Science Policy For All

Because science policy affects everyone.

Archive for April 2017

Science Policy Around the Web – April 29, 2017

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By: Saurav Seshadri, PhD

digital forensics 5” by jon crel is licensed under CC BY 2.0

Forsensic Science

Now Who Will Push Ahead on Validating Forensic Science Disciplines?

The realities of forensic science remain far removed from the white-coated wizardry depicted on shows like CSI. Although forensic results often heavily influence criminal trials, there is a substantial gap between the perceived and true reliability of commonly used methods such as fingerprint and bitemark identification. The National Commission on Forensic Science (NCFS) was established in 2013 to help close this gap, by promoting rigorous, independent evaluation of forensic techniques, as well as communication between law enforcement agencies and academic scientists. The NCFS was supported jointly by the Department of Justice (DOJ) and National Institutes of Standards and Technology (NIST), and has published over forty documents reflecting the consensus of scientists, lawyers, law enforcement officers, and other stakeholders.

Recently confirmed Attorney General Jeff Sessions has decided not to renew the NCFS’ charter, which expired on April 23, 2017. Its work will ostensibly be taken over by a new entity, which will be developed by a DOJ Subcommittee on Forensics and spearheaded by an as-yet-unnamed, DOJ-appointed Senior Forensic Advisor. The DOJ is currently seeking input on how best to organize this initiative, but its actions already suggest an unwillingness to follow expert guidance, such as the original recommendations from the National Academy of Sciences that led to the creation of the NCFS. The recommendations include ‘[t]his new entity must be an independent federal agency…[i]t must not be part of a law enforcement agency’ and ‘…no existing or new division or unit within DOJ would be an appropriate location for a new entity governing the forensic science community’.

Despite this setback, some of the NCFS’ contributions, such as promoting acceptance of the need for licensing and accreditation, may have a lasting influence on the field. In the NCFS’ absence, NIST is expected to play a central role in coordinating the forensic science community. Support for these efforts will be critical to improving standards in forensic practice, and ultimately, to providing justice to the American public. (Suzanne Bell, The Conversation)

Infectious Disease

Ghana, Kenya and Malawi to Take Part in WHO Malaria Vaccine Pilot Program

While interventions such as insecticide-treated mosquito nets have dramatically reduced malaria-related deaths, almost half a million people still die annually from the disease, predominantly children in sub-Saharan Africa. Continuing the fight against malaria, the World Health Organization Regional Office for Africa (WHO/AFRO) has announced that a pilot program to test the world’s first malaria vaccine will begin in 2018. The vaccine (RTS,S or MosquirixTM) is the result of over $500 million in investment from GlaxoSmithKline and the Bill & Melinda Gates Foundation. It has shown promising results in Phase 3 trials, reducing rates of malaria by almost half in children treated at 5-17 months old. Following guidance from two independent advisory groups, the WHO will implement the vaccine in three countries that have high malarial burdens despite ongoing, large-scale anti-malaria efforts. The first stage of the program, which is being funded by several international health organizations in addition to WHO and GSK, will span 2018-2020, with final results expected in 2022.

RTS,S has followed an unconventional route to its current stage of development. It was approved by the European Medicines Agency (EMA) under Article 58, a mechanism that allows the EMA’s Committee for Medicinal Products for Human Use (CHMP) to collaborate with the WHO and international regulatory agencies to evaluate drugs intended for use in developing countries. However, in the first ten years after its inception in 2004, just seven drugs received positive opinions from CHMP through Article 58, and among these, the EMA has reported limited commercial success. This track record, combined with the emergence of more attractive incentive programs to develop drugs for tropical diseases (including a priority review voucher system launched by the FDA in 2007), has raised questions about Article 58’s effectiveness. A positive outcome for RTS,S could revitalize the program and lead to more innovative treatments for vulnerable populations worldwide. (WHO/AFRO press release)

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April 29, 2017 at 8:56 pm

Science Policy Around the Web – April 25, 2017

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By: Eric Cheng, PhD

Photo source:


FDA Nominee Gottlieb Tackles Vaccines, Trial Design at Hearing

The President’s nominee to head the FDA, Scott Gottlieb, MD, sat before lawmakers for his confirmation hearing before the Senate’s health committee. Gottlieb, a hospitalist and former FDA official, was questioned on many controversial topics on health.  On the topic of vaccines and autism, Gottlieb said, “I think we need to come to the point where we can accept ‘No’ for an answer, and come to the conclusion that there is no causal link between vaccinations and autism.”

On the topic of double-blind randomized trials as the “gold standard” for medical treatment research, Gottlieb was more cautious. He believed that there are more “opportunities to modernize how we do clinical trials in ways that aren’t going to sacrifice on the gold standard of safety and effectiveness. Perhaps there are ways to think of clinical trial constructs that don’t require the tight randomization that current clinical trials do.” What this suggests is a push towards more adaptive trials that would allow researchers to review results before a study’s endpoint and would allow changes to treatment groups in a study, which is in contrast to traditional randomized controlled trials.

Another less controversial but popular topic in the hearing was on opioid abuse. Gottlieb believed that opioid abuse is “a public health emergency on the order of Ebola and Zika” and that bolder steps will be needed to address this issue.

The committee will vote on whether to move Gottlieb’s nomination to the Senate floor after the Senate returns in late April from a 2-week recess. (Joyce Frieden, MedPage Today)

Healthcare Policy

Trump Administration Still Plans to Undo Parts of the ACA, Tom Price Testifies

Health and Human Services Secretary Tom Price made one thing clear during his testimony to the House appropriations committee: “The administration is still intent on dismantling parts of the Affordable Care Act even if Republicans lack the votes to rewrite it.”

Price discussed how, as the Health and Human Services Secretary, his department could scale back several federal mandates that include “essential benefits” in coverage to make insurance plans cheaper. He did not say if the administration will continue to provide cost-sharing subsidies for insurers, which has been a topic of discussion on items to change in the Affordable Care Act. However, removing subsidies will bring “significant premium increases,” said Michael Adelberg, a health-care principal at FaegreBD Consulting. He predicts that the removal of these subsidies will cause some insurers to drop out while the remaining insurers will seek rate increases to compensate.

Regardless of these discussions, the individual mandate remains in place with Price telling the panel, “So long as the law’s on the books, we at the department are obliged to uphold the law.” (Juliet Eilperin and Mike DeBonis, Washington Post)

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April 25, 2017 at 9:53 am

Science Policy Around the Web – April 21, 2017

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By: Rachel F Smallwood, PhD

Source: pixabay

Scientific Awareness

Earth Day and the March for Science

This Saturday, April 22, is Earth Day and the day scientists have chosen to hold demonstrations in the name of science. The March for Science primary demonstration will be held in Washington, D.C., with over 500 satellite events in other locations around the world. According to their website, the goal of the marches, rallies, and teach-ins is to “defend the vital role science plays in our health, safety, economies, and governments.” In a time where there has been increasing disregard and disdain for sound scientific research, scientists and science enthusiasts are passionate about raising awareness of the importance of scientific research and the funding and support of that research. Many scientists are also hoping to clear up commonly held stereotypes and allow people to see the diversity in scientific careers and that careers can be collaborative, interesting, and enjoyable.

There are those, however, who disagree that these demonstrations and events are the way to bolster funding and awareness. The March for Science professes to be non-partisan, but there are some who see it as a chance to protest against President Trump and his controversial views and statements on various scientific matters. Those who oppose the march feel that there could be unintended consequences for speaking out against a political figure or party, and many believe science should remain objective and not politicized in general. There are many supporters of the march who agree that science should remain politically unbiased but are further motivated to march given the recent budget proposals that would significantly cut funding to the National Institutes of Health and the Environmental Protection Agency.

Not surprisingly, there will also be scientists working at the March for Science. Sociologists from the University of Maryland will be conducting surveys of march attendees. Their goal is to learn more about the people who protest in support of science: their motivations, work backgrounds, and political activism levels. They hope to better understand our current political culture and attitudes about science, as well as see what kind of impact these demonstrations have in the future. (Adam Frank, NPR)


California Vaccination Rate Hits New High after Tougher Immunization Law

Following an outbreak of measles in Disneyland in late 2014, California passed a law that abolished the right for parents to refuse to have their children vaccinated based on personal beliefs. The students enrolling in kindergarten for the 2016-2017 academic year were the first that this law applied to. Comparing this year to the previous, vaccination rates increased from 92.8 percent to 95.6 percent, making this California’s highest year for vaccination rates since the new set of requirements was instated fifteen years ago. This rate is considered high enough to prevent measles transmission which, after being eliminated in 2000, has reemerged as a risk due to an increase in parents exempting their children from receiving vaccinations because of personal beliefs.

California still has a number of at-risk students and residents, however. These requirements have only been in place for the current school year, meaning older class years still have many students whose parents opted to not vaccinate them based on personal beliefs. There are even more unvaccinated adults who were already through school before the current set of requirements. California is still being vigilant to protect the unvaccinated. An unvaccinated high school student in Laguna Beach contracted measles earlier this month, and the school quickly moved to identify other unvaccinated students in the school and bar them from returning until it could be assured that transmission would not occur. The Centers for Disease Control and Prevention (CDC) provide a recommended schedule for vaccination of children (and adolescents and adults) who have no health contraindications. To provide the maximum resistance to measles, a highly contagious disease, the CDC recommends vaccinating between 12-15 months and again between 4-6 years of age. It will likely take some time before the long-term effect of the new law can be observed. (Lena H. Sun, The Washington Post)

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How Science Policy Affects Pandemic Pathogen Research

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By: Samuel Porter, PhD

         In 2012, a pair of studies were published in Nature and Science weeks apart igniting one the biggest national debates about science in recent memory. These studies demonstrated that a few mutations in the highly pathogenic H5N1 strain of influenza virus (colloquially known as “bird flu”) could enable it to be transmitted through the air to mammals. At the heart of controversy was the question of whether scientists should be creating more virulent and/or pathogenic strains of deadly viruses in the lab. This controversial research is known as “gain of function” studies.

Critics claimed that the research was too dangerous that the risk of an accidental or deliberate release of these lab strains was far greater than the scientific and public health benefits. In an attempt to respond to the growing concern over their work, the community of researchers working with these pathogens voluntarily agreed to suspend this gain of function research for 60 days to discuss new policies on conducting the research safely.

But that was not enough to satisfy critics of the research, who continued to lobby the Obama administration to take official action. On October 17, 2014 the White House Office of Science and Technology Policy (OSTP), abruptly announced a pause on all U.S. Government funding of gain of function research on influenza, Middle East respiratory syndrome (MERS), and severe acute respiratory syndrome (SARS) coronavirus until the National Science Advisory Board for Biosecurity (NSABB) could make recommendations for policy regulating the research going forward. The NSABB was formed in 2005 (in the wake of the anthrax attacks in 2001), and is composed of scientists from universities around the nation, and administrators from 14 separate agencies in the federal government. The board reports to the Secretary for Health and Human Services (HHS) and is tasked primarily with recommending policies to the relevant government entities on preventing published research in the biological sciences from negatively impacting national security and public health.

The move drew harsh criticism from researchers in the field, many of whom thought that it was too broad. They claimed it would jeopardize their ability to predict, detect, and respond to potentially emerging pandemics. In the private sector, several companies said that the order would prevent them from working on new antiviral drugs and vaccines. Furthermore, many young scientists worried that an inability to do their experiments could jeopardize their careers. In an effort to bring attention to the issue, many scientists (including the two flu researchers whose research triggered the pause) formed the group Scientists for Science, which advocates against blanket bans on research. In addition, researchers were especially upset by the recommendation of the NSABB to censor the publications resulting from the experiments due to fears that this research could have a “dual use” that would threaten national security. However, not all researchers in the field support gain of function research (the opposition group is called Cambridge Working Group) and maintain that the risks of the research outweigh benefits.

The moratorium lasted until January 9th, 2017, when the OSTP released the guidelines for funding this research in the future. The new rules are essentially the same recommendations put forth by the NSABB seven months earlier. The NSABB had concluded that these studies involving “potentially pandemic pathogens” (PPP) do indeed have important benefits to public health, but warranted additional screening prior to funding approval. It directed federal agencies to create a pre-funding review mechanism using eight criteria (including whether the pathogen is likely to cause a naturally occurring pandemic, and if there are alternative methods of answering the scientific question). The results of these reviews must be reported to the White House OSTP. Importantly, the policy was implemented in the final days of the Obama administration rather than leave it to the incoming Trump administration, who, as of this date, has yet to fill nearly any top science positions, and may not have issued guidance for months, if at all.  Researchers welcomed the decision to finally lift the ban, but questioned when the projects would be allowed to resume.

What can we learn from this situation from a science policy perspective? First, we must learn not to overreact to hysteria regarding the risks of this type of research. Indeed, there are risks in performing research on potentially pandemic strains of influenza and other pathogens, as there are with other types of research. But issuing overly broad, sweeping moratoriums halting ground breaking research for years is not the answer, nor is government censorship of academic publication. While in the end, the studies were given the green light to resume, and were published without modification, there is no making up for the lost time. These studies are not machines than can simply be turned on and off on a whim without repercussions. When we delay research into learning how viruses become pandemic, we hurt our ability to detect and respond to naturally occurring outbreaks. Additionally, when American scientists are prevented from doing research that other countries are still pursuing, American leadership in the biomedical sciences is at a competitive disadvantage. (The European Academies Science Advisory Council also recently updated its recommendations for PPP research in 2015, but did not institute a moratorium.) What we learn from these studies could potentially save countless lives. Secondly, the freedom to publish without any government censorship must be valiantly defended in any and all fields, especially with a new administration with an aggressively anti-science and anti-climate stance. Lastly, the scientific community must do a better job educating the public both on the importance of these studies from a public health perspective, and on the precautions put into place to ensure that these studies are conducted safely.

In the future, there will inevitably be debates over the safety or ethics of the latest experiments in a particular field. In attempting to wade through the murky waters of a complex controversy, science policy makers should make decisions that balance public health, safety, and ethics, rather than reactionary policies like censorships and moratoriums.

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April 21, 2017 at 8:47 am

Scientific Activism: Voting to Speed Up Discovery with Preprint Publishing

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By: Thaddeus Davenport, PhD

Source: Public Library of Science, via Wikimedia

         The election of Donald Trump to the Oval Office and the early actions of his administration have sparked a wave of protests in support of women’s rights and immigration, among other issues. Like other citizens, scientists have some cause to be concerned about the administration’s early actions that reveal a general disregard for facts and scientific evidence. In response, organizers have planned the March for Science for this Saturday, April 22nd, as an opportunity for people to gather in cities around the world to voice their support for factual information and scientific research. And while it is important to denounce the actions of the Trump administration that are harmful to science and health, it may be even more critical to acknowledge the underlying partisan divisions that created a niche for his rhetoric and to begin the difficult work of bridging the divide. For example, a Pew Research Center poll from 2015 indicates that 89% of liberal Democrats believe government investment in basic science pays off in the long-run, while only 61% of conservative Republicans feel the same way. Additionally, American adults with less knowledge of scientific topics are more likely to believe that government funding of basic science does not pay off. This suggests that improved science education and outreach will be important in building public support for scientific research. However, scientists often lead very busy lives and have little time outside of their professional activities to devote to valuable pursuits like science outreach. How, then, might scientists work towards building a better relationship with the public?

The products of science – knowledge, medicines, technology – are the clearest evidence of the value of research, and they are the best arguments for continued research funding. Efficiency in science is good not only for scientists hoping to make a name for themselves, but also for the public, who as the primary benefactors of academic research, must benefit from the products of that research. If taxpayers’ demand for scientific inquiry dissipates because of a perceived poor return on their investment, then the government, which supposedly represents these taxpayers, will limit its investment in science. Therefore, in addition to communicating science more clearly to the public, scientists and funding agencies should ensure that science is working efficiently and working for the public.

Information is the primary output of research, and it is arguably the most essential input for innovation. Not all research will lead to a new product that benefits the public, but most research will yield a publication that may be useful to other scientists. Science journals play a critical role in coordinating peer review and disseminating new research findings, and as the primary gatekeepers to this information, they are in the difficult position of balancing accessibility to the content of their journals with the viability of their business. This position deserves some sympathy in the case of journals published by scientific societies, which are typically non-profit organizations that perform valuable functions including scientific outreach, education and lobbying. However, for-profit journals are less justified in making a significant profit out of restricting access to information that was, in most cases, obtained through publicly-funded research.

Restricting access to information gathered in the course of research risks obscuring the value of research to a public that is already skeptical about investing in basic science, and it slows down and increases the cost of innovation. In light of this, there is growing pressure on publishers to provide options for open-access publishing. In 2008, the National Institutes of Health adopted a public access policy, which requires that “investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, that the NIH shall implement the public access policy in a manner consistent with copyright law.” This policy was extended through an executive order from the Obama Administration in 2013 to include all federal agencies with research budgets greater than $100 million, with additional requirements to improve accessibility.

These requirements are changing scientific publishing and will improve access to information, but they remain limited relative to the demand for access, as evidenced by the existence of paper pirating websites, and the success of open access journals like PLoS and eLife.  Additionally, other funding agencies like the Bill and Melinda Gates Foundation and the Wellcome Trust have imposed even more stringent requirements for open access. Indeed, researchers will find a spectrum of open-access policies among the available journals, with the most rapid access to information allowed by so-called ‘preprint’ publishers like Given that many research manuscripts require months or years of revision and re-revision during submission to (usually multiple) journals, preprint servers accelerate the dissemination of information that is potentially valuable for innovation, by allowing researchers to post manuscripts prior to acceptance in a peer-reviewed journal. Many journals have now adopted explicit policies for handling manuscripts that have been previously submitted to bioRxiv, with many of them treating these manuscripts favorably.

Given that most journals accept manuscripts that have been previously published on bioRxiv, and some journals even look to bioRxiv for content, there is little incentive to submit to journals without also submitting to bioRxiv. If the goal is, as stated above, to improve the transparency and the efficiency of research in order to make science work for the public, then scientists should take every opportunity to make their data as accessible as possible, and as quickly as possible. Similarly, funding agencies should continue to push for increased access by validating preprint publications as acceptable evidence of productivity in progress reports and grant applications, and incentivizing grant recipients to simultaneously submit manuscripts to preprint servers and peer-reviewed journals. Scientists have many options when they publish, and by voting for good open-access practices with their manuscripts, they have the opportunity to guide the direction of the future of scientific publishing. These small, but important, actions may improve the vitality of research and increase the rate at which discoveries tangibly benefit taxpayers, and, in combination with science outreach and education, may ultimately strengthen the relationship between scientists and the public.

March for Science this Saturday, if it feels like the right thing to do, and then strive to make science work better for everyone by sharing the fruits of research.

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April 20, 2017 at 11:44 am

Science Policy Around the Web – April 18, 2017

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By: Nivedita Sengupta, PhD

Source: pixabay

DNA Testing

23andMe Given Green Light to Sell DNA Tests for 10 Diseases

On April 6th, the US Food and Drug Administration (FDA) approved the first at-home genetic test kits, which can be sold over the counter in pharmacies, to determine the risk of developing certain genetic diseases. Since 2006, 23andMe, a company based in California, has been analyzing DNA from saliva samples of its customers to provide genetic insights into their risk of developing 240 different diseases and disorders. However, in 2013, FDA was concerned about customers using test results to make medical decisions on their own, and ordered 23andMe to halt the service. In 2015, FDA eased some of the restrictions and allowed the company to reveal to their customers only the information regarding genetic anomalies that can be transferred to their children, and not any information about the person’s own disease risk.

23andMe now has permission to inform its customers about genetic mutations that are strongly associated with a small group of medical conditions such as Parkinson’s disease, late-onset Alzheimer’s disease, celiac disease and a hereditary blood-clot disorder called thrombophilia. However, it should be noted that the results from these tests are not equivalent to a medical diagnosis, as the development of a disease is also influenced by a person’s family history, lifestyle and environment.

The decision made by the FDA paves the way for a wave of do-it-yourself diagnostic tests, which will be flooding the market in the coming years. “It’s a watershed moment for us and the FDA,” says Kathy Hibbs, chief legal and regulatory officer at 23andMe. However, there are concerns regarding the limits of medical knowledge among common people to understand and interpret the results and the limitations of these tests, which could lead to misinterpretation of the results and complications. (Amy Maxmen, Nature News)

Neonatal Care

Giving Newborns Medicine is a Dangerous Guessing Game. Can We Make it Safer?

Medical emergencies in neonates are on the rise. It might be surprising for many parents to know that 90% of the medications administered in a neonatal intensive care unit are not medically approved by the FDA for use in newborns. Neonates are routinely treated with drugs that are not adequately tested for safety, dosing, or effectiveness. This is a global problem, and many factors contribute to it. Firstly, parents and doctors are afraid of enlisting newborns in clinical trials. Secondly, pharmaceutical companies are afraid to test drugs on neonates as the risk of liability is very high. It is also a small market, so pharmaceutical companies may not make money by getting drugs approved for neonates.

In 2015, an FDA funded nonprofit organization launched two global efforts to encourage clinical trials in newborns. One of which is the International Neonatal Consortium (INC), which published a guide to clinical trials in neonates last year. Dr. Jonathan Davis, Director of INC said, “We’ve got to do something.” Without information on drug data for newborns, “we can’t be certain which drugs, in which doses, to use when.” Under the current system, doctors are making decisions based on either anecdotes or intuition, which essentially means that every sick newborn is an uncontrolled, unapproved study without the guarantee of seeing improvement. No data collection is done, thus not providing any information for treating other infants around the world.

Physicians often take decisions by scaling down from how medications are used in adults. But this can be fatal and lead to disasters as we have seen in the past, with the use of the antibiotic chloramphenicol in the 1950s, and the preservatives benzyl alcohol and propylene glycol in the 1980s. Infants are not tiny adults, and they adsorb, metabolize, and excrete drugs in different ways than adults. The majority of studies done in neonates in recent years have not been able to establish efficacy. More studies need to be done, and this requires proper designing of clinical trials with reduced risk, and eliminating unnecessary interventions. (Megan Scudellari, STATNews)

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April 18, 2017 at 10:45 am

Science Policy Around the Web – April 14, 2017

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By: Leopold Kong, PhD

Fatty foods: By Lucasmartin2 (Own work) [CC BY-SA 4.0], via Wikimedia Commons

Health Policy

Banning Trans Fats in New York Prevented Thousands of Heart Attacks

In an effort to lower the incidence of heart disease, the leading cause of death in the United States, the FDA will prohibit food manufacturers from using trans fats next summer. FDA’s decision was based on decades of research linking trans fat consumption with increased risk of heart disease. A study published this Wednesday in JAMA Cardiology provided further support for the ban. Using data from the New York State Department of Public Health, collected from 11 counties where trans fats restriction was recently implemented, the researchers showed a statistically significant decline in heart attack (7.8%) and stroke (3.6%) events since then. “The most important message from these data is that they confirm what we predicted — benefit in the reduction of heart attacks and strokes,” said the lead author, Dr. Eric J. Brandt, a fellow in cardiovascular medicine at Yale. “This is a well-planned and well-executed public policy.” With the rising cost of health care in the United States, the FDA’s long awaited trans fat ban is urgently needed to lighten the public health burden. (Leah Samuel, STATNews)

Vaccine Research

The Human Vaccines Project, Vanderbilt and Illumina Join Forces to Decode the Human Immunome

Rapidly evolving viruses such as HIV and Hepatitis C have been difficult targets for traditional vaccine development, in which inactivated viruses or viral proteins are used as vaccine components. Despite the success of small molecule therapeutics against HIV and Hepatitis C, an effective vaccine remains the most cost effective solution to curb the global pandemics caused by these viruses. Scientists now seek to optimize vaccine candidates based on a deeper understanding of host-pathogen interactions using multidisciplinary approaches, ranging from protein engineering and evolutionary biology to immunology and genetics. To facilitate these sophisticated efforts, the Human Vaccines Project, an international public-private collaboration, was established. A major initiative of the project, the Human Immunome Program, is led by Vanderbilt University Medical Center. Now, Illumina has joined the collaboration to help decipher the genetic features of the immune system, or the “immunome,” using cutting edge sequencing technology. DNA sequences from immune cells during infection may capture how the immune system adapts to viruses, providing guidelines for vaccine design. “Successfully defining the human immunome will provide the foundational knowledge to usher in a new era of vaccine, diagnostic, and therapeutic development,” says Gary Schroth, vice president for product development at Illumina. Greater understanding of the immunome may also lead to more effective cancer vaccines. (Human Vaccines Project)


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