Biotechnology

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FDA Approves Direct-to-Consumer Genetic Tests

April 6, 2017

In a turnaround for the Food and Drug Administration (FDA), the agency has announced it will "allow a company to sell genetic tests for disease risk directly to consumers," according to the New York Times23andMe, a private genomics and biotechnology company based in Mountain View, California, pioneered products to allow customers to learn about their genome without the involvement of a doctor, genetic counselor or other health care professional. There are two levels of test offered; the default will only include the gene variants that could lead to the development of 10 rare conditions such as factor XI deficiency, Gaucher disease type 1 and celiac disease. For the genes associated with illnesses such as Parkinson's and Alzheimer's, there is a separate track that includes access to genetic counselors. An attempt by 23andMe to offer similar direct-to-consumer tests in 2013 was quashed by the FDA because of concerns about how patients might misinterprete potentially bad news without professional guidance. However, according to Dr. Robert C. Green, a Consortium collaborator who has researched the matter, studies since then have "there is some potential for distress, but it is much, much smaller than was anticipated.” Read the entire article here

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Patient-led Medicine Symposium on Harvard Bill of Health Blog

March 6, 2017

A symposium published today on Bill of Health, a blog edited by the Petrie-Flom Center at Harvard Law School, expands on discussions held at the Consortium's Deinard Memorial Lecture last December, "How Patients Are Creating Medicine’s Future." The Deinard lecture featured four speakers – Ernesto Ramirez of Fitabase, Jason Bobe of the Mount Sinai School of Medicine, Barbara Evans of the University of Houston Law Center, and Kingshuk K. Sinha of the Carlson School of Management at the University of Minnesota. The Bill of Health symposium provides commentary on their lectures and further reflections on the ways citizen science and wearables are transforming both health care and medical research. A video of the entire Deinard lecture can be viewed here

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Prof. Kingshuk Sinha

Recall of Medical Devices Needs to be More Timely

February 20, 2017

A new study by Consortium collaborator Kingshuk Sinha illustrates troubling lags in the recall of flawed medical devices. In the paper, Prof. Sinha, a professor in the University of Minnesota's Carlson School, "applied digital analytics to millions of medical device product reports and recall records" to reveal what Sinha calls "under-reaction bias," according to the Minneapolis Star Tribune. The article details efforts by the Food and Drug Administration to use data-mining to improve surveillance of health technology. However, despite robust evidence that problem devices can have significant negative health effects, such adverse-event reports aren't consistently sought or entered into the federal tracking system, known as MAUDE. Prof. Sinha was one of the presenters in the recent Deinard Memorial Lecture on Law & Medicine, How Patients Are Creating Medicine’s Future, during which he shared Big Data and supply chain perspectives on health improvement; a video of that event can be viewed here

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Medical Device Tax Under Fire

January 9, 2017

A 2.3% excise tax on medical devices is among the many aspects of the Affordable Care Act (ACA) likely to be repealed during the current congressional session. The tax was collected starting in 2013, with the intention of offsetting expected ACA-driven profits for companies benefiting from expanded federally-funded Medicare and Medicaid payments. However, Congress passed a two-year repeal of the tax that was enacted in 2015 in an effort led by legislators representing states, like Minnesota, with robust medical device industries. According to the Star Tribune, "With [medical device excise tax] collections set to start again in January 2018, [Republican GOP Representative Erik] Paulsen is going for the coup de grace with a GOP-controlled House, Senate and White House that have made repealing the ACA a top priority." The article notes that the bill's co-sponsors, Paulsen and Wisconsin Democrat Ron Kind, "adopted the industry’s talking points in opposing the tax as a job killer that also took money away from research and development."

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Experts Explore the Opportunities and Perils of Patient-Led Medicine

December 7, 2016

Yesterday's Deinard Memorial Lecture on Law & Medicine was a fitting conclusion to a visionary series. Hundreds of attendees heard from a multidisciplinary panel on the fast-moving, emerging field of patient-led medicine. Prof. Jason Bobe (Mount Sinai School of Medicine) kicked things off by examining the obstacles to broad patient engagement in research, and shared his efforts to empower potential research participants through the Personal Genome Project and Open Humans. Ernesto Ramirez of Fitabase discussed the move toward gathering, analyzing and sharing personal data, and how that has both sparked patient-driven collaborations and led to the development of devices such as the "artificial pancreas," for those with Type 1 Diabetes. Prof. Kingshuk K. Sinha (Carlson School of Management, University of Minnesota) broadened the conversation to include business perspectives, such as supply-chain management, that can be used to increase access to new health-care products, and also highlighted some potential pitfalls of self-treatment, such as patients using unproven or dangerous approaches. Prof. Barbara Evans (University of Houston Law Center) wrapped up with remarks about the ways laws and regulations meant to protect patients have, in some cases, served as an obstacle to participation in research. An article about the event from the Minneapolis Star Tribune can be read here

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Prof. Susan M. Wolf

Prof. Wolf Appointed to National Academies Committee on Science, Engineering, Medicine and Public Policy

December 5, 2016

Consortium Chair Susan M. Wolf has been appointed to the National Academies' Committee on Science, Engineering, Medicine and Public Policy. This is the only committee that crosses all three academies – Sciences, Engineering, and Medicine – and includes the presidents of the three branches. According to their website, “the Committee is charged with the responsibility ‘to deliberate on initiatives for new studies in the area of science and technology policy, taking especially into account the concerns and requests of the President's Science Advisor, the Director of the NSF, the Chairman of the National Science Board, and the chairmen of key science and technology-related committees of the Congress.’” In addition to chairing the Consortium, Prof. Wolf is the McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; and Professor of Medicine. She is an elected member of the National Academy of Medicine. 

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What Are the Diagnostic Limits of New Technology?

November 18, 2016

"Would you trust an algorithm to help you with a medical diagnosis?" This question is posed by Christina Farr of Fast Company in her discussion of a collaboration between University of California, San Francisco (UCSF) and General Electric with the goal of finding out what Big Data approaches to diagnosis can – and can't – accomplish. The two organizations will be partnering for the next three years to "develop a set of algorithms to help radiologists distinguish between a normal result and one that requires further attention." Knowing the medical community will be skeptical about such machine-learning approaches, not to mention the lack of appropriate regulation for a diagnosis by a non-human, Michael Blum of UCSF notes, "There is a lot of concern from the public and from clinicians that we’ll be developing things to replace doctors. These developments will be focused on supporting clinicians and in developing safer workflows." Read the entire article here

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GMOs Fail to Deliver Higher Crop Yields, Lower Pesticide Use

November 1, 2016

According to an in-depth article in the New York Times, while "the controversy over genetically modified crops has long focused on largely unsubstantiated fears that they are unsafe to eat. . . the debate has missed a more basic problem — genetic modification in the United States and Canada has not accelerated increases in crop yields or led to an overall reduction in the use of chemical pesticides." This conclusion is drawn from data comparing the two North American countries to Western Europe, where genetically modified organisms (GMOs) have largely been rejected. In fact, during the 20-year period studied, pesticide use increased in the US while in France, the biggest European agriculture producer, it has been reduced. Biotech companies like Monsanto defend their products, saying they can help meet the food needs of an explosively growing global population. However, Michael Owen, a weed scientist at Iowa State University, notes "they still 'haven't found the mythical yield gene.'" Read the entire article here

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Nanobot in bloodstream

Chemistry Nobel Prize Goes to Nanotech Scientists

October 5, 2016

Three scientists have been awarded the 2016 Nobel Prize in Chemistry for their work on designing tiny machines "a thousand times thinner than a strand of hair," according to the BBCJean-Pierre Sauvage (Strasbourg University), Fraser Stoddart (Northwestern University) and Bernard Feringa (University of Groningen) will share the prize, which is worth approximately $930,000. Nanotechnology – "the creation of structures on the scale of a nanometer, or a billionth of a meter," as described in the New York Times – could be used to precisely deliver pharmaceuticals within the human body and may lead to entirely new therapeutic approaches. Consortium Chair Susan M. Wolf has led significant efforts, funded by the National Science Foundation and National Institutes of Health, to determine the best way to protect human beings who participate in nanotechnology research. Two major symposia evaluated oversight models using a historical and comparative approach and produced the first systematic, comprehensive recommendations on how to protect human participants in nanotech research. To see all the Consortium's work on nanotechnology, click here

Research

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Consortium Chair, 3 Colleagues Awarded Grand Challenges Research Grant

September 29, 2016

Consortium Chair Susan Wolf and three Co-Investigators – Profs. Pamala JacobsonKingshuk Sinha, and Ellen Demerath – on behalf of the Working Group on Advancing Health Through Tailored Solutions, have been awarded a Grand Challenges grant from the Office of the Provost to establish the Minnesota Precision Medicine Collaborative (MPMC). This 2-year, $500,000 grant will fund creation of a transformative University-wide initiative to use 21st century technologies – including genomics, informatics, bioengineering, analysis of environmental exposures, and behavioral sciences – to tailor health care to the challenges facing individuals and their communities. This precision medicine approach will fundamentally alter our understanding of health, disease prevention, and treatment. Core to this project is partnering with citizens, patients, and healthcare providers to understand and effectively address major health problems. MPMC will create a living laboratory, starting with demonstration projects on Alzheimer’s disease, lung cancer, and depression. All three are diseases whose incidence, burden, and mortality rates reveal disturbing health disparities. This focus will enable us to leverage U of M research strengths across many disciplines and to engage with partners in the health industry and Minnesota’s underserved communities. By investing in the development and delivery of precision medicine, our university will contribute to the national effort to transform science, medicine, and public health through more precise understanding of the factors contributing to health and disease. MPMC aims to make a unique contribution through collaborative research, cutting-edge innovation, responsible policy, and sustained commitment to improving health equitably across our communities.    

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Prof. Jerrold Vitek

Major Grant Will Focus on Promising Parkinson's Treatment

September 26, 2016

The University of Minnesota has been awarded a five-year, $9 million grant for Parkinson’s research. Jerrold Vitek, MD, PhD, will lead the study, which establishes a prestigious Udall Center of Excellence in Parkinson's Disease Research on campus, one of only nine such centers in the nation. An article about the grant in Twin Cities Business Magazine quotes Brian Herman, PhD, the U's Vice President for Research: "I think it puts this university in a very elite class of other major U.S. and international research universities that have recognized expertise." Prof. Vitek's work focuses on the therapeutic effect of deep brain stimulation (DBS), which he likens to "a pacemaker for the brain." Watch a video about the grant and DBS here

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Consortium Lecturers Discuss Fecal Transplant Pill

August 2, 2016

An article by Ed Yong in The Atlantic describes attempts to create effective stool substitutes to replace fecal transplants used to treat Clostridium difficile, which kills almost 30,000 Americans each year. One such substitute, from Seres Therapeutics, recently failed during a phase 2 drug trial. Yong quotes Dianne Hoffmann, who spoke last spring during the Consortium's Microbiome Therapeutics lecture series: she notes that "whole stool" is clearly more effective than bacterial pills. "Something in there is working. We just don’t know what it is, and it might be hard to deconstruct.” Another speaker in the lecture series, Alexander Khoruts, adds "The full spectrum of microbes harvested from donors has been designed by nature, and has a proven safety track record in the original host. That’s a very hard benchmark to improve upon with any kind of synthetic." You can view Diane Hoffmann's lecture on regulating microbiome therapeutics here; Alex Khoruts' talk, The Evolving Human Microbiome, is here.

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Use of Robot to Kill Dallas Shooter Raises Legal, Ethical Questions

July 11, 2016

Last week, a robot was used to kill the attacker who fatally shot five police officers and injured seven others during a peaceful protest rally in Dallas. After a multi-hour standoff, Dallas police jury-rigged a robot originally designed to disarm bombs by attaching an explosive device and remotely detonating it near the gunman. This is the first known incident of a robot being used to kill a suspect in the history of American policing. An article on Motherboard analyzes the relevant legal and ethical principles; according to tech attorney Jay Stanley of the American Civil Liberties Union, “Because ground robots may allow deadly force to be applied more safely and easily, they raise the danger that they will be overused. . . . Remote uses of force raise policy issues that should be carefully considered and addressed by our society as technology advances." Ian Kerr of the University of Ottawa raises another important point: "Once you send a robot in, compared to a human, you’re no longer thinking about it as a human process of negotiation. A human can think — is this guy going to lay down arms or not? [A robot can only be used] once they’ve decided the situation is far past the point of negotiation.” Read the entire article here

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Biospecimens in lab

Controversy Erupts on Informed Consent for Biospecimens

May 16, 2016

A new proposal by the Obama administration would require scientists who work with human biospecimens to obtain consent from patients prior to using them in research, even when all personal information is removed. The proposed change is part of the revision of the Common Rule, the federal law used to govern research with human participants, which is currently under review. In effect, the new policy would broaden the definition of "human subject" to include tissues, blood, and urine. Some scientists, medical device manufacturers, and advocacy groups are concerned about the chilling effect this could have on research, including the Precision Medicine Initiative. Bioethicists have raised issues about plans to offer new forms of consent, with Consortium collaborator Ellen Wright Clayton, MD, JD, of Vanderbilt University questioning whether those could be effective: “The idea that this informed consent will be in any way meaningful I think is illusory.” Read an article about the debate from STAT here

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Prof. Efie Kokkoli

Efie Kokkoli Honored by AIMBE

May 12, 2016

Professor Efie Kokkoli, PhD, has been inducted into the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows, a top honor in her field of Chemical Engineering. Prof. Kokkoli was recognized for outstanding contributions to the design of peptide- and aptamer-amphiphiles for the development of functionalized biomaterials. The AIMBE College of Fellows represents 1,500 individuals, the top 2 percent of the most accomplished and distinguished medical and biological engineers responsible for innovation and discovery, consisting of clinicians, industry professionals, academics and scientists. Prof. Kokkoli has collaborated on two major nanotechnology research projects involving the Consortium, DNA Nanotechnology: Developing and Analyzing a New Tool for Sensing and Targeting Disease and NIRT: Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context.

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Girl using BCI headseht to race drone

First Race of Brain-controlled Drones Builds on U of M Research

April 26, 2016

A recent competition at the University of Florida featured a race of 16 drones guided by human thoughts. The technology, called Brain Computer Interface (BCI), has been used in the past to help some paralyzed people manipulate prosthetics with their minds. In 2013, University of Minnesota biomedical engineering professor Bin He, PhD, first presented a drone controlled by BCI, in which electroencephalogram (EEG) headsets are fine-tuned to determine the electrical activity linked with specific thoughts in the brain. Programmers then write code to convert these signals into commands a computer sends to the drones. Regarding the drone race, Prof. He noted: "The progress of the BCI field has been faster than I had thought ten years ago. We are getting closer and closer to broad application." Read more about the competition and the technology behind it here

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Dr. Stacy Kahn lecturing

Pediatric Microbiome Therapeutics Lecture – Video Now Available

March 31, 2016

Prof. Stacy A. Kahn, MD, (University of Chicago School of Medicine, Comer Children's Hospital) recently delivered a lecture on Fecal Microbiota Transplantation (FMT): Ethical Challenges and Regulatory Hurdles. Dr. Kahn, a pediatrician, discussed the real-world challenges faced by clinicians whose patients see FMT as a magic bullet for the treatment of Inflammatory Bowel Diseases (IBD), despite a lack of evidence that it works for those conditions. She reviewed the differences between Clostridium difficile, for which FMT has been proven effective, and other digestive diseases, and provided an overview of ethical and regulatory issues presented by FMT. A video of her entire talk, which was the second in a series of three on Microbiome Research & Microbiota Therapeutics, can be found here

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Baby

Cesarean Babies Benefit from Exposure to Mother's Microbiome

February 9, 2016

New research led by Dr. Maria Gloria Dominguez-Bello indicates a promising new therapy for babies born by c-section. Cesarean infants typically have less diverse microbiomes when compared to babies born vaginally, a factor associated with increased risk for immune and metabolic disorders. In the study, described in Nature Medicine, infants delivered by c-section were swabbed with their mothers' vaginal fluids immediately upon being born. Subsequently, the gut, oral and skin bacterial communities of these babies was enriched and more closely resembled those who were delivered vaginally. Dr. Alexander Khoruts, MD, of the University of Minnesota's Microbiota Therapeutics Program, discussed the research and its implications in an article also published in Nature Medicine. On Wednesday, Feb. 17, Dr. Khoruts will be lecturing on Dr. Gloria Dominguez-Bello's research, his own pioneering therapeutic interventions, and the threat of antibiotic-resistant rogue superbugs. 

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Research lab with test tubes

Unintended Consequences: Culture Wars Drove State Stem Cell Research Funding

November 6, 2015

When President George W. Bush restricted federal funding for embryonic stem cell research in 2001, he wasn't looking to expand state funding of this research, but that's exactly what happened. An article in Kaiser Health News recounts how, after the ban, several states started their own stem cell programs or offered economic incentives to local scientists and companies. While these efforts haven't yet produced any miracle cures because of the amount of research still to be done, Jakub Tolar, director of Consortium member the Minnesota Stem Cell Institute, notes that potential results are worth the wait. “We started on drugs a hundred years ago. Then we went to monoclonal antibodies – biologicals,” he said. “We are now getting ready to use cells as a third way of doing medicine. We are at a historical sweet spot.” The U's Stem Cell Institute was established in 1999, before the ban on research with embryonic cells, and is the world's first interdisciplinary institute dedicated to stem cell research.

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