Wayback articles from ZikaResponse.Org
The following is a resource base of articles that were published on the website ZikaResponse.org, which has since been deleted. The website appears to have been written mainly by Jill Glasspool-Malone.
The saved text in this article is likely only a partial list of the articles that were published. The “web archive” is difficult to use and sporadic in what was saved. There may be errors in the way I have “cut and pasted” the data. This article is intended to be a starting point for research only. Take care to veryify any sources you quote from here. Much of the text was taken from other articles in the news at the time.
There is a similar deleted website of the Malones named Atheric.com that I also plan to archive.
The links come from here: https://web.archive.org/web/*/http://www.zikaresponse.org/news*
February 10, 2016
https://web.archive.org/web/20160219202858/http://www.zikaresponse.org/news/
Two months after a 68-year old British man became sick with Zika virus, traces of the germ lingered in his semen, researchers reported Friday. The finding suggests that the mosquito-spread virus may unexpectedly hang around in the body for much longer than symptoms appear, which typically only last for about a week. (Though only a quarter or so of people infected with Zika experience any symptoms.) The viral loitering may up the chances of transmission, the authors speculate.
(Note: The original article quoted is from Ars Technica): “https://web.archive.org/web/20160223081919/http://arstechnica.com/science/2016/02/traces-of-zika-found-in-a-mans-semen-two-months-after-he-was-infected/
February 10, 2016
https://web.archive.org/web/20160219202858/http://www.zikaresponse.org/news/
The current pattern of Zika-associated disease observed in Brazil represents a significant public health risk. Based on estimated incidence of Zika infection in Brazil, and the confirmed incidence of excess microcephaly, Brazilian mothers infected with Zika during pregnancy are between 3,700 to 11,000 times more likely to deliver infants with primary microcephaly than uninfected mothers. The current best estimates for the incidence of Zika virus infection in Brazil range between 440,000 and 1,300,000 cases, resulting in an estimated annual (2015) attack rate between 0.30% and 0.88%. 3,530 confirmed cases of Zika-associated primary microcephaly were reported between October 22, 2015 and January 9, 2016, a rate predicting approximately 16,000 cases of Zika-associated primary microcephaly in Brazil during 2016 assuming constant incidence. The estimated risk that a mother infected with Zika during pregnancy will deliver a baby with primary microcephaly ranges from 18% to 53%. Incidence estimates for Zika-associated Guillain-Barre syndrome (GBS) in adults and other types of birth defects other than microcephaly are not yet available. In some Brazilian hospitals adult GBS mortality during 2015 may be as high as 50%.
Methods and policies designed to delay the spread of the virus into uninfected regions will buy critical time to develop medical countermeasures. Rapid development and deployment of diagnostic tests for Zika to clinical laboratoriesshould be a top priority. Cases acquired abroad will continue to be identified in non-endemic countries and must be differentiated from autochthonous outbreaks. Strategies for rapidly developing specific medical countermeasures may involve drugs and biologicals with antiviral and immunotherapeutic activities for use by pregnant women in their first and second trimesters. Surges in GBS may require augmented availability of intensive care and ventilator support (including trained personnel), equipment for plasma exchange, stockpiles of intravenous immunoglobulin, and development of novel therapeutic strategies. In contrast, development of a general use prophylactic vaccine for Zika virus may require considerable time and careful evaluation to mitigate typical vaccine-associated risks in previously healthy unexposed general populations for which Zika infection poses modest morbidity and mortality (GBS) risks.
February 13, 2016
https://web.archive.org/web/20160219202858/http://www.zikaresponse.org/news/
ZIKA VIRUS: MEDICAL COUNTERMEASURE DEVELOPMENT CHALLENGE
With the sudden emergence of Zika virus as an evolving epidemic we are confronted with the need to simultaneously study and understand a new disease and to develop countermeasures. In many ways Zika presents a much more complex challenge than Ebola, and it may impact more lives. It is vector borne, and therefore its range of transmission will be determined by vector ecosystem. It cannot be significantly contained by limiting movement or contact of people. Acute infection may be unapparent, so patients cannot be quarantined. It exerts its most devastating effects on the unborn fetus with a delay to diagnosis. The transplacental pathology is not understood. Zika virus associated disease has an autoimmune component. It is epidemic in a region with a high degree of global connectivity; cases will be widely disseminated. The Zika epidemic is moving very rapidly. Research reagents, animal models, and fundamental science knowledge are much less well developed than they were for Ebola. On the other hand, decades of experience with dengue, yellow fever, and West Nile have equipped us with familiarity with ADE and flavivirus vaccine development strategies. Zika virus is likely a harbinger of future diseases driven by ecosystem change and global interconnectedness.
Perhaps the biggest challenge with Zika will be to recognize it for what it is: a new disease which does not fit the epidemiology or response paradigm of Ebola or dengue and which will demand effort, resources, unparalleled collaboration, and above all open mindedness in formulating responses.(Click here to go to the manuscript)
February 17, 2016
https://web.archive.org/web/20160219202858/http://www.zikaresponse.org/news/
WHO reveals its shopping list for weapons against Zika:
Check it out in The Lancet!
February 17, 2016
Detection and sequencing of Zika virus from amniotic fluid of fetuses with microcephaly in Brazil
Another new paper today in The Lancet
FEBRUARY 17, 2016
A surge in the number of Zika virus cases in tandem with a rise in cases of a severe birth defect is leading scientists to consider an intriguing possibility: Perhaps it’s not just one causing the other.
Instead, some researchers are theorizing that Zika is contributing to an unexpectedly high rate of side effects because it is spreading in a population in which a large number of people have been previously infected with a closely related virus, dengue.
The theory — and it’s only that right now — is that prior infection with one or more of the four dengue viruses may be contributing to a spike in Brazil’s cases of neurological complications among some adults infected with Zika and cases of microcephaly — underdeveloped heads and brains — in some infants born to women infected with the virus during pregnancy.
Dengue — which, like Zika, is primarily transmitted by mosquitoes — is common in Brazil and other countries where Zika outbreaks have been occurring in the past couple of years.
Read more: What you should know about the birth defect tied to Zika virus
“It’s an idea that’s on the table at the moment. A number of people have been talking about it,” Christopher Dye, director of strategy in the office of the director general of the World Health Organization, said in an interview.
Dr. Michael Diamond, an expert on viral immunology, told STAT that dengue experts are focused on the theory that the disease could be playing a role in Zika’s apparent change in behavior. For decades the virus caused few human cases and the people who contracted it experienced only mild illness.
“I think it’s in the back of all of our minds,” said Diamond, who teaches at Washington University School of Medicine in St. Louis. “We don’t know. But I think those of us in the field think it could.’’
A soon-to-be published study from French Polynesia, which had a Zika outbreak in 2013-14, may support the idea. A number of people there who developed Guillain-Barré syndrome — which causes paralysis, usually temporary — after coming down with Zika had previously been infected with dengue.
Still, experts caution that the theory is only one of several. Others have mused that Zika virus has simply mutated over the past couple of years, causing it to behave differently than it has in the past.
Read more: Can scientists outsmart the mosquitoes carrying Zika virus?
Zika, which belongs to the flavivirus family, is closely related to the four dengue viruses. (The four dengue viruses are called serotypes.) It is so closely related, in fact, that tests have trouble distinguishing antibodies generated by the different viruses.
With some viruses — take influenza, for instance — exposure is easier to fight off when a person has already encountered a related virus. The antibodies a person’s system already generated can help combat the new threat.
Dengue is a different beast. Infection with one of the types of virus will render a person immune against that type for life — but will offer no protection against the others. In fact, getting infected with a second type of dengue raises the risk that a person will develop severe disease — dengue hemorrhagic fever — which can be life-threatening.
The phenomenon is called antibody-dependent enhancement. Antibodies to the first dengue strain that a person encounters actually help a second dengue virus trigger worse disease.
If a person has the enormous bad fortune of experiencing three or four dengue infections, the risk starts to decline again. Diamond said the greatest risk of enhanced disease is seen with the second infection.
He outlined how this still-hypothetical scenario might work: Women with antibodies to dengue viruses might develop higher levels of virus in the blood if they contract Zika virus. Those higher levels of virus in the blood might allow Zika to occasionally cross the placenta into the fetus, and trigger infection that damages its developing brain.
“Certainly what we know about the interactions between dengue serotypes suggests that this kind of thing is not impossible in a virus of this sort,” the WHO’s Dye said.
Read more: Scientists on remote island unravel Zika’s mysteries
With Guillain-Barré syndrome, some researchers speculate that multiple infections of dengue or related viruses might increase the risk that the immune system might turn on itself, leading to paralysis, suggested Dr. Carlos Pardo-Villamizar, a neurologist at Johns Hopkins School of Medicine in Baltimore, who has been working in Colombia on the Zika response there.
Diamond wonders whether the phenomenon might work in reverse — whether people who have contracted Zika and then go on to be infected with dengue might be at higher risk of having severe dengue infections.
If the theory about dengue compounding Zika’s side effects turns out to be true, it will be good news for places — such as most of the continental US — where dengue viruses have not circulated. It would mean the risk posed by Zika might be lower than currently expected.
Public health authorities in the US have said local spread of Zika virus could occur in parts of the country where the right type of mosquitoes circulate. But they do not currently expect the large explosive type of outbreak being experienced across South and Central America and the Caribbean.
February 18, 2016
Zika virus: Scientists 'on the verge' of linking disease to paralysing Guillain-Barre syndrome
https://web.archive.org/web/20160219202858/http://www.zikaresponse.org/news/
Scientists found persistent infection from Zika can trigger a chain reaction, causing the immune system to go rogue and attack the nerves Link here for full story
February 18, 2016
Why People Want to Believe the Zika Virus Is a Conspiracy
Of course, this Salon article is "preaching to the choir," but it is still a good read. This article also does not follow the money. Companies are making money on this hysteria. For each blog, website someone links to, advertising $$$ poor into the site. These companies work hard to make their conspiracy science articles go viral! Link to the article here.
http://www.wired.com/2016/02/zika-conspiracy-theories/
February 18, 2016
Zika Virus Rumors and Theories That You Should Doubt: NYT
Another great piece of writing by the New York Times debunking the latest round of conspiracy theories.
February 18, 2016
The Zika Situation: An Intelligence Failure?
Jim Wilson, MD is an independent voice in the public health intelligence/surveillance community and a member our our team. He likes to explore outside the box and his linked-in essays are always worth reading and thinking about.
"The hubris is beyond getting old. And the excuses pointing to a "need for more funding" hasn't produced results. At some point we should consider peer review of these operational entities and the mission we have all entrusted them with. Meanwhile, the lack of examination of this ongoing trend of intelligence failures in public health continues to empower and embolden these bureaucracies." Click here to go to the link.
February 18, 2016.
Former Ebola czar Ron Klain on Zika, pandemics, and the right way to respond
Ron Klain, former Ebola response coordinator for the White House, at his office in Washington.
WASHINGTON — It would be hard to blame Ron Klain for being distracted from his day job as general counsel at a venture capital firm. He was President Obama’s Ebola czar (officially, Ebola response coordinator) from October 2014 to February 2015. So even from outside government, he is following news about Zika virus day by day and informally offering counsel to his former White House colleagues.
Plus there’s the campaign; he coaches Hillary Clinton for every one of her debates.
But Zika was Topic A (mostly) as we sat down in his downtown office here this week. The conversation that follows has been edited and condensed.
Should we be worried about Zika?
Spring will come. Mosquitoes will come back to life in the United States. And we will have transmission of the disease. I understand why people are worried about that.
I don’t think it’s one of those horrific scenarios, but I think it is a public health risk to the United States and it needs a robust response.
What’s the biggest lesson from Ebola?
We learned a lot of things in the Ebola response that color how the administration will look at what it’s doing with Zika. The administration got behind the eight ball and we were playing catch-up all along on Ebola. And to their credit they are ahead of it on Zika.
In the case of Ebola, we submitted our emergency funding request to Congress the first week of November, six or seven weeks into the peak of the Ebola fear. President Obama has already sent a $1.8 billion funding request to combat Zika. So acknowledging the fears and trying to get at them preemptively is definitely a lesson learned.
Should there be a Zika czar?
I don’t think there needs to be a Zika czar.
I do think that it would make sense for perhaps the next president to set up a pandemic response directorate inside the National Security Council. We have a permanent directorate to manage threats from [weapons of mass destruction]. We have a permanent directorate to manage threats from climate change. We have a permanent directorate to manage threats from terrorism. We need one to manage threats from pandemics.
A pandemic czar?
Well, a person who is a senior White House staffer whose responsibility is pandemic preparation and response. That said, the whole czar thing is a big misnomer. I was in charge of the Ebola response at the White House. I didn’t feel very czar-like. Nor should someone. We’re a democratic society. We don’t have czars.
I’m not complaining. I’m just saying that one thing we have to understand about all these epidemic outbreak responses is we live in a society in America with a very diffuse and pluralistic health care system, right? So even the senior federal official working on one of these things doesn’t control what the governors do.
Even if someone, somehow, in our system — which would never happen — had power over all public officials, we have a largely private health care system in the United States. The Ebola response was powered largely by people who work for private organizations, nonprofit providers, agreeing to go volunteer to fight this disease.
Are you angling for pandemic coordinator?
No. I’ve had my experience dealing with one of these things and I’m very happy here living life in the private sector. That’s a job for someone else.
Zika has come up only a bit in the presidential campaign. Should the handling of it be an issue?
It probably will become one as time passes. I know that Secretary Clinton has come up with a statement about her approach, and some of the Republican candidates have. You’d hope that how a country fights an epidemic illness would not become a political issue. You’d hope we could agree that this is something where science and medicine should decide it — not politics.
Has your Ebola experience greatly deepened your interest in science and medicine?
No question. I was brought in to serve what was largely a bureaucratic function.
But in the course of doing it, it piqued my interest in how we as a country prepare for what’s coming. To me, Zika is front and center. But what America should really be concerned about is how prepared — or not — we are for a truly dangerous pandemic, which will come, sooner or later.
The Ebola experience was a bit of a test run for that. It was a relatively easy test run in the sense that Ebola is relatively hard to transmit, it broke out in three very small countries. And they were countries that were happy to accept outside help, well-aligned with the West, where we could send a few thousand troops to Liberia, and they’d be greeted as a welcome addition.
The world faces a pandemic threat that’s very different than that. Some kind of pandemic flu that is airborne and transmits very easily and very rapidly. It could break out in a global megacity, in a densely populated area, it could break out in a country where lots of travelers every day come to the United States. It could break out in a country where 3,000 US troops would not be welcome, where thousands of US volunteers would not be welcome. And I still think as a country and as a world, we’re not prepared for that.
You were the longtime top aide to Vice President Biden. What’s your take on his cancer moonshot?
It’s so hard to separate my feeling about his personal loss and his personal pain and just how hard it’s been for him and his family. But what’s great is seeing him turn that into an effort to help a lot of other families and turn that pain outward to how we can galvanize a stronger cancer response. He deserved credit for not overpromising. He hasn’t said that cancer will be gone in a year.
But isn’t it really tough as a lame duck to achieve what he wants?
It’s hard but I also think this is an issue where it will be hard for bureaucrats and agency heads to say no to him. Both because he is the vice president of the United States, and because of what has happened to him and his family. It’s hard: There are entrenched bureaucracies. There are entrenched budgets. There are entrenched perspectives. But between the irresistible force of Joe Biden and the immovable object of the bureaucracy, I would bet on the irresistible force of Joe Biden.
ALEX HOGAN/STAT
Are you at risk for contracting Zika virus? Your level of risk depends in part on your living conditions.
Rick Berke can be reached at rick.berke@statnews.co
February 18, 2016
Zika Virus Rumors and Theories That You Should Doubt: NYT
Another great piece of writing by the New York Times debunking the latest round of conspiracy theories.
UNAVAILABLE
https://web.archive.org/web/20160219203336/http://www.zikaresponse.org/projects/
PROJECTS
Dr. Robert Malone has discovered a class of drugs that act as anti-virals against Zika Virus, and which are safe for pregnant women. The World Health Organization is now advocating these drugs to be developed as a first defense for pregnant women!
For more information, please contact Dr. Malone directly at rwmalonemd@gmail.com
Dr. Jane Homan and her team have completed computational epitope analysis of Zika and comparative epitope analysis of related viruses [(Dengue virus (Den), Yellow Fever virus (YF), and West Nile virus (WN)] and the human proteome.
Dr. Daniel Janies and his team are developing Infectious disease outbreak modeling and forecasting for Zika Virus.
Dr. Jim Wilson has successfully surveyed physicians in the US, Mexico and Argentina via on-line tools, on the Zika Virus.
The team is moving forward on three more peer reviewed articles that will influence the science, epidemiology, drug and vaccine development and clinical care of patients with Zika. Join our newsletter for updates or check back into this site for more information.
THE TEAM HAS PRODUCED A WHITE PAPER, THAT WAS SUBMITTED IN JANUARY TO GOVERNMENT OFFICIALS AT THE HIGHEST LEVELS.
THE TEAM HAS PRODUCED A MANUSCRIPT SUBMITTED TO PLOS NEGLECTED TROPICAL DISEASES
A revised manuscript submitted to PLOS Neglected Tropical Diseases
Zika Virus: Medical Countermeasure Development Challenges
(Click on here to go to the manuscript)
FEBRUARY 19, 2016.
https://web.archive.org/web/20160228033731/http://www.zikaresponse.org/news/2016/2/19/stay-tuned-the-science-behind-zika-is-about-to-get-interesting
Stay Tuned... The Science Behind Zika Is About To Get Interesting!
Is there a smoking gun behind the GBS and the Zika Fetal Syndrome, many of us believe that there is. The dengue results from French Polynesia are suggestive and highly intriguing. Data will be coming out soon!
http://www.statnews.com/2016/02/17/zika-dengue-infections/
Dengue could be the surprise culprit making Zika worse, researchers say
FELIPE DANA/AP
Angelica Pereira feeds her daughter, who was born with microcephaly, in Santa Cruz do Capibaribe, Brazil.
February 19, 2016
The Zika Response Working Group is under the Infectious Outbreak Response Group, also known as iOrg (non profit status pending). The team is comprised of industry leaders, infectious and biothreat specialists, academics and thought leaders. Please peruse the bios of our team members, and think about how you can help. Because...right now, the world must work together to solve this crisis. If you are a person who has something to offer our program, please contact us! We are also accepting donations, and are looking for investors or philanthropists because the world can't move fast enough to find treatments and diagnostic options for women and children exposed to this virus.
Robert W. Malone, M.D., M.S. CEO and co-founder of RW Malone MD, LLC. Dr. Malone has extensive research and development experience in the areas of clinical trials, vaccines, gene therapy, bio-defense, and immunology. He has over twenty years of management and leadership experience in the academia, pharmaceutical and biotechnology industries. His FDA, HHS, and DoD agency knowledge is extensive. Dr. Malone is an internationally recognized scientist and is known as one of the original inventors of “DNA Vaccination.” Dr. Malone holds numerous fundamental domestic and foreign patents in the fields of gene delivery, delivery formulations, and vaccines. He has over fifty peer-reviewed publications, has been an invited speaker at over thirty-five conferences, has chaired numerous conferences and he has sat on numerous study sections. Dr. Malone is in the Harvard Medical School Global Clinical Scholars Program in 2015-2016.
In August 2014, colleagues at the Department of Defense/Defense Threat Reduction Agency asked Dr. Malone to step in and help NewLink manage the Ebola project and develop the contracts necessary to move the "orphan" PHAC/rVSV ZEBOV vaccine forward quickly. Dr. Malone got the project on track, recruited our client Focus Clinical Trials to team with USAMRIID/WRAIR to develop the immunoassays, put WHO leadership in touch with Pentagon leadership to expedite the initial WRAIR clinical trials, recruited the government of Norway to help fund the clinical research, used social media (LinkedIn) to recruit Merck Vaccines to join the project, recruited a management team, and lead the development of the BARDA and DTRA contracts - yielding over 200M$ in resources. Those were frightening times, but now we have a remarkably effective vaccine, developed in record time.
Jane Homan, Ph.D., MRCVS CEO and co-founder, ioGenetics. Jane is a veterinary epidemiologist and microbiologist who came to the biotechnology sector after 20 years international, research and administrative experience in academia, including field research in arbovirology in Latin America. The EigenBio uTOPE™ analysis is a powerful immunoinformatics system developed at ioGenetics. uTOPE™ analysis enables integrated mapping of proteins to identify predicted B-cell epitopes, predicted MHC-I and MHC-II binding affinity and cross presentation across abroad array of HLA types, and protein topology mapping. The statistical methods underlying uTOPE™ mapping are based on principal component analysis of amino acids. The analytical output can be portrayed in high data-density graphs of epitope maps, in which patterns of epitope distribution are shown. uTOPE™ mapping is applicable to proteins of any source including microbial, mammalian, plant or synthetic biopharmaceutical proteins. A high throughput system, uTOPE™ analysis can be applied to whole microbial proteomes, or to compare epitopes conserved across microbial strains or protein isotypes. uTOPE™ analysis provides a reasoning environment for design of vaccines, diagnostics and antibodies, as well furthering the understanding of the immune response. It has applications in infectious diseases, allergy, autoimmunity and cancer biology.
Daniel Janies, PhD The Carol Grotnes Belk Distinguished Professor of Bioinformatics and Genomics, University of North Carolina at Charlotte. Dr. Janies received a Bachelor of Sciences degree in Biology from the University of Michigan in 1988 and a Ph.D. in Zoology from the University of Florida in 1995. Dr. Janies worked as a postdoctoral fellow (1996 - 1999) and a principal investigator (2000-2002) at the American Museum of Natural History in New York City where he lead a team that, using off-the-shelf PC components, built one of the worlds largest computing clusters in 2001. Most recently Dr. Janies was a tenured faculty member in the College of Medicine at the Ohio State University. Dr. Janies is a national principal investigator in the Tree of Life program of the National Science foundation and is funded by the Defense Applied Research Projects Agency. His work involves empirical studies of organismal diversity and development of software, such as Supramap. Supramap is used by public health scientists to put pathogen genomic data into context with geography and hosts. The results are akin to weather maps for disease.
Jim Wilson, MD FAAP CEO, Founder M2, Nevada State Infectious Disease Forecast Station @ UNR, University of Nevada Reno. Dr. Wilson founded the analytic discipline of indication and warning signature processing for infectious disease events. He is a world authority on operational infectious disease forecasting and event signature processing. Dr. Wilson led the creation of the Haiti Epidemic Advisory System (HEAS), the first infectious disease forecasting station in the world. The HEAS provided first public warning of the cholera disaster in Haiti as well as the first public announcement of the disaster's origins as the UN Mirebalais base. Since then, he has created several additional forecast stations, including the first operational station inside the US. Dr. Wilson led the team that provided warning of the 2009 H1N1 pandemic to CDC and WHO. He was the Principal Investigator of Project Argus, Chief of the Argus Research Operations Center, and Division Head of Integrated Biodefense at the Imaging Science and Information Systems Center, Georgetown University. He conceptualized and created the Biosurveillance Indication and Warning Analysis Community (BIWAC) for the US government. He was a member of the Department of Homeland Security National Biosurveillance Integration System (NBIS) Concept Design Review team and the first Chief of Analytic Operations at the National Biosurveillance Integration Center (NBIC).
Dr. Wilson has served as a Special Assistant to the Director for Weapons of Mass Destruction at the US Army Medical Research and Materiel Command Telemedicine and Advanced Technology Research Center (USAMRMC-TATRC), Ft. Detrick, Maryland; Visiting Scientist at NASA-Goddard Space Flight Center; consultant to NOAA’s National Environmental Satellite, Data, and Information Service (NESDIS); and research team member of the World Health Organization Tai Forest Project on Ebola Hemorrhagic Fever.Jill Glasspool Malone, Ph.D. President and co-founder, RW Malone MD, LLC. Dr. Glasspool has experience in preclinical, regulatory, and clinical project management, with special expertise in public policy and Federal regulatory issues. Dr. Glasspool has held supervisory and management positions in the biotechnology industry and academia. She also was a co-founder of Inovio, USA, and Intradigm. She has an extensive publication record in vaccination and gene therapy, as well as behavioral research and is currently enlisted in the Harvard Medical School Global Clinical Scholars Program 2015-2016.
Stefanie M. Hone, M.S. has over sixteen years of experience in immunology of infectious disease, with a focus on pre-clinical and clinical assay development and validation. In this capacity, she has worked on immune assay development for diseases such as Tuberculosis, HIV, Toxoplasmosis, Tularemia, Plague, Botulinum, Influenza and Travellers Diarrhea. As a result of her broad experience in advanced vaccine development, she has gained proficiency in GLP/GCLP/GMP quality systems, the FDA “Animal Rule”, and is adept in writing validation protocols, study protocols, study reports, analytical testing plans, SOPs and equipment IOQs to meet regulatory requirements. She also has successfully contributed to CMC sections, managed the preparation of regulatory documents in support of IND submissions and as a participant in FDA Type C meetings in support of phase 3 clinical trials. Mrs Hone received her M.S. in Biophysical Chemistry and Biochemistry from the University of Frankfurt, Germany.
Mr. Jeffry J. DiFrancesco Jeffrey is the Founder and Executive Director for Avancer Group, Inc. and its predecessor company BioPharm CA, Inc. His professional conviction is "Closing the gap between vision and reality!" Professionally, Jeffrey has over twenty-five years of corporate and life science related experience. He has held numerous senior positions – including chief executive, chief financial, chief operating and chief strategic planning officer – and has served as a member of the board of directors of public and private organizations. As an executive, he has planned and commercialized new businesses and product lines, and managed day-to-day profit-loss, operations and global strategic investments. Jeffrey has also orchestrated major transactions including $1.3 billion in public securities, $100 million in divestures, $1 billion in acquisitions, and $30 million in private securities. As a management consultant, he has advised many emerging and Fortune 500 organizations. As a thought-leader, Jeffrey has published original research in peer-reviewed journals, chaired and spoken at over 40 industry international conferences, and has been quoted and interviewed by numerous industry trade journals. In addition, he is a recipient of industry recognitions and corporate awards. Academically, Jeffrey is an adjunct Assistant Professor of Pharmaceutical Business, Mayes College of Healthcare Business and Policy, University of the Sciences in Philadelphia. He teaches graduate courses in capital investment and finance and performs primary research on the operational performance of clinical trials. He has also been an Adjunct Professor at St. Joseph's University Graduate Program and an adjunct faculty member at Drexel University's Bennett S. Lebow College of Business. Educationally, Jeffrey holds a Master of Science in Finance from Johns Hopkins University, a Master of Engineering in Engineering Science from Penn State University, and a Bachelor of Science in Mathematics from Illinois Institute of Technology. He also has certificates in mergers and acquisitions from the Wharton School of the University of Pennsylvania, Level 1 Change Agent from Conner Partners, and Black Belt Six Sigma from Goodwin College of Drexel University.
Sean J. Hart, Ph.D – President & Chief Executive Officer of LumaCyte. Dr. Hart is the President and Chief Executive Officer of LumaCyte, a revolutionary research, instrumentation and diagnostics company headquartered in Charlottesville, VA. Dr. Hart and his team developed the technology behind LumaCyte’s label-free analysis and sorting platforms while working on systems for biowarfare defense at the Naval Research Laboratory (NRL), with funding from both NRL and the Defense Threat Reduction Agency (DTRA). LumaCyte’s technologies provide biopharmaceutical companies with a powerful new tool to detect changing cell phenotypes in drug candidates. The technology can also rapidly detect viral infection in mammalian cells, which is useful for infectivity studies for viral vectors and live/attenuated vaccine development and production.
James D. Talton, Ph.D., Co-founder, President and Chief Executive Officer or Nanotherapuetics. Prior to founding Nanotherapeutics, Dr. Talton served as the President and Chief Executive Officer of D&E Management Systems, a leading service organization in Florida. Dr. Talton is a co-inventor of Nanotherapeutics' technologies and has authored several peer-reviewed publications and book chapters involved in drug delivery systems with a primary focus in drug analysis and controlled release formulations, pharmacokinetics, and pulmonary drug delivery. Dr. Talton received his B.S. and M.S. in Materials Science and Engineering and his Ph.D. in Pharmaceutical Sciences from the University of Florida. Dr. Talton is also a Director of BioFlorida, on the Advisory Council at Keck Graduate Institute, and has been a reviewer for the NIH for over ten years.
Ron Cobb, PhD, Chief Scientific Officer Dr. Cobb joined Nanotherapeutics in 2011. As Chief Scientific Officer, Dr. Cobb is responsible for the development of novel vaccines, biologics, and medical devices. He also works to help procure outside funding for the company’s strategic programs. During his tenure at Nanotherapeutics, Dr. Cobb led project teams focused on recombinant protein based drug and vaccine development as well as medical device development. Prior to joining Nanotherapeutics, he was Director of Research and Development at RTI Biologics. Under his leadership over 20 new products and line extensions were launched and a stem cell based technology was initiated. He also spent 7 years as Head of Protein Expression and Purification Group at Berlex Biosciences (subsidiary of Schering, AG). He has over 20 years of experience in biopharmaceutical and medical device Research and Development and has provided molecular biology expertise to numerous projects ranging from early stage research to supporting protein expression and purification for a Phase II clinical program. He has over 40 peer-reviewed publications and book chapters and has been a reviewer for several different journals for over 10 years.
Ivan Ruzic, Ph.D., President of Analytical Outcomes. Dr. Ruzic has served in a variety of senior executive leadership roles for multiple technology companies both domestically and internationally. Scientifically trained, he is an analytically-focused executive with the ability to identify and execute the concrete tasks that produce results. An accomplished team builder, Dr. Ruzic has consistently demonstrated his leadership skills by initiating significant change in both startup and established business environments. More recently, Dr. Ruzic has focused on the transformative potential of Big Data and has pioneered the application of sophisticated Big Data analytics to issues of national security, public health, economics and electoral politics at both state and federal levels. Dr. Ruzic received his B.Sc. in Chemistry and Biochemistry as well as a Ph.D. from Monash University, Melbourne, Australia. He also holds a Masters equivalent in Information Technology from Chisholm Institute of Technology (now part of Monash University).
Other members of our team include Adriano De Bernardi Schneider (doctoral student), Adriano's contributions have been invaluable to the group. Rebecca Zimler (doctoral student), and Lambodhar Damoaran (intern). Their contributions have been significant and we appreciate their hard work!
February 19, 2016.
https://web.archive.org/web/20160229084542/http://www.zikaresponse.org/news/2016/2/19/former-ebola-czar-ron-klain-on-zika-pandemics-and-the-right-way-to-respond
"Former Ebola Czar Ron Klain on Zika, Pandemics and the Right Way to Respond"
"The Ebola response was powered largely by people who work for private organizations, nonprofit providers, agreeing to go volunteer to fight this disease." Well, isn't that the truth and these words coming from the former Ebola Czar! So many of us on this team are working so hard, with no compensation and we are not alone.
But his idea that it would:
"make sense for perhaps the next president to set up a pandemic response directorate inside the National Security Council. We have a permanent directorate to manage threats from [weapons of mass destruction]. We have a permanent directorate to manage threats from climate change. We have a permanent directorate to manage threats from terrorism. We need one to manage threats from pandemics"
...is excellent!Click here to link to the full story
Source: http://www.statnews.com/2016/02/18/ron-klain-zika-virus/
February 22, 2016.
CDC Arrives In Brazil To Investigate Zika Outbreak": NPR
UNAVAILABLE
February 26, 2016.
https://web.archive.org/web/20160410060405/http://www.zikaresponse.org/news/2016/2/26/cdc-issues-advice-for-travel-to-the-2016-summer-olympic-games
UNAVAILABLE
February 27, 2016.
The World Health Organization has asked Dr. Robert Malone to come to Geneva for three days next week -March 7-9 for the first meeting about research and development about Zika. The WHO is paying all expenses for this trip.
His recent discoveries about classes of anti-viral drugs to fight Zika, as well as our work to design clinical trials to test them rapidly (to be deployed within months), have the potential to make a huge difference in the world. Last night, he connected some dots, which will change a lot of the science and understanding of Zika. Talk about a tunnel though - most of the team doesn't sleep much these days. We work, we discuss, we research, we write, we communicate. We of course, are mostly doing this pro bono -so the money situation is dicey. We are hopeful that will improve soon.
We still need help though. Donations, of course (we have yet to receive a single dime). But we could sure use a lawyer to help get the pending non-profit iORG through the process of approved non-profit status.Also, so proud also of my dear friend Steffi Hone, who is here working her butt off with us. She is brilliant and amazing. Like us, her work is pretty much pro bono at this point.
March 4, 2016
Atheric Pharmaceutical LLC is providing solutions for Zika
https://web.archive.org/web/20160822020856/http://www.zikaresponse.org/news/
SOME OF OUR ZIKA RESPONSE WORKING GROUP MEMBERS HAVE STARTED A NEW COMPANY CALLED ATHERIC PHARMACEUTICAL LLC. ATHERIC PHARMACEUTICAL LLC ("ATHERIC(TM)") IS A BIOPHARMACEUTICAL COMPANY FOCUSED ON THE RAPID DEVELOPMENT AND COMMERCIALIZATION OF RE-PURPOSED DRUGS TO PREVENT AND TREAT ZIKA AS WELL AS FLAVIVIRUS DISEASE. ATHERIC(TM)'S LEAD DRUG PRODUCTS, HYDROXYCHLOROQUINE AND AMODIAQUINE, ARE REFORMULATED BROAD SPECTRUM 4-AMINOQUINOLINE-CLASS ANTIVIRAL DRUGS THAT INHIBIT AUTOPHAGY-DEPENDENT VIRAL REPLICATION. ATHERIC IS COMMITTED TO PROVIDING BROAD-SPECTRUM MEDICAL COUNTERMEASURES FOR ZIKA AND OTHER NEGLECTED TROPICAL DISEASES. PROVISIONAL PATENTS COVERING THE USED OF THESE COMPOUNDS FOR ZIKA AND OTHER FLAVIVIRUSES HAVE BEEN FILED WITH THE US PATENT AND TRADEMARK OFFICE. CLINICAL TRIALS TO DETERMINE CORRECT DOSING AND PROPRIETARY FORMULATIONS APPROPRIATE FOR THE INDICATED THERAPIES ARE BEING RAPIDLY DEVELOPED. REGULATORY DISCUSSIONS WITH FDA HAVE BEEN INITIATED.
Zika outbreak medical countermeasure (MCM) strategies have been identified, with the most promising MCM available for expedited clinical testing identified being re-purposed anti-malarial drugs Of these, the most suitable for immediate clinical testing for use in protecting against the Zika Virus infection; to prevent development of Zika Virus fetal syndrome and GBS have been identified. Provisional patents covering the used of these compounds for Zika and other Flaviviruses have been filed with the US Patent and Trademark Office. Clinical trials to determine correct dosing and proprietary formulations appropriate for the indicated therapies are being rapidly developed. Regulatory discussions with FDA have been initiated. Zika virus has been postulated as playing a key role in the pathogenesis of Zika-associated primary microcephaly and GBS. The anti-malarial drugs under pending patents are autophagy inhibitors, and in vitro testing has demonstrated efficacy. Of interest is that these drugs have been safely used during pregnancy, and cross the placenta enabling clinically significant pharmacodistribution to both mother and fetus. Systemic literature review with meta- analysis indicates that prenatal exposure to these drugs during maternal autoimmune disease treatment does not appear to increase the risk of adverse pregnancy outcomes, except those associated with the underlying disease.
March 8, 2016
"Nobody wanted to believe antibody-dependent enhancement. The only problem is it’s true. "
Q&A with Scott Halstead: Zika will subside in ‘5 years, max’
in Science Magazine, AAAS March 2016
"What might be the mechanism behind Zika virus harming fetuses? A: I think dengue antibody is complexing with Zika virus and the immune complex is infecting monocytes so you have a much higher amount of virus produced. Maybe above a certain concentration of virus you begin to get virus spilling over into placenta.
Q: When you proposed that antibodies against the four different strains of dengue could enhance the virus you weren’t immediately celebrated for the idea. A: Let me tell you something, it’s no fun to discover something that nobody wants to hear. I’ve always thought to myself I really discovered something pretty important, but actually it’s kind of horrible: People are making antibodies and killing themselves. Nobody wanted to believe antibody-dependent enhancement. The only problem is it’s true. "
"It absolutely would not surprise me to find that dengue antibodies enhance Zika infections and that this entire sweep of Zika across the Pacific and into South America has all been promoted and propelled by enhancement."
Click here for the full article
March 17, 2016
Therapeutic efficacy of the small molecule GS-5734 against Ebola virus in rhesus monkeys
Nature. 2016 Mar 2. doi: 10.1038/nature17180. [Epub ahead of print]
Therapeutic efficacy of the small molecule GS-5734 against Ebola virus in rhesus monkeys.
https://web.archive.org/web/20160822020856/http://www.zikaresponse.org/news/
Abstract
The most recent Ebola virus outbreak in West Africa, which was unprecedented in the number of cases and fatalities, geographic distribution, and number of nations affected, highlights the need for safe, effective, and readily available antiviral agents for treatment and prevention of acute Ebola virus (EBOV) disease (EVD) or sequelae. No antiviral therapeutics have yet received regulatory approval or demonstrated clinical efficacy. Here we report the discovery of a novel small molecule GS-5734, a monophosphoramidate prodrug of an adenosine analogue, with antiviral activity against EBOV. GS-5734 exhibits antiviral activity against multiple variants of EBOV and other filoviruses in cell-based assays. The pharmacologically active nucleoside triphosphate (NTP) is efficiently formed in multiple human cell types incubated with GS-5734 in vitro, and the NTP acts as an alternative substrate and RNA-chain terminator in primer-extension assays using a surrogate respiratory syncytial virus RNA polymerase. Intravenous administration of GS-5734 to nonhuman primates resulted in persistent NTP levels in peripheral blood mononuclear cells (half-life, 14 h) and distribution to sanctuary sites for viral replication including testes, eyes, and brain. In a rhesus monkey model of EVD, once-daily intravenous administration of 10 mg kg-1 GS-5734 for 12 days resulted in profound suppression of EBOV replication and protected 100% of EBOV-infected animals against lethal disease, ameliorating clinical disease signs and pathophysiological markers, even when treatments were initiated three days after virus exposure when systemic viral RNA was detected in two out of six treated animals. These results show the first substantive post-exposure protection by a small-molecule antiviral compound against EBOV in nonhuman primates. The broad-spectrum antiviral activity of GS-5734 in vitro against other pathogenic RNA viruses, including filoviruses, arenaviruses, and coronaviruses, suggests the potential for wider medical use. GS-5734is amenable to large-scale manufacturing, and clinical studies investigating the drug safety and pharmacokinetics are ongoing.
Click here for the full article.
March 19, 2016
https://web.archive.org/web/20160322072039/http://www.zikaresponse.org:80/news/2016/3/19/xi924bwzcsifhvp0vpicbr8op1h5ds
"Zika-linked microcephaly was rare in early cases, but it’s only ‘tip of the iceberg’"
"IN A COMMENTARY RODRIGUES WROTE FOR THE LANCET, SHE USED NIELSEN-SAINES’ DATA TO SUGGEST THAT THE RISK OF MICROCEPHALY AFTER A FIRST TRIMESTER INFECTION MIGHT BE AS HIGH AS 22 PERCENT. RODRIGUES TEACHES AT THE LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE.
SHE AND CAUCHEMEZ AGREED THAT THE TRUE PICTURE IS STILL COMING INTO FOCUS, AND THERE WILL BE MORE EVIDENCE ON WHICH TO MAKE SUCH ESTIMATES SOON. NIELSEN-SAINES AND HER GROUP PLAN TO ISSUE AN UPDATE ON THE WOMEN THEY ARE FOLLOWING — THE COHORT NOW HAS 300 PREGNANT WOMEN REGISTERED — IN THE NEXT TWO MONTHS. OTHER GROUPS IN BRAZIL AND COLOMBIA WILL ALSO BE REPORTING RESULTS.
LIKEWISE, CAUCHEMEZ NOTED THAT, AS NIELSEN-SAINES REPORTED, THERE IS A SPECTRUM OF NEUROLOGICAL HEALTH PROBLEMS IN BABIES BORN TO WOMEN WHO WERE INFECTED WITH ZIKA DURING PREGNANCY. AND PROBLEMS ARE EVIDENT EVEN WHEN THE WOMEN WERE INFECTED IN THE SECOND AND THIRD TRIMESTERS.
“IT’S NOT SAYING ‘IF YOUR CHILD ISN’T MICROCEPHALIC, HE’S FINE.’ THERE COULD BE OTHER COMPLICATIONS,” HE NOTED."
"A RECENT STUDY BY AMERICAN AND BRAZILIAN SCIENTISTS REPORTED THAT ABNORMALITIES WERE SEEN IN 29 PERCENT OF FETUSES CARRIED BY A GROUP OF WOMEN WHO WERE CONFIRMED TO HAVE BEEN INFECTED WITH ZIKA DURING PREGNANCY."
“I PERSONALLY THOUGHT THAT MICROCEPHALY WAS JUST THE TIP OF THE ICEBERG, THAT THERE WAS A WHOLE HOST OF CONDITIONS ASSOCIATED WITH THIS INFECTION — WHICH MAKES SENSE WITH ALL WE KNOW ABOUT CONGENITAL INFECTIONS,” SHE SAID. “THERE’S NEVER ONLY ONE FINDING. THERE’S ALWAYS A SYNDROME, YOU KNOW? MANY THINGS.” CLICK HERE FOR THE FULL STORY.
March 23, 2016
https://web.archive.org/web/20160822020856/http://www.zikaresponse.org/news/
Zika Innovation Hack-a-thon
An urgent call to develop innovations that address the spread of the Zika virus and other vector-borne diseases
Attention designers, engineers, clinicians and all innovators! We need your knowledge and expertise for a 48-hour hack-a-thon to create new product concepts, design novel personal protective equipment and develop new methods for local vector control that will help bend the curve of the Zika epidemic and similar outbreaks. Join us and be part of the solution!
Even better yet! The Zika Response Working Group has members from our UNC Charlotte team participating. We can't wait to see what they come up with -UNC Charlotte team:
Adriano de Bernardi Schneider
Gregorio Linchangco
Denis Jacob Machado (University of Sao Paulo - visiting scholar at UNCC)
Click here to go to the Zika Innovation Hack-a-thon website!
March 24, 2016
"Scientists advance in medicine to prevent spread of the zika virus"
"A group of scientists has advanced in the search for a remedy to prevent the spread of the virus zika. Conducted mainly by Americans, the study is in the preclinical phase and is made ith existing drugs, such as those used to contain malaria. The goal is that clinical trials are carried out before the 2016 Olympic Games, which begin in August in Rio de Janeiro .
"We need other options while vaccines are being developed. An important finding is that we have identified drugs that have activity (in laboratory tests) against the virus zika," said Robert W. Malone, director of pharmaceutical Atheric Pharmaceutical and part of the group Zika Response working Group.
It is expected to be required at least three years for the vaccine virus to be ready. To date, there are 23 vaccine projects in development in the US, France, Brazil, India and Austria, according to WHO. The organization also said he believes the vaccine will be ready only after the end of the outbreak of the virus .
"We are accelerating the development of these drugs in cooperation with the WHO, the US Department of Health and hope to start working together with the Ministry of Health of Brazil, PAHO and Fiocruz," said Malone.
According to the scientist, tests involving cell infection in vitro by Zika virus and further combat with different drugs. The medicine to fight malaria, such as amodiaquine, showed satisfactory results. The first tests show that the compound can block infection of cells by the virus, says the researcher.
The amodiaquine has been used in the past in Brazil to treat malaria, explains Andrew Smith, a researcher at the National Institute of Infectious Diseases Evandro Chagas, Fiocruz. It is one of the active ingredients of a low-cost remedy used in African countries malaria. The cost ASAQ in 2014, less than US $ 1 for the treatment of three days given to adults, according to Sanofi manufacturer.
Our focus is on prophylactic drugs to be made available for a low cost worldwide and are safe for use by pregnant women. It is much easier to prevent infection than to cure an existing one. But it is too early to speculate that "
The US group plans to begin clinical trials in humans before the Olympic Games in 2016. For this, Malone says it will take "hard work and luck", as well as resources for research. If these remedies become effective, they can get to Brazil after approval of ANVISA (National Health Surveillance Agency). "
To read the story in UOL, click here
Gabriel Francisco Ribeiro
From UOL in São Paulo03/24/2016 (auto -translation)
March 24, 2016.
A group of scientists has advanced in the search for a medicine that prevents contagion by the zika virus. Conducted mainly by Americans, the study is in the pre-clinical phase and is carried out with drugs that already exist, such as those used to contain malaria. The goal is for clinical trials to be carried out before the 2016 Olympic Games, which begin in August in Rio de Janeiro.
"We need other options while vaccines are being developed. An important discovery is that we have identified drugs that have activity (in laboratory tests) against the Zika virus," explained Robert W. Malone, director of Atheric Pharmaceutical and part of the group Research Center Zika Response Group.
It is expected that it will take at least three years for vaccines against the virus to be ready. So far, there are 23 vaccine projects under development in the US, France, Brazil, India and Austria, according to the WHO. The entity also stated that it believes that the vaccine will only be ready after the end of this virus outbreak.
"We are accelerating the development of these drugs in cooperation with the WHO, the US Department of Health and we hope to start working together with the Brazilian Ministry of Health, PAHO and Fiocruz", explains Malone.
According to the scientist, the tests involve the contamination of cells in vitro by the zika virus and the subsequent combat with different drugs. Medicines that fight malaria, such as amodiaquine, showed satisfactory results. The first tests indicate that the compound can block the infection of cells by the virus, says the researcher.
Amodiaquine has already been used in the past in Brazil to treat malaria, explains André Siqueira, a researcher at the Evandro Chagas National Institute of Infectology, at Fiocruz. It is one of the active principles of a low-cost medicine used in African countries against malaria. ASAQ cost, in 2014, less than US$ 1 for the three-day treatment given to adults, according to information from the manufacturer Sanofi.
Our focus is on prophylactic drugs that can be made available at low cost worldwide and that are safe for use by pregnant women. It is much easier to prevent an infection than to cure an existing one. But it's too early to speculate on that."
The North American group intends to start clinical trials in humans even before the 2016 Olympic Games. For that, Malone says that it will take "a lot of work and luck", in addition to resources for research. If these remedies become effective, they may arrive in Brazil after authorization by Anvisa (National Health Surveillance Agency).
March 25, 2016
Zika virus response: The rise of the BioNerds?
Watching the Zika literature roll out, I am amazed at how decentralized the authors, countries of origin, and institutions are. There are important contributions to the peer reviewed literature being made from a wide range of non-aligned groups (non-government, non-university), and from a wide range of countries and institutions that are often relegated to publication in obscure journals.
While attending the recent WHO Zika R&D consultation, one theme that surprised me was that important scientific and epidemiologic contributions had been blocked from publication in major journals such as Nature etc., apparently because the submitting authors and institutions were considered of insufficient status and merit. So the world (including US CDC/HHS and WHO) slept while Brazil burned. One response has been for many of the established scientific journals to change their policies regarding publication, and to allow the use of pre-print servers without compromising publication rights.
In the face of the leadership vacuum of the USG and WHO, many others are now stepping in to fill the void. Our group (Zika Response Working Group andAtheric Pharmaceutical LLC) has been at the forefront of this wave, but now I am seeing many other non-aligned groups (meaning non-Governmental, non-University, and not associated with established NGO) forming and making important contributions. PATH, Bill and Melinda Gates Foundation, Paul Allen, and others seem to be waiting on the sidelines. Only the Wellcome Trust has responded promptly.
The US flavivirus "establishment" including the epidemiology group @ Yale, Scott Weaver @ UTMB, CDC, NIAID, BARDA are contributing very little to this first wave of publications and knowledge.
I speculate that what we are seeing is the awakening of decentralized, non-institutional biology. The rise of a new cadre of Bionerds.
Of course, my colleagues in the intelligence and Defense Threat Reduction communities will immediately recognize the threat that this represents.
DTRA and the IC have long recognized the biosecurity threat that would manifest if garage biology became a reality.
What is happening with Zika, I suggest, is that the failure of large institutions (government, worldwide organizations and academia) to provide effective leadership and agile response capability has now become self evident to the world.
The R&D emphasis of WHO and HHS are exclusively focused on vaccines and diagnostics. There is a complete failure to recognize that the timelines for development of a vaccine are mis-matched with the rate of spread of Zika virus. At best, we will have a vaccine 2-3 years after most susceptible populations have been infected. WHO and HHS have no interest in supporting development of re-purposed drug, antibody and other biologics countermeasures, even those are the only solutions which have any chance of providing timely benefit to the tens to hundreds of millions of people at risk.
The large pharmaceutical companies are largely waiting this out because they spent a lot of treasure and time to try to support the world response to Ebola, and have provided virtually no return on investment to their shareholders. There are still no licensed drugs, immunotherapeutics or vaccines for Ebola, so no profit.
The failure of the world community to fund the WHO effort to respond to Zika is actually an implicit indictment of WHO leadership. Countries appear unwilling to trust WHO with their money. Similarly, the failure of the US Congress to fund HHS Zika research objectives is an implicit indictment of HHS leadership.
And into the breach, we are seeing a diverse global community of biologists step in. BioHacking.
This will have consequences. The good news is that this diversity of opinions and effort are enabling innovation and circumventing the myopic focus of WHO and HHS on vaccines as the only viable countermeasure.
But once this happens, and you have a swarm of BioNerd tinkerers that feel empowered, then pandora's box will be opened and all kinds of things will jump out. Custom DNA and RNA synthesis has become a routine commodity, available all over the world. With the advent of CRISPR-Cas9 technology, commodity genetic modification of a wide range of organisms (including human) will soon follow. The fantastic dystopic visions of Philip K Dick and Ridley Scott are now upon us.
Not just one pandora's box, but multiple, all over the world.
This is happening now, before our eyes.
Zika is changing our world in many ways.
Things may never be the same again. I think that I can say that more assertively. Things will never be the same again.
Welcome to a world inhabited by empowered garage BioNerds.
Written by Robert W Malone, MD, MS: CEO/Atheric Pharmaceutical LLC
March 26, 2016
https://web.archive.org/web/20160412121720/http://www.zikaresponse.org/news/2016/3/26/vqq4iac1utou2zx39ucvmg3llvpwir
BELOW IS A TIMELINE OF OUR ACCOMPLISHMENTS AND CONTRIBUTIONS TO THE FIGHT AGAINST THE ZIKA VIRUS. THE ZIKA RESPONSE GROUP, GOING AT THIS 24/7 HAS DONE AMAZING WORK AND HAVE MADE A DIFFERENCE: AND MOST OF IT HAS BEEN A VOLUNTEER EFFORT. THE GOOD NEWS IS THAT WE AREN'T FINISHED YET- SO KEEP CHECKING BACK FOR MORE DISCOVERIES, INSIGHTS AND MAYBE EVEN FURTHER DEVELOPMENT OF AN ANTI-VIRAL DRUG THAT COULD SAVE LIVES!
The timeline:
Zika Response Working Group have produced a white paper, that was submitted in January to Government Officials at the highest levels.
A member of the group, Dr. Robert Malone has discovered a class of drugs that act as anti-virals against Zika Virus, and which are safe for pregnant women. The World Health Organization has advocated these drugs to be developed as a first defense for pregnant women!
For more information, please contact Dr. Malone directly at rwmalonemd@gmail.com or go to www.atheric.com (a company set up to develop these anti-viral drugs).
A member of the Zika Response Working Group, Dr. Malone participated in a consultation in Genevea at the World Health Organization to present a TPP on anti-viral drugs against the Zika Virus.
The Zika Response Working Group have published a peer reviewed paper in PLoS Neglected Tropical Diseases.
PLoS Negl Trop Dis. 2016 Mar 2;10(3):e0004530. doi: 10.1371/journal.pntd.0004530. eCollection 2016.
Zika Virus: Medical Countermeasure Development Challenges.
Malone RW1,2, Homan J3, Callahan MV4, Glasspool-Malone J1,2, Damodaran L5, Schneider Ade B5, Zimler R6, Talton J7, Cobb RR7, Ruzic I8, Smith-Gagen J9,Janies D5, Wilson J10; Zika Response Working Group.
ABSTRACT
INTRODUCTION:
Reports of high rates of primary microcephaly and Guillain-Barré syndrome associated with Zika virus infection in French Polynesia and Brazil have raised concerns that the virus circulating in these regions is a rapidly developing neuropathic, teratogenic, emerging infectious public health threat. There are no licensed medical countermeasures (vaccines, therapies or preventive drugs) available for Zika virus infection and disease. The Pan American Health Organization (PAHO) predicts that Zika virus will continue to spread and eventually reach all countries and territories in the Americas with endemic Aedes mosquitoes. This paper reviews the status of the Zika virus outbreak, including medical countermeasure options, with a focus on how the epidemiology, insect vectors, neuropathology, virology and immunology inform options and strategies available for medicalcountermeasure development and deployment.
METHODS:
Multiple information sources were employed to support the review. These included publically available literature, patents, official communications, English and Lusophone lay press. Online surveys were distributed to physicians in the US, Mexico and Argentina and responses analyzed. Computational epitope analysis as well as infectious disease outbreak modeling and forecasting were implemented. Field observations in Brazil were compiled and interviews conducted with public health officials.
(Click on here to go to the manuscript)
Dr. Jane Homan and other members of our group have completed computational epitope analysis of Zika and comparative epitope analysis of related viruses [(Dengue virus (Den), Yellow Fever virus (YF), and West Nile virus (WN)] and the human proteome. A paper has been submitted on this work to PLoS NTD. The preprint, found here is before.
Antibody mediated epitope mimicry in the pathogenesis of Zika virus related disease
Jane Homan, Robert W Malone, Steven J Darnell, Robert D Bremel
doi: http://dx.doi.org/10.1101/044834
The association of Guillain-Barré syndrome with Zika virus infection raises suspicion of autoimmunity in the pathogenesis of Zika associated disease. Using computational analysis to identify predicted B and T cell epitopes, we assessed whether antibodies elicited by B cell epitopes in Zika virus may also target B cell epitopes in the human proteome. We detected amino acid motifs predicted to be B cell epitopes in Zika virus proteins which are also present in human proteins, including pro-neuropeptide Y (proNPY), NAV2 and other proteins with interacting neurophysiologic function. We examine the predicted MHC binding of peptides likely to provide T cell help to the potential mimic epitopes. Some potential mimic epitopes in Zika virus envelope have apparently strong T cell help, likely facilitating immunoglobulin class switch. We also identify epitope mimic commonalities with dengue serotypes 1 and 3. We hypothesize that antibodies to Zika virus epitopes may contribute to the pathogenesis of Zika-associated Guillain-Barré syndrome, microcephaly, and ocular lesions, and may be a driver of autoimmunity. The risk associated with responses to potential epitope mimics must be addressed in the development of vaccines and therapeutics for Zika virus infections.
Dr. Daniel Janies at UNC and other members of our group are developing Infectious disease outbreak modeling, RNA virus modelling and forecasting for Zika Virus. A Manuscript is about to be submitted on this work.
Dr. Jim Wilson and other members of our group has successfully surveyed physicians in the US, Mexico and Argentina via on-line tools, on the Zika Virus. A paper is about to be subitted on this work
Zika Virus Disease: A Simple Model Approach to Rapid Impact Assessment
James Wilson, Robert Malone, Julie Smith Gagen, Roman Pabayo, Zika Response Working Group
doi: http://dx.doi.org/10.1101/044248
Click here for a link to the preprintDr. Robert Malone, MD, MS will be conducting a round table discussion on Zika virus: Challenges for medical countermeasure development at the World Vaccine Congress on March 29th, 2016. Click here for a link to the schedule.
April 3, 2016
https://web.archive.org/web/20160408031721/http://www.zikaresponse.org/news/2016/4/3/larvicide-automatic-dispenser-wins-most-implementable-solution-award
OUR OWN ADRIANO DE BERNARDI SCHNEIDER, MEMBER OF THE ZIKA RESPONSE WORKING GROUP AND PHD CANDIDATE, DEPARTMENT OF BIOINFORMATICS AND GENOMICS AT UNC CHARLOTTE WAS ON THE WINNING TEAM! THEIR PROJECT, FOR A LARVICIDE AUTOMATIC DISPENSER WON THE MOST IMPLEMENTABLE SOLUTION AWARD AT THE ZIKA INNOVATION HACK-A-THON THIS WEEKEND!
The event was organized by CAMTech Consortium for Affordable Medical Technologies, Global Disarter Response, Massachusetts General Hospital - Global Heath, MIT Hacking Medicine, Harvard, Global Health Institute, Design That Matters, Medtech Boston. The Hack-a-thon received generous sponsorship by GE Foundation, Johnson & Johnson, and Merck.
Their project, called L.A.D. (Larvicide Automated Dispenser), was awarded "Most Implementable Solution" sponsored by GE Foundation. The device has the potencial to help control mosquitos borne diseases such as Zika, Chikungunya, Dengue, and Malaria at the same time it reduces health care costs in countries affected by them.
Source: http://www.massgeneralcenterforglobalhealth.org/camtech/zika-h
April 7, 2016
"WHO may be leading Brazil down wrong path on Zika virus"
https://web.archive.org/web/20160412120836/http://www.zikaresponse.org:80/news/2016/4/7/who-may-be-leading-brazil-down-wrong-path-on-zika-virus
"Nearly a year after Zika began to be reported here, and five months after the government declared a public-health emergency, no one has yet found proof that Aedes aegypti is spreading Zika or whether it may be one among several vectors. One critical question is whether the virus can be transmitted by another mosquito – possibly one in the genus Culex, which is vastly more common than Aedes aegypti.
Yet Brazil, on the advice of the World Health Organization, has based its entire response to the Zika crisis on combatting this one mosquito species. And the political and economic crisis gripping the country has sidelined an already haphazard and underfunded response.
But Ms. Rousseff was wrong. Her government does not know even this one fact about Zika. Although there is good cause to suspect that Aedes aegypti, the mosquito species with distinctive black-and-white striped legs, is the agent of infection, there are no confirmed findings of the virus in aegypti in Brazil.
Nearly a year after Zika began to be reported here, and five months after the government declared a public-health emergency, no one has yet found proof that Aedes aegypti is spreading Zika or whether it may be one among several vectors. One critical question is whether the virus can be transmitted by another mosquito – possibly one in the genus Culex, which is vastly more common than Aedes aegypti.
"Scientists outside Brazil increasingly share her fears. Fiona Hunter, an entomologist with Brock University in St. Catharines, Ont., who attended the Aedes summit, said she is deeply concerned that the country might be making a mistake in its response. “The fact that there are no data as far as I can tell that Aedes aegypti is driving this Zika epidemic just flabbergasts me.”
Dr. Hunter was involved in the first surveillance to find the vector for West Nile in Canada. To do that, she said, scientists set traps to gather every mosquito existent in an area, then tested and retested dozens of species to establish beyond doubt which one was driving the epidemic.
“That’s how research into a new emerging disease ought to be done,” she said, and the vicious behaviour of Zika in Brazil merits treating it as a new disease. “But they didn’t figure it out – the Brazilians automatically assumed it’s aegypti. I hear physicians here on the radio in Canada saying you don’t have to worry ever about Zika – well, yes you do. There are implications for the spread of this virus around the world.”
Dr. Capurro in Sao Paulo said that she would like to be analyzing 2,000 mosquitoes a month but is constrained by the lack of a national network. “I need connections with hospitals [to identify prospective capture sites] and municipal administrations – who do I even call?” she said.
May 02, 2016.
Zika Fetal syndrome, N. Brazil and Thalidomide: Thank you Robert Malone for another amazing insight.
Jill Glasspool Malone, PhD
President at The Malone Institute
Published May 2, 2016
As usual, Robert Malone puts science together in ways other people miss. The missing link that clinicians and scientists missed in Brazil about Zika. In Northern Brazil, leprosy is a significant issue. In Northern Brazil -it is very poor. Drugs are scarce, so people share their drugs. The treatment for leprosy is Thalidomide. Much of the "other" birth defects (the syndrome part of Zika Fetal Syndrome) of Zika in the fetus is probably caused by Thalidomide. He has done the research, the Zika conference he is in down in Atlanta - has lots of photos, lots of scientists and there is beginning to be significant agreement on this. Our new paper also has his research into this, it is just buried in the back of the discussion section.
The mind of my husband is a national treasure. Seriously. So glad to see back in the research game under his own name and actually taking a bit of credit, rather than ceding his ideas and research to whatever company he is consulting for.
May 06, 2016: United Nations Zika Response Multi-Partner Trust Fund Launched
United Nations Secretary-General Ban Ki-moon has established the United Nations Zika Response Multi-Partner Trust Fund to finance critical unfunded priorities in the response to the Zika outbreak. The Trust Fund provides a rapid, flexible and accountable platform to support a coordinated response from the United Nations system and partners.
Urgent funds are required to support the implementation of national response plans and address the broader social and economic challenges that lie ahead. The United Nations Zika Response Multi-Partner Trust Fund will directly support the Zika Strategic Response Framework, developed by the World Health Organization (WHO) in consultation with United Nations agencies, partners, and international epidemiological experts.
Donors contribute to a central point and an Advisory Committee directs funds to the highest-priority activities in the affected countries. Member States, regional organizations, intergovernmental organizations, businesses and individuals can make contributions through http://mptf.undp.org/factsheet/fund/ZKA00.
https://web.archive.org/web/20170624121216/http://www.zikaresponse.org:80/our-impact-mojave/
https://web.archive.org/web/20170624121216/http://www.zikaresponse.org:80/our-impact-mojave/
http://www.zikaresponse.org/our-impact-mojave/
March 21, 2017.
https://web.archive.org/web/20170624121734/http://www.zikaresponse.org/news/2017/3/21/contagion-live-interviewed-dr-robert-malone-ceo-of-atheric-on-repurposing-licensed-drugs-for-use-against-the-zika-virus-and-other-emerging-infectious-diseases
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Archived June 24, 2017.
Our Impact - Zika Response
Perhaps the biggest challenge with Zika is recognize it for what it is: a new disease which does not fit the epidemiology or response paradigm of past outbreaks and which will demand effort, resources, unparalleled collaboration, and above all open mindedness in formulating responses.
ROBERT W MALONE, MD, MS / FEBRUARY 2016
How we work
THE ZIKA RESPONSE GROUP
With the sudden emergence of Zika virus as an evolving epidemic we are confronted with the need to simultaneously study and understand a new disease and to develop countermeasures. In many ways Zika presents a much more complex challenge than Ebola, and it may impact more lives. It is vector borne, and therefore its range of transmission will be determined by vector ecosystem. It cannot be significantly contained by limiting movement or contact of people. Acute infection may be unapparent, so patients cannot be quarantined. It exerts its most devastating effects on the unborn fetus with a delay to diagnosis. The transplacental pathology is not understood. Zika virus associated disease has an autoimmune component. It is epidemic in a region with a high degree of global connectivity; cases will be widely disseminated. The Zika epidemic is moving very rapidly. Research reagents, animal models, and fundamental science knowledge are much less well developed than they were for Ebola. On the other hand, decades of experience with dengue, yellow fever, and West Nile have equipped us with familiarity with ADE and flavivirus vaccine development strategies. Zika virus is likely a harbinger of future diseases driven by ecosystem change and global interconnectedness.
Perhaps the biggest challenge with Zika will be to recognize it for what it is: a new disease which does not fit the epidemiology or response paradigm of Ebola or dengue and which will demand effort, resources, unparalleled collaboration, and above all open mindedness in formulating responses.
“While we were calling them neglected tropical diseases, the 'tropical' part is probably a misnomer, most of the world's neglected tropical diseases are in wealthy countries. It's the poor living among the wealthy.”
PETER HOTEZ, MD, PHD | 2016
iORG began in the winter of 2016. News of Zika was rapidly spreading and the founders of iORG, Dr's Robert and Jill Malone wanted to do something to really make a difference. Having worked in infectious disease outbreak response teams for many years, they realized that the usual governmental response was slow and inefficient. The usual response time just was not a good solution to solve the spread of Zika and to develop a better understanding of the disease, so that treatments could be developed. Robert spoke to many colleagues and the response was overwhelming. together, they founded the Zika Response Group with iORG as the parent organizations. The was goal was simply to impact on the public health response to make it more efficient and to make a difference. The team of people assembled worked night and day - and accomplished amazing things.
Some of the early successes are:
• Zika Response Working Group wrote a comprehensive meta analysis of Zika and available medical countermeasure options that has helped guide government officials, clinicians and front line public health workers as they are responding to the virus outbreak in January 2016.
• Zika Response Working Group wrote an extensive review paper on Zika that has helped guide scientists about the virus. Published in PLoS NTD. The paper now has over 40,000 readers and is one of the most cited Zika references.
• Members of the Zika Response Group have performed epitope mapping and computational biology analyses, showing the evolution of the virus - which will lead to a better vaccine and a better understanding of how the disease is causing damage to fetuses, as well as the mechanisms of action of GBS. This effort culminated in two peer reviewed papers being published. The Evolution of the Zika Virus paper, published in the fall of 2016, is one of Wiley's most read scientific articles, and is in the 99% of their top publications- with 72,000 readers having already viewed the paper.
• Members of our team have extensively consulted with USG and Brazilian government officials on how to control the pandemic.
• Members of our team have consulting with the World Health Organization, and foreign public health officials on how to control the pandemic.
• A member of the Zika Response Working Group is working in South America on GBS.
• Members of our team have discovered possible anti-viral drugs that are safe for pregnant women and designed clinical trials, and are in the process of procuring funding and building partners in Latin America to move forward with clinical trials!
The relationship between infection with Zika virus and primary microcephaly meets most accepted criteria for causality, and it has become clear that Zika infection during pregnancy is associated with a cluster of birth defects known as Zika Fetal Syndrome as well as Guillain–Barré syndrome (GBS), kidney disease and other reproductive tract infections.
The Zika Response Working Group, under the non-profit non-governmental organization iOrg (Infectious Outbreak Response Group), rapidly responded to critical needs. Our activities focused on;
· Threat and risk assessment and determination
· Identifying existing licensed drugs likely to have anti-Zika activity
· Modeling the outbreak to help inform government and corporate planning
· Geo-spatial tracking and sequence analysis
· Computational immunology and comparative proteome analysis including epitope mapping
· Using surveys and alternative media to track the spread of Zika virus, Zika disease, Zika communication, and to identify the unmet needs of medical caregivers and their patients
· Diagnostics and diagnostic technology research and development
· Development, manufacturing and production of medical countermeasures for Zika disease (devices, drugs, biologicals, and vaccines)
· Facilitating clinical trial design/clinical protocol development for rapid testing of preventative and therapeutic treatments
· Expediting clinical development to licensure of diagnostics, devices, drugs, biotherapies and vaccines to prevent Zika Fetal syndrome and GBS
Our group is united by a commitment to enable rapid responses to the global human threat posed by Zika virus.
We also believe that, while speed is essential when managing an emerging infectious disease outbreak, it is also important to first observe, analyze, think, discuss, and then to act.
The Zika Response Working Group (iORG) developed threat assessments, that went to the highest levels in government. Those assessments translated into critically important papers that have influenced the science and research into the Zika virus.
THESE PEER REVIEWED PUBLICATIONS INCLUDE:
Molecular evolution of Zika virus as it crossed the Pacific to the Americas. Cladistics. 2016
Zika Virus: Medical Countermeasure Development Challenges. PLoS Negl Trop Dis. 2016
Zika Fetal Neuropathogenesis: Etiology of a Viral Syndrome. PLoS Negl Trop Dis. 2016
Antibody mediated epitope mimicry in the pathogenesis of Zika virus related disease. BioRx. 2016.
Of note, the Molecular evolution of Zika virus paper (Cladistics) has been read almost 73,000 times, and is in the 99th percentile: it's in the top 5% of all research outputs ever tracked by Altmetric (Wiley online).
The Zika Virus Countermeasures paper has been read over 40,000 times.
The Zika Fetal Neuropathogenesis paper has been read over 8,500 times.
OUR PRESIDENT, ROBERT W MALONE HAS BEEN SPEAKER OR CHAIRPERSON AT THE FOLLOWING CONFERENCES:
• Chairperson, Repurposing drugs. International Conference on Zika Virus. Washington, DC Feb 22-25, 2017.
• Accelerated Discovery and Development of re-purposed licensed drugs for Zika virus outbreak antiviral prophylaxis and therapy. International Conference on Zika Virus. Washington, DC Feb 22-25, 2017.
• Bridging the Sciences: Zika Virus. Speaker. Zika Virus: Accelerating Development of Medical Countermeasures by Re-purposing Licensed Drugs, Emery, Atlanta, GA 1-3 May, 2016
• World Vaccine Conference. Speaker/Round table- Zika virus: Challenges for Medical Countermeasure Development Washington, DC. 29-31 March, 2016
• The World Health Organization (WHO) Consultation for Zika Virus: Research and Development. Presentation of Drug Development TPP. Geneva, Switzerland. 12-14 March, 2016
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Thanks for posting all this.
It was obvious to anyone paying attention at the time that Zika was an op. Interesting to know that Malone was behind the scenes.
Thanks for this info. Let us know if you find something about the possible origins of Morgellons Disease, a lab disaster back in the early 2000's that the CDC covered up by claiming patients were 'delusional'.