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Blood test could predict who will benefit from immunotherapy, researchers find – News@UofT

Posted on August 8, 2020 by Danzig

A test that detects changing levels of tumour fragments in the blood may be an easy, non-invasive and quick way to predict who will benefit from immunotherapy, University of Toronto researchers say.

Immunotherapy canshrink tumours and prolong survival for patients for whom other treatments have failed. But it only helps about 20 to 30 per cent of patients and so far, clinicians have been unable to predict who will benefit.

Since immunotherapy can have severe side effects in a small percentage of patients, knowing whether to begin or continue would be helpful for patients weighing different treatment options.

A team of scientists and clinicians addressed this question with a novel study evaluating various cancer patients response to a specific immunotherapy drug usinga customized test based on each patients tumour profile.

They found that individual response to treatment can be predicted within weeks, based on increasing or decreasing levels of DNA fragments which are shed from the tumour into the blood.

Genomic testing with powerful new technologies can detect the same genetic mutations in the fragments circulating in the blood as in the actual tumour. These fragments are called circulating DNA or ctDNA.

Specifically, the study found that a decrease in these circulating tumour DNA fragments at six toseven weeks after treatment with the immunotherapy drug pembrolizumab was associated with a beneficial response to the drug and longer survival.

The study, Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab, was published in Nature Cancer this week.

Dr. Lillian Siu, a professor in the department of medicine at U of T's Faculty of Medicine, senior scientist and medical oncologist at Princess Margaret Cancer Centre and BMO Chair in Precision Cancer Genomics, noted that the study is one of the first studies across a broad spectrum of tumours to show that measuring levels of ctDNA could be useful as a predictor of who responds well to immunotherapy.

Its like a molecular CT scan that gives us a molecular dimension, an added layer of information to know whether a tumour is growing or not, saidSiu, a co-senior author of the paper. Thats why this is so exciting. It helps to predict early on what may happen over time. Although important, computerized tomography (CT) and other scans alone will not tell us what we need to know quickly or accurately enough.

Dr. Scott Bratman, an associate professor of radiation oncology and medical biophysics and first author on the paper, saidit may take many months to detect whether a tumour is shrinking with various imaging scans.

New next-generation sequencing technologies can detect and measure these tiny bits of cellular debris floating in the blood stream accurately and sensitively, allowing us to pinpoint quite quickly whether the cancer is active, said Bratman, a radiation oncologist and senior scientist at Princess Margaret.

The prospective study analyzed the change in ctDNA from 74 patients, with different types of advanced cancers, being treated with pembrolizumab.

To customize or personalize the test, all the genes from the tumour biopsy tissue of each patient were sequenced or decoded, with specific attention to the mutations that occur in cancer.These mutations ranged from dozens to tens of thousands of mutations per tissue sample, differing according to cancer type.

Sixteen genetic mutations for each patient were then selected for a specific test to be developed and customized to detect personalized ctDNA of each patient via a simple blood sample.

When we looked at all 20,000 genes in each cancer, the range of mutations in different individuals was huge due to the many different cancer types in the study, saidDr. Trevor Pugh. Aco-senior author on the paper and an associate professor in the department of medical biophysics, he is alsoa senior scientist at Princess Margaret and director of genomics at the Ontario Institute for Cancer Research.

The novelty is that, rather than taking a one-size-fits-all approach, we designed a personalized blood test for each person based on their own cancers mutation list, Pugh said.

Of the 74 patients, 33 had a decrease in ctDNA levels from their original baseline levels to week six to seven after treatment with the drug. These patients had better treatment responses and longer survival. Even more striking was that all 12 patients who had clearance of the ctDNA to undetectable levels during treatment were still alive at a median follow-up of 25 months.

Conversely, a rise in ctDNA levels was linked to a rapid disease progression in most patients, and poor survival.

Few studies have used a clinical biomarker across different types of cancers, saidSiu, who is also the clinical lead for the Tumor Immunotherapy Program at the Princess Margaret, adding that the observation that ctDNA clearance during treatment and its link to long-term survival is novel and provocative, suggesting that this biological marker can have broad clinical impact.

This research was funded by the Princess Margaret Cancer Foundation, Ontario Institute for Cancer Research, Terry Fox Research Institute, Gattuso-Slaight Personalized Cancer Fund, BMO Chair in Precision Cancer Genomics, Canada Research Chair in Translational Genomics, Canada Foundation for Innovation, Ontario Ministry of Research and Innovation, and Merck for the study drug.

Blood test could predict who will benefit from immunotherapy, researchers find - News@UofT

Edited Transcript of ALNY earnings conference call or presentation 6-Aug-20 12:30pm GMT – Yahoo Finance

Posted on August 8, 2020 by Danzig

Cambridge Aug 7, 2020 (Thomson StreetEvents) -- Edited Transcript of Alnylam Pharmaceuticals Inc earnings conference call or presentation Thursday, August 6, 2020 at 12:30:00pm GMT

* Akshay K. Vaishnaw

Alnylam Pharmaceuticals, Inc. - President of Research & Development

Alnylam Pharmaceuticals, Inc. - Senior VP & Head of U.S.

* Barry E. Greene

Alnylam Pharmaceuticals, Inc. - President

Alnylam Pharmaceuticals, Inc. - Senior VP of IR & Corporate Communications

* Jeffrey V. Poulton

Alnylam Pharmaceuticals, Inc. - Executive VP, CFO and Principal Financial & Accounting Officer

* John M. Maraganore

Alnylam Pharmaceuticals, Inc. - CEO & Executive Director

* Yvonne L. Greenstreet

Alnylam Pharmaceuticals, Inc. - COO

SVB Leerink LLC, Research Division - MD of Genetic Medicines & Senior Research Analyst

Stifel, Nicolaus & Company, Incorporated, Research Division - Co-Head of the Biotech Team, MD & Senior Analyst

UBS Investment Bank, Research Division - Associate Director and Research & Analysis Associate

Sanford C. Bernstein & Co., LLC., Research Division - VP

Ladies and gentlemen, thank you for standing by. Welcome to the Alnylam Pharmaceuticals Conference Call Second Quarter 2020. (Operator Instructions) Please be advised that this call is being taped at the company's request.

I would now like to turn the call over to the company. Please go ahead.

Christine Regan Lindenboom, Alnylam Pharmaceuticals, Inc. - Senior VP of IR & Corporate Communications [2]

Good morning. I'm Christine Lindenboom, Senior Vice President of Investor Relations and Corporate Communications at Alnylam. With me today on the phone are John Maraganore, Chief Executive Officer; Barry Greene, President; Akshay Vaishnaw, President of R&D; Jeff Poulton, Chief Financial Officer; and Yvonne Greenstreet, Chief Operating Officer. Andy Orth, Head of the U.S. Business, is also on the phone and available for Q&A. For those of you participating via conference call, the accompanying slides can be accessed by going to the Events section of the Investors page of our website, investors.alnylam.com/events.

During today's call as outlined in Slide 2, John will provide some introductory remarks and general context, Barry will provide an update on our commercial and medical affairs progress, Akshay will review recent clinical and preclinical updates, Jeff will review our financials and Yvonne will provide a brief summary of upcoming milestones before opening the call for your questions.

I would like to remind you that this call will contain remarks concerning Alnylam's future expectations, plans and prospects, which constitute forward-looking statements for the purpose of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our most recent quarterly report on file with the SEC. In addition, any forward-looking statements represent our view only as of the date of this recording. It should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements.

With that, I'd like to turn the call over to John.

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John M. Maraganore, Alnylam Pharmaceuticals, Inc. - CEO & Executive Director [3]

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Thanks, Christine, and thank you, everyone, for joining the call today. Let me start by expressing Alnylam's support for Black Lives Matter and our support for the efforts to end systemic racism in our country. At Alnylam, we stand against all forms of discrimination; and in our core, we believe, in justice, equity and inclusion. We stand in support of peaceful protest aimed at achieving real and sustainable change. Enough is enough, and it's time to finally cure the refractory scourge of hate.

I'd also like to comment briefly on the Trump administration's recent announcement on drug prices. While we fully support the need to reduce or even eliminate patient out-of-pocket costs for prescription drugs, the administration's proposal to potentially introduce a so-called Most Favored Nation executive order is both unfortunate and misguided. Importing foreign price controls will harm American innovation and hurt our patients. Even if this executive order is finalized, we don't believe it will stand.

With that, let's now turn to our business. As all of you know, the COVID-19 pandemic remains dynamic, uncertain and unpredictable. That said, we continue to view the situation in the same framework we discussed last quarter: a pandemic phase in Q2, a recovery phase in Q3 and a new normal starting in Q4. While the pandemic continues or even worsens in many states in the U.S., we believe Alnylam's business is benefiting from our broad global presence. In spite of the ebbs and flows, we are seeing health care systems now remaining open, and we don't currently expect a repeat shutdown of health care systems like what was seen in Q2, especially in the April-May time frame.

Our confidence in the second half is reflected in an upward revision in our ONPATTRO revenue guidance range. Overall, we're really proud of our field teams around the world and their ability to adapt quickly and safely to meet the needs of patients, embodying our challenge accepted mentality.

We are extremely pleased with global ONPATTRO and GIVLAARI top line performance in Q2, which Barry will elaborate on shortly. We're also proud of the significant progress we made across our pipeline in the quarter, as Akshay will discuss. Another highlight for the quarter was our landmark strategic financing collaboration and inclisiran royalty monetization we completed with Blackstone Life Sciences worth up to $2 billion. We believe this collaboration secures our bridge toward a self-sustainable financial profile without the need for any future equity financings.

Now before I share my -- before I close -- before I share my closing remarks, I want to take a moment to acknowledge the news we announced earlier this morning about Barry Greene's planned departure from Alnylam at the end of the quarter. Barry and I have been working side by side for over 20 years, first at Millennium and then for 17 years at Alnylam. And I know that I speak for everyone at Alnylam in thanking Barry for his exceptional contributions and dedication to the company. We all owe him tremendous gratitude for his outstanding leadership and track record that have contributed to the delivery of RNAi therapeutics as a whole new class of medicines for patients. I have no doubt Barry will continue to be a highly impactful leader in the life sciences. I'm grateful for his agreement to consult with Alnylam as needed for a 2-year period, and I wish him all the very best in his next endeavors.

We are also very pleased to share that Yvonne Greenstreet, our current Chief Operating Officer, will step into the expanded role of President and Chief Operating Officer on October 1. We believe Yvonne is uniquely suited for this opportunity given her strong command of our business, strategic leadership and proven ability to drive results.

We are initiating a search for a Chief Commercial Officer. And during the search, we anticipate no impact to our ongoing commercial execution. Please join me in wishing Barry well as he pursues the next chapter of a remarkable career and congratulating Yvonne on her expanded role at Alnylam.

I'd like to finish with my perspective on the big picture for the company. We continue to lead the advancement of RNAi therapeutics as a whole new class of medicines, and we remain on track to achieve and exceed our Alnylam 2020 goals, exiting 2020 as a multiproduct global commercial company with a deep clinical pipeline for future growth and a robust and organic product engine for sustainable innovation. Without a doubt, we're excited for the promising future that Alnylam is poised to deliver as a top-tier biopharmaceutical company focused on advancing medicines with transformative potential for patients around the world.

With that, I will now turn the call over to Barry -- for one last time, Barry, to review our commercial progress and medical affairs activities in more detail. Barry, take it away.

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Barry E. Greene, Alnylam Pharmaceuticals, Inc. - President [4]

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Thanks, John, and good morning, everyone. Before I provide the quarterly highlights, I'd like to make some brief remarks about my planned transition from Alnylam. First, congratulations again to Yvonne Greenstreet. She is a remarkable person and well deserves the President and COO role. I know that Yvonne will make sure that Alnylam continues to be a company doing the right things and focusing on patients, and I'm counting on it.

As for me, it's been a tremendous privilege to serve as President of Alnylam for such a long period of time. I'm very proud of what we've been able to accomplish during my 17 years, and we built a global fully integrated multiproduct company that is recognized for excellence in R&D and recently for our commercial strength as well. My decision to transition is based on the desire to pursue new leadership opportunity in the next chapter of my career. I'm fully confident Alnylam will achieve its ambitious goals with quality and excellence with the great team we have in place. I'll continue to support Alnylam throughout this transition and have no doubt about the company's future prospects as a top-tier biopharmaceutical company.

So let's now review our (inaudible). For ONPATTRO, we achieved $66.5 million in global net product revenues. As of June 30, over 1,050 patients were on commercial ONPATTRO treatment worldwide, representing an increase of over 100 patients from end of Q1, a very impressive accomplishment in the height of the global pandemic during Q2.

Let's start with some more color on the U.S. As anticipated, the COVID-19 pandemic had impact on our business in the second quarter, with patient demand decreasing due to reduced adherence as some patients skip doses or experience dose delays while moving to new care sites. Also as anticipated, we saw the pace of new patient initiating therapy slow in the U.s. during the quarter due to reduced genetic testing, diagnosis and patient flow through the health care systems. Finally, our U.S. business was also impacted by inventory destocking and an increase in cost in the second quarter. Jeff will provide more color on these details later in the call.

While our focus today is on Q2, as we enter Q3, we're now seeing what looks like a healthy return of genetic testing and patient flow through the U.S. health care system even in states where COVID-19 cases are rising. And in fact, our July, on our last numbers are near the January numbers we saw earlier in the year. A really good sign.

In the second quarter, we continue to see great progress in new prescribers. For the second quarter, 40% of submitted start forms came from new writers with an equal mix of neurologists and cardiologists. In the U.S., we saw continued concomitant use of ONPATTRO with TTR stabilizers in the quarter. We believe this trend will continue to grow as physicians see progression of polyneuropathy on stabilizers and treat the different manifestations of hATTR amyloidosis.

Now turning to the rest of the world. We made very positive progress with ONPATTRO in the second quarter. Rest of world sales for ONPATTRO were [$34.2 million] and relative to the U.S. benefited from continued geographic expansions with launches in Spain, Italy and other countries. In addition, we saw relative strength in our ex U.S. markets between Europe and Japan for their management of the pandemic. As John noted, this is a nice validation of the decision to build a global, fully integrated business.

With today's announcement of achieving pricing and reimbursement agreement in France, we're pleased to report that access has been secured in all priority markets in Western Europe. Notably, our team has secured pricing and reimbursement approval in all major European markets in under 2 years post-approval by the EMA. This is a much faster rate than most orphan medicines are able to achieve.

Japan was again a country of strength for ONPATTRO. Japan has now become our second-largest country after the U.S. for our ONPATTRO revenue, and we expect continued growth in new patient (inaudible) discussion on stabilizer therapy.

On the medical care side, our team remains committed to addressing the challenge of raising disease awareness and improving diagnosis of hATTR amyloidosis, including with Alnylam Act, our third-party genetic screening initiative in the U.S., Canada and Brazil. As of July, over 27,000 samples have been submitted, out of which over 1,600 have tested positive for pathogenic TTR mutation, which is tracking at a historic 6% to 8% positivity rate. These numbers show the testing slowdown in Q2 we mentioned on our last earnings call. The good news is that (inaudible), those numbers have picked up to near January levels.

Moving on to GIVLAARI. We are really pleased with the progress in our launch, most of which was done virtually. We achieved $11 million in global net product revenues. We received over 85 start forms in the U.S. with over 100 patients globally on commercial treatment from launch through June 30. As we have now begun to open ex U.S. territories and also because currently 25% to 30% of U.S. patients come from outside the start form channel, we'll discontinue providing start form metrics in future quarters as we did last year for ONPATTRO.

In the U.S., we observed a broad prescriber mix, including hepatologists, gastroenterologists and other specialties, both in preferred centers of excellence and in the community. Of note, 76% of our Q2 starts were from new writers.

Our progress with value-based agreements has been extremely strong with 7 VBAs completed with U.S. payers, and we now have confirmed access for over 75% of covered U.S. lives across commercial, Medicaid and other government payers. We've not experienced any care (inaudible) to date, pleased to see plans adopt medical policies, not more restrictive than our labeled indication.

ASMR III saw strong initial performance as well with the successful and as noted virtual launch in Germany as well as named patient sales in other countries, including French cohort ATU program.

We've been positively encouraged by the responsiveness of European payers despite the COVID-19 pandemic. Of note, GIVLAARI received an improvement of medical benefit or ASMR score of 2 in France, concluding that GIVLAARI offers significant additional therapeutic value. This is an enormous accomplishment. For context, only 2 new commercial medicines were granted with an ASMR rating of 2 for 2019.

Our medical affairs team is also focused on improving awareness and diagnosis with AHP. Through Alnylam Act, we can report 937 test submitted and 92 patients with positive AHP mutations as of mid-July, showing continued 10% positivity rate. A notable diagnosis trend emerging is the robust use of urinary PPG test informed diagnosis, and we expect patient identification efforts will be meaningfully enhanced by this nongenetic testing method.

Of course, we're now also preparing for the potential launch of lumasiran later this year. Importantly, we'll be leveraging our existing commercial infrastructure for this launch with small additions of resources for field-based teams. When we gain approval, we'll let (inaudible) specific commercialization (inaudible) support medicine (inaudible) therapeutic expected to market.

In conclusion, the second quarter was challenging due to the pandemic particularly in the United States, but was much better than the downside case we anticipated as we entered Q2. The credit goes to our teams around the world who face the obstacles head on to deliver the important medicines to our patients.

With that, I'll now turn the call over to Akshay to review our recent R&D and pipeline progress. Akshay?

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Akshay K. Vaishnaw, Alnylam Pharmaceuticals, Inc. - President of Research & Development [5]

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Good morning, everyone, and thank you, Barry. I should say thank you, Barry, for guiding me, for helping build our company and, most of all, for working so tirelessly to help all the patients we seek to serve.

So with that, I'll start with our efforts in ATTR amyloidosis where we're advancing our 2 product candidates: patisiran and vutrisiran. As ONPATTRO is currently approved in multiple markets around the world to treat polyneuropathy associated with hATTR amyloidosis, we're committed to expanding the product's label to include the treatment of cardiomyopathy in both hereditary and wild-type ATTR amyloidosis patients. To this end, we continue to enroll patients in APOLLO-B and continue to expect completion of enrollment in 2021.

We've seen enrollment pick up over the last month as clinical sites start to open up around the world. In addition, we're also advancing vutrisiran, an investigational RNAi therapeutic delivered by quarterly subcutaneous injection that's also in development for the treatment of ATTR amyloidosis. Here, we're conducting 2 Phase III studies. The first is HELIOS-A, which is evaluating vutrisiran in hATTR amyloidosis patients with polyneuropathy. Enrollment is complete in HELIOS-A, and we remain on track to report top line results early next year. The second Phase III study of vutrisiran is HELIOS-B, which is being conducted in in inherited and wild-type ATTR amyloidosis patients with cardiomyopathy. As with APOLLO-B, site activation enrollment in HELIOS-B are now picking up. If HELIOS-B is positive, it could allow for vutrisiran's entry into the very large wild-type ATTR amyloidosis market opportunity with the product label that includes cardiovascular outcomes.

Let's move to GIVLAARI, which is approved in the U.S., EU and now in Brazil to treat acute hepatic porphyria in adults. Of course, the highlight of GIVLAARI in the recent period was our Brazilian approval, and we're continuing our geographic expansion for this product with MAA submitted in Switzerland and Israel and plans for submission in Japan in the coming months. During the second quarter, we also presented a new 12-month interim data from the ENVISION Phase III study, demonstrating sustained efficacy and acceptable safety through 12 months of treatment, with evidence for potentially improved efficacy over time. In addition, we're proud to have published pivotal results from the ENVISION Phase III study in The New England Journal of Medicine. This is our ninth paper on RNAi therapeutics published in the journal.

I'll now turn to recent progress with lumasiran, an investigational RNAi therapeutic that we're developing for the treatment of primary hyperoxaluria type 1, or PH1. At the ERA-EDTA meeting in June, we reported the full set of positive results from ILLUMINATE-A, which demonstrated that lumasiran significantly reduced urinary oxalate levels, the cause of progressive kidney failure in PH1. In addition, lumasiran showed an encouraging safety profile. Our overall lumasiran program also includes our ILLUMINATE-B study in pediatric patients under 6 years of age. Enrollment is complete, and we remain on track to report top line results soon in mid-2020. The ILLUMINATE-C study in severe PH1 continues to enroll and has been proceeding well even during the pandemic. We completed our NDA and MAA submissions in the second quarter. The FDA granted priority review for the NDA and has set an action date of December 3, 2020. EMA has granted accelerated assessment of the MAA.

As you know, we have 2 additional late-stage programs that are in development with partners. This includes inclisiran in the development -- in development for hypercholesterolemia partnered with Novartis, which is currently under review for approval in the U.S. and EU. Both NDA and MAA filings have been accepted, and Novartis expects initial approval in the U.S. in late 2020. Novartis has indicated that they remain on track for approval this year with a December action date in the U.S.

Our late-stage pipeline also includes fitusiran in development for hemophilia A or B with or without inhibitors, partnered with Sanofi. Sanofi has recently disclosed that 2 of the 3 ATLAS Phase III studies have completed enrollment and that they remain on track to report top line ATLAS Phase III data in the first half of 2021. Sanofi also presented new positive results from an interim analysis of the Phase II OLE study of fitusiran, showing impressive reductions in the annualized bleeding rate with encouraging safety.

Now in addition to our late-stage clinical programs, we believe we've also been making great progress with our early and mid-stage programs. The highlights of the quarter was the positive top line results from our ALN-AGT Phase I study in patients with hypertension, specifically ALN-AGT demonstrated an over 90% knockdown of angiotensinogen and a greater than 10 millimeters mercury lowering systolic blood pressure with the durability that's caused a quarterly or even less frequent subcutaneous dosing regimen. We're also encouraged by the tolerability profile for ALN-AGT. We now look forward to presenting more complete data from the ongoing Phase I study at a scientific meeting in the second half, assuming abstract acceptance. We're very excited about the potential for ALN-AGT to reimagine the treatment of hypertension with tonic-controlled blood pressure that we believe could result in important benefit for patients.

Our next clinical program is ALN-HSD, an investigational RNAi therapeutic for the treatment of NASH, for which we recently filed a CTA. This program is being advanced in collaboration with Regeneron. We're also making strong progress on our many RNAi therapeutic opportunities beyond the liver.

For our COVID-19 RNAi therapeutic collaboration with Vir, we selected a development candidate, ALN-COV or VIR-2703, with potent and highly cross-reactive activity towards SARS-CoV-2, the virus that causes COVID-19. We continue to expect an IND filing around year-end 2020.

We're also pleased to announce today that Regeneron has elected to opt-in to the ALN-APP program. We aim to get an IND filed for ALN-APP in mid-2021, and this is expected to be our first CNS program to enter clinical development.

And with that, let me now turn it over to Jeff to review our financial results. Jeff?

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Jeffrey V. Poulton, Alnylam Pharmaceuticals, Inc. - Executive VP, CFO and Principal Financial & Accounting Officer [6]

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Thanks, Akshay, and good morning, everyone. I'm pleased to be presenting Alnylam's Q2 2020 results. As Barry has already highlighted, it was a very strong quarter of commercial execution, with outstanding results for both ONPATTRO and GIVLAARI.

Turning to our results first for ONPATTRO, generated $66.5 million in global net ONPATTRO revenue for the quarter, which was impacted by the pandemic, particularly in the U.S., with global growth being flat versus the first quarter of 2020 and a 74% increase compared with Q2 2019. U.S. growth decreased 13% during the quarter compared with Q1 and was primarily impacted by the following: a 4% decrease in demand from reduced patient adherence due to the COVID-19 pandemic, as Barry previously mentioned; an 8% reduction due to inventory destocking during the quarter with pending inventory now at 1.5 weeks in the distribution channel at the end of Q2; and a 1% decrease due to a modest increase in gross to net deductions in the quarter. We continue to expect gross to net deductions will remain in the mid-20s globally for ONPATTRO in 2020.

In our international markets, performance was very strong in spite of the pandemic, with growth of 16% versus Q1. Growth in Europe was highlighted by strength in recently launched markets in Italy and Spain. While in Asia, growth in Japan remains robust, with Japan now representing our second-largest market for ONPATTRO based on dollar sales, as Barry mentioned. First time this quarter, the contribution of our international markets to global ONPATTRO sales exceeded the U.S. contribution. We are pleased to have a strong and global brand, which we believe is beneficial to long-term growth.

Turning to our results for GIVLAARI. We had a strong second quarter, generating $11 million in global net revenue in the quarter, representing over 100% growth compared to the first quarter. This growth was driven by ongoing success of the U.S. launch where we did not experience reductions in patient adherence at the same level as ONPATTRO as well as an additional contribution from our international markets with a successful launch in Germany and named patient sales in other countries, including France. Our combined product sales for ONPATTRO and GIVLAARI were $77.5 million for the quarter, representing 6% growth versus Q1, a strong result given the challenges associated with COVID-19 in the quarter.

Turning now to a summary of our full P&L results for the quarter. Net revenue from collaborations for the second quarter was $26.4 million, a significant increase from last year primarily due to revenue recognized from our Regeneron and Vir collaborations. Gross margin as a percentage of total revenue was 81% for the quarter, down from 90% in Q2 2019 primarily due to the current utilization of ONPATTRO full cost inventory. Last year benefited from 0 cost ONPATTRO inventory as well as having a higher proportion of sales in the second quarter of 2020 coming from lower-margin international markets and a write-off of ONPATTRO inventory at our contract manufacturer.

Our R&D expenses decreased on a non-GAAP basis in the second quarter of 2020 compared to the same period in the prior year primarily due to nonrecurring expenses in 2019 from license fees related to the execution of our collaboration agreement with Regeneron as well as a decrease in expenses associated with material manufactured for clinical trials. Conversely, SG&A expenses increased modestly on a non-GAAP basis in the second quarter of 2020 compared to the same period in the prior year primarily due to increased investment in commercial and medical affairs activity to support the ongoing launches of ONPATTRO and GIVLAARI and initial launch preparation activities for lumasiran.

Importantly, our non-GAAP operating loss for the second quarter decreased by approximately $40 million compared with the same period in 2019 driven by a combination of strong top line growth and very moderate growth in operating expenses. We remain confident that 2019 represents our peak non-GAAP operating loss year as we expect the trend of strong top line growth and moderate growth in operating expenses will continue for the balance of the year.

We ended the quarter with cash and investments of $1.95 billion, which includes $600 million in proceeds received in the second quarter from the partial sale of future inclisiran royalties and issuance of common stock to Blackstone.

Finally, turning to our financial guidance. We believe our results for the second quarter demonstrate the strength of our commercial teams in challenging circumstances. As a result of the strong commercial performance for ONPATTRO that exceeded our initial expectations back in the earlier phase of the pandemic in May, we are further revising our full year revenue guidance for ONPATTRO, with an increase in the midpoint of our guidance as we narrow the range from $270 million to $300 million to $280 million to $300 million. Guidance range for combined non-GAAP R&D and SG&A expenses as well as our guidance for net revenue from collaborations remain unchanged. Please note that we have revised the midpoint of our GAAP combined R&D and SG&A operating expense guidance downward by $25 million, reflecting a reduction in expected stock-based compensation during the year.

Regarding cash, we believe our strategic financing collaboration with Blackstone, adding up to $2 billion in cash, secures Alnylam's bridge towards a self-sustainable financial profile without the need for future equity financings.

And with that, I'll now turn the call over to Yvonne to review our goals for the remainder of the year. Yvonne?

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Yvonne L. Greenstreet, Alnylam Pharmaceuticals, Inc. - COO [7]

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Thanks, Jeff, and hello, everyone. Looking ahead to the second half of 2020, we have a number of important milestones lined up. Of course, we plan to continue our global commercialization of both ONPATTRO and GIVLAARI, and we're looking forward to our GIVLAARI launch in Brazil and an upcoming NDA filing for GIVLAARI in Japan. We're also expecting 2 additional regulatory approvals by the end of the year for lumasiran and inclisiran. We plan to continue enrollment in our ATTR cardiomyopathy studies, specifically APOLLO-B with patisiran and HELIOS-B with vutrisiran. With lumasiran, we're on track to share top line results of the ILLUMINATE-B Phase III study in mid-2020. And of course, we'll also continue advancing the rest of our pipeline as well as exciting preclinical efforts, and we'll highlight these milestones throughout the year as they occur. Among these will be our presentation of additional clinical results from the ongoing Phase I trial of ALN-AGT in hypertension program we're very excited about. We also plan to initiate a Phase I trial of ALN-HSD for NASH, having now filed the CTA for that program. And our partner, Regeneron, plans to initiate a Phase I study of cemdisiran in combination with pozelimab, having now filed the CTA for that study. We also hope that you'll join us for our remaining RNAi roundtables focused on lumasiran, givosiran and our TTR programs later in August and September.

Let me now turn it back to Christine to coordinate our Q&A session. Christine?

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Christine Regan Lindenboom, Alnylam Pharmaceuticals, Inc. - Senior VP of IR & Corporate Communications [8]

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Thank you, Yvonne. I just wanted to quickly acknowledge, we found issue with Barry's prepared remarks. There are some storms that are rolling through his area that impacted the audio quality, and we will plan to have Barry rerecord his remarks for the replay of this call.

So operator, let's now open the call for questions. (Operator Instructions)

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Questions and Answers

Excerpt from:

Edited Transcript of ALNY earnings conference call or presentation 6-Aug-20 12:30pm GMT - Yahoo Finance

In Honor of August and Art – Yakima Herald-Republic

Posted on August 8, 2020 by Danzig

Its August, which means its time for our annual art issue.

It probably sounds odd, but when I see August and art in the same sentence I cant help thinking about a couple of long-passed relatives. My grandfathers name was August, and I had an uncle named Art.

August Schwardt could build or fix pretty much anything. One of my most prized possessions is a beautiful, hand-carved wooden chess set that he made. I keep it in an old round, wooden tobacco box, which he also made with a homemade lathe that he rigged up in his shop. When you open the lid to the box, you can still catch a rich whiff of his pipe tobacco.

He was a quiet, thoughtful man who could be comically absent-minded. He once spent months building a boat in his shop, and as he showed it to one of his friends, the friend asked, Howre you gonna get it out the door, Gus? Grandpa said nothing for days, but spent hours examining the boat, the shop and his tools. Finally, he tore the boat apart and never spoke of it again.

Math fascinated him, and he loved talking theories and equations with the math teachers at the Kansas school where he worked as a janitor. Hard times and family moves had forced him to quit school early.

My Uncle Art, on the other hand, was an engineer with a big oil company in Kansas City. He and Aunt Marge would come out West to visit our family every summer, and Art would bore the pants off my father and me as he threw open the hood of his enormous sedan and started holding forth about how fuel really worked in internal combustion engines.

Art was also a Scoutmaster, and he insisted on taking me on tortuous hikes and quizzing me on the knots hed tried to teach me to tie the summer before. But I never listened and usually forgot everything he said within minutes. Which hole was the bunny supposed to jump through to complete the knot again?

But Uncle Arts true passion was barbecuing. Seizing control of our patio grill to set off the inescapable family cookout portion of his visit, he often sent flames curling high above the eaves of our house. There now THATS a fire, Art would say triumphantly as my father watched in horror and my mother retreated to the kitchen.

Wow sorry. Guess I kind of wandered off there. But maybe that gets us to the real point anyway. While August is generally one of the best months to be in the Yakima Valley (normally, of course, wed be in the thick of a packed schedule of festivals, concerts, wine-tastings and other events), this year is clearly different.

It doesnt mean art and creativity arent still thriving, though.

Far from it. Maybe all this isolation and social turmoil is actually forcing us all to think a little more creatively than usual.

Consider local art teachers like East Valley Central Middle Schools Ken Weyrick. As he tells our Glenda Tjarnberg, hes had to redouble his own professional creativity to teach creative arts to his students. Or think about people who long to be on ocean cruises or exploring exotic places this travel season, but are stuck at home during this global pandemic. Christine Conklin reports that theyve had to turn up the creativity, too which for some means taking virtual trips and seeing the sights from their computer screens.

The creative challenges have been just as great for the artists who look forward to annual events like the Downtown Yakima Chalk Art Festival. Molly Allens story offers some colorful memories of past festivals and addresses when artists might return to the citys sidewalks.

If theres a lesson here, its that nothing seems to crush creativity for long. Despite our current situation, art adorns most of what youll read about in this issue. From the handsome designs of Timberloom that Shannon Mahre describes, to the sweeping beauty and captivating paintings of Robert and Lisa Vickers home, which Melissa Labberton tours in this months Yakima Abodes feature, the Yakima Valleys artistry is flourishing.

See? Arts as vibrant and vital as ever, and it can take you a lot of places. Lets go see some of them

- John Taylor

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In Honor of August and Art - Yakima Herald-Republic

Why We Should Turn to Earned Income Tax Credit to Aid Those Struggling Through Pandemic – The National Interest

Posted on August 8, 2020 by Danzig

The pandemic is driving American families to the edge, with tens of millions at risk of losing their homes and over 1 in 10 U.S. adults reporting their households didnt have enough to eat in the previous week.

While Congress debates extending unemployment benefits that expired on July 31 and other additional aid, theres an important program that already exists that could help struggling Americans get through the crisis however long it lasts. Known as the earned income tax credit, or EITC, it provides aid primarily to the working poor. In a typical year, it lifts more than 8.5 million people out of poverty, while improving the health and well-being of parents and children.

Since the credit depends on earned income, many families may be at risk of losing all or some of the benefit because so many were laid off as economies in many states shut down. Even as restaurants and other businesses reopen, its likely that many of those who lost their jobs will remain unemployed or underemployed for many months or longer.

Our own research shows changes to the structure of the U.S. economy, with the sharp growth of low-wage and unstable jobs, is weakening the EITCs effectiveness at fighting poverty.

Some lawmakers are trying to reform the EITC as part of the next coronavirus bailout to ensure it helps more Americans and make it more like a basic income guarantee. We believe doing so would not only ensure low-income Americans continue to have access to this vital tax credit during the pandemic, additional changes could also strengthen the program for years to come.

The EITC success story

The earned income tax credit, which supplements earnings for many low- and moderate-income workers, has helped buffer economic hardship for single parents and other recipients since it was created in 1975.

Eligible taxpayers receive the credit after they file their taxes. And unlike a deduction, even those who didnt pay any income tax can receive the credit, which theyll get as part of their refund. Twenty-eight states and the District of Columbia also offer their own EITCs, typically based on the federal credit.

In 2019, taxpayers received about US$63 billion in credits through the federal EITC, making it the governments largest cash safety net program for working families with children. Recipients qualify for the credit based on how much money they earn and depending on their marital status and number of children. The benefit rises with each dollar earned until reaching a peak and then phasing out.

For example, in 2019, a single person earning $13,545 a year received $392, while a typical family of four with an annual income of $22,261 received roughly $2,951 which comes out to an extra $250 a month.

Put another way, a family with one child receives an average credit of 34 cents for every dollar of earned income, which rises to 40 cents for two and 45 cents for three or more children.

The tax credit has been tremendously successful. In 2018, the latest data available, the EITC lifted about 10.6 million people out of poverty and reduced its severity for another 17.5 million. And since its inception, it has reduced child poverty by 25%.

But the benefits extend well beyond providing struggling families with more income. Research shows the credit has helped improve the mental and physical health of mothers, improves perinatal health of mothers and their children, improves child development, reduces incidents of low birth weight among infants and improves childrens cognitive function.

It also enjoys strong bipartisan support because of its focus on encouraging and supporting working.

But the EITC only helps individuals able to find work, which becomes a bigger challenge in a pandemic or severe recession.

Our unpublished calculations from a national representative survey showed that about a fifth of the 25 million EITC beneficiaries in 2019 lost their jobs from March to April and over 16% remained unemployed in June, the latest data we have available. That means over 4 million working families could lose a large portion of their benefits in 2021, depending on a variety of factors.

Reforming the EITC

While these problems are most obvious in a recession, theyve worsened over the past four decades as the labor market has changed.

The share of workers doing low-skill, low-wage work has jumped from 42% in 1980 to about 54% in 2016. And an increasing number of these jobs are in the precarious gig economy that doesnt provide stable incomes. That means workers are less likely to see a steady aid from the EITC because the maximum benefits are gained when working full time at minimum wage.

The EITCs also provides very little support to those without children. A nonpartisan think tank estimates that about 5.8 million adult workers without any children as dependents are taxed into poverty or impoverished further each year because their EITC is too small to offset their federal income and payroll taxes.

House Democrats are pushing to reform the EITC in the next coronavirus relief bill. Specifically, theyd like to tweak the credits phase-in so that workers receive more benefits for fewer hours worked, allowing those who lost their jobs and remained unemployed for the remainder of 2020 to maintain benefits similar to last year. They also would lower the minimum age for receiving the credit to 18 from 25 for certain vulnerable groups like those experiencing homeless.

Wed suggest also increasing the benefit for tax filers without children and lowering the minimum age for everyone so that the millions of young people graduating from high school and college into an economic recession can get additional support.

These reforms would not only help now but could also deepen the impact of the EITC by creating an income floor for more people as the economy changes, essentially creating something very much like a basic income guarantee. A key difference, however, is that most universal basic income proposals dont require recipients to work.

While we cannot fully predict how interactions between job losses and the tax and benefit system will play out, this moment presents an opportunity to test reforms that would benefit low-income working families for years and decades to come.

Rebecca Hasdell, Postdoctoral fellow, Stanford University; Alice Milivinti, Postdoctoral Researcher, Stanford University, and David Rehkopf, Associate Professor of Medicine, Stanford University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Image: Reuters

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Why We Should Turn to Earned Income Tax Credit to Aid Those Struggling Through Pandemic - The National Interest

Cryptocurrency Mining Software Market Incredible Possibilities, Growth Analysis and Forecast To 2025 – The Daily Chronicle

Posted on August 8, 2020 by Danzig

The Cryptocurrency Mining Software market study added by Market Study Report, LLC, enumerates an in-depth analysis of the powerful trends prevailing in the industry. This study also encompasses valuable information relating to the profitability prospects, growth dynamics, market size, market share forecast, and revenue estimation of this business vertical. The study descriptively charts out the competitive backdrop of eminent players partaking in the industry share, in consort with their offering portfolio & business strategies.

The recent report on Cryptocurrency Mining Software market is an in-depth documentation of various dynamics at play in the industry space. As per the report, Cryptocurrency Mining Software market is poised to amass substantial revenues while growing with a y-o-y growth rate of XX% over the forecast period.

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Cryptocurrency Mining Software Market Incredible Possibilities, Growth Analysis and Forecast To 2025 - The Daily Chronicle

This AI Could Bring Us Computers That Can Write Their Own Software – Singularity Hub

Posted on August 8, 2020 by Danzig

When OpenAI first published a paper on their new language generation AI, GPT-3, the hype was slow to build. The paper indicated GPT-3, the biggest natural language AI model yet, was advanced, but it only had a few written examples of its output. Then OpenAI gave select access to a beta version of GPT-3 to see what developers would do with it, and minds were blown.

Developers playing with GPT-3 have taken to Twitter with examples of its capabilities: short stories, press releases, articles about itself, a search engine. Perhaps most surprising was the discovery GPT-3 can write simple computer code. When web developer, Sharif Shameem, modified it to spit out HTML instead of natural language, the program generated code for webpage layouts from prompts like a button that looks like a watermelon.

I used to say that AI research seemed to have an odd blind spot towards automation of programming work, and I suspected a subconscious self-preservation bias, tweeted John Carmack, legendary computer game developer and consulting CTO at Oculus VR. The recent, almost accidental, discovery that GPT-3 can sort of write code does generate a slight shiver.

While the discovery of GPT-3s coding skills may have been somewhat serendipitous, there is, in fact, a whole field dedicated to the development of machine learning algorithms that can code. The research has been making progress, and a new algorithm just recently took another step.

The algorithm, called machine inferred code similarity (MISIM), is the brainchild of researchers from Intel, Georgia Institute of Technology, University of Pennsylvania, and MIT. Trained on the huge amount of code already publicly available on the web, MISIM can figure out what a program is supposed to do. Then, after finding other similar programs and comparing it to them, MISIM can offer ways to make the program faster or more efficient.

It isnt the first machine learning algorithm to make recommendations or compare similarity, but according to the researchers in a new preprint paper on MISIM, it was up to 40 times more accurate at the task when it went head to head with several of its most advanced competitors.

Near term, the AI could be a useful sidekick for todays programmers. Further out, the field could open programming to anyone who can describe what they want to create in everyday language or bring machines that write and maintain their own code.

The pursuit of computers that can code is almost as old as modern computer science itself. While there have been advances in programming automation, the recent explosion in machine learning is accelerating progress in a field called machine programming.

In a 2018 paper on the field, a group of Intel and MIT researchers wrote, The general goal of machine programming is to remove the burden of writing correct and efficient code from a human programmer and to instead place it on a machine.

Researchers are pursuing systems that can automate the steps required to transform a persons intentthat is, what they want a piece of software to dointo a working program. Theyre also aiming to automate the maintenance of software over time, like, for instance, finding and fixing bugs, keeping programs compatible, or updating code to keep up with hardware upgrades.

Thats easier said than done, of course. Writing software is as much art as it is science. It takes a lot of experience and creativity to translate human intent into the language of machines.

But as GPT-3 shows, language is actually a skill machine learning is rapidly mastering, and programming languages are not so different from English, Chinese, or Swahili. Which is why GPT-3 picking up a few coding skills as a byproduct of its natural language training is notable.

While algorithmic advances in machine learning, like GPT-3, are key to machine programmings success, theyd be useless without good training data. Luckily, theres a huge amount of publicly available code on sites like GitHubreplete with revision histories and notesand code snippets and comment threads on sites like Stack Overflow. Even the internet at large, with accessible webpages and code, is an abundant source of learning material for AI to gobble up.

In theory, just as GPT-3 ingests millions of example articles to learn how to write, machine programming AIs could consume millions of programs and learn to code. But how to make this work in practice is an open question. Which is where MISIM comes in.

MISIM advances machine programming a step by being able to accurately identify what a snippet of code is supposed to do. Once its classified the code, it compares it to millions of other snippets in its database, surfaces those that are most similar, and suggests improvements to the code snippet based on those other examples.

Because MISIM classifies the codes purpose at a high level, it can find code snippets that do the same thing but are written differentlytheres more than one way to solve the same problemand even snippets in other programming languages. Simplistically, this is a bit like someone reading a New Yorker article, identifying its topic, and then finding all the other articles on that topicwhether theyre in Der Spiegel or Xinhua.

Another benefit of working at that higher level of classification is the program doesnt need the code to be compiled. That is, it doesnt have to translate it into the machine code thats executed by the computer. Since MISIM doesnt require a compiler, it can analyze code snippets as theyre being written and offer similar bits of code that could be faster or more efficient. Its a little like an email autocomplete feature finishing your sentences.

Intel plans to offer MISIM to internal developers for just this purpose. The hope is itll prove a useful sidekick, making the code-writing process faster, easier, and more effective. But theres potentially more it can do. Translation between computer languages, for example, could also be a valuable application. It could perhaps help coders update government software written in archaic languages to something more modern.

But Justin Gottschlich, director of machine programming at Intel, has an even grander vision: the full democratization of coding.

Combine MISIM (or something like it) with natural language AI, and future programmers could simply write down what they want a piece of software to do, and the computer whips up the code. That would open programming to anyone with a decent command of their native language and a desire to make something cool.

As Gottschlich told MIT Technology Review, I would like to see 8 billion people create software in whatever way is most natural for them.

Image credit: Markus Spiske /Unsplash

This AI Could Bring Us Computers That Can Write Their Own Software - Singularity Hub

Construction of the World’s Biggest Nuclear Fusion Plant Just Started in France – Singularity Hub

Posted on August 8, 2020 by Danzig

Fusion power promises to provide limitless green energy using cheap and abundant fuel, but its a long-running joke that its always 20 years away. Last week, though, construction started on the ITER fusion plant in France, which hopes to prove the commercial viability of fusion power.

While conventional nuclear power plants generate energy by splitting atoms, nuclear fusion involves smashing two atoms together. This produces dramatically more energy than the process of fission that weve already mastered and doesnt produce long-lived radioactive waste. It also doesnt rely on radioactive elements like uranium and plutonium for fuel, instead using abundant isotopes of hydrogen called deuterium and tritium.

The only catch is that trying to contain a nuclear fusion reaction is like trying to keep the sun in a box. Its the same reaction that powers all stars, and trying to corral that kind of raw power and turn it into something we can use effectively is a challenge scientists have been struggling with for decades.

To get the fuel to fuse, it first has to be heated to 10 times the temperature of the suns core, which creates a superhot plasma. To maintain the fusion reactions, this plasma needs to be strictly confined and isolated from other components. Fortunately, plasmas can be manipulated using magnetic fields, and so gigantic electromagnets are used to keep the plasma spinning around a donut-shaped reactor called a tokamak.

The problem is that all this heating and magnetic confinement requires colossal amounts of energy. While weve managed to get fusion reactions running on Earth theyve always used considerably more energy than theyve produced. The International Thermonuclear Experimental Reactor (ITER) in France is designed to change that.

The project has been a long time in the making. The idea was formulated at the tail end of the Cold War as a multinational collaboration, but design work didnt properly start until the turn of the millennium, and its parent organization wasnt launched until 2007. Last week French president Emmanuel Macron hosted a ceremony to celebrate the beginning of the assembly of the reactor.

Over the past five years factories, universities, and national laboratories all over the world have been working to build the components for the plant, some of which weigh several hundred tons, including a magnet powerful enough to lift an aircraft carrier. It will take another five years to piece all the parts together and get the reactor ready for its first test run.

Constructing the machine piece by piece will be like assembling a three-dimensional puzzle on an intricate timeline, director-general of ITER Bernard Bigot said in a press release. Every aspect of project management, systems engineering, risk management, and logistics of the machine assembly must perform together with the precision of a Swiss watch.

The hope is that by 2025 the plant will be able to produce first plasma, a test designed to make sure the reactor works; the test will produce roughly 500 megawatts of thermal power. It will be another decade until the plant is expected to produce enough energy to be commercially viable, though. That will involve building an even larger plasma chamber to provide 10-15 times more electrical power.

While 15 years away might not seem like much of an improvement over 20, those behind the project are confident that these are the first steps towards fusion power fulfilling its promise of revolutionizing our energy systems.

It faces some competition, though. Both the UK government and a variety of startups have announced plans to pursue nuclear fusion, often aiming for much smaller and easier-to-build reactors than ITER. And despite its heavy backing from multiple nation-states, the projects long history of cost overruns and delays means its certainly not a sure-fire winner.

But the project will soon be one of the worlds largest science experiments, and winner or not, theres little doubt it will significantly push forward our understanding of fusion power. Harnessing the power of the sun on Earth may not sound like a crazy idea for much longer.

Image Credit: ITER

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Construction of the World's Biggest Nuclear Fusion Plant Just Started in France - Singularity Hub

Rob Nail: 3 Ways To Create A Better Reality Virtually – Forbes

Posted on August 8, 2020 by Danzig

getty

When crisis strikes, it is helpful to call on people looking not just today but tomorrow.

One of those thinkers isRob Nail, former CEO of Singularity U, and a successful technology entrepreneur. "I'm an engineer. I like to build stuff. And I like to solve hard problems. One of those challenges is artificial intelligence, which he spoke about at length in an interview with Rhett Power and me on our LinkedIn Live program,Whats Next: Previews, Predictions and Prognostications.

Three areas of interest, or endeavors, guide Nails thinking as he looks to the future and how AI technology will shape and complement it. The first endeavor is empathy. I think there's always going to be things that humans want to do with other humans, right? The emotional interaction, biological love, you name it. I mean, some people will bring in technology to more of that than others do.

The secondendeavoris entertainment. We're creative beings. We want to play and think and be creative and solve problems. That's going to be fun. For Nail, an engineer at heart, problem-solving is fun.

The thirdendeavoris exploration. For me, it's about exploring the big questions of humanity. Like the big questions, the philosophers for thousands of years have wanted to dive deeper into it. Why are we here? What else is there? What is consciousness? If we can stop fighting with each other, we could put all of our efforts on these explorations. Then we're going to go places.

Nail challenges technology investors to think about the future of companies in their portfolio. One of my recommendations is that when you're interviewing entrepreneurs, or if you're an entrepreneur, spend some of your time fantasizing about that future.

For example, what would happen, as it did in the case of Google and Facebook, what would happen if billions of people became customers?What does that feel like? What, how could that be abused and misused, and if necessary, corrected? What would I do today to avoid that malign future? This is all in the spirit of taking a little time, doing some future scenario planning. Social responsibility must be a concern for all tech entrepreneurs.

Look for opportunity

The pandemic has disrupted the lives of everyone on this planet. For Nail, that is an opportunity. There is an amazing opportunity to build a bridge between jobs disrupted and opportunities coming. And this is an area that I want to work on. Together with colleagues and investors, we have been thinking about it, but I'm always looking for new angles and people interested in that space."

While it may be tempting to go long and go bold, just trying one new thing can be beneficial, says Nail. Doing so gives you the ability to experiment without breaking the bank. It may be even better for small companies. The advantage small have over big companies is that they can be more nimble and adaptable. They can move faster on those potential trends that are very differentiating," Of course, such companies do not have the financial resources of larger companies. Still, they may have greater impetus and ability to get things done more efficiently and effectively.

For example, Nail himself, who began his career after Stanford in robotics with Velocity 11, is engineering an AI avatar who can help Nail plan more carefully, test assumptions, and make better decisions. As forward-thinking as that is, Nail is also linking that avatar to a smartwatch to monitor physical health. Big idea yes, but related to something practical and doable.

Rob Nail, explorer-engineer, embodies the thinking that will help us shape our "new normal." It will be women, and men like him, who challenge us to think beyond our immediate environment to dream about, and ultimately, create the future that benefits us best. This effort fuels human ambition.

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Rob Nail: 3 Ways To Create A Better Reality Virtually - Forbes

During coronavirus, monasteries and convents take spirituality online – DW (English)

Posted on August 8, 2020 by Danzig

"We've always had guests in the chapel. But since we couldn't receive them because of the coronavirus, we decided to stream our services," explained Sister Walburga, a Benedictine nun at Minster Abbey in Kent, southern England.

She's the youngest of 11 nuns, and launched the abbey's Twitter account almost a year and a half ago. Today, it boasts more than 5,000 followers, and she's responsible for keeping it up-to-date and making sure the midday office, a daily prayer service, can be followed live on YouTube.

Technically, it's fairly simple. The images aren't especially riveting the camera is fixed on a view of the altar and the high, sun-filled windows but the singing nuns can be heard loud and clear. Sister Walburga told DW that the viewer numbers ranged from 30 to 50 each day, but said it was important for the nuns to once again share their song and prayers with others. She'll also send the text of the service by email on request. "All the nuns see this as a positive thing, even our oldest one who is 94!"

Minster Abbey isn't the only religious establishment to have turned to livestreaming during the coronavirus pandemic. In Germany, several monasteries and convents have also been using digital means to ensure worshippers can take part in their services.

Read more:German churches overcoming coronavirus isolation

"We launched on March 21 after rehearsing for about three days," said Father Maximilian from Mnsterschwarzach Abbey, northwest of Nuremberg. "We had no livestreaming experience." He told DW that it took "quite a lot of rehearsing and readjusting until the quality was acceptable."

His abbey's services have been drawing between 70 and 120 live viewers, with several hundred tuning in later. There has been "plenty of praise and thanks" but also technical tips, along with donations. Many people have also filled out the abbey's online form asking for a particular prayer.

The German Conference of Superiors of Religious Orders (DOK), which represents Catholic orders in Germany, has a list of many of the various available streaming sessions on its website. Spokesperson Arnulf Salmen said the pandemic had "forced" congregations to become more familiar with new forms of communication, such as Facebook, YouTube, Twitter and Zoom and the experience had been positive.

"Some of the orders have been extremely professional despite having very simple means," he said, adding that there was always a community member on hand to help with any technical issues.

Read more:Russia's devout push back against coronavirus church closures

Many of the larger monasteries have expanded their online offering. Apart from Mnsterschwarzach, the St. Ottilien Archabbey and the Roggenburg Abbey in Bavaria, as well as the Gerleve Abbey and the Stiepel Priory in North Rhine-Westphalia, also decided to stream their services. In Austria, the Cistercian Abbey of Heiligenkreuz has been streaming the audio of all five of its daily offices.

Viera Pirker, of the University of Vienna's theology department, finds the whole development "very interesting," in part because the traditional offices in these establishments aren't usually that accessible to the public.

"This should not be seen as advertising," she insisted. "The monasteries simply want to maintain their spiritual services and allow people to participate." After all, this is about "solidarity within the church."

Pirker also thought it was good that establishments hadn't tailored or perfected their livestreams in any way. To her, it didn't matter that somebody's voice might not be perfect, or that the camera wasn't flattering. "It's just normal, and the monasteries are daring to show normality."

The Protestant Stadtkloster Segen is church in a touristy part of Prenzlauer Berg in Berlin, opposite a Jewish cemetery and not far from one of the city's biggest organic supermarkets. It began streaming its Sunday evening service on Zoom after Easter, attracting between 35 and 50 viewers every week.

"It was an important experience for us," said Georg Schubert of the Don Camillo community, which holds the services. "Some Sundays, we couldn't have a service. But we were able to find a way for people to do the same thing at the same time."

Read more:Religious celebrations in the time of coronavirus

Schubert also said the live nature of the experience was crucial. One of the regular viewers is a New Yorker who had once stayed at the Stadtkloster, while another is a neighbor who doesn't dare come to the church because she's in the high-risk category for COVID-19.

Schubert said he wanted the church to continue with the weekly streaming session. "It's important for us as the church to go toward people, and not simply expect them always to come to us."

People hoping for help from the heavens above in difficult times in particular when they had money problems would pray to Saint Corona. Treasure hunters and gamblers are said to invoke her name. She is said to have lived in the 2nd century A.D. and was killed for comforting a martyr, becoming one herself, tied between two palm trees bent to the ground that were released to tear her apart.

Here's a patron saint for "impossible cases," including abused wives, parents, lonely hearts and widows: Rita of Cascia. The 15th-century Italian woman who later joined an Augustinian convent pledged to forgive her abusive husband's killers and convinced her sons to do so, too. She was called the "peacemaker of Cascia."

By the end of the 1st century A.D., Christians had begun to honor other Christians who had died, praying for their help. Described in the gospels of Luke and John and a witness to Jesus' resurrection of her brother Lazarus Martha is the patron saint of housewives and domestic workers. Why? She is said to have shown Jesus hospitality at her home in Bethany near Jerusalem.

Ambrose, Bishop of Milan in the 4th century, is the patron saint of beekeepers. Legend has it that when he was a baby, a swarm of bees settled on his face and fed him honey while he lay in his cradle regarded as a sign that he would one day be a great orator. He is often depicted with symbols of wisdom: bees or a beehive.

A martyr killed in the 3rd century, Christopher's most famous legend has it that he carried a child across a river and the child later revealed himself as Christ. He is the patron saint of travelers: cab, bus and truck drivers often enough evoke his protection with visor clips, decals and small adhesive figurines.

Astronauts and pilots have their own patron saint as well: Joseph of Cupertino, a 17th-century Italian Franciscan priest prone to ecstatic visions and legend has it levitations. Flying was widely believed to be based on witchcraft, so the Inquisition took an interest in Joseph, who was later exonerated.

Sir Thomas More was a 16th-century English philosopher and statesman. He was also counselor to King Henry VIII, but opposed the King's separation from the Roman Catholic Church and was thus convicted of treason and beheaded. In the year 2000, Pope John Paul declared him the "heavenly patron of statesmen and politicians."

Born in the 2nd or 3rd century, Cecilia is thought to have been the daughter of a wealthy Roman family forced to marry the pagan Valerian. The martyr condemned to suffocate, almost decapitated is regarded as the patroness of music and singers because she heard heavenly music in her heart when she was married.

The Italian, born in the late 12th century to a prosperous merchant family, instead embraced a life of poverty. Legend has it had a great love and a knack for communicating with animals. He is the founder of the Franciscan order and the patron saint of ecologists, animals and veterinarians.

Along with Gambrinus, Florian, Bonifacius, Arnulf and Nicholas of Myra, Augustine of Hippo is only one of many patron saints of beer brewers. Augustine lived in the 4th century, and after initially living a wild and loose life, became a bishop. To this very day, many breweries and beers people's standard drink centuries ago are named after a saint.

The patron saint of firefighters and chimney sweeps was a Roman officer in 3rd-century Austria, responsible for organizing firefighting brigades. Legend has it he was to be burned at the stake for refusing to pray to the Roman Gods but was drowned instead, a millstone around his neck, after threatening to climb to heaven on the flames.

Author: Dagmar Breitenbach

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During coronavirus, monasteries and convents take spirituality online - DW (English)

Alabama Mercedes plant among first in world to use innovative production system – Alabama NewsCenter

Posted on August 8, 2020 by Danzig

Mercedes-Benz U.S. International (MBUSI) in Tuscaloosa is among the first auto plants in the world to implement elements of Mercedes new MO360 digitized production system

Mercedes-Benz Cars Operations 360 (MO360) is being dubbed a digital ecosystem that uses a mix of software and hardware in all phases of the auto production process with the goal of improving efficiency and quality.

Mercedes-Benz Alabama plant incorporating new digital production system from Alabama NewsCenter on Vimeo.

Using technology like sensors on the vehicle bodies to hand-held tablets and smartphones, MO360 is a merging of modern innovations like the internet of things (IOT) and artificial intelligence (AI) with the historic innovation of the assembly line.

With MO360, Mercedes-Benz is setting milestones in digital production, Jrg Burzer, member of the Board of Management of Mercedes-Benz AG responsible for Production and Supply Chain Management. The key enablers of the new digital ecosystem are smart data usage, maximum transparency and streamlined processes. This makes the seamless networking of previously separate processes possible and increase efficiency.

Thanks to improved processes, comprehensive data availability in our MO360 data lake and fast decisions based on real-time data, we will be able to increase production efficiency by more than 15 percent by 2022, Burzer said. We are ensuring the complete digital support of each member of the production staff.

Key components of MO360 include:

The Alabama Mercedes plant has incorporated most of the elements of MO360.

Parts of MO360 such as digital shop floor management (SFMdigital), Quality Live and Paperless Factory are already implemented, said Michael Goebel, president and CEO of MBUSI. The integration of MO360 is already progressing extremely well. Some features, such as 5G and the API (Application Programming Interface) architecture, are being successively integrated.

Technologically, MO360 relies on reusable APIs, scalable cloud solutions, and free and open source software (FOSS). The result is ease of use for the new tech-savvy worker that feels comfortable using a smartphone or tablet.

A key success factor for MO360 lies in the fact that cross-functional teams of production and IT experts develop the ecosystem by agile and iterative collaboration,said Jan Brecht, CIO of Daimler and Mercedes-Benz. Organizational boundaries no longer have a role to play. All teams systematically utilize continuous feedback from production to optimize and enhance the digital tools. The teams continuously improve the software in short-cycle sprints with the aim of providing MO360 users with lasting perceptible benefits. In this way we are able to achieve regular software release cycles of just two weeks. For software engineering in the field of production, that is an absolute record.

Burzer said the MO360 system will be made available to suppliers who want to incorporate it into their processes. He said the companys $248.2 million Global Logistics Center in Bibb County will incorporate MO360.

Its another sign of the talented workforce that exists in Alabama.

MBUSI has been one of Alabamas great success stories, so it should come as no surprise that they are once again part of the cutting-edge production innovations Mercedes-Benz is implementing on a global scale, said Alabama Commerce Secretary Greg Canfield.

MO360 is being used in full for the first time at the new Factory 56 in Sindelfingen, Germany. When it opens next month, that plant will serve as a blueprint for all plants throughout the Mercedes-Benz Cars production network.

MBUSI produces the GLS and GLE SUVs and the GLE Coupe.

Mercedes-Benz launches MO360 global digital production system from Alabama NewsCenter on Vimeo.

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Alabama Mercedes plant among first in world to use innovative production system - Alabama NewsCenter

Enhanced efficiency thanks to new family of applications: Digital Mercedes-Benz production ecosystem MO360: global production networked in real time -…

Posted on August 8, 2020 by Danzig

Mercedes-Benz Cars Operations 360 (MO360) makes complex vehicle production completely transparent and maximises its efficiency. The new digital ecosystem comprises a family of software applications which are connected via shared interfaces and standardized user interfaces. These applications use real-time data to support the worldwide vehicle production of Mercedes-Benz Cars. Large parts of MO360 are already in use at more than 30 plants around the world. The networked plants supply data which the MO360 applications can access. Other applications for the digital support of production staff at Mercedes-Benz Cars are set to be integrated into MO360 successively. MO360 combines efficiency and quality tools in a functional unit for maximum transparency in highly digitalised automotive production. The digital ecosystem is being used in full for the first time at the new Factory 56 in Sindelfingen. It will thus serve as a blueprint for all plants throughout the Mercedes-Benz Cars production network.

With MO360, Mercedes-Benz is setting milestones in digital production. The key enablers of the new digital ecosystem are smart data usage, maximum transparency and streamlined processes. This makes the seamless networking of previously separate processes possible and increase efficiency, explains Jrg Burzer, Member of the Board of Management of Mercedes-Benz AG responsible for Production and Supply Chain Management. MO360 enables the automotive manufacturer to make use of cutting-edge big-data analytics and also to implement artificial intelligence methods in production. Thanks to improved processes, comprehensive data availability in our MO360 data lake and fast decisions based on real-time data, we will be able to increase production efficiency by more than 15 percent by 2022. We are ensuring the complete digital support of each member of the production staff, according to Burzer.

MO360 integrates the information from the main production processes and IT systems of the more than 30 Mercedes-Benz passenger car plants worldwide and brings together important software applications. It delivers significantly optimised KPI-based production control, for example. It also makes individual, needs-based information and work instructions available to each employee in real time. One precondition for the transparency of all production processes, equipment monitoring and access in real time is that all elements in the system speak the same language. Mercedes-Benz ensures this by comprehensive, worldwide use of the control software Integra: from sensor level at individual machines right up to production control, and also in its cooperation with all suppliers and system partners. Sophisticated cloud solutions deliver scalability and allow extensive big-data processing. All this makes MO360 the key ecosystem of Mercedes-Benz Cars Operations and therefore also the new benchmark for highly digitalised automotive production.

All in all, MO360 reflects the Mercedes-Benz Cars Operations aspiration to manufacture excellent products based on outstanding production methods. The ecosystem is based on all Mercedes-Benz Cars Operations strategic pillars: driving digitalisation forward, using resources sustainably, delivering the potential to use and expand motivated employees, providing maximum flexibility in the global production network as well as outstanding processes and maximum operating safety.

A key success factor for MO360 lies in the fact that cross-functional teams of production and IT experts develop the ecosystem by agile and iterative collaboration. Organisational boundaries no longer have a role to play, stresses Jan Brecht, Chief Information Officer (CIO) of Daimler and Mercedes-Benz. All teams systematically utilise continuous feedback from production to optimise and enhance the digital tools. The teams continuously improve the software in short-cycle sprints with the aim of providing MO360 users with lasting perceptible benefits. In this way we are able to achieve regular software release cycles of just two weeks. For software engineering in the field of production, that is an absolute record, explains Brecht.

New standard for highly digitalised automotive production

The importance of MO360 is also shown by the Factory 56 at the Mercedes-Benz Sindelfingen plant, which will be opened in September 2020. With it, Mercedes-Benz is redefining automotive production. This factory of the future meets all of the criteria for fully digital, flexible and sustainable production. For this, as one of the most modern automotive production facilities in the world, it relies consistently and comprehensively on innovative technologies and processes with Industry 4.0 technologies. High-speed mobile phone networks are also installed in parts of the production hall based on the future-oriented 5G standard, in order to connect processes, machines, plants and devices to each other. MO360 also comprises inch-perfect tracking of all vehicles in the factory halls in real time, so that each application in the ecosystem knows precisely, at any time, where a particular vehicle is located.

In the Factory 56, the employees work in a fully digital manner. As a key component of MO360, the PAPERLESS FACTORY gives each employee precisely the individually tailored information they need to work on the Mercedes-Benz vehicle right in front of them. In addition, all worker feedback, such as on quality inspections, is in digital form. This way of working not only increases efficiency, but also sets standards for sustainable production. Factory 56 alone will save around ten tonnes of paper per year thanks to the PAPERLESS FACTORY.

360-degree quality assurance

Mercedes-Benz produces top-quality vehicles. It is therefore crucial that all employees in production are supported to optimum effect in their work. The QUALITY LIVE quality management system, which is likewise part of the MO360 ecosystem, provides them at all times with press-button access to the live status of each individual vehicle. To make it possible to react to any non-conformities immediately and before the end of the production line, QUALITY LIVE has access to all production data. The system informs the quality management representatives and the workers proactively by smartphone or handheld about the current quality status in their area. As a subsystem of MO360, QUALITY LIVE also supports the structured problem-solving process as well as continuous process optimisation. It does this, when necessary, by making suggestions for efficient rework using AI methods. This makes for optimised quality control loops with the objective of ensuring that vehicles roll off the line without the need for rework. The stored knowledge is available to all the plants of the global production network.

Data availability and compatibility in real time

The applications of the MO360 ecosystem interlink seamlessly with each other: They are fully integrated both in terms of processes and data. As a result, production data for example flow fully automatically into digital Shopfloor Management (SFMdigital), so that those responsible are aware of the live status of production at any time. They have fast and focused access to production- and control-related KPIs (Key Performance Indicators), enabling them to react quickly and transparently to what is currently happening on the production line. Alongside workforce deployment, the KPIs include the first time capability rate (all vehicles without rectification work), the production targets per shift or the work in process, which shows how many vehicles make up the target/actual comparison in an area, for example in interior fitting. MO360 thus simplifies the decision-making process for efficient control of production while maintaining vehicle production in perfect quality constantly at the highest possible level. In daily shop floor rounds, SFMdigital supports the structured application of quality processes and at the same time functions as a digital communication tool for the problem-solving process, for example.

State-of-the-art software engineering

In developing the MO360 digital ecosystem, Mercedes-Benz relies on cross-functional, collaborating teams made up of IT and production experts. The focus of this product-oriented approach is on Full Digital Value the added value created by a digital tool in production. Newly developed functions are continually tested in ongoing production. The feedback gained in this way flows directly back into software development in short cycles.

State-of-the-art IT technologies and procedures play a dominant role in the digitalisation of Mercedes-Benz production. A key element is DevOps: with this form of organisation for modern software development, integrated teams take on overall responsibility not only for development (Dev) of the software components, but also for their subsequent operations (Ops). Technologically, MO360 relies on reusable API interfaces (Application Programming Interface), scalable cloud solutions, and primarily on Free and Open Source Software (FOSS). As such, the MO360 teams make use of the advantages of the global developer community as well as the dynamism and cost-efficiency of Open Source projects.

The modular family of applications is intuitive to use thanks to a modern user interface and clear controls. A common element of all MO360 applications is the so-called microservice architecture. This refers to the modular design of the overall system using independent components, which, in turn, communicate via API interfaces. The microservice architecture enables further applications to be successively integrated into MO360 without coming up against complexity limits.

Thus, for example, in future the maintenance of all Mercedes-Benz plants around the world will be connected to the MO360 digital ecosystem with the SMART MAINTANANCE application. This is because maintenance data provides new potential, such as for predictive maintenance. An example: If MO360 can detect that an electric motor in a production facility will soon need replacing, this can be done promptly in a suitable time window before wear and downtimes result in possible additional costs. In future, the AUTO SC application will also be used to optimise logistical processes both between and within plants.

In a next step it is planned to network a complete factory with MO360 at one location and develop it as a test factory for the plants worldwide. It is also conceivable to make parts of MO360 available to interested partners. Our know-how is very much in demand we received this feedback in initial informal discussions in completely different fields of activity and sectors, says Jrg Burzer. Jan Brecht goes on to explain: For this, too, we are clearly thinking along the lines of Open Source. We will release our MO360 Frontend Toolkit on Github.com in the third quarter of 2020. We are already excited about receiving feedback and, above all, about additional innovation impulses from the worldwide community.

SOURCE: Daimler

Peril in the hills: Extreme weather a danger for Nilgiri ecosystem – Down To Earth Magazine

Posted on August 8, 2020 by Danzig

Despite consecutive years of extreme precipitation over short periods in the Nilgiri Biosphere, hardly any step has been taken to address ecological security

Thousands of trees lay dead and strewn around the western parts of the Nilgiri Plateau in southern India. Deep gashes scar ancient mountains, standing a stark contrast to the lush green vegetation that they otherwise support.

As conservationists and activists are fighting to protect forests and wilderness areas from being deforested, mined and diverted to developmental projects, there is another level of destruction happening to our last remaining wild spaces. Climate change is causing widespread collapse of ecosystems.

Carbon dioxide levels in the atmosphere hit a record-breaking 417 parts per million (ppm) in May 2020, highest inthreemillion years. Along with global warming caused sea level rise and the melting of polar ice caps and glaciers, the steep increase in greenhouse gas concentrations has led to a surge in the frequency of extreme climate events.

A region where climate change caused weather extremities are exceedingly apparent are the coastal plains and Western Ghats of southern India. In the last four years, this region has been affected by eight tropical cyclones and consecutive extreme rainfall events during the southwest monsoon periods of the last two years. These bouts of intense storms have been interspersed with periods of severe droughts, heatwaves, deficient and failed monsoons.

On August 8, 2019, the Avalanche and Emerald valley regions, which are part of the Kundha watershed, received an unprecedented 900 millimetre (mm) rainfall within 24 hours. It broke the record for the highest rainfall in Tamil Nadu, by nearly twice the amount. Over four days, the region experienced close to 2,500 mm rainfall.

To put this in perspective, Coimbatore, the nearest city in the plains of Tamil Nadu, receives 600 mm of rain annually. The Kundha watershed bore a deluge that was four times the annual rainfall amount, over just four days. The upper watershed of the Kundha river is a complex of several peaks above 2,400 m and broad deep valleys.

The river, which is a primary tributary to the Bhavani that feeds into the Cauvery, is fed by numerous streams and rivulets at the headwater sections. With the barraging downpour, nearly every stream and rivulet burst its course. Vast tracts of precious soil and shola ecology slipped away on either side of the watercourses.

Gone are the rich black soil layers topped with spongy humus that line the streams; washed away are the dark moss and wild balsam covered rocks that shaped the flow of every stream; lost are the thousands of shola trees, dwarf bamboo and forest kurinji (shrubs of blue flowers which covered the hills) that guarded the streams, saplings, ferns and orchids of the forest floor.

In place of these are deep cuts of gauged out Earth, revealing the underlying lateritic soil and rocks.

(Left) An Aerides ringens orchid growing on a shola tree; (Right)Neela-Kurinjior Strobilanthes kunthiana flowering in the grassland habitats of the Nilgiris. This spectacle takes place only once in 12 years.Photo: Godwin Vasanth Bosco

Shola-grassland mosaic in danger

The cloud forest ecology, known as sholas, grows along the folds and valleys of these mountains. They are old-growth vegetation and harbour several endemic and rare species of flora and fauna. These naturally confined forests are already some of the most endangered forest types because of habitat loss and destruction.

The recent episode of extreme precipitation caused landslides have dealt a telling blow on these last remaining forest tracts. What is even more shocking is that montane grassland stretches have also experienced large landslides.

The montane grasslands occur over larger portions of the mountains here, covering all the other areas that sholas do not grow in. Together, the shola-grassland mosaic is most adept at absorbing high rainfall amounts and releasing it slowly throughout the year, giving rise to perennial streams.

Over a year they can experience 2,500-5,500 mm of rainfall, which is intricately sequestered by complex hydrological anatomy that carefully lets down most of this water, using what is needed to support the ecology upstream.

The native tussock grasses are highly adapted to hold the soil strongly together on steep slopes. However, even this ecology is now giving way under pressure from extreme weather events.

The shola-grassland mosaic ecology cannot withstand the tremendously high amounts of rainfall (over 2,400 mm) that occur in significantly short periods (over four days). Worsening climate change is driving the intensity and frequency of extreme weather events, resulting in a level of ecosystem collapse, never witnessed before.

A massive landslide in one of the largest sholas in the Avalanche region, with hundreds of native trees and the stream ecology washed away. Photo: Godwin Vasanth Bosco

In the southwest monsoon season of 2018, unusually high rainfall over the highland districts of Idukki, Wayanad and Coorg caused hundreds of landslides. A predominant view was that this was primarily because of the indiscriminate construction of roads and proliferating concretisation of the hills.

However, even within the highly stable shola-grassland ecology, a large number of landslides occurred in spots with no apparent disturbance such as roads and pathways cut through them. This signifies that climate change has reached a level that is beyond the capacity of the ecosystem and land resilience.

What is causing the collapse of the last remaining wild spaces is the cumulation of every action that has contributed to the climate crisis. The actions invariably stem from places that have long lost their plant ecological cover the global urban-industrial-agricultural complex. There is no time to keep ignoring this primary cause.

If we overlook the main cause and only try to safeguard the last remaining wilderness areas from the more direct forms of destruction, they will be susceptible to climate change-related collapse. It is important that threats closer to the last remaining ecological spaces are also curtailed.

But despite the consecutive years of extreme precipitation over short periods in the Nilgiri Biosphere, hardly any step has been taken to address ecological security. Building regulations stand to get eased and road expansion works continue in full swing.

Till June-end, parts of Tamil Nadu experienced a 45 per cent deficiency in the monsoon. The trend is worryingly similar to what happened in the last two years when much of the annual rainfall was concentrated over a few days later in the monsoon period.

Destruction by dams and tunnels

The Kundha watershed region can be broadly divided into two the higher slopes and the descending valleys. Shola-grassland ecology dominates the higher slopes with various types of land uses such as tea cultivation, vegetable farming, villages and non-native tree plantations dominating the descending valleys.

An example of intact shola-grassland mosaic in the hills of the Nilgiri plateau, with the sholas growing in valleys and grasslands covering the slopes.Photo: Godwin Vasanth Bosco

The descending valleys are covered with several dams and hydroelectric structures. The Kundha Hydro-Electric Power Scheme is one of the largest hydropower generating installations in Tamil Nadu with 10 dams, several kilometres of underground tunnels and a capacity of 585 MW.This system is getting two more dams and a seriesof tunnels to set up a pumped storage hydropower facility, which is claimed to generate 1500 MW for peak hour demand but will expend 1800 MW in the process.

With the level of destruction that extreme precipitation events are bringing to the Kundha watershed, it is disastrous to add more large dams and tunnels. The intensity of floods has turned so strong that even the largest dam complexes in the world face threats of being breached.

Safeguarding the last remaining zones of ecology and biodiversity from threats of direct destruction is crucial. Concurrently, the larger worldwide urban-industrial-agricultural complex, from where the climate crisis stems from, needs drastic change. The constant incursions into more and more ecological spaces in the form of new dams, roads, and buildings are also connected to this complex.

Whether it is the landslides in the grasslands of the high elevation plateaus in southern India; the melting glaciers of the Himalayas in northern India; the dying coral and rising sea levels elsewhere in the planet; the COVID-19 pandemic that has brought about unimaginable changes we have to understand the interconnectedness of these dire effects and learn from nature.

Godwin Vasanth Bosco is an ecologist working to restore shola and grassland ecology in the Nilgiri Biosphere. He is the author of the book Voice of a Sentient Highland on the Nilgiri Biosphere

This was first published in Down To Earths print edition (dated 1-15 August, 2020)

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Peril in the hills: Extreme weather a danger for Nilgiri ecosystem - Down To Earth Magazine

IPL returns but will be played in UAE; Indian cricket ecosystem loses out – The Times of India Blog

Posted on August 8, 2020 by Danzig

The 2020 version of IPL is finally going to be held but it will be the UAE that is to play host. Even if it is not the best option, it is still a welcome development. The long hiatus appears to have affected the financial health of the cricket board, BCCI. Media reports suggest payments within the cricket ecosystem have been delayed.

The forthcoming IPL will be the longest ever edition, 53 days. It plans to tweak rules to account for the pandemic- unlimited Covid-19 substitutes will be allowed. The tournament will be held in a bio-secure environment following the example set recently by England and West Indies who played a full fledged test series.

Ideally, the IPL should have been held in India given that it is over six weeks away. However, the inclination of state governments to revert to lockdowns and the slow pace of return to normalcy has made it impossible. It represents lost economic opportunities for many in the Indian cricket ecosystem.

Read also: BCCI shares detailed plan for IPL 2020 in UAE

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IPL returns but will be played in UAE; Indian cricket ecosystem loses out - The Times of India Blog

theScore’s latest funding will help with sports gambling expansion – CalvinAyre.com

Posted on August 8, 2020 by Danzig

As the sports industry starts to see signs of life, now is a great time to get behind licensed sports gambling companies. Score Media and Sports, the parent company of sports wagering platform theScore, is ready to take its operations to a whole new level, completing a secondary funding round that saw it add $25 million to its coffers. That money will come in handy as the company looks to expand across North America and capture a large portion of a mega-billion-dollar industry.

theScore offers an app that allows users to receive personalized results on live scores, news, stats and gambling information. It also offers a mobile sports gambling app, theScore Bet, which has already been introduced to sports gambling fans in New Jersey. After completing a $40-million funding round last September, the addition of another $25 million through the latest offering shows the value investors see in the companys future.

In addition to its New Jersey operations, theScore is now ready to get into Colorado. It just received approval this week from the Colorado Division of Gaming to launch mobile and online sports gambling, which will prove highly lucrative given the states recent success with its sports betting. In just the first full month of legalized sports gambling in May, the state saw a handle of $25.62 million not bad, considering there were no major U.S. sports in action at the time. In a press release, company founder and CEO John Levy asserts, We cant wait to launch theScore Bet in Colorado later this month and showcase our incredible betting product to the passionate sports fans there, said John Levy, Founder and CEO of theScore. This regulatory approval is another significant step toward theScore Bets multi-state expansion as we roll out our uniquely integrated media and betting experience across the country.

The company is also introducing its app to Indiana, where it has worked out a deal to be the skin for Penn National Gaming. This past June, it scored another big partnership when it became an authorized gaming operator for MLB. The continued expansion into different markets and facets of sports is leading to the company quickly becoming one of the major sports gambling entities in the U.S. The fact that it has been able to score important deals in both Colorado and Indiana is noteworthy, because both of these states are expected to be leaders among all states that legalize sports gambling.

The funds collected by Score Media will be put to good use right away. It says in a statement, theScore intends to use the net proceeds from the Offering for working capital and general corporate purposes, including funding the continued growth and development of its gaming operations in the United States and Canada.

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theScore's latest funding will help with sports gambling expansion - CalvinAyre.com

Sharp increase in callers to Kentucky gambling helpline likely linked to pandemic – LEX18 Lexington KY News

Posted on August 8, 2020 by Danzig

FRANKLIN COUNTY, Ky. (LEX 18) The 2020 coronavirus pandemic shuttered kids and adults at home, giving way for some individuals who gamble and game to become addicted to those activities.

The Kentucky Council on Problem Gambling reports seeing at 20% jump in calls to the state helpline from June to July for those struggling with gambling and gaming addictions.

Council Executive Director Mike Stone explained, "the isolation of the pandemic plays well with the typical secrecy and isolation of problem and addicted gamblers. And that could be the same with somebody who's excessively video gaming."

He said the World Health Organization started sounding the alarm for gaming disorders in 2019 and the pandemic accelerated it for hundreds of players of all ages.

Stone said the WHO defined a gaming disorder as "people that spent too much time playing video games to their own detriment in their families, in their own health." He added that they "have seen research that indicates that there's a transference of that gaming behavior that possibly could go into gambling."

Many gamers are young people. And this year, kids have had more time for gaming with many extracurricular activities canceled due to the pandemic.

"Parents and others need to just monitor what's going on with gaming, Stone said. If it becomes excessive, then it might be advisable to pay more attention to what the what the young person is doing."

Stone said he hopes players realize KCPA does not want to deter them from playing.

"No, we're not saying don't play video games, we're not saying ban them. We're not saying don't gamble. We're not saying to go in and ban all gambling activities, he said. What we are saying is, please be responsible in your actions. And if it's gotten out of control. If you can't game--if you can't play the video games, as purely entertainment if they become an obsession. If you can't gamble as entertainment. Then it--try to recognize that and then reach out for help.

Stone noted that 1-800-GAMBLERS is open 24 hours a day, and it's completely confidential. Its operators are ready to help anyone who reaches out across Kentucky.

"There are trained telephone counselors who have been trained about gambling addiction and how to talk to people who are who are gambling ethics or families with gambling addicts or somebody that's concerned about a gambling problem, he said. And they're starting to learn the basics of how to talk to people about gaming as well. They do have resources that they can refer people to all across the Commonwealth at the community mental health centers."

All in all, Stone explained there is one particular warning sign gamblers and gamers need to look out for:

"The number one, one thing, I believe, is if it's no fun anymore. If what you're doing is something that you're being driven internally to do. And you're not really enjoying it. That is when he said you need to get help.

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Sharp increase in callers to Kentucky gambling helpline likely linked to pandemic - LEX18 Lexington KY News

Worldwide Online Gambling and Sports Betting Market Study for 2020 to 2025 providing information on Key Players, Growth Drivers and Industry…

Posted on August 8, 2020 by Danzig

The ' Online Gambling and Sports Betting market' report Added by Market Study Report, LLC, enumerates information about the industry in terms of market share, market size, revenue forecasts, and regional outlook. The report further illustrates competitive insights of key players in the business vertical followed by an overview of their diverse portfolios and growth strategies.

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NBA Gambling Picks August 4th – Last Word on Pro Basketball

Posted on August 8, 2020 by Danzig

Heading into another day with a full NBA bubble slate Last Word on Hoops NBA Gambling picks are looking to give you some winners today. Yesterdays picks went 2-1 and ended up winning .86 Units. We also hit our first Bonus Parlay to win three units. Hopefully, todays NBA gambling picks will bring you more of the same.

Today is the first day of back-to-backs inside the NBA bubble. For a lot of teams, these games could prove to be problematic, but it may be just the opposite for the Indiana Pacers. The Pacers are riding high after their first two games in the bubble. In todays game against the Orlando Magic, the Pacers are hoping to ride the momentum of those wins and pick up another one. The Magic are coming into the game undefeated as well but this game will end with one less undefeated team inside the bubble.

Take everything that was said about back to backs in the last pick, and throw it out the window. The Miami Heat are coming into todays game against the Boston Celtics off of a loss to the Toronto Raptors yesterdays. In their Tuesday win against the Portland Trailblazers, the Celtics relied heavily on Jayson Tatum and Jaylen Brown down the stretch and will look for much of the same from that duo today. Tatum and Brown have certainly blossomed into one of the best combo punches in the league right now.

This game will have a ton of points. That is the only thing you can be certain of with these two teams getting together. The best argument for the Portland Trailblazers is the resurgence of Jusuf Nurki. The Houston Rockets will not have an answer for the Portland big man. This game could very well come down to who has the ball last. The Blazers are coming off arguably the worst 10 seconds of basketball that has been played inside the bubble. Todays game will give them the opportunity to bounce back from a tough loss to the Celtics, and with the clash of two high powered offenses, anything is possible.

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NBA Gambling Picks August 4th - Last Word on Pro Basketball

UK Gambling Commission Rolls Out Public Awareness on Gambling Control, Safeguards, and Rights – Tunf.com News

Posted on August 8, 2020 by Danzig

The U.Ks gambling commission (UKGC) has rolled out its most recent public campaign that is meant to promote ways to stay safe while gambling. The campaign is dubbed nine ways to keep yourself safe when gaming.

The campaign aims to raise awareness on safer gambling measures and tools, facilities as well as support systems like GamCare and GambleAware. Additionally, UKGC is seeking to offer better and all-round guidance on effective ways to monitor personal activity on licensed platforms.

The Gambling Commission reminds all users to undertake realities checks to figure out why they are gambling are they looking to escape debt or make quick cash?

The body also reminds users of the rights they hold, including the right to request a timeout from all gambling-related activity for a given period.

The commission reminds all vulnerable users that licensed gambling operators are required to offer them access to self-exclusion programs like GAMSTOP, which enforces a longer time-out from gambling, up-to six months.

The UKGC, through this campaign, is expected to widen its initiative on creating public awareness on consumer rights as well as responsibilities during gambling.

Source: https://europeangaming.eu/portal/latest-news/2020/08/04/75353/uk-gambling-commission-launches-public-awareness-campaign-on-gambling-controls-rights-and-safeguards/

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UK Gambling Commission Rolls Out Public Awareness on Gambling Control, Safeguards, and Rights - Tunf.com News

Last Week in the Federal Circuit (July 27-31): Gambling on an APA Challenge – JD Supra

Posted on August 8, 2020 by Danzig

It was a moderately eventful week at the Federal Circuit as the judges geared up for their August argument session and perhaps returned from their summer vacations.The Court issued 13 opinions and 2 orders on petitions for a writ of mandamus (1 grant and 1 denial).And the Court finally acted on a petition for rehearing that had been pending since December (and that wepreviouslymentioned).The original panel modified its opinion to order further proceedings on a claim it previously held ineligible under Section101, and an evenly divided en banc Court denied en banc rehearing. That denial drew 2 concurring opinions, 3 dissenting opinions, and 1 dissent without opinion.Below we provide our other usual statistics and our case of the weekour highly subjective selection based on whatever case piqued our interest.

Precedential opinions: 7

Non-precedential opinions:6

Rule 36:0

Longest pending case from argument: Australian Therapeutic Supplies Pty. Ltd. v. Naked TM, LLC, No.19-1567 (199 days)

Shortest pending case from argument (non-Rule 36): Tie betweenTakeda Pharmaceuticals U.S.A., Inc. v. Mylan Pharmaceuticals Inc., No.20-1407, andTakeda Pharmaceuticals U.S.A., Inc. v. Alkem Laboratories Limited, No.20-1545 (53 days each)

Case of the week:FanDuel, Inc. v. Interactive Games LLC, No.19-1393 (July 29, 2020)

Panel:Judges Dyk, Moore, and Hughes, with Judge Hughes writing the majority opinion and Judge Dyk concurring in part and dissenting in part.

You should read this case if:You have an IPR appeal involving a procedural challenge under the APA.

As our readers likely know, one important difference between district court litigation and Patent Trial and Appeal Board proceedings is that PTAB proceedings like IPRs are subject to the requirements of the Administrative Procedure Act.In our case of the week, a patent owner took a gamble on an APA challenge at the Federal Circuit but went bust.

FanDuel petitioned for an inter partes review of a patent owned by Interactive Games related to remote gambling. It asserted that the challenged claims were unpatentable for obviousness based on a combination of three references.In Interactive Gamess preliminary patent owner response, it defended the validity of a dependent claim (claim6) only by arguing that the reference on which FanDuel relied for claim6s additional limitations did not qualify as prior art.The Board instituted an IPR, finding a reasonable likelihood that FanDuel would prevail on its challenge to claim6 but only expressly discussing the prior-art issue.But the Boards final written decision ultimately upheld claim6.It did not discuss whether the disputed reference qualified as prior art; instead, it found that FanDuel had not demonstrated a motivation to combine that reference with the other asserted references.

On appeal, FanDuel argued that the Board violated the APA by changing theories midstream and adopting a new theory that Interactive Games never raised in its submissions, all without giving FanDuel notice and an opportunity to respond to this supposedly new theory.The Federal Circuit rejected that contention, observing that FanDuels argument that it lacked notice that the Board might address and reject the obviousness arguments made in FanDuels own petition strains credulity.The Court gave two somewhat overlapping reasons for its conclusion.

First, the Court pointed to the different standards of proof required to institute versus to invalidate.At institution, the Board need only find a reasonable likelihood that a petitioner will succeed, whereas in a final decision, the Board must find invalidity by a preponderance of the evidence.Those differing standards permit the Board to adopt different views of the sufficiency of a petitioners asserted obviousness arguments in its initial versus final decisions without first alerting the parties to that possibility.In fact, the Court recognized, [t]his happens with some frequency.

Second, the Court observed that the burden of proving invalidity in an IPR remains on the petitioner throughout the proceeding. Indeed, the Court explained, a patent owner carries no obligation to raise any objection to the petitioners challenges at all.Thus, the petitioners contentions, rather than a patent owners response, define the universe of issues the Board may address in its final written decision.Applying those principles, the Court noted that the central question throughout the IPR was whether FanDuel proved its theory as to how the asserted references combined to make claim6 obvious.FanDuel was on notice that the Board would decide that issue [f]rom the moment FanDuel filed its petition.And that was exactly what the Board ultimately did in its final written decision.The Court concluded that [n]o APA violation results from such a course.

The Court went on to reject FanDuels challenge to the substance of the Boards non-obviousness determination.Judge Dyk dissented from that part of the majoritys opinion but agreed with the majority in rejecting FanDuels procedural challenge.

[View source.]

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Last Week in the Federal Circuit (July 27-31): Gambling on an APA Challenge - JD Supra

Your Pension May Be Gambling On Human Life, Profiting From COVID Deaths – GoLocalProv

Posted on August 8, 2020 by Danzig

Wednesday, August 05, 2020

Edward Siedle, Guest MINDSETTER

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Edward Siedle

Many public and private pensions are gambling on highly speculative funds that invest in so-called longevity-contingent assets, such as life insurance policies insuring the lives of individuals who are generally at least 70 years old. The insured individual must have a life expectancy ranging from, say, not less than two years to not more than 15 years. A given fund may have exposure to hundreds of lives in the portfolio with an average insured age of over 80 years old.

The sooner the terminally ill and other elderly insured individuals die, the betteras far as your pension is concerned.

With more than80% of COVID deathsin the United States occurring in people aged 65 and older, this should be the best of times for gambling on these controversial funds which often promise annualized returns ranging from 8-12%. (Actual net returns are likely to be less than half those promised.)

If so, would it comfort you to know your pension was profiting from the misery of others?

Do you know whether your pension invests in life settlements? Have any such investments been clearly disclosed to you? Do the people managing your pension even know?

Believe it or not, they may not.

Today many alternative investment funds provide that they may withhold disclosure of underlying investments from pensions and participants, including stinky stuff like payday loans and life settlements.

Life settlement funds are controversial for a host of obvious and not-so-obvious reasons. Gambling on these highly speculative investments in a pension ensuring the retirement security of workers is doubly problematic.

Many regulators, lawmakers and other governmental authorities, as well as many insurance companies and insurance industry organizations, oppose the selling and buying of longevity-contingent assets. The industry and some of its participants have long been in legal and regulatory hot water. Opponents of the industry argue that these life insurance transactions are contrary to public policy by promoting financial speculation on human life and all-too-often involve elements of fraud and other wrongdoing.

Ask yourself: Why would an elderly, sickly or terminally ill insured person sell his or her life insurance policy? Because he or she needs cash to cover rising medical costs and living expenses? What are the chances the sale of that individuals life insurance policy may have been coerced or induced by fraud? Its no surprise that thoughtful regulators and lawmakers would be highly concerned.

The limited regulatory oversight of these funds is another major red flag. Many funds take the position that whole life settlements do not constitute securities under the federal securities laws and do not register as investment companies under the Investment Company Act of 1940. Compliance with other federal and state securities laws is also a concern. The SEC has long had difficulty reigning in industry abuses since unless securities are involved the agency generally lacks jurisdiction.

Worst of all, since the portfolio investments of these funds do not currently have a readily available market for valuation purposes, the likelihood that portfolio values, as well as investment returns may be inflated by the managers is high. This is particularly troublesome for open-ended investment funds, where new investors may be buying into a fund at an already inflated Net Asset Value (NAV). The life settlement asset class has had a troubled past with respect to inflated NAVs caused by funds underestimating life expectancies.

In other words, fund managers, are so hopeful that the old and sick insureds will die sooner rather than later, they assume the life expectancies will be shorter.

In Europe,a number of open-end funds (so-called sickened death bond funds) have gated, trapping investors. After waiting several years for the funds to liquidate, investors have recovered only pennies on the dollar.

In my opinion, additional regulatory action regarding overvaluations of the portfolios of these funds is almost certainly coming. If so, your pensionyour retirement securitymay be at risk.

In 2016, the Office of the Virgin Islands Inspector Generalissued ascathing reportfinding that the Virgin Islands General Employees Retirement System had entered into an extremely risky and questionable life settlement investment that jeopardized about $42 million of its investment portfolio. This was done without performing the necessary due diligence and obtaining the necessary expert advice, before exposing the pension fund to this high-risk investment. As a result, GERS has already written-off 20% or $8.4 million of the remaining value. In addition, GERS also granted a $10 million line of credit to the same partnership that is handling the viatical. The majority of the proceeds were to pay past due and near term premiums for the policies.

An advisor to the pension noted, There is uncertainty on the use of viaticals as an investment by a defined benefit plan. Also, The nature of the investment in viaticals, that is an investment seeking profits off death, raises issues of social responsibility.

To be sure, in my opinion, life settlement funds are the antithesis of socially responsible investing.

Should your retirement savings be in longevity-contingent assets supporting speculation on human life which often involve elements of fraud and other wrongdoing? First, find out whether your pension is invested in these funds, then let your voice be heard. Best case scenarioyour pension is profiting from the misery of others. Far more likelyits losing money playing in this nasty sandbox.

For more on how to protect your pension, see my bookWho Stole My Pension?

This piece was first published in Forbes.

"Pension Detective." Born Edward Ahmed Hamilton Siedle, I grew up in Trinidad, Venezuela, Panama, Peru, England, Uganda, Egypt and the U.S. I am a former SEC attorney, former Legal Counsel and Director of Compliance to Putnam Investments. For over 20 years, I owned securities trading and investment banking firms. My firm, Benchmark Financial Services, Inc. and I have pioneered over $1 trillion in forensic investigations of the money management industry. I am nationally recognized as an authority on pensions and investment management matters, having testified before the Senate Banking Committee regarding the mutual fund scandals and as an expert in various Madoff and other litigations. I am an active member of the Florida Bar. In 2017, I secured the largest SEC whistleblower award in history ($48 million) and in 2018, the largest CFTC award in history ($30 million)

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Your Pension May Be Gambling On Human Life, Profiting From COVID Deaths - GoLocalProv

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Last Week in the Federal Circuit (July 27-31): Gambling on an APA Challenge – JD Supra

Your Pension May Be Gambling On Human Life, Profiting From COVID Deaths – GoLocalProv