Thursday, January 15, 2015

Revolutionizing Drug Discovery and Delivery: How Ebola Vaccine Research changed Bio-Pharma

Source: CDC


Recently, a paper entitled: Rethinking the development of Ebola treatments by Rajesh Gupta, was published in The Lancet. The paper stipulates:
"Therapeutic Ebola research is heavily funded by the US government under the auspices of threats to national security,11and international activities are limited to a few research groups. To allow for greater participation of researchers globally, real-time accessibility of crucial data is necessary.In silico methods are still in development and rapidly evolving, but have been successful in identifying potential candidates for various diseases and the risk of using such methods are very low. Their ability to affect, at scale, drug development processes, costs, and timelines is unknown but likely to be considerable given the private sector's strong interest and investment in this area. Equally likely is that these approaches will be able to affect a wide range of diseases. Although these approaches are currently directed towards diseases with clear revenue streams (eg, inflammatory bowel disease and cancer), such approaches could be used for unprofitable diseases that affect the most underserved populations of the world." Source: http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(14)70304-3/fulltext?rss=yes
"The inequities already posed by a disease of poverty such as Ebola become further exacerbated when novel technologies are used first to explore diseases that are viable commercial opportunities. This does not have to be the pattern moving forward, and Ebola might provide the opportunity to apply new technological approaches to drug development (such as in silico methods) for traditional “market failure” diseases. If the global community is truly committed to rapidly developing a new drug for Ebola, multiple novel approaches, methods, and technologies will need to be used to beat the inherent hurdles of drug development." Source: http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(14)70304-3/fulltext?rss=yes
Diseases of poverty and their orphan drug development counterparts are often considered so highly limited that the costs of research and  investment are prohibitive. Most Category A and some Category B diseases (defined under CDC), considered a national security priority are funded by a multitude of US government programs. Such funding was put in place following the US anthrax attacks. What has changed since then is our approach from one bug one drug to development of a range of technologies which foresee one drug covering a wide range of infectious disease. This is particularly true of Ebola vaccines and therapeutics. 
We need only look to the annual WHO smallpox retention debate at the World Health Congress, held each May to understand how research into even eradicated disease (smallpox being the only one to date), offers a host of novel drug research, development and manufacturing techniques which would not perhaps have been generated quite so swiftly without the crisis aspect defining the current Ebola outbreak in West Africa.  We must also consider how emergency investigational new drug (IND's) applications are evaluated and approved by FDA; although this may be considered a downstream issue. Drug development for Ebola will likely convey significant benefit to other diseases, particularly influenza and HIV, which may not have been the case in the time frames we are now witnessing. 

In order to take full advantage of this opportunity we need protocols and evaluations in step with the pace of accelerated discovery. We need to rethink evaluation processes in light of far more agile drug and drug platform discovery and development. Not only will drug research and development on Ebola vaccines and therapeutics prove advantageous to other emerging disease but will likely revolutionize fundamental aspects of this. One example is of course DARPA and Medicago's one month challenge to produce millions of vaccines. Immuno-therapies are likely to gain a strong foothold due to application to Ebola research in markets they held lesser positions. Additionally, advances in delivery such as nano vaccines and VLP's (virus like particles) as a delivery platform for gene therapy and other therapeutics is likely to become a serious technology a range of applications perhaps not considered for emergency use. The most recent discovery announced by MIT "In a paper published July 27 in the journal PLoS One, the researchers tested their drug against 15 viruses, and found it was effective against all of them — including rhinoviruses that cause the common cold, H1N1 influenza, a stomach virus, a polio virus, dengue fever and several other types of hemorrhagic fever. The drug works by targeting a type of RNA produced only in cells that have been infected by viruses. “In theory, it should work against all viruses,” says Todd Rider, a senior staff scientist in Lincoln Laboratory’s Chemical, Biological, and Nanoscale Technologies Group who invented the new technology." (Source: http://www.carbonated.tv/lifestyle/new-drug-could-cure-nearly-any-viral-infection) These types of discoveries which move far away from one bug one drug, an issue which has haunted bio-defence could well be an obsolete approach given the revolution in drug discovery we are currently witnessing. 
While the current Ebola outbreak has devastated West African and I don't think this can be understated, if there is a positive to be drawn, it is the explosion of drug discovery and bio-technology applications which are likely to effect the future of how we control epidemic and pandemic disease. I believe significant strides in broad spectrum drug development will greatly increase our ability to eradicate several diseases entirely, polio being first on the list. 



Dr.Jill Bellamy is an internationally recognized expert on biological warfare and defence. She has formerly advised NATO and for the past seventeen years has represented a number of bio-pharmaceutical and government clients working on procurement strategy between NATO MS and Washington DC. Her private government relations consultancy Warfare Technology Analytics is based in the Netherlands. Dr. Bellamy's articles have appeared in the National Review, The Wall Street Journal, The Washington Post, The Sunday Times of London, Le Temps, Le Monde and the Jerusalem Post among other publications. She is a CBRN SME with the U.S. Department of Defence, Chemical, Biological, Radiological and Nuclear Defence Information Analysis Center and CEO of Warfare Technology Analytics.

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