Category Archives: Genetic Engineering

By Melissa Healy

Los Angeles Times

To capture the speed and audacity of its plan to field a coronavirus vaccine, the Trump administration reached into science fictions vault for an inspiring moniker: Operation Warp Speed.

The vaccine initiatives name challenges a mantra penned by an actual science fiction writer, Arthur C. Clarke: Science demands patience.

Patience is essential for those who ply the science of vaccines. But in that field, challenging economic conditions and a forbidding regulatory system converge with the immune systems complexity and the resilience of microscopic pathogens. Add in drug companies preference for big profits and the result is a trash heap of failed and abandoned efforts.

In the last 25 years, the U.S. Food and Drug Administration has approved new vaccines for only seven diseases. A vaccine to protect against the Ebola virus won approval just last year, three years after the epidemic in West Africa ended.

But in the midst of a COVID-19 pandemic that has killed more than 100,000 Americans and cratered the U.S. economy, Trump has shown little tolerance for sciences deliberate pace. And scientists, with fingers crossed, are falling in line.

The president declared that he wants 300 million doses enough to protect as many as 90% of Americans developed, manufactured and delivered by January 2021. He has ordered academics, government officials, private companies and the U.S. military to work together to make it so.

That means big and it means fast, Trump said. A massive scientific, industrial and logistical endeavor unlike anything our country has seen since the Manhattan Project.

The new effort will demand the support, development, testing and assessment of several promising vaccine candidates by scientists at the National Institutes of Health, the FDA and companies and academic institutions across the world.

It will require the manufacture, procurement and storage of complex biologic medicines, as well as the vials, needles, syringes and storage equipment needed to deliver them. All will be needed on a massive scale.

And all that materiel will need to be transported, distributed and possibly administered by an army of logistics specialists.

Wherever possible, Operation Warp Speed envisions that many steps that have always followed each other in strict sequence clinical trials and production, for instance, or government approval and supply-chain development be done in parallel.

The program has awarded a total of $2.16 billion so far to five companies with vaccine candidates at different stages of development.

To lead the effort, Trump tapped immunologist Moncef Slaoui, a pharmaceutical venture capitalist and former chairman of vaccines at the drug giant GlaxoSmithKline. The U.S. Armys most senior logistics and procurement specialist, Gen. Gustave Perna, will be the operations chief operating officer. Both expressed confidence in the operations success.

Pena called the project herculean. Slaoui, who has been criticized for holding a major stake in at least one of the vaccine makers that stands to benefit from Operation Warp Speed, told Trump we will do the best we can.

The time is short and the stakes are high. Just over four months after the coronavirus announced its presence inside the United States, President Trump is determined to send the country back to work.

With no effective treatment in sight, and no indication that the coronavirus would magically disappear, as Trump has frequently predicted, a vaccine will be the ultimate game changer in the pandemic, according Dr. Anthony Fauci, the nations leading expert on the outbreak.

Theres never a guarantee of success, Fauci said. But he added that he was cautiously optimistic that by winter, at least one of nearly a dozen promising vaccine candidates would have shown itself to be safe and effective in inducing immunity in humans.

Vaccine scientists are similarly cautious, especially of a testing schedule that will compress both the size and duration of safety and effectiveness trials and even overlap them in a bid to save time.

Its fine for politicians to say were going to have a vaccine next month, said Mayo Clinic immunologist Dr. Gregory Poland. But the literature is littered with false starts and unanticipated safety effects in vaccines.

Poland noted that a vaccines rarer side effects are often not recognized until its put into broad use. To ferret out an adverse outcome that only occurs in one person in 100,000, for instance, a company would need to test it in 384,250 people from broad backgrounds and with a variety of medical conditions, he said.

Such large trials are unlikely in the rush to field a vaccine, Poland said, and he fears the result could be a dangerous erosion of public trust. The yearly flu shot carries a risk of less than 1 in 1 million cases of the neurological complication Guillain-Barre syndrome, he said. And even with that low a risk, close to half of Americans refuse to get it.

You have a whole spectrum of people out there who wont be reassured by any amount of information, Poland said. If we dont pay strict attention to safety, this is going to backfire.

Money may help. Congress approved $8.3 billion in early March to fund federal agencies pandemic response. And scientists across the world have been scrambling to design vaccines to protect a population with no immunity to the deadly new pathogen.

Scientists in China, Kazakhstan, India, Russia, Germany, Sweden and the United States have brought 10 potential COVID-19 vaccines to the point where they are being evaluated in humans in some form. Another 115 are considered by the World Health Organization to be in the preclinical stage of development.

In some cases, these preclinical vaccine candidates are scarcely off the drawing board. In others, they are still being tweaked or tested in cells. Some are being tried in lab animals.

The prospective vaccines range widely in their design and novelty. There are those that challenge a persons immune system with a killed or attenuated virus, the traditional approach used by the polio vaccine and other immunizations. Others are products of genetic engineering and have never been tried in a vaccine before.

The vaccine candidates also vary in their ease of manufacture, the number of doses a patient needs to gain lasting immunity, and the way they are administered.

FDA Commissioner Dr. Stephen Hahn has said his agency evaluated about 10 vaccine candidates in early studies. By late May, it had narrowed its focus to five candidates that will begin a rapid and sometimes overlapping progression through human studies of safety and effectiveness.

Meanwhile, the groundwork for large-scale production is already being laid. Trump has said that the U.S. military may aid in the manufacture, and companies with the capability to produce vaccines will be recruited to do so.

Given the pressing urgency of the administrations deadline, vaccine candidates that can be produced fastest, transported most easily and administered to patients most efficiently will likely win the most and earliest support, experts said.

The redundancy built into Operation Warp Speed may also prove a vital safeguard against failure.

If the coronavirus shows signs that it is mutating in ways that could make one vaccine candidate ineffective, the scientific judges could swiftly shift their preferences toward a competitor that can be adapted more readily to changes in the virus. If rare but untoward effects show up with broader use, back-up vaccines could be brought on line. Some vaccines will be found to work better or worse in specific populations, and can be used accordingly.

The result will be an evolving panoply of vaccine choices, not only because some will be ready earlier than others, but because some will be more effective than others in certain populations.

There will be of necessity multiple types of vaccines, Poland said.

Link:
Can Operation Warp Speed deliver a COVID-19 vaccine by the end of the year? - The Daily World

Samir Kumar Saha and his daughter Senjuti Saha.Facebook photo

The first-ever sequencing of the new coronavirus genome in Bangladesh indicates that the strain sequenced entered the country from the United Kingdom, according to the team that accomplished the sequencing.

We believe that the strain we sequenced was carried to Bangladesh by someone travelling from the UK, said Samir Kumar Saha, the leader of the team of scientists from Child Health Research Foundation, a non-governmental organisation that successfully ran the sequencing.

He said that the time was yet to come to say with one hundred per cent certainty where the virus strain they sequenced came from for a similar strain could also be found infecting people in Saudi Arabia, Russia and Taiwan.

But it is most likely that it came from the UK, said Samir, an eminent microbiologist and the executive director of CHRF.

He said that they were working with genetic engineers and biotechnologists to determine whether the virus strain underwent any unique mutation after entering Bangladesh.

He said that the virus strain supposedly underwent nine mutations by the time it entered Bangladesh and there were signs that it mutated after it entered the country.

A transmission map available on the website of GISAID, a database of thousands of genetic sequencing done across the world on the new coronavirus, showed that the strain sequenced from the UK travelled a long way.

The strain travelled out of the UK early February towards other European countries such as the Netherlands, Germany, Austria, Hungary and then moved on to infect people in Turkey, Iran, Afghanistan, Pakistan and India.

The map was produced by analysing data provided by 5,234 genome sequencings that also showed that the strain first went out of China late December toward Africa via Asia and the Middle East and reached Latin America by early January.

It entered the USA within a few days and then travelled towards the UK, where it reached early February, showed the GISAID transmission map.

The strain that was sequenced in Bangladesh entered the country in April and the person from whom the virus was isolated for sequencing got infected on April 18, said Samir.

Bangladesh announced its firs coronavirus infection on March 8 and the first death from the infection 10 days later.

So far the virus killed 298 people in Bangladesh and more than 300,000 around the world while infecting over four million people globally. More than 20,000 people got infected in Bangladesh.

Bangabandhu Sheikh Mujibur Rahman Agricultural University biotechnology and genetic engineering professor Tofazzal Islam said that genome sequencing was all about finding out the basic structure of an organism.

The coronavirus is made of four nucleotides arranged in about 30,000 permutations and combinations as revealed in genome sequencings across the globe, Tofazzal added.

A virus starts duplicating itself once inside a host and the duplication often comes with error in RNA virus, resulting in changes in the order of the constituting nucleotides, which is called mutation, he explained.

Different strains may appear as the mutation continues as the virus is always trying to adapt to new conditions as the pandemic caused by it progresses across geographical and environmental conditions, he said.

Scientists around the world still debate the number of strains the new coronavirus has developed and they are far from specifying the order of nucleotides responsible for a certain quality in the virus such as its virulence or transmissibility or resistance against medication.

Scientists at the Los Alamos National Laboratory in the US revealed in April that a mutation strengthens the protein spike through which the coronavirus attaches to host cell.

The scientists said that the mutated strain was primarily very uncommon but later became dominant in Europe, North America and Australia.

We are dealing with one of the smartest viruses in history, said Samir.

He said that changing symptoms in infected people bears testimony to the coronavirus mutating fast in various environments.

Soon after the emergence the virus caused loose motion among patients in China but the people it infected in countries such as the UK complained about losing sense of taste and smell, he said.

The virus causes hypoxia that can remain hidden until it pushes the patient to the verge of dying, he said.

Until a stage the established notion was that the virus could only be found in the respiratory system but lately it was detected in semen samples in Europe, he said.

It is likely that it gets to brain as well, said Samir.

Samir plans to sequence 80 to 100 samples in the next two months from different localities and times to find out if different strains were prevalent in Bangladesh and the way they were mutating.

We need to block mutations where it can get even more deadly. Genome sequencing helps us to go there, said Samir.

Continued here:
Coronavirus may have come to Bangladesh from UK: Samir Saha - newagebd.net

BILTHOVEN, Netherlands and PROVIDENCE, Rhode Island, June 2, 2020 /PRNewswire/ -- Intravacc, one of the world's leading translational research and development vaccine institutes, with an extensive track record in developing viral and bacterial vaccines, and EpiVax, a biotechnology company based in Providence with expertise in developing vaccines and therapeutics, announce that they have entered into a collaboration agreement to further progress an novel vaccine against COVID-19, based on Intravacc's proprietary Outer Membrane Vesicles (OMV) technology platform.

For this joint research project, Intravacc will combine its safe and immunogenic OMV delivery platform with synthetically produced COVID-19 epitopes (protein allergens), designed and optimized by EpiVax using advanced immunoinformatics tools, in order to generate a safe and highly effective T-cell response against SARS-CoV-2 and related coronaviruses. Pre-clinical studies will start immediately so as to select the best candidate peptides for the vaccine. Intravacc will utilize its in-house pilot-scale facility for the GMP production of the OMV-peptide vaccine, for clinical (phase I) studies expecting to start in Q4 2020.

Annie De Groot, MD, CEO and CSO of EpiVax, said:

"We are thrilled to enter into a partnership with Intravacc using their very novel 'click-on' OMV technology and the highly immunogenic and safe SARS-CoV-2 multi-epitope-bearing peptides designed using the iVAX toolkit at EpiVax. We believe that the combination of technologies and the strength of our longstanding collaboration with Intravacc will lead to the development of an effective and safe vaccine that could rapidly benefit hundreds of millions of people around the globe."

Dr. Jan Groen, CEO of Intravacc, stated:

"A COVID-19 vaccine based on this approach is expected to be very safe and to reduce the morbidity and mortality rates associated with COVID-19. The vaccine is expected to lower the risk that individuals infected with SARS-CoV-2 will require hospitalization and/or intensive care. It also expected to induce long-term memory responses to prevent COVID-19 disease and infection from other beta-corona viruses. We expect that leveraging Intravacc's unique vaccine development expertise, broad-based network and successful track record in global technology transfer to vaccine manufacturers will bring success".

About Intravacc's OMV platform technology

For the development of vaccines against pathogens, Intravacc has designed and developed a platform based on outer membrane vesicles (OMVs) spherical particles with intrinsic adjuvating properties. Using genetic engineering, the OMVs can be decorated with immunogenic peptides that combine T- cell epitopes that will drive effective adaptive immunity. Heterologous OMV vaccines are a suitable alternative approach to protect against pathogens that require a high level of containment, that are difficult to cultivate, or that contain viral and/or parasitic proteins. The antigens of choice are attached to the 'empty' OMV carrier resulting in a more effective immune response.

Intravacc also has developed genetic tools to increase the yield of OMVs, to reduce toxicity, and to achieve the desired antigenic composition. Intravacc's OMV platform is fully scalable and allows for fast and efficient modification of antigen composition, either via genetic modification of the bacterial host or by associating antigens to stockpiled carrier OMVs.

About Intravacc

The Netherlands-based Intravacc is one of the world's leading institutes for translational vaccinology. As an established independent R&D organization with over 100 years' experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology all over the globe, including oral polio vaccines, measles vaccines, and DPT, Hib and influenza vaccines. Intravacc offers a wide range of expertise to independently develop vaccines from lead concept to clinical phase I/II studies for partners worldwide such as academia, public health organizations (WHO, BMGF), and biotech and pharmaceutical companies.

Intravacc also has its own proprietary vaccine platform. Intravacc has established state-of-the-art research and production (GMP) facilities. Its aim is to substantially reduce development risks and costs of new vaccines in order to contribute to global health and equity in access to vaccines worldwide.

About EpiVax

EpiVax is a 22-year old privately-held biotechnology company located in Providence, RI, with a broad portfolio of projects including vaccines and immunotherapies for infectious diseases, autoimmunity and cancer. Scientists at EpiVax, led by co-founders Annie De Groot, MD and Bill Martin, have a strong history of developing and applying innovative approaches to improving vaccines and biologics, making the former more immunogenic and the latter less immunogenic using their advanced immunoinformatic tools. The ISPRI and iVAX toolkits for therapeutics and vaccines are used by a global roster of companies. Visit http://www.epivax.com for more information.

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SOURCE Intravacc

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Intravacc and EpiVax Team up in Development of COVID-19 Emerging Vaccine - Stockhouse

The long-awaited updates from the United States Department of Agriculture (USDA) to its genetically engineered (GE) organism regulation are finally here. Issued on May 18th, this final rule completed a more than ten-year process started back in 2008 to revise regulations promulgated in 1987.This article discusses these new regulations and some of their potential impacts.Overall, the new rule ignores the calls from industry, consumer organizations, and environmental groups for continued oversight and transparency. The new regulations, including an option for developers to self-determine whether their products are regulated, could lead to adverse environmental and/or agricultural impacts, potential food safety risks, trade disruptions, and lack of consumer acceptance of new food technologies.

To understand USDAs new regulation of GE plants, it is important to understand how USDA has regulated GE plants since 1987.USDA regulates the import, interstate movement, and environmental release of GE plants under its legal authority to manage plant pests under the Plant Protection Act.A plant pest is any organism that can directly or indirectly injure, cause damage to, or cause disease in any plants or plant product.Under USDAs regulations, a GE plant has been considered a potential plant pest if any of its newly introduced DNA came from an organism on USDAs list of plant pests, or if the method of introducing DNA into the plants genome involved an organism on USDAs list of plant pests.For example, if a GE plant was developed using the plant pest Agrobacterium to introduce new DNA, as many are, it was regulated.However, if the same DNA were introduced using the gene-gun method of transformation, USDA would not regulate the GE plant.

Under the regulations (found at 7 CFR part 340), developers were required to submit their GE plant products to one of three oversight processes before environmental release.

For each regulatory process, USDA is ensuring that the GE plant is not going to become a plant pest and cause harm to agricultural interests.

Up until 2011, every GE plant tested outdoors either submitted a notification or received a permit, and all commercialized plants satisfactorily completed the petition process. Then, in 2011, USDA established a process whereby GE seed developers could inquire to USDA about whether the GE plants they were developing required regulation, or whether they were exempt because they did not involve any plant pest components. USDA responded to these Am I regulated? inquiries stating whether the GE plant was not regulated and could be planted without oversight. By the end of 2019, USDA determined that more than 85 plants did not fall within its regulatory authority and are exempt from oversight.So, over the last eight years, we have seen a decrease in how many GE plants USDA regulates.[1]

The new rule (called the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient, (SECURE) Rule), which will be implemented over the next 18 months, applies to organisms produced through genetic engineering, which is defined to include techniques that use recombinant, synthesized, or amplified nucleic acids to modify or create a genome.This broad definition includes classical genetic engineering, which add one or more new genes to organism (what consumers consider GMOs), and newer gene editing techniques such as CRISPR, which can make edits within an organisms existing genome.

While the definition captures all GE plants, USDA exempts many of them from any oversight.First, it exempts products with a single sequence deletion, substitution, or addition (if the addition is from the plant's gene pool). Second, it exempts any GE plant that has the same plant-trait-mechanism of action as any GE plant previous regulated by USDA.This means that if USDA previously regulated a GE plant, such as a glyphosate-tolerant corn, a new GE glyphosate-tolerant corn is exempt if it employs the same mechanism of action (meaning it biologically operates the same way to provide tolerance).Developers can self-determine whether they qualify for these exemptions; confirmation of their self-determination from USDA is not required and the agency need not be informed.

If a GE plant is not exempt, the developer can either: (1) apply for a permit if the GE plant has potential plant pest risks; or (2) seek a Regulatory Status Review (RSR).The RSR starts with an initial 180-day process where USDA determines if the GE plant has any plausible plant pest risks.That initial RSR step is a closer look at the GE plant than the current Am I regulated process, but less detailed than the process used for petitions for non-regulated status.USDA stated that the initial review does not require any plant-specific laboratory or field-test data.If USDA decides there are no plausible risks, USDA sends a letter to the developer stating the plant is not regulated and publishes the letter on its website. If USDA cannot conclude there are no plausible risks, then the developer can either: (1) request that USDA conduct the second part of the RSR, which is detailed evaluation of potential plant pest risks (which can take up to 15 months), or (2) apply for a permit.The more lengthy and detailed RSR evaluation by USDA is comparable to the current petition for non-regulated status process and ends in USDA determining either than the GE plant is not regulated or that it needs a permit.If a developer receives a permit from USDA, any outdoor planting (e.g. a field trial or a commercial planting) is subject to restrictions to prevent inadvertent release into the environment and any adverse plant pest impacts. These are the same restrictions that virtually all GE plants were subject to prior to 2012 under the notification and permitting processes.Only GE plants that receive permits have any continued oversight by USDA.

The most significant problem with USDAs rule is the exemptions.First, they are not supported by scientific evidence showing that these categories of GE plants do not pose risks.Instead, USDA states that since a single deletion, substitution, or addition produces a plant that could be achieved by conventional breeding methods, and because conventionally bred plants have not raised plant pest risks, gene edited plants that are the same as products that could be achieved through conventional breeding will not pose plant pest risks.The problem with this argument is that a science-based regulatory system should base its oversight on whether the plant possesses traits that make it a potential plant risks, not the plants method of production.One of USDAs reasons for revising its rules was to focus on the properties of a product, not how it was developed, yet that is the very approach these exemptions enshrine.While many, if not most, plants with a single deletion may not present any plant pest risks, if one does, shouldnt USDA regulate it?

If USDA does not know which GE plants are exempt, how can it confirm that determination is correct?

The second problem is that the developer self-determines if its product qualifies for an exemption.This sets up an inherent conflict of interest because developers have financial incentives to determine themselves exempt.While some developers will diligently determine the regulatory status of their GE plant, others may not.In addition, when a developer self-determines its product is exempt, neither USDA nor the public knows that the GE plant is being released into the environment and entering the food supply because there is no requirement to notify the agency of ones self-determination.If USDA does not know which GE plants are exempt, how can it confirm that determination is correct?

Fortunately, the rule is not all bad.One positive is USDAs decision to limit the exemptions to single edits.USDAs reasoning for this decision was that while a single edit mimics a product that can be produced through conventional breeding methods, the same is not true for products with multiple edits.Therefore, if a developer makes two or more edits, the developer must apply for a permit or ask for an RSR. The first gene edited commercial product in the USCalyxts high oleic soybean, which USDA exempted from regulation under the Am I regulated? processwould not be exempt under the new rules because it has two edited genes.If most gene edited products end up having two or more edits, the exemptions may have limited applicability.

While multi-edited products are not automatically exempt, USDA is likely to find in the initial step of the RSR process that many do not pose any plausible plant pest risk.So, the result may be the samethese products are not regulated.However, at least the initial RSR determination (instead of a developer self-determination), is made public, so stakeholders will know which multi-edited products are entering the market.

USDA states that one goal of its revisions is to provide regulatory relief, and the final rule clearly achieves that.Many GE plants that historically required containment for field trials through either the notification or permitting process will no longer be subject to any substantive regulation.They either will be exempt or deemed to have no plausible plant pest risks through the initial step of the RSR process.What this means in practice is that GE plant developers (both private developers and academic scientists) can conduct field trials without any confinement conditions that ensure the GE plants do not persist in the environment after the trial is completed.USDA stated in its proposed rule that it hopes developers voluntarily continue confinement measures, but that may or may not happen.GE plants have escaped from field trials with USDA oversight in the past and the likelihood of that happening will only increase without USDA oversight. That could mean new proteins inadvertently entering our food supply before they are deemed safe for human consumption.Experimental GE plants persisting in the environment after a field trial is concluded could also harm non-target organisms. Finally, if an unregulated GE plant escapes from a field trial and enters the export market, it could result in rejection of the US commodity because the experimental plant has not been approved in the importing country.

USDA states that one goal of its revisions is to provideregulatory relief,and the final rule clearly achieves that.

The final rule also fails to provide needed transparency on GE plants that will be commercialized.USDA, food industry stakeholders, and consumers will be at the mercy of developers to make information public about products they are developing that they have deemed exempt.How will the food industry know which foods contain GE plants to ensure they are complying with export market legal requirements?How will food manufacturers and retailers answer questions from consumers asking whether their products contain ingredients from genetically engineered or gene edited plants?If consumers are unable to access information about which GE plants are commercialized, will they become skeptical about those products and their safety?The lack of transparency inherent in the rule will result in international trade problems and misinformation to consumers.

GE plants have and will continue to provide benefits to farmers and the environment and could be beneficial to consumers in the future.However, the USDA rule could impact acceptance of those products by the food industry and leave consumers wondering what developers are hiding.

Excerpt from:
Biotech Blog: USDA's New Biotech Rule Explained | Center for Science in the Public Interest - CSPI Newsroom

In May, federal regulators finalized a new biotechnology policy that will bring sweeping changes to the U.S. food system. Dubbed SECURE, the rule revises U.S. Department of Agriculture regulations over genetically engineered plants, automatically exempting many gene-edited crops from government oversight. Companies and labs will be allowed to self-determine whether or not a crop should undergo regulatory review or environmental risk assessment.

Initial responses to this new policy have followed familiar fault lines in the food community. Seed industry trade groups and biotech firms hailed the rule as important to support continuing innovation. Environmental and small farmer NGOs called the USDAs decision shameful and less attentive to public well-being than to agribusinesss bottom line.

But the gene-editing tool CRISPR was supposed to break the impasse in old GM wars by making biotechnology more widely affordable, accessible and thus democratic.

In my research, I study how biotechnology affects transitions to sustainable food systems. Its clear that since 2012 the swelling R&D pipeline of gene-edited grains, fruits and vegetables, fish and livestock has forced U.S. agencies to respond to the so-called CRISPR revolution.

Yet this rule change has a number of people in the food and scientific communities concerned. To me, it reflects the lack of accountability and trust between the public and government agencies setting policies.

The USDA Animal and Plant Health Inspection Service, or APHIS, serves as the dominant U.S. regulator for plant health. Since the mid-1990s, genetically modified crops have typically fallen under APHIS oversight because Agrobacterium, a plant pest, is commonly used as a tool to engineer GM products. Using a plant pest did not prevent many GM crops from being approved. But it did mean that if APHIS suspected a plant pest or noxious weed had been created through genetic engineering, the agency would regulate the biotech product, including its release into the environment, and its import, handling, and interstate movement.

Changes to APHIS regulations began during the Obama administration. In January 2017, the agency released new draft rules. However, the Trump administration withdrew these nine months later after pushback from industry and biotech developers which argued that the rules would stifle innovation.

Last summer, USDA released a revised rule for public comment, which it finalized on May 18, 2020. Most changes go into effect in April 2021.

Hints to how USDA intended to treat gene-edited crops came early on, when Penn States nonbrowning mushrooms and DuPonts waxy corn were approved by APHIS in 2015 and 2016, respectively.

Then in March 2018, USDA Secretary Perdue clarified the agencys stance. USDA does not currently regulate, or have any plans to regulate, plants that could otherwise have been developed through traditional breeding techniques as long as they are developed without the use of a plant pest as the donor or vector and they are not themselves plant pests.

The new SECURE rule establishes several ways for developers to qualify for deregulated status. Included are CRISPR modifications like deletions of sections of the genetic code, tiny substitutions, and introductions of DNA from related species. So, for example, a CRISPRd cauliflower would not be regulated if a chunk of DNA was deleted. But it would still be regulated if CRISPR introduced foreign DNA into cauliflower in a way that USDA believes could turn the product into a plant pest.

Another significant change is that companies and scientists will get to decide for themselves if a new product qualifies for exemption from oversight. APHIS says that developers may consult regulators if at any point they arent sure if a new crop is exempt. However, the agency has already expressed confidence that only about 1% of plants might not qualify for an exemption or for deregulation after an initial review.

Ironically, this policy has begun aligning communities typically at loggerheads in the polarized GM conversation. For example, the UC-based Innovative Genomics Institute, founded by CRISPR co-inventor Jennifer Doudna, wrote in its public comments to APHIS: While we recognize the agencys rationale behind self-determination and desire to provide regulatory relief in order to spur innovation, we are concerned that rather than stimulating innovation, such an undisclosed step may have the effect of dampening trust through the loss of transparency in the development and oversight process.

Meanwhile, GM-watchdog organizations including the National Family Farmers Coalition, Pesticide Action Network and Friends of the Earth issued a joint press statement criticizing a rule that allows industry to self-determine its regulatory status. The new framework, they said, has dealt a devastating blow to the security of farmers livelihoods, the health of their farms and communities, and their ability to build the biodiverse, climate-resilient, and economically robust farming systems that we so urgently need.

My research on democratizing biotechnology has helped me unpack the problematic ways in which democracy is being hitched to technological innovation. When it comes to CRISPR, the public has been told that being cheap, easy to use and free from regulation is a powerful cocktail that makes gene editing intrinsically more democratic.

Like many convenient narratives, there are certain truths to this story. But just as clearly, cheapness is not equivalent to democratic. According to USDA, some 6,150 comments were received on the draft rule during the three-month public feedback period, a window designed to give citizens a say in government policy.

The agency admitted that most letters expressed general opposition to GE products. Of the comments that specifically addressed provisions of the rule, approximately 25 expressed some support for the rule. This means a vast majority of the comments did not. Yet, the USDA disregarded this feedback. Such a lack of civic input can lead to environmental and health concerns being sidelined.

Thoughtful scientists, social movements and governments are now asking if there is an alternative way to regulate engineered food. For example, the Norwegian Biotechnology Advisory Board has set out an ethics-based regulatory framework aimed at advancing genetic technology, while protecting community and environmental health and promoting societal welfare.

In the academic sphere, colleagues in Europe have proposed a framework for responsible innovation. I have developed a set of principles and practices for governing CRISPR based on dialogue with front-line communities who are most affected by the technologies others usher in. Communities dont just have to adopt or refuse technology they can co-create it.

One way to move forward in the U.S. is to take advantage of common ground between sustainable agriculture movements and CRISPR scientists. The struggle over USDA rules suggests that few outside of industry believe self-regulation is fair, wise or scientific.

At present, companies dont even have to notify the USDA of biotech crops they will commercialize. The result, as Greg Jaffe of the Center for Science in the Public Interest told Science, is that government regulators and the public will have no idea what products will enter the market. Farmers and everyone else will pay the price,said Jim Goodman, dairy farmer and board president of the National Family Farm Coalition.

Reclaiming a baseline of accountability, then, is the first step in building public confidence in regulatory systems that work for people as well as science that the public believes in.

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How a new biotech rule will foster distrust with the public and impede progress in science - The Conversation US

[Courtesy of the Ministry of Oceans and Fisheries]

More than 7,500 tons of abalone are consumed annually in South Korea. However, it's not easy for abalone farmers to keep their prized product alive during summer as the shellfish die easily when the sea temperature rises above 32 degrees Celsius (89.6 degrees Fahrenheit). To increase the production of abalone by increasing survivability in warm water temperatures, some farmers in China and other countries use genetic modification.

Temperatures of the sea around the Korean peninsula showed abnormality due to global warming, rising on an average of 0.44 degrees Celsius every year over the last decade, according to the Korea Meteorological Administration. Abalone farmers lost more than 13.6 billion won ($10 million) in 2018 due to high sea temperatures.

The National Institute of Fisheries Science (NIFS), a scientific body operated by the Ministry of Oceans and Fisheries, said in a statement that it has found a selective breeding method that involves no genetic engineering by using genetic markers. The institute will commercialize the method after a pilot project at actual abalone farms.

"With the recent trend of rising sea temperature, the future of abalone farms depends on developing breeds that can survive in places where the water temperature varies greatly," NIFS researcher Nam Bo-hye was quoted as saying.

Based on the institute's 2014 finding that a certain breed of abalone is capable of staying alive in seas warmer than 32 degrees Celsius, NIFS researchers have analyzed genetic characteristics, which are genetic markers, of the more heat-tolerant breed. Abalone farmers can check genetic markers to sort out the heat-tolerant breed in a simple and quick manner.

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Researchers find new selective-breeding method for heat-tolerant abalone without genetic modification - Aju Business Daily

A recent gift of $1 million from the Manning family, strong supporters of the University of Virginia, established The Manning Fund for COVID-19 Research, designed to support the Universitys practically oriented research on COVID-19-related topics that can be acted upon quickly and have commercial potential.

More than 50 proposals were received from UVA faculty for projects related to developing COVID-19-related solutions.

The offices of the Provost and the Vice President for Research, which co-manage the fund, havefunded eight proposals that support improved antibody testing, vaccine development and improving patient outcomes.

These researchers showed they had both great ideas for conquering COVID-19, and a solid plan for how to accomplish their goals, said Melur Ram Ramasubramanian, vice president for research. We couldnt be more pleased with the projects proposed and their potential impact.

Many of our researchers have set current and pressing projects aside to redirect their energies to COVID-19, said Liz Magill, the Universitys provost. Were grateful that the Manning Fund has enabled this critical research that takes advantage of the cross-disciplinary networks UVA has nurtured over the past few years.

I want to thank the entire research team and administrationfor their acute sense of urgency and entrepreneurship to come up with these helpful solutions to the COVID crisis. They set short term goals and achieved them, said local businessman and investor Paul Manning. I am very grateful.

A rundown of the selected projects:

IgG to SARS-CoV-2 With ImmunoCAPJeffrey Wilson, School of Medicine, Asthma, Allergy & Immunology

Jeffrey Wilson and his team plan to develop a novel assay to measure antibodies to SARS-CoV-2, taking advantage of the lmmunoCAP platform and producing a quantitative readout of how much IgG is present instead of just a yes or a no, as is common in current commercial systems. This has implications in developing an understanding of the likely attachment sites of the virus and accelerating the development of effective vaccines.

A COVID-19 Killed Whole Cell Genome Reduced E. coli Fusion Peptide Subunit VaccineSteven Zeichner, School of Medicine, Pediatrics

A vaccine for COVID-19 is urgently needed to control the pandemic. Steven Zeichner and his team aim to develop a vaccine that helps the body develop antibodies directed against a specific fusion peptide found on the surface of SARS-CoV-2 virus as a component of its spike protein. The novelty of this project is the use a modified E. coli bacterial surface to display this peptide and help the body develop specific antibodies against it. When the real virus enters the body due to infection, the body can recognize this fusion peptide and neutralize the virus.

We expect the results from this project can be quickly translated into a safe, inexpensive, scalable, and effective vaccine appropriate for pandemic response globally, enabling an end to the COVID-19 pandemic not only in developed countries, but around the world, said Steven Zeichner.

Targeted Antibodies From Convalescent Plasma to Protect Against COVID-19Peter Kasson, School of Medicine, Molecular Physiology & Biomedical Engineering

Individuals vary substantially in their antibody response to COVID-19, both in amount and type of antibodies produced. Peter Kassons team aims to purify the serum from recovered patients and identify specific antibodies that are most potent against SARS-CoV-2 and to produce concentrated amounts of these target specific antibodies for the treatment of patients with increased potency.

Novel Reagents to Improve Testing for COVID-19 AntibodiesJames Zimring, School of Medicine, Pathology

The goal of James Zimring and his team is to develop novel testing reagents to eliminate the problem of cross-reactivity with common coronaviruses and develop a neutralization reagent that can be added to any serological assay and any analytic platform for antibody testing, which will eliminate signal from other non-COVID-19 antibodies and improve the accuracy of the test significantly.

Adenosine A2A Receptor Agonists in the Prevention of COVID-19-Related Lung Injury and Systemic Inflammatory ResponsesKenneth Brayman, School of Medicine, Surgery & Molecular Physiology, Infectious Diseases

The main cause of death in COVID-19 is acute respiratory distress syndrome, which is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. Kenneth Brayman and his team aim to test the use of Adenosine A2AR agonists to reduce the mortality associated with COVID-19. This immunotherapy is expected to be used preemptively, in the asymptomatic phase to prevent onset of COVID-19 or in the symptomatic phase, to reverse progression.

Isolation and Identification of Novel T-cell Receptors Responsive to SARS-CoV-2 for the Genetic Engineering of Third-Party T-cells for Off-the-Shelf Therapeutic UseDaniel Lee, School of Medicine, Hematology/Oncology, Pediatric

Daniel Lee and his team plan to study the T-cell-based immune response from patients who have been infected SARS-CoV-2 to identify viral specific T-cell receptors with the future goal of genetically engineering third-party, allogeneic T-cells with the responsive T-cell receptor, thereby producing an off-the-shelf cellular therapeutic bank for the treatment of subsequent infected patients experiencing severe symptoms. This cell therapy would be especially beneficial for immunocompromised patients infected with COVID-19.

Mass Cytometry to Identify Biomarkers for COVID-19 Severity and Response to JAK InhibitionHema Kothari, School of Medicine, Medicine & Cardiovascular Medicine

Cytokine storm in patients has been linked to COVID-19 disease severity. Hema Kotharis team aims to develop a customized diagnostic biomarker assay for early identification of those at risk of a cytokine storm and improve patient outcomes by taking timely action to block cytokines.

COVID-19: Big Data and Analytics for Early Detection of Cardiorespiratory DeteriorationRandall Moorman, School of Medicine, Medicine, Biomedical Engineering and Molecular Physiology and Biological Physics

Randall Moormans team at UVA Center for Advanced Medical Analytics plans to apply artificial intelligence and big data techniques to the problem of acute and unsuspected clinical deterioration of SARS-CoV-2-infected patients, with the goal to provide continuous risk estimation of imminent deterioration using mathematical analysis of readily available clinical and monitoring data.

Read the rest here:
Eight Research Projects Receive Funding from Manning Fund for COVID-19 Research - University of Virginia

THE ultimate warrior would be unable feel fear or pain, capable of running at Olympic speeds, and even immune to modern weapons.

Their existence was once only possible in the realm of science fiction but a new worldwide arms race is pitting nation states against each other to be the first to successfully create real genetically modified super soldiers.

Militaries have a long history of using powerful drugs to temporarily turn their troops into transcendant Terminator-style killers.

Nazis took methamphetamine or "crystal meth" during the Second World War to stay alert and awake for superhuman stretches of time.

And even the British military bought thousands of Modafinil pills which boost brain-power ahead of the Iraq War.

In China, it is reasonable to assume that they are enhancing their battlefield soldiers on all these fronts.

But with advances in technology, it could now be possible to alter soldiers' DNA to give them godlike powers all the time, from Herculean strength to lizard-like limb regeneration.

GM technology is proven with plants, it could absolutely be applied to the person, said Professor John Louth, an expert at defence think tank Rusi.

In China, it is reasonable to assume that they are enhancing their battlefield soldiers on all these fronts.

China's armed forces are the largest in the world, consisting of a staggering 2.2million personnel.

This year alone, Beijing is spending $178.16billion on its defence budget.

But as the country's international relations flare up, they could be looking to be the first army to have genetically modified super soldiers to get ahead of adversaries.

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These combatants would be stronger, faster and even smarter than their battlefield opponents.

Their DNA could also be adapted to help them recover more quickly from injuries or give them superior hearing and night vision.

The threat is obvious and real. Chinese money could be stealing a march on western armed forces and that is deeply concerning," Prof Louth said.

Concerns about China's super soldier plans came after a Chinese scientist, He Jiankui, claimed to have successfully created genetically modified babies using gene editing technology.

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China jailed Dr Jiankui for illegal medical practices over his claims to have made three babies immune to HIV.

But it's now suspected that Chinese military chiefs are backing trials into human gene editing.

But they're not alone.

The US has also conducted some strange super-soldier research projects.

They've already publicly unveiled a 5million Iron Man-style exoskeleton which gives fighters incredible muscle-power.

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And the Defense Advanced Research Projects Agency (DARPA) developed ways for warfighters to scale walls by studying the skin of geckos.

Novelist Simon Conway, who was granted behind-the-scenes access at the secretive Pentagon agency, revealed a string of other super soldier programmes underway there in 2012.

He claims scientists were working on gene modification that would allow soldiers' bodies to convert fat into energy more efficiently, allowing them to go days without eating.

What is gene editing?

"It's all about improving the efficiency of energy creation in the body," Conway told the Sunday Express.

"Soldiers would be able to run at Olympic speeds, carry large weights and go without sleep and without food."

But the US isn't just looking at how biotechnology can give their soldiers the upper-hand on the battlefield.

They're also carrying out research into medical regeneration, allowing severely injured soldiers who've lost limbs or suffered extensive burns to heal organically.

This is already a reality in the animal kingdom, where lizards can regrow amputated tails and salamanders can restore entire severed limbs.

"We would like it to be as restorative as possible, resist infection and be durable," said Army Lt. Col. David Saunders, extremity repair product manager for the U.S. Army Medical Materiel Development Activity.

"[There are] many wonderful things emerging in the field of regenerative medicine to restore form and function to our wounded warfighters."

As recently as January 2020, the US military was unveiling incredible advances in warzone genetics.

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Army researchers developed a gene therapy that allowed mice to create proteins that would protect them against nerve agents deadly chemical weapons that attack the nervous system, like the Russian Novichok used in the Salisbury poisonings in 2018.

The same gene therapy given to the mice that made them chemical weapon-proof could theoretically be used in soldiers entering hazardous environments.

Before Russia's nerve agents were used with terrible effect, president Vladimir Putin had warned of an even more terrifying weapon.

Speaking at a 2017 youth festival in Sochi, Putin spoke openly about the destructive possible consequences of gene-editing.

"A man has the opportunity to get into the genetic code created by either nature, or as religious people would say, by the God," he said, The Express reports.

"He can be a genius mathematician, a brilliant musician or a soldier, a man who can fight without fear, compassion, regret or pain.

"As you understand, humanity can enter, and most likely it will in the near future, a very difficult and very responsible period of its existence.

"What I have just described might be worse than a nuclear bomb."

But instead of this being something in the "near future", Russia is already factoring genetics into its military strategy.

Alexander Sergeyev, the head of the country's Academy of Sciences, revealed the armed forces were researching "genetic passports" in 2019, Forbes reports.

The passports would predict a soldier's "resistance to stress, ability to perform physical and mental operations under the conditions of this stress, and so on."

Sergeyev added that they could be used to sort which branch of the armed forces personnel would be sent to.

"There are already serious developments in this area," he said.

"It is about understanding at the genetic level who is more prone to, for example, to service in the fleet, who may be more prepared to become a paratrooper or a tankman."

What I have just described might be worse than a nuclear bomb.

And unlike other world leaders, Putin has a very close interest in genetic editing.

That's because his eldest daughter, Maria Vorontsova, is a scientist who specialises in genetic engineering and acts as his adviser on the matter.

In 2018, before He Jiankui revealed his HIV-immune babies in China, Putin had already allotted $2billion for genetic research, Bloomberg reports.

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He even put Vorontsova in charge of the 30-person panel overseeing the experiments.

Watching world superpowers will undoubtedly be paying attention to Putin's potential to weaponise the research.

After all, as Putin says, genetic editing is an area of science which will "determine the future of the whole world".

Originally posted here:
Inside the super-soldier arms race to create genetically modified killing machines unable to feel pain or fe - The Sun

WILLIAMSVILLE, N.Y., June 03, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII) (22nd Century or the Company), a leading plant biotechnology company primarily focused on reduced nicotine tobacco and also hemp/cannabis plant genetics research and development, announced today that James A. Mish has been appointed Chief Executive Officer, effective June 22, 2020. The Company also announced that John Franzino has been appointed Chief Financial Officer, effective immediately.

Mish brings extensive global executive leadership experience in science-driven organizations with a recent focus on the development, manufacturing and commercialization of active pharmaceutical ingredients (API), including cannabinoids, and related consumer products. He has an outstanding track record of delivering profitable growth at both privately held and publicly traded companies. Prior to joining 22nd Century, Mish served as Chief Executive Officer of Noramco, a global leader in the production of controlled substances for the pharmaceutical industry, and Purisys, a synthetic cannabinoid API, ingredients and solutions provider to pharmaceutical and consumer products companies. Mish led the creation and spinoff of Purisys from Noramco during his tenure.

We are very pleased to welcome Jim as our new Chief Executive Officer at this critical juncture in our Companys history, said Nora B. Sullivan, Chairperson of the Board of Directors of 22nd Century. Jims extensive and proven executive leadership capabilities, substantial science-based industry background and deep experience with pharmaceutical and consumer products make him an outstanding candidate to successfully execute on the Companys initiatives and strategic plan going forward. We are confident that under Jims demonstrated leadership capabilities, 22nd Century will continue to build its portfolio of assets and create value for the benefit of our shareholders. We expect that with Jims direction and guidance, 22nd Century will achieve meaningful growth as the Company looks towards the anticipated authorization of our MRTP application for our proprietary, reduced nicotine cigarettes, and as we work to develop new hemp/cannabis intellectual property and proprietary plants with valuable cannabinoid profiles.

I am delighted to join 22nd Century Group at this pivotal time in the Companys growth as it looks to deliver on its primary mission to reduce smoking-related harm and also bring new and valuable hemp-derived cannabinoid products to market, said Mish. 22nd Century is an innovative, plant-based biotech company with an extensive and growing intellectual property portfolio that is poised to disrupt both the tobacco and hemp/cannabis industries. I look forward to partnering with 22nd Centurys Board and management team to drive the business forward to deliver value to our customers and shareholders.

Sullivan continued, We are also pleased to welcome John Franzino into the role of Chief Financial Officer. John is an accomplished strategic financial executive with a track record of successful leadership in high-growth, highly regulated, consumer-facing industries including tobacco and alcoholic beverages. We are excited to have a CFO of his caliber on the executive management team to help lead the Company through the next chapter of its growth.

Prior to joining 22nd Century Group, Franzino served as Chief Financial Officer of the West Point Association of Graduates. Additionally, he has extensive strategic financial leadership experience serving as Vice President of Finance and Controller at Bard College; as Chief Financial Officer of Santa Fe Natural Tobacco Company, a subsidiary of Reynolds American, Inc.; and as Chief Financial Officer of Labatt USA. Franzino is a Certified Public Accountant (CPA) and holds a Master of Business Administration degree from Farleigh Dickinson University.

Also, on behalf of the Companys Board of Directors, I would like to thank Andrea Jentsch, who has resigned as Chief Financial Officer due to personal reasons, for her service and significant contributions to the Company. Despite the challenges presented by COVID-19, Andrea has built a very strong team critical to advancing the Companys accounting, finance, information technology and human resources activities, and she has made a number of significant improvements to the Companys processes, internal reporting and IT resources that will be important enablers for the commercialization of the Companys proprietary plants and products. We wish Andrea the best in her future endeavors, Sullivan added.

About 22nd Century Group, Inc.22nd Century Group, Inc. (NYSE American: XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing and modern plant breeding. The Companys primary mission in tobacco is to reduce the harm caused by smoking by bringing its proprietary reduced nicotine content tobacco cigarettes containing 95% less nicotine than conventional cigarettes to adult smokers in the U.S. and international markets. The Companys primary mission in hemp/cannabis is to develop proprietary hemp/cannabis plants with valuable cannabinoid profiles and agronomic traits and to commercialize those plants through a synergistic portfolio of strategic partnerships in the hemp/cannabis industry.

Learn more at xxiicentury.com, on Twitter @_xxiicentury and on LinkedIn.

Cautionary Note Regarding Forward Looking StatementsThis press release contains forward-looking statements concerning our business, operations and financial performance and condition as well as our plans, objectives and expectations for our business operations and financial performance and condition that are subject to risks and uncertainties. All statements other than statements of historical fact included in this press release are forward-looking statements. You can identify these statements by words such as aim, anticipate, assume, believe, could, due, estimate, expect, goal, intend, may, objective, plan, potential, positioned, predict, should, target, will, would and other similar expressions that are predictions of or indicate future events and future trends. These forward-looking statements are based on current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management's beliefs and assumptions. These statements are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. All forward-looking statements are subject to risks and uncertainties and others that could cause actual results to differ materially from those contained in our forward-looking statements. Please refer to the Risk Factors in our Annual Report on Form 10-K filed on March 11, 2020 and in our subsequently filed Quarterly Report on Form 10-Q. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as otherwise required by law.

Contacts:Mei Kuo22nd Century Group, Inc.(716) 300-1221mkuo@xxiicentury.com

Cory ZiskindICR(646) 277-1232cory.ziskind@icrinc.com

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22nd Century Group Appoints James A. Mish as Chief Executive Officer and John Franzino as Chief Financial Officer - BioSpace

June 2, 2020 Three teams with ties to Harvard T.H. Chan School of Public HealthVincere Health, Concerto Biosciences, and SanaRxwere among the finalists in the 2020 Presidents Innovation Challenge presented by the Harvard Innovation Labs, and two were awarded prizes.

At the May 21 virtual awards ceremony, 25 teams from across 13 Harvard schools showcased their ventures in five tracks: Social Impact or Cultural Enterprise; Health & Life Sciences; Open Track; Launch Lab X (Alumni); and Pagliuca Harvard Life Lab. The Bertarelli Foundation furnished prizes totaling $510,00, with $75,000 going to each Grand Prize winner and $25,000 to each runner-up. Harvard President Larry Bacow offered congratulatory remarks at the opening of the event, and Matt Segneri, the Bruce and Bridgitt Evans Executive Director of the Harvard Innovation Labs, served as emcee.

Vincere Health

Vincere Healthfounded by Jacob Keteyian, MPH 19, Shalen De Silva, MPH 19, Hadi Javeed, and Trevor Campbellreceived the Grand Prize in the Launch Lab X (Alumni) Track, earning $75,000 for their venture. Vincere Healths virtual care delivery model helps smokers quit with a combination of counseling, remote health monitoring, behavioral nudges, and financial incentives. Through a mobile app paired with a carbon monoxide monitor as well as counseling, Vincere Heath offers patients a custom incentive program. The software and programming can be compatible with many different health devices.

This telehealth model, which has the potential to be applied to a variety of chronic conditions, is timely: with the COVID-19 pandemic, insurer coverage has expanded to accommodate reimbursement for an increasing number of telehealth services.

Our clients and strategic partners have been eager to roll out our digital tools to keep people out of the clinics and offer smoking-cessation support to reduce the risks associated with COVID-19 exposure, which are higher for smokers, said Keteyian.

The two credit fellow MPH studentsincluding Katie Klatt, MPH 21; Nimerta Sandhu, MPH 20; Puay-Shi Ng, MPH 20; and Tsung-Hsien Tsai, MPH 20with providing help along the way. Being a finalist and winning the competition in our alumni venture track was a huge honor and a privilege, given the exquisite caliber of all the other participants and finalists, said De Silva. We would love for this result to highlight the importance of entrepreneurship and health care innovation coming out of the Harvard Chan School. The prize money will enable to team to find additional support to meet increasing demand and hire additional permanent employees.

Concerto Biosciences

Concerto Biosciencesfounded by Adil Bahalim, DrPH 20, Bernardo Cervantes, Cheri Ackerman, and Jared Kehewas the runner-up in the Health & Life Sciences Track, receiving $25,000 to advance their venture. Using a patented platform that constructs and screens millions of specific microbial communities, the team aims to discover groups of microbes that work in concert to accomplish important functions in human healthsuch as promoting the growth of a beneficial microbe or suppressing the growth of a pathogenas well as in agriculture and industry.

We are focused on revolutionizing the way the world relates to microbes, said Bahalim. We want to harness the power of microbes working together to solve the worlds most challenging problems.

One example comes from the human skin microbiome, a community of microbes on the skin that collectively protects against pathogens and teaches the immune system not to attack beneficial microbes. Weve recently observed that people with conditions like eczema or psoriasis have different skin microbiome compositionsthey lack microbes that would otherwise protect the skin, said Bahalim. If we discover combinations of microbes responsible for skin health, we can manufacture them at scale and deliver them as therapeutics to people with skin diseases.

SanaRx

SanaRx, founded by Rick Pierce, Jeffrey Wagner (a former postdoctoral fellow in the Eric Rubin Lab), Fred Mermelstein, and Carl Novina, was a finalist in the Pagliuca Life Lab category. SanaRx leverages synthetic biology and genetic engineering to improve detection, visualization, and treatment of three rare diseases of the gastrointestinal tract. The current standard of care for these diseases requires frequent invasive proceduressuch as colonoscopiesunder anesthesia, whereas SanaRx products use bacterial genetic engineering to detect the diseases noninvasively, reduce the frequency of invasive interventions, and treat the diseases.

Jan Reiss

Photos courtesy Shalen De Silva (Vincere Health) and Adil Bahalim (Concerto Biosciences)

More here:
Harvard Chanaffiliated teams compete in finals of President's Innovation Challenge - HSPH News