LSI Scholar Profile: Drew Hensley

The Center is home to an incredible faculty and host to the top minds at the intersection of law, science, and technology. But we also attract some of the brightest student scholars around; you should meet them.

Drew Hensley, class of 2020

Hometown: Phoenix, Arizona

Education: BS in Neurobiology, Physiology, and Behavior from ASU’s Barrett, the Honors College

During Drew’s undergraduate studies, he worked as a medical scribe for orthopedic physicians. Drew also has an extensive background in music performance and composition, completing his undergraduate honors thesis in pop composition and music theory. Drew composed and recorded three a cappella albums with his undergraduate group, Priority Male.

Drew interests in law fall in the areas of Intellectual Property and Health Law. Drew is an O’Connor Merit Scholar and was awarded the Alan Matheson Award for the 2017-2018 school year. Drew is the founder and current director of ASU’s law school-based a cappella group, Law Cappella. Additionally, as the 1L Representative for ASU’s branch of Volunteer Legal Assistance for Artists, Drew’s pro bono efforts are focused in the area of IP law.

Fun Facts:

  • Has been stung by scorpions 14 times (ouch!).
  • Has previously performed at cocktail hours for many alumni events at the law school.
  • Plays six instruments.

 

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FDA Moves on Regulation of Medical Laboratory Tests

The U.S. Food and Drug Administration (FDA) recently authorized a new laboratory developed test (LDT) for genetically profiling tumors. This test uses next generation sequencing (NGS) to help doctors develop strategic treatment plans for cancer patients.

The FDA traditionally did not provide oversight of LDTs, which are developed and administered by doctors in laboratories. Rather, the FDA focused its oversight efforts on in vitro diagnostic (IVD) test kits, which are sold to laboratories or directly to customers for use in the home.

This latest authorization may indicate that the FDA plans to move forward with its previously announced plan to ramp up oversight of LTDs.

Faculty Fellow Dr. Roger D. Klein believes that the FDA’s plan to regulate LTDs would be a mistake. He argues that LTDs provide doctors with safe and useful tests that can be modified quickly in response to the latest medical advancements. As he wrote recently in Investor’s Business Daily, the FDA risks stifling a useful tool:

The FDA approval process for these tests is lengthy and expensive. Obtaining approval for updates that keep tests current with rapidly advancing medical and scientific knowledge can be difficult and costly. Unsurprisingly, there are few genetic and genomic IVDs.

Dr. Klein recommends instead that the FDA focus on “operational safety issues,” and leave the medicine to the doctors. You can read Dr. Klein’s full commentary here: Fixing How FDA Regulates Diagnostic Lab Tests.

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Center Fellows on Regulating Nanomaterials in Cosmetics

Faculty Fellows Diana Bowman and Andrew Maynard, with ASU College of Law alum and Research Fellow Nathaniel May, authored a chapter on regulating nanomaterials in cosmetics in the recently published Analysis of Cosmetic Products, Second Edition.

Cosmetics are big business with estimated global sales of $675 billion by 2020. Competition in the market drives innovation and the adoption of new technology, including nanotechnology and nanomaterials. For many people, whether they know it or not, cosmetics will be their first contact with nanomaterials.

These materials provide interesting challenges for regulators around the world. The potential health risks associated with nanomaterials are uncertain or unknown. And some of these products blur the traditional regulatory divide between simple cosmetics and therapeutic goods (or drugs).

Bowman, Maynard, and May describe the evolving, and diverging, regulatory approaches found in the United States and European Union. The differences will reveal the strengths and weakness of either approach and provide important guidance for future regulation of cosmetics incorporating nanomaterials.

Professor Bowman will be co-teaching a course on Nanotechnology at the Sandra Day O’Connor College of Law in the Spring 2018 semester with Dean Douglas Sylvester.

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A New Model for Governance of Emerging Technologies

Faculty Director Gary Marchant and Faculty Fellow Yvonne Stevens have published a law review article that proposes a new model for governing emerging technologies that is based on the concept of resilience.

Current efforts to govern emerging technologies like synthetic biology, artificial intelligence, and nanotechnology involve a mix of ex ante strategies such as risk analysis and precaution. But given the inherent and massive uncertainties about the risks posed by emerging technologies, regulatory restrictions that impede innovation are often adopted based on very speculative fears that may never manifest. And when things do go wrong, they often are for unanticipated risks that society is not prepared to deal with.

Marchant and Stevens propose a new model that gives greater weight to ex post application of resilience. Anticipatory resilience means putting in place a variety of measures that can help minimize any harm that may be caused by emerging technologies, while avoiding unwarranted preemptive restrictions on the technologies. The authors propose two types of resilience measures for emerging technologies:

  • Procedural resilience measures put in place processes for the early detection and rapid response to any harms caused by the technology.
  • Substantive resilience measures involve a variety of tools that can help minimize harm if it occurs, such as back-up regulatory programs that would kick in, financial assurance requirements, stockpiling harm mitigation supplies, and technology kill switches.

While these ex post resilience measures cannot and should not replace ex ante risk analysis and precaution entirely, they can be used to reduce the pressure and reliance on these ex ante methods that often face insurmountable challenges in accurately predicting the impact of emerging technologies.

Marchant and Stevens’ article was published in a symposium issue of the UC Davis Law Review and is available for free here: Resilience: A New Tool in the Risk Governance Toolbox for Emerging Technologies. Marchant’s panel discussion at that symposium can be viewed here (Marchart’s talk begins at 14:00). The same issue of the journal features a number of other interesting articles on the governance of various emerging technologies.

A special tip of the hat to professor Anupam Chander – formerly of ASU, now at UC Davis – who chaired the symposium and authored a superb and highly recommended introduction to the special issue entitled Future-Proofing Law.

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23andMe… for your dog?

This article was written by Caroline Saunders. Saunders is a 3L at the Sandra Day O’Connor College of Law and Articles Editor of Jurimetrics: The Journal of Law, Science, and Technology.

As technology advances at an unprecedented rate, startups and venture capitalists are scrambling to get involved with the next best tech trend. These purveyors of up-and-coming technology have recently taken notice of the latest fad: pet tech.

The pet industry is booming; consumers spending about $66.75 billion last year.1 As a result, techies and investors are making sure that Fido is not left out of the IoT fun. For example, in 2015, the Boyko brothers teamed up with Cornell University College of Veterinary Medicine and Spencer Wells to found the canine genetics startup, Embark Veterinary Inc.2

Embark is not the first company to offer dog DNA testing, but with a database of over 200,000 genetic markers, it rightfully touts itself as the world leader in dog genetics.3 The company’s impressive doggy databank was built from nearly a decade of research, testing village dogs and thousands of samples from the Cornell Veterinary Biobank.4

Embark’s business model, as well as its sample collection and testing procedure, closely resembles its human counterpart, 23andME.5 For about $200, a consumer can mail in a dog’s saliva swab, and Embark will test the sample against its massive database to determine Duke’s breed ancestry, traits, and risk of developing certain genetic health conditions.6 Unlike 23andMe, the FDA has not elected to enforce regulations for animal genetic tests, so Embark and its competitors can roam regulation-free for the time being.7

1 Pet Industry Market Size & Ownership Statistics, Am. Pet Products Ass’n.
2 Matt Weinstein, DOGGY DNA: Unique startup has roots at Cornell, Ithaca J.
Embark Dog DNA Test – Our Story, Embark Dog DNA Test; Dog DNA Test reviews and comparisons, Dog Identifier.
4 Weinstein, supra note 2.
5 Laura Entis, Venture Capitalists Are Going Barking Mad for Pet Startups, Fortune.
6 Embark Dog DNA Test.
7 Arielle Duhaime-Ross, Doggie DNA startup wants to learn about human diseases from dog drool, Ithaca J.

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LSI Scholar Profile: Elizabeth Bertram

The Center is home to an incredible faculty and host to the top minds at the intersection of law, science, and technology. But we also attract some of the brightest student scholars around; you should meet them.

Elizabeth Bertram, class of 2018

Hometown: Cameron, Missouri

Education: BS in History with minor in Legal Studies, Missouri Western State University

Elizabeth has always enjoyed science, both scientific advances for their own sake and their place at the intersection of ethics and morality. She has written on gene editing and CRISPR, ethics and the egg donation industry, and ethics in the programming of autonomous vehicles.

Elizabeth is the Vice President of the Law & Science Student Association and is the Chair of Recruitment on the Executive Moot Court Board. Last summer, Elizabeth interned with the Bioethics Defense Fund.

Fun Facts:

  • Was homeschooled from kindergarten through high school.
  • Has banded birds and enjoys holding them (at least the nice ones).
  • Really likes curling.

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Guy Cardineau on Genetically Engineered Plants

Professor Emeritus and Center Faculty Fellow Guy Cardineau presented at the 4th Congreso Internacional Meredith Gould at the Autonomous University of Baja California in Ensenada, Mexico on October 22. The congress brings together international institutions in biological sciences to create an environment for students and researchers to learn from and interact with one another.

Cardineau, who has worked for more than 20 years in industrial biotechnology and agroscience, was invited to speak on Advances in Genetically Engineered Plants: Historical Perspective & New Opportunities, as well as providing career perspectives directed at student attendees.

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LSI Scholar Profile: Selene Presseller

The Center is home to an incredible faculty and host to the top minds at the intersection of law, science, and technology. But we also attract some of the brightest student scholars around; you should meet them.

Selene Presseller, class of 2019

Hometown: Scottsdale, Arizona

Education: BS in Business Administration with concentration in Marketing and Information Technology Management

Selene is interested in cybersecurity and data privacy. Selene attended Seton Hall University in New Jersey for her undergraduate degree and focused her studies on social media marketing. She became intrigued by the laws, or lack there of, that protect consumers from companies that are able to collect massive amounts of data as a result of every day interest usage. This burning question surrounding what role the law should play in regulating the internet and other emerging tech is what inspired her to go to law school. She hopes to focus her legal studies around the intersection of the law and the internet.

Fun Facts:

  • Has been horseback riding since she was 3 years old and has competed a number of times.
  • Studied abroad in Seville, Spain and is fluent in Spanish.
  • Her first language was Italian.

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Marchant on Regulating Gene Editing in Plants and Animals

Faculty Director Gary Marchant spoke at the 10th World Conference of Science Journalists in San Francisco on October 26th. He presented as part of a Symposium On New Genetic Technologies: Ethical Debates And Global Science Policy organized by The Hastings Center.

Marchant discussed the regulatory challenges and opportunities with respect to editing the genes of plants and animals. How will variations in international regulation of gene editing affect international trade? How are policymakers, regulators, and journalists supposed to explain these complex issues to the public?

The Symposium was live streamed on The Hasting Center’s Facebook page. An archived version of the entire Symposium can be accessed there (Marchant’s talk begins at 24:00).

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Center Scholar Helps Win $6M for Transportation Tech

Center Scholar Dominic Papa, through his Institute for Digital Progress (iDP), helped Arizona and Maricopa County win a $6 million grant for transportation technology deployment.

The U.S. Department of Transportation’s Federal Highway Administration awards the Advanced Transportation and Congestion Management Technologies Deployment grant program for large-scale deployment of advanced technologies.The Arizona Department of Transportation (ADOT) previously applied for this grant and was denied.

Papa and iDP set out to fix this. iDP created the Smart & Connected AZ Council – a coalition of community leaders working together to leverage technology for the provision of public and private services. This year ADOT applied for the grant in partnership with the iDP’s Council. They won.

ADOT and Maricopa County were awarded $6 million for the Loop 101 Mobility Project to improve safety and existing capacity on the Loop 101 corridor through new transportation technology. The project is slated to deploy a Decision Support System to provide Loop 101 drivers with real-time information on traffic, accidents, and detours, as well as connected vehicle technology to improve accessibility for transit vehicles.

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