Category Archives: regulation

Gene editing and personalized medicine: Canada

Back in the fall of 2018 I came across one of those overexcited pieces about personalized medicine and gene editing tha are out there. This one came from an unexpected source, an author who is a “PhD Scientist in Medical Science (Blood and Vasculature” (from Rick Gierczak’s LinkedIn profile).

It starts our promisingly enough although I’m beginning to dread the use of the word ‘precise’  where medicine is concerned, (from a September 17, 2018 posting on the Science Borealis blog by Rick Gierczak (Note: Links have been removed),

CRISPR-Cas9 technology was accidentally discovered in the 1980s when scientists were researching how bacteria defend themselves against viral infection. While studying bacterial DNA called clustered regularly interspaced short palindromic repeats (CRISPR), they identified additional CRISPR-associated (Cas) protein molecules. Together, CRISPR and one of those protein molecules, termed Cas9, can locate and cut precise regions of bacterial DNA. By 2012, researchers understood that the technology could be modified and used more generally to edit the DNA of any plant or animal. In 2015, the American Association for the Advancement of Science chose CRISPR-Cas9 as science’s “Breakthrough of the Year”.

Today, CRISPR-Cas9 is a powerful and precise gene-editing tool [emphasis mine] made of two molecules: a protein that cuts DNA (Cas9) and a custom-made length of RNA that works like a GPS for locating the exact spot that needs to be edited (CRISPR). Once inside the target cell nucleus, these two molecules begin editing the DNA. After the desired changes are made, they use a repair mechanism to stitch the new DNA into place. Cas9 never changes, but the CRISPR molecule must be tailored for each new target — a relatively easy process in the lab. However, it’s not perfect, and occasionally the wrong DNA is altered [emphasis mine].

Note that Gierczak makes a point of mentioning that CRISPR/Cas9 is “not perfect.” And then, he gets excited (Note: Links have been removed),

CRISPR-Cas9 has the potential to treat serious human diseases, many of which are caused by a single “letter” mutation in the genetic code (A, C, T, or G) that could be corrected by precise editing. [emphasis mine] Some companies are taking notice of the technology. A case in point is CRISPR Therapeutics, which recently developed a treatment for sickle cell disease, a blood disorder that causes a decrease in oxygen transport in the body. The therapy targets a special gene called fetal hemoglobin that’s switched off a few months after birth. Treatment involves removing stem cells from the patient’s bone marrow and editing the gene to turn it back on using CRISPR-Cas9. These new stem cells are returned to the patient ready to produce normal red blood cells. In this case, the risk of error is eliminated because the new cells are screened for the correct edit before use.

The breakthroughs shown by companies like CRISPR Therapeutics are evidence that personalized medicine has arrived. [emphasis mine] However, these discoveries will require government regulatory approval from the countries where the treatment is going to be used. In the US, the Food and Drug Administration (FDA) has developed new regulations allowing somatic (i.e., non-germ) cell editing and clinical trials to proceed. [emphasis mine]

The potential treatment for sickle cell disease is exciting but Gierczak offers no evidence that this treatment or any unnamed others constitute proof that “personalized medicine has arrived.” In fact, Goldman Sachs, a US-based investment bank, makes the case that it never will .

Cost/benefit analysis

Edward Abrahams, president of the Personalized Medicine Coalition (US-based), advocates for personalized medicine while noting in passing, market forces as represented by Goldman Sachs in his May 23, 2018 piece for statnews.com (Note: A link has been removed),

One of every four new drugs approved by the Food and Drug Administration over the last four years was designed to become a personalized (or “targeted”) therapy that zeros in on the subset of patients likely to respond positively to it. That’s a sea change from the way drugs were developed and marketed 10 years ago.

Some of these new treatments have extraordinarily high list prices. But focusing solely on the cost of these therapies rather than on the value they provide threatens the future of personalized medicine.

… most policymakers are not asking the right questions about the benefits of these treatments for patients and society. Influenced by cost concerns, they assume that prices for personalized tests and treatments cannot be justified even if they make the health system more efficient and effective by delivering superior, longer-lasting clinical outcomes and increasing the percentage of patients who benefit from prescribed treatments.

Goldman Sachs, for example, issued a report titled “The Genome Revolution.” It argues that while “genome medicine” offers “tremendous value for patients and society,” curing patients may not be “a sustainable business model.” [emphasis mine] The analysis underlines that the health system is not set up to reap the benefits of new scientific discoveries and technologies. Just as we are on the precipice of an era in which gene therapies, gene-editing, and immunotherapies promise to address the root causes of disease, Goldman Sachs says that these therapies have a “very different outlook with regard to recurring revenue versus chronic therapies.”

Let’s just chew on this one (contemplate)  for a minute”curing patients may not be ‘sustainable business model’!”

Coming down to earth: policy

While I find Gierczak to be over-enthused, he, like Abrahams, emphasizes the importance of new policy, in his case, the focus is Canadian policy. From Gierczak’s September 17, 2018 posting (Note: Links have been removed),

In Canada, companies need approval from Health Canada. But a 2004 law called the Assisted Human Reproduction Act (AHR Act) states that it’s a criminal offence “to alter the genome of a human cell, or in vitroembryo, that is capable of being transmitted to descendants”. The Actis so broadly written that Canadian scientists are prohibited from using the CRISPR-Cas9 technology on even somatic cells. Today, Canada is one of the few countries in the world where treating a disease with CRISPR-Cas9 is a crime.

On the other hand, some countries provide little regulatory oversight for editing either germ or somatic cells. In China, a company often only needs to satisfy the requirements of the local hospital where the treatment is being performed. And, if germ-cell editing goes wrong, there is little recourse for the future generations affected.

The AHR Act was introduced to regulate the use of reproductive technologies like in vitrofertilization and research related to cloning human embryos during the 1980s and 1990s. Today, we live in a time when medical science, and its role in Canadian society, is rapidly changing. CRISPR-Cas9 is a powerful tool, and there are aspects of the technology that aren’t well understood and could potentially put patients at risk if we move ahead too quickly. But the potential benefits are significant. Updated legislation that acknowledges both the risks and current realities of genomic engineering [emphasis mine] would relieve the current obstacles and support a path toward the introduction of safe new therapies.

Criminal ban on human gene-editing of inheritable cells (in Canada)

I had no idea there was a criminal ban on the practice until reading this January 2017 editorial by Bartha Maria Knoppers, Rosario Isasi, Timothy Caulfield, Erika Kleiderman, Patrick Bedford, Judy Illes, Ubaka Ogbogu, Vardit Ravitsky, & Michael Rudnicki for (Nature) npj Regenerative Medicine (Note: Links have been removed),

Driven by the rapid evolution of gene editing technologies, international policy is examining which regulatory models can address the ensuing scientific, socio-ethical and legal challenges for regenerative and personalised medicine.1 Emerging gene editing technologies, including the CRISPR/Cas9 2015 scientific breakthrough,2 are powerful, relatively inexpensive, accurate, and broadly accessible research tools.3 Moreover, they are being utilised throughout the world in a wide range of research initiatives with a clear eye on potential clinical applications. Considering the implications of human gene editing for selection, modification and enhancement, it is time to re-examine policy in Canada relevant to these important advances in the history of medicine and science, and the legislative and regulatory frameworks that govern them. Given the potential human reproductive applications of these technologies, careful consideration of these possibilities, as well as ethical and regulatory scrutiny must be a priority.4

With the advent of human embryonic stem cell research in 1978, the birth of Dolly (the cloned sheep) in 1996 and the Raelian cloning hoax in 2003, the environment surrounding the enactment of Canada’s 2004 Assisted Human Reproduction Act (AHRA) was the result of a decade of polarised debate,5 fuelled by dystopian and utopian visions for future applications. Rightly or not, this led to the AHRA prohibition on a wide range of activities, including the creation of embryos (s. 5(1)(b)) or chimeras (s. 5(1)(i)) for research and in vitro and in vivo germ line alterations (s. 5(1)(f)). Sanctions range from a fine (up to $500,000) to imprisonment (up to 10 years) (s. 60 AHRA).

In Canada, the criminal ban on gene editing appears clear, the Act states that “No person shall knowingly […] alter the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants;” [emphases mine] (s. 5(1)(f) AHRA). This approach is not shared worldwide as other countries such as the United Kingdom, take a more regulatory approach to gene editing research.1 Indeed, as noted by the Law Reform Commission of Canada in 1982, criminal law should be ‘an instrument of last resort’ used solely for “conduct which is culpable, seriously harmful, and generally conceived of as deserving of punishment”.6 A criminal ban is a suboptimal policy tool for science as it is inflexible, stifles public debate, and hinders responsiveness to the evolving nature of science and societal attitudes.7 In contrast, a moratorium such as the self-imposed research moratorium on human germ line editing called for by scientists in December 20158 can at least allow for a time limited pause. But like bans, they may offer the illusion of finality and safety while halting research required to move forward and validate innovation.

On October 1st, 2016, Health Canada issued a Notice of Intent to develop regulations under the AHRA but this effort is limited to safety and payment issues (i.e. gamete donation). Today, there is a need for Canada to revisit the laws and policies that address the ethical, legal and social implications of human gene editing. The goal of such a critical move in Canada’s scientific and legal history would be a discussion of the right of Canadians to benefit from the advancement of science and its applications as promulgated in article 27 of the Universal Declaration of Human Rights9 and article 15(b) of the International Covenant on Economic, Social and Cultural Rights,10 which Canada has signed and ratified. Such an approach would further ensure the freedom of scientific endeavour both as a principle of a liberal democracy and as a social good, while allowing Canada to be engaged with the international scientific community.

Even though it’s a bit old, I still recommend reading the open access editorial in full, if you have the time.

One last thing abut the paper, the acknowledgements,

Sponsored by Canada’s Stem Cell Network, the Centre of Genomics and Policy of McGill University convened a ‘think tank’ on the future of human gene editing in Canada with legal and ethics experts as well as representatives and observers from government in Ottawa (August 31, 2016). The experts were Patrick Bedford, Janetta Bijl, Timothy Caulfield, Judy Illes, Rosario Isasi, Jonathan Kimmelman, Erika Kleiderman, Bartha Maria Knoppers, Eric Meslin, Cate Murray, Ubaka Ogbogu, Vardit Ravitsky, Michael Rudnicki, Stephen Strauss, Philip Welford, and Susan Zimmerman. The observers were Geneviève Dubois-Flynn, Danika Goosney, Peter Monette, Kyle Norrie, and Anthony Ridgway.

Competing interests

The authors declare no competing interests.

Both McGill and the Stem Cell Network pop up again. A November 8, 2017 article about the need for new Canadian gene-editing policies by Tom Blackwell for the National Post features some familiar names (Did someone have a budget for public relations and promotion?),

It’s one of the most exciting, and controversial, areas of health science today: new technology that can alter the genetic content of cells, potentially preventing inherited disease — or creating genetically enhanced humans.

But Canada is among the few countries in the world where working with the CRISPR gene-editing system on cells whose DNA can be passed down to future generations is a criminal offence, with penalties of up to 10 years in jail.

This week, one major science group announced it wants that changed, calling on the federal government to lift the prohibition and allow researchers to alter the genome of inheritable “germ” cells and embryos.

The potential of the technology is huge and the theoretical risks like eugenics or cloning are overplayed, argued a panel of the Stem Cell Network.

The step would be a “game-changer,” said Bartha Knoppers, a health-policy expert at McGill University, in a presentation to the annual Till & McCulloch Meetings of stem-cell and regenerative-medicine researchers [These meetings were originally known as the Stem Cell Network’s Annual General Meeting {AGM}]. [emphases mine]

“I’m completely against any modification of the human genome,” said the unidentified meeting attendee. “If you open this door, you won’t ever be able to close it again.”

If the ban is kept in place, however, Canadian scientists will fall further behind colleagues in other countries, say the experts behind the statement say; they argue possible abuses can be prevented with good ethical oversight.

“It’s a human-reproduction law, it was never meant to ban and slow down and restrict research,” said Vardit Ravitsky, a University of Montreal bioethicist who was part of the panel. “It’s a sort of historical accident … and now our hands are tied.”

There are fears, as well, that CRISPR could be used to create improved humans who are genetically programmed to have certain facial or other features, or that the editing could have harmful side effects. Regardless, none of it is happening in Canada, good or bad.

In fact, the Stem Cell Network panel is arguably skirting around the most contentious applications of the technology. It says it is asking the government merely to legalize research for its own sake on embryos and germ cells — those in eggs and sperm — not genetic editing of embryos used to actually get women pregnant.

The highlighted portions in the last two paragraphs of the excerpt were written one year prior to the claims by a Chinese scientist that he had run a clinical trial resulting in gene-edited twins, Lulu and Nana. (See my my November 28, 2018 posting for a comprehensive overview of the original furor). I have yet to publish a followup posting featuring the news that the CRISPR twins may have been ‘improved’ more extensively than originally realized. The initial reports about the twins focused on an illness-related reason (making them HIV ‘immune’) but made no mention of enhanced cognitive skills a side effect of eliminating the gene that would make them HIV ‘immune’. To date, the researcher has not made the bulk of his data available for an in-depth analysis to support his claim that he successfully gene-edited the twins. As well, there were apparently seven other pregnancies coming to term as part of the researcher’s clinical trial and there has been no news about those births.

Risk analysis innovation

Before moving onto the innovation of risk analysis, I want to focus a little more on at least one of the risks that gene-editing might present. Gierczak noted that CRISPR/Cas9 is “not perfect,” which acknowledges the truth but doesn’t convey all that much information.

While the terms ‘precision’ and ‘scissors’ are used frequently when describing the CRISPR technique, scientists actually mean that the technique is significantly ‘more precise’ than other techniques but they are not referencing an engineering level of precision. As for the ‘scissors’, it’s an analogy scientists like to use but in fact CRISPR is not as efficient and precise as a pair of scissors.

Michael Le Page in a July 16, 2018 article for New Scientist lays out some of the issues (Note: A link has been removed),

A study of CRIPSR suggests we shouldn’t rush into trying out CRISPR genome editing inside people’s bodies just yet. The technique can cause big deletions or rearrangements of DNA [emphasis mine], says Allan Bradley of the Wellcome Sanger Institute in the UK, meaning some therapies based on CRISPR may not be quite as safe as we thought.

The CRISPR genome editing technique is revolutionising biology, enabling us to create new varieties of plants and animals and develop treatments for a wide range of diseases.

The CRISPR Cas9 protein works by cutting the DNA of a cell in a specific place. When the cell repairs the damage, a few DNA letters get changed at this spot – an effect that can be exploited to disable genes.

At least, that’s how it is supposed to work. But in studies of mice and human cells, Bradley’s team has found that in around a fifth of cells, CRISPR causes deletions or rearrangements more than 100 DNA letters long. These surprising changes are sometimes thousands of letters long.

“I do believe the findings are robust,” says Gaetan Burgio of the Australian National University, an expert on CRISPR who has debunked previous studies questioning the method’s safety. “This is a well-performed study and fairly significant.”

I covered the Bradley paper and the concerns in a July 17, 2018 posting ‘The CRISPR ((clustered regularly interspaced short palindromic repeats)-CAS9 gene-editing technique may cause new genetic damage kerfuffle‘. (The ‘kerfufle’ was in reference to a report that the CRISPR market was affected by the publication of Bradley’s paper.)

Despite Health Canada not moving swiftly enough for some researchers, they have nonetheless managed to release an ‘outcome’ report about a consultation/analysis started in October 2016. Before getting to the consultation’s outcome, it’s interesting to look at how the consultation’s call for response was described (from Health Canada’s Toward a strengthened Assisted Human Reproduction Act ; A Consultation with Canadians on Key Policy Proposals webpage),

In October 2016, recognizing the need to strengthen the regulatory framework governing assisted human reproduction in Canada, Health Canada announced its intention to bring into force the dormant sections of the Assisted Human Reproduction Act  and to develop the necessary supporting regulations.

This consultation document provides an overview of the key policy proposals that will help inform the development of regulations to support bringing into force Section 10, Section 12 and Sections 45-58 of the Act. Specifically, the policy proposals describe the Department’s position on the following:

Section 10: Safety of Donor Sperm and Ova

  • Scope and application
  • Regulated parties and their regulatory obligations
  • Processing requirements, including donor suitability assessment
  • Record-keeping and traceability

Section 12: Reimbursement

  • Expenditures that may be reimbursed
  • Process for reimbursement
  • Creation and maintenance of records

Sections 45-58: Administration and Enforcement

  • Scope of the administration and enforcement framework
  • Role of inspectors designated under the Act

The purpose of the document is to provide Canadians with an opportunity to review the policy proposals and to provide feedback [emphasis mine] prior to the Department finalizing policy decisions and developing the regulations. In addition to requesting stakeholders’ general feedback on the policy proposals, the Department is also seeking input on specific questions, which are included throughout the document.

It took me a while to find the relevant section (in particular, take note of ‘Federal Regulatory Oversight’),

3.2. AHR in Canada Today

Today, an increasing number of Canadians are turning to AHR technologies to grow or build their families. A 2012 Canadian studyFootnote 1 found that infertility is on the rise in Canada, with roughly 16% of heterosexual couples experiencing infertility. In addition to rising infertility, the trend of delaying marriage and parenthood, scientific advances in cryopreserving ova, and the increasing use of AHR by LGBTQ2 couples and single parents to build a family are all contributing to an increase in the use of AHR technologies.

The growing use of reproductive technologies by Canadians to help build their families underscores the need to strengthen the AHR Act. While the approach to regulating AHR varies from country to country, Health Canada has considered international best practices and the need for regulatory alignment when developing the proposed policies set out in this document. …

3.2.1 Federal Regulatory Oversight

Although the scope of the AHR Act was significantly reduced in 2012 and some of the remaining sections have not yet been brought into force, there are many important sections of the Act that are currently administered and enforced by Health Canada, as summarized generally below:

Section 5: Prohibited Scientific and Research Procedures
Section 5 prohibits certain types of scientific research and clinical procedures that are deemed unacceptable, including: human cloning, the creation of an embryo for non-reproductive purposes, maintaining an embryo outside the human body beyond the fourteenth day, sex selection for non-medical reasons, altering the genome in a way that could be transmitted to descendants, and creating a chimera or a hybrid. [emphasis mine]

….

It almost seems as if the they were hiding the section that broached the human gene-editing question. It doesn’t seem to have worked as it appears, there are some very motivated parties determined to reframe the discussion. Health Canada’s ‘outocme’ report, published March 2019, What we heard: A summary of scanning and consultations on what’s next for health product regulation reflects the success of those efforts,

1.0 Introduction and Context

Scientific and technological advances are accelerating the pace of innovation. These advances are increasingly leading to the development of health products that are better able to predict, define, treat, and even cure human diseases. Globally, many factors are driving regulators to think about how to enable health innovation. To this end, Health Canada has been expanding beyond existing partnerships and engaging both domestically and internationally. This expanding landscape of products and services comes with a range of new challenges and opportunities.

In keeping up to date with emerging technologies and working collaboratively through strategic partnerships, Health Canada seeks to position itself as a regulator at the forefront of health innovation. Following the targeted sectoral review of the Health and Biosciences Sector Regulatory Review consultation by the Treasury Board Secretariat, Health Canada held a number of targeted meetings with a broad range of stakeholders.

This report outlines the methodologies used to look ahead at the emerging health technology environment, [emphasis mine] the potential areas of focus that resulted, and the key findings from consultations.

… the Department identified the following key drivers that are expected to shape the future of health innovation:

  1. The use of “big data” to inform decision-making: Health systems are generating more data, and becoming reliant on this data. The increasing accuracy, types, and volume of data available in real time enable automation and machine learning that can forecast activity, behaviour, or trends to support decision-making.
  2. Greater demand for citizen agency: Canadians increasingly want and have access to more information, resources, options, and platforms to manage their own health (e.g., mobile apps, direct-to-consumer services, decentralization of care).
  3. Increased precision and personalization in health care delivery: Diagnostic tools and therapies are increasingly able to target individual patients with customized therapies (e.g., individual gene therapy).
  4. Increased product complexity: Increasingly complex products do not fit well within conventional product classifications and standards (e.g., 3D printing).
  5. Evolving methods for production and distribution: In some cases, manufacturers and supply chains are becoming more distributed, challenging the current framework governing production and distribution of health products.
  6. The ways in which evidence is collected and used are changing: The processes around new drug innovation, research and development, and designing clinical trials are evolving in ways that are more flexible and adaptive.

With these key drivers in mind, the Department selected the following six emerging technologies for further investigation to better understand how the health product space is evolving:

  1. Artificial intelligence, including activities such as machine learning, neural networks, natural language processing, and robotics.
  2. Advanced cell therapies, such as individualized cell therapies tailor-made to address specific patient needs.
  3. Big data, from sources such as sensors, genetic information, and social media that are increasingly used to inform patient and health care practitioner decisions.
  4. 3D printing of health products (e.g., implants, prosthetics, cells, tissues).
  5. New ways of delivering drugs that bring together different product lines and methods (e.g., nano-carriers, implantable devices).
  6. Gene editing, including individualized gene therapies that can assist in preventing and treating certain diseases.

Next, to test the drivers identified and further investigate emerging technologies, the Department consulted key organizations and thought leaders across the country with expertise in health innovation. To this end, Health Canada held seven workshops with over 140 representatives from industry associations, small-to-medium sized enterprises and start-ups, larger multinational companies, investors, researchers, and clinicians in Ottawa, Toronto, Montreal, and Vancouver. [emphases mine]

The ‘outocme’ report, ‘What we heard …’, is well worth reading in its entirety; it’s about 9 pp.

I have one comment, ‘stakeholders’ don’t seem to include anyone who isn’t “from industry associations, small-to-medium sized enterprises and start-ups, larger multinational companies, investors, researchers, and clinician” or from “Ottawa, Toronto, Montreal, and Vancouver.” Aren’t the rest of us stakeholders?

Innovating risk analysis

This line in the report caught my eye (from Health Canada’s Toward a strengthened Assisted Human Reproduction Act ; A Consultation with Canadians on Key Policy Proposals webpage),

There is increasing need to enable innovation in a flexible, risk-based way, with appropriate oversight to ensure safety, quality, and efficacy. [emphases mine]

It reminded me of the 2019 federal budget (from my March 22, 2019 posting). One comment before proceeding, regulation and risk are tightly linked and, so, by innovating regulation they are by exttension alos innovating risk analysis,

… Budget 2019 introduces the first three “Regulatory Roadmaps” to specifically address stakeholder issues and irritants in these sectors, informed by over 140 responses [emphasis mine] from businesses and Canadians across the country, as well as recommendations from the Economic Strategy Tables.

Introducing Regulatory Roadmaps

These Roadmaps lay out the Government’s plans to modernize regulatory frameworks, without compromising our strong health, safety, and environmental protections. They contain proposals for legislative and regulatory amendments as well as novel regulatory approaches to accommodate emerging technologies, including the use of regulatory sandboxes and pilot projects—better aligning our regulatory frameworks with industry realities.

Budget 2019 proposes the necessary funding and legislative revisions so that regulatory departments and agencies can move forward on the Roadmaps, including providing the Canadian Food Inspection Agency, Health Canada and Transport Canada with up to $219.1 million over five years, starting in 2019–20, (with $0.5 million in remaining amortization), and $3.1 million per year on an ongoing basis.

In the coming weeks, the Government will be releasing the full Regulatory Roadmaps for each of the reviews, as well as timelines for enacting specific initiatives, which can be grouped in the following three main areas:

What Is a Regulatory Sandbox? Regulatory sandboxes are controlled “safe spaces” in which innovative products, services, business models and delivery mechanisms can be tested without immediately being subject to all of the regulatory requirements.
– European Banking Authority, 2017

Establishing a regulatory sandbox for new and innovative medical products
The regulatory approval system has not kept up with new medical technologies and processes. Health Canada proposes to modernize regulations to put in place a regulatory sandbox for new and innovative products, such as tissues developed through 3D printing, artificial intelligence, and gene therapies targeted to specific individuals. [emphasis mine]

Modernizing the regulation of clinical trials
Industry and academics have expressed concerns that regulations related to clinical trials are overly prescriptive and inconsistent. Health Canada proposes to implement a risk-based approach [emphasis mine] to clinical trials to reduce costs to industry and academics by removing unnecessary requirements for low-risk drugs and trials. The regulations will also provide the agri-food industry with the ability to carry out clinical trials within Canada on products such as food for special dietary use and novel foods.

Does the government always get 140 responses from a consultation process? Moving on, I agree with finding new approaches to regulatory processes and oversight and, by extension, new approaches to risk analysis.

Earlier in this post, I asked if someone had a budget for public relations/promotion. I wasn’t joking. My March 22, 2019 posting also included these line items in the proposed 2019 budget,

Budget 2019 proposes to make additional investments in support of the following organizations:
Stem Cell Network: Stem cell research—pioneered by two Canadians in the 1960s [James Till and Ernest McCulloch]—holds great promise for new therapies and medical treatments for respiratory and heart diseases, spinal cord injury, cancer, and many other diseases and disorders. The Stem Cell Network is a national not-for-profit organization that helps translate stem cell research into clinical applications and commercial products. To support this important work and foster Canada’s leadership in stem cell research, Budget 2019 proposes to provide the Stem Cell Network with renewed funding of $18 million over three years, starting in 2019–20.

Genome Canada: The insights derived from genomics—the study of the entire genetic information of living things encoded in their DNA and related molecules and proteins—hold the potential for breakthroughs that can improve the lives of Canadians and drive innovation and economic growth. Genome Canada is a not-for-profit organization dedicated to advancing genomics science and technology in order to create economic and social benefits for Canadians. To support Genome Canada’s operations, Budget 2019 proposes to provide Genome Canada with $100.5 million over five years, starting in 2020–21. This investment will also enable Genome Canada to launch new large-scale research competitions and projects, in collaboration with external partners, ensuring that Canada’s research community continues to have access to the resources needed to make transformative scientific breakthroughs and translate these discoveries into real-world applications.

Years ago, I managed to find a webpage with all of the proposals various organizations were submitting to a government budget committee. It was eye-opening. You can tell which organizations were able to hire someone who knew the current government buzzwords and the things that a government bureaucrat would want to hear and the organizations that didn’t.

Of course, if the government of the day is adamantly against or uninterested, no amount of persusasion will work to get your organization more money in the budget.

Finally

Reluctantly, I am inclined to explore the topic of emerging technologies such as gene-editing not only in the field of agriculture (for gene-editing of plants, fish, and animals see my November 28, 2018 posting) but also with humans. At the very least, it needs to be discussed whether we choose to participate or not.

If you are interested in the arguments against changing Canada’s prohibition against gene-editing of humans, there’s an Ocotber 2, 2017 posting on Impact Ethics by Françoise Baylis, Professor and Canada Research Chair in Bioethics and Philosophy at Dalhousie University, and Alana Cattapan, Johnson Shoyama Graduate School of Public Policy at the University of Saskatchewan, which makes some compelling arguments. Of course, it was written before the CRISPR twins (my November 28, 2018 posting).

Recaliing CRISPR Therapeutics (mentioned by Gierczak), the company received permission to run clinical trials in the US in October 2018 after the FDA (US Food and Drug Administration) lifted an earlier ban on their trials according to an Oct. 10, 2018 article by Frank Vinhuan for exome,

The partners also noted that their therapy is making progress outside of the U.S. They announced that they have received regulatory clearance in “multiple countries” to begin tests of the experimental treatment in both sickle cell disease and beta thalassemia, …

It seems to me that the quotes around “multiple countries” are meant to suggest doubt of some kind. Generally speaking, company representatives make those kinds of generalizations when they’re trying to pump up their copy. E.g., 50% increase in attendance  but no whole numbers to tell you what that means. It could mean two people attended the first year and then brought a friend the next year or 100 people attended and the next year there were 150.

Despite attempts to declare personalized medicine as having arrived, I think everything is still in flux with no preordained outcome. The future has yet to be determined but it will be and I , for one, would like to have some say in the matter.

S.NET (Society for the Study of New and Emerging Technologies) 2019 conference in Quito, Ecuador: call for abstracts

Why isn’t the S.NET abbreviation SSNET? That’s what it should be, given the organization’s full name: Society for the Study of New and Emerging Technologies. S.NET smacks of a compromise or consensus decision of some kind. Also, the ‘New’ in its name was ‘Nanoscience’ at one time (see my Oct. 22, 2013 posting).

Now onto 2019 and the conference, which, for the first time ever, is being held in Latin America. Here’s more from a February 4, 2019 S.Net email about the call for abstracts,

2019 Annual S.NET Meeting
Contrasting Visions of Technological Change

The 11th Annual S.NET meeting will take place November 18-20, 2019, at the Latin American Faculty of Social Sciences in Quito, Ecuador.

This year’s meeting will provide rich opportunities to reflect on technological change by establishing a dialogue between contrasting visions on how technology becomes closely intertwined with social orders.  We aim to open the black box of technological change by exploring the sociotechnical agreements that help to explain why societies follow certain technological trajectories. Contributors are invited to explore the ramifications of technological change, reflect on the policy process of technology, and debate whether or why technological innovation is a matter for democracy.

Following the transnational nature of S.NET, the meeting will highlight the diverse geographical and cultural approaches to technological innovation, the forces driving sociotechnical change, and social innovation.  It is of paramount importance to question the role of technology in the shaping of society and the outcomes of these configurations.  What happens when these arrangements come into being, are transformed or fall apart?  Does technology create contestation?  Why and how should we engage with contested visions of technology change?

This is the first time that the S.NET Meeting will take place in Latin America and we encourage panels and presentations with contrasting voices from both the Global North and the Global South. 

Topics of interest include, but are not limited to:

Sociotechnical imaginaries of innovation
The role of technology on shaping nationhood and nation identities
Decision-making processes on science and technology public policies
Co-creation approaches to promote public innovation
Grassroots innovation, sustainability and democracy
Visions and cultural imaginaries
Role of social sciences and humanities in processes technological change
In addition, we welcome contributions on:
Research dynamics and organization Innovation and use
Governance and regulation
Politics and ethics
Roles of publics and stakeholders

Keynote Speakers
TBA (check the conference website for updates!)

Deadlines & Submission Instructions
The program committee invites contributions from scholars, technology developers and practitioners, and welcome presentations from a range of disciplines spanning the humanities, social and natural sciences.  We invite individual paper submissions, open panel and closed session proposals, student posters, and special format sessions, including events that are innovative in form and content. 

The deadline for abstract submissions is *April 18, 2019* [extended to May 12, 2019].  Abstracts should be approximately 250 words in length, emailed in PDF format to 2019snet@gmail.com.  Notifications of acceptance can be expected by May 30, 2019.

Junior scholars and those with limited resources are strongly encouraged to apply, as the organizing committee is actively investigating potential sources of financial support.

Details on the conference can be found here: https://www.flacso.edu.ec/snet2019/

Local Organizing Committee
María Belén Albornoz, Isarelis Pérez, Javier Jiménez, Mónica Bustamante, Jorge Núñez, Maka Suárez.

Venue
FLACSO Ecuador is located in the heart of Quito.  Most hotels, museums, shopping centers and other cultural hotspots in the city are located near the campus and are easily accessible by public or private transportation.  Due to its proximity and easy access, Meeting participants would be able to enjoy Quito’s rich cultural life during their stay.  

About S.NET
S.NET is an international association that promotes intellectual exchange and critical inquiry about the advancement of new and emerging technologies in society.  The aim of the association is to advance critical reflection from various perspectives on developments in a broad range of new and emerging fields, including, but not limited to, nanoscale science and engineering, biotechnology, synthetic biology, cognitive science, ICT and Big Data, and geo-engineering.  Current S.NET board members are: Michael Bennett (President), Maria Belen Albornoz, Claire Shelley-Egan, Ana Delgado, Ana Viseu, Nora Vaage, Chris Toumey, Poonam Pandey, Sylvester Johnson, Lotte Krabbenborg, and Maria Joao Ferreira Maia.

Don’t forget, the deadline for your abstract is *April 18, 2019* [extended to May 12, 2019].

For anyone curious about what Quito might look like, there’s this from Quito’s Wikipedia entry,

Clockwise from top: Calle La Ronda, Iglesia de la Compañía de Jesús, El Panecillo as seen from Northern Quito, Carondelet Palace, Central-Northern Quito, Parque La Carolina and Iglesia y Monasterio de San Francisco. Credit: various authors – montage of various important landmarks of the City of Quito, Ecuador taken from files found in Wikimedia Commons. CC BY-SA 3.0 File:Montaje Quito.png Created: 24 December 2012

Good luck to all everyone submitting an abstract.

*Date for abstract submissions changed from April 18, 2019 to May 12, 2019 on April 24, 2019

Summer (2019) Institute on AI (artificial intelligence) Societal Impacts, Governance, and Ethics. Summer Institute In Alberta, Canada

The deadline for applications is April 7, 2019. As for whether or not you might like to attend, here’s more from a joint March 11, 2019 Alberta Machine Intelligence Institute (Amii)/
Canadian Institute for Advanced Research (CIFAR)/University of California at Los Angeles (UCLA) Law School news release
(also on globalnewswire.com),

What will Artificial Intelligence (AI) mean for society? That’s the question scholars from a variety of disciplines will explore during the inaugural Summer Institute on AI Societal Impacts, Governance, and Ethics. Summer Institute, co-hosted by the Alberta Machine Intelligence Institute (Amii) and CIFAR, with support from UCLA School of Law, takes place July 22-24, 2019 in Edmonton, Canada.

“Recent advances in AI have brought a surge of attention to the field – both excitement and concern,” says co-organizer and UCLA professor, Edward Parson. “From algorithmic bias to autonomous vehicles, personal privacy to automation replacing jobs. Summer Institute will bring together exceptional people to talk about how humanity can receive the benefits and not get the worst harms from these rapid changes.”

Summer Institute brings together experts, grad students and researchers from multiple backgrounds to explore the societal, governmental, and ethical implications of AI. A combination of lectures, panels, and participatory problem-solving, this comprehensive interdisciplinary event aims to build understanding and action around these high-stakes issues.

“Machine intelligence is opening transformative opportunities across the world,” says John Shillington, CEO of Amii, “and Amii is excited to bring together our own world-leading researchers with experts from areas such as law, philosophy and ethics for this important discussion. Interdisciplinary perspectives will be essential to the ongoing development of machine intelligence and for ensuring these opportunities have the broadest reach possible.”

Over the three-day program, 30 graduate-level students and early-career researchers will engage with leading experts and researchers including event co-organizers: Western University’s Daniel Lizotte, Amii’s Alona Fyshe and UCLA’s Edward Parson. Participants will also have a chance to shape the curriculum throughout this uniquely interactive event.

Summer Institute takes place prior to Deep Learning and Reinforcement Learning Summer School, and includes a combined event on July 24th [2019] for both Summer Institute and Summer School participants.

Visit dlrlsummerschool.ca/the-summer-institute to apply; applications close April 7, 2019.

View our Summer Institute Biographies & Boilerplates for more information on confirmed faculty members and co-hosting organizations. Follow the conversation through social media channels using the hashtag #SI2019.

Media Contact: Spencer Murray, Director of Communications & Public Relations, Amii
t: 587.415.6100 | c: 780.991.7136 | e: spencer.murray@amii.ca

There’s a bit more information on The Summer Institute on AI and Society webpage (on the Deep Learning and Reinforcement Learning Summer School 2019 website) such as this more complete list of speakers,

Confirmed speakers at Summer Institute include:

Alona Fyshe, University of Alberta/Amii (SI co-organizer)
Edward Parson, UCLA (SI co-organizer)
Daniel Lizotte, Western University (SI co-organizer)
Geoffrey Rockwell, University of Alberta
Graham Taylor, University of Guelph/Vector Institute
Rob Lempert, Rand Corporation
Gary Marchant, Arizona State University
Richard Re, UCLA
Evan Selinger, Rochester Institute of Technology
Elana Zeide, UCLA

Two questions, why are all the summer school faculty either Canada- or US-based? What about South American, Asian, Middle Eastern, etc. thinkers?

One last thought, I wonder if this ‘AI & ethics summer institute’ has anything to do with the Pan-Canadian Artificial Intelligence Strategy, which CIFAR administers and where both the University of Alberta and Vector Institute are members.

Science and the 2019 Canadian federal government budget

There’s been a lot of noise about how the 2019 Canadian federal government budget is designed to please the various constituencies that helped bring the Liberal party back into power in 2015 and which the Liberals are hoping will help re-elect them later in 2019. I don’t care about that, for me, it’s all about the science.

In general, it seems the budget excitement is a bit milder than usual and some of that possibly due to the SNC-Lavalin (a huge Canadian engineering and construction firm) scandal resulting in the loss of two cabinet ministers, Trudeau’s top personal/political advisor, and Canada’s top bureaucrat; a 3rd reshuffling of Trudeau’s cabinet in less than three months; and the kind of political theatrics from the Liberals, the Conservatives, and the NDP (New Democratic Party) that I associate more strongly with our neighbours to the south. .

(As for the SNC-Lavalin mess which includes allegations of political interference on behalf of a company accused of various offences, you might find this brief March 11, 2019 article by David Ljunggren for Reuters insightful as it reviews the response from abroad, specifically, the OECD [Organization for Economic Cooperation and Development. For anyone who wants an overview and timeline of the crisis, there’s this March 10, 2019 news item on Huffington Post Canada and, for context, there’s this March 10, 2019 video report (roughly 3 mins.) on SNC-Lavalin’s long history of corruption by Daniel Tencer for Huffington Post Canada. )

In any event, it’s a been a very busy first quarter for 2019 and the science funding portion of the budget holds a few rays of light but in the main, the science funding portion suggests the government is treading water (term to describe a swimmer who is keeping their head above water and staying in place while being vertical). As for the rest of the 2019 budget, I leave to experience political pundits.

Let’s start with the sections that gladdened my heart, just a little.

Rays of light

We’re in Chapter 2 of the 2019 federal budget, in Part 5: Building a Nation of Innovators; Bringing Innovation to Regulations, and I’m happy to see this, as I think it’s absolutely essential that we become more innovative with regulations when emerging technologies pose new challenges at an ever increasing pace (Note: The formatting has been changed),

Simply put, regulations are rules that stipulate how businesses must operate. When they are effective, they contribute to the protection of health, safety, security and the environment. They also support innovation, productivity and competition by establishing the rules for fair markets and a predictable environment for businesses, reducing barriers to trade and fostering new investment. While the OECD [Organization for Economic Cooperation and Development] Regulatory Policy Outlook (2018) has again ranked Canada in the top five jurisdictions on many key measures of regulatory governance, recent reports from panels convened to advise the Government, such as the Advisory Council on Economic Growth and the Economic Strategy Tables, have called for Canada to take steps to change how we design and administer regulations. The Government is responding.

In Budget 2018, the Government announced its intention to review regulatory requirements and practices that impede innovation and growth in the following high-growth sectors:

Agri-food and aquaculture.
Health and bio-sciences.
Transportation and infrastructure.

The 2018 Fall Economic Statement continued this work, proposing additional ways to reform and modernize federal regulations, with an emphasis on making it easier for businesses to grow while continuing to protect Canadians’ health and safety and the environment. As a next step, Budget 2019 introduces the first three “Regulatory Roadmaps” to specifically address stakeholder issues and irritants in these sectors, informed by over 140 responses from businesses and Canadians across the country, as well as recommendations from the Economic Strategy Tables.

Introducing Regulatory Roadmaps

These Roadmaps lay out the Government’s plans to modernize regulatory frameworks, without compromising our strong health, safety, and environmental protections. They contain proposals for legislative and regulatory amendments as well as novel regulatory approaches to accommodate emerging technologies, including the use of regulatory sandboxes and pilot projects—better aligning our regulatory frameworks with industry realities.

Budget 2019 proposes the necessary funding and legislative revisions so that regulatory departments and agencies can move forward on the Roadmaps, including providing the Canadian Food Inspection Agency, Health Canada and Transport Canada with up to $219.1 million over five years, starting in 2019–20, (with $0.5 million in remaining amortization), and $3.1 million per year on an ongoing basis.

In the coming weeks, the Government will be releasing the full Regulatory Roadmaps for each of the reviews, as well as timelines for enacting specific initiatives, which can be grouped in the following three main areas:

What Is a Regulatory Sandbox? Regulatory sandboxes are controlled “safe spaces” in which innovative products, services, business models and delivery mechanisms can be tested without immediately being subject to all of the regulatory requirements.
– European Banking Authority, 2017

1. Creating a user-friendly regulatory system:
The Roadmaps propose a more user-friendly regulatory system, including the use of more digital services (e.g. online portals, electronic templates), and clearer guidance for industry so that innovative and safe products are available for Canadians more quickly.

2. Using novel or experimental approaches:
The Roadmaps propose greater exploration, innovation, and the use of sandboxes and pilot programs for new and innovative products. This will allow these products to be approved for use in a risk-based and flexible way—encouraging ongoing innovation while continuing to protect Canadians’ health and safety, and the environment.

3. Facilitating greater cooperation and reducing duplication:
The Roadmaps propose greater alignment and coordination within the federal government and across Canadian and international jurisdictions.

Real Improvements for Business

Digitizing Canadian Food Inspection Agency services
The Canadian Food Inspection Agency currently relies on a paper-based system for issuing export certificates. As a result, Canadian exporters are required to submit forms by mail and wait for those forms to be returned prior to exporting their products. When Canadian firms are allowed to complete the application process online and have their reviewed forms returned electronically, Canadian business owners will be able to export their products more rapidly.

Updating the Canadian grains legislative and regulatory frameworks
The Canada Grain Act has not been substantially updated in decades, and its requirements are not aligned with current market realities. A broad-based review of the Act, and of the operations of the Canadian Grain Commission, will be undertaken to address a number of issues raised by the Canadian grain industry, including redundant inspections and issues within the current grain classification process that unnecessarily restrict Canadian grain exporters.

Establishing a regulatory sandbox for new and innovative medical products
The regulatory approval system has not kept up with new medical technologies and processes. Health Canada proposes to modernize regulations to put in place a regulatory sandbox for new and innovative products, such as tissues developed through 3D printing, artificial intelligence, and gene therapies targeted to specific individuals.

Modernizing the regulation of clinical trials
Industry and academics have expressed concerns that regulations related to clinical trials are overly prescriptive and inconsistent. Health Canada proposes to implement a risk-based approach to clinical trials to reduce costs to industry and academics by removing unnecessary requirements for low-risk drugs and trials. The regulations will also provide the agri-food industry with the ability to carry out clinical trials within Canada on products such as food for special dietary use and novel foods.

Enhancing the road safety transfer payment program
Road safety and transportation requirements vary among Canadian provinces and territories, creating barriers and inefficiencies for businesses that transport goods by road. Transport Canada will support provinces and territories in working towards improved alignment of these requirements, including for the use of autonomous and connected vehicles. Funding would be made available to other stakeholders, such as academia and industry associations, to identify innovative road safety options, including for emerging technologies.

Introducing a regulatory sandbox for dangerous goods electronic shipping documents
Currently, shipments of dangerous goods in Canada must be accompanied by paper documentation which can be burdensome and inefficient for businesses. Under this initiative, Transport Canada would work with industry, American counterparts and provincial/territorial jurisdictions to identify options for the sharing of shipping documents by electronic means, based on existing technologies.

Removing federal barriers to the interprovincial trade of alcohol
To facilitate internal trade, the Government intends to remove the federal requirement that alcohol moving from one province to another be sold or consigned to a provincial liquor authority. Provinces and territories would continue to be able to regulate the sale and distribution of alcohol within their boundaries.

To ensure that these Roadmaps can be implemented in a timely manner, Budget 2019 proposes to provide up to $67.8 million over five years, starting in 2019–20, for Justice Canada resources. These funds will strengthen the Government’s capacity to draft the legislative and regulatory changes needed to facilitate a new approach to regulations in these sectors and others.

Harmonizing Regulations
When regulations are more consistent between jurisdictions, Canadian companies are better able to trade within Canada and beyond, while also giving Canadian consumers greater choice. The Government is working with provinces and territories to better harmonize regulations across provincial and territorial boundaries, opening up the door to more seamless internal trade. Canada also has an opportunity to harmonize regulations with its international trading partners, making Canada an even more attractive place to invest in and grow a business. The Government does this through a number of regulatory cooperation bodies, for example, the Canadian Free Trade Agreement Regulatory Reconciliation and Cooperation Table, the Canada-U.S. Regulatory Cooperation Council and the Regulatory Cooperation Forum of the Canada-European Union Comprehensive Economic and Trade Agreement.  

Budget 2019 proposes to provide $3.1 million per year in ongoing funding to the Treasury Board Secretariat, starting in 2020–21, to support its leadership of the Government’s regulatory cooperation priorities at home and abroad.

Modernizing Regulations
In the 2018 Fall Economic Statement, the Government announced its plan to introduce an annual modernization bill consisting of legislative amendments to various statutes to help eliminate outdated federal regulations and better keep existing regulations up to date. In Budget 2019, the Government proposes to introduce legislation to begin this work. Work also continues to identify opportunities to make regulatory efficiency and economic growth a permanent part of regulators’ mandates, while continuing to prioritize health and safety and environmental responsibilities.

As part of these ongoing efforts, the President of Treasury Board will announce shortly the establishment of an External Advisory Committee on Regulatory Competitiveness, which will bring together business leaders, academics and consumer representatives from across the country, to help identify opportunities to streamline regulations and for novel regulatory approaches as well as to advise the Government on other sectors for consideration in the next round of regulatory reviews. 

Safe Food for Canadians Regulations
A recent regulatory modernization success is related to the coming into force of the new Safe Food for Canadians Regulations in January 2019.These modern regulations apply across all sectors and have introduced an outcomes-based approach to food safety regulations.

The other ‘ray of light’ concerns high speed internet access. Interestingly, some of the text about high speed access echoes faintly echoes descriptions of Estonia’s perspective on this issue. (Note: Canada’s Treasury Board signed a memorandum of understanding with Estonia in May 2018 as per this May 29, 2018 article by Silver Tambur for estonian world (how estonians see it),

Canada and Estonia have signed a memorandum of understanding on digital cooperation, aiming to work together on joint projects.

The new partnership was signed during the Estonian prime minister, Jüri Ratas’s, visit to Ottawa on 28 May [2018]. Welcomed by his Canadian counterpart, Justin Trudeau, Ratas became the first Estonian prime minister to make an official visit to Canada.

Both countries already share a membership of Digital 7 – a network of leading digital governments, currently comprising Canada, Estonia, Israel, New Zealand, South Korea, United Kingdom and Uruguay. The group is seeking to harness digital technology and improve digital services for the benefit of its citizens.[emphasis mine]

Under the new cooperation agreement between Canada and Estonia, both countries will work together on joint projects, the exchange of experts and other ways to share good practices as well as concrete digital solutions to advance these priorities.

Of course, there’s no point to improving digital services for citizens who do not have high speed internet or much of any kind of connectivity, as the Estonians must have realized fairly early on. This excerpt from an Estonian tourist website has a scrap of text that bears a resemblance to text in the Canadian 2019 budget (from the homepage of visit estonia),

“e-Estonia”, the E is for electronic, has become the go to tag to describe Estonia’s immensely successful love affair with all things networked and digitised.

Country wide enthusiasm for the efficiency of E has enthralled both citizens and policymakers alike. Estonian programmers have been behind the creation of digital brands such as Skype, Hotmail and more recently Transferwise (a online currency converter which has attracted investment from the likes of Richard Branson). Estonia has declared internet access a human right, [emphasis mine] it has a thriving IT start up culture and has digitally streamlined an unprecedented number of public services for citizens and businesses.

The roots of this revolution began in 1991, the year of Estonian independence, Estonian policy makers were given the rare gift of a bureaucratic clean slate. Placing their faith in the burgeoning possibilities of the internet and value of innovation, they steered the country into a position where it could leapfrog to become one of the most advanced e-societies in the world.

Now, here’s what the 2019 federal budget had to say bout connectivity in Canada (from Chapter 2; Part 3: Connecting Canadians), Note: Formatting has been changed),

Access to High-Speed Internet for All Canadians

In 2019, fast and reliable internet access is no longer a luxury—it’s a necessity. [emphasis mine]

For public institutions, entrepreneurs, and businesses of all sizes, quality high-speed internet is essential to participating in the digital economy—opening doors to customers who live just down the street or on the other side of the world. It is also important in the lives of Canadians. It lets students and young people do their homework, stay in touch with their friends, and apply for their very first jobs. It helps busy families register for recreational programs, shop online and pay their bills and access essential services. For many seniors, the internet is a way to stay up on current events and stay connected to distant family members and friends.

Canadians have a strong tradition of embracing new technologies, and using them to help generate long-term economic growth and drive social progress. In recent years, Canada and Canadian companies built mobile wireless networks that are among the fastest in the world and made investments that are delivering next-generation digital technologies and services to people and communities across the country. Yet, unfortunately, many Canadians still remain without reliable, high-speed internet access. In this time in the 21st Century, this is unacceptable.

How We Will Achieve a Fully Connected Canada

Delivering universal high-speed internet to every Canadian in the quickest and most cost-effective way will require a coordinated effort involving partners in the private sector and across all levels of government. To meet this commitment, Budget 2019 is proposing a new, coordinated plan that would deliver $5 billion to $6 billion in new investments in rural broadband over the next 10 years:

Support through the Accelerated Investment Incentive to encourage greater investments in rural high-speed internet from the private sector.
Greater coordination with provinces, territories, and federal arm’s-length institutions, such as the CRTC and its $750 million rural/remote broadband fund.
Securing advanced Low Earth Orbit satellite capacity to serve the most rural and remote regions of Canada.
New investments in the Connect to Innovate program and introduction of the Government’s new Universal Broadband Fund.
New investments by the Canada Infrastructure Bank to further leverage private sector investment.

Or, you could describe internet access as a human right. Whether you like it or not, it seems, short of a planetary disaster, internet access will be almost as important as food, water, and air.

This next ‘ray of light’ is a bit of a mixed bag, from Paul Wells’s March 19, 2019 article for Maclean’s,

… There’s $2.2 billion, refreshingly free of attached strings, in “much needed infrastructure funds” right now, this year.

Why infrastructure funds would still be “much needed,” four years into the tenure of the third prime minister in a row to make infrastructure spending a personal priority, is an interesting question for another day.

I’m hoping that at least some of this money is going to address the government’s digital infrastructure and I don’t understand any more than Paul Wells does as to why we’d still be talking about infrastructure. Stephen Harper’s Conservative government was in place for almost 10 years and Trudeau’s government for almost four years now (I don’t include Paul Martin’s government as that was fairly short lived) and with both of these prime ministers touting infrastructure, what’s taking so much time?

I hope some of this money is being dedicated to replacing the government’s dangerously aging digital infrastructure. I included some excerpts from an excellent article by James Bagnall on the state of the government’s digital infrastructure in my March 19, 2019 posting (scroll down about 15% of the way), which is a commentary on the Chief Science Advisor’s Office (CSO) 2018 annual report. Bagnall’s description is shocking and when I looked at the CSO’s 2018 report and saw that approximately 80% of the digital infrastructure for government science is conducted facilities that are between 50 and 25 years old with, presumably, similarly aged hardware and software, I couldn’t help but wonder when the Canadian government digital armageddon would occur.

I dug further into the 2019 budget and in Chapter Four, Part Six: Better Government found no mention of their digital infrastructure or of monies allocated to replacing any or all of the digital infrastructure. (sigh)

More happily, there was some reference to the Phoenix payroll system debacle and attempts to rectify the situation,

Ensuring Proper Payment for Public Servants

Canada’s public servants work hard in service of all Canadians and deserve to be paid properly and on time for their important work. The Phoenix pay system for federal public servants was originally intended to save money, however, since its launch it has resulted in unacceptable pay inaccuracies—resulting in hardships for public servants across the country. Serious issues and challenges with the pay system continue, and too many of Canada’s public servants are not being properly paid, or are waiting for their pay issues to be resolved.

To continue progress on stabilizing the current pay system, Budget 2019 provides an additional $21.7 million in 2018–19 to address urgent pay administration pressures (partially sourced from existing departmental funds), and proposes to invest an additional $523.3 million over five years, starting in 2019–20, to ensure that adequate resources are dedicated to addressing payroll errors. This investment will also support system improvements, to reduce the likelihood of errors occurring in the first place.

To ensure that the Canada Revenue Agency is able to quickly and accurately process income tax reassessments for federal government employees that are required due to Phoenix pay issues, and to support related telephone enquiries, Budget 2019 proposes to provide the Agency with an additional $9.2 million in 2019–20.

While the Phoenix pay system has been underpaying some public servants, it has also been paying others too much. Under current legislation, any employee who received an overpayment in a previous year is required to pay back the gross amount of this overpayment to their employer. The employee must recover from the Canada Revenue Agency the excess income tax, Canada Pension Plan contributions and Employment Insurance premiums that were deducted by their employer when the overpayment was made. On January 15, 2019, the Government proposed legislative amendments that would allow overpaid employees working in both the public and private sectors to repay their employer only the net amount they received after these deductions. The proposed amendments are intended to alleviate the burden faced by employees who were required to make repayments larger than the amounts they received from their employer, creating uncertainty and potential financial hardship.

Moving Toward the Next Generation Pay System for the Federal Public Service

In Budget 2018, the Government announced its intention to move away from the Phoenix pay system toward one better aligned to the complexity of the Government’s pay structure and to the future needs of Canada’s world-class public service.

Working cooperatively with experts, federal public sector unions, employees, pay specialists and technology providers, the Treasury Board Secretariat (TBS) launched a process to review lessons learned, and identify options for a next-generation pay solution.

As part of this process, pay system suppliers were invited to demonstrate possible solutions, which were directly tested with users. Based on feedback from users and participating stakeholders, TBS has been able to identify options with the potential to successfully replace the Phoenix pay system. As a next step, the Government will work with suppliers and stakeholders to develop the best options, including pilot projects that will allow for further testing with select departments and agencies, while assessing the ability of suppliers to deliver.

Finally, TBS will continue to engage public servants throughout this process, to ensure that their feedback is fully reflected in any future solution.

Interestingly, at the time of James Bagnoll’s article (excerpt in my March 19, 2019 posting), the only government data centre being replaced was Revenue Canada’s. It suggests that anything else can fall to pieces but the government should always be able to collect tax.

Getting back to my more cheerful and optimistic self, on balance, it’s encouraging to see thoughtful approaches to modernizing our regulatory system.

Treading water

There’s more to the’ 2019 commitment to science (from the 2019 budget’s Chapter 2; Part 6: Building Research Excellence in Canada: Support for Science, Research and Technology Organizations),

Canada is home to world-leading non-profit organizations that undertake research and bring together experts from diverse backgrounds to make discoveries, accelerate innovation and tackle health challenges. The Government helps support these collaborative efforts with targeted investments that return real economic and social benefits for Canadians.
Budget 2019 proposes to make additional investments in support of the following organizations:
Stem Cell Network: Stem cell research—pioneered by two Canadians in the 1960s—holds great promise for new therapies and medical treatments for respiratory and heart diseases, spinal cord injury, cancer, and many other diseases and disorders. The Stem Cell Network is a national not-for-profit organization that helps translate stem cell research into clinical applications and commercial products. To support this important work and foster Canada’s leadership in stem cell research, Budget 2019 proposes to provide the Stem Cell Network with renewed funding of $18 million over three years, starting in 2019–20.
Brain Canada Foundation: The Brain Canada Foundation is a national charitable organization that raises funds to foster advances in neuroscience discovery research, with the aim of improving health care for people affected by neurological injury and disease. To help the medical community better understand the brain and brain health, Budget 2019 proposes to provide the Brain Canada Foundation’s Canada Brain Research Fund with up to $40 million over two years, starting in 2020–21. This investment will be matched by funds raised from other non-government partners of the Brain Canada Foundation.
Terry Fox Research Institute: The Terry Fox Research Institute manages the cancer research investments of the Terry Fox Foundation. Budget 2019 proposes to provide the Terry Fox Research Institute with up to $150 million over five years, starting in 2019–20, to help establish a national Marathon of Hope Cancer Centres Network. The Institute would seek matching funding through a combination of its own resources and contributions that it would seek from other organizations,, including hospital and research foundations.
Ovarian Cancer Canada: Ovarian Cancer Canada supports women living with the disease and their families, raises awareness and funds research. Budget 2019 proposes to provide Ovarian Cancer Canada with $10 million over five years beginning in 2019–20 to help address existing gaps in knowledge about effective prevention, screening, and treatment options for ovarian cancer.
Genome Canada: The insights derived from genomics—the study of the entire genetic information of living things encoded in their DNA and related molecules and proteins—hold the potential for breakthroughs that can improve the lives of Canadians and drive innovation and economic growth. Genome Canada is a not-for-profit organization dedicated to advancing genomics science and technology in order to create economic and social benefits for Canadians. To support Genome Canada’s operations, Budget 2019 proposes to provide Genome Canada with $100.5 million over five years, starting in 2020–21. This investment will also enable Genome Canada to launch new large-scale research competitions and projects, in collaboration with external partners, ensuring that Canada’s research community continues to have access to the resources needed to make transformative scientific breakthroughs and translate these discoveries into real-world applications.
Let’s Talk Science: Science, technology, engineering and math (STEM) are not just things we study in school—together, they are transforming all aspects of our lives, and redefining the skills and knowledge people need to succeed in a changing world. Let’s Talk Science engages youth in hands-on STEM activities and learning programs, such as science experiments, helping youth develop critical thinking skills and opening up doors to future study and work in these fields. It also helps ensure more girls—and other groups that are underrepresented in STEM—gain and maintain interest in STEM from an early age. Budget 2019 proposes to provide Let’s Talk Science with $10 million over two years, starting in 2020–21, to support this important work.

There’s nothing earth shattering on that list. Five of these organizations could be described as focused on medical research and I have seen at least three of them mentioned in previous federal budgets. The last organization, Let’s Talk Science (established in 1993), focused on science promotion for children and youth, is being mentioned for the first time in a budget (as far as I know).

In the next section, the budget blesses physics or more specifically, TRIUMF. From the 2019 budget’s Chapter 2; Part 6: Building Research Excellence in Canada: Strengthening Canada’s World-Class physics research,

TRIUMF is a world-class sub-atomic physics research laboratory located in British Columbia, and home to the world’s largest cyclotron particle accelerator. TRIUMF has played a leading role in many medical breakthroughs—such as developing alongside Canadian industrial partners new approaches to the medical imaging of diseases—and brings together industry partners, leading academic researchers and scientists, and graduate students from across Canada and around the world to advance medical isotope production, drug development, cancer therapy, clinical imaging, and radiopharmaceutical research.

Budget 2019 proposes to provide TRIUMF with $195.9 million over five years, starting in 2019–20, to build on its strong track record of achievements. Combined with an additional $96.8 million from the existing resources of the National Research Council, federal support for TRIUMF will total $292.7 million over this five-year period.

When are the folks at the Canadian Light Source (our synchrotron) going to get some love? Year after year it’s either TRIUMF or the Perimeter Institute getting a major infusion of cash. I exaggerate but only mildly.You can find some of my comments on the 2018 federal budget in this March 16, 2018 posting and my comments on the 2017 federal budget in this March 24, 2017 posting.

Maybe one day a ray of light?

Here’s something new but I imagine you’ll quickly see what makes this an odd addition to the budget (from the 2019 budget’s Chapter 2; Part 6: Building Research Excellence in Canada: Taking a new approach With the Strategic Science Fund),

To make federal investments in third-party science and research more effective, Budget 2019 proposes to establish a new Strategic Science Fund. This new Fund will respond to recommendations that arose during consultations with third-party science and research organizations. It will operate using a principles-based framework for allocating federal funding that includes competitive, transparent processes. This will help protect and promote research excellence.

Under the Fund, the principles-based framework will be applied by an independent panel of experts, including scientists and innovators, who will provide advice for the consideration of the Government on approaches to allocating funding for third-party science and research organizations.

Budget 2019 proposes to establish and operate the Strategic Science Fund starting in 2022–23.

This Strategic Science Fund will be the Government’s key new tool to support third-party science and research organizations. Going forward, the selection of recipient organizations and corresponding level of support will be determined through the Fund’s competitive allocation process, with advice from the expert panel and informed by the Minister of Science’s overall strategy. The Minister of Science will provide more detail on the Fund over the coming months.

No money until 2022, eh? That’s interesting given that would be a year before the election (2023) after this one later in 2019. And, it’s anyone’s guess as to which government will be in power. Crossing my fingers again, I hope these good intention bear fruit in light of Daniel Banks’s (of the Canadian Neutron Beam Centre] March 21, 2019 essay (on the Canadian Science Policy Centre website) about the potential new oversight (Note: Prepare yourself for some alphabet soup; the man loves initialisms and sees no reason to include full names),

From a science policy perspective, which is about how science is managed, as well as funded, the biggest change may be one item that had no dollar amount attached.

Budget 2019 announces a “new approach” for funding so-called “third-party science and research.” The Fundamental Science Review defined “third-party science entities” as those operating outside the jurisdiction of NSERC, CIHR, SSHRC, CFI. Genome Canada, Mitacs, and Brain Canada are a few examples.

The Review raised concerns, not with the quality of these organizations’ output, but with how they are each governed as one-offs, via term-limited contribution agreements with ISED. Ad hoc governance arrangements have been needed until now because these organizations don’t fit within the existing programs of the granting councils. Lack of a suitable program required scientists to lobby for funds, rather than participate in peer-reviewed competitions. Over time, the Review warned, this approach could “allow select groups of researchers to sidestep the intensity of peer review competitions, and facilitate unchecked mission drift as third-party partner organizations shift their mandates to justify their continuation.”

The Strategic Science Fund could be a precedent for another portion of the science community that faces similar challenges: so-called Big Science, or Major Research Facilities (MRFs), such as TRIUMF, SNOLAB, Ocean Networks Canada, the Canadian Light Source, and large facilities for astronomy or neutron scattering. In the absence of a systematic means of overseeing Canada’s portfolio of these shared national resources, an array of oversight mechanisms have been created for these facilities on an ad hoc basis, much like the case for third-party research organizations. The Fundamental Science Review was the latest in a string of reports that have pointed problems with this ad hoc approach, stretching back at least 20 years.

Stewardship of Canada’s MRFs has improved following the introduction of the CFI’s Major Science Initiatives Fund in 2012, and the expansion of its mandate to include more facilities under its program in 2014. Nonetheless, there are still many facilities that are not covered by this Fund. No agency has responsibility for the entire portfolio of MRFs to allow it to plan for the creation of new MRFs as others wind-down, or provide predictable funding over the life-cycle of an MRF. Other MRFs still fall through jurisdictional cracks, where no federal agency is clearly responsible for them. Such jurisdictional cracks were one contributing factor in the loss of Canada’s neutron scattering facilities in 2018.

it’s one of the things I’ve found most difficult about following the Canadian science scene, it’s very scattered. In his essay, Banks explains, in part, why this situation exists.Let’s hope that one government or another addresses it.

On balance, it’s encouraging to see thoughtful approaches to modernizing our regulatory system and to better integrating the various agencies that serve our science initiatives. As for infrastructure and the Strategic Science Fund, I have, as previously noted, my fingers crossed. Let’s hope they manage it this time.

Artificial intelligence (AI) brings together International Telecommunications Union (ITU) and World Health Organization (WHO) and AI outperforms animal testing

Following on my May 11, 2018 posting about the International Telecommunications Union (ITU) and the 2018 AI for Good Global Summit in mid- May, there’s an announcement. My other bit of AI news concerns animal testing.

Leveraging the power of AI for health

A July 24, 2018 ITU press release (a shorter version was received via email) announces a joint initiative focused on improving health,

Two United Nations specialized agencies are joining forces to expand the use of artificial intelligence (AI) in the health sector to a global scale, and to leverage the power of AI to advance health for all worldwide. The International Telecommunication Union (ITU) and the World Health Organization (WHO) will work together through the newly established ITU Focus Group on AI for Health to develop an international “AI for health” standards framework and to identify use cases of AI in the health sector that can be scaled-up for global impact. The group is open to all interested parties.

“AI could help patients to assess their symptoms, enable medical professionals in underserved areas to focus on critical cases, and save great numbers of lives in emergencies by delivering medical diagnoses to hospitals before patients arrive to be treated,” said ITU Secretary-General Houlin Zhao. “ITU and WHO plan to ensure that such capabilities are available worldwide for the benefit of everyone, everywhere.”

The demand for such a platform was first identified by participants of the second AI for Good Global Summit held in Geneva, 15-17 May 2018. During the summit, AI and the health sector were recognized as a very promising combination, and it was announced that AI-powered technologies such as skin disease recognition and diagnostic applications based on symptom questions could be deployed on six billion smartphones by 2021.

The ITU Focus Group on AI for Health is coordinated through ITU’s Telecommunications Standardization Sector – which works with ITU’s 193 Member States and more than 800 industry and academic members to establish global standards for emerging ICT innovations. It will lead an intensive two-year analysis of international standardization opportunities towards delivery of a benchmarking framework of international standards and recommendations by ITU and WHO for the use of AI in the health sector.

“I believe the subject of AI for health is both important and useful for advancing health for all,” said WHO Director-General Tedros Adhanom Ghebreyesus.

The ITU Focus Group on AI for Health will also engage researchers, engineers, practitioners, entrepreneurs and policy makers to develop guidance documents for national administrations, to steer the creation of policies that ensure the safe, appropriate use of AI in the health sector.

“1.3 billion people have a mobile phone and we can use this technology to provide AI-powered health data analytics to people with limited or no access to medical care. AI can enhance health by improving medical diagnostics and associated health intervention decisions on a global scale,” said Thomas Wiegand, ITU Focus Group on AI for Health Chairman, and Executive Director of the Fraunhofer Heinrich Hertz Institute, as well as professor at TU Berlin.

He added, “The health sector is in many countries among the largest economic sectors or one of the fastest-growing, signalling a particularly timely need for international standardization of the convergence of AI and health.”

Data analytics are certain to form a large part of the ITU focus group’s work. AI systems are proving increasingly adept at interpreting laboratory results and medical imagery and extracting diagnostically relevant information from text or complex sensor streams.

As part of this, the ITU Focus Group for AI for Health will also produce an assessment framework to standardize the evaluation and validation of AI algorithms — including the identification of structured and normalized data to train AI algorithms. It will develop open benchmarks with the aim of these becoming international standards.

The ITU Focus Group for AI for Health will report to the ITU standardization expert group for multimedia, Study Group 16.

I got curious about Study Group 16 (from the Study Group 16 at a glance webpage),

Study Group 16 leads ITU’s standardization work on multimedia coding, systems and applications, including the coordination of related studies across the various ITU-T SGs. It is also the lead study group on ubiquitous and Internet of Things (IoT) applications; telecommunication/ICT accessibility for persons with disabilities; intelligent transport system (ITS) communications; e-health; and Internet Protocol television (IPTV).

Multimedia is at the core of the most recent advances in information and communication technologies (ICTs) – especially when we consider that most innovation today is agnostic of the transport and network layers, focusing rather on the higher OSI model layers.

SG16 is active in all aspects of multimedia standardization, including terminals, architecture, protocols, security, mobility, interworking and quality of service (QoS). It focuses its studies on telepresence and conferencing systems; IPTV; digital signage; speech, audio and visual coding; network signal processing; PSTN modems and interfaces; facsimile terminals; and ICT accessibility.

I wonder which group deals with artificial intelligence and, possibly, robots.

Chemical testing without animals

Thomas Hartung, professor of environmental health and engineering at Johns Hopkins University (US), describes in his July 25, 2018 essay (written for The Conversation) on phys.org the situation where chemical testing is concerned,

Most consumers would be dismayed with how little we know about the majority of chemicals. Only 3 percent of industrial chemicals – mostly drugs and pesticides – are comprehensively tested. Most of the 80,000 to 140,000 chemicals in consumer products have not been tested at all or just examined superficially to see what harm they may do locally, at the site of contact and at extremely high doses.

I am a physician and former head of the European Center for the Validation of Alternative Methods of the European Commission (2002-2008), and I am dedicated to finding faster, cheaper and more accurate methods of testing the safety of chemicals. To that end, I now lead a new program at Johns Hopkins University to revamp the safety sciences.

As part of this effort, we have now developed a computer method of testing chemicals that could save more than a US$1 billion annually and more than 2 million animals. Especially in times where the government is rolling back regulations on the chemical industry, new methods to identify dangerous substances are critical for human and environmental health.

Having written on the topic of alternatives to animal testing on a number of occasions (my December 26, 2014 posting provides an overview of sorts), I was particularly interested to see this in Hartung’s July 25, 2018 essay on The Conversation (Note: Links have been removed),

Following the vision of Toxicology for the 21st Century, a movement led by U.S. agencies to revamp safety testing, important work was carried out by my Ph.D. student Tom Luechtefeld at the Johns Hopkins Center for Alternatives to Animal Testing. Teaming up with Underwriters Laboratories, we have now leveraged an expanded database and machine learning to predict toxic properties. As we report in the journal Toxicological Sciences, we developed a novel algorithm and database for analyzing chemicals and determining their toxicity – what we call read-across structure activity relationship, RASAR.

This graphic reveals a small part of the chemical universe. Each dot represents a different chemical. Chemicals that are close together have similar structures and often properties. Thomas Hartung, CC BY-SA

To do this, we first created an enormous database with 10 million chemical structures by adding more public databases filled with chemical data, which, if you crunch the numbers, represent 50 trillion pairs of chemicals. A supercomputer then created a map of the chemical universe, in which chemicals are positioned close together if they share many structures in common and far where they don’t. Most of the time, any molecule close to a toxic molecule is also dangerous. Even more likely if many toxic substances are close, harmless substances are far. Any substance can now be analyzed by placing it into this map.

If this sounds simple, it’s not. It requires half a billion mathematical calculations per chemical to see where it fits. The chemical neighborhood focuses on 74 characteristics which are used to predict the properties of a substance. Using the properties of the neighboring chemicals, we can predict whether an untested chemical is hazardous. For example, for predicting whether a chemical will cause eye irritation, our computer program not only uses information from similar chemicals, which were tested on rabbit eyes, but also information for skin irritation. This is because what typically irritates the skin also harms the eye.

How well does the computer identify toxic chemicals?

This method will be used for new untested substances. However, if you do this for chemicals for which you actually have data, and compare prediction with reality, you can test how well this prediction works. We did this for 48,000 chemicals that were well characterized for at least one aspect of toxicity, and we found the toxic substances in 89 percent of cases.

This is clearly more accurate that the corresponding animal tests which only yield the correct answer 70 percent of the time. The RASAR shall now be formally validated by an interagency committee of 16 U.S. agencies, including the EPA [Environmental Protection Agency] and FDA [Food and Drug Administration], that will challenge our computer program with chemicals for which the outcome is unknown. This is a prerequisite for acceptance and use in many countries and industries.

The potential is enormous: The RASAR approach is in essence based on chemical data that was registered for the 2010 and 2013 REACH [Registration, Evaluation, Authorizations and Restriction of Chemicals] deadlines [in Europe]. If our estimates are correct and chemical producers would have not registered chemicals after 2013, and instead used our RASAR program, we would have saved 2.8 million animals and $490 million in testing costs – and received more reliable data. We have to admit that this is a very theoretical calculation, but it shows how valuable this approach could be for other regulatory programs and safety assessments.

In the future, a chemist could check RASAR before even synthesizing their next chemical to check whether the new structure will have problems. Or a product developer can pick alternatives to toxic substances to use in their products. This is a powerful technology, which is only starting to show all its potential.

It’s been my experience that these claims having led a movement (Toxicology for the 21st Century) are often contested with many others competing for the title of ‘leader’ or ‘first’. That said, this RASAR approach seems very exciting, especially in light of the skepticism about limiting and/or making animal testing unnecessary noted in my December 26, 2014 posting.it was from someone I thought knew better.

Here’s a link to and a citation for the paper mentioned in Hartung’s essay,

Machine learning of toxicological big data enables read-across structure activity relationships (RASAR) outperforming animal test reproducibility by Thomas Luechtefeld, Dan Marsh, Craig Rowlands, Thomas Hartung. Toxicological Sciences, kfy152, https://doi.org/10.1093/toxsci/kfy152 Published: 11 July 2018

This paper is open access.

Call for abstracts: Seventh annual conference on governance of emerging technologies & science (GETS)

The conference itself will be held from May 22 – 24, 2019 at Arizona State University (ASU) and the deadline for abstracts is January 31, 2019. Here’s the news straight from the January 8, 2019 email announcement,

The Seventh Annual Conference on Governance of Emerging Technologies & Science (GETS)

May 22-24, 2019 / ASU / Sandra Day O’Connor College of Law
111 E. Taylor St., Phoenix, AZ
 
The conference will consist of plenary and session presentations and discussions on regulatory, governance, legal, policy, social and ethical aspects of emerging technologies, including nanotechnology, synthetic biology, gene editing, biotechnology, genomics, personalized medicine, digital health, human enhancement, artificial intelligence, virtual reality, internet of things (IoT), blockchain and much, much more!
 
Submit Your Abstract Here: 2019 Abstract
or
Conference Website
 
Call for abstracts:
 
The co-sponsors invite submission of abstracts for proposed presentations. Submitters of abstracts need not provide a written paper, although provision will be made for posting and possible post-conference publication of papers for those who are interested. 
Abstracts are invited for any aspect or topic relating to the governance of emerging technologies, including any of the technologies listed above.
 
·         Abstracts should not exceed 500 words and must contain your name and email address.
·         Abstracts must be submitted by January 31, 2019 to be considered. 
·         The sponsors will pay for the conference registration (including all conference meals and events) for one presenter for each accepted abstract. In addition, we will have limited funds available for travel subsidies (application included in submission form).
For more informationcontact our Executive Director Josh Abbott at Josh.Abbott@asu.edu.

Good luck on your submission!

More memory, less space and a walk down the cryptocurrency road

Libraries, archives, records management, oral history, etc. there are many institutions and names for how we manage collective and personal memory. You might call it a peculiarly human obsession stretching back into antiquity. For example, there’s the Library of Alexandria (Wikipedia entry) founded in the third, or possibly 2nd, century BCE (before the common era) and reputed to store all the knowledge in the world. It was destroyed although accounts differ as to when and how but its loss remains a potent reminder of memory’s fragility.

These days, the technology community is terribly concerned with storing ever more bits of data on materials that are reaching their limits for storage.I have news of a possible solution,  an interview of sorts with the researchers working on this new technology, and some very recent research into policies for cryptocurrency mining and development. That bit about cryptocurrency makes more sense when you read what the response to one of the interview questions.

Memory

It seems University of Alberta researchers may have found a way to increase memory exponentially, from a July 23, 2018 news item on ScienceDaily,

The most dense solid-state memory ever created could soon exceed the capabilities of current computer storage devices by 1,000 times, thanks to a new technique scientists at the University of Alberta have perfected.

“Essentially, you can take all 45 million songs on iTunes and store them on the surface of one quarter,” said Roshan Achal, PhD student in Department of Physics and lead author on the new research. “Five years ago, this wasn’t even something we thought possible.”

A July 23, 2018 University of Alberta news release (also on EurekAlert) by Jennifer-Anne Pascoe, which originated the news item, provides more information,

Previous discoveries were stable only at cryogenic conditions, meaning this new finding puts society light years closer to meeting the need for more storage for the current and continued deluge of data. One of the most exciting features of this memory is that it’s road-ready for real-world temperatures, as it can withstand normal use and transportation beyond the lab.

“What is often overlooked in the nanofabrication business is actual transportation to an end user, that simply was not possible until now given temperature restrictions,” continued Achal. “Our memory is stable well above room temperature and precise down to the atom.”

Achal explained that immediate applications will be data archival. Next steps will be increasing readout and writing speeds, meaning even more flexible applications.

More memory, less space

Achal works with University of Alberta physics professor Robert Wolkow, a pioneer in the field of atomic-scale physics. Wolkow perfected the art of the science behind nanotip technology, which, thanks to Wolkow and his team’s continued work, has now reached a tipping point, meaning scaling up atomic-scale manufacturing for commercialization.

“With this last piece of the puzzle now in-hand, atom-scale fabrication will become a commercial reality in the very near future,” said Wolkow. Wolkow’s Spin-off [sic] company, Quantum Silicon Inc., is hard at work on commercializing atom-scale fabrication for use in all areas of the technology sector.

To demonstrate the new discovery, Achal, Wolkow, and their fellow scientists not only fabricated the world’s smallest maple leaf, they also encoded the entire alphabet at a density of 138 terabytes, roughly equivalent to writing 350,000 letters across a grain of rice. For a playful twist, Achal also encoded music as an atom-sized song, the first 24 notes of which will make any video-game player of the 80s and 90s nostalgic for yesteryear but excited for the future of technology and society.

As noted in the news release, there is an atom-sized song, which is available in this video,

As for the nano-sized maple leaf, I highlighted that bit of whimsy in a June 30, 2017 posting.

Here’s a link to and a citation for the paper,

Lithography for robust and editable atomic-scale silicon devices and memories by Roshan Achal, Mohammad Rashidi, Jeremiah Croshaw, David Churchill, Marco Taucer, Taleana Huff, Martin Cloutier, Jason Pitters, & Robert A. Wolkow. Nature Communicationsvolume 9, Article number: 2778 (2018) DOI: https://doi.org/10.1038/s41467-018-05171-y Published 23 July 2018

This paper is open access.

For interested parties, you can find Quantum Silicon (QSI) here. My Edmonton geography is all but nonexistent, still, it seems to me the company address on Saskatchewan Drive is a University of Alberta address. It’s also the address for the National Research Council of Canada. Perhaps this is a university/government spin-off company?

The ‘interview’

I sent some questions to the researchers at the University of Alberta who very kindly provided me with the following answers. Roshan Achal passed on one of the questions to his colleague Taleana Huff for her response. Both Achal and Huff are associated with QSI.

Unfortunately I could not find any pictures of all three researchers (Achal, Huff, and Wolkow) together.

Roshan Achal (left) used nanotechnology perfected by his PhD supervisor, Robert Wolkow (right) to create atomic-scale computer memory that could exceed the capacity of today’s solid-state storage drives by 1,000 times. (Photo: Faculty of Science)

(1) SHRINKING THE MANUFACTURING PROCESS TO THE ATOMIC SCALE HAS
ATTRACTED A LOT OF ATTENTION OVER THE YEARS STARTING WITH SCIENCE
FICTION OR RICHARD FEYNMAN OR K. ERIC DREXLER, ETC. IN ANY EVENT, THE
ORIGINS ARE CONTESTED SO I WON’T PUT YOU ON THE SPOT BY ASKING WHO
STARTED IT ALL INSTEAD ASKING HOW DID YOU GET STARTED?

I got started in this field about 6 years ago, when I undertook a MSc
with Dr. Wolkow here at the University of Alberta. Before that point, I
had only ever heard of a scanning tunneling microscope from what was
taught in my classes. I was aware of the famous IBM logo made up from
just a handful of atoms using this machine, but I didn’t know what
else could be done. Here, Dr. Wolkow introduced me to his line of
research, and I saw the immense potential for growth in this area and
decided to pursue it further. I had the chance to interact with and
learn from nanofabrication experts and gain the skills necessary to
begin playing around with my own techniques and ideas during my PhD.

(2) AS I UNDERSTAND IT, THESE ARE THE PIECES YOU’VE BEEN
WORKING ON: (1) THE TUNGSTEN MICROSCOPE TIP, WHICH MAKE[s] (2) THE SMALLEST
QUANTUM DOTS (SINGLE ATOMS OF SILICON), (3) THE AUTOMATION OF THE
QUANTUM DOT PRODUCTION PROCESS, AND (4) THE “MOST DENSE SOLID-STATE
MEMORY EVER CREATED.” WHAT’S MISSING FROM THE LIST AND IS THAT WHAT
YOU’RE WORKING ON NOW?

One of the things missing from the list, that we are currently working
on, is the ability to easily communicate (electrically) from the
macroscale (our world) to the nanoscale, without the use of a scanning
tunneling microscope. With this, we would be able to then construct
devices using the other pieces we’ve developed up to this point, and
then integrate them with more conventional electronics. This would bring
us yet another step closer to the realization of atomic-scale
electronics.

(3) PERHAPS YOU COULD CLARIFY SOMETHING FOR ME. USUALLY WHEN SOLID STATE
MEMORY IS MENTIONED, THERE’S GREAT CONCERN ABOUT MOORE’S LAW. IS
THIS WORK GOING TO CREATE A NEW LAW? AND, WHAT IF ANYTHING DOES
;YOUR MEMORY DEVICE HAVE TO DO WITH QUANTUM COMPUTING?

That is an interesting question. With the density we’ve achieved,
there are not too many surfaces where atomic sites are more closely
spaced to allow for another factor of two improvement. In that sense, it
would be difficult to improve memory densities further using these
techniques alone. In order to continue Moore’s law, new techniques, or
storage methods would have to be developed to move beyond atomic-scale
storage.

The memory design itself does not have anything to do with quantum
computing, however, the lithographic techniques developed through our
work, may enable the development of certain quantum-dot-based quantum
computing schemes.

(4) THIS MAY BE A LITTLE OUT OF LEFT FIELD (OR FURTHER OUT THAN THE
OTHERS), COULD;YOUR MEMORY DEVICE HAVE AN IMPACT ON THE
DEVELOPMENT OF CRYPTOCURRENCY AND BLOCKCHAIN? IF SO, WHAT MIGHT THAT
IMPACT BE?

I am not very familiar with these topics, however, co-author Taleana
Huff has provided some thoughts:

Taleana Huff (downloaded from https://ca.linkedin.com/in/taleana-huff]

“The memory, as we’ve designed it, might not have too much of an
impact in and of itself. Cryptocurrencies fall into two categories.
Proof of Work and Proof of Stake. Proof of Work relies on raw
computational power to solve a difficult math problem. If you solve it,
you get rewarded with a small amount of that coin. The problem is that
it can take a lot of power and energy for your computer to crunch
through that problem. Faster access to memory alone could perhaps
streamline small parts of this slightly, but it would be very slight.
Proof of Stake is already quite power efficient and wouldn’t really
have a drastic advantage from better faster computers.

Now, atomic-scale circuitry built using these new lithographic
techniques that we’ve developed, which could perform computations at
significantly lower energy costs, would be huge for Proof of Work coins.
One of the things holding bitcoin back, for example, is that mining it
is now consuming power on the order of the annual energy consumption
required by small countries. A more efficient way to mine while still
taking the same amount of time to solve the problem would make bitcoin
much more attractive as a currency.”

Thank you to Roshan Achal and Taleana Huff for helping me to further explore the implications of their work with Dr. Wolkow.

Comments

As usual, after receiving the replies I have more questions but these people have other things to do so I’ll content myself with noting that there is something extraordinary in the fact that we can imagine a near future where atomic scale manufacturing is possible and where as Achal says, ” … storage methods would have to be developed to move beyond atomic-scale [emphasis mine] storage”. In decades past it was the stuff of science fiction or of theorists who didn’t have the tools to turn the idea into a reality. With Wolkow’s, Achal’s, Hauff’s, and their colleagues’ work, atomic scale manufacturing is attainable in the foreseeable future.

Hopefully we’ll be wiser than we have been in the past in how we deploy these new manufacturing techniques. Of course, before we need the wisdom, scientists, as  Achal notes,  need to find a new way to communicate between the macroscale and the nanoscale.

As for Huff’s comments about cryptocurrencies and cyptocurrency and blockchain technology, I stumbled across this very recent research, from a July 31, 2018 Elsevier press release (also on EurekAlert),

A study [behind a paywall] published in Energy Research & Social Science warns that failure to lower the energy use by Bitcoin and similar Blockchain designs may prevent nations from reaching their climate change mitigation obligations under the Paris Agreement.

The study, authored by Jon Truby, PhD, Assistant Professor, Director of the Centre for Law & Development, College of Law, Qatar University, Doha, Qatar, evaluates the financial and legal options available to lawmakers to moderate blockchain-related energy consumption and foster a sustainable and innovative technology sector. Based on this rigorous review and analysis of the technologies, ownership models, and jurisdictional case law and practices, the article recommends an approach that imposes new taxes, charges, or restrictions to reduce demand by users, miners, and miner manufacturers who employ polluting technologies, and offers incentives that encourage developers to create less energy-intensive/carbon-neutral Blockchain.

“Digital currency mining is the first major industry developed from Blockchain, because its transactions alone consume more electricity than entire nations,” said Dr. Truby. “It needs to be directed towards sustainability if it is to realize its potential advantages.

“Many developers have taken no account of the environmental impact of their designs, so we must encourage them to adopt consensus protocols that do not result in high emissions. Taking no action means we are subsidizing high energy-consuming technology and causing future Blockchain developers to follow the same harmful path. We need to de-socialize the environmental costs involved while continuing to encourage progress of this important technology to unlock its potential economic, environmental, and social benefits,” explained Dr. Truby.

As a digital ledger that is accessible to, and trusted by all participants, Blockchain technology decentralizes and transforms the exchange of assets through peer-to-peer verification and payments. Blockchain technology has been advocated as being capable of delivering environmental and social benefits under the UN’s Sustainable Development Goals. However, Bitcoin’s system has been built in a way that is reminiscent of physical mining of natural resources – costs and efforts rise as the system reaches the ultimate resource limit and the mining of new resources requires increasing hardware resources, which consume huge amounts of electricity.

Putting this into perspective, Dr. Truby said, “the processes involved in a single Bitcoin transaction could provide electricity to a British home for a month – with the environmental costs socialized for private benefit.

“Bitcoin is here to stay, and so, future models must be designed without reliance on energy consumption so disproportionate on their economic or social benefits.”

The study evaluates various Blockchain technologies by their carbon footprints and recommends how to tax or restrict Blockchain types at different phases of production and use to discourage polluting versions and encourage cleaner alternatives. It also analyzes the legal measures that can be introduced to encourage technology innovators to develop low-emissions Blockchain designs. The specific recommendations include imposing levies to prevent path-dependent inertia from constraining innovation:

  • Registration fees collected by brokers from digital coin buyers.
  • “Bitcoin Sin Tax” surcharge on digital currency ownership.
  • Green taxes and restrictions on machinery purchases/imports (e.g. Bitcoin mining machines).
  • Smart contract transaction charges.

According to Dr. Truby, these findings may lead to new taxes, charges or restrictions, but could also lead to financial rewards for innovators developing carbon-neutral Blockchain.

The press release doesn’t fully reflect Dr. Truby’s thoughtfulness or the incentives he has suggested. it’s not all surcharges, taxes, and fees constitute encouragement.  Here’s a sample from the conclusion,

The possibilities of Blockchain are endless and incentivisation can help solve various climate change issues, such as through the development of digital currencies to fund climate finance programmes. This type of public-private finance initiative is envisioned in the Paris Agreement, and fiscal tools can incentivize innovators to design financially rewarding Blockchain technology that also achieves environmental goals. Bitcoin, for example, has various utilitarian intentions in its White Paper, which may or may not turn out to be as envisioned, but it would not have been such a success without investors seeking remarkable returns. Embracing such technology, and promoting a shift in behaviour with such fiscal tools, can turn the industry itself towards achieving innovative solutions for environmental goals.

I realize Wolkow, et. al, are not focused on cryptocurrency and blockchain technology per se but as Huff notes in her reply, “… new lithographic techniques that we’ve developed, which could perform computations at significantly lower energy costs, would be huge for Proof of Work coins.”

Whether or not there are implications for cryptocurrencies, energy needs, climate change, etc., it’s the kind of innovative work being done by scientists at the University of Alberta which may have implications in fields far beyond the researchers’ original intentions such as more efficient computation and data storage.

ETA Aug. 6, 2018: Dexter Johnson weighed in with an August 3, 2018 posting on his Nanoclast blog (on the IEEE [Institute of Electrical and Electronics Engineers] website),

Researchers at the University of Alberta in Canada have developed a new approach to rewritable data storage technology by using a scanning tunneling microscope (STM) to remove and replace hydrogen atoms from the surface of a silicon wafer. If this approach realizes its potential, it could lead to a data storage technology capable of storing 1,000 times more data than today’s hard drives, up to 138 terabytes per square inch.

As a bit of background, Gerd Binnig and Heinrich Rohrer developed the first STM in 1986 for which they later received the Nobel Prize in physics. In the over 30 years since an STM first imaged an atom by exploiting a phenomenon known as tunneling—which causes electrons to jump from the surface atoms of a material to the tip of an ultrasharp electrode suspended a few angstroms above—the technology has become the backbone of so-called nanotechnology.

In addition to imaging the world on the atomic scale for the last thirty years, STMs have been experimented with as a potential data storage device. Last year, we reported on how IBM (where Binnig and Rohrer first developed the STM) used an STM in combination with an iron atom to serve as an electron-spin resonance sensor to read the magnetic pole of holmium atoms. The north and south poles of the holmium atoms served as the 0 and 1 of digital logic.

The Canadian researchers have taken a somewhat different approach to making an STM into a data storage device by automating a known technique that uses the ultrasharp tip of the STM to apply a voltage pulse above an atom to remove individual hydrogen atoms from the surface of a silicon wafer. Once the atom has been removed, there is a vacancy on the surface. These vacancies can be patterned on the surface to create devices and memories.

If you have the time, I recommend reading Dexter’s posting as he provides clear explanations, additional insight into the work, and more historical detail.

US National Institute of Occupational Health and Safety (NIOSH) released four new documents for handling nanomaterials

A March 12, 2018 news item on Nanowerk announced the latest from the US National Institute of Occupational Health and Safety (NIOSH) on the safe handling of nanomaterials in the workplace,

Realizing the promise of any scientific advancement requires understanding of its potential human health effects, and its safe and responsible development, even at the level of engineered nanomaterials, which can be nearly atomic-sized. The National Institute for Occupational Safety and Health (NIOSH) launched four new products this week intended to provide options to companies for controlling possible exposure of their workers to nanomaterials on the job.

A March 12, 2018 NIOSH news release, which originated the news item, fills in some details,

Engineered nanomaterials are intentionally produced to have at least one primary dimension less than 100 nanometers (nm). These very small particles have unique shapes and physical and chemical properties. These materials become desirable for specific product applications in areas including medicine, electronics, biomaterials, and consumer products. Workers in industries that use or make these uniquely engineered nanomaterials may inhale nanoparticles on a daily basis, posing a potential respiratory hazard.

“Researching, developing, and utilizing these nano properties is at the heart of new technology, just as worker safety is at the heart of what we do at NIOSH,” said NIOSH Director John Howard, M.D. “The information contained in these new workplace design solution documents provide employers with strategic steps towards making sure their employees stay safe while handling nanomaterials.”

The four new documents provide helpful recommendations on minimizing exposures during common processes and tasks, including:

Each workplace design solutions document provides key tips on the design, use, and maintenance of exposure controls for nanomaterial production, post processing, and use. The poster poses questions that employers and workers should consider before starting work with a nanomaterial. For each question, the poster provides options to reduce exposures to nanomaterials based on the physical form. The poster can be displayed in a lab or work environment, making it an easily accessible reminder of the important health and safety considerations for working with nanomaterials.

To access the products, and for more information about nanotechnology research at NIOSH, please visit https://www.cdc.gov/niosh/topics/nanotech/pubs.html

NIOSH is the federal institute that conducts research and makes recommendations for preventing work-related injuries and illnesses. More information about NIOSH can be found at www.cdc.gov/niosh.

That’s all folks!

Nanomaterials the SUN (Sustainable Nanotechnologies) project sunsets, finally and the Belgians amend their registry

Health, safety, and risks have been an important discussion where nanotechnology is concerned. The sense of urgency and concern has died down somewhat but scientists and regulators continue with their risk analysis.

SUN (Sustainable Nanotechnologies) project

Back in a December 7, 2016 posting I mentioned the Sustainable Nanotechnologies (SUN) project and its imminent demise in 2017. A February 26, 2018 news item on Nanowerk announces a tool developed by SUN scientists and intended for current use,

Over 100 scientists from 25 research institutions and industries in 12 different European Countries, coordinated by the group of professor Antonio Marcomini from Ca’ Foscari University of Venice, have completed one of the first attempts to understand the risks nanomaterials carry throughout their life-cycle, starting from their fabrication and ending in being discarded or recycled.

From nanoscale silver to titanium dioxide for air purification, the use of nanomaterials of high commercial relevance proves to have clear benefits as it attracts investments, and raises concerns. ‘Nano’ sized materials (a nanometre is one millionth of a millimetre) could pose environmental and health risks under certain conditions. The uncertainties and insufficient scientific knowledge could slow down innovation and economic growth.

How do we evaluate these risks and take the appropriate preventative measures? The answer comes from the results of the Sustainable Nanotechnologies Project (SUN), which has been given 13 million euros of funding from the European Commission.

Courtesy: SUN Project

A February 26, 2018 Ca’ Foscari University of Venice press release describes some of the SUN project’s last t initiatives including, https://sunds.gd/  or the ‘SUNDS; Decision support system for risk management of engineered nanomaterials and nano-enabled products’,

After 3 years of research in laboratories and in contact with industrial partners, the scientists have processed, tested and made available an online platform (https://sunds.gd/) that supports industries and control and regulating institutions in evaluating potential risks that may arise for the production teams, for the consumers and for the environment.

The goal is to understand the extent to which these risks are sustainable, especially in relation to the traditional materials available, and to take the appropriate preventative measures. Additionally, this tool allows us to compare risk reduction costs with the benefits generated by this innovative product, while measuring its possible environmental impact.

Danail Hristozov, the project’s principal investigator from the Department of Environmental Sciences, Informatics and Statistics at Ca’ Foscari, commented: “The great amount of work done for developing and testing the methods and tools for evaluating and managing the risks posed by nanomaterials has not only generated an enormous amount of new scientific data and knowledge on the potential dangers of different types of nanomaterials, but has also resulted in key discoveries on the interactions between nanomaterials and biological or ecological systems and on their diffusion, on how they work and on their possible adverse consequences. These results, disseminated in over 140 research papers, have been immediately taken up by industries and regulators and will inevitably have great impact on developing safer and more sustainable nanotechnologies and on regulating their risks”.”.

The SUN project has also composed a guide for the safest products and processes, published on its website: www.sun.fp7.eu.

Studied Materials

Scientists have focused their research on specific materials and their us, in order to analyse the entire life cycle of the products. Two of the best-known were chosen: nanoscale silver that is used in textiles, and multi-walled carbon nanotubes that is used in marine coatings and automotive parts. Less known materials that are of great relevance for their use were also included: car pigments and silica anticaking agents used by food industry.

Lastly, SUN included nanomaterials of high commercial value which are extremely innovative: Nitrogen doped Titanium Dioxide for air purification is a new product enabled by SUN and exploited by the large colour ceramics company Colorobbia. The copper based coating and impregnation for wood protection has been re-oriented based on SUN safety assessment, and the Tungsten Carbide based coatings for paper mills is marketed based on SUN results.

You can find out more about the SUN project here and about ‘SUNDS; Decision support system for risk management of engineered nanomaterials and nano-enabled products’ here.

Belgium’s nanomaterials reigster

A February 26, 2018 Nanowerk Spotlight article by Anthony Bochon has a   rather acerbic take on Belgium’s efforts to regulate nanomaterials with a national register,

In Alice’s Adventures in Wonderland, the White Rabbit keeps saying “Oh dear! Oh dear! I shall be too late.” The same could have been said by the Belgian federal government when it adopted the Royal Decree of 22nd December 2017, published in the annexes of the Belgian Official Gazette of 15th January 2018 (“Amending Royal Decree”), whose main provisions retroactively enter into force on 31st December 2016. …

The Belgian federal government unnecessarily delayed the adoption of the Amending Royal Decree until December 2017 and published it only mid-January 2018. It creates legal uncertainty where it should have been avoided. The Belgian nanomaterials register (…) symbolizes a Belgian exceptionalism in the small world of national nanomaterials registers. Unlike France, Denmark and Sweden, Belgium decided from the very beginning to have three different deadlines for substances, mixtures and articles.

In an already fragmented regulatory landscape (with 4 EU Member States having their own national nanomaterials register and 24 EU Member States which do not have such registration requirements), the confusion around the deadline for the registration of mixtures in Belgium does not allow the addressees of the legal obligations to comply with them.

Even though failure to properly register substances – and now mixtures – within the Belgian nanomaterials register exposes the addressees of the obligation to criminal penalties, the function of the register remains purely informational.

The data collected through the registration was meant to be used to identify the presence of manufactured nanomaterials on the Belgian market, with the implicit objective of regulating the exposure of workers and consumers to these nanomaterials. The absence of entry into force of the provisions relating to the registration of articles is therefore incoherent and should question the relevance of the whole Belgian registration system.

Taking into account the author’s snarkiness, Belgium seems to have adopted (knowingly or unknowingly) a chaotic approach to registering nanomaterials.  For anyone interesting in the Belgian’ nanoregister’, there’s this September 3, 2014 posting featuring another Anthony Bochon article on the topic and for anyone interested in Bochon’s book, there’s this August 15, 2014 posting (Note: his book, ‘Nanotechnology Law & Guidelines: A Practical Guide for the Nanotechnology Industries in Europe’, seems to have been updated [there is a copyright date of 2019 in the bibliographic information on the publisher’s website]).