LSI Center Scholar Walter Johnson publishes article in the Journal of Food Law and Policy

LSI Center Scholar and 3L Walter Johnson has an upcoming article in the Journal of Food Law and Policy. The article, “Blockchain Meets Genomics: Governance Considerations for Promoting Food Safety and Public Health,” considers the promise and challenges of two emerging technologies coming together to improve food safety.

Foodborne illnesses remain a significant public health issue in the U.S. and globally. To better respond to outbreaks, government agencies like the Food and Drug Administration and Centers for Disease Control and Prevention have begun exploring new technical tools. Whole genomic sequencing (WGS) is one such tool, which reveals the DNA of the pathogen responsible for contaminating foods. Scientists can then use the DNA to infer where contamination began and work with food distributors who may have received products from those areas. Meanwhile, blockchain has gained notoriety as more than just a platform for Bitcoin. Large companies including IBM and Walmart have partnered to use blockchain to track food products through global supply chains. Distributors can use this system to work backwards to find each site in the
supply chain that may have harbored contaminated food.

Combining the two technologies may not be a silver bullet for foodborne illness, but blockchain and genomics each have promising benefits and can cover some of the other’s weaknesses.

Despite the promise, bringing together WGS and blockchain systems may create regulatory challenges and conflicts. Government WGS programs and private-driven blockchain systems will require data to flow across the public-private barrier and could raise issues of data integrity, competition between private firms, and system interoperability. Whether the blockchain platforms are public or private, permissioned or permissionless, and which entities control the platforms take on new significance in this context.

The article examines how the design of these technologies and who operates them will create different regulatory hurdles, arguing for early efforts including technical standards and voluntary public-private collaborations to facilitate positive public health outcomes.

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Scientists Add Names to Global Moratorium on Embryo Editing

Leaders of the American Society of Gene and Cell Therapy sent a letter to the Secretary of Health and Human Services, adding their names to the list of scientists who have called for a global moratorium on experiments that could alter the genes of future generations, NPR reports.
This comes after the controversial experiment in China last year that reportedly produced children with edited genomes.

Scientists now are speaking out against the idea of engineering embryos until an “international framework” can be built to proceed responsibly. They wish to continue studies to determine if DNA in human embryos can be edited safely and effectively, as well as ethically. The appropriate uses for this process also need to be determined, such as preventing genetic disorders.
It has been stressed that this moratorium is not permanent, but temporary until the pros and cons of genetically editing embryos are evaluated.

Interested in learning more about genetic editing? Come checkout our panel at the 2019 GETS conference later this month.

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Marchant Speaks at LawSeq Symposium on DNA Sequencing

Faculty Directory Gary Marchant recently spoke at a LawSeq symposium discussing DNA sequencing and the legal aspects that come into play when introduced to the public as a direct-to-consumer option.

Marchant and his LawSeq colleagues met at the University of Minnesota to examine ways the legal world can keep up with the ever changing scientific landscape.  LawSeq is an innovative project that gathers experts to analyze the current US federal and state laws and regulations on translational genomics so they can generate a consensus outline on what the law should be.  

With DNA based tests becoming more available to the public, the concern for legal liability is on the rise. New problems are coming to light as these tests are being used, such as: the healthcare providers disconnect between the tests results and their level of care to provide, and the advancements of technology in the future finding new variants that were deemed meaningless years ago, but now have been proven to be harmful. With the level of care issue that health providers are facing, the typical fallback for most providers would be a rigorous standard of care, which is something that could act as a shield, legally speaking, against malpractice claims. Now this is becoming hazy considering that a patient’s results come from a testing company as opposed to a doctor’s office, which would mean that the doctor has all of the information needed to see what course of action to take. With that, a patient could take a test now, have the results come back with no malicious abnormalities and a certain genetic variant could be deemed meaningless. With new advancements it may come to light, possibly years later, the lab may contact a doctor and notify them that the genetic variant the patient was told to not worry about, is now known to be harmful and the patient is nowhere to be found. Now who can be held liable is up in the air, as the doctors didn’t have the results to notify the patient and the testing company may not have regularly reviewed scientific literature to track the understanding of the gene variants it tests for. Just last year, the South Carolina Supreme Court declared that a testing lab qualifies as a health care provider, therefore holding them liable under medical malpractice.  The case that determined this decision was the death of a boy whose mother contends that the testing lab failed to classify the genetic mutation he carried as pathogenic, leading to inappropriate treatment.

Marchant also discussed at the symposium the various liability claims he anticipates as genomics starts in the clinical care world. Some of these claims could be: failing to test, over testing, and failing to warn family about a variant the patient carries that they might have as well. LawSeq is creating an outline of recommendations to help labs, health care providers, and others to protect them from the legal risks that could come up. This outline will be released in a forthcoming paper and LawSeq’s participants will write up their recommendations.

 

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Marchant and Tournas Publish Anti-Aging Article

Faculty Director Gary Marchant and Lucille Tournas recently published an article in the Food and Drug Law Journal about the regulatory challenges and health span assisting interventions.

The article, “The Fountain of Youth Revisited: Regulatory Challenges and Pathways for Health span Promoting Interventions,” covers the progress that has been made in the scientific understanding of the aging process. This process comes from a new paradigm call the “geroscience” hypothesis and recognizes that aging is the number one risk factor in all chronic diseases. This means that there could be some intrinsic aging factors that can be specifically targeted with interventions, instead of attempting to extend healthy life by treating one chronic disease at a time. By utilizing genetic and other data showing that the aging process is malleable and can be slowed, scientists have identified key aging processes that underlie most chronic diseases and the symptoms of aging (ex. Fragility and cognitive decline.) Next, the potential interventions that can affect the aging process needs to be identified. Currently there are a number of “geroprotectors” have been identified, mainly in animal studies but a few cases in humans as well. This progress has been achieved in the past decade and has advanced a numerous interventions to the point where they are now ready to begin human clinical trials, regulatory approval and commercialization.

There has been a roadblock in this process, though, just as the scientific advancements made health span extension a possibility, regulatory and legal impediments have popped up to slow down the further advancement of these interventions. Mainly because the that the Food and Drug Administration drug approval process is based on prevention and the treatment of diseases, aging is not considered to be a disease and there is no straightforward regulatory approval pathway for therapeutics that may slow aging and extend lifespans.

Marchant and Tournas’ article explores this dilemma, identifies alternative regulatory and commercialization pathways for health span extending interventions, and argues that the FDA should take a more proactive role in speeding these clinical trials and regulatory period for these agents. 

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Jurimetrics Banquet Highlights Students and Alumni

Jurimetrics: The Journal of Law, Science, and Technology recently held its annual banquet at the Sandra Day O’Connor College of Law. The banquet is an opportunity to mingle with current and former Jurimetrics members and to recognize outstanding students and alumni.

The editors chose to recognize past Editor-in-Chief Ted Wimsatt with the Outstanding Jurimetrics Alumni Award. Wimsatt headed Jurimetrics from 2007 to 2008. He graduated Summa Cum Laude and was the recipient of the John S. Armstrong and Steven G. Lisa Awards for academic excellence and contributions to the Center for Law, Science and Innovation. Wimsatt currently serves as the Senior Director of Intellectual Property at Honeywell.

Outstanding students were also highlighted during the banquet. Student award winners included:

Outstanding 3L Mentor
Nicole Prefontaine and Justin Larson

Outstanding 2L Editor
Krislin Nuzum

Outstanding 3L Editor
Antonio Arias

Best Note
Walter Johnson

Lastly, current Editor-in-Chief Grant Frazier passed the baton to the incoming Editor-in-Chief, Krislin Nuzum. Congratulations Krislin!

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Experts Gather for eDiscovery and Digital Evidence Conference

The Eighth Annual ASU-Arkfeld eDiscovery and Digital Evidence Conference featured a bevy of successful panels and addresses. The conference focused on the practical and cutting-edge issues affecting the management of digital evidence. Leading industry experts, jurists, attorneys and technological professionals came together to discuss the exciting world of eDiscovery.

The conference featured stellar keynote speakers. Shawnna Hoffman-Childress opened the conference with the keynote on the Convergence of AI, Blockchain and the Law. Hoffman serves as the Global Co-Leader of the IBM Cognitive Legal Practice, as well as an Automotive, Aerospace & Defense Client Partner and was certified as an IBM Thought Leader.  She went into detail on recent AI and blockchain innovations and how they are changing the industry, as well as current trends in emerging technologies.

Maura Grossman, Research Professor and Director of Women in Computer Science, University of Waterloo, was featured in the 2016 February issue of The American Lawyer and the September 2016 Issue of the ABA Journal where she was recognized as a “Legal Rebel.” Grossman’s keynote address discussed the convergence of legal practice and AI. She provided an overview of legal AI products currently on the market and the benefits and challenges that legal professionals face as AI applications mature.

On the last day of the conference the Hon. Xavier Rodriguez, U.S. District Court Judge for the Western District of Texas, discussed the role of eDiscovery in the demise of civil jury trials as the percentage of civil cases resolved by a jury trial at a historic low-just %1. Judge Rodriguez was then joined by other esteemed judges for a panel with a behind-the-bench perspective on eDiscovery practice.

The conference featured numerous other panels discussing important topics such as data privacy, blockchain, information governance, internet of things, AI, and much more. To check out past conferences and more on conference speakers please click here.

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See to Antarctica with ASU Law and Thunderbird

What are you doing for New Years Eve 2020? We’ll be in Antarctica. Want to come?

Faculty Fellow Diana Bowman, through a partnership with ASU Law and the Thunderbird School of Global Management, invites you on a 10-night expedition to the bottom of the world. This once-in-a-lifetime educational voyage will be lead by world-leading specialists in fields like history, marine biology, geology, photography, and more. Guided excursions and personal conversations throughout the expedition provide guests with an even richer experience and deeper understanding of the fragile ecosystem of Antarctica, as well as the fascinating history of early polar explorers.

Participants will travel form December 28, 2020 to January 8, 2021. Do the “polar bear plunge” into the icy waters of the Gerlache Strait, to listen to icebergs snap, crackle and pop, come face to face with a penguin or elephant seal, explore the highly contested Falkland Island, and earn CLE credit along the way.

Learn more and reserve your spot now!

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