A Case for BARDA to Produce Therapeutics

Doctors Without Borders (MSF) recently noted the one of the best products to treat deadly snakebites has ended production and the remaining supply will soon be exhausted. FAV-Afrique can be used to treat bites from ten venomous snakes, and has been a mainstay in sub-Saharan Africa. At the root of this incredible situation is the fact that Sanofi Pasteur had stopped producing FAV-Afrique years before due to cost competitiveness. The World Health Organization (WHO), MSF, and other related organizations knew of this production stoppage and advocated for transfer of IP from Sanofi to another company to continue production. Yet, this life-saving products remains shelved and would be at least a few years from replenishment even under the most ideal circumstances. 

 

In the United States, under Health and Human Services, an organization exists whose charter is to produce late stage therapeutics  -especially in therapeutic areas that Big Pharma has largely exited. In fact, Peptineo had lobbied to employ this same resource to produce a late stage Ebola vaccine that had been shelved. This process was successfully engaged for MAPP Pharmaceuticals (producers of ZMapp) to produce its Ebola antibody cocktail -and BARDA has a pipeline of other products that it is producing. Under BARDA, a virtual pharmaceutical manufacturing capability has been established to take a therapeutic into production and complete all required regulatory milestones for FDA licensure. While BARDA may not be positioned to produce this desperately needed anti-venom, the model for producing late-stage or previously approved regulatory products is worth consideration. Given that modern manufacturing of pharmaceuticals has experienced a significant reduction in infrastructure costs and physical footprints to produce products (example: NNE Pharmaplan flexible manufacturing designs), perhaps the WHO and others should consider establishing rapid manufacturing capabilities similar to BARDA. Not only can products be made, but a streamlined process has also been developed to move products quickly through necessary regulatory efforts. The following links directly to additional background on the incredible stoppage and shelving of the FAV-Afrique anti-venom and is found here

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US Preparing for Zika

US Preparing for Zika

The United States of America is preparing for Zika to reach its shores. As it prepares, the CDC has an emergency response group working behind the scenes to anticipate and respond to this emerging health concern.  

#Zika

#Zika

For more information on what the CDC is doing to prepare for Zika see below... 

 

CDC prepares for Zika

Key Recent Data on Zika Cases in Brazil

Here is a recent update on cases being reported in Brazil on Zika.  The data was compiled by Brazil Ministry of Health and assembled by Ian MacKay, PhD.  

 

CNS and related effects of Zika

CNS and related effects of Zika

Confirmed Zika Diagnoses

Confirmed Zika Diagnoses

Top Medical Center Discusses Zika

Emory university, one of the first US hospitals to treat Ebola now prepares for the next health concern - Zika.  Here is a video of Grand Rounds at Emory university.  

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Zika Prevention Starts with You

Want to learn more about how to prevent Zika?  This infographic from the US Centers for Disease Control may be helpful.  

 

Zika prevention starts with you

Zika prevention starts with you

Be proactive! 

Is there a path forward to treat Ebola?

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We really need to focus on how we address diseases that affect the entire global community. Ebola, as a disease, while still in Africa is certainly something that can affect other communities across the globe. Right now, many treatment strategies are still sitting on the shelf... We all understand the risks of developing new medicines, but when big pharma cannot find a business case to get behind something like this, we all have a problem. Let's start a new hashtag #globalconscience4Africa 

Nature put out an interesting article on technologies sitting on the shelf that could address infectious diseases in general...  When will enough people globally or at least in developed countries die from Ebola so that making a vaccine for it becomes profitable to big pharma given the significant investment required in research and development on the front end? The economic factors driving the lack of efforts have not been sufficiently discussed in mainstream media. The focus has been more on whether and how it might spread. Public pressure on big pharma is non-existent because we view this as an African disease and therefore not important. We accept that there is no cure but don't discuss the politics and economics of vaccine development. African lives at stake, the potential global spread of the disease, and the incredibly high mortality rate make finding a treatment/cure paramount.

A live updated feed on Ebola

Ebola virus outbreak: live - Telegraph