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IBM has reached an agreement to sell its Watson Health data and analytics business to the private-equity firm Francisco Partners

Reporter: Aviva Lev-Ari, PhD, RN

@pharma_BI is asking: What will be the future of WATSON Health?

@AVIVA1950 says on 1/26/2022:

Aviva believes plausible scenarios will be that Francisco Partners will:

A. Invest in Watson Health – Like New Mountains Capital (NMC) did with Cytel

B. Acquire several other complementary businesses – Like New Mountains Capital (NMC) did with Cytel

C. Hold and grow – Like New Mountains Capital (NMC) is doing with Cytel since 2018.

D. Sell it in 7 years to @Illumina or @Nvidia or Google’s Parent @AlphaBet

1/21/2022

IBM said Friday it will sell the core data assets of its Watson Health division to a San Francisco-based private equity firm, marking the staggering collapse of its ambitious artificial intelligence effort that failed to live up to its promises to transform everything from drug discovery to cancer care.

https://www.statnews.com/2022/01/21/ibm-watson-health-sale-equity/

IBM has reached an agreement to sell its Watson Health data and analytics business to the private-equity firm Francisco Partners. … He said the deal will give Francisco Partners data and analytics assets that will benefit from “the enhanced investment and expertise of a healthcare industry focused portfolio.”5 days ago


IBM Is Selling Watson Health Unit to Private-Equity Firmhttps://www.barrons.com › articles › ibm-selling-watson-h…
About featured snippetsFeedback
IBM is selling off Watson Health to a private equity firm.https://www.nytimes.com › 2022/01/21 › business › ibm-…

5 days ago — IBM has been trying to find buyers for the Watson Health business for more than a year. And it was seeking a sale price of about $1 billion, The …Missing: Statement ‎| Must include: Statement


IBM Sells Some Watson Health Assets for More Than $1 Billionhttps://www.bloomberg.com › news › articles › ibm-is-s…

5 days ago — International Business Machines Corp. agreed to sell part of its IBM Watson Health business to private equity firm Francisco Partners, …
IBM has sold Watson Health. It was a long time coming.https://www.protocol.com › bulletins › ibm-watson-heal…

5 days ago — IBM announced today that it has sold its Watson Health data and analytics assets to private equity firm Francisco Partners.
IBM to sell Watson Health assets to Francisco Partnershttps://www.healthcareitnews.com › news › ibm-sell-wa…

5 days ago — IBM on Friday announced a deal with Bay Area-based Francisco Partners to sell off healthcare data and analytics assets from its Watson …
IBM is selling off its Watson Health assets – CNNhttps://www.cnn.com › 2022/01/21 › tech › ibm-selling-w…

5 days ago — IBM said Friday that it will sell off the healthcare data and analytics assets housed under its Watson Health unit to private equity firm …
IBM to sell Watson Health division to private equity firmhttps://www.healthcaredive.com › news › ibm-sell-wats…

5 days ago — Tom Rosamilia, senior vice president of IBM Software, said in a statement the deal is a next step allowing IBM to focus more intensely on its …
IBM sells Watson Health assets to investment firm Francisco …https://www.fiercehealthcare.com › tech › ibm-sells-wat…

5 days ago — IBM has reached a deal to sell the healthcare data and analytics assets from its Watson Health business to investment firm Francisco …
Francisco Partners to Acquire IBM’s Healthcare Data and …https://newsroom.ibm.com › 2022-01-21-Francisco-Par…

5 days ago — “IBM remains committed to Watson, our broader AI business, and to the clients and partners we support in healthcare IT.Missing: Statement ‎| Must include: Statement
IBM Sells Portion of Watson Health Business to Francisco …https://www.channele2e.com › ChannelE2E Blog

5 days ago — IBM Watson Health – Certain Assets Sold: Executive Perspectives. In a prepared statement about the deal, Tom Rosamilia, senior VP, IBM Software, …


IBM Watson Health Finally Sold by IBM After 11 Months of …https://www.enterpriseai.news › 2022/01/21 › ibm-wats…

5 days ago — Another IBM executive, Tom Rosamilia, a senior vice president with IBM Software, said in a statement that the sale of the Watson Health assets …
Francisco Partners scoops up bulk of IBM’s Watson Health unithttps://techcrunch.com › 2022/01/21 › francisco-partne…

5 days ago — In what has to be considered an anticlimactic ending, IBM sold off the data assets of its Watson Health unit to private equity firm …
IBM Sells Some Watson Health Assets for More Than $1 Billionhttps://www.bloombergquint.com › Business

IBM confirmed an earlier Bloomberg report on the sale in a statement on Friday, … “IBM remains committed to Watson, our broader AI business, and to the …
IBM offloads Watson Health business data, analyticshttps://searchbusinessanalytics.techtarget.com › news › IB…

5 days ago — IBM has sold the bulk of its Watson Health data and analytics business to a … In a press statementIBM said offloading its Watson Health …
IBM selling Watson Health data and analytics business to …https://digitalhealth.modernhealthcare.com › Finance

5 days ago — IBM announced Friday that Francisco Partners will acquire its … The news comes after IBM sold three components of its Watson Health …
IBM to sell Watson Health assets to private equity firmhttps://www.auntminnie.com › …

5 days ago — IBM has agreed to sell healthcare data analytics assets from its current Watson Health business to private equity firm Francisco Partners.
IBM sells off large parts of Watson Health business -https://pharmaphorum.com › news › ibm-sells-off-large…

2 days ago — Tech giant IBM draws back from its digital health aspirations, agreeing a deal to sell a large chunk of IBM Watson Health to private equity …
IBM sells off Watson AI healthcare unit – Verdicthttps://www.verdict.co.uk › ibm-sells-off-watson-ai-hea…

2 days ago — IBM is to sell off its Watson Health data assets, bringing all but the final blow to … Senior Vice President, IBM Software in a statement.
IBM Sells Portions Of Watson Health Unit To Investment Firmhttps://www.investors.com › news › technology › ibm-s…

5 days ago — The sale to Francisco Partners is the latest step by IBM to refocus its … said IBM senior vice president Tom Rosamilia in a statement.


IBM Sells Off Watson Health Assets | Healthcare Innovationhttps://www.hcinnovationgroup.com › news › ibm-sells…

5 days ago — 5, IBM (NYSE: IBM) initially explored putting IBM Watson Health up for sale in … senior vice president of IBM Software, in a statement.
IBM is selling off its Watson Health assets – KESQhttps://kesq.com › money › 2022/01/21 › ibm-is-selling…

5 days ago — “The Watson Health sale has been anticipated for quite some time,” Paddy … senior vice president of IBM Software, said in a statement.
Report: IBM seeking to sell Watson Health unit for $1B+https://siliconangle.com › 2022/01/06 › report-ibm-see…

Jan 6, 2022 — IBM Corp. has launched a new effort to sell its Watson Health division, Axios reported on Wednesday, and the company is said to be hoping …
History of IBM – Wikipediahttps://en.wikipedia.org › wiki › History_of_IBM
As the sales force grew into a highly professional and knowledgeable arm of the company, Watson focused their attention on providing large-scale tabulating …
Remember IBM’s Amazing Watson AI? Now it’s desperately …https://almooon.com › remember-ibms-amazing-watson…

Jan 7, 2022 — IBM’s infamous Watson artificial intelligence once defeated two $1 … offering the health portion of its much-hyped algorithm for sale.
IBM shifts focus with sale of Watson marketing, commerce …https://www.marketingdive.com › news › ibm-shifts-foc…

Apr 9, 2019 — IBM plans to sell its Watson marketing and commerce solutions to the private equity firm Centerbridge Partners, the company announced in a …
IBM and Salesforce Join Forces to Bring Watson and Einstein …http://www.smartcustomerservice.com › News-Features

Jan 26, 2018 — IBM has, meanwhile, named Salesforce its preferred customer engagement platform for sales and service. “The combination of IBM Cloud and …
IBM Sells Watson Health Assets to Investment Firm – WSJhttps://www.wsj.com › articles › ibm-sells-watson-health-a…

5 days ago — International Business Machines Corp. IBM 5.65% agreed to sell the data and analytics assets from its Watson Health business to investment …Missing: Statement ‎| Must include: Statement
Latest News & Videos, Photos about ibm watson health – The …https://economictimes.indiatimes.com › topic › ibm-wat…
IBM is said to consider sale of Watson Health amid cloud focus … Research India and CTO IBM India /South Asia, was quoted as saying in an IBM statement.
IBM explores sale of Watson Health | Fox Businesshttps://www.foxbusiness.com › healthcare › ibm-explores-…

Feb 18, 2021 — International Business Machines Corp. is exploring a potential sale of its IBM Watson Health business, according to people familiar with the …


IBM Explores Sale of IBM Watson Health – Slashdothttps://slashdot.org › story › ibm-explores-sale-of-ibm-…

Feb 19, 2021 — IBM is exploring a potential sale of its IBM Watson Health business, WSJ is reporting, citing people familiar with the matter, …
Watson Applications Software Sales Specialist | IBM Careershttps://krb-sjobs.brassring.com › HomeWithPreLoad

Job Details: Do you have experience helping clients implement innovative enterprise technology solutions that help them sol.
Georgia Watson – Sales Enablement Festivalhttps://festival2021.salesenablementcollective.com › ge…

Working for IBM as a Sales Enablement and Skills Transformation lead, Georgia was recently recognized as an Innovator of the Year in the International Business …
IBM’s Watson Health is sold off in parts | Hacker Newshttps://news.ycombinator.com › item

3 days ago — Please don’t make such definite statements. You even say it in your own comment … People outside tech were buzzing about IBM and Watson.
Data Before Technology: IBM Watson’s Vision – Forresterhttps://www.forrester.com › Featured Blogs

Nov 2, 2014 — I sat down with Steve Cowley, General Manager for IBM Watson, on Tuesday at … Steve surprised me with this statement, “[With] traditional …
How IBM Watson Overpromised and Underdelivered on AI …https://spectrum.ieee.org › how-ibm-watson-overpromised…
After its triumph on Jeopardy!, IBM’s AI seemed poised to revolutionize medicine. Doctors are still waiting.
You’re probably using IBM’s Watson computer and don’t know ithttps://www.vox.com › ibm-ginni-rometty-watson

Jun 1, 2016 — But please don’t call it “artificial intelligence,” IBM’s CEO says. … sales figures aren’t yet disclosed in its financial statements.
IBM is selling off its Watson Health assets – KYMAhttps://kyma.com › news › 2022/01/21 › ibm-is-selling-…

5 days ago — “The Watson Health sale has been anticipated for quite some time,” Paddy … senior vice president of IBM Software, said in a statement.
IBM, investment firm reach deal for Watson Health assetshttps://www.mmm-online.com › home › channel › brea…

5 days ago — IBM will sell the healthcare data and analytics assets of its Watson Health business to investment firm Francisco Partners as part of a deal …
IBM has sold off Watson at a steep discount, and is exiting the …https://www.reddit.com › Futurology › comments › ib…

3 days ago — Nuance played a part in building watson in supplying the speech recognition component of Watson. Through the years, Nuance has done some serious …

Goal Attainment Scaling Record: 2021 – A Year in Review

Curator: Aviva Lev-Ari, PhD, RN, Founder, 1.0 & 2.0 LPBI Group

STRATEGIC MISSIONS

Mission #1: Medical Text Analysis using NLP, ML-AI

Wolfram Vendor selection

Workflow Ten-steps Template for NLP in Books

NLP – Book Assignment

– Genomics Volume 1: Satwik – Started on 1/4/2022

– Genomics Volume 2: Madison – DONE

– Cancer Volume 1: Satwick – NLP – DONE

– Danielle – Book prep PART B

– Cancer Volume 2: Juliet Wu

– Nitric Oxide: Yash C.

– 3D BioPrinting: Ms. Joshi

Organizational

July 19: Launch of LPBI India

Marketing Communication

  • March 2: Podcast with many updates – LPBI is a Very Unique Organization
  • DESIGN of CONTENT PROMOTION campaigns: Montero & GTO

Mission #2: Blockchain for Content Monetization and Auction of

(1) Curations as NFT and

(2) Therapeutics Molecules

9/14: Selection of Fluree Foundation for our Blockchain

  1. IT & Data Science Internship – LPBI gained the code to run Article Views by any date, 2012 – 2021 – Contributions by Srini and by Abhisar
  2. Text to Sound: 150 of the 270 Interviews with Scientific Leaders were converted to Podcasts – Contribution by Ethan
  3. Sign up agreement with SpeechKit – Text to Sound conversion for (a) $204 for 360 podcasts per year (b) Archive bulk conversion 20 cents per Podcast (c) Use API for Spanish Text to Spanish Sound
  4. ALL 18 BOOKS have a COVER PAGE and an eTOCs in Spanish – Montero competed its Contract and was paid by a Loan Aviva made to LPBI.  On 9/1/2021 wired the funds to cover the Invoice.
  • DESIGN and ENABLEMENT of Content Monetization – Blockchain
  • IT & Data Science – Audit capabilities to Journal Articles

Mission #3: New Genre Scientific Books

1/4/2022 UPDATE

PART A: Spanish Audio

and Bi-lingual Text for eTOCs

PART B: NLP

PART C: Editorials Audio

BUSINESS SIDE

GUEST SPEAKERS:

2/9/2021: Prof. James Jordan, CMU

Discussion on SPACs:

3/9/2021:

– I_del_C, MONTERO-LS, Madrid, Spain

– MvR, MD, Helsinki, Finland

– DaveS, CMAA, Medworld Advisors

4/6/2021:

Dan Halpern on Mercantile Banks

5/11/2021:

– Olivier Jarry, Atlas Advisors, NY, NY

Mr. Bahl, Mr. Gamota, Mr. Halpern

Dr. Ofer, Dr. Williams, Dr. Pearlman

6/8/2021: Montero & GTO Presentations

Mission #4: Drug Design with Synthetic Biology Software

  • LPBI strategy is for BLOCKCHAIN technology to be MARRIED to NLP FOR CONTENT MONETIZATION
  • BLOCKCHAIN for Auction of New molecules:
  1. Give Dr. Nir Right of Use
  2. Hosting the molecules in Blockchain Knowledge Graph Data Base
  3. Open up the molecules for licensing in a cyber secured confidential Auction
  4. Host molecules inventories from Technology Transfer Offices in several Academic centers around the Globe. We have relations to three Academic institutions in Israel, and three in the US

8/10: Spanish Translation going on

11/14: Erich of Blockchain Schema

12/14: Xavier and Eric on NFT as Presented by LPBI Group’s Portfolio of IP Assets Classes I – XIV

SCIENCE SIDE

GUEST SPEAKERS:

1/12/2021:

Prof. Martin Schiller

2/9/2021:

Prof. A. Gupta on Ramatroban

– Prof. S. Yedgar

– Dr. Raphael Nir

– Dr. Yigal Blum

Amor18 – ACC

3/9/2021:

– Dr. Tetz & Dr. Kogan

– Prof. A. Gupta on Ramatroban

– Prof. S. Yedgar

4/6/2021:

– Dr. Tetz & Dr. Kogan

– Prof. A. Gupta on Ramatroban

– Prof. S. Yedgar

5/11/2021:

– Discussion on Content sharing with Linguamatics

6/8/2021: Ramatroban

Rehearsal of Linguamatics Proposal for a Health Care Insurer

8/10: Synthetic Biology Software – New Molecules DESIGN

10/12: Dr. Williams presented

  • Wolfram Platform: What can LPBI do to get access for MULTIPLE computers beyond 2 seats, currently held by Madison and by Yash – WHAT can we do with Wolfram to enable access to all INTERNS?
  • What is the state of development for the decision on the Software to be selected for Synthetic Biology for our Interns?
  • HOW the work by David MacMillan on BioCatalysis can be harnessed for our Synthetic Biology for Drug Discovery effort

11/9: PROTAC – PRossetaC with Prof. Nir London, Weizmann Institute

Debbie Nickerson Dies

Reporter: Aviva Lev-Ari, PhD, RN

Jan 03, 2022 | staff reporter

From

https://www.genomeweb.com/scan/debbie-nickerson-dies?adobe_mc=MCMID%3D34480469763973098982318083811122311334%7CMCORGID%3D138FFF2554E6E7220A4C98C6%2540AdobeOrg%7CTS%3D1641234870&CSAuthResp=1%3A%3A618831%3A273%3A24%3Asuccess%3A1AF77CF7470112199AEA1647462A9EDB#.YdNBvhPMKLo

Debbie Nickerson, a leader of human genome sequencing and its application in precision medicine, has died at the age of 67, according to the University of Washington, where she was a professor in the Department of Genome Sciences.

“Always pushing the existing boundaries with an infectious mix of creativity, vision, impatience, and a wicked sense of humor, Debbie exhorted herself and everyone around her to do more than they thought they could,” Francis Collins, former director of the National Institutes of Health, tells UW. “Her imprint on genomic medicine is profound, and she will be sorely missed.”

At the time of her death, from abdominal cancer, Nickerson was director of UW’s Center for Mendelian Genomics and a principal contributor to the NIH All of Us Research Program. During her career, she published more than 350 original research papers.

She was also a forceful advocate for women in science. “She fought for a culture that would not require women to sacrifice their personal lives to pursue careers in science,” UW writes. “In parallel, she advanced the training of young scientists from underrepresented minority backgrounds.”

Nickerson, who hailed from Mineola, New York, had been at UW since 1992. “Her former students and postdocs are now a powerful force in human genetics and genomics,” the university notes.

New studies link cell cycle proteins to immunosurveillance of premalignant cells

Curator: Stephen J. Williams, Ph.D.

The following is from a Perspectives article in the journal Science by Virinder Reen and Jesus Gil called “Clearing Stressed Cells: Cell cycle arrest produces a p21-dependent secretome that initaites immunosurveillance of premalignant cells”. This is a synopsis of the Sturmlechener et al. research article in the same issue (2).

Complex organisms repair stress-induced damage to limit the replication of faulty cells that could drive cancer. When repair is not possible, tissue homeostasis is maintained by the activation of stress response programs such as apoptosis, which eliminates the cells, or senescence, which arrests them (1). Cellular senescence causes the arrest of damaged cells through the induction of cyclin-dependent kinase inhibitors (CDKIs) such as p16 and p21 (2). Senescent cells also produce a bioactive secretome (the senescence-associated secretory phenotype, SASP) that places cells under immunosurveillance, which is key to avoiding the detrimental inflammatory effects caused by lingering senescent cells on surrounding tissues. On page 577 of this issue, Sturmlechner et al. (3) report that induction of p21 not only contributes to the arrest of senescent cells, but is also an early signal that primes stressed cells for immunosurveillance.Senescence is a complex program that is tightly regulated at the epigenetic and transcriptional levels. For example, exit from the cell cycle is controlled by the induction of p16 and p21, which inhibit phosphorylation of the retinoblastoma protein (RB), a transcriptional regulator and tumor suppressor. Hypophosphorylated RB represses transcription of E2F target genes, which are necessary for cell cycle progression. Conversely, production of the SASP is regulated by a complex program that involves super-enhancer (SE) remodeling and activation of transcriptional regulators such as nuclear factor κB (NF-κB) or CCAAT enhancer binding protein–β (C/EBPβ) (4).

Senescence is a complex program that is tightly regulated at the epigenetic and transcriptional levels. For example, exit from the cell cycle is controlled by the induction of p16 and p21, which inhibit phosphorylation of the retinoblastoma protein (RB), a transcriptional regulator and tumor suppressor. Hypophosphorylated RB represses transcription of E2F target genes, which are necessary for cell cycle progression. Conversely, production of the SASP is regulated by a complex program that involves super-enhancer (SE) remodeling and activation of transcriptional regulators such as nuclear factor κB (NF-κB) or CCAAT enhancer binding protein–β (C/EBPβ) (4).

Sturmlechner et al. found that activation of p21 following stress rapidly halted cell cycle progression and triggered an internal biological timer (of ∼4 days in hepatocytes), allowing time to repair and resolve damage (see the figure). In parallel, C-X-C motif chemokine 14 (CXCL14), a component of the PASP, attracted macrophages to surround and closely surveil these damaged cells. Stressed cells that recovered and normalized p21 expression suspended PASP production and circumvented immunosurveillance. However, if the p21-induced stress was unmanageable, the repair timer expired, and the immune cells transitioned from surveillance to clearance mode. Adjacent macrophages mounted a cytotoxic T lymphocyte response that destroyed damaged cells. Notably, the overexpression of p21 alone was sufficient to orchestrate immune killing of stressed cells, without the need of a senescence phenotype. Overexpression of other CDKIs, such as p16 and p27, did not trigger immunosurveillance, likely because they do not induce CXCL14 expression.In the context of cancer, senescent cell clearance was first observed following reactivation of the tumor suppressor p53 in liver cancer cells. Restoring p53 signaling induced senescence and triggered the elimination of senescent cells by the innate immune system, prompting tumor regression (5). Subsequent work has revealed that the SASP alerts the immune system to target preneoplastic senescent cells. Hepatocytes expressing the oncogenic mutant NRASG12V (Gly12→Val) become senescent and secrete chemokines and cytokines that trigger CD4+ T cell–mediated clearance (6). Despite the relevance for tumor suppression, relatively little is known about how immunosurveillance of oncogene-induced senescent cells is initiated and controlled.

Source of image: Reen, V. and Gil, J. Clearing Stressed Cells. Science Perspectives 2021;Vol 374(6567) p 534-535.

References

2. Sturmlechner I, Zhang C, Sine CC, van Deursen EJ, Jeganathan KB, Hamada N, Grasic J, Friedman D, Stutchman JT, Can I, Hamada M, Lim DY, Lee JH, Ordog T, Laberge RM, Shapiro V, Baker DJ, Li H, van Deursen JM. p21 produces a bioactive secretome that places stressed cells under immunosurveillance. Science. 2021 Oct 29;374(6567):eabb3420. doi: 10.1126/science.abb3420. Epub 2021 Oct 29. PMID: 34709885.

More Articles on Cancer, Senescence and the Immune System in this Open Access Online Scientific Journal Include

Bispecific and Trispecific Engagers: NK-T Cells and Cancer Therapy

Natural Killer Cell Response: Treatment of Cancer

Issues Need to be Resolved With ImmunoModulatory Therapies: NK cells, mAbs, and adoptive T cells

New insights in cancer, cancer immunogenesis and circulating cancer cells

Insight on Cell Senescence

Immune System Stimulants: Articles of Note @pharmaceuticalintelligence.com

Reporter: Stephen J. Williams, Ph.D.

From: Heidi Rheim et al. GA4GH: International policies and standards for data sharing across genomic research and healthcare. (2021): Cell Genomics, Volume 1 Issue 2.

Source: DOI:https://doi.org/10.1016/j.xgen.2021.100029

Highlights

  • Siloing genomic data in institutions/jurisdictions limits learning and knowledge
  • GA4GH policy frameworks enable responsible genomic data sharing
  • GA4GH technical standards ensure interoperability, broad access, and global benefits
  • Data sharing across research and healthcare will extend the potential of genomics

Summary

The Global Alliance for Genomics and Health (GA4GH) aims to accelerate biomedical advances by enabling the responsible sharing of clinical and genomic data through both harmonized data aggregation and federated approaches. The decreasing cost of genomic sequencing (along with other genome-wide molecular assays) and increasing evidence of its clinical utility will soon drive the generation of sequence data from tens of millions of humans, with increasing levels of diversity. In this perspective, we present the GA4GH strategies for addressing the major challenges of this data revolution. We describe the GA4GH organization, which is fueled by the development efforts of eight Work Streams and informed by the needs of 24 Driver Projects and other key stakeholders. We present the GA4GH suite of secure, interoperable technical standards and policy frameworks and review the current status of standards, their relevance to key domains of research and clinical care, and future plans of GA4GH. Broad international participation in building, adopting, and deploying GA4GH standards and frameworks will catalyze an unprecedented effort in data sharing that will be critical to advancing genomic medicine and ensuring that all populations can access its benefits.

In order for genomic and personalized medicine to come to fruition it is imperative that data siloes around the world are broken down, allowing the international collaboration for the collection, storage, transferring, accessing and analying of molecular and health-related data.

We had talked on this site in numerous articles about the problems data siloes produce. By data siloes we are meaning that collection and storage of not only DATA but intellectual thought are being held behind physical, electronic, and intellectual walls and inacessible to other scientisits not belonging either to a particular institituion or even a collaborative network.

Scientific Curation Fostering Expert Networks and Open Innovation: Lessons from Clive Thompson and others

Standardization and harmonization of data is key to this effort to sharing electronic records. The EU has taken bold action in this matter. The following section is about the General Data Protection Regulation of the EU and can be found at the following link:

https://ec.europa.eu/info/law/law-topic/data-protection/data-protection-eu_en

Fundamental rights

The EU Charter of Fundamental Rights stipulates that EU citizens have the right to protection of their personal data.

Protection of personal data

Legislation

The data protection package adopted in May 2016 aims at making Europe fit for the digital age. More than 90% of Europeans say they want the same data protection rights across the EU and regardless of where their data is processed.

The General Data Protection Regulation (GDPR)

Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data. This text includes the corrigendum published in the OJEU of 23 May 2018.

The regulation is an essential step to strengthen individuals’ fundamental rights in the digital age and facilitate business by clarifying rules for companies and public bodies in the digital single market. A single law will also do away with the current fragmentation in different national systems and unnecessary administrative burdens.

The regulation entered into force on 24 May 2016 and applies since 25 May 2018. More information for companies and individuals.

Information about the incorporation of the General Data Protection Regulation (GDPR) into the EEA Agreement.

EU Member States notifications to the European Commission under the GDPR

The Data Protection Law Enforcement Directive

Directive (EU) 2016/680 on the protection of natural persons regarding processing of personal data connected with criminal offences or the execution of criminal penalties, and on the free movement of such data.

The directive protects citizens’ fundamental right to data protection whenever personal data is used by criminal law enforcement authorities for law enforcement purposes. It will in particular ensure that the personal data of victims, witnesses, and suspects of crime are duly protected and will facilitate cross-border cooperation in the fight against crime and terrorism.

The directive entered into force on 5 May 2016 and EU countries had to transpose it into their national law by 6 May 2018.

The following paper by the organiztion The Global Alliance for Genomics and Health discusses these types of collaborative efforts to break down data silos in personalized medicine. This organization has over 2000 subscribers in over 90 countries encompassing over 60 organizations.

Enabling responsible genomic data sharing for the benefit of human health

The Global Alliance for Genomics and Health (GA4GH) is a policy-framing and technical standards-setting organization, seeking to enable responsible genomic data sharing within a human rights framework.

he Global Alliance for Genomics and Health (GA4GH) is an international, nonprofit alliance formed in 2013 to accelerate the potential of research and medicine to advance human health. Bringing together 600+ leading organizations working in healthcare, research, patient advocacy, life science, and information technology, the GA4GH community is working together to create frameworks and standards to enable the responsible, voluntary, and secure sharing of genomic and health-related data. All of our work builds upon the Framework for Responsible Sharing of Genomic and Health-Related Data.

GA4GH Connect is a five-year strategic plan that aims to drive uptake of standards and frameworks for genomic data sharing within the research and healthcare communities in order to enable responsible sharing of clinical-grade genomic data by 2022. GA4GH Connect links our Work Streams with Driver Projects—real-world genomic data initiatives that help guide our development efforts and pilot our tools.

From the article on Cell Genomics GA4GH: International policies and standards for data sharing across genomic research and healthcare

Source: Open Access DOI:https://doi.org/10.1016/j.xgen.2021.100029PlumX Metrics

The Global Alliance for Genomics and Health (GA4GH) is a worldwide alliance of genomics researchers, data scientists, healthcare practitioners, and other stakeholders. We are collaborating to establish policy frameworks and technical standards for responsible, international sharing of genomic and other molecular data as well as related health data. Founded in 2013,3 the GA4GH community now consists of more than 1,000 individuals across more than 90 countries working together to enable broad sharing that transcends the boundaries of any single institution or country (see https://www.ga4gh.org).In this perspective, we present the strategic goals of GA4GH and detail current strategies and operational approaches to enable responsible sharing of clinical and genomic data, through both harmonized data aggregation and federated approaches, to advance genomic medicine and research. We describe technical and policy development activities of the eight GA4GH Work Streams and implementation activities across 24 real-world genomic data initiatives (“Driver Projects”). We review how GA4GH is addressing the major areas in which genomics is currently deployed including rare disease, common disease, cancer, and infectious disease. Finally, we describe differences between genomic sequence data that are generated for research versus healthcare purposes, and define strategies for meeting the unique challenges of responsibly enabling access to data acquired in the clinical setting.

GA4GH organization

GA4GH has partnered with 24 real-world genomic data initiatives (Driver Projects) to ensure its standards are fit for purpose and driven by real-world needs. Driver Projects make a commitment to help guide GA4GH development efforts and pilot GA4GH standards (see Table 2). Each Driver Project is expected to dedicate at least two full-time equivalents to GA4GH standards development, which takes place in the context of GA4GH Work Streams (see Figure 1). Work Streams are the key production teams of GA4GH, tackling challenges in eight distinct areas across the data life cycle (see Box 1). Work Streams consist of experts from their respective sub-disciplines and include membership from Driver Projects as well as hundreds of other organizations across the international genomics and health community.

Figure thumbnail gr1
Figure 1Matrix structure of the Global Alliance for Genomics and HealthShow full caption


Box 1
GA4GH Work Stream focus areasThe GA4GH Work Streams are the key production teams of the organization. Each tackles a specific area in the data life cycle, as described below (URLs listed in the web resources).

  • (1)Data use & researcher identities: Develops ontologies and data models to streamline global access to datasets generated in any country9,10
  • (2)Genomic knowledge standards: Develops specifications and data models for exchanging genomic variant observations and knowledge18
  • (3)Cloud: Develops federated analysis approaches to support the statistical rigor needed to learn from large datasets
  • (4)Data privacy & security: Develops guidelines and recommendations to ensure identifiable genomic and phenotypic data remain appropriately secure without sacrificing their analytic potential
  • (5)Regulatory & ethics: Develops policies and recommendations for ensuring individual-level data are interoperable with existing norms and follow core ethical principles
  • (6)Discovery: Develops data models and APIs to make data findable, accessible, interoperable, and reusable (FAIR)
  • (7)Clinical & phenotypic data capture & exchange: Develops data models to ensure genomic data is most impactful through rich metadata collected in a standardized way
  • (8)Large-scale genomics: Develops APIs and file formats to ensure harmonized technological platforms can support large-scale computing

For more articles on Open Access, Science 2.0, and Data Networks for Genomics on this Open Access Scientific Journal see:

Scientific Curation Fostering Expert Networks and Open Innovation: Lessons from Clive Thompson and others

Icelandic Population Genomic Study Results by deCODE Genetics come to Fruition: Curation of Current genomic studies

eScientific Publishing a Case in Point: Evolution of Platform Architecture Methodologies and of Intellectual Property Development (Content Creation by Curation) Business Model 

UK Biobank Makes Available 200,000 whole genomes Open Access

Systems Biology Analysis of Transcription Networks, Artificial Intelligence, and High-End Computing Coming to Fruition in Personalized Oncology

UK Biobank Makes Available 200,000 whole genomes Open Access

Reporter: Stephen J. Williams, Ph.D.

The following is a summary of an article by Jocelyn Kaiser, published in the November 26, 2021 issue of the journal Science.

To see the full article please go to https://www.science.org/content/article/200-000-whole-genomes-made-available-biomedical-studies-uk-effort

The UK Biobank (UKBB) this week unveiled to scientists the entire genomes of 200,000 people who are part of a long-term British health study.

The trove of genomes, each linked to anonymized medical information, will allow biomedical scientists to scour the full 3 billion base pairs of human DNA for insights into the interplay of genes and health that could not be gleaned from partial sequences or scans of genome markers. “It is thrilling to see the release of this long-awaited resource,” says Stephen Glatt, a psychiatric geneticist at the State University of New York Upstate Medical University.

Other biobanks have also begun to compile vast numbers of whole genomes, 100,000 or more in some cases (see table, below). But UKBB stands out because it offers easy access to the genomic information, according to some of the more than 20,000 researchers in 90 countries who have signed up to use the data. “In terms of availability and data quality, [UKBB] surpasses all others,” says physician and statistician Omar Yaxmehen Bello-Chavolla of the National Institute for Geriatrics in Mexico City.

Enabling your vision to improve public health

Data drives discovery. We have curated a uniquely powerful biomedical database that can be accessed globally for public health research. Explore data from half a million UK Biobank participants to enable new discoveries to improve public health.

Data Showcase

Future data releases

This UKBB biobank represents genomes collected from 500,000 middle-age and elderly participants for 2006 to 2010. The genomes are mostly of a European descent. Other large scale genome sequencing ventures like Iceland’s DECODE, which collected over 100,000 genomes, is now a subsidiary of Amgen, and mostly behind IP protection, not Open Access as this database represents.

UK Biobank is a large-scale biomedical database and research resource, containing in-depth genetic and health information from half a million UK participants. The database is regularly augmented with additional data and is globally accessible to approved researchers undertaking vital research into the most common and life-threatening diseases. It is a major contributor to the advancement of modern medicine and treatment and has enabled several scientific discoveries that improve human health.

A summary of some large scale genome sequencing projects are show in the table below:

BiobankCompleted Whole GenomesRelease Information
UK Biobank200,000300,000 more in early 2023
TransOmics for
Precision Medicien
161,000NIH requires project
specific request
Million Veterans
Program
125,000Non-Veterans Affairs
researchers get first access
100,000 Genomes
Project
120,000Researchers must join Genomics
England collaboration
All of Us90,000NIH expects to release 2022

Other Related Articles on Genome Biobank Projects in this Open Access Online Scientific Journal Include the Following:

Icelandic Population Genomic Study Results by deCODE Genetics come to Fruition: Curation of Current genomic studies

Exome Aggregation Consortium (ExAC), generated the largest catalogue so far of variation in human protein-coding regions: Sequence data of 60,000 people, NOW is a publicly accessible database

Systems Biology Analysis of Transcription Networks, Artificial Intelligence, and High-End Computing Coming to Fruition in Personalized Oncology

Diversity and Health Disparity Issues Need to be Addressed for GWAS and Precision Medicine Studies

FDA Approves First Drug to Improve Growth in Children with Most Common Form of Dwarfism

Reporter: Aviva Lev-Ari, PhD, RN

The FDA has approved BioMarin Pharmaceutical’s Voxzogo (vosoritide), an injectable drug for increasing growth in children five years and up with achondroplasia, the most common form of dwarfism.

The FDA green light was supported by a 121-person phase 3 study showing children receiving Voxzogo grew 1.57 centimeters on average vs. placebo.  

This is the first approval of its kind for this pediatric population, but since Voxzogo was cleared under an accelerated pathway, the drug must still be evaluated in a confirmatory trial assessing final adult height.

The approval “fulfills an unmet medical need for more than 10,000 children in the United States,” said Theresa Kehoe, the FDA’s director of the Division of General Endocrinology within the Center for Drug Evaluation and Research.

For Immediate Release:

November 19, 2021

Today, the U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older with achondroplasia and open epiphyses (growth plates), meaning these children still have the potential to grow. Achondroplasia is the most common form of dwarfism. 

“Today’s approval fulfills an unmet medical need for more than 10,000 children in the United States and underscores the FDA’s commitment to help make new therapies available for rare diseases,” said Theresa Kehoe, M.D., director of the Division of General Endocrinology in the FDA’s Center for Drug Evaluation and Research. “With this action, children with short stature due to achondroplasia have a treatment option that targets the underlying cause of their short stature.” 

Achondroplasia is a genetic condition that causes severely short stature and disproportionate growth. The average height of an adult with achondroplasia is approximately four feet. People with achondroplasia have a genetic mutation that causes a certain growth regulation gene called fibroblast growth factor receptor 3 to be overly active, which prevents normal bone growth. Voxzogo works by binding to a specific receptor called natriuretic peptide receptor-B that reduces the growth regulation gene’s activity and stimulates bone growth. 

Voxzogo’s safety and efficacy in improving growth were evaluated in a year-long, double-blind, placebo-controlled, phase 3 study in participants five years and older with achondroplasia who have open epiphyses. In the study, 121 participants were randomly assigned to receive either Voxzogo injections under the skin or a placebo. Researchers measured the participants’ annualized growth velocity, or rate of height growth, at the end of the year. Participants who received Voxzogo grew an average 1.57 centimeters taller compared to those who received a placebo. 

The most common side effects of Voxzogo include injection site reactions, vomiting and decreased blood pressure. Voxzogo’s labeling also lists decreased blood pressure as a warning and precaution, which means it is a potentially serious side effect.

The FDA approved Voxzogo under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need, based on a surrogate or intermediate clinical endpoint. A condition of this accelerated approval is a post-marketing study that will assess final adult height. This application also received priority review designation.

The FDA granted the approval of Voxzogo to BioMarin.
 SOURCE

https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-improve-growth-children-most-common-form-dwarfism

Defective viral RNA sensing gene OAS1 linked to severe COVID-19

Reporter: Stephen J. Williams, Ph.D.

Source: https://www.science.org/doi/10.1126/science.abm3921

Defective viral RNA sensing linked to severe COVID-19

JOHN SCHOGGINS SCIENCE•28 Oct 2021•Vol 374, Issue 6567•pp. 535-536•DOI: 10.1126/science.abm39214,824

Why do some people with COVID-19 get sicker than others? Maybe exposure to a particularly high dose of the causative virus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), accounts for the difference. Perhaps deficiencies in diet, exercise, or sleep contribute to worse illness. Although many factors govern how sick people become, a key driver of the severity of COVID-19 appears to be genetic, which is common for other human viruses and infectious agents (1). On page 579 of this issue, Wickenhagen et al. (2) show that susceptibility to severe COVID-19 is associated with a single-nucleotide polymorphism (SNP) in the human gene 2′-5′-oligoadenylate synthetase 1 (OAS1).The authors reasoned that SARS-CoV-2 should be inhibited by interferon-mediated antiviral responses, which are among the first cellular defense mechanisms produced in response to a viral infection. Interferons are a group of cytokines that induce the transcription of a large cadre of genes, many of which encode proteins with the potential to directly inhibit the invading virus. Wickenhagen et al. interrogated many hundreds of these putative antiviral proteins for their ability to suppress SARS-CoV-2 in cultured cells and found that OAS1 was particularly potent against SARS-CoV-2.OAS1 is an enzyme that is activated in the presence of double-stranded RNA, which is scattered along an otherwise singlestranded SARS-CoV-2 genome because of an assortment of RNA hairpins and other secondary structures. Once activated, OAS1 catalyzes the polymerization of adenosine triphosphate (ATP) into a second messenger, 2′-5′-oligoadenylate. This then triggers the conversion of ribonuclease L (RNaseL) into its active form so that it can cleave viral RNA, effectively blunting viral replication (3). Wickenhagen et al. found that OAS1 is expressed in respiratory tissues of healthy donors and COVID-19 patients and that it interacts with a region of the SARS-CoV-2 genome that contains double-stranded RNA secondary structures (see the figure).OAS1 exists predominantly as two isoforms in humans—a longer isoform (p46) and a shorter version (p42). Genetic variation dictates which isoform will be expressed. In humans, p46 is expressed in people who have a SNP that causes alternative splicing of the OAS1 messenger RNA (mRNA). This results in the utilization of a terminal exon that is not used to translate p42. Thus, the carboxyl terminus of the p46 OAS1 protein contains a distinct four–amino acid motif that forms a prenylation site. Prenylation is a posttranslational modification that targets proteins to membranes. In cell culture experiments, Wickenhagen et al. showed that only OAS1 p46, but not p42, could inhibit SARS-CoV-2. However, when the prenylation site of p46 was engineered into p42, this chimeric p42 protein was able to inhibit SARS-CoV-2, which strongly implicates a role for OAS1 specifically at membranes.Why are membranes important? SARS-CoV-2, like all coronaviruses, co-opts cellular membranes at the endoplasmic reticulum to form double-membrane vesicles, in which the virus replicates its genome. Thus, membrane-bound OAS1 p46 may be specifically activated by RNA viruses that form membrane-bound vesicles for replication. Indeed, the unrelated cardiovirus A, which also forms vesicular membranous structures, was inhibited by OAS1. Conversely, other respiratory RNA viruses, such as human parainfluenza virus type 3 and human respiratory syncytial virus, which do not use membrane-tethered vesicles for replication, were not inhibited by p46.Wickenhagen et al. examined a cohort of 499 COVID-19 patients hospitalized in the UK. Whereas all patients expressed OAS1, 42.5% of them did not express the antiviral p46 isoform. These patients were statistically more likely to have severe COVID-19 (be admitted to the intensive care unit). This suggests that OAS1 is an important antiviral factor in the control of SARS-CoV-2 infection and that its inability to activate RNaseL results in prolonged infections and severe disease, although other factors likely contribute. The authors also examined animals known to harbor different coronaviruses. They found evidence for prenylated OAS1 proteins in mice, cows, and camels. Notably, horseshoe bats, which are considered a possible reservoir for SARS-related coronaviruses (4), lack a prenylation motif in their OAS1 because of genomic changes that eliminated the critical four-amino acid motif. A horseshoe bat (Rhinolophus ferrumequinum) OAS1 was unable to inhibit SARS-CoV-2 infection in cell culture. Conversely, the black flying fox (Pteropus alecto)—a pteropid bat that is a reservoir for the Nipah and Hendra viruses, which can also infect humans—possesses a prenylated OAS1 that can inhibit SARS-CoV-2. These findings indicate that horseshoe bats may be genetically and evolutionarily primed to be optimal reservoir hosts for certain coronaviruses, like SARS-CoV-2.Other studies have now shown that the p46 OAS1 variant, which resides in a genomic locus inherited from Neanderthals (57), correlates with protection from COVID-19 severity in various populations (89). These findings mirror previous studies indicating that outcomes with West Nile virus (10) and hepatitis C virus (11) infection, both of which also use membrane vesicles for replication, are also associated with genetic variation at the human OAS1 locus. Another elegant functional study complements the findings of Wickenhagen et al. by also demonstrating that prenylated OAS1 inhibits multiple viruses, including SARS-CoV-2, and is associated with protection from severe COVID-19 in patients (12).There is a growing body of evidence that provides critical understanding of how human genetic variation shapes the outcome of infectious diseases like COVID-19. In addition to OAS1, genetic variation in another viral RNA sensor, Toll-like receptor 7 (TLR7), is associated with severe COVID-19 (1315). The effects appear to be exclusive to males, because TLR7 is on the X chromosome, so inherited deleterious mutations in TLR7 therefore result in immune cells that fail to produce normal amounts of interferon, which correlates with more severe COVID-19. Our knowledge of the host cellular factors that control SARS-CoV-2 is rapidly increasing. These findings will undoubtedly open new avenues into SARS-CoV-2 antiviral immunity and may also be beneficial for the development of strategies to treat or prevent severe COVID-19.

References and Notes

1J. L. Casanova, Proc. Natl. Acad. Sci. U.S.A.112, E7118 (2015).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR2A. Wickenhagen et al., Science374, eabj3624 (2021).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR3H. Kristiansen, H. H. Gad, S. Eskildsen-Larsen, P. Despres, R. Hartmann, J. Interferon Cytokine Res.31, 41 (2011).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR4S. Lytras, W. Xia, J. Hughes, X. Jiang, D. L. Robertson, Science373, 968 (2021).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR5S. Zhou et al., Nat. Med.27, 659 (2021).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR6H. Zeberg, S. Pääbo, Proc. Natl. Acad. Sci. U.S.A.118, e2026309118 (2021).CROSSREFPUBMEDGOOGLE SCHOLAR7F. L. Mendez, J. C. Watkins, M. F. Hammer, Mol. Biol. Evol.30, 798 (2013).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR8A. R. Banday et al., medRxiv2021).GO TO REFERENCECROSSREFGOOGLE SCHOLAR9E. Pairo-Castineira et al., Nature591, 92 (2021).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR10J. K. Lim et al., PLOS Pathog.5, e1000321 (2009).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR11M. K. El Awady et al., J. Gastroenterol. Hepatol.26, 843 (2011).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR12F. W. Soveg et al., eLife10, e71047 (2021).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR13T. Asano et al., Sci. Immunol.6, eabl4348 (2021).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR14C. Fallerini et al., eLife10, e67569 (2021).CROSSREFPUBMEDGOOGLE SCHOLAR15C. I. van der Made et al., JAMA324, 663 (2020).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR

For more on COVID-19 Please see our Coronavirus Portal at

Moderna Vaccine Patent Application needs to include Names of Three NIH Scientists that Shared the Genome Sequence of SAR-Cov-2 with Moderna Early on

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 11/12/2021

Within the filing, Moderna said it had “reached the good-faith determination” that three NIH scientists — John Mascola, Barney Graham and Kizzmekia Corbett — “did not co-invent” the sequence that prompts the body’s immune response to the coronavirus spike protein. The NIH, meanwhile, says the trio worked with Moderna at the outset of the pandemic to design the component in question.

In response to an Endpoints News request for comment, a Moderna spokesperson said the company has “all along” recognized the role the NIH played in developing the Covid-19 shot. But the spokesperson insisted only Moderna scientists invented mRNA-1273 — the codename for the company’s vaccine.

In the new book A Shot to Save the World out last month detailing the inventions of the mRNA Covid-19 vaccines, Wall Street Journal reporter Gregory Zuckerman wrote the three NIH scientists in question designed a sequence for a vaccine and sent it to Moderna. The biotech then used it to confirm their own designs and produce that vaccine.

Zuckerman wrote:

On Thursday, January 23, Wang packed his material in a container, trying hard to ensure it didn’t leak, and shipped it all to Kizzmekia Corbett, the government scientist who was doing similar work with other’s in Graham’s lab. Corbett, Graham and John Mascola chose an ideal spike-protein design and sent it to Moderna. The company’s scientists, relying on McLellan and Wang’s earlier work, had built their own spike-protein design. It matched the one from the government scientists, confirming they made the right choice. Moderna took their chosen sequence, employed some sophisticated computer software, and built an mRNA molecule capable of producing the stabilized spike protein. This would become Moderna’s vaccine antigen.

SOURCE

What Moderna says: The company argues that the NIH scientists — John Mascola, Barney Graham and Kizzmekia Corbett — were not part of selecting the messenger RNA sequence that became the Covid-19 shot authorized today. That sequence patent is essentially the heart of the product.

Moderna “has recognized the substantial role that the NIAID has played” in the vaccine development by including those scientists on other patents but “just because someone is an inventor on one patent application relating to our COVID-19 vaccine does not mean they are an inventor on every patent application relating to the vaccine,” it tweeted.

“Moderna remains the only company to have pledged not to enforce its COVID-19 intellectual property during the pandemic,” the company added.

It’s far from over: Moderna, which never brought a product to market before its effective Covid-19 shot, has received nearly $10 billion in government funding for the vaccine — a figure that advocates return to repeatedly when pressing for global access to patents and production.

SOURCE

From: POLITICO Pulse <pulse@email.politico.com>
Reply-To: “POLITICO, LLC” <reply-fe8c1d737662017574-630320_HTML-638333449-1376319-0@politicoemail.com>
Date: Friday, November 12, 2021 at 10:02 AM
To: Aviva Lev-Ari <Avivalev-ari@alum.Berkeley.edu>
Subject: Moderna vs. The Government

11/9/2021 and 11/11/2021

The NIH told the New York Times earlier this week that three of its scientists — John Mascola, Barney Graham, who recently retired, and Kizzmekia Corbett, who has since moved over to Harvard — worked with Moderna to design the genetic sequence that prompts the vaccine to produce an immune response.

“I think Moderna has made a serious mistake here in not providing the kind of co-inventorship credit to the people who played a major role in the development of the vaccine that they are now making a fair amount of money on. We did our best to try to resolve this and ultimately failed but we are not done,” NIH Director Francis Collins told Reuters in an interview yesterday.

Dr. Barney Graham, left, and his colleague at the time, Dr. Kizzmekia Corbett, right, explaining the role of spike proteins to President Biden at the National Institutes of Health in Bethesda, Md., in February 2021

The vaccine grew out of a four-year collaboration between Moderna and the N.I.H., the government’s biomedical research agency — a partnership that was widely hailed when the shot was found to be highly effective. A year ago this month, the government called it the “N.I.H.-Moderna Covid-19 vaccine.”

The agency says three scientists at its Vaccine Research Center — Dr. John R. Mascola, the center’s director; Dr. Barney S. Graham, who recently retired; and Dr. Kizzmekia S. Corbett, who is now at Harvard — worked with Moderna scientists to design the genetic sequence that prompts the vaccine to produce an immune response, and should be named on the “principal patent application.”

https://www.nytimes.com/2021/11/09/us/moderna-vaccine-patent.html?referringSource=articleShare

If the three agency scientists are named on the patent along with the Moderna employees, the federal government could have more of a say in which companies manufacture the vaccine, which in turn could influence which countries get access. It would also secure a nearly unfettered right to license the technology, which could bring millions into the federal treasury.

“Omitting N.I.H. inventors from the principal patent application deprives N.I.H. of a co-ownership interest in that application and the patent that will eventually issue from it.”

According to the NYT article,

But experts said the disputed patent was the most important one in Moderna’s growing intellectual property portfolio. It seeks to patent the genetic sequence that instructs the body’s cells to make a harmless version of the spike proteins that stud the surface of the coronavirus, which triggers an immune response.

While it has not publicly acknowledged the rift until now, the Biden administration has expressed frustration that Moderna has not done more to provide its vaccine to poorer nations even as it racks up huge profits.

Epidemiological measurement on COVID-19 pandemic may have statistical biases which might affect next variant responses

Reporter: Stephen J. Williams Ph.D.

Source: https://www.science.org/doi/10.1126/science.abi6602

From the jounal Science

Tackling the pandemic with (biased) data

CHRISTINA PAGEL AND CHRISTIAN A. YATESSCIENCE•22 Oct 2021•Vol 374, Issue 6566•pp. 403-404•DOI: 10.1126/science.abi66027,757

Accurate and near real-time data about the trajectory of the COVID-19 pandemic have been crucial in informing mitigation policies. Because choosing the right mitigation policies relies on an accurate assessment of the current state of the local epidemic, the potential ramifications of misinterpreting data are serious. Each data source has inherent biases and pitfalls in interpretation. The more data sources that are interpreted in combination, the easier it is to detect genuine changes in an epidemic. Recently, in many countries, this has involved disentangling the varying impact of rising but heterogeneous vaccination rates, relaxation of mitigations, and the emergence of new variants such as Delta.The exact data collected and their accuracy will vary by country. Typical data common to many countries are numbers of tests, confirmed cases, hospital and intensive care unit (ICU) admissions and occupancy, deaths, and vaccinations (1). Many countries additionally sequence a proportion of new positive tests to identify and track emerging variants. Some countries also now collect and publish data on infections, hospitalizations, and deaths by vaccination status (e.g., Israel and the UK). Stratifying all available data by different demographic factors (e.g., age, location, measures of deprivation, and ethnicity) is crucial for understanding patterns of spread, potential impact of policies, and efficacy of vaccines (age, timing of breakthrough infections, and prevalent variants).It is also necessary to be aware of what data are not being collected. For example, persistent symptoms of COVID-19 (Long Covid) were recognized as a long-term adverse outcome by the autumn of 2020. However, no simple diagnostic test has been associated with the up to 200 different reported symptoms (2). Counting Long Covid relies on a clinical diagnosis, based on a history of having had COVID-19 and a failure to fully recover, with development of some characteristic symptoms and with no obvious alternative cause (3). These features make it very difficult to measure routinely, and so it rarely is. As a result, Long Covid is often neglected in decision-making. Failure to account for the disease load associated with Long Covid may lead to an unnecessary long-term societal health burden.The feedback between different types of outcomes, different severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, different mitigation policies (including vaccination), and individual risks (a combination of exposure and clinical risk) is complex and must be factored into both interpretation of data and the development of policy. Using all available data to quantify transmission is crucial to ensuring rapid and effective responses to early phases of renewed exponential growth and to evaluating mitigation measures. Relying too much on a single data source, or without disaggregating data, risks fundamentally misunderstanding the state of the epidemic.The inherent biases and lags in data are particularly important to understand from the point of view of policy-makers. Because of the natural time scales of COVID-19 disease progression (see the figure), policy changes can take several weeks to show up in the data. Purely reactive policy-making is likely to be ineffective. When cases are rising, increases in hospital admissions and deaths will follow. When a new variant is outcompeting existing strains, it is likely to become dominant without action to suppress. The precautionary principle suggests acting early and emphatically. Conversely, when releasing restrictions, governments must wait long enough to assess them before continuing with re-opening.The most up-to-date indicator of the state of the epidemic is typically the number of confirmed cases, as ascertained through testing of both symptomatic individuals and those tested frequently regardless of symptoms. Symptom-based testing is likely to pick up more adults and fewer younger individuals (4). Infections in children are harder to detect: children are more likely to be asymptomatic than adults, are harder to administer tests to (particularly young children), are often exposed to other viruses with similar symptoms, and can present with symptoms that are atypical in adults (e.g., abdominal pain or nausea). Children under 12 are not routinely offered the COVID-19 vaccination, and their mixing in schools provides ongoing opportunities for the virus to circulate, so it will be important for countries to track infections in children as accurately as possible. Other testing biases include accessibility, reporting lags, and the ability to act lawfully upon receiving a positive result. Substantial changes in the number of people seeking tests may further confound case figures (5). Case positivity rates may provide a more accurate reflection of the state of the epidemic (6) but are dependent on the mix of symptomatic and asymptomatic people being tested.SARS-CoV-2 variants have been an important driver of local epidemics in 2021. The four main SARS-CoV-2 variants of concern, to date, are B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), and B.1.617.2 (Delta). Some have been more transmissible (Alpha), some have substantial resistance to previous infection or vaccines (Beta), and some have elements of both (Gamma and Delta) (7). Currently, the high transmissibility of Delta combined with some immune evasion has made it the world’s dominant variant. Determining which variants pose a substantial threat is difficult and takes time, particularly when many variants cocirculate. This is especially true for situations in which a dominant variant is declining, and a new one growing. While the declining variant remains dominant, its decrease masks increases in the new variant because case numbers remain unchanged or fall overall. Only when a new variant becomes dominant does its growth become apparent in aggregated case data, by which time it is, by definition, too late to contain its spread. This dynamic has been observed across the world with Delta over the latter half of 2021.With multiple variants circulating, there are, effectively, multiple epidemics occurring in parallel, and they must be tracked separately. This typically requires the availability of sequencing data, which is unfortunately limited in most countries. Sequencing takes time and so is typically a few weeks out of date. These lags, and the uncertainty in sampling, can lead to hesitancy in acting. The rapid path to dominance of the Delta variant in the UK highlights the need for action when a quickly growing variant represents a few percent (or less) of overall cases.Hospital admissions or occupancy data do not suffer the same biases associated with testing behaviors and provide unequivocal evidence of widespread transmission, its geography, and demographics. However, hospital admissions lag infections more than reported cases do, rendering these data less useful for proactive decision-making. Hospital data are also biased toward older people, who are more likely to suffer severe COVID-19, and now, unvaccinated populations. ICU occupancy data show a younger age profile than admissions because younger patients have a better chance of benefitting from the invasive treatment procedures (8).Deaths are the most lagged indicator, typically occurring 3 or more weeks after infection and with an additional lag in registration and reporting. Death data should never be used to inform real-time policy decisions. Instead, death figures can act as an eventual measure of the success of a country’s epidemic strategy and implementation. The age distribution of those who eventually die from COVID-19 is different from other metrics of the epidemic—skewed furthest toward older age groups (9). Those with clinical risk factors (such as immunodeficiency, obesity, or existing lung conditions), high exposure (health care workers and low-income workers), and the unvaccinated are overrepresented in COVID-19 deaths.In countries with high vaccination rates, vaccination has had a substantial impact—reducing COVID-19 cases, hospitalizations, and deaths. However, when looking at the raw numbers in highly vaccinated populations, it can be the case that more fully vaccinated people are dying of COVID-19 than unvaccinated. If these raw statistics are misinterpreted—or worse, deliberately misused—they can damage vaccine confidence. More vaccinated people may die than unvaccinated because such a high proportion of people are vaccinated (10). This does not mean vaccines are not effective at preventing death. Looking at the rates of death in vaccinated and unvaccinated individuals separately within age groups demonstrates that vaccines provide considerable protection against severe disease and death. This example illustrates how important it is to curate and manage the way in which data are presented.

COVID-19 progressionAn approximate timeline from infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to various outcomes. When current infections show up in different data sources depends on this timeline. Collecting data for Long Covid, asymptomatic infection, and vaccine history will improve understanding of the pandemic.GRAPHIC: N. CARY/SCIENCE

Each country has established its own vaccination priority lists and dosing schedules to best achieve its goals (1112). Each of these strategies will manifest differently in the data. Additionally, many countries are using multiple vaccines in tandem and administer them differently for different demographics. Some countries are vaccinating adolescents, and others are not or not offering them the full approved dose. Most vaccines require two doses, spaced between 3 and 12 weeks apart, except for the Johnson & Johnson single-dose vaccine. This matters, particularly as variants spread, because different vaccines have different effectiveness after one and two doses, different timelines to full effectiveness, and different effectiveness against variants (13).Data published on the vaccination delivery itself must thus go beyond the raw numbers of people vaccinated. Vaccine uptake must be reported by whether fully or partially (one-dose in a two-dose regimen) vaccinated and using the whole population as a denominator. It is vital to disaggregate vaccine data by age, gender, and ethnicity as well as location so that it is possible, for example, to understand the impact of deprivation on vaccine coverage or vaccine hesitancy in particular demographics. When interpreting vaccination data, it is important to remember that there is also a lag between delivery and the build-up of immunity.Data on reinfection and post-vaccination (breakthrough) infection are also important to determine the relative benefits of infection-mediated and vaccine-mediated immunity and the length of protection offered. Studies that show those who were immunized earlier were acquiring COVID-19 with higher rates than those vaccinated more recently may suggest waning vaccine protection (14). Such studies have already prompted vaccine booster programs in some countries. However, any study that suggests waning immunity must be extremely careful to ensure that the “early” and “recent” subgroups are properly controlled. Differences in prior exposure, affluence, education level, age, and other demographic factors between these cohorts may be enough to explain the disparities in SARS-CoV-2 infection rates, even in the absence of waning immunity. Waning immunity must also be reported separately for different outcomes; for example, there might be waning in terms of preventing symptomatic infection but far less or none in preventing death (15). Additionally, there are ethical concerns about mass booster programs in high-income countries while many lower-income countries have been unable to procure vaccines.Moving into the vaccination era, reported cases, hospitalizations, and deaths should also be disaggregated by vaccination status (and by which vaccine), which will be easier in countries where national linked datasets exist. Additionally, incorporating Long Covid into routine reporting and policy-making is crucial. Consistent diagnostic criteria and well-controlled studies will be vital to this effort. These elusive data will be of critical importance to navigate our way successfully out of the pandemic.

Acknowledgments

C.P. and C.A.Y. are both members of Independent SAGE: www.independentsage.org.

References and Notes

1M. Roser et al., Our World in Data (2021); https://bit.ly/3kepLgw.GO TO REFERENCEGOOGLE SCHOLAR2H. E. Davis et al., E. Clin. Med.38, 101019 (2021).GO TO REFERENCEGOOGLE SCHOLAR3M. Sivan, S. Taylor, BMJ371, m4938 (2020).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR4S. M. Moghadas et al., Proc. Natl. Acad. Sci. U.S.A.117, 17513 (2020).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR5J. Wise, BMJ370, m3678 (2020).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR6D. Dowdy, G. D’Souza, COVID-19 Testing: Understanding the “Percent Positive” (2020); https://bit.ly/3CeN8wl.GO TO REFERENCEGOOGLE SCHOLAR7C. E. Gómez et al., Vaccines (Basel)9, 243 (2021).CROSSREFPUBMEDGOOGLE SCHOLAR8A. B. Docherty et al., BMJ369, 1985 (2020).GO TO REFERENCECROSSREFPUBMEDGOOGLE SCHOLAR9Office for National Statistics, Deaths registered weekly in England and Wales by age and sex: covid-19 (2021); https://bit.ly/3Ci2obS.

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