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The WHO team is expected to soon publish a 300-page final report on its investigation, after scrapping plans for an interim report on the origins of SARS-CoV-2 — the new coronavirus responsible for killing 2.7 million people globally

March 27, 2021 by 2012pharmaceutical

The WHO team is expected to soon publish a 300-page final report on its investigation, after scrapping plans for an interim report on the origins of SARS-CoV-2 — the new coronavirus responsible for killing 2.7 million people globally

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 4/1/2021

Coronavirus: More work needed to rule out China lab leak theory says WHO

START QUOTE

The head of the World Health Organization (WHO) has said further investigation is needed to conclusively rule out that Covid-19 emerged from a laboratory in China.

Tedros Adhanom Ghebreyesus said that although a lab leak was the least likely cause, more research was needed.

The US and other countries have criticised China for failing to provide the WHO with sufficient data.

Beijing has always dismissed the allegations of a virus leak.

A report by WHO and Chinese experts released on Tuesday, said the lab leak explanation was highly unlikely and the virus had probably jumped from bats to humans via another intermediary animal.

China has yet to respond to the WHO’s latest statement.

‘All hypothesis on the table’

However the theory that the virus might have come from a leak in a laboratory “requires further investigation, potential with additional missions involving specialist experts,” Dr Tedros said on Tuesday.

“Let me say clearly that as far as WHO is concerned, all hypothesis remain on the table,” he added.

The virus was first detected in Wuhan, in China’s Hubei province in late 2019. An international team of experts travelled to to the city in January to probe the origins of the virus.

The team investigated all possibilities, including one theory that the virus had originated at the Wuhan Institute of Virology. The institute is the world’s leading authority on the collection, storage and study of bat coronaviruses.

International criticism

In response to the WHO report, the US and 13 allies including South Korea, Australia and the UK voiced concern over the findings and urged China to provide “full access” to experts.

The statement said the mission to Wuhan was “significantly delayed and lacked access to complete, original data and samples”.

“Scientific missions like these should be able to do their work under conditions that produce independent and objective recommendations and findings.”

The group pledged to work together with the WHO.

Former US President Donald Trump was among those who supported the theory that the virus might have escaped from a lab.

WHO investigation team leader, Peter Ben Embarek said on Tuesday his team had felt under political pressure, including from outside China but said he was never pressed to remove anything from the team’s final report.

He also confirmed his team had found no evidence that any laboratories in Wuhan were involved in the outbreak.

MORE …

SOURCE

https://www.bbc.com/news/world-asia-china-56581246

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Ex-CDC Director Robert Redfield believes COVID-19 came from Wuhan lab

By Lia Eustachewich

March 26, 2021 | 10:03am | Updated

START QUOTE

The former director of the Centers for Disease Control and Prevention believes the virus that causes COVID-19 escaped from a lab in Wuhan, China, according to a new interview.

Robert Redfield told CNN on Friday that it was his “opinion” that SARS-CoV-2 — the new coronavirus responsible for killing 2.7 million people globally — did not evolve naturally.

“I’m of the point of view that I still think the most likely etiology of this pathology in Wuhan was from a laboratory — escaped,” said Redfield, who led the CDC during the height of the pandemic. “Other people don’t believe that. That’s fine. Science will eventually figure it out.”

Researchers believe the deadly and highly transmissible strain of coronavirus behind the global pandemic mutated from a virus that infects animals — namely, bats — to one that sickens humans.

But some believe the virus was somehow released from the Wuhan Institute of Virology — which is the only lab in China authorized to study the most dangerous known pathogens, according to Axios.

“It’s not unusual for respiratory pathogens that are being worked on in a laboratory to infect the laboratory worker. … That’s not implying any intentionality,” Redfield said. “It’s my opinion, right? But I am a virologist. I have spent my life in virology.

“I do not believe this somehow came from a bat to a human and at that moment in time, that the virus came to the human, became one of the most infectious viruses that we know in humanity for human-to-human transmission.”

Redfield said usually when a virus jumps from animals to humans, “it takes a while for it to figure out how to become more and more efficient in human-to-human transmission.”

SOURCE

https://nypost.com/2021/03/26/ex-cdc-director-believes-covid-19-came-from-wuhan-lab/?utm_campaign=SocialFlow&utm_source=NYPTwitter&utm_medium=SocialFlow

START QUOTE

What they’re saying: “I’m of the point of view that I still think the most likely etiology of this pathology in Wuhan was from a laboratory. Escaped. Other people don’t believe that. That’s fine. Science will eventually figure it out,” Redfield told CNN’s Sanjay Gupta.

  • “It’s not unusual for respiratory pathogens that are being worked on in a laboratory to infect the laboratory worker. … That’s not implying any intentionality. It’s my opinion, right? But I am a virologist. I have spent my life in virology,” he continued.
  • “I do not believe this somehow came from a bat to a human and at that moment in time that the virus came to the human, became one of the most infectious viruses that we know in humanity for human-to-human transmission.”

Between the lines: Lab accidents in the U.S. are not especially rare, as USA Today’s Alison Young noted in a recent opinion piece arguing why the Wuhan lab theory cannot be ruled out. The CDC itself experienced a possible contamination in a lab where it was making COVID-19 test kits early in the pandemic.

What to watch: The WHO team is expected to soon publish a 300-page final report on its investigation, after scrapping plans for an interim report amid mounting tensions between the U.S. and China.

SOURCE

https://www.axios.com/wuhan-lab-coronavirus-cdc-director-c599cf7b-9e30-4314-909b-a9bdac28ead6.html?utm_source=twitter&utm_medium=social&utm_campaign=editorial&utm_content=health-covid

Posted in COVID-19, Mechanisms of infection by SARS-CoV-2, Population Health Management, Population Health Management, Genetics & Pharmaceutical, SARS-CoV-2, Virtual Drug Molecule Screening targeting SAR-CoV-2 proteins, Virus Infective Acute Respiratory Syndrome: SARS-CoV | Leave a Comment »

Protected: How to position LPBI for a Sale – Joel’s Conversation with Aditya Bahl, 3/23/2021

March 24, 2021 by 2012pharmaceutical

This content is password-protected. To view it, please enter the password below.

Posted in LPBI Group, e-Scientific Media, DFP, R&D-M3DP, R&D-Drug Discovery, US Patents: SOPs and Team Management |

Gene Therapy could be a Boon to Alzheimer’s disease (AD): A first-in-human clinical trial proposed

March 22, 2021 by Dr. Pati

Gene Therapy could be a Boon to Alzheimer’s disease (AD): A first-in-human clinical trial proposed

Reporter: Dr. Premalata Pati, Ph.D., Postdoc

A recent research work performed by the Researchers at the University of California San Diego School of Medicine has shared their first-in-human Phase I clinical trial to assess the safety and viability of gene therapy to deliver a key protein into the brains of persons with Alzheimer’s Disease (AD) or Mild Cognitive Impairment (MCI), a condition that often precedes full-blown dementia.  

Mark Tuszynski, M.D., Ph.D., Professor of Neuroscience and Director of the Translational Neuroscience Institute at UC San Diego and team predicted that Gene therapy could be a boon to potential treatments for the disorders like AD and MCI.

The study provides an insight into the genetic source of these mental diseases.

The roots of mental disorders have remained an enigma for so many years. Alzheimer’s disease (AD) is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks. AD is a neurodegenerative condition. A buildup of plaques and tangles in the brain, along with cell death, causes memory loss and cognitive decline. In most people with the disease, those with the late-onset type – symptoms first appear in their mid-60s. Alzheimer’s disease is the mostly appearing type of dementia in patients.

Drawing comparing a normal aged brain (left) and the brain of a person with Alzheimer’s (right).
Image Source: https://en.wikipedia.org/wiki/Alzheimer%27s_disease

What the study impart?

Despite decades of effort and billions of dollars of research investment, there are just mere two symptomatic treatments for AD. There is no cure or approved way to slow or stop the progression of the neurological disorder that afflicts more than 5 million Americans and is the sixth leading cause of death in the United States.

Prof. Tuszynski said gene therapy has been tested on multiple diseases and conditions, represents a different approach to a disease that requires new ways of thinking about the disease and new attempts at treatments.

The research team found that delivering the BDNF to the part of the brain that is affected earliest in Alzheimer’s disease; the entorhinal cortex and hippocampus – was able to protect from ongoing cell degeneration by reversing the loss of connections. “These trials were observed in aged rats, amyloid mice, and aged monkeys.”

The protein, called Brain-Derived Neurotrophic Factor or BDNF, a family of growth factors found in the Brain and Central Nervous System that support the survival of existing neurons and promote growth and differentiation of new neurons and synapses. BDNF is especially important in brain regions susceptible to degeneration in AD. It is normally produced throughout life in the entorhinal cortex, an important memory center in the brain and one of the first places where the effects of AD typically appear in the form of short-term memory loss. Persons with AD have diminished levels of BDNF.

However, BDNF is a large molecule and cannot pass through the Blood-Brain Barrier. As a solution, researchers will use gene therapy in which a harmless Adeno-Associated Virus (AAV2) is modified to carry the BDNF gene and injected directly into targeted regions of the brain, where researchers hope it will prompt the production of therapeutic BDNF in nearby cells.

Precautions were taken precisely in injecting the patient to avoid exposure to surrounding degenerating neurons since freely circulating BDNF can cause adverse effects, such as seizures or epileptic conditions.

The recent research and study speculate a safe and feasible assessment of the AAV2-BDNF pathway in humans. A previous gene therapy trial from 2001 to 2012 using AAV2 and a different protein called Nerve Growth Factor (NGF) was carried out by Prof. Tuszynski and team where they observed immense growth, axonal sprouting, and activation of functional markers in the brains of participants.

He also shared that “The BDNF gene therapy trial in AD represents an advancement over the earlier NGF trial, BDNF is a more potent growth factor than NGF for neural circuits that degenerate in AD. Besides, new methods for delivering BDNF will more effectively deliver and distribute it into the entorhinal cortex and hippocampus.”

The research team hopes that the three-year-long trial will recruit 12 participants with either diagnosed AD or MCI to receive AAV2-BDNF treatment, with another 12 persons serving as comparative controls over that period.

The researchers have plans to build on recent successes of gene therapy in other diseases, including a breakthrough success in the treatment of congenital weakness in infants (spinal muscular atrophy) and blindness (Leber Hereditary Optic Neuropathy, a form of retinitis pigmentosa).”

Main Source

https://www.universityofcalifornia.edu/news/could-gene-therapy-halt-progression-alzheimers-disease-first-human-clinical-trial-will-seek?utm_source=fiat-lux

Related Articles

Connecting the Immune Response to Amyloid-β Aggregation in Alzheimer’s Disease via IFITM3
New Explanations for Evolution of Alzheimer’s Disease (AD): The Association between Brain neuroanatomy,  Brain Pathology and AD Biomarkers – Orientation and Attention are affected by the roles of Temporo-parietal junction (TPJ), Ventral attentional control network, Theory of mind, Inferior parietal cortex
Alzheimer’s Disease and Diabetes Mellitus
https://pharmaceuticalintelligence.com/2016/04/21/alzheimers-disease-and-dm/
Role of infectious agent in Alzheimer’s Disease?
https://pharmaceuticalintelligence.com/2016/03/21/role-of-infectious-agent-in-alzheimers-disease/
Alzheimer’s Disease – tau art thou, or amyloid
https://pharmaceuticalintelligence.com/2016/02/15/alzheimers-disease-tau-art-thou-or-amyloid/

Posted in Alzheimer's Disease, Drug Carrier Design, Gene Therapy & Gene Editing Development, Neurodegenerative Diseases, Neurological Diseases | Tagged , , , , | Leave a Comment »

Two brothers with MEPAN Syndrome: A Rare Genetic Disorder

March 21, 2021 by Amandeep Kaur

Two brothers with MEPAN Syndrome: A Rare Genetic Disorder

Reporter: Amandeep Kaur

In the early 40s, a married couple named Danny and Nikki, had normal pregnancy and delivered their first child in October 2011.  The couple was elated after the birth of Carson because they were uncertain about even conceiving a baby. Soon after birth, the parents started facing difficulty in feeding the newborn and had some wakeful nights, which they used to called “witching hours”. For initial six months, they were clueless that something was not correct with their infant. Shortly, they found issues in moving ability, sitting, and crawling with Carson. Their next half year went in visiting several behavioral specialists and pediatricians with no conclusion other than a suggestion that there is nothing to panic as children grow at different rates.

Later in early 2013, Caron was detected with cerebral palsy in a local regional center. The diagnosis was based on his disability to talk and delay in motor development. At the same time, Carson had his first MRI which showed no negative results. The parents convinced themselves that their child condition would be solved by therapies and thus started physical and occupational therapies. After two years, the couple gave birth to another boy child named Chase in 2013. Initially, there was nothing wrong with Chase as well. But after nine months, Chase was found to possess the same symptoms of delaying in motor development as his elder brother. It was expected that Chase may also be suffering from cerebral palsy. For around one year both boys went through enormous diagnostic tests starting from karyotyping, metabolic screen tests to diagnostic tests for Fragile X syndrome, lysosomal storage disorders, Friedreich ataxia and spinocerebellar ataxia. Gene panel tests for mitochondrial DNA and Oxidative phosphorylation (OXPHOS) deficiencies were also performed. No conclusion was drawn because each diagnostic test showed the negative results.

Over the years, the condition of boys was deteriorating as their movements became stiffer and ataxic, they were not able to crawl anymore. By the end of 2015, the boys had an MRI which showed some symmetric anomalies in their basal ganglia indicating a metabolic condition. The symptoms of Carson and Chase was not even explained by whole exome sequencing due to the absence of any positive result. The grievous journey of visits to neurologist, diagnostic tests and inconclusive results led the parents to rethink about anything happened erroneous due to them such as due to their lifestyle, insufficient intake of vitamins during pregnancy or exposure to toxic agents which left their sons in that situation.

During the diagnostic odyssey, Danny spent many restless and sleepless nights in searching PubMed for any recent cases with symptoms similar to his sons and eventually came across the NIH’s Undiagnosed Diseases Network (UDN), which gave a light of hope to the demoralized family. As soon as Danny discovered about the NIH’s Diseases Network, he gathered all the medical documents of both his sons and submitted the application. The submitted application in late 2015 got accepted a year later in December 2016 and they got their first appointment in early 2017 at the UDN site at Stanford. At Stanford, the boys had gone through whole-genome sequencing and some series of examinations which came back with inconclusive results. Finally, in February 2018, the family received some conclusive results which explained that the two boys suffer from MEPAN syndrome with pathogenic mutations in MECR gene.

  • MEPAN means Mitochondrial Enoyl CoA reductase Protein-Associated Neurodegeneration
  • MEPAN syndrome is a rare genetic neurological disorder
  • MEPAN syndrome is associated with symptoms of ataxia, optic atrophy and dystonia
  • The wild-type MECR gene encodes a mitochondrial protein which is involved in metabolic processes
  • The prevalence rate of MEPAN syndrome is 1 in 1 million
  • Currently, there are 17 patients of MEPAN syndrome worldwide

The symptoms of Carson and Chase of an early onset of motor development with no appropriate biomarkers and T-2 hyperintensity in the basal ganglia were matching with the seven known MEPAN patient at that time. The agonizing journey of five years concluded with diagnosis of rare genetic disorder.

Despite the advances in genetic testing and their low-cost, there are many families which still suffer and left undiagnostic for long years. To shorten the diagnostic journey of undiagnosed patients, the whole-exome and whole-genome sequencing can be used as a primary tool. There is need of more research to find appropriate treatments of genetic disorders and therapies to reduce the suffering of the patients and families. It is necessary to fill the gap between the researchers and clinicians to stimulate the development in diagnosis, treatment and drug development for rare genetic disorders.

The family started a foundation named “MEPAN Foundation” (https://www.mepan. org) to reach out to the world to educate people about the mutation in MECR gene. By creating awareness among the communities, clinicians, and researchers worldwide, the patients having rare genetic disorder can come closer and share their information to improve their condition and quality of life.

Reference: Danny Miller, The diagnostic odyssey: our family’s story, The American Journal of Human Genetics, Volume 108, Issue 2, 2021, Pages 217-218, ISSN 0002-9297, https://doi.org/10.1016/j.ajhg.2021.01.003 (https://www.sciencedirect.com/science/article/pii/S0002929721000033)

Sources:

https://www.variantyx.com/2020/02/26/in-silico-panel-expansion/

https://www.orpha.net/consor/cgi-bin/OC_Exp.php?lng=EN&Expert=508093

https://www.mepan. org

Other related articles were published in this Open Access Online Scientific Journal, including the following:

Effect of mitochondrial stress on epigenetic modifiers

Larry H. Bernstein, MD, FCAP, Curator, LPBI

https://pharmaceuticalintelligence.com/2016/05/07/effect-of-mitochondrial-stress-on-epigenetic-modifiers/

The Three Parent Technique to Avoid Mitochondrial Disease in Embryo

Reporter and Curator: Dr. Sudipta Saha, Ph.D.

https://pharmaceuticalintelligence.com/2016/10/07/the-three-parent-technique-to-avoid-mitochondrial-disease-in-embryo/

New Insights into mtDNA, mitochondrial proteins, aging, and metabolic control

Larry H. Bernstein, MD, FCAP, Curator, LPBI

https://pharmaceuticalintelligence.com/2016/04/20/new-insights-into-mtdna-mitochondrial-proteins-aging-and-metabolic-control/

Mitochondrial Isocitrate Dehydrogenase and Variants

Writer and Curator: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/04/02/mitochondrial-isocitrate-dehydrogenase-and-variants/

Update on mitochondrial function, respiration, and associated disorders

Larry H. Benstein, MD, FCAP, Gurator and writer

https://pharmaceuticalintelligence.com/2014/07/08/update-on-mitochondrial-function-respiration-and-associated-disorders/

Posted in Academic Publishing, Behavioral Genetics, Biological Networks, Biomarkers & Medical Diagnostics, Cerebrovascular and Neurodegenerative Diseases, Chemical Biology and its relations to Metabolic Disease, Clinical Diagnostics, Clinical Genomics, Disease Biology, Medical Devices R&D Investment, Metabolism, Molecular Genetics & Pharmaceutical, MRI, mtDNA, Neurodegenerative Diseases, Neurological Diseases, Oxidative phosphorylation | Tagged , , , , , , , , , , , , | Leave a Comment »

National Resilience, Inc. is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption – the Acquisition of Two Premier Biologics Manufacturing Facilities: Boston and in Ontario, Canada

March 4, 2021 by 2012pharmaceutical

National Resilience, Inc. is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption – the Acquisition of Two Premier Biologics Manufacturing Facilities: Boston and in Ontario, Canada

 

Reporter: Aviva Lev-Ari, PhD, RN

Resilience’s new facility, located at 500 Soldiers Field Rd., Boston, MA. (Photo: Business Wire) – The Genzyme-Sanofi Building

 

SAN DIEGO & BOSTON–(BUSINESS WIRE)–Resilience (National Resilience, Inc.), a new company building the world’s most advanced biopharmaceutical manufacturing ecosystem, announced it has acquired two premier commercial manufacturing facilities in North America, joining other facilities already in Resilience’s network to boost total capacity under management to more than 750,000 square feet.

“These locations will serve as hubs for the future of biopharma manufacturing, leading the way and shaping the future of Resilience.”

  • The acquired facilities include a 310,000-square-foot plant in Boston, MA, purchased from Sanofi; and in a separate transaction,
  • a 136,000-square-foot plant in Mississauga, Ontario, Canada.

Both facilities, which currently produce commercial, marketed products, will see significant investments as Resilience adds capacity and capabilities to produce new therapies at these locations. In addition, the company has offered employment to the existing plant staff and intends to add more jobs at each facility.

“We have big plans for these facilities including investing in new capacity, applying new manufacturing technologies, creating jobs and bringing in new customers,” said Rahul Singhvi, Sc.D, Chief Executive Officer of Resilience. “These locations will serve as hubs for the future of biopharma manufacturing, leading the way and shaping the future of Resilience.”

As part of its agreement with Sanofi, Resilience will continue to manufacture a marketed product at the Boston location. The facility plan includes a build out to facilitate multi-modality manufacturing and state-of-the-art quality laboratories to ensure safe, reliable supply to patients. The facility itself is certified ISO 14001 (Environmental management system), OSHAS 18001 (Health & safety management system) and ISO 50001 (Energy management system).​

This is currently the largest of several facilities in Resilience’s growing biologics and advanced therapeutics manufacturing network, with plans to acquire and develop other sites in the U.S. this year. The facility offers 24/7/365 production, multiple 2000L bioreactors capacity and multiple downstream processing trains, with investment in additional capabilities to come.

Our state-of-the-art flexible facility in Mississauga, Ontario, provides upstream, downstream and aseptic fill finish, and is designed to comply with cGMP. The plant has been inspected and approved by multiple regulatory bodies, and handles development and commercialized products.

About Resilience

Resilience (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience offers the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients’ lives.

For more information, visit www.Resilience.com.

Contacts

Ryan Flinn
Head of Communications
Ryan.flinn@Resilience.com
510-207-7616

SOURCE

https://www.businesswire.com/news/home/20210302005391/en/Resilience-Expands-North-American-Capacity-with-the-Acquisition-of-Two-Premier-Biologics-Manufacturing-Facilities

Posted in Advanced Drug Manufacturing Technology, Automated Cell Processing, Bio Instrumentation in Experimental Life Sciences Research, Biological Engineering, Biological Networks, Biological Networks, Gene Regulation and Evolution, Biomedical Measurement Science, BioTechnology - Venture Creation, Venture Capital, Seeking Talent, Virology | Leave a Comment »

19 of the 49 New Therapeutic Molecular Entities FDA approved in 2020 — as well as a new Cell-based therapy — are Personalized Medicines

March 2, 2021 by 2012pharmaceutical

19 of the 49 New Therapeutic Molecular Entities FDA approved in 2020 — as well as a new Cell-based therapy — are Personalized Medicines

Reporter: Aviva Lev-Ari, PhD, RN

 

2020 DRUG APPROVALS

19 of the 49 new therapeutic molecular entities FDA approved in 2020 — as well as a new cell-based therapy — are personalized medicines.

Newly Approved Therapeutic Molecular Entities

1. Ayvakit (avapritinib) — for the treatment of metastatic gastrointestinal stromal tumor (GIST). The decision to use this product is informed by the PDGFRA exon 18 biomarker status in the tumors of patients.

2. Nexletol (bempedoic acid) — for the treatment of adults with familial hypercholesterolemia who require additional lowering of LDL-C. The use of this product can be informed by the FH biomarker (LOLR, APOB, PCSK9) status in patients.

3. Tukysa (tucatinib) — for the treatment of metastatic breast cancer. The decision to use this product is informed by the HER2 biomarker status in the tumors of patients.

4. Pemazyre (pemigatinib) — for the treatment of cholangiocarcinoma. The decision to use this product is informed by the FGFR2 biomarker status in the tumors of patients.

5. Trodelvy (sacituzumab govitecan-hziy) — for the treatment of metastatic triple-negative breast cancer. The decision to use this product is informed by the estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) biomarker statuses in the tumors of patients. Personalized Medicine at FDA 7

6. Tabrecta (capmatinib) — for the treatment of non-small cell lung cancer (NSCLC). The decision to use this product is informed by the MET exon 14 biomarker status in the tumors of patients.

7. Retevmo (selpercatinib) — for the treatment of lung and thyroid cancers. The decision to use this product is informed by the RET fusion biomarker status in the tumors of patients.

8. Uplizna (inebilizumab-cdon) — for the treatment of neuromyelitis optica spectrum disorder. The decision to use this product is informed by the AQP4 biomarker status in patients.

9. Rukobia (fostemsavir) — for the treatment of human immunodeficiency virus (HIV) infection in adults with multidrug-resistant HIV-1 infection. The use of this product can be informed by the HIV-1 expression levels in patients.

10. Evrysdi (risdiplam) — for the treatment of spinal muscular atrophy. This product selectively targets the SMN2 biomarker in patients.

11. Olinvyk (oliceridine) — for the management of acute pain. The use of this product can be informed by the CYP2D6 biomarker status in patients.

12. Viltepso (viltolarsen) — for the treatment of Duchenne muscular dystrophy. This product selectively targets, and its use is informed by, the DMD gene exon 53 biomarker in patients.

13. Enspryng (satralizumab-mwge) — for the treatment of neuromyelitis optica spectrum disorder. The decision to use this product is informed by the AQP4 biomarker status in patients.

14. Gavreto (pralsetinib) — for the treatment of non-small cell lung cancer (NSCLC). The decision to use this product is informed by the RET fusion biomarker status in the tumors of patients.

15. Zokinvy (lonafarnib) — for the treatment of progeroid laminopathies. The decision to use this product is informed by the LMN4 and/or ZMPSTE24 biomarker statuses in patients. 8 Personalized Medicine at FDA Methodology: When evaluating new molecular entities, PMC defined personalized medicines as those therapeutic products for which the label includes reference to specific biological markers, often identified by diagnostic tools, that help guide decisions and/or procedures for their use in individual patients.

16. Oxlumo (lumasiran) — for the treatment of hyperoxaluria type 1. This product selectively targets the hydroxy acid oxidase 1 (HAO1) biomarker in patients.

17. Imcivree (setmelanotide) — for the treatment of obesity due to pro-opiomelanocortin (POMC) deficiency. The decision to use this product is informed by the POMC, PCSK1, or LEPR biomarker statuses in patients.

18. Orladeyo (berotralstat) — for the treatment of hereditary angioedema types I and II. The use of this product can be informed by the C1-INH biomarker status in patients.

19. Margenza (margetuximab-cmkb) — for the treatment of breast cancer. The decision to use this product is informed by the human epidermal growth factor receptor 2 (HER2) biomarker status in the tumors of patients. Newly Approved Cell-Based Therapy

20. Tecartus (brexucabtagene autoleucel) — for the treatment of mantle cell lymphoma (MCL). The treatment is a fully integrated CD19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of adult patients with refractory MCL.

 

SOURCE

https://mma.prnewswire.com/media/1436855/PM_at_FDA_The_Scope_Significance_of_Progress_in_2020.pdf?p=pdf

Posted in FDA Regulatory Affairs, New Drug Approval, Personalized and Precision Medicine & Genomic Research | Leave a Comment »

Happy 80th Birthday: Radioiodine (RAI) Theranostics: Collaboration between Physics and Medicine, the Utilization of Radionuclides to Diagnose and Treat: Radiation Dosimetry by Discoverer Dr. Saul Hertz, the early history of RAI in diagnosing and treating Thyroid diseases and Theranostics

March 2, 2021 by 2012pharmaceutical

Happy 80th Birthday: Radioiodine (RAI) Theranostics: Collaboration between Physics and Medicine, the Utilization of Radionuclides to Diagnose and Treat: Radiation Dosimetry by Discoverer Dr. Saul Hertz, the early history of RAI in diagnosing and treating Thyroid diseases and Theranostics

 

Guest Author: Barbara Hertz

 203-661-0777

htziev@aol.com

Celebrating eighty years of radionuclide therapy and the work of Saul Hertz

First published: 03 February 2021
https://doi.org/10.1002/acm2.13175

Both authors contributed to the development, drafting and final editing of this manuscript and are responsible for its content.

Abstract

March 2021 will mark the eightieth anniversary of targeted radionuclide therapy, recognizing the first use of radioactive iodine to treat thyroid disease by Dr. Saul Hertz on March 31, 1941. The breakthrough of Dr. Hertz and collaborator physicist Arthur Roberts was made possible by rapid developments in the fields of physics and medicine in the early twentieth century. Although diseases of the thyroid gland had been described for centuries, the role of iodine in thyroid physiology had been elucidated only in the prior few decades. After the discovery of radioactivity by Henri Becquerel in 1897, rapid advancements in the field, including artificial production of radioactive isotopes, were made in the subsequent decades. Finally, the diagnostic and therapeutic use of radioactive iodine was based on the tracer principal that was developed by George de Hevesy. In the context of these advancements, Hertz was able to conceive the potential of using of radioactive iodine to treat thyroid diseases. Working with Dr. Roberts, he obtained the experimental data and implemented it in the clinical setting. Radioiodine therapy continues to be a mainstay of therapy for hyperthyroidism and thyroid cancer. However, Hertz struggled to gain recognition for his accomplishments and to continue his work and, with his early death in 1950, his contributions have often been overlooked until recently. The work of Hertz and others provided a foundation for the introduction of other radionuclide therapies and for the development of the concept of theranostics.

SOURCE

https://aapm.onlinelibrary.wiley.com/doi/full/10.1002/acm2.13175

 

 

SOURCE

https://www.youtube.com/watch?v=34Qhm8CeMuc

 

http://www.wjnm.org/article.asp?issn=1450-1147;year=…

http://www.wjnm.org/text.asp?2019/18/1/8/250309

Abstract

Dr. Saul Hertz was Director of The Massachusetts General Hospital’s Thyroid Unit, when he heard about the development of artificial radioactivity. He conceived and brought from bench to bedside the successful use of radioiodine (RAI) to diagnose and treat thyroid diseases. Thus was born the science of theragnostics used today for neuroendocrine tumors and prostate cancer. Dr. Hertz’s work set the foundation of targeted precision medicine.

Keywords: Dr. Saul Hertz, nuclear medicine, radioiodine

 

How to cite this article:
Hertz B. A tribute to Dr. Saul Hertz: The discovery of the medical uses of radioiodine. World J Nucl Med 2019;18:8-12

 

How to cite this URL:
Hertz B. A tribute to Dr. Saul Hertz: The discovery of the medical uses of radioiodine. World J Nucl Med [serial online] 2019 [cited 2021 Mar 2];18:8-12. Available from: http://www.wjnm.org/text.asp?2019/18/1/8/250309

 

 

  • Dr Saul Hertz (1905-1950) discovers the medical uses of radioiodine

Barbara Hertz, Pushan Bharadwaj, Bennett Greenspan»

Abstract » PDF» doi: 10.24911/PJNMed.175-1582813482

 

SOURCE

http://saulhertzmd.com/home

 

  • Happy 80th Birthday: Radioiodine (RAI) Theranostics

Thyroid practitioners and patients are acutely aware of the enormous benefit nuclear medicine has made to mankind. This month we celebrate the 80th anniversary of the early use of radioiodine(RAI).

Dr. Saul Hertz predicted that radionuclides “…would hold the key to the larger problem of cancer in general,” and may just be the best hope for diagnosing and treating cancer successfully.  Yes, RAI has been used for decades to diagnose and treat disease.  Today’s “theranostics,” a term that is a combination of “therapy” and “diagnosis” is utilized in the treatment of thyroid disease and cancer. 

            This short note is to celebrate Dr. Saul Hertz who conceived and brought from bench to bedside the medical uses of RAI; then in the form of 25 minute iodine-128.  

On March 31st 1941, Massachusetts General Hospital’s Dr. Saul Hertz (1905-1950) administered the first therapeutic use of Massachusetts Institute of Technology (MIT) cyclotron produced RAI.  This landmark case was the first in Hertz’s clinical studies conducted with MIT, physicist Arthur Roberts, Ph.D.

[Photo – Courtesy of Dr Saul Hertz Archives ]

Dr Saul Hertz demonstrating RAI Uptake Testing

            Dr. Hertz’s research and successful utilization of radionuclides to diagnose and treat diseases and conditions, established the use of radiation dosimetry and the collaboration between physics and medicine and other significant practices.   Sadly, Saul Hertz (a WWII veteran) died at a very young age.  

 

About Dr. Saul Hertz

Dr. Saul Hertz (1905 – 1950) discovered the medical uses of radionuclides.  His breakthrough work with radioactive iodine (RAI) created a dynamic paradigym change integrating the sciences.  Radioactive iodine (RAI) is the first and Gold Standard of targeted cancer therapies.  Saul Hertz’s research documents Hertz as the first and foremost person to conceive and develop the experimental data on RAI and apply it in the clinical setting.

Dr. Hertz was born to Orthodox Jewish immigrant parents in Cleveland, Ohio on April 20, 1905. He received his A.B. from the University of Michigan in 1925 with Phi Beta Kappa honors. He graduated from Harvard Medical School in 1929 at a time of quotas for outsiders. He fulfilled his internship and residency at Mt. Sinai Hospital in Cleveland. He came back to Boston in 1931 as a volunteer to join The Massachusetts General Hospital serving as the Chief of the Thyroid Unit from 1931 – 1943.

Two years after the discovery of artifically radioactivity, on November 12, 1936 Dr. Karl Compton, president of the Massachusetts Institute of Technology (MIT), spoke at Harvard Medical School.  President Compton’s topic was What Physics can do for Biology and Medicine. After the presentation Dr. Hertz spontaneously asked Dr. Compton this seminal question, “Could iodine be made radioactive artificially?” Dr. Compton responded in writing on December 15, 1936 that in fact “iodine can be made artificially radioactive.”

Shortly thereafter, a collaboration between Dr. Hertz (MGH) and Dr. Arthur Roberts, a physicist of MIT, was established. In late 1937, Hertz and Roberts created and produced animal studies  involving 48 rabbits that demonstrated that the normal thyroid gland concentrated Iodine 128 (non cyclotron produced), and the hyperplastic thyroid gland took up even more Iodine.  This was a GIANT step for Nuclear Medicine.

In early 1941, Dr. Hertz administer the first therapeutic treatment of MIT Markle Cyclotron produced radioactive iodine (RAI) at the Massachusetts General Hospital.  This  led to the first series of twenty-nine patients with hyperthyroidism being treated successfully with RAI. ( see “Research” RADIOACTIVE IODINE IN THE STUDY OF THYROID PHYSIOLOGY VII The use of Radioactive Iodine Therapy in Hyperthyroidism, Saul Hertz and Arthur Roberts, JAMA Vol. 31 Number 2).

In 1937, at the time of the rabbit studies Dr Hertz conceived of RAI in therapeutic treatment of thyroid carsonoma.  In 1942 Dr Hertz gave clinical trials of RAI to patients with thyroid carcinoma.

After serving in the Navy during World War II, Dr. Hertz wrote to the director of the Mass General Hospital in Boston, Dr. Paxon on March 12, 1946, “it is a coincidence that my new research project is in Cancer of the Thyroid, which I believe holds the key to the larger problem of cancer in general.”

Dr. Hertz established the Radioactive Isotope Research Institute, in September, 1946 with a major focus on the use of fission products for the treatment of thyroid cancer, goiter, and other malignant tumors. Dr Samuel Seidlin was the Associate Director and managed the New York City facilities. Hertz also researched the influence of hormones on cancer.

Dr. Hertz’s use of radioactive iodine as a tracer in the diagnostic process, as a treatment for Graves’ disease and in the treatment of cancer of the thyroid remain preferred practices. Saul Hertz is the Father of Theranostics.

Saul Hertz passed at 45 years old from a sudden death heart attack as documented by an autopsy. He leaves an enduring legacy impacting countless generations of patients, numerous institutions worldwide and setting the cornerstone for the field of Nuclear Medicine. A cancer survivor emailed, The cure delivered on the wings of prayer was Dr Saul Hertz’s discovery, the miracle of radioactive iodine. Few can equal such a powerful and precious gift. 

To read and hear more about Dr. Hertz and the early history of RAI in diagnosing and treating thyroid diseases and theranostics see –

http://saulhertzmd.com/home

 

   References in https://www.wjnm.org/article.asp?issn=1450-1147;year=2019;volume=18;issue=1;spage=8;epage=12;aulast=Hertz

 

 Top

 

1.
Hertz S, Roberts A. Radioactive iodine in the study of thyroid physiology. VII The use of radioactive iodine therapy in hyperthyroidism. J Am Med Assoc 1946;131:81-6.  Back to cited text no. 1
2.
Hertz S. A plan for analysis of the biologic factors involved in experimental carcinogenesis of the thyroid by means of radioactive isotopes. Bull New Engl Med Cent 1946;8:220-4.  Back to cited text no. 2
3.
Thrall J. The Story of Saul Hertz, Radioiodine and the Origins of Nuclear Medicine. Available from: http://www.youtube.com/watch?v=34Qhm8CeMuc. [Last accessed on 2018 Dec 01].  Back to cited text no. 3
4.
Braverman L. 131 Iodine Therapy: A Brief History. Available from: http://www.am2016.aace.com/presentations/friday/F12/hertz_braverman.pdf. [Last accessed on 2018 Dec 01].  Back to cited text no. 4
5.
Hofman MS, Violet J, Hicks RJ, Ferdinandus J, Thang SP, Akhurst T, et al. [177Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): A single-centre, single-arm, phase 2 study. Lancet Oncol 2018;19:825-33.  Back to cited text no. 5
6.
Krolicki L, Morgenstern A, Kunikowska J, Koiziar H, Krolicki B, Jackaniski M, et al. Glioma Tumors Grade II/III-Local Alpha Emitters Targeted Therapy with 213 Bi-DOTA-Substance P, Endocrine Abstracts. Vol. 57. Society of Nuclear Medicine and Molecular Imaging; 2016. p. 632.  Back to cited text no. 6
7.
Baum RP, Kulkarni HP. Duo PRRT of neuroendocrine tumours using concurrent and sequential administration of Y-90- and Lu-177-labeled somatostatin analogues. In: Hubalewska-Dydejczyk A, Signore A, de Jong M, Dierckx RA, Buscombe J, Van de Wiel CJ, editors. Somatostatin Analogues from Research to Clinical Practice. New York: Wiley; 2015.  Back to cited text no. 7

 

SOURCE

From: “htziev@aol.com” <htziev@aol.com>

Reply-To: “htziev@aol.com” <htziev@aol.com>

Date: Tuesday, March 2, 2021 at 11:04 AM

To: “Aviva Lev-Ari, PhD, RN” <AvivaLev-Ari@alum.berkeley.edu>

Subject: Dr Saul Hertz : Discovery for the Medical Uses of RADIOIODINE (RAI) MARCH 31ST: 80 Years

 

Other related articles published in this Open Access Online Scientific Journal include the following:

 

Experience with Thyroid Cancer

Author: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/11/23/my-experience-with-thyroid-cancer/

 

New Guidelines and Meeting Information on Advanced Thyroid Cancer as Reported by Cancer Network (Meeting Highlights)

Reporter: Stephen J. Williams, Ph.D.

https://pharmaceuticalintelligence.com/2015/10/20/new-guidelines-and-meeting-information-on-advanced-thyroid-cancer-as-reported-by-cancer-network-meeting-highlights/

The Experience of a Patient with Thyroid Cancer

Interviewer and Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2014/07/14/the-experience-of-a-patient-with-thyroid-cancer/

 

Parathyroids and Bone Metabolism

Writer and Curator: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/02/10/parathyroids-and-bone-metabolism/

 

Thyroid Function and Disorders

Writer and Curator: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/02/05/thyroid-function-and-disorders/

Summary and Perspectives: Impairments in Pathological States: Endocrine Disorders, Stress Hypermetabolism and Cancer

Author and Curator: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2014/11/09/summary-and-perspectives-impairments-in-pathological-states-endocrine-disorders-stress-hypermetabolism-cancer/

Introduction to Impairments in Pathological States: Endocrine Disorders, Stress Hypermetabolism and Cancer

Author and Curator: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2014/11/08/introduction-to-impairments-in-pathological-states-endocrine-disorders-stress-hypermetabolism-cancer/

Metformin, Thyroid-Pituitary Axis, Diabetes Mellitus, and Metabolism

Larry H, Bernstein, MD, FCAP, Author and Curator
and Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/9/27/2014/Metformin,_thyroid-pituitary_ axis,_diabetes_mellitus,_and_metabolism

Autophagy-Modulating Proteins and Small Molecules Candidate Targets for Cancer Therapy: Commentary of Bioinformatics Approaches

Author and Curator: Larry H Bernstein, MD, FCAP and Article Architect: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/09/18/autophagy-modulating-proteins-and-small-molecules-candidate-targets-for-cancer-therapy-commentary-of-bioinformatics-approaches/

 

Neural Activity Regulating Endocrine Response

Writer and Curator: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/02/13/neural-activity-regulating-endocrine-response/

 

Pituitary Neuroendocrine Axis

Writer and Curator: Larry H. Bernstein, MD, FCAP 

https://pharmaceuticalintelligence.com/2015/02/04/pituitary-neuroendocrine-axis/

On the Influence of Hormones on Cancer

VOLUME 4: Human Reproductive System, Genomic Endocrinology and Cancer Types

(Series D: BioMedicine & Immunology) Kindle Edition. On Amazon.com  since February 2, 2021

http://www.amazon.com/dp/B08VTFWVKM

Posted in Biomedical Measurement Science, Bone Disease and Musculoskeletal Disease, Bone marrow derived cells, Ca2+ triggered activation, Calcium, Calcium Signaling, Calmodulin Kinase and Contraction, CANCER BIOLOGY & Innovations in Cancer Therapy, Cancer Screening, Clinical Diagnostics, Diagnostics and Lab Tests, Drug Carrier Design, Drug Delivery Platform Technology, Drug Toxicity, Endocrine Diseases, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Prostate Cancer: Monitoring vs Treatment | Leave a Comment »

2.0 LPBI is a Very Unique Organization 

March 2, 2021 by 2012pharmaceutical

2.0 LPBI is a Very Unique Organization

Author: Aviva Lev-Ari, PhD, RN, Founder of 1.0 LPBI and 2.0 LPBI, April 2012 to Present

UPDATED on 9/17/2021

LPBI is seeking strategic avenues that are DIFFERENT than

  • Private Debt
  • Direct Public Offering

LPBI Group’s situation in 2021 is CLEAR

LPBI is Debt Free and needs to Sell Outright its Portfolio of Intellectual Property Assets:

1.0 LPBI IP Asset Classes I to X, as describe in  https://pharmaceuticalintelligence.com/2019-vista/

2.0 LPBI IP Asset Classes to be created in 2021 – 2025 – Work-in-Progress on XI, XII, XIII, as described, below

  • IP Asset Class XI – the outcomes of Missions #1 – NLP on Journal Articles, Books, E-Proceedings, Biological Images Text Legend
  • IP Asset Class XII – the outcomes of Missions #3 – New Genre of Scientific Books: Spanish, Audio, NLP Results
  • IP Asset Class XIII – the outcomes of Missions #4 – Drug Discovery with Synthetic Biology Software

Design of Blockchain Content Monetization Platform is in earnest on two fronts:

  • Internal: Erich and LMU CS Department using Fluree open source
  • External: Alliance with BurstIQ, Denver if deployment is needed in 3 months

Deep Learning NLP for Text Analysis: Journal articles (N=6,085), 18 e-Books, 100 e-Proceedings, +6,200 Biological Images with text legend

  • Internal: Wolfram Deep Learning NLP
  • External: Linguamatics/IQVIA, if Scaling up from Proof-of-Concept to all Books called by a Joint Customer [Insurer in UT is Aviva’s Contact]

LPBI Team members understand that the following two strategies are not the appropriate strategies for us to undertake. These strategies are:

  • Private Debt

No person on LPBI’s Team would sign a LOAN and commit to pay it back. Even if we incorporate – the Team members will not take such a responsibility.

  • Direct Public Offering (DPO)

DPO – most likely is not suitable for any IP Portfolio. These asset classes, their value has a very strong INTANGIBLE component, they are Intellectual Property not Real estate or tangible assets. Thus, can’t be treated as securities.

Therefore, LPBI’s Founder and Board are seeking an Acquirer that will

  • Acquire the assets
  • Incorporate the business and
  • Bring a new Team
  • In this scenario, the new business may be suitable for Private Debt ????
  • LPBI’s Team members are not suitable to raise debt

UPDATED on 8/11/2021

Potential opportunities for ownership transfer need to consider three components:

(a) 1.0 LPBI: the Portfolio of TEN Intellectual Property (IP) Asset Classes developed in 2012-2020

(b) 2.0 LPBI: FOUR Missions for 2021-2025, and

(c) the TEAM in the USA and in India

An inclusive plan for three Exit Options was developed:

Exit Option #1:

  • Outright Sale of 10 IP assets

Exit Option #2:

  • Turnaround Version 1: A [Outright Sale of 10 IP assets] + B [Inorganic] EXTERNAL management and EXTERNAL ownership for 2.0 strategy, make use of the already in place and which represents the economic potential of 1.0 LPBI when it is developed by new technologies beyond the e-Scientific Publishing art. Unleashing this potential for generation of new digital products is boundless, it includes the following five alliances, but is not limited to only these listed, below:
  1. Alliances in Medical Text Analysis using NLP, Proof-of-Concept was tested. It will be followed by scaling up to all content of following four IP asset classes to benefit from Text Analysis with Machine Learning algorithms, i.e., in text format (Journal articles, e-Books, e-Proceedings and Gallery of Biological Images with text legends)
  2. Alliance in Blockchain Transactions Network for B2B & B2C enabling Content Monetization. Status: design phase
  3. Alliance for English Book translation to Spanish. Status: completed, all 18 books (Cover Page and eTOCs).
  4. Alliances in Content promotion in Spanish speaking countries. Status: Plan developed and
  5. Alliance in Synthetic Biology Software for targeted therapeutics in Drug Discovery.Status: ongoing

AND the Team of Experts in the US and in India.

Exit Option #3:

  • Turnaround Version 2: Organic – “Equity” Sharing Buyout

  1. Buying out Aviva’s LION’s share AND
  2. Buying out Dr. Larry’s share  AND
  3. Continue 2.0 LPBI by LPBI INTERNAL management [SJW & JFM] AND NEW EXTERNAL Ownership.
  4. The Right of First Refusal is offered INTERNALLY to 1.0 LPBI member(s) to take the helm of 2.0 LPBI to execute on Missions #1, #2, #3, #4

AND the Team of Experts in the US and in India

2.0 LPBI Strategy for 2021-2025

Smart use of customizable software in conjunction with

1.0 LPBI IP assets and Team’s competencies:

1.0 LPBI and 2.0 LPBI

  1. Use of the existing content to create new Digital products
  2. Train Biologists in NLP Software for Mission #1: Text Analysis with NLP, and
  3. Train Biologists in Synthetic Biology Software for Mission #4: Synthetics Biology Software in drug discovery
  4. 2.0 LPBI via our five Academic INTERNSHIPS means training MASTERS LEVEL and PostDoc BIOLOGISTS and Computer Scientists to use software for: (a) Mission #1 and (b) Mission #4
  5. Use Blockchain architecture for content monetization of the following IP assets:
  • all 1.0 LPBI digital products
  • all 2.0 LPBI digital products created in Mission #1, #3 and #4 described, below

The Four Missions of 2.0 LPBI Strategy for 2021-2025

Mission #1:

Natural Language Processing (NLP) – Team in USA & India – Medical Text Analysis with NLP – on LPBI 3.3 Giga Bytes of Content. Two NLP types:

(a) Statistical NLP and

(b) Semantic NLP with Deep Learning by Machine Learning algorithms using Wolfram Language for Biological Sciences

https://pharmaceuticalintelligence.com/2021-medical-text-analysis-nlp/

In Mission #1: Using Machine Learning (ML) algorithms for Text Analysis of our 3.3 Giga Bytes of English Text

Statistical Natural Language Processing (NLP) is yielding:

  • WordClouds and Bar Diagrams for each article, and

Deep Learning (DL) for Semantic Analysis of the Text will yield:

  • Hyper-graphs for collections of articles using knowledge graphs in knowledge graph databases.
  • Tree Diagrams for collection of articles

Domain knowledge experts will perform Interpretation of the visualization results generated by the Statistical NLP and the Semantic NLP with Deep Learning.

  • The Interpretation text will be in English and in foreign languages and in Audio Podcasts per language

Mission #2:

Blockchain IT and NLP Processing API generating NLP visualization products using Knowledge Graphs stored in Graph Databases on the Blockchain IT to be design for Content monetization use with unique infrastructures for  B2B and B2C.

1.0 LPBI was Open Access and Equity Sharing e-Scientific Publisher using a Cloud-based Authoring platform

2.0 LPBI will be focusing on Content Monetization and user of multiple software technologies unique for each of the its Missions: #1, #2, #3, #4.

  • The Open Access status will change when we will migrate all the four classes of content relevant for Text Analysis with NLP to the Blockchain Transactions Network. IT platform is currently under design.

Scenario from the End User Perspective

  • Interested parties posing queries to the system (B2C)
  • System responds by triggering a Recommendation Engine Response (RER) that will fetch: top articles by views
  • If the article was published in a book THEN the selected Article in the context of all articles in same chapter in the book it was featured will form the article collection for NLP performance.
  • If article not in a book then in the context of other articles in same categories of research, ones selected by the recommendation engine and ranked by views.
  • Biological images in these articles will be displayed
  • NLP results in visual graphics will be displayed
  • Major Data Science procedures in the back-end are using graph databases for on the Fly generation of NLP results not performed before, thus, not stored in the knowledge graph databases
  • Domain Knowledge Expert interpretation of the graphics available for selection in several Foreign languages presented in the front-end.
  • System invokes Blockchain features embedded per LPBI specifications into the API layer(s) of the Blockchain Transactions Network for its cardinal technology features: i.e.,
  1. Permissions
  2. Immutable LEDGER
  3. Smart Contracts
  4. Cyber security of IP assets in blocks

Full feature operations of the Blockchain platform will enable

  • B2C – Digital Store on a Healthcare Digital Marketplace
  • B2B – Installation at Big Pharma, Healthcare Insurers and CRO

https://pharmaceuticalintelligence.com/blockchain-transactions-network/

In Mission #2: The Transactions-enabled blockchain platform for Content Monetization of IP assets embodies the  development of a Blockchain information technology infrastructure that is transactions-enabled allowing payments for content digital products. On the blockchain we will store all the following Digital products.

All newly produced digital products by NLP serve as a compelling justification for the selection of Blockchain Transactions Network architecture as our IS/IT platform selected among other IT alternatives, using Knowledge Graph database the schema of which is derived from the Journal Ontology of 730 categories of research.

1.0 LPBI Four IP Asset Classes for Application of NLP – Original Products

IP Asset Class I: Journal articles +6,085

IP Asset Class II: electronic Books in Medicine. The five specialties in medicine are:

Series A: Cardiovascular Diseases: six volumes,

Series B: Genomics: two volumes,

Series C: Cancer and Oncology: two volumes,

Series D: Immunology: Metabolomics, Genomic Endocrinology and Infectious diseases: four volumes, and

Series E: Precision Medicine: four volumes

2a.     18 e-books in English on Amazon.com

2b.     18 Bi-Lingual electronic Table of Contents (eTOCs): Spanish & English

  • From IP Asset II: BioMed e-Books: All digital products

2.0 LPBI – NLP on Four IP Asset Classes – All results of NLP on the Original Products

2c.     18 e-Books – NLP visualization products [WordClouds, Bar Diagrams, Hyper-graphs, Tree Diagrams]

  • From IP Asset Class I: Journal Articles and from II: BioMed e-Books

2d.     18 e-Books Domain Knowledge Expert written Interpretations of the NLP visualization results: Spanish & English

  • From IP Asset Class I: Journal Articles and from II: BioMed e-Books

2e.     For 18 books all audio Podcasts in Spanish & English – selective content, i.e., Editorials: Preface, Introduction, Summary, Epilogues as English podcasts.

  • From IP Asset II: BioMed e-Books: All digital products

2f.     For each e-Series, A,B,C,D,E we plan to publish a volume containing the Bi-Lingual Spanish-English electronic Table of Contents in each e-Series for all the e-Books in the e-Series – an additional 5 Bi-Lingual e-Books.

  • From IP Asset II: BioMed e-Books: All digital products

IP Asset Class III:      e-Proceedings and Tweet Collections: 100 volumes

IP Asset Class V:       Gallery of Biological Images 6,200 to grow given that the NLP yields 10 graphs 📊 per article

2.0 LPBI all Products of NLP, see Yields for Mission #1, above

PLUS

Pipeline Products, 2021-2025 beyond 1.0 Ten IP Asset Classes:

New IP Asset Classes are: XI, XII, XIII

IP Asset Class XI (Queries yielding results on the Fly) – ending up in Blockchain storage available for monetization as a new product

  • New Digital Products as a result of Discovery 💡 of new digital products derived from and created from the new queries by users to be generated on the fly not in existence in the knowledge graph database

In addition, all new Digital Products of Mission #3 and Mission #4

IP Asset Class XII (Mission #3) – ending up in Blockchain storage available for monetization transactions as new products

  • All digital products of Mission #3, below: New Genre of Scientific Books N =18, see book architecture, below,

IP Asset Class XIII (Mission #4) – ending up in Blockchain storage available for monetization transactions as new products

  • All digital products of Mission #4, below: New therapeutics molecules generated for 12 Galectins by Synthetic Biology software

Mission #3:

New GENRE of Multimedia Scientific Books: These 18 LPBI e-Books will be the first on the Medical Books Market to contain Text Analysis with NLP of the original e-Books. BioMed e-Books – Book Republishing in new GENRE – Bi-Lingual and Multimedia Audio Podcast for Books in the 18-e-Books in five e-Series: A,B,C,D,E . The New book architecture for each Book:

  • Part A: Spanish and English electronic Table of Contents in Text and in Audio Podcast.
  • Part B: NLP & Expert Interpretation of the visualizations in Text and Podcast: English and Spanish,NLP results for the content of the e-Book
    • Hyper-graphs for each Chapter
    • Domain Knowledge Expert Interpretation of all NLP results:

    TO BE CREATED – English Text and Spanish Text

    TO BE CREATED – English Audio Podcast and Spanish Audio Podcast

  • Part C: Editorial of original book (Preface, Volume Introduction, Volume Summary and Epilogue) – English Audio Podcast of existing Text.

https://pharmaceuticalintelligence.com/2021/07/24/proposal-for-new-e-book-architecture-combining-a-bi-lingual-etocs-english-spanish-with-nlps-results-of-medical-text-analysis-series-b-genomics-volume-1-2-and-series-c-cancer-volume-1/

Mission #4:

Synthetic Biology Software for Drug Discovery 💡 targeting Galectins.

  • See all the details in the link, below 

https://pharmaceuticalintelligence.com/synthetic-biology-in-drug-discovery/

LPBI’s VALUATION

LPBI’s VALUATION is the stream of INNOVATIONS to date achieved while staying DEBT free: We need an unconventional approach to valuation and to prospecting for a Merger and Acquisition for LPBI.

Being debt free and loaded on Intellectual Property place LPBI Group in a special position for Transfer of Ownership. Only a 3rd party who value Intellectual Property in Pharmaceutical Media belongs to the discussion.
The accomplishments of the last almost ten years 2012 -2020, are described, below.
PERSPECTIVE

Leaders in Pharmaceutical Business Intelligence aka LPBI is a Registered Domain Name on WordPress.com.

  • LPBI is a Cloud-based Internet Business.

LPBI is not a manufacturing plant or a brick and mortar chain with Assets and Liabilities and AMORTIZATION and the discount rate that is chosen for the present value calculation (NPV) – these methods are terms not used for

  1. the valuation of Intellectual Property portfolios and not used for
  2. MEDIA ventures deriving prominence from digital reputation of intangible assets

Our Content is updated daily and it grows daily. We enjoy +20,000 e-Readers a month and the planned Medical Text Analysis with machine learning (Natural Language Processing) will general ~10 new digital artifacts per each existing article [N = +6,080].

• LPBI’s Valuation of Intellectual Property does not correspond to the Discount Rate of Net Present Value (NPV) which is the difference between the present value of cash inflows and the present value of cash outflows over a period of time. NPV is used in capital budgeting and investment planning to analyze the profitability of a projected investment or project. It does not correspond because nor the innovation type or the rate of innovations are predictable by any set of assumptions that would under lie such models.

• LPBI’s Valuation of Intellectual Property does not correspond to its revenues derived from Royalties on Books. The Pay per View as practiced by Page Download is hindering books sales and Royalties are determined by Amazon.com they have never been in favor of Authors. Our page download equate to 64 books not sold because of the option of Pay per View.

• LPBI’s Intellectual Property is a factor of production as input to the Drug discovery process, see Mission 4, below or to Claims adjudication, see Mission 1, below.

• LPBI’s Intellectual Property is a critical component in information syndication of Pharmaceutical Media, see Mission 3, below

• LPBI’s Intellectual Property has the potential to become an input into the development process of software application development for Pharma and Biotech by IT Organizations like Apple Health, Intel Health, Google’s Verily, SAP, Oracle and IBM Watson.
• LPBI’s Intellectual Property is a formidable candidate for a Holding company with existing Online health publishing, Health Care Media, Web-Health and Health Information Markets, i.e., KKR
• LPBI’s Intellectual Property is an attractive candidate for the EDTech industry supplying education content for the Global and very fast growing emerging Online Education sector including all tiers of the Academic ecosystem as boundaries are getting blurred. Ivy League institutions offering Certificates along the side of Academic degrees. Certificates are coveted by employers. LPBI is running a One year Academic Certificate in NLP for Medical Text Analysis in Mission #1 and another one in Synthetic Biology Software in Mission #4.
  • LPBI Opportunities Map is comprehensive and includes 12 Economic Segments include the follwoing: Holding Companies; Investment Bankers and Private Equity; Information Technology Companies – Health Care; Scientific Publishers; Big Pharma; Internet Health Care Media & Digital Health; Online Education; Health Insurance Companies & HMOs; Medical and Pharma Associations; Medical Education; Information Syndicators; Global Biotech & Pharmaceutical Conference Organizer and CRO & CRA.

A perspective on the valuation of companies with significant Intangible assets, like LPBI is presented and analyzed in the following curation on the Intangible Asset of Firm’s Reputation. In the case of LPBI, the intangible assets it possesses are key determinants of its reputation and digital reputation on the Internet as is the case in the Media World.

The Digital Age Gave Rise to New Definitions – New Benchmarks were born on the World Wide Web for the Intangible Asset of Firm’s Reputation: Pay a Premium for buying e-Reputation

  • e-Reputation: LPBI’s Twitter handles are followed by the most esteemed Institutions, see Here and Here.

A stream of Ten INNOVATIONS in the Life of LPBI since

inception in 2012 to 2021

  1. 4/2012 – LPBI was the Launcher of a novel Scientific Curation Methodology for scientific findings in published primary research in the Global e-Scientific Publishing industry https://pharmaceuticalintelligence.com/
  • As late as 2016, no big publisher, not even one, i.e., Elsevier, John Wiley had curation-based publications: Journals, Books, e-Proceedings or Gallery of thousands of Biological Images as an IP asset class
  • At LPBI, Curation of scientific findings was performed in +6,000 articles with +2MM e-Views by Global e-Readers
  1. 6/2013 – LPBI was the Publisher of the 1st e-book in Medicine in Kindle Store on the Life Sciences & Medicine Shelf – Upload to this shelf by Amazon.com
  1. 2/2021 – Completion of the 18 volumes, BioMed e-Series in five Specialties in Medicine: each article in each volume is a curation-based publication.
  1. On Amazon.com on 7/2021 – LPBI’s e-books in Medicine enjoy +128,100 PAGE DOWNLOADS – the ONE and ONLY publisher in that range of page downloads. The record is the equivalent of 64 books at an average of 2,000 pages a volume !!!! LPBI smallest book is 1,000 pages and its biggest is +3,700 pages
  1. LPBI launched its Natural Language Processing (NLP) Practice in 1/2020 as Mission #1. NLP is one method of Machine Learning (ML). ML is a family of methods in Artificial Intelligence (AI) which is a field in the Computer Science Academic discipline since the early 60s.

In 4/2021 Linguamatics/IQVIA performed NLP on LPBI’s 33 articles and 20 Biological Images. RESULTS:  +670 entity relations DISCOVERED by Linguamatics and unknown to Pharma and to Insurers, entity relations between:

  • Gene-Disease
  • Gene-Drug
  • Disease-Drug

These results were jointly presented to a Healthcare Insurer, SLC, UT on 7/13/2021, forthcoming meeting in 9/2021.

  1. LPBI and BurstIQ are architecting NOW the first Natural Language Processing – Blockchain Information Technology infrastructure in existence, This statement is TRUE.
  • Updated on 7/28/2021: Fluree Flur.ee, the Web3 Data Platform Open source semantic graph database & LeadSemantics.com presented their solution for NLP and Blockchain on 7/28/2021. Erich G. was lured as Chief architect for LPBI’s Mission #2: NLP & Blockchain
  • Linguamatics, the leader in NLP did not hear of Blockchain and BurstIQ did not have a request for NLP – LPBI PUT THESE TWO TECHNOLOGIES AND PARTIES TOGETHER

LPBI workflow overview

IMAGE SOURCE: BurstIQ image for LPBI

  1. On 7/19/2021 – LPBI had launched LPBI India for Synthetic Biology Software for Drug Discovery targeting Galectins – Collaboration with Dr. Raphael Nir, President and CSO, SBH Sciences, Inc., Natick, MA
  1. On 7/25/2021 – LPBI announced that it will have the NEWLY to be published BioMed e-Books As Mission #3:

A NEW Publishing GENRE of SCIENTIFIC BOOKS

    • Bi-Lingual electronic Table Of Contents (eTOCs), English & Spanish with Montero Language Services, Madrid as the Translator of eighteen Books’ Cover Pages and the 18 books electronic Table of Contents.
    • The Content promotion in the Spanish speaking Countries with GTO, Madrid as AD Agency.
    • NLPs results of Medical Text Analysis with domain knowledge expert Interpretations in Foreign Languages and in Audio: in Spanish and in other languages, forthcoming
    • Original English Book – Only Editorials (Preface, Introductions, Summaries and Epilogue) because the Bi-Lingual part has the eTOCs of the e-Book
    • This is a new genre and a new architecture of 18 MULTIMEDIA SCIENTIFIC e-Books with (a) NLP results of the Medical Text analysis with machine learning, (b) Expert Interpretation of the Visualization Results. Bi-Lingual Podcasts: (c) eTOCs and (d) Bi-Lingual Expert Interpretation in English and Spanish Text and audio Podcasts, and (e) Books’ Editorials in English Audio Podcast

Content promotion proposal by GTO, Madrid

20210622_lpbi_pipeline_gto_europe-1

IMAGE SOURCE: Rendition by GTO, Madrid of BurstIQ Image, above

  1. The Content Monetization effort includes the Price List for LPBI 1.0 digital products and of LPBI 2.0 – NLP Products

Under development

  • IP Valuation Model per IP asset class is needed to be compared with Master_Financials and to supplement it
  • Pricing Model and Product Mix Models for the digital products to be generated by the process of Text Analysis with NLP are using a Product Price List already developed.
  • The scenarios for a Probabilistic Product Mix for the B2B sector are work-in-progress. Scenarios of Product Mix for $500,000 B2B engagements with NLP scaling up with NLP Alliances. The Alliances are the Labor component and LPBI represent Materials (Content) as 25% of the contract price, on top of total, to be paid by the B2B customer as materials in use for the engagement.
  • B2C Customers on Blockchain will use the Price List for all Digital Products of LPBI 1.0 and LPBI 2.0 – Pay per Use

10.  LPBI Group runs FIVE ACADEMIC INTERNSHIPS as Certificate Programs: a One Year long or a One Semester long: Volunteer base offering Verifiable Certificates, as described in https://pharmaceuticalintelligence.com/certificate-1-year/

LPBI has Students and their education goals in mind:

  • We Offer esteemed Affiliation, Mentorship by Scientists
  • NEW skills development in NLP, ML, AI applications to Medical Text Analysis
  • Skills in Synthetic Biology for Drug Discovery
  • References and Resume paragraph on accomplishments and goals during the INTERNSHIP
  • Opportunity to contribute to Publications and Podcasting
  • Explorations of opportunities in Life Sciences in the US

Below, are listed the FIVE ACADEMIC INTERNSHIPS as Verifiable Certificate Programs, One year or One semester: Volunteer base

  1.  NLP – Medical Text Analysis
  2. Synthetic Biology in Drug Discovery targeting Galectins
  3. IT Projects and Administration of IP Asset Classes. we developed a Plan for SOPs for LPBI Group’s IT & Data Science Management Projects https://pharmaceuticalintelligence.com/2019-vista/summer-2019-plan-research-associates-tasks/

The Informations technology & systems of LPBI include:

  • Journal, Books, e-Proceedings & Tweet Collections, and
  • GALLERY of +6,200 Biological Images.
  • All the platforms: Authoring, publishing and portals. Business analytics for Internet platforms presence:
  • Twitter Analytics +1,100 followers of two handles and
  • LinkedIn ~8,000 1st degree connections +1, 200 endorsements of LPBI’s Founder, and 
  • LinkedIn Followers: +500 CEOs.

4.  BLOCKCHAIN Architecture Design: Interface to NLP. The powerful aspect is hydrating a knowledge graph with NLP inferences so that they can be used for DISCOVERY. Storing those inferences on a blockchain have the value of committing the NLP inferences to a blockchain for purposes of provenance. However, the very important part is The INFRASTRUCTURE behind BurstIQ which is NOT JUST A BLOCKCHAIN. NLP-Blockchain IT Infrastructure is needed. The NLP inferences are part of a knowledge graph database In BurstIQ case is a LifeGraph – the larger architecture of the system functionality [the voice of Erich G., Chief Architect, LPBI Blockchain Mission #2].

5.  Corporate Finance, Business Analytics and Financial Modeling using Statistics, Operations Research (OR) and Econometrics. Students in Economics, Finance, OR and MBA students seeking a Capstone project will gain unmatched experience and new skills.

For Valuation of its portfolio of IP assets and the Team:

LPBI is challenging professors of Economics and Finance at the top American Ten Business Schools to contain the above described LPBI’s stream of ten innovations into a Discount rate of Net Present Value Model for valuation of LPBI as a venture. 

Current management and the Founder believe that we need a non-institution acquisition process, namely, we need to “Go Direct” Go Direct – find an interested CEO for a vertical or horizontal integration into existing production.

Of NOTE

Critical Missions and New Competencies, 2020 and beyond

  • Addressing Information Market needs for Text Analysis with NLP and Deep Learning in Medicine, Life Sciences and Health Care
  • Development and application of a Content monetization system of the cutting edge Blockchain IT platform of a Transactions Network customized to implement NLP on several API layers of the Blockchain architecture is featured in a detailed description HERE and is representing work-in-progress for 2021-2022.
  • Drug Discovery using Synthetic Biology Software for inhibitors of Galectins.

Venture Type

  • LPBI is an Internet-based Media e-Scientific Publisher and Medical Text Analysis with Machine Learning and Content Monetization of existing digital products and for the to be produced digital products by Natural Language Processing (NLP)
  • NLP and Blockchain are cutting edge technologies [full flag implementation Blockchain is 5 years old!!].

  • When these two are combined together as LPBI 2.0 strategy states – a technological frontier for content monetization is born and it could be applied to any content, i.e., Legal, Environmental, Economics and others, not limited to pharmaceutical & medical which represent the LPBI pioneering case.

  • NOVELTY in methodologies, practice and digital artifacts is contained in 3.3 GIGA BYTES.
  • We launched a NEW Genre for Scientific Books: Bi-Lingual: English – Spanish with the NLP Results of the Text Analysis by NLP and Domain Knowledge Expert Interpretations in Text and in Sound. The eTOCs in Spanish Audio, NLP results Interpretation in English Audio and in Spanish Audio and Editorial in English Audio.
  • We will pursue a Joint effort with Dr. Raphael Nir in Drug-discovery targeting Galectins using Synthetic Biology software

2012-2020 – Milestones accomplished by 1.0 LPBI

for

Ten Intellectual Property Asset Classes

  1. Multi-authoring system not in use by any other website on WordPress.com – World LARGEST hosting company of independent websites. It was Dr. Lev-Ari’s idea to augment the functionality and usage of the infrastructure from single to a multi-author system.
  2. IP Asset Class I: 2MM e-Readers are recorded for the content on the Journal, +6,000 articles and 730 categories of research. The Curation Methodology was applied to +6,000 times in two versions: Original Curations and Scientific Reporting.
  3. IP Asset Class V: Gallery of Biological Images embedded in original text producing prior art images, a Gallery of 6,200 in the WordPress.com cloud. If NLP created ~10 new images per article then the gallery of initial 5,100 [prior to NLP graphs uploaded to the Gallery] will involve adding 60,000 new images as a result of the visualization output of Natural Language Processing deployment.
  4. IP Asset Class IV: Cloud-based Platforms and Portals. Composition of Methods: (a) Software code for 25 keywords extraction and running executables for statistical and Semantic NLP using Deep Learning algorithms. (b) Formats for Curations, (c) Formats for electronic Table Of Contents (eTOCs), (d) Role definition for Editors and Experts, Authors, Writers. (e) Template system for e-Proceedings, (f) Template system for Tweeting in real time at VOLUME [Case in Point: +200 tweets in 20 hours, 2019 World Medical Innovation Forum on AI in Medicine, organized by MGH and BWH, Ranked Influencer #2, #3, #4 by the Twitter.com Rating Agencies: symplur and NodeXL].
  5. IP Asset Class X: Luminary Podcasts with (a) Life Sciences Scholars at LPBI, and (b) a Podcast Library of 270 Interviews with Scientific Leaders
  6. IP Asset Class II: BioMed e-Series of 18 Volumes in Medicine and Life Sciences featuring +50,000 pages of thematic selections and expert interpretations FRONTIERS of the scientific inquiry in five specialties in Medicine and in several disciplines in the Life Sciences, Pharmaceutics and Health Care. LPBI’s e-Books pioneered the entrance in e-Scientific Publishing. In 6/2013 when we published the 1st book, Elsevier and John Wiley – DID NOT YET HAVE ANY e-BOOKS. Page downloads from LPBI e-books is +128,000. All Books on Amazon.com https://lnkd.in/ekWGNqA
  7. IP Asset Class VII: Amazon.com transfers every 90 days Royalties on book sales and Page downloads. The Pay per View option deters and has deleterious effects on selling books. Payments for page download deposited for authors are pennies per page, though, +128,000 pages were downloaded to date and a significant sum was collected by Amazon.com.
  8. IP Asset Class III: We have 70 e-Proceedings documents [60 by Aviva and 10 by Dr. Williams] and 36 Tweet collections [by Aviva]. 100 Documents representing e-Proceedings of 70 Top Conferences and 36 Tweet collections of the latest 36 Conference covered, 2014-2021. 100 volumes available for download.
  9. IP Asset Class IX: AKA as Intangible assets. This topic is elaborated in 1.0 LPBI Prospectus, 300 pps.
  10. IP Asset Class VIII: 2,650 subscribers to the website
  11. IP Asset Class VI: The Team of Experts in the Organization Chart, below. A revised organization chart to Include LPBI India is work-in-progress and will exhibit all the missions and the personnel assigned.

Organization Chart for LPBI’s Venture Structure

Workflow and Talent for LPBI USA and LPBI India

New_Org_chart_LPBI

2021-2025: 2.0 LPBI’s Four Missions and IT Infrastructure Plan:

INSERT HERE IT Projects been pursued

Recap the four missions briefly as LPBI’s exposition of the pipelines for 2021 -2025:

Mission #1:  NLP – Team in USA & India – Medical Text Analysis with NLP – on LPBI 3.3 Giga Bytes of Content. Statistical NLP and Deep Learning by Machine Learning using Wolfram Language for Biological Sciences

https://pharmaceuticalintelligence.com/2021-medical-text-analysis-nlp/

Mission #2:  Blockchain IT and NLP Processing API generating NLP visualization Products used by Knowledge Graphs stored in Graph Databases – Content monetization infrastructure B2B and B2C.

https://pharmaceuticalintelligence.com/blockchain-transactions-network/

Mission #3:  BioMed e-Books – Book Republishing in new GENRE – Bi-Lingual and Multimedia Audio Podcast for Books in the 18-e-Books in five e-Series: A,B,C,D,E

https://pharmaceuticalintelligence.com/2021/07/24/proposal-for-new-e-book-architecture-combining-a-bi-lingual-etocs-english-spanish-with-nlps-results-of-medical-text-analysis-series-b-genomics-volume-1-2-and-series-c-cancer-volume-1/

Mission #4:  Synthetic Biology Software: Drug discovery Galectins

https://pharmaceuticalintelligence.com/synthetic-biology-in-drug-discovery/

Dr. Lev-Ari is the Founder of 1.0 LPBI, 2012-2020 and 2.0 LPBI, 2021-2025

Earning a PhD at University of California, Berkeley in 1983 enabled Aviva to join the Top Tier Management Consulting industry. The World Think Tank, SRI International in Menlo Park, CA and head a Practice on Research and Advanced Analytics. Followed by Head of Research of the Economic and Decision Analysis Center (EDAC) at MITRE. Next, director level positions in Research at Perot Systems Corporation (PSC) and McGraw Hill, 1985 to 2004. Her work is mentioned in the Annual Reports of SRI International, 1987, and in PSC’s Annual Report, 1999.

  • It is noteworthy that Dr. Lev-Ari was a student at the Hebrew University in Jerusalem, 1970-1976 and a Research Associated at Technion, Israel Institute of Technology, 1977-1978, in preparation for doctoral studies at UC, Berkeley.

In the Healthcare Delivery Industry, 2005-2012, Aviva got the National Board of Nursing Registration in 1/2008. Jointly with her Prof. of Pharmacology, Dr. Lev-Ari developed a combination drug therapy concept for major cardiovascular events prevention. She was Supervisor of a Long Term Acute Care Hospital in Waltham, MA and was Clinical Nurse Manager of two units in Post Acute Facilities in Boston, Belmont and Canton, MA.

In 2012, Dr. Lev-Ari launched as Founder the Medical Media venture PharmaceuticalIntelligence.com 

Aviva Lev-Ari, PhD, RN is the inventor of the curation methodology for clinical interpretation of scientific findings

  • the inventor of the eTOCs format for the BioMed e-Series. As Editor-in-chief, architected the five e-Series: A,B,C,D,E and specified the book Titles.
  • Jointly, with Dr. Williams all the cover pages were designed for the 18 volumes.
  • the inventor One click e-Proceedings generation and the Tweeting template system
  • the inventor of the fusion of NLP and Blockchain, and

Of 6,080, under her name are 3,550 articles [Dashboard read on 8/1/2021]

Twelve Economic Segments for LPBI Group’s IP – Prospects for Transfer of Ownership

This list is repeated for reiteration that the technologies at LPBI are serving 12 verticals

https://pharmaceuticalintelligence.com/2019-vista/opportunities-map-in-the-acquisition-arena/

  1.     Holding Companies, Investment Bankers and Private Equity
  2.     Information Technology Companies – Health Care
  3.     Scientific Publishers
  4.     Big Pharma
  5.     Internet Health Care Media & Digital Health
  6.     Online Education
  7.     Health Insurance Companies & HMOs
  8.     Medical and Pharma Associations
  9.     Medical Education
  10.     Information Syndicators
  11.     Global Biotech & Pharmaceutical Conference Organizer
  12.     CRO & CRA

Financial Projections are in an Excel file with three spreadsheets:

  • 1.0 LPBI, 2012-2020 – AVAILABLE FOR MONETIZATION FOLLOWING INDEXING AND MIGRATION TO THE BLOCKCHAIN as soon as the platform will be up and running
  • 2.0 LPBI, 2021-2025 – NLP Proof-of-Concept in Phase 2 with Linguamatics was completed and presented on on 7/13/2021 to a potential Joint client of Linguamatics and LPBI. Forthcoming next meeting in 9/2021.
  • In-house, Wolfram algorithms applied on LPBI’s content: Journal articles and 18 e-Books in Medicine is ongoing. The Assignments are presented on 7/27/2021 UPDATE on https://pharmaceuticalintelligence.com/2021-medical-text-analysis-nlp/
  • Combined, 2012-2025 presents the Projected Financials for 1.0 and 2.0 LPBI

Two charts are presented, below.

  • The first exhibits the cumulative number of views 7/2013 – 6/2020, will be updated on 1/1/2022.
  • The second chart presents the Actual article views 4/2012 – 6/2020 and projected article views 2021-2025. Each view is equated to an article download at $30. Potential cumulative Journal revenues are presented on the Y axis: 2012-2020 base on actual data, 2021-2025 represent prediction.
  • Reference for the methods in use for the prediction is listed, below.

Source:

PharmaceuticalIntelligence.com Journal – Projecting the Annual Rate of Article Views

https://pharmaceuticalintelligence.com/vision/pharmaceuticalintelligence-com-journal-projecting-the-annual-rate-of-article-views/

Following the description of the accomplishments of 1.0 LPBI and the four missions of 2.0 LPBI, we are repeating here the Exit three Options seen by management.

The potential opportunities for ownership transfer need to consider

the Portfolio of TEN IP Asset Classes and FOUR missions for 2021-2025 and the TEAM

An inclusive Plan for three Exit Options are revisited:

  • Option 1,
  • Option 2: Version 1 and
  • Option 2: Version 2

Option 1:

Outright Sale of 10 IP assets created by 1.0 LPBI, 2021 – 2020.

Option 2:

Turnaround Version 1: A + B [Inorganic]

[A = Outright Sale of 10 IP assets]

AND

  1. [B = INORGANIC –  EXTERNAL management and EXTERNAL ownership for 2.0 strategy
  • Alliances in NLP Proof-of-Concept to be followed by scaling up to all content of four IP asset classes
  • Alliance in Blockchain Transactions Network for B2B & B2C. Status: design phase
  • Alliances in Content promotion in Spanish speaking countries and
  • Alliance in Synthetic Biology SW for targeted therapeutics in Drug Discovery

AND

The Team of Experts in the US and in India

Option 3:

Turnaround Version 2: Organic – “Equity” Sharing Buyout

[A = Buying out Aviva’s LION’s share] AND [B = Buying out Dr. Larry’s share]

AND

[C = ORGANIC – Continue 2.0 LPBI by LPBI INTERNAL management [SJW & JFM]] AND NEW EXTERNAL Ownership. The Right of First Refusal is offered INTERNALLY to 1.0 LPBI member(s) to take the helm of 2.0 LPBI]

AND

The Team of Experts in the US and in India

Opening and Closing Statement

Current management and the Founder believe that we need a non-institution acquisition process, namely, we need to “Go Direct”

Go Direct – find an interested CEO.

Posted in LPBI Group, e-Scientific Media, DFP, R&D-M3DP, R&D-Drug Discovery, US Patents: SOPs and Team Management | Leave a Comment »

FDA emergency use authorization would bring the public a third vaccine for the novel coronavirus – J&J single vaccine – Authorized on 2/28/2021

March 1, 2021 by 2012pharmaceutical

FDA emergency use authorization would bring the public a third vaccine for the novel coronavirus – J&J single vaccine – Authorized on 2/28/2021

 

Reporter: Aviva Lev-Ari, PhD, RN

 

J&J’s Covid-19 vaccine gets vote of confidence from FDA advisory panel

The committee voted 22-0 on the question of whether the benefits of Johnson & Johnson’s Covid-19 vaccine outweigh its risks. FDA emergency use authorization would bring the public a third vaccine for the novel coronavirus.

By FRANK VINLUAN

 Post a comment / Feb 26, 2021 at 7:35 PM

The U.S. is one step closer to making available another Covid-19 vaccine after a panel of experts voted unanimously Friday to recommend emergency use authorization for a shot developed by Johnson & Johnson.

The independent panel, comprised of mostly physicians, voted 22-0 to support the vaccine with no one abstaining. These votes aren’t binding on the FDA, but the agency often follows the recommendations of its panels. A decision could come as early as this weekend. The two Covid vaccines currently cleared for emergency use received their authorizations the day after their respective advisory panel meetings.

Top ArticlesFDA authorizes third Covid-19 vaccine; J&J pledges 20M shots by month’s end
AD MOREFDA authorizes third Covid‑19vaccine; J&J pledges 20Mshots by month’s end ‑ MedCity News00:14/00:30SKIP ADFDA authorizes third Covid-19 vaccine; J&J pledges 20M shots by month’s end

The Johnson & Johnson vaccine would offer an alternative to the ones currently available from the Pfizer and BioNtech alliance, and Moderna. Those messenger RNA vaccines must be distributed and stored at ultra-cold temperatures, then thawed before use. Those shots are given as two doses, weeks apart. The J&J vaccine can be kept at refrigerator temperatures. Another key difference is that the J&J jab requires a single shot. Together, those features will make the J&J vaccine easier to distribute to more people in more places through distribution channels that are already in place.

Panel members expressed support for the J&J vaccine, saying that the safety and efficacy data supported its authorization. But panelists also cautioned the public against picking vaccine favorites.

“It’s important that people do not think one vaccine is better than another,” said Cody Meissner, an infectious disease expert and professor of pediatrics at the Tufts University School of Medicine. “There is no preference for one vaccine over another and all vaccines work with what appears to be equal safety and equal efficacy as of this time.”

 

GUIDANCE DOCUMENT

Emergency Use Authorization for Vaccines to Prevent COVID-19 Guidance for Industry FEBRUARY 2021

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-1137
Issued by:
Center for Biologics Evaluation and Research

FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic.  FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.

SOURCE
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-vaccines-prevent-covid-19

 

FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

The following is attributed to Acting Commissioner Janet Woodcock, M.D. and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research

NEWS PROVIDED BY

U.S. Food and Drug Administration 

Feb 26, 2021, 18:50 ET

SILVER SPRING, Md., Feb. 26, 2021 /PRNewswire/ — Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution.

Additional Resources:

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: Email or 888-INFO-FDA

SOURCE

https://www.prnewswire.com/news-releases/fda-statement-on-vaccines-and-related-biological-products-advisory-committee-meeting-301236757.html

Posted in COVID-19, Population Health Management, Genetics & Pharmaceutical, SARS-CoV-2, Vaccinology, Virus Infective Acute Respiratory Syndrome: SARS-CoV | Leave a Comment »

Medical Device Representatives coach Surgeons in the Operating Rooms

March 1, 2021 by 2012pharmaceutical

Medical Device Representatives coach Surgeons in the Operating Rooms

Reporter: Aviva Lev-Ari, PhD, RN
Medical Device Representatives: The Untold Story
February 23, 2021 | Ryan Egeland, MD, PhD | Experience Stories
Sponsored by Cardiovascular Systems, Inc.
Tom Fogarty, a cardiovascular surgeon who holds more than 100 surgical patents, says the pace of medical innovation necessitates that sales representatives play a teaching role in operating rooms. “In our training as doctors, we’re not taught to accommodate emerging technologies,” he told Stanford Medicine Magazine. That’s problematic, Fogarty said, because “Medical innovators and inventors are very impatient. They truly believe what they are creating is better than what currently exists. They want to get it to the patient as quickly as possible.” ²

Coaching and Guidance

The second role that sales representatives play is to coach and provide guidance to physicians as they perform procedures. In a widely read New Yorker article, the surgeon Dr. Atul Gawande wrote about his experience using a coach to improve his surgical technique. Yet, as any doctor practicing in a busy metropolitan hospital will tell you, their peers are much too busy managing their patient loads to spend time coaching them. ³

Sponsored by Cardiovascular Systems, Inc.

What Reps Don’t Do

As a surgeon and a healthcare executive, I’ve learned that the best device representatives are defined by what they won’t do: push a physician to use their product when it’s inappropriate. Villa says she sometimes sees patients who have blood clots in their arteries. “I will never recommend our product when there’s a clot because you can do more harm than good,” she says. “Ultimately, it’s up to the doctor’s discretion, but I’ll come right out and tell them, ‘I don’t know if CSI is the right product for that.’”

Just like physicians, device sales representatives have reputations to protect. A physician will recommend a helpful and knowledgeable sales representative to a colleague; but if the sales representative is clearly only interested in their bottom line — as opposed to the patient’s well-being — they’ll soon find that their calls go unanswered. For this reason, Nasser says he often finds himself advising physicians that his product isn’t appropriate for a patient. “You might not get the case,” he says, “but you’ll earn the trust of the physician.”

There’s a second — and more important — explanation for why these device representatives won’t push their products to boost sales. Simply put, that’s not why they’re in business. Nasser, for example, got into device sales after his father died of a heart attack. “I approach every case as if that were my family member and I ask what would be best for them,” he says.

“You can’t fake the passion and the caring you have,” adds Staub. “People see through if it’s just a business transaction.” Instead, he attributes his longevity to “engaging physicians in an educational way and getting across that you can be a partner in the care of their patients.”

When asked why she does her job, Villa thinks about the 77-year old woman she helped the day she drove to the hospital early in the morning. When the woman’s foot, which initially had turned grey, started to turn pink after the procedure, Villa says she was overcome with “a wonderful feeling. That patient had a fear of losing her limb and woke up knowing that her leg was still there. Saving limbs and saving lives. That’s the beauty of our job.”

¹ O’Connor B, Pollner F, Fugh-Berman A (2016) Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives. PLoS ONE 11(8): e0158510. https://doi.org/10.1371/journal.pone.0158510

² White, T. Stanford Medicine Magazine, 2006, Fall Issue. Father of invention – Stanford Medicine Magazine – Stanford University School of Medicine

³ Gawande, A. The New Yorker, October 3, 2011. The Coach in the Operating Room | The New Yorker

 

SOURCE

 

https://www.cardiovascularbusiness.com/sponsored/2052/medical-device-representatives-untold-story

From: Cardiovascular Business <announcements@mail.cardiovascularbusiness.com>

Reply-To: Cardiovascular Business <announcements@mail.cardiovascularbusiness.com>

Date: Monday, March 1, 2021 at 10:30 AM

To: “Aviva Lev-Ari, PhD, RN” <AvivaLev-Ari@alum.berkeley.edu>

Subject: The Untold Story of Medical Device Reps: A Physician’s Perspective

Posted in Cardiac and Cardiovascular Surgical Procedures | Leave a Comment »

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