It is depressing to read about the havoc wreaked in some cases by apparently not credible “blood splatter science,” and some other fringe areas of “expert” testimony in criminal cases. A broad view of a wrongful conviction is set in a December 20, 2018 NYT article.   Also see this May 31, 2018 article at Pro Publica.   One wonders how many related civil suits for damages have been or will been filed for persons wrongly convicted, when cops and prosecutors should have known better.

More and more molecular data will arrive over the next few years; some of it will be very valuable for more deeply understanding when and how diseases arise. Consider, for example, the fact that genes matter a great deal because they contain the instructions for producing proteins, but we need to know more about actual outputs of proteins coded for by the genes. The proteins, after all, are the actual doers of the work to promote health or fight off disease. Accordingly, it is useful to know which inherited or somatic mutations completely cut off production of a protein (null mutations), while other mutations may have a range of effects, from very little to material.

Today, researchers can answer many questions about the effect of mutations in some genes, and some combinations of genes. However, researchers seek to know more about the protein production results that arise from different combinations of inherited mutations.  With that in mind, consider the disease-related knowledge, questions and hypotheses that will arise from the following collaboration, which is described in a December 14, 2018 press release from SomaLogic and deCode.

___________________________________________

Largest-ever Protein Measurement Study Enhances deCODE’s Efforts in Basic Research, Drug Discovery and Novel Protein-based Diagnostics

deCODE genetics, an Amgen subsidiary, and SomaLogic, Inc. today announced a collaboration that brings together SomaLogic’s expertise in human proteins with deCODE’s expertise in human genetics. The collaboration combines deCODE’s rich data sets with SomaLogic’s leading protein measurement capabilities to enhance the understanding of how human disease and health are mediated through proteins to influence health outcomes.

“I am excited to see what deep proteomic analysis will add to what we already know about human health based on our study of genetics,” said Kári Stefánsson, M.D., Dr. Med., founder and chief executive officer of deCODE genetics. “SomaLogic’s ability to measure thousands of proteins brings a whole new dimension to our efforts, and we look forward to seeing the results.”

Under the collaboration agreement, SomaLogic will analyze up to 40,000 deCODE samples with the proprietary SOMAscan® assay, which can rapidly measure the levels of 5,000 proteins in each sample across a wide range of concentrations. deCODE will use the assay data for therapeutic drug discovery and development. SomaLogic will use the assay results and related clinical information to further develop clinical applications of the SOMAscan assay in an effort to improve health management.

“This collaboration with deCODE gives us an exciting opportunity to work with one of the most highly characterized and understood datasets in the world, as well as with world-class genomic and pharmaceutical scientists,” said Stephen Williams, M.D., chief medical officer at SomaLogic. “We are undertaking together the largest protein study ever performed — over 200 million individual protein measurements — to gain substantial new knowledge about normal and disease biology across many common and rare conditions.”

Specific details of the collaboration were not disclosed.

###

deCODE Contact
Jon Gustafsson
T: +354 664 1905
jon@decode.is

SomaLogic Contact 
Laura S. Mizoue, Ph.D.
Communications Specialist
T: 720 417 7509
lmizoue@somalogic.com

About deCODE genetics
Based in Reykjavik, Iceland, deCODE is a global leader in analyzing and understanding the human genome. Using its unique expertise and population resources, deCODE has discovered genetic risk factors for dozens of common diseases. The purpose of understanding the genetics of disease is to use that information to create new means of diagnosing, treating and preventing disease. deCODE is a wholly-owned subsidiary of Amgen.

About SomaLogic
SomaLogic seeks to empower a healthier world by delivering actionable health-management insights for every seeker and enabler of human health. These essential insights, which are provided through a global network of partners and users, are derived from SomaLogic’s unique ability to measure changes in thousands of individual human proteins over time with high precision, sensitivity and throughput. For more information, visit www.somalogic.com and follow @somalogic on Twitter.

Forward Looking Statement
This news release contains forward-looking statements that are based on the current expectations and beliefs of deCODE and its affiliates. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements regarding improvements in scientific understanding and drug discovery and development.  No forward-looking statement can be guaranteed and actual results may differ materially from those deCODE and its affiliates project. Results may be affected by clinical and regulatory developments and their research, testing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any research and testing will lead to the identification of any particular product candidate or new potential indication for an existing product or aid in their development, or that the development of a particular product candidate or development of a new indication for an existing product will be successful and become a commercial product.

 

“Nationwide, 14% of law-school enrollees are pursuing non-J.D. programs, newly released numbers from the American Bar Association show, compared with 8% five years ago.” The chart and the quote are from a December 20, 2018 WSJ article noting the trend.

It is good to see a focus on the evolution of law schools to offer various forms of degrees and specialized learning, rather like like some specialized MBA programs.  The article would be more cogent if it focused more attention on law school programs focused multidisciplinary programs. A prime example is the Center for Law Science & Innovation at Arizona State University’s Sandra Day O’Connor School of Law.  That program is now 30 years old, and has inspired other similar programs. The LS&I Center is a great success in providing both lawyers to be and science specialists with the legal and non-legal knowledge needed to work in rapidly evolving areas, such as the intersections between genomics and law. See https://law.asu.edu/degree-programs/law-technology.

A brilliant new study on parachute use was recently published in the British Journal of Medicine. The researchers/authors presumably will go on to enjoy long careers as expert witnesses in lawsuits involving injuries related to sky-diving. The study is open access and online; it is titled: Parachute use to prevent death and major trauma when jumping from aircraft: randomized controlled trial
BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k5094 (Published 13 December 2018)
Cite this as: BMJ 2018;363:k5094

The authors included the following notable disclosure:

“RWY had the original idea but was reluctant to say it out loud for years. In a moment of weakness, he shared it with MWY and BKN, both of whom immediately recognized this as the best idea RWY will ever have. RWY and LRV wrote the first draft. CS, DBK, JBS, EAS, and JLH provided critical review. RMD provided subject matter expertise. DSK took this work to another satirical level. All authors suffered substantial abdominal discomfort from laughter. RWY worried that BKN would not keep his mouth shut until the Christmas issue was published.”

Set out below is an image of a twitter post from one of the authors.

 

 

 

 

Yes, there is medical malpractice as to genomic information. The first real study on the topic is from ASU’s Gary Marchant (PhD in genetics and lawyer/law professor) and Rachel Lindor (physician/lawyer). A brief synopsis is provided in a December 5, 2018 post at an ASU law school blog, Bits Bots and Biomarkers.  The full paper is online and open access at this page of the Food and Drug Law Journal.

Another step forward is happening in the effort to find lung cancers early.  It’s an early detection study – in the UK – using both liquid biopsy and LDCT scans.  The program will start in 2019. The program is a joint effort between Grail, UK government agencies and UK medical centers.

The pace of change remains significant. Just under three years ago, Grail and its liquid biopsy goals were publicly announced.  The business is now well underway;  the SUMMIT  project is the third for Grail. The December 3, 2018 press release is pasted below; it provides further specifics.

GRAIL Announces Plans to Initiate SUMMIT Study to Support Development of Blood Test for  Early Cancer Detection

SUMMIT Study Partners Include UCL and University College London Hospitals NHS Foundation Trust in the United Kingdom, and Lung Cancer Alliance

December 03, 2018 07:01 PM Eastern Standard Time

MENLO PARK, Calif.–(BUSINESS WIRE)–GRAIL, Inc., a healthcare company focused on the early detection of cancer, today announced plans to initiate the SUMMIT study in early 2019. SUMMIT is a prospective, observational, longitudinal, cohort study designed to enroll approximately 50,000 men and women age 50 to 77 years who do not have a cancer diagnosis at the time of enrollment. The study will evaluate the ability of an investigational blood test using next-generation sequencing (NGS) technology to detect multiple cancer types, including lung cancer. Approximately half the participants will be people at high risk for lung and other cancers due to a significant smoking history, and the other half will be people who are not at high risk for cancer based on smoking history.

SUMMIT will be conducted in the United Kingdom in partnership with UCL (University College London) and University College London Hospitals National Health Service (NHS) Foundation Trust (UCLH). Lung Cancer Alliance (LCA), a non-profit organization based in Washington, DC, is also a SUMMIT study partner and provided guidance on the study design.

“The SUMMIT study will support the development of our blood test for the early detection of multiple cancer types in a diverse population,” said Anne-Renee Hartman, MD, Vice President of Clinical Development at GRAIL. “We are excited to partner with UCL, University College London Hospitals NHS Foundation Trust, and Lung Cancer Alliance on the SUMMIT study, as we continue to evaluate new ways to improve the early detection of cancer.”

SUMMIT also supports UCL’s and UCLH’s goal of assessing the feasibility of implementing lung cancer screening in the United Kingdom. By participating in the study, people determined to be at high risk for lung cancer will have an opportunity to undergo lung cancer screening with low dose computed tomography (LDCT) and will have access to resources for smoking cessation through the NHS in the United Kingdom. In the United States, LDCT is recommended by the U.S. Preventive Services Task Force (USPSTF) for people at high risk for lung cancer due to current or former smoking. However, currently in the United Kingdom, LDCT is not widely used as a screening tool.

“We have a common goal with GRAIL in conducting the SUMMIT study – the early detection of cancer,” said Sam Janes, Professor of Respiratory Medicine at UCL and Principal Investigator of the SUMMIT study. “By working together, we hope to bring lung cancer screening to people in the United Kingdom, while we also deepen our understanding of potential new technologies for early cancer detection.”

About GRAIL’s Clinical Research Program

GRAIL is conducting what the company believes to be one of the largest clinical research programs ever pursued in genomic medicine in collaboration with leading community and academic medical centers globally. In addition to SUMMIT, GRAIL is conducting two other large-scale studies, which are designed to characterize the landscape of genomic cancer signals in the blood, and to develop and evaluate GRAIL’s blood test for the early detection of multiple cancer types. The Circulating Cell-free Genome Atlas (CCGA) study is a prospective, observational, longitudinal study enrolling at least 15,000 people with and without cancer across 142 sites in the United States and Canada. The STRIVE study is a prospective, observational, longitudinal, cohort study that has enrolled approximately 100,000 women at the time of their screening mammogram across 37 sites in the United States.

About GRAIL

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is using the power of high-intensity sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop and commercialize pioneering products for the early detection of cancer. The company is located in Menlo Park, California and Hong Kong. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.

About UCLH

UCLH (University College London Hospitals NHS Foundation Trust) provides first-class acute and specialist services in six hospitals in Central London. UCLH is committed to education and research and forms part of UCLPartners which in March 2009 was officially designated as one of the United Kingdom’s first academic health science centres by the Department of Health. UCLH works closely with UCL, translating research into treatments for patients. For more information visit www.uclh.nhs.uk or follow on Facebook (UCLHNHS), Twitter (@uclh), Youtube (UCLHvideo), or instagram (@uclh).

UCLH Cancer Collaborative is the Cancer Alliance for north and east London and brings together hospital trusts, GPs, health service commissioners, local authorities and patients to improve early cancer diagnosis, outcomes and care for patients in our area. Working with its stakeholders, its mission is to achieve world-leading patient outcomes and experience for our local population.

About UCL (University College London)

UCL was founded in 1826. UCL was the first English university established after Oxford and Cambridge, the first to open up university education to those previously excluded from it, and the first to provide systematic teaching of law, architecture and medicine. UCL is among the world’s top universities, as reflected by performance in a range of international rankings and tables. UCL currently has over 39,000 students from 150 countries and over 12,500 staff. UCL’s annual income is more than £1 billion. For more information visit www.ucl.ac.uk, or follow on Twitter (@uclnews), or YouTube (YouTube.com/UCLTV).

About Lung Cancer Alliance

Lung Cancer Alliance (LCA) serves and listens to those living with and at risk for lung cancer to reduce stigma, improve quality of life and increase survival. LCA empowers its community by helping people navigate the paths of early detection, diagnosis and treatment. Insights allow LCA to improve care, amplify awareness, drive advocacy and lead research with the vision of tripling the number of survivors in the next decade. For more information, please visit www.lungcanceralliance.org.

Contacts
GRAIL, Inc.
Charlotte Arnold, 650-255-1909
pr@grail.com

 

 

It’s an interesting week for thinking about risk. As it happens, I’m presenting on lethal diseases and “real world evidence” at the annual meeting of the Society for Risk Analysis. Meanwhile, the General Counsel of Praedicat recently published an interesting article on:  “What’s the risk in learning about risks?” It’s well worth reading. The article starts out as follows:

“In talking with product stewardship and risk management professionals, we occasionally see a fear of too much knowledge.  You may believe that knowing about a specific risk means being held legally responsible if the risk manifests.  Unfortunately, that’s true.

Proving liability when a harm results requires showing that the risk was reasonably foreseeable.  And known risks are by definition reasonably foreseeable.  In product liability cases in particular, a manufacturer has a duty to warn consumers of any risks that it knows about or reasonably should know about.”

 

 

The latest global failure of cyber security is covered in detail in a November 30, 2018 post at Krebs on Security, and is headline news around the world. Initial data shows a massive, global scale to the failure. This breach also is only one of many at international and national hotel chains, as explained by Krebs.

Market failures often lead to regulation. And, the pressure to block cyber failure is growing issue for corporate boards because so much corporate value lies in corporate reputation, data and intangibles, rather than tangible things, according to a 2015  article at the World Economic Forum.  One wonders how all of this will evolve vis a vis state based immunity and/or regulation at state, national and global levels.  And, if a global immunity/regulation process is built for cyber security, will that process then lead to more global regulation in other substantive areas? Global class actions? Or, will soft law provide alternative answers and outcomes? Interesting times ahead.

As explained by Krebs:

“Marriott said the breach involved unauthorized access to a database containing guest information tied to reservations made at Starwood properties on or before Sept. 10, 2018, and that its ongoing investigation suggests the perpetrators had been inside the company’s networks since 2014.

Marriott said the intruders encrypted information from the hacked database (likely to avoid detection by any data-loss prevention tools when removing the stolen information from the company’s network), and that its efforts to decrypt that data set was not yet complete. But so far the hotel network believes that the encrypted data cache includes information on up to approximately 500 million guests who made a reservation at a Starwood property.

“For approximately 327 million of these guests, the information includes some combination of name, mailing address, phone number, email address, passport number, Starwood Preferred Guest account information, date of birth, gender, arrival and departure information, reservation date and communication preferences,” Marriott said in a statement released early Friday morning.

A press release yesterday brought news of an interesting next step in the process of increasing the intersections between law and molecular science. In short, liability insurance clients of Allianz will receive access to the ChemMeta analytic system developed by Praedicat. The ChemMeta system evaluates scientific literature regarding a selected set of chemicals that are or alleged to be “toxic” to some degree or another. I’ve been publicly pointing out Praedicat since 2014. See Praedicat – Foretelling the Future of Toxic Tort Litigation.  Their work ties well to our work at ToxicoGenomica. Their latest action is further proof that the future is arriving more quickly than many anticipated. The press release is pasted below, and well worth reading.

“PRESS RELEASE. London/New York/Munich/Paris/Singapore – November 27, 2018.

Allianz Global Corporate & Specialty (AGCS), the Allianz corporate insurance carrier, together with Praedicat, an InsurTech analytics company based in Los Angeles, are expanding their partnership to provide a unique analytic resource to policyholders. Specifically, clients will benefit from access to ChemMeta®, Praedicat’s software solution delivering science and regulatory risk analytics for industrial companies. ChemMeta helps both chemical manufacturers and those who incorporate chemicals downstream minimize their product safety risks. Based on the latest peer-reviewed scientific literature and risk analysis, ChemMeta provides companies customized intelligence on thousands of chemicals and materials to help make better decisions across critical functions, including product stewardship, R&D, enterprise risk management, EHS and regulatory affairs.

“By offering access to ChemMeta with our product liability policies, we help clients maximize the overall safety of their products and production processes, striking the right balance between innovation and risk,” explains Hartmut Mai, Chief Underwriting Officer, AGCS. “Those opting to use ChemMeta will better understand which substances are more likely to cause negative impact on human health and wellbeing or trigger regulatory action in the future, helping them to look around the corner. This is another example of enriching our product offering with strategic risk management services that can prevent or mitigate potential losses.”

“Today’s science is tomorrow’s regulatory action and ChemMeta uses both AI and machine learning to scan, analyze and synthesize data from millions of peer-reviewed scientific journals to identify product risk,” says Robert Reville, CEO of Praedicat. “The early warning provided by mining technical literature at scale allows companies to make proactive product decisions.”

Understanding emerging risks inherent in any manufacturing process is particularly relevant in the chemical, pharmaceutical and food & beverage industries. In the end, it is relevant to any corporation which produces or uses chemicals within their own value chain.

Large companies from the mentioned sectors might employ teams of up to 100 scientists to monitor scientific publications and track relevant findings. However, the scope of their activity is often limited due to manual analysis and, as a result, only a certain number of production elements can be thoroughly investigated. For small and medium companies, resources are even scarcer. At the same time, there is exponential growth of data and information as a result of digitalization. To comprehensively evaluate chemical products or ingredients at a company, a scalable approach is required.

“Take DEHP, one of the most widely used phthalates, a plastics additive. More than 3,500 scientific papers are currently published on DEHP globally – with more than 200 articles having been released this past year alone,” explains Jessica Schuler, VP of Strategic Initiatives at Praedicat. “ChemMeta, when coupled with the expertise of the in-house teams, allows clients to significantly expand the scale of their research activities. As a result, they can track all relevant chemicals in their company’s portfolio throughout the product lifecycle, prioritize critical ingredients and more easily identify substances which can be replaced, if and when needed.”

“One of the exciting developments of InsurTech is the ability to bundle insurance with risk insights at scale,” says Nina Everding, Head of Business Analysis at AGCS Liability. “The Praedicat partnership allows us to bring product stewardship risk insights to our product liability clients. AGCS is committed to bringing the benefits of InsurTech directly to our clients.”

“With this partnership, product liability insurance instead becomes product stewardship insurance,” says Dr. Reville.

AGCS liability insurance policyholders may receive access to ChemMeta for a defined period. After this period, they can opt for their own subscription to the analytics.

AGCS and Praedicat began their partnership in 2014 to better predict key catastrophe liability risks of the future. By combining Praedicat’s forward-looking predictive modelling approach with its own underwriting expertise and extensive liability risk portfolio analysis, AGCS aims to accelerate its risk analytic capabilities to identify next generation catastrophe liability risks far earlier than currently possible. AGCS and Praedicat regularly publish white papers on emerging liability risks; the most recent risk bulletin “The Toxic Trio” investigates the potential impact of hazardous chemicals in personal care products.”