Translational science

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National Institutes of Health Announces Adoption of SMART IRB

March 24, 2017

Multisite clinical trials are a powerful way to drive the discovery of new therapies, but ensuring that the health and privacy of study participants are protected across multiple Institutional Review Boards (IRBs) has slowed things down in the past. Today, the NIH reached a major milestone: all of their Clinical and Translational Science Awards program sites have agreed to a new authorization agreement, SMART IRB. The agreement – whose acronym stands for Streamlined, Multisite, Accelerated Resources for Trials IRB – "will enable all participating study sites to rely on the ethics review of one IRB for each study, making it possible to initiate multisite studies within weeks instead of months. For patients waiting to enroll in a study, this could make a life-saving difference." Among the signatories on the agreement is Consortium member the Clinical and Translational Science Institute (CTSI).

Publication

O'Daniel JM, McLaughlin HM, Amendola LM, Bale SJ, Berg JS, Bick D, Bowling KM, Chao EC, Chung WK, Conlin LK, Cooper GM, Das S, Deignan JL, Dorschner MO, Evans JP, Ghazani AA, Goddard KA, Gornick M, Farwell Hagman KD, Hambuch T, Hegde M, Hindorff LA, Holm IA, Jarvik GP, Knight Johnson A, Mighion L, Morra M, Plon SE, Punj S, Richards CS, Santani A, Shirts BH, Spinner NB, Tang S, Weck KE, Wolf SM, Yang Y, Rehm HL. A Survey of Current Practices for Genomic Sequencing Test Interpretation and Reporting Processes in US Laboratories. Genetics in Medicine 2016;18(11). Download PDF (638.01 KB)

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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

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Prof. Suma Jacob

DNA-based Autism Research May Support Early Interventions

September 28, 2016

A growing amount of evidence points to the importance of early behavioral interventions in the treatment of autism. However, health professionals typically won't diagnose the disorder sooner than 18 months, and often much later. To help close this gap, a major, national research study is being led in Minnesota by Prof. Suma Jacob, MD, PhD, of Consortium member the Center for Neurobehavioral Development. The study, SPARK, has the goal of collecting DNA and other data from 50,000 people with autism and their family members. An article in MinnPost quotes Prof. Jacob as saying "There have been studies that have shown that there are strong heritable components in autism. . . . What’s exciting about [SPARK] is we know that we need to gather a large number of families with autism to find as many potential connections as possible. We are in the process of collecting that large sample." She cautions, however, "The disorder is different in each individual. . . . Generalizations just don’t fit."

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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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Liquid being transferred from test tube to beaker

New Rules: Researchers Must Publish Results of All Clinical Trials

September 19, 2016

In a step toward greater transparency, the US Department of Health and Human Services (HHS) has announced that, going forward, researchers funded by the National Institutes of Health (NIH) must report the design and results of all clinical trials, whether successful or not. An article in Nature describes the new rules, which are designed to reduce the number of clinical trials that aren't reported; a 2013 study found that approximately half the time, trial results aren't published if they have unfavorable results. The article notes, "Under the new rule, trials must be registered on ClinicalTrials.gov within 21 days of enrolling their first patient — researchers can no longer wait for the results of their trails to report their data." For the first time, those who don't adhere to the guidelines can be penalized by having their funding withdrawn. Bioethicist Jennifer Miller of New York University’s Langone Medical Center praises the change, noting "You need a clear law so you can have clear compliance." 

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Cancer Moonshot logo

Cancer Moonshot Announces Next Steps for Transformative Research

September 8, 2016

In his 2016 State of the Union address, President Barack Obama announced the Cancer Moonshot, an intensive research collaborative to accelerate immunotherapy as an effective treatment for cancer patients. Led by Vice President Joe Biden, doctors, patients, researchers, pharmaceutical companies, insurance companies, and technologists are striving to managing cancer as a chronic condition, like diabetes, rather than a devastating and life-threatening illness. Last June, Consortium member center Masonic Cancer Center hosted a local event that was part of the national launch of the Moonshot, which featured remarks by VP Biden and US Senators Amy Klobuchar and Al Franken. Yesterday, a Blue Ribbon Panel released its roadmap for the effort, recommending 10 transformative research approaches for achieving major strides in cancer prevention, diagnosis and treatment by 2020. The report can be read here.

Lecture

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Scan of brain with Parkinson's Disease

Feud Over Parkinson's Drug Trial Reveals Power of Gatekeepers

August 31, 2016

A dispute between Dr. Charbel Moussa, a scientist at Georgetown University, and the Michael J. Fox Foundation (MJFF) has exposed some challenges of conducting independent drug research in collaboration with a major advocacy group. An article in STAT outlines the conflict, noting that the MJFF-funded Phase 2 trial based on Moussa's previous research "was supposed to begin in October, but Fox and the Georgetown team had a bitter falling out, and it’s unclear whether Georgetown will be able to obtain the medicine from its manufacturer so that the study can proceed. [MJFF], meanwhile, is moving forward on its own, and has established a separate group to study the same drug." The article provides a glimpse into unusually public discord within the world of high-stakes research. In a statement, MJFF states the conflict with Dr. Moussa and his team is a result of differences of opinion regarding the design and execution of the study, citing "the limitations of open-label clinical trials in Parkinson's, which have been shown to be disproportionately affected by placebo response." Leigh Turner, a professor at Consortium member the Center for Bioethics, is quoted in the STAT article, saying funders and journal editors should "be above reproach in their handling of insider information. [Turner cautions] 'You have these gatekeeper moments, where it is possible to take advantage of positions like that, to gobble up as much information as possible, and repurpose it for your own advantage.'"

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Model of crystal structure for CRISPR-Cas9

There's More Than One Way to Edit a Gene

August 15, 2016

The gene-editing technique known as CRISPR has generated immense excitement for enabling scientists to alter genomes "with unprecedented precision, efficiency and flexibility," in hopes of accelerating cures for genetic diseases. However, while CRISPR has been receiving the lion's share of attention in the media, a new article in Scientific American outlines its limitations: as researchers have used CRISPR, particularly the Cas9 tool, they've been reminded "how fragile every new technology is," according to George Church of the Harvard Medical School. The article describes several alternatives that researchers hope will offer more precise pathways for rewriting DNA, which plant scientist Daniel Voytas of the University of Minnesota notes is essential to the advancement of the field: “Everyone says the future is editing many genes at a time, and I think: ‘We can’t even do one now with reasonable efficiency.'" Each month seems to bring new advances in the field: read the article, which provides an up-to-date overview of what's happening, here

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Poo lookalike ice cream sundae from Beijing

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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National Academies Call for Halt to Common Rule Update

June 29, 2016

The National Academies of Sciences, Engineering, and Medicine (NASEM) have issued a call for the withdrawal of the Notice of Proposed Rulemaking (NPRM), which is intended to update the federal guidelines for research with human participants, also known as the Common Rule. In the view of the National Academies, the NPRM "is marred by omissions, the absence of essential elements, and a lack of clarity," an opinion shared by many scientific groups. In its place, NASEM suggests a national commission be appointed to issue a "course correction" that will update the rules without increasing regulatory burdens or diminishing the effectiveness of human subjects research. An article in Science describes the debate and the initial response by a Department of Health and Human Services spokesperson, who notes they've "received more than 2,100 public comments" on the NPRM and will "take all public comments seriously" as they develop the final rule.

Research

LawSeq logo corrected Dec 2016

LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application

This innovative 3-year project, based cooperatively at the University of Minnesota and Vanderbilt University, has convened a national Working Group of top legal and scientific experts to analyze current federal and state law and regulation on translational genomics and to generate consensus guidance on what the law should be. The project team will build a searchable online database of relevant law and an annotated bibliography for free public access, systematically collect and analyze a range of stakeholder inputs, convene a national public conference, and publish analyses and recommendations to help shape the law to support genomic medicine.

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LawSeq logo stacked

Consortium Awarded $2M NIH Grant to Co-lead Genomic Law Recommendations

June 7, 2016

The National Institutes of Health (NIH) has just awarded the first-ever grant dedicated to laying the policy groundwork needed to translate genomic medicine into clinical application. The project – LawSeqSM– will convene legal, ethics and scientific experts from across the country to analyze what the state of genomic law is and create much-needed guidance on what it should be. The principal investigators leading the grant are Consortium Chair Susan M. Wolf, JD; Ellen Wright Clayton, MD, JD (Vanderbilt University); and Frances Lawrenz, PhD (University of Minnesota). They will be joined by a group of 22 top experts – from academia, industry, and clinical care – who will collaborate over the course of this 3-year project to clarify current law, address gaps, and generate the forward-looking recommendations needed to create the legal foundation for successfully translating genomics into clinical care. Learn more about the project here

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Mustache Dash fun run

Mindy Kurzer-led Research Inspires Major Prostate Cancer Trial

June 3, 2016

In 2013, Mindy Kurzer, PhD, published research demonstrating that "aerobic exercise influences the way our bodies break down estrogens to produce more of the ‘good’ metabolites that lower breast cancer risk." Kurzer, director of Consortium member center Healthy Foods, Health Lives, is a professor in the Department of Food Science and Nutrition. The results of her 2013 study are now being deployed to see whether they can be applied to the treatment of advanced prostate cancer. “We want to actually prove [exercise] does more than just makes you feel better and actually prolongs your survival,” explained Dr. Fred Saad, MD, of the University of Montreal Hospital Research Centre. The University of Minnesota is leading a coalition of more than 100 researchers around the world, including those in Australia, Ireland and several Canadian provinces. The clinical trial is funded by the Movember Foundation, which raises money by sponsoring mustache-growing contests each November to foster men's health, particularly the fight against prostate and testicular cancers. Read more about the study here

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Medicine capsules

Personalized Prescriptions Hampered by Insurance Gaps, Doctor Confusion

May 24, 2016

Despite the promise of pharmacogenomics – selecting drugs based on a patient's genetic makeup – significant obstacles to its wide implementation remain. According to an article in Scientific American, "fewer than 10 hospitals around the country. . . are offering pharmacogenomic tests," citing two primary impediments to wider use: inadequate insurance reimbursement and the fact that "doctors are not accustomed to making medication choices using genetics." This matters because each year, "half of all medical patients get a drug that could interact with their genes and cause serious side effects." To build understanding and acceptance of the practice, a research group led by Mary Relling, PharmD, of St. Jude Research Hospital in Memphis, has received funding from the National Institutes of Health to document any new drug-gene relations solidified with new research. Pharmacogenomics is the topic of this year's University of Minnesota Precision Medicine Conference on June 20, featuring nationally-known experts in the field; learn more and register here.  

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C difficile bacteria

Sadowsky, Khoruts Sound Cautionary Note on FMT

February 29, 2016

In today's issue of Nature Microbiology, University of Minnesota professors Michael J. Sadowsky, PhD, and Alexander Khoruts, MD, warn against the spread of fecal microbiota transplantation (FMT) into clinical or domestic settings that may not allow for the proper administration of the therapy. They note that the relative simplicity of using FMT to treat recurrent C. difficile infections has led to "the proliferation of an unregulated FMT industry around the world, as well as 'do it yourself' protocols. . . . Such practices are potentially risky, as they generally lack the necessary rigor for pathogen screening." Earlier this month, Dr. Khoruts delivered a lecture on this topic hosted by the Consortium, The Evolving Human Microbiome, which was moderated by Prof. Sadowsky – video of that event can be found here. The next lecture in our microbiome series, Fecal Microbial Translplantation, will be presented on March 8 by pediatrician Stacy A. Kahn, MD, of the University of Chicago.

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Brain scan side view

Research Pinpoints Neural Circuits Driving PTSD

February 23, 2016

CBC News reports that new research has identified a key mechanism of Post-Traumatic Stress Disorder (PTSD). Dr. Apostolos Georgopoulos, who is on the faculty of Consortium member the Center for Cognitive Sciences, also leads the Brain Sciences Center at the Minneapolis VA. His lab has identified the neural pathways that drive the flashbacks and panic attacks that characterize PTSD. Healthy brains are able to re-form neural networks, wiping the slate clean of past stimuli to allow the absorption of new information. Using brain scans to compare healthy people vs. those who suffer from PTSD, the scientists at the lab observed "healthy people had the ability to maintain the flexibility of their networks at various trauma strength exposures," according to Georgopolous. However, those with PTSD had "inflexible" neural networks that were "locked in and couldn't be modulated." The hope is this research can be applied to create more effective PTSD therapies. Read the entire article 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.