development

Xconomy Raleigh-Durham — 

Ebola research has yet to yield a proven vaccine or antiviral drug but the work done so far could be paving the way for something else—faster and more efficient ways of testing drug candidates for other diseases.

Jeffrey Spaeder, chief medical officer for Durham, NC, contract research organization Quintiles (NYSE: Q), says the current Ebola outbreak has placed urgency on a drug development process that typically requires years of testing to determine safety and efficacy. But he says urgency also leads life science companies, non-profit organizations, and government bodies to work together in new ways.

“I never want to look at a catastrophe like this as having something good about it but we are learning things, potentially, about accelerating drug development, working in collaborations,” Spaeder says. “Can we take lessons learned from this, and apply it, not only for the other infectious diseases that affect the emerging world, but [also] other significant global healthcare burdens?”

Spaeder was one of the speakers Monday at Ebola NC: Local Response, Global Impact, which featured researchers, clinicians, and public health officials. The nonprofit Triangle Global Health Consortium and the North Carolina Biotechnology Center jointly coordinated and hosted the conference.

Quintiles, which runs clinical trials among other services it provides to pharmaceutical companies, has done work for companies developing and testing Ebola drugs and vaccines but the company does not disclose its clients. Spaeder, a cardiologist, says Ebola presents several challenges for drug trials. The disease is rare, and therefore, medical expertise in Ebola is also rare. That makes it difficult to find the medical professionals qualified to conduct Ebola clinical trials. The treatment setting can also introduce a bias into the studies that factors into the trial results. While mortality rates for the current Ebola outbreak are around 70 percent, patients who have been treated in the United States have fared much better. That makes it hard to assess whether the patient is responding to a particular medical intervention or the standard of care.

Two Durham companies, BioCryst (NASDAQ: BCRX) and Chimerix (NASDAQ: CMRX), are moving forward on tests of antiviral drug candidates. BioCryst’s antiviral has shown activity against Ebola in laboratory tests, and is now being tested in animals. Chimerix’s antiviral is starting a Phase 2 trial in Ebola—it’s gotten this far so quickly because … Next Page »

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  • Barbara Nelsen

    One straightforward solution both feasible and near-term are diagnostics that measure changes in viral load. They will provide an early indicator of efficacy allowing for effective treatment choices for the patient and the provider while new therapies for pandemics and developed.

  • Barbara Nelsen

    One straightforward solution both feasible and near-term are diagnostics that measure changes in viral load. They will provide an early indicator of efficacy allowing for effective treatment choices for the patient and the provider while new therapies for pandemics and developed.

  • Mark Nelson

    Highly critical of saying that we should apply this process to future drug development. Arms length and oversight should be in place for a reason. The biggest well known example being the review of thalidomide that was marketed for morning sickness. Ebola is a little different in that the option not to move forward simply sucks worse.