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Archive for the ‘Pharmaceutical Discovery’ Category

A laboratory for the use of AI for drug development has been launched in collaboration with Pfizer, Teva, AstraZeneca, Mark and Amazon

Reporter: Aviva Lev-Ari, PhD, RN

AION Labs unites pharma, technology and funds companies including IBF to invest in startups to integrate developments in cloud computing and artificial intelligence to improve drug development capabilities. An alliance of four leading pharmaceutical companies –  
AION Labs
 , the first innovation lab of its kind in the world and a pioneer in the process of adopting cloud technologies, artificial intelligence and computer science to solve the R&D challenges of the pharma industry, today announces its launch.
AstraZeneca ,  
Mark ,  
Pfizer  and 
Teva  – and two leading companies in the field of high-tech and biotech investments, respectively – AWS ( 
Amazon Web Services Inc ) and the Israeli investment fund IBF ( 
Israel Biotech Fund ) – which joined together to establish groundbreaking ventures Through artificial intelligence and computer science to change the way new therapies are discovered and developed.  “We are excited to launch the new innovation lab in favor of discoveries of drugs and medical devices using groundbreaking computational tools,” said Matti Gil, CEO of AION Labs. We are prepared and ready to make a difference in the process of therapeutic discoveries and their development. 
With a strong pool of talent from Israel and the world, cloud technology and artificial intelligence at the heart of our activities and a significant commitment by the State of Israel, we are ready to contribute to the health and well-being of the human race and promote industry in Israel. 
I thank the partners for the trust, and it is an honor for me to lead such a significant initiative. ” 
In addition, AION Labs has announced a strategic partnership with X  
BioMed  , an independent biomedical research institute operating in Heidelberg, Germany. 
BioMed X has a proven track record in advancing research innovations in the field of biomedicine at the interface between academic research and the pharmaceutical industry. 
BioMed X’s innovation model, based on global mass sourcing and incubators to cultivate the most brilliant talent and ideas, will serve as the R & D engine to drive AION Labs’ enterprise model.

SOURCE

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A Platform called VirtualFlow: Discovery of Pan-coronavirus Drugs help prepare the US for the Next Coronavirus Pandemic

Reporter: Aviva Lev-Ari, PhD, RN

 

ARTICLE|ONLINE NOW, 102021

A multi-pronged approach targeting SARS-CoV-2 proteins using ultra-large virtual screening

Open AccessPublished:January 04, 2021DOI:https://doi.org/10.1016/j.isci.2020.102021

 

The work was made possible in large part by about $1 million in cloud computing hours awarded by Google through a COVID-19 research grant program.

The work reported, below was sponsored by

  • a Google Cloud COVID-19 research grant. Funding was also provided by the
  • Fondation Aclon,
  • National Institutes of Health (GM136859),
  • Claudia Adams Barr Program for Innovative Basic Cancer Research,
  • Math+ Berlin Mathematics Research Center,
  • Templeton Religion Trust (TRT 0159),
  • U.S. Army Research Office (W911NF1910302), and
  • Chleck Family Foundation

 

Harvard University, AbbVie form research alliance to address emergent viral diseases

This article is part of Harvard Medical School’s continuing coverage of medicine, biomedical research, medical education and policy related to the SARS-CoV-2 pandemic and the disease COVID-19.

Harvard University and AbbVie today announced a $30 million collaborative research alliance, launching a multi-pronged effort at Harvard Medical School to study and develop therapies against emergent viral infections, with a focus on those caused by coronaviruses and by viruses that lead to hemorrhagic fever.

The collaboration aims to rapidly integrate fundamental biology into the preclinical and clinical development of new therapies for viral diseases that address a variety of therapeutic modalities. HMS has led several large-scale, coordinated research efforts launched at the beginning of the COVID-19 pandemic.

“A key element of having a strong R&D organization is collaboration with top academic institutions, like Harvard Medical School, to develop therapies for patients who need them most,” said Michael Severino, vice chairman and president of AbbVie. “There is much to learn about viral diseases and the best way to treat them. By harnessing the power of collaboration, we can develop new therapeutics sooner to ensure the world is better prepared for future potential outbreaks.”

“The cataclysmic nature of the COVID-19 pandemic reminds us how vital it is to be prepared for the next public health crisis and how critical collaboration is on every level—across disciplines, across institutions and across national boundaries,” said George Q. Daley, dean of Harvard Medical School. “Harvard Medical School, as the nucleus of an ecosystem of fundamental discovery and therapeutic translation, is uniquely positioned to propel this transformative research alongside allies like AbbVie.”

AbbVie will provide $30 million over three years and additional in-kind support leveraging AbbVie’s scientists, expertise and facilities to advance collaborative research and early-stage development efforts across five program areas that address a variety of therapeutic modalities:

  • Immunity and immunopathology—Study of the fundamental processes that impact the body’s critical immune responses to viruses and identification of opportunities for therapeutic intervention.

Led by Ulirich Von Andrian, the Edward Mallinckrodt Jr. Professor of Immunopathology in the Blavatnik Institute at HMS and program leader of basic immunology at the Ragon Institute of MGH, MIT and Harvard, and Jochen Salfeld, vice president of immunology and virology discovery at AbbVie.

  • Host targeting for antiviral therapies—Development of approaches that modulate host proteins in an effort to disrupt the life cycle of emergent viral pathogens.

Led by Pamela Silver, the Elliot T. and Onie H. Adams Professor of Biochemistry and Systems Biology in the Blavatnik Institute at HMS, and Steve Elmore, vice president of drug discovery science and technology at AbbVie.

  • Antibody therapeutics—Rapid development of therapeutic antibodies or biologics against emergent pathogens, including SARS-CoV-2, to a preclinical or early clinical stage.

Led by Jonathan Abraham, assistant professor of microbiology in the Blavatnik Institute at HMS, and by Jochen Salfeld, vice president of immunology and virology discovery at AbbVie.

  • Small molecules—Discovery and early-stage development of small-molecule drugs that would act to prevent replication of known coronaviruses and emergent pathogens.

Led by Mark Namchuk, executive director of therapeutics translation at HMS and senior lecturer on biological chemistry and molecular pharmacology in the Blavatnik Institute at HMS, and Steve Elmore, vice president of drug discovery science and technology at AbbVie.

  • Translational development—Preclinical validation, pharmacological testing, and optimization of leading approaches, in collaboration with Harvard-affiliated hospitals, with program leads to be determined.

SOURCE

https://hms.harvard.edu/news/joining-forces

 

 

A Screen Door Opens

Virtual screen finds compounds that could combat SARS-CoV-2

This article is part of Harvard Medical School’s continuing coverage of medicine, biomedical research, medical education, and policy related to the SARS-CoV-2 pandemic and the disease COVID-19.

Less than a year ago, Harvard Medical School researchers and international colleagues unveiled a platform called VirtualFlow that could swiftly sift through more than 1 billion chemical compounds and identify those with the greatest promise to become disease-specific treatments, providing researchers with invaluable guidance before they embark on expensive and time-consuming lab experiments and clinical trials.

Propelled by the urgent needs of the pandemic, the team has now pushed VirtualFlow even further, conducting 45 screens of more than 1 billion compounds each and ranking the compounds with the greatest potential for fighting COVID-19—including some that are already approved by the FDA for other diseases.

“This was the largest virtual screening effort ever done,” said VirtualFlow co-developer Christoph Gorgulla, research fellow in biological chemistry and molecular pharmacology in the labs of Haribabu Arthanari and Gerhard Wagner in the Blavatnik Institute at HMS.

The results were published in January in the open-access journal iScience.

The team searched for compounds that bind to any of 15 proteins on SARS-CoV-2 or two human proteins, ACE2 and TMPRSS2, known to interact with the virus and enable infection.

Researchers can now explore on an interactive website the 1,000 most promising compounds from each screen and start testing in the lab any ones they choose.

The urgency of the pandemic and the sheer number of candidate compounds inspired the team to release the early results to the scientific community.

“No one group can validate all the compounds as quickly as the pandemic demands,” said Gorgulla, who is also an associate of the Department of Physics at Harvard University. “We hope that our colleagues can collectively use our results to identify potent inhibitors of SARS-CoV-2.

In most cases, it will take years to find out whether a compound is safe and effective in humans. For some of the compounds, however, researchers have a head start.

Hundreds of the most promising compounds that VirtualFlow flagged are already FDA approved or being studied in clinical or preclinical trials for other diseases. If researchers find that one of those compounds proves effective against SARS-CoV-2 in lab experiments, the data their colleagues have already collected could save time establishing safety in humans.

Other compounds among VirtualFlow’s top hits are currently being assessed in clinical trials for COVID-19, including several drugs in the steroid family. In those cases, researchers could build on the software findings to investigate how those drug candidates work at the molecular level—something that’s not always clear even when a drug works well.

It shows what we’re capable of computationally during a pandemic.

Hari Arthanari

SOURCE

https://hms.harvard.edu/news/screen-door-opens?utm_source=Silverpop&utm_medium=email&utm_term=field_news_item_1&utm_content=HMNews02012021

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Global Tert-Amylbenzene Market Size by Application (Pharmaceuticals, Chemical Intermediaries, Batteries), Industry Analysis Report, Regional Outlook, Application Development Potential, Price Trend, Competitive Market Share & Forecast, 2020 – 2026

Published Date: Dec 2020  |  Report ID: GMI4883  |  Authors: Kunal Ahuja, Harneet Mehar

Report Format:  PDF   |   Pages: 140   |   Base Year: 2019

https://www.gminsights.com/toc/detail/tert-amylbenzene-market

 

Guest Authors: Kunal Ahuja, Harneet Mehar

 

From: Devesh Billore <devesh.b@gminsights.com>

Date: Tuesday, January 5, 2021 at 11:22 AM

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

Subject: RE: Editorial Inquiry For Exclusive Content on Tert-Amylbenzene Market

 

Hello,

 

Thanks for your response. Yes you can publish the TABLE of CONTENTS of Tert-Amylbenzene Market. Please provide report hyperlink also.

 

Report link: https://www.gminsights.com/industry-analysis/tert-amylbenzene-market

 

It would be great if you can share the URL of the article once you publish it on the website.

Regards,

Devesh Billore

Global Market Insights

E-mail:devesh.b@gminsights.com| Web: www.gminsights.com 

 

Report Content

Chapter 1   Methodology & Scope

1.1    Market definitions

1.2    Base estimates & calculations

1.3    Forecast calculations

1.4    Data Sources

1.4.1    Primary

1.4.2    Secondary

1.4.2.1    Paid Sources

1.4.2.2    Public Sources

Chapter 2   Executive Summary

2.1    Global Tert-Amylbenzene Industry 3600 synopsis, 2020-2026

2.1.1    Business trends

2.1.2    Regional trends

2.1.3    Application trends

Chapter 3   Global Tert-Amylbenzene Industry Insights

3.1    Industry segmentation

3.2    COVID-19 overview of the world economy

3.3    Industry ecosystem analysis

3.3.1    Distribution channel analysis

3.3.1.1    Distributors

3.3.1.2    Technology Providers

3.3.2    Vendor matrix

3.3.3    Impact of COVID-19 on industry value chain

3.4    Raw Material Analysis

3.4.1    Benzene

3.4.2    Tertiary Amylalcohol

3.4.3    Cumene

3.4.4    Propene

3.5    Regulatory landscape

3.5.1    U.S.

3.5.1.1    Toxic Substances Control Act (TSCA) Inventory

3.5.1.1.1    OSHA 1910.1200

3.5.2    Europe

3.5.2.1    REACH (EC 1907/2006)

3.5.3    Product purity certification analysis

3.6    Industry impact forces

3.6.1    Growth drivers

3.6.1.1    Rising demand from electronics industry

3.6.1.2    Pharmaceutical industry growth

3.6.2    Industry pitfalls & challenges

3.6.2.1    High health and environmental effects

3.7    Technology landscape

3.8    Innovation & Sustainability

3.9    Growth potential analysis, 2019

3.9.1    Emerging business models

3.9.1.1    Collaboration/Joint ventures

3.9.1.2    Distribution partnership

3.9.1.3    Digital platform

3.10    Cost structure analysis, 2019

3.11    Porter’s analysis

3.11.1    Bargaining power of suppliers

3.11.2    Bargaining power of buyers

3.11.3    Threat of new entrants

3.11.4    Threat of substitutes

3.12    Pricing Analysis, 2015-2026

3.12.1    North America

3.12.2    Europe

3.12.3    Asia Pacific

3.12.4    Latin America

3.12.5    Middle East & Africa

3.13    Competitive landscape, 2019

3.13.1    Company market share analysis, 2019

3.13.2    Strategy dashboard

3.13.3    List of potential customers/end-users

3.14    PESTEL analysis

3.15    Impact of COVID-19 on tert-amylbenzene demand, by application

3.15.1    Pharmaceuticals

3.15.2    Chemical Intermediates

3.15.3    Battery

Chapter 4   Global Tert-Amylbenzene Market, By Application

4.1    Key application trends

4.2    Pharmaceuticals

4.2.1    Global Tert-Amylbenzene market from pharmaceuticals application, 2015 – 2026

4.2.2    Global Tert-Amylbenzene market from pharmaceuticals application, by region, 2015 – 2026

4.3    Chemical intermediaries

4.3.1    Global Tert-Amylbenzene market from chemical intermediaries application, 2015 – 2026

4.3.2    Global Tert-Amylbenzene market from chemical intermediaries application, by region, 2015 – 2026

4.4    Batteries

4.4.1    Global Tert-Amylbenzene market from batteries application, 2015 – 2026

4.4.2    Global Tert-Amylbenzene market from batteries application, by region, 2015 – 2026

Chapter 5   Global Tert-Amylbenzene Market, By Region

5.1    Key regional trends

5.2    North America

5.2.1    North America Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.2.2    North America Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.2.3    U.S.

5.2.3.1    U.S. Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.2.3.2    U.S. Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.2.4    Canada

5.2.4.1    Canada Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.2.4.2    Canada Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.2.5    Mexico

5.2.5.1    Mexico Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.2.5.2    Mexico Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.3    Europe

5.3.1    Europe Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.3.2    Europe Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.3.3    Germany

5.3.3.1    Germany Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.3.3.2    Germany Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.3.4    UK

5.3.4.1    UK Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.3.4.2    UK Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.3.5    France

5.3.5.1    France Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.3.5.2    France Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.3.6    Italy

5.3.6.1    Italy Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.3.6.2    Italy Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.3.7    Spain

5.3.7.1    Spain Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.3.7.2    Spain Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.3.8    Russia

5.3.8.1    Russia Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.3.8.2    Russia Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.4    Asia Pacific

5.4.1    Asia Pacific Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.4.2    Asia Pacific Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.4.3    China

5.4.3.1    China Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.4.3.2    China Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.4.4    India

5.4.4.1    India Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.4.4.2    India Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.4.5    Japan

5.4.5.1    Japan Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.4.5.2    Japan Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.4.6    South Korea

5.4.6.1    South Korea Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.4.6.2    South Korea Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.4.7    Australia

5.4.7.1    Australia Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.4.7.2    Australia Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.4.8    Malaysia

5.4.8.1    Malaysia Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.4.8.2    Malaysia Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.5    LATAM

5.5.1    LATAM Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.5.2    LATAM Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.5.3    Brazil

5.5.3.1    Brazil Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.5.3.2    Brazil Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.6    MEA

5.6.1    MEA Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.6.2    MEA Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.6.3    Saudi Arabia

5.6.3.1    Saudi Arabia Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.6.3.2    Saudi Arabia Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.6.4    UAE

5.6.4.1    UAE Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.6.4.2    UAE Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

5.6.5    South Africa

5.6.5.1    South Africa Tert-Amylbenzene market, 2015 – 2026, (Tons) (USD Thousand)

5.6.5.2    South Africa Tert-Amylbenzene market, by application, 2015 – 2026, (Tons) (USD Thousand)

Chapter 6   Company Profiles

6.1    Jiujiang Pro High Technology Materials Co., Ltd.

6.1.1    Business Overview

6.1.2    Financial Data

6.1.3    Product Landscape

6.1.4    Swot Analysis

6.2    Hunan Jinxi Chemical Co. Ltd.

6.2.1    Business Overview

6.2.2    Financial Data

6.2.3    Product Landscape

6.2.4    Swot Analysis

6.3    Zhenjiang Haitong Chemical industry Co., Ltd.

6.3.1    Business Overview

6.3.2    Financial Data

6.3.3    Product Landscape

6.3.4    Swot Analysis

6.4    Solvay

6.4.1    Business Overview

6.4.2    Financial Data

6.4.3    Product Landscape

6.4.4    Strategic Outlook

6.4.5    Swot Analysis

6.5    Sigma Aldrich

6.5.1    Business Overview

6.5.2    Financial Data

6.5.3    Product Landscape

6.5.4    Swot Analysis

6.6    Frontier Scientific, Inc.

6.6.1    Business Overview

6.6.2    Financial Data

6.6.3    Product Landscape

6.6.4    Swot Analysis

6.7    Alfa Chemistry

6.7.1    Business Overview

6.7.2    Financial Data

6.7.3    Product Landscape

6.7.4    Swot Analysis

6.8    TCI Chemical Trading

6.8.1    Business Overview

6.8.2    Financial Data

6.8.3    Product Landscape

6.8.4    Swot Analysis

6.9    Alfa Aesar (part of Thermo Fisher Scientific)

6.9.1    Business Overview

6.9.2    Financial Data

6.9.3    Product Landscape

6.9.4    Swot Analysis
Data Tables

TABLE 1      Global Tert-Amylbenzene market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 2      Global  Tert-Amylbenzene market volume, by region, 2015 – 2026 (Tons)

TABLE 3      Global  Tert-Amylbenzene market revenue, by region, 2015 – 2026 (USD thousand)

TABLE 4      Global  Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 5      Global  Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 6      Projections of GDP growth (%) in 2020 based on three scenarios

TABLE 7      Global tert amyl benzene distribution channel analysis

TABLE 8      Vendor matrix

TABLE 9      Purity of tert-amylbenzene offered by global companies

TABLE 10     Industry impact forces

TABLE 11     Cost elements

TABLE 12     List of potential customers/end-users

TABLE 13     Global  Tert-Amylbenzene demand, by region, 2015 – 2026 (Tons)

TABLE 14     Global  Tert-Amylbenzene supply, by region, 2015 – 2026 (Tons)

TABLE 15     Global  Tert-Amylbenzene  market from pharmaceuticals application, 2015 – 2026 (Tons)  (USD Thousand)

TABLE 16     Global  Tert-Amylbenzene market volume from pharmaceuticals application, by region, 2015 – 2026 (Tons)

TABLE 17     Global  Tert-Amylbenzene market revenue from pharmaceuticals application, by region, 2015 – 2026 (USD thousand)

TABLE 18     Global  Tert-Amylbenzene  market from chemical intermediaries application, 2015 – 2026 (Tons)  (USD Thousand)

TABLE 19     Global  Tert-Amylbenzene market volume from chemical intermediaries application, by region, 2015 – 2026 (Tons)

TABLE 20     Global  Tert-Amylbenzene market revenue from chemical intermediaries application, by region, 2015 – 2026 (USD thousand)

TABLE 21     Global  Tert-Amylbenzene  market from batteries application, 2015 – 2026 (Tons)  (USD Thousand)

TABLE 22     Global  Tert-Amylbenzene market volume from batteries application, by region, 2015 – 2026 (Tons)

TABLE 23     Global  Tert-Amylbenzene market revenue from batteries application, by region, 2015 – 2026 (USD thousand)

TABLE 24     North America Tert-Amylbenzene market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 25     North America  Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 26     North America  Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 27     U.S.  Tert-Amylbenzene market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 28     U.S.   Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 29     U.S.   Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 30     Canada   Tert-Amylbenzene market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 31     Canada    Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 32     Canada Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 33     Mexico Tert-Amylbenzene market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 34     Mexico  Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 35     Mexico  Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 36     Europe  Tert-Amylbenzene market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 37     Europe  Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 38     Europe  Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 39     Germany     Tert-Amylbenzene market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 40     Germany Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 41     Germany Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 42     UK   Tert-Amylbenzene market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 43     UK Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 44     UK Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 45     France     Tert-Amylbenzene market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 46     France Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 47     France Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 48     Italy Tert-Amylbenzene market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 49     Italy Tert-Amylbenzene  market volume, by application, 2015 – 2026 (Tons)

TABLE 50     Italy Tert-Amylbenzene  market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 51     Spain Tert-Amylbenzene market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 52     Spain Tert-Amylbenzene  market volume, by application, 2015 – 2026 (Tons)

TABLE 53     Spain Tert-Amylbenzene  market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 54     Russia Tert-Amylbenzene  market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 55     Russia  Tert-Amylbenzene  market volume, by application, 2015 – 2026 (Tons)

TABLE 56     Russia  Tert-Amylbenzene  market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 57     Asia Pacific  Tert-Amylbenzene market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 58     Asia Pacific   Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 59     Asia Pacific   Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 60     China Tert-Amylbenzene  market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 61     China  Tert-Amylbenzene  market volume, by application, 2015 – 2026 (Tons)

TABLE 62     China  Tert-Amylbenzene  market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 63     India  Tert-Amylbenzene  market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 64     India Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 65     India Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 66     Japan  Tert-Amylbenzene  market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 67     Japan Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 68     Japan Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 69     South Korea  Tert-Amylbenzene  market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 70     South Korea Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 71     South Korea Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 72     Australia  Tert-Amylbenzene  market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 73     Australia Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 74     Australia Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 75     Malaysia  Tert-Amylbenzene  market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 76     Malaysia Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 77     Malaysia Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 78     LATAM  Tert-Amylbenzene market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 79     LATAM   Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 80     LATAM   Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 81     Brazil  Tert-Amylbenzene  market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 82     Brazil Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 83     Brazil Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 84     MEA  Tert-Amylbenzene market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 85     MEA   Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 86     MEA   Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 87     Saudi Arabia  Tert-Amylbenzene  market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 88     Saudi Arabia Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 89     Saudi Arabia Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 90     UAE  Tert-Amylbenzene  market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 91     UAE Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 92     UAE Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

TABLE 93     South Africa Tert-Amylbenzene market, 2015 – 2026, (Tons)  (USD Thousand)

TABLE 94     South Africa Tert-Amylbenzene market volume, by application, 2015 – 2026 (Tons)

TABLE 95     South Africa Tert-Amylbenzene market revenue, by application, 2015 – 2026 (USD Thousand)

 

Charts & Figures

FIG. 1     Global Tert-Amylbenzene industry 3600 synopsis

FIG. 2     Europe Pulp & Paper Industry Revenue, 2015 – 2019 (USD Billion)

FIG. 3     Confirmed COVID-19 cases in Europe, by cases, as of 30 November 2020 (Number of cases)

FIG. 4     Demand for Lithium-ion batteries from Electric Vehicles, 2015-2030 (Gwh)

FIG. 5     Industry segmentation

FIG. 6     Industry ecosystem analysis

FIG. 7     Global Benzene Production, 2015-2022, (Million Metric Tons)

FIG. 8     China Benzene Production Capacities, 2015-2025 (Million Metric Tons)

FIG. 9     U.S. Benzene Production, 2016-2019, (Thousand Metric Tons)

FIG. 10    Global Cumene Consumption, By Region, 2019, (%)

FIG. 11    U.S. Cumene Prices, 2017-2020, (USD/barrel)

FIG. 12    Global Propylene Production and Consumption, 2018, (Mn MT)

FIG. 13    U.S. Propene Demand, 2016-2019, (Mn MT)

FIG. 14    Consumer electronics revenue in Western Europe, Q4 2015 – Q1 2020 (USD Billion)

FIG. 15    Growth of the middle class population, by region,  2015 – 2030 (Million persons)

FIG. 16    Global pharmaceutical industry revenue, 2014-19, (USD Billion)

FIG. 17    Share of population aged 65 years and above in Europe, major countries, 2019, (%)

FIG. 18    Production Technique of Tert.-Amylbenzene

FIG. 19    Growth Potential Analysis, 2019

FIG. 20    Cost structure analysis, 2019

FIG. 21    Porter’s analysis

FIG. 22    Company market share analysis, 2019

FIG. 23    PESTEL analysis

 

 

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Danny Bar-Zohar, MD –  New R&D Leader for new pipelines at Merck KGaA as Luciano Rossetti steps out

Reporter: Aviva Lev-Ari, PhD, RN

 

Danny Bar-Zohar, MD – A Pharmaceutical Executive Profile in R&D: Ex-Novastis, Ex-Teva

Experience

Education

SOURCE

https://www.linkedin.com/in/danny-bar-zohar-513904a/

 

Novartis vet Danny Bar-Zohar leaps back into R&D, taking over the development team at Merck KGaA as Luciano Rossetti steps out

John Carroll
Editor & Founder

After a brief stint as a biotech investor at Syncona, Novartis vet Danny Bar-Zohar is back in R&D, and he’s taking the lead position at Merck KGaA’s drug division.

Bar-Zohar had led late-stage clinical development across a variety of areas — neuroscience, immunology, oncology and ophthalmology, among others — before joining the migration of talent out of the Basel-based multinational. He had been at Novartis for 7 years, which followed an earlier chapter in research at Teva.

Luciano Rossetti
The scientist is taking the lead on development at Merck KGaA, in place of Luciano Rossetti, who had a mixed record in R&D that nevertheless marked a big improvement over the dismal run the company had endured earlier. Joern-Peter Halle will continue on as global head of research. Rossetti is retiring after 6 years of running the research group, which has extensive operations in Germany as well as Massachusetts.

Their PD-L1 Bavencio — allied with Pfizer — has had a few successes, and a whole slate of failures. Sprifermin was touted as a big potential advance in osteoarthritis, but Merck KGaA is now auctioning off that part of the portfolio. One of the few late-stage bright spots has been their MET inhibitor tepotinib, which won breakthrough status and now is under priority review. That drug faces a rival at Novartis — capmatinib — that won an accelerated OK at the FDA in May.

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There’s also a BTK inhibitor, evobrutinib, that’s being developed for MS. But that’s a very crowded field, and Sanofi has been bullish about its prospects in the same research niche after buying out Principia.

Moving back into mid-stage development, there’s a major program underway for bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, which Merck KGaA has high hopes for.

That all marks some bright, though limited, prospects for Merck KGaA, highlighting the need to find something new to beef up the pipeline. Bar-Zohar will get a say in that.

AUTHOR
John Carroll

SOURCE

https://endpts.com/novartis-vet-danny-bar-zohar-leaps-back-into-rd-taking-over-the-team-at-merck-kgaa-as-luciano-rossetti-steps-out/

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Tweet Collection by @pharma_BI and @AVIVA1950 and Re-Tweets for e-Proceedings 14th Annual BioPharma &amp; Healthcare Summit, Friday, September 4, 2020, 8 AM EST to 3-30 PM EST – Virtual Edition

Real Time Press Coverage: Aviva Lev-Ari, PhD, RN

 

e-Proceedings 14th Annual BioPharma & Healthcare Summit, Friday, September 4, 2020, 8 AM EST to 3-30 PM EST – Virtual Edition

Real Time Press Coverage: Aviva Lev-Ari, PhD, RN

Founder & Director, LPBI Group

https://pharmaceuticalintelligence.com/2020/07/28/14th-annual-biopharma-healthcare-summit-friday-september-4-2020-8-am-est-to-3-30-pm-est-virtual-edition/

 

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Dr. Hal Barron, Chief Scientific Officer and President R&D, GlaxoSmithKline GWAS not easy to find which gene drives the association  Functional Genomics gene by gene with phenotypes using machine learning significant help

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK GWAS not easy to find which gene drives the association  Functional Genomics gene by gene with phenotypes using machine learning significant help

Srihari Gopal
@sgopal2

Enjoyed hearing enthusiasm for Neuroscience R&D by Roy Vagelos at #USAIC20. Wonderful interview by Mathai Mammen

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Aviva Lev-Ari
@AVIVA1950

#USAIC20 Nina Kjellson, General Partner, Canaan Data science is a winner in Healthcare Women – Data Science is an excellent match

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Arpa Garay, President, Global Pharmaceuticals, Commercial Analytics, Merck & Co. Data on Patients and identification who will benefit fro which therapy  cultural bias risk aversion

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Dr. Najat Khan, Chief Operating Officer, Janssen R&D Data Sciences, Johnson & Johnson Data Validation  Deployment of algorithms embed data by type early on in the crisis to understand the disease

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Sastry Chilukuri, President, Acorn AI- Medidata Opportunities in Data Science in Paharma COVID-19 and Data Science

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Dr. Maya Said, Chief Executive Officer, Outcomes4Me Cancer patients taking change of their care Digital Health – consumerization of Health, patient demand to be part of the decision, part the information FDA launched a Program Project Patient Voice

USAIC
@USAIC

We’re taking a quick break at #USAIC20 before our next panel on rare diseases starts at 12:20pm EDT. USAIC would like to thank our Sponsors and Partners for supporting this year’s digital event.

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Aviva Lev-Ari
@AVIVA1950

#USAIC20 Dr. Roy Vagelos, Chairman of the Board, Regeneron HIV-AIDS: reverse transcriptase converted a lethal disease to a chronic disease, tried hard to make vaccine – the science was not there

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Dr. Roy Vagelos, Chairman of the Board, Regeneron Pharmaceuticals Congratulates Big Pharma for taking the challenge on COVID-19 Vaccine, Antibody and anti-viral Government funding Merck was independent from Government – to be able to set the price

1

Dr Kapil Khambholja
@kapilmk

Christopher Viehbacher, Gurnet Point Capital touches very sensitive topic at #USAIC20 He claims that we are never going to have real innovation out of big pharma! Well this isn’t new but not entirely true either… any more thoughts?
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Aviva Lev-Ari
@AVIVA1950

#USAIC20 Daphne Zohar, Founder & CEO, PureTech Health Disease focus, best science is the decision factors

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Aviva Lev-Ari
@AVIVA1950

#USAIC20 Christopher Viehbacher, Managing Partner, Gurnet Point Capital Dream of every Biotech – get Big Pharma coming to acquire and pay a lot Morph and adapt

anju ghangurde
@scripanjug

Biogen’s chair Papadopoulos big co mergers is an attempt to solve problems; typically driven by patent expirations.. #usaic20

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anju ghangurde
@scripanjug

Chris Viehbacher/Gurnet Point Capital on US election: industry will work with whoever wins; we’ll have to ‘morph & adapt’ #usaic20

1

Dr Kapil Khambholja
@kapilmk

of

talks about various philosophies and key reasons why certain projects/molecules are killed early. My counter questions- What are chances of losing hope little early? Do small #biopharma publish negative results to aid to the knowledge pool? #USAIC20

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Aviva Lev-Ari
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#USAIC20 Dr. Laurie Glimcher, President & CEO, Dana-Farber Cancer Institute DNA repair and epignetics are the future of medicine

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Dr. Laurie Glimcher, President & CEO, Dana-Farber Cancer Institute COlonorectal cancer is increasing immuno therapy 5 drugs marketed 30% cancer patients are treated early detection key vs metastatic 10% of cancer are inherited treatment early

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Rehan Verjee, President, EMD Serono Charities funding cancer research – were impacted and resources will come later and in decreased amount New opportunities support access to Medicine improve investment across the board

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Dr. Philip Larsen, Global Head of Research, Bayer AG Repurposing drugs as antiviral from drug screening innovating methods Cytokine storm in OCVID-19 – kinase inhibitors may be antiviral data of tested positive allows research of pathway in new ways

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Dr. Laurie Glimcher, President & CEO, Dana-Farber 3,000 Telemedicine session in the first week of the Pandemic vs 300 before – patient come back visits patient happy with Telemedicine team virtually need be reimbursed same rate working remotely

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Dr. Raju Kucherlapati, Professor of Genetics, Harvard Medical School New normal as a result of the pandemic role of personalized medicine

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Rehan Verjee, President, EMD Serono entire volume of clinical trials at Roche went down same at EMD delay of 6 month, some were to be initiated but was put on hold Charities funding cancer research were impacted and resources will come later smaller

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Dr. Laurie Glimcher, President & CEO, Dana-Farber Cancer Institute Dana Farber saw impact of COVID-19 on immunosuppressed patients coming in for Cancer Tx – switch from IV Tx to Oral 96% decrease in screenings due to Pandemic – increase with Cancer

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Kenneth Frazier, Chairman of the Board and Chief Executive Officer, Merck & Co. Pharma’s obligation for next generations requires investment in R&D vs Politicians running for 4 years Patients must come first vs shareholders vs R&D investment in 2011

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Kenneth Frazier, Chairman of the Board and Chief Executive Officer, Merck & Co. Antibiotic research at Merck – no market incentives on pricing for Merck to invest in antibiotics people will die from bacterial resistance next pandemic be bacterial

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Kenneth Frazier, Chairman of the Board and Chief Executive Officer, Merck & Co. Strategies of Merck = “Medicine is for the People not for Profit” – Ketruda in India is not reembureable in India and million are in need it Partnership are encouraged

Dr Kapil Khambholja
@kapilmk

Chairman Stelios Papadopoulos asks #KennethFrazier if wealthy nations will try to secure large proportion of #COVID19 drugs/vaccines. #KennethFrazie rightly mentions: pharma industry’s responsibility to balance the access to diff countries during pandemic. #USAIC20

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Dr Kapil Khambholja
@kapilmk

Almost 60% participants at #USAIC20 feel that MNCs are more likely to run their #clinicalTrials in #INDIA seeing changing environment here, reveals the poll. Exciting time ahead for scientific fraternity as this can substantially increase the speed of #DrugDevelopment globally

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@AVIVA1950

#USAIC20 Dr. Barry Bloom, Professor & former Dean, Harvard School of Public Health Vaccine in clinical trials, public need to return for 2nd shot, hesitancy Who will get the Vaccine first in the US  most vulnerable of those causing transmission Pharma’s risk

4

Aviva Lev-Ari
@AVIVA1950

#USAIC20 Dr. Barry Bloom, Professor & former Dean, Harvard School of Public Health Testing – PCR expensive does not enable quick testing is expensive result come transmission occurred Antibody testing CRISPR test based Vaccine in clinical trials

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Aviva Lev-Ari
@AVIVA1950

#USAIC20 Dr Andrew Plump, President of R&D, Takeda Pharmaceuticals COllaboration effort around the Globe in the Pandemic therapy solutions including Vaccines

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National Public Radio interview with Dr. Anthony Fauci on his optimism on a COVID-19 vaccine by early 2021

Reporter: Stephen J. Williams, PhD

Below I am giving a link to an important interview by NPR’s Judy Woodruff with Dr. Anthony Fauci on his thoughts regarding the recent spikes in cases, the potential for a COVID-19 vaccine by next year, and promising therapeutics in the pipeline.  The interview link is given below however I will summarize a few of the highlights of the interview.

 

Some notes on the interview

Judy Woodruff began her report with some up to date news regarding the recent spike and that Miami Florida has just ordered the additional use of facemasks.  She asked Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases (NIAD), about if the measures currently in use are enough to bring this spike down.  Dr. Fauci said that we need to reboot our efforts, mainly because people are not doing three things which could have prevented this spike mainly

  1. universal wearing of masks
  2. distancing properly from each other
  3. close the bars and pubs (see Wisconsin bars packed after ruling)

It hasn’t been a uniform personal effort

Dr. Fauci on testing

We have to use the tests we have out there efficiently and effectively And we have to get them out to the right people who can do the proper identification, isolation, and do proper contract tracing and need to test more widely in a surveillance way to get a feel of the extent and penetrance of this community spread.  there needs to be support and money for these testing labs

We have a problem and we need to admit and own it but we need to do the things we know are effective to turn this thing around.

On Vaccines

“May be later this year”

His response to Merck’s CEO Ken Frazer who said officials are giving false hop if they say ‘end of year’ but Dr. Fauci disagrees.  He says a year end goal is not outlandish.

What we have been doing is putting certain things in line with each other in an unprecedented way.

Dr. Fauci went on to say that, in the past yes, it took a long time, even years to develop a vaccine but now they have been able to go from sequence of virus to a vaccine development program in days, which is unheard of.  Sixty two days later we have gone into phase 1 trials. the speed at which this is occurring is so much faster.  He says that generally it would take a couple of years to get a neutralizing antibody but we are already there.  Another candidate will be undergoing phase 3 trials by end of this month (July 2020).

He is “cautiously optimistic” that we will have one or more vaccines to give to patients by end of year because given the amount of cases it will be able to get a handle on safety and efficacy by late fall.

Now he says the game changer is that the government is working with companies to ramp up the production of doses of the candidate vaccines so when we find which one works we will have ample doses on hand.  He is worried about the anti vaccine movement derailing vaccine testing and vaccinations but says if we keep on informing the public we can combat this.

Going back to school

Dr. Fauci is concerned for the safety of the vulnerable in schools, including students and staff.  He wants the US to get down to a reasonable baseline of cases but in the US that baseline after the first wave was still significantly higher than in most countries, where the baseline was more like tens of cases not hundreds of cases.

For more information on COVID-19 Please go to our Coronavirus Portal at

https://pharmaceuticalintelligence.com/coronavirus-portal/

 

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From Cell Press:  New Insights on the D614G Strain of COVID: Will a New Mutated Strain Delay Vaccine Development?

Reporter: Stephen J. Williams, PhD

Two recent articles in Cell Press, both peer reviewed, discuss the emergence and potential dominance of a new mutated strain of COVID-19, in which the spike protein harbors a D614G mutation.

In the first article “Making Sense of Mutation: What D614G means for the COVID-19 pandemic Remains Unclear”[1] , authors Drs. Nathan Grubaugh, William Hanage, and Angela Rasmussen discuss the recent findings by Korber et al. 2020 [2] which describe the potential increases in infectivity and mortality of this new mutant compared to the parent strain of SARS-CoV2.  For completeness sake I will post this article as to not defer from their interpretations of this important paper by Korber and to offer some counter opinion to some articles which have surfaced this morning in the news.

Making sense of mutation: what D614G means for the COVID-19 pandemic remains unclear

 

Nathan D. Grubaugh1 *, William P. Hanage2 *, Angela L. Rasmussen3 * 1Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT 06510, USA 2Center for Communicable Disease Dynamics, Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, MA 02115, USA 3Center for Infection and Immunity, Columbia Mailman School of Public Health, New York, NY 10032, USA Correspondence: grubaughlab@gmail.com

 

Abstract: Korber et al. (2020) found that a SARS-CoV-2 variant in the spike protein, D614G, rapidly became dominant around the world. While clinical and in vitro data suggest that D614G changes the virus phenotype, the impact of the mutation on transmission, disease, and vaccine and therapeutic development are largely unknown.

Introduction: Following the emergence of SARS-CoV-2 in China in late 2019, and the rapid expansion of the COVID19 pandemic in 2020, questions about viral evolution have come tumbling after. Did SARS-CoV-2 evolve to become better adapted to humans? More infectious or transmissible? More deadly? Virus mutations can rise in frequency due to natural selection, random genetic drift, or features of recent epidemiology. As these forces can work in tandem, it’s often hard to differentiate when a virus mutation becomes common through fitness or by chance. It is even harder to determine if a single mutation will change the outcome of an infection, or a pandemic. The new study by Korber et al. (2020) sits at the heart of this debate. They present compelling data that an amino acid change in the virus’ spike protein, D614G, emerged early during the pandemic, and viruses containing G614 are now dominant in many places around the world. The crucial questions are whether this is the result of natural selection, and what it means for the COVID-19 pandemic. For viruses like SARS-CoV-2 transmission really is everything – if they don’t get into another host their lineage ends. Korber et al. (2020) hypothesized that the rapid spread of G614 was because it is more infectious than D614. In support of their hypothesis, the authors provided evidence that clinical samples from G614 infections have a higher levels of viral RNA, and produced higher titers in pseudoviruses from in vitro experiments; results that now seem to be corroborated by others [e.g. (Hu et al., 2020; Wagner et al., 2020)]. Still, these data do not prove that G614 is more infectious or transmissible than viruses containing D614. And because of that, many questions remain on the potential impacts, if any, that D614G has on the COVID-19 pandemic.

The authors note that this new G614 variant has become the predominant form over the whole world however in China the predominant form is still the D614 form.  As they state

“over the period that G614 became the global majority variant, the number of introductions from China where D614 was still dominant were declining, while those from Europe climbed. This alone might explain the apparent success of G614.”

Grubaugh et al. feel there is not enough evidence that infection with this new variant will lead to higher mortality.  Both Korber et al. and the Seattle study (Wagner et al) did not find that the higher viral load of this variant led to a difference in hospitalizations so apparently each variant might be equally as morbid.

In addition, Grubaugh et al. believe this variant would not have much affect on vaccine development as, even though the mutation lies within the spike protein, D614G is not in the receptor binding domain of the spike protein.  Korber suggest that there may be changes in glycosylation however these experiments will need to be performed.  In addition, antibodies from either D614 or G614 variant infected patients could cross neutralize.

 

Conclusions: While there has already been much breathless commentary on what this mutation means for the COVID19 pandemic, the global expansion of G614 whether through natural selection or chance means that this variant now is the pandemic. As a result its properties matter. It is clear from the in vitro and clinical data that G614 has a distinct phenotype, but whether this is the result of bonafide adaptation to human ACE2, whether it increases transmissibility, or will have a notable effect, is not clear. The work by Korber et al. (2020) provides an early base for more extensive epidemiological, in vivo experimental, and diverse clinical investigations to fill in the many critical gaps in how D614G impacts the pandemic.

The link to the Korber Cell paper is here: https://www.cell.com/cell/fulltext/S0092-8674(20)30820-5

Tracking changes in SARS-CoV-2 Spike: evidence that D614G increases infectivity of the COVID-19 virus

DOI: https://doi.org/10.1016/j.cell.2020.06.043

Keypoints

  • The consistent increase of G614 at regional levels may indicate a fitness advantage

 

  • G614 is associated with lower RT PCR Ct’s, suggestive of higher viral loads in patients

 

  • The G614 variant grows to higher titers as pseudotyped virions

Summary

A SARS-CoV-2 variant carrying the Spike protein amino acid change D614G has become the most prevalent form in the global pandemic. Dynamic tracking of variant frequencies revealed a recurrent pattern of G614 increase at multiple geographic levels: national, regional and municipal. The shift occurred even in local epidemics where the original D614 form was well established prior to the introduction of the G614 variant. The consistency of this pattern was highly statistically significant, suggesting that the G614 variant may have a fitness advantage. We found that the G614 variant grows to higher titer as pseudotyped virions. In infected individuals G614 is associated with lower RT-PCR cycle thresholds, suggestive of higher upper respiratory tract viral loads, although not with increased disease severity. These findings illuminate changes important for a mechanistic understanding of the virus, and support continuing surveillance of Spike mutations to aid in the development of immunological interventions.

 

References

  1. Grubaugh, N.D., Hanage, W.P., Rasmussen, A.L., Making sense of mutation: what D614G means for the COVID-19 pandemic remains unclear, Cell (2020), doi: https:// doi.org/10.1016/j.cell.2020.06.040.
  2. Korber, B., Fischer, W.M., Gnanakaran, S., Yoon, H., Theiler, J., Abfalterer, W., Hengartner, N., Giorgi, E.E., Bhattacharya, T., Foley, B., et al. (2020). Tracking changes in SARS-CoV-2 Spike: evidence that D614G increases infectivity of the COVID-19 virus. Cell 182.
  3. Endo, A., Centre for the Mathematical Modelling of Infectious Diseases COVID-19 Working Group, Abbott, S., Kucharski, A.J., and Funk, S. (2020). Estimating the overdispersion in COVID-19 transmission using outbreak sizes outside China. Wellcome Open Res 5, 67.
  4. Hu, J., He, C.-L., Gao, Q.-Z., Zhang, G.-J., Cao, X.-X., Long, Q.-X., Deng, H.-J., Huang, L.-Y., Chen, J., Wang, K., et al. (2020). The D614G mutation of SARS-CoV-2 spike protein enhances viral infectivity and decreases neutralization sensitivity to individual convalescent sera. bioRxiv 2020.06.20.161323.
  5. Wagner, C., Roychoudhury, P., Hadfield, J., Hodcroft, E.B., Lee, J., Moncla, L.H., Müller, N.F., Behrens, C., Huang, M.-L., Mathias, P., et al. (2020). Comparing viral load and clinical outcomes in Washington State across D614G mutation in spike protein of SARS-CoV-2. Https://github.com/blab/ncov-D614G.

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The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Partnership on May 18, 2020: Leadership of AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eisai, Eli Lilly, Evotec, Gilead, GlaxoSmithKline, Johnson & Johnson, KSQ Therapeutics, Merck, Novartis, Pfizer, Roche, Sanofi, Takeda, and Vir. We also thank multiple NIH institutes (especially NIAID), the FDA, BARDA, CDC, the European Medicines Agency, the Department of Defense, the VA, and the Foundation for NIH

Reporter: Aviva Lev-Ari, PhD, RN

May 18, 2020

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) An Unprecedented Partnership for Unprecedented Times

JAMA. Published online May 18, 2020. doi:10.1001/jama.2020.8920

First reported in Wuhan, China, in December 2019, COVID-19 is caused by a highly transmissible novel coronavirus, SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). By March 2020, as COVID-19 moved rapidly throughout Europe and the US, most researchers and regulators from around the world agreed that it would be necessary to go beyond “business as usual” to contain this formidable infectious agent. The biomedical research enterprise was more than willing to respond to the challenge of COVID-19, but it soon became apparent that much-needed coordination among important constituencies was lacking.

Clinical trials of investigational vaccines began as early as January, but with the earliest possible distribution predicted to be 12 to 18 months away. Clinical trials of experimental therapies had also been initiated, but most, except for a trial testing the antiviral drug remdesivir,2 were small and not randomized. In the US, there was no true overarching national process in either the public or private sector to prioritize candidate therapeutic agents or vaccines, and no efforts were underway to develop a clear inventory of clinical trial capacity that could be brought to bear on this public health emergency. Many key factors had to change if COVID-19 was to be addressed effectively in a relatively short time frame.

On April 3, leaders of the National Institutes of Health (NIH), with coordination by the Foundation for the National Institutes of Health (FNIH), met with multiple leaders of research and development from biopharmaceutical firms, along with leaders of the US Food and Drug Administration (FDA), the Biomedical Advanced Research and Development Authority (BARDA), the European Medicines Agency (EMA), and academic experts. Participants sought urgently to identify research gaps and to discuss opportunities to collaborate in an accelerated fashion to address the complex challenges of COVID-19.

These critical discussions culminated in a decision to form a public-private partnership to focus on speeding the development and deployment of therapeutics and vaccines for COVID-19. The group assembled 4 working groups to focus on preclinical therapeutics, clinical therapeutics, clinical trial capacity, and vaccines (Figure). In addition to the founding members, the working groups’ membership consisted of senior scientists from each company or agency, the Centers for Disease Control and Prevention (CDC), the Department of Veterans Affairs (VA), and the Department of Defense.

Figure.

Accelerating COVID-19 Therapeutic Interventions and Vaccines

ACTIV’s 4 working groups, each with one cochair from NIH and one from industry, have made rapid progress in establishing goals, setting timetables, and forming subgroups focused on specific issues (Figure). The goals of the working group, along with a few examples of their accomplishments to date, include the following.

 

The Preclinical Working Group was charged to standardize and share preclinical evaluation resources and methods and accelerate testing of candidate therapies and vaccines to support entry into clinical trials. The aim is to increase access to validated animal models and to enhance comparison of approaches to identify informative assays. For example, through the ACTIV partnership, this group aims to extend preclinical researchers’ access to high-throughput screening systems, especially those located in the Biosafety Level 3 (BSL3) facilities currently required for many SARS-CoV-2 studies. This group also is defining a prioritization approach for animal use, assay selection and staging of testing, as well as completing an inventory of animal models, assays, and BSL 3/4 facilities.

 

The Therapeutics Clinical Working Group has been charged to prioritize and accelerate clinical evaluation of a long list of therapeutic candidates for COVID-19 with near-term potential. The goals have been to prioritize and test potential therapeutic agents for COVID-19 that have already been in human clinical trials. These may include agents with either direct-acting or host-directed antiviral activity, including immunomodulators, severe symptom modulators, neutralizing antibodies, or vaccines. To help achieve these goals, the group has established a steering committee with relevant expertise and objectivity to set criteria for evaluating and ranking potential candidate therapies submitted by industry partners. Following a rigorous scientific review, the prioritization subgroup has developed a complete inventory of approximately 170 already identified therapeutic candidates that have acceptable safety profiles and different mechanisms of action. On May 6, the group presented its first list of repurposed agents recommended for inclusion in ACTIV’s master protocol for adaptive clinical trials. Of the 39 agents that underwent final prioritization review, the group identified 6 agents—including immunomodulators and supportive therapies—that it proposes to move forward into the master protocol clinical trial(s) expected to begin later in May.

 

The Clinical Trial Capacity Working Group is charged with assembling and coordinating existing networks of clinical trials to increase efficiency and build capacity. This will include developing an inventory of clinical trial networks supported by NIH and other funders in the public and private sectors, including contract research organizations. For each network, the working group seeks to identify their specialization in different populations and disease stages to leverage infrastructure and expertise from across multiple networks, and establish a coordination mechanism across networks to expedite trials, track incidence across sites, and project future capacity. The clinical trials inventory subgroup has already identified 44 networks, with access to adult populations and within domestic reach, for potential inclusion in COVID-19 trials. Meanwhile, the survey subgroup has developed 2 survey instruments to assess the capabilities and capacities of those networks, and its innovation subgroup has developed a matrix to guide deployment of innovative solutions throughout the trial life cycle.

 

The Vaccines Working Group has been charged to accelerate evaluation of vaccine candidates to enable rapid authorization or approval.4 This includes development of a harmonized master protocol for adaptive trials of multiple vaccines, as well as development of a trial network that could enroll as many as 100 000 volunteers in areas where COVID-19 is actively circulating. The group also aims to identify biomarkers to speed authorization or approval and to provide evidence to address cross-cutting safety concerns, such as immune enhancement. Multiple vaccine candidates will be evaluated, and the most promising will move to a phase 2/3 adaptive trial platform utilizing large geographic networks in the US and globally.5 Because time is of the essence, ACTIV will aim to have the next vaccine candidates ready to enter clinical trials by July 1, 2020.

References

1.

Desai  A .  Twentieth-century lessons for a modern coronavirus pandemic.   JAMA. Published online April 27, 2020. doi:10.1001/jama.2020.4165
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2.

NIH clinical trial shows remdesivir accelerates recovery from advanced COVID-19. National Institutes of Health. Published April 29, 2020. Accessed May 7, 2020. https://www.nih.gov/news-events/news-releases/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19

3.

NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options. National Institutes of Health. Published April 17, 2020. Accessed May 7, 2020. https://www.nih.gov/news-events/news-releases/nih-launch-public-private-partnership-speed-covid-19-vaccine-treatment-options

4.

Corey  L , Mascola  JR , Fauci  AS , Collins  FS .  A strategic approach to COVID-19 vaccine R&D.   Science. Published online May 11, 2020. doi:10.1126/science.abc5312PubMedGoogle Scholar

5.

Angus  DC .  Optimizing the trade-off between learning and doing in a pandemic.   JAMA. Published online March 30, 2020. doi:10.1001/jama.2020.4984
ArticlePubMedGoogle Scholar

6.

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) portal. National Institutes of Health. Accessed May 15, 2020. https://www.nih.gov/ACTIV

7.

Accelerating Medicines Partnership (AMP). National Institutes of Health. Published February 4, 2014. Accessed May 7, 2020. https://www.nih.gov/research-training/accelerating-medicines-partnership-amp
SOURCE

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Live Notes, Real Time Conference Coverage 2020 AACR Virtual Meeting April 28, 2020 Symposium: New Drugs on the Horizon Part 3 12:30-1:25 PM

Reporter: Stephen J. Williams, PhD

New Drugs on the Horizon: Part 3
Introduction

Andrew J. Phillips, C4 Therapeutics

  • symposium brought by AACR CICR and had about 30 proposals for talks and chose three talks
  • unfortunately the networking event is not possible but hope to see you soon in good health

ABBV-184: A novel survivin specific T cell receptor/CD3 bispecific therapeutic that targets both solid tumor and hematological malignancies

Edward B Reilly
AbbVie Inc. @abbvie

  • T-cell receptors (TCR) can recognize the intracellular targets whereas antibodies only recognize the 25% of potential extracellular targets
  • survivin is expressed in multiple cancers and correlates with poor survival and prognosis
  • CD3 bispecific TCR to survivn (Ab to CD3 on T- cells and TCR to survivin on cancer cells presented in MHC Class A3)
  • ABBV184  effective in vivo in lung cancer models as single agent;
  • in humanized mouse tumor models CD3/survivin bispecific can recruit T cells into solid tumors; multiple immune cells CD4 and CD8 positive T cells were found to infiltrate into tumor
  • therapeutic window as measured by cytokine release assays in tumor vs. normal cells very wide (>25 fold)
  • ABBV184 does not bind platelets and has good in vivo safety profile
  • First- in human dose determination trial: used in vitro cancer cell assays to determine 1st human dose
  • looking at AML and lung cancer indications
  • phase 1 trial is underway for safety and efficacy and determine phase 2 dose
  • survivin has very few mutations so they are not worried about a changing epitope of their target TCR peptide of choice

The discovery of TNO155: A first in class SHP2 inhibitor

Matthew J. LaMarche
Novartis @Novartis

  • SHP2 is an intracellular phosphatase that is upstream of MEK ERK pathway; has an SH2 domain and PTP domain
  • knockdown of SHP2 inhibits tumor growth and colony formation in soft agar
  • 55 TKIs there are very little phosphatase inhibitors; difficult to target the active catalytic site; inhibitors can be oxidized at the active site; so they tried to target the two domains and developed an allosteric inhibitor at binding site where three domains come together and stabilize it
  • they produced a number of chemical scaffolds that would bind and stabilize this allosteric site
  • block the redox reaction by blocking the cysteine in the binding site
  • lead compound had phototoxicity; used SAR analysis to improve affinity and reduce phototox effects
  • was very difficult to balance efficacy, binding properties, and tox by adjusting stuctures
  • TNO155 is their lead into trials
  • SHP2 expressed in T cells and they find good combo with I/O with uptick of CD8 cells
  • TNO155 is very selective no SHP1 inhibition; SHP2 can autoinhibit itself when three domains come together and stabilize; no cross reactivity with other phosphatases
  • they screened 1.5 million compounds and got low hit rate so that is why they needed to chemically engineer and improve on the classes they found as near hits

Closing Remarks

 

Xiaojing Wang
Genentech, Inc. @genentech

Follow on Twitter at:

@pharma_BI

@AACR

@CureCancerNow

@pharmanews

@BiotechWorld

@HopkinsMedicine

#AACR20

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The Problem and Challenges of Commercialization

Curator and Reporter: Joel Shertok, PhD

 

As the old saying goes,

Anybody can do something once; the problem is: can you do it twice, or for that matter, over and over again?

This is the essential issue faced by those personnel in the throes of the commercialization process.

Any successful commercial process has to meet a number of criteria:

  1. The process must be reproducible — it must yield the same product/results given the same inputs.
  2. The process must be economically viable: given the constraints of raw material, energy, and labor costs, depreciation schedules for equipment, expected process failures, R/D, Marketing, and Sales support costs, the process needs to yield both a profit and positive cash flow
  3. The process should be implemented using readily available commercial components and control instrumentation. On occasion, successful implementation of a project will require specialized components; however these components themselves must meet the criteria for successful commercialization
  4. The process must be “simple” enough so that suitably trained operators can manage the process. A unit that requires Ph.D.’s to maintain operations is doomed to failure

History is replete with novel processes that worked on the lab scale, but were failures when a commercial operation was attempted. The issues that are most responsible for lab-to-production failure are listed under the general classification of “scale-up”. Scale-up principles are covered in my monograph, “The Art of Scale-up” (www.artofscaleup.com), but in general follow these rules:

  • Identification of those process parameters that will have major impact on commercial viability: reaction kinetics, mass transfer vs. temperature/kinetic control; if multi-phase systems are involved, the type and energy of required stirring; heat transfer considerations; side reactions; etc.

  • Materials of construction; raw material and product hazards; etc.

  • Regulatory considerations: FDA, OSHA, EPA.

Failure to address any of these issues prior to commercialization will lead to surprises during commercialization.

In addition to the engineering/scale-up aspects of commercialization, there are several other criteria that may need attention:

  1. When to launch a product – where will the new product fit into the overall corporate product portfolio?
  2. Where is the proper location to launch?  A product aimed at flu symptom suppression in cold-weather conditions may not do well in Florida; ….. super-sweet tea does well in the South, and not so well in New England, so that a product to replace sugar might do well in the South.
  3. Who is going to use the product?  Are you targeting doctor’s offices, hospitals, or direct to consumer routes?
  4. How to launch – social media and “influencers” have given rise to new avenues of product introductions.

The old aphorism of “measure twice, cut once” has a special resonance when doing commercialization of a new process or product. The more the process is thought out ahead of time, the less issues there will be down the road. In the commercial world, there is constant pressure to rush things to meet management deadlines, which always leads to problems and extra expense. A crusty of R/D chemist once remarked, “There is never time to do it right, but always time to do it twice.” Everyone needs to keep this in the back of their mind

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