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Big Data Analytics: New Possibilities In The Pharmaceutical Industry

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Big Data Analytics: New Possibilities In The Pharmaceutical Industry

Big data in Pharmaceutical

When pharmaceutical companies collect large amounts of data at different stages of the value chain, from drug discovery to real-time use, they can leverage big data analytics to generate actionable insights for research and development.

Workflow software can provide an efficient and easy-to-use method for automating day-to-day tasks, data, and processes. With advanced analytics, pharmaceutical companies can search huge datasets of drug discovery and data distribution, and vaccine supply chain management to accelerate drug discovery and faster workflows — saving time and money. 

Consequently, services and solutions for big data have become an integral part of leading companies.

In a market where most organizational structures are already struggling with the necessary skills and knowledge, big data technology is perceived as a paradigm shift and powerful business weapon for the healthcare and pharmaceutical industries.

These companies can use predictive analytics to analyze large amounts of clinical and molecular data to determine a compound that can be converted to a possible drug based on various parameters such as the chemical structure of the molecule, disease, goals, etc.

Effective use of this data will help pharmaceutical companies better identify new potential drug candidates and convert them into effective, approved, and reimbursable costs more effectively.

Using clinical monitoring programs and detailed data, pharmaceutical companies can understand new trends and patterns that will enable them to develop more targeted drugs for patients.

The power of Big Data

Big data can be a key factor in precision medicine, where a disease is diagnosed and treated using appropriate data on a patient’s genetic makeup, environmental factors, and behaviors. By leveraging big data technologies to filter unstructured genomic data, pharmaceutical companies can define models that can help their patients develop a more effective and personalized drug and receive important data from a variety of sources to help them make key decisions in marketing strategies and sales. 

Pharmaceutical companies can use data science and analysis to analyze various data sources, such as publicly available information sources, social media, health databases, drug databases, scientific publications, human genomes, sensor data, etc. Companies can use predictive analytics to analyze large amounts of data. Clinical and molecular data, according to various parameters such as the chemical structure of the molecule, disease, target, etc., determine the compound that can be converted into a possible drug. These data will help pharmaceutical companies better identify potential new drug candidates for drug trials and turn them into effective drugs 

Pharma companies can analyze clinical monitoring programs and detailed data to quickly extract relevant information from the available literature to develop more targeted drugs for patients and improve drug discovery and launch. With the help of big data, companies can recruit suitable patients for clinical trials using genetic information, personality traits, and disease status, which in turn increase the effectiveness of the drug. 

The research performed using Big Data analytics is done via predictive modeling to analyze toxicity, drug interactions, and inhibition using historical data collected from various sources such as clinical trials, drug trials, and more. This data can then be used to model strategy as the pipeline progresses, which leads to better clinical trials, better risk management for pharmaceutical companies, better patient safety, and closer collaboration between different pharmaceutical organizations.

Data analytics can help improve healthcare for all stakeholders in the industry, from healthcare and medical systems to patients, pharmaceutical and medical device companies, and specialty companies. To harness these key health analytics capabilities you need state-of-the-art software and a robust process that transforms data into actionable, real-world evidence. This data facilitates understanding of complex business processes which in turn leads to better clinical trials, better risk management for pharmaceutical companies, greater patient safety, and closer collaboration among different pharmaceutical companies.

With advanced analytics, pharmaceutical companies can intelligently search large amounts of patent data, clinical trial data, drug distribution, and vaccine supply chain management data sets to speed up drug discovery and workflow. Pharmaceutical companies can use data science and analysis to analyze various data sources, such as public information sources, social media, health databases, drug databases, scientific publications, human genomes, sensor data, etc. Big data can help design matching blockbusters and recruit multiple patients for clinical trials, which in turn increases the likelihood of drug success.

Final Thoughts

According to a survey by GlobalData, a data and analytics firm, healthcare professionals have identified artificial intelligence and big data/analytics as the best technologies that will transform pharmaceutical development and development, marketing, and sales. Whether it’s using Big Data for precision medicine or to reduce drug research failures or lowering research and drug discovery costs, big data analytics has a bright future in the pharmaceutical world.

With this information, companies can make informed decisions during research and development. Leveraging Big Data and machine learning, companies can perform predictive analytics to find patterns in the collected data and to make accurate forecasts of industry trends. Our research shows that pharmaceutical companies can expand the amount of data they collect and improve their approach to managing and analyzing that data from a variety of sources, including the R&D process itself, retailers, patients, and healthcare professionals. 

Big data analytics in the pharmaceutical industry can solve this problem by combining genomic sequencing data, patient medical sensor data (a device that can be worn during treatment to track the physical changes of a person), and electronic medical records. This can help scientists and researchers examine patterns in past records and regulate drug reactions, which in turn influence the beneficial process in the pharmaceutical industry. 

As a result of Big Data analysis, we now have the ability to process and analyze this information, which opens up huge opportunities for every industry. Over the years, the demand for data has grown exponentially, and now rapid integration is seen as a business need. Although clinical trials can be conducted manually or according to traditional methods, Big Data has completely changed the way clinical trials work in the pharmaceutical industry.

Author Bio:

XcelPros Team

At XcelPros – A Microsoft Dynamics Partner, Our team brings together years of experience and a high level of technical expertise. We strive to generate high-quality, engaging content with up-to-date information from reliable sources.
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Janssen Reports Positive Phase 2 Results for TREMFYA® for Crohn’s Disease

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Janssen Reports Positive Phase 2 Results for TREMFYA® for Crohn’s Disease

Nov 17, 2021: “The Janssen Pharmaceutical Companies of Johnson & Johnson announced topline results from the Phase 2 GALAXI 1 clinical trial which showed rates of clinical remission (Crohn’s Disease Activity Index [CDAI]<150) previously reported at week 12 increased at week 48 among adults with moderately to severely active Crohn’s disease (CD) treated with TREMFYA® (guselkumab).

At week 48, 65 percent of patients receiving TREMFYA achieved clinical remission. TREMFYA is under investigation and not currently approved for the treatment of CD in the U.S.

Janssen previously announced week 12 interim analyses from the 48-week, double-blind, placebo-controlled, multicenter Phase 2 dose-ranging GALAXI 1 study.

The primary endpoint of the Phase 2 study is change from baseline in CDAI scores at week 12 in patients treated with TREMFYA compared to placebo.

Overall, all TREMFYA treatment groups during the 48-week treatment period in GALAXI 1 had comparable safety data, consistent with the known safety profile for TREMFYA.

“We look forward to sharing the comprehensive GALAXI 1 48-week results at an upcoming scientific medical meeting while we continue to progress and enroll patients in the pivotal Phase 3 GALAXI 2 and 3 studies,” said Jan Wehkamp, M.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC.

The 48-week GALAXI 1 results mark the first long-term data evaluating TREMFYA in moderately to severely active CD.

Phase 3 clinical trials evaluating TREMFYA for the treatment of moderately to severely active CD and moderately to severely active ulcerative colitis are ongoing and enrolling participants. Learn more through the Janssen Global Trial Finder.

About GALAXI 1
GALAXI 1 is a double-blind, placebo-controlled, multicenter Phase 2 dose-ranging study evaluating the efficacy and safety of TREMFYA in participants with moderately to severely active CD with inadequate response/intolerance to conventional therapies (corticosteroid, immunosuppressives) and/or biologics (TNF antagonists, vedolizumab).

Participants were randomized equally into five treatment arms, including treatment with TREMFYA dosed at 200, 600 or 1200 mg intravenously (IV) at weeks 0, 4 and 8, respectively; or treatment with the reference arm, ustekinumab, dosed at ~6mg/kg IV at week 0 and then dosed at 90 mg subcutaneously (SC) at week 8; or IV placebo. Comparison with placebo was not conducted beyond week 12.

The primary endpoint of the Phase 2 GALAXI 1 study is change from baseline in CDAI scores at week 12. Additional key outcomes evaluated at week 12 include clinical remission (CDAI<150), clinical response (decrease from baseline in CDAI ≥100 or CDAI<150), Patient Report Outcome (PRO)-2 remission (abdominal pain mean daily score ≤1 and mean daily stool frequency score ≤3), clinical biomarker response (clinical response and ≥50 percent reduction from baseline in C-reactive protein or fecal calprotectin), endoscopic response (≥50 percent improvement from baseline in the SES-CD), and safety in participants treated with TREMFYA compared with placebo. Participants may receive treatment through five years.

About Crohn’s Disease (CD)

CD is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans.

CD is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet or other environmental factors. 

Symptoms of CD can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever.

There is currently no cure for CD.

About TREMFYA® (guselkumab)

Developed by Janssen, TREMFYA is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor.

IL-23 is an important driver of the pathogenesis of inflammatory diseases such as moderate to severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA).

TREMFYA is approved in the U.S., Canada, Japan, and a number of other countries worldwide for the treatment of adults with moderate to severe plaque PsO who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light), and for the treatment of adult patients with active PsA.

It is also approved in the EU for the treatment of moderate to severe plaque PsO in adults who are candidates for systemic therapy and for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA®.”

https://www.janssen.com/janssen-reports-positive-topline-week-48-phase-2-results-tremfyar-guselkumab-adults-moderately

New R&D recommendations for artificial intelligence-based screening technologies

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New R&D recommendations for artificial intelligence-based screening technologies

November 17, 2021: “WHO joins advocates around the world to commemorate a landmark Day of Action for Cervical Cancer Elimination and welcome groundbreaking new initiatives to end this devastating disease, which claims the lives of over 300 000 women each year.

As with COVID-19, access to lifesaving tools is constrained, with women and adolescent girls in the poorest countries deprived of clinical screening facilities, human papillomavirus (HPV) vaccines and treatments which those in affluent places take for granted.

The disparity between deaths from cervical cancer in high-income compared with low-income countries tells a stark story, similar to that we have seen during the pandemic, with 9 in 10 deaths from cervical cancer happening in low and middle-income countries.

Over the last decade, manufacturers have tilted supply toward wealthier locations. In 2020, just 13% of girls aged 9–14 years globally were vaccinated against HPV – the virus that causes almost all cases of cervical cancer. Around 80 countries – home to nearly two thirds of the global cervical cancer burden – are yet to introduce this lifesaving vaccine.

During this special day, WHO’s Director-General Dr Tedros Adhanom Ghebreyesus, together with celebrities, first ladies, cancer survivors and health and community organizations, will help raise awareness and mobilize action – one year after WHO launched its landmark global initiative to eliminate cervical cancer.

WHO is also highlighting important new breakthroughs to prevent and treat the disease, including the prequalification of a fourth vaccine (Cecolin from a third manufacturer, Innovax) for HPV, which is expected to increase and diversify vital vaccination supply.

“Cervical cancer causes immense suffering, but it’s almost completely preventable and, if diagnosed early enough, one of the most successfully treatable cancers,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

“We have the tools to make cervical cancer history, but only if we make those tools available to everyone who needs them. Together with our partners in the WHO cervical cancer elimination initiative, that’s what we aim to do.”

The risk of cervical cancer increases six-fold for women living with HIV, but many have not had access to vaccination or screenings.

Tackling cervical cancer during the COVID-19 pandemic

Dr Tedros applauded countries that have adopted innovative ways to increase access to technologies and services that can stop cervical cancer during the COVID-19 pandemic.

In the past year, the HPV vaccine was introduced in seven countries – Cameroon, Cape Verde, El Salvador, Mauritania, Qatar, Sao Tome and Principe, and Tuvalu – bringing the total to 115.

Some countries trained healthcare workers with newer, portable devices to thermally ablate precancers. Others expanded the use of self-sampling – endorsed in recently published WHO guidelines – to allow women to collect their own cervical swab.

This option can reduce stigma for women, provides access to those living far from health facilities, and helps congested health centres maintain safe services while respecting COVID-19 safety measures.

The self-collected sample can be run on the same laboratory platforms that countries have been investing in to support PCR testing for COVID-19.

But setbacks have occurred. Access to screening services has fallen for many women and in a recent survey, 43% of countries reported disruption to cancer treatment.

Meanwhile HPV vaccination rates globally fell from 15% in 2019 to 13% in 2020, amidst health service disruptions and school closures.

“There has been important progress towards cervical cancer elimination even over this unprecedented year,” said Dr Princess Nono Simelela, Special Advisor to the Director-General on Strategic Priorities, including Cervical Cancer Elimination.

“While we have seen major advances in new technologies and research, the critical next step is to ensure these are designed for and accessible in low- and middle-income countries, and that the health and rights of women and girls everywhere are prioritized in the recovery from COVID-19.”

New technologies, investments and research to aid the fight against cervical cancer

Adding to important milestones achieved over the course of the past year, today WHO is releasing new recommendations to guide research into artificial intelligence (AI)-based screening technologies. This first-of-its-kind guidance supports developers to bring cervical cancer screening into the future, and ensure pre-cancers are detected as early as possible.

The first designated “WHO Collaborating Centre for Cervical Cancer Elimination” was also announced at the Sylvester Comprehensive Cancer Centre at the University of Miami, which will be an important site for research and technical assistance to help countries achieve elimination targets.

The Day of Action will encompass a major global event and press availability, organized from WHO headquarters in Geneva.

It will feature performances and remarks from cancer survivors and renowned artists such as Angelique Kidjo, as well as community efforts to promote vaccinations and screenings.

100 world monuments are being illuminated in teal – the colour of cervical cancer elimination – to mark the day, from the Temple of Heaven in Beijing to city skylines across Australia and Canada’s Niagara Falls.

“We have the tools and knowledge to eliminate cervical cancer. What we do with that is up to us,” said H.E. Neo Jane Masisi, First Lady of the Republic of Botswana, who is participating in the day’s events.

“We can make choices that condemn women to a painful, avoidable death. Or, we can prioritize their health, so that a future generation of women and their families look back with pride at the choices we made today.”

Several partners also announced important global commitments and investments during the day’s events:

  • FIND, the global alliance for diagnostics, announced the launch of a new initiative to improve cervical cancer testing and screening using innovative technologies in low- and middle-income countries;
  • Unitaid reaffirmed its commitment to lay the groundwork for wide-scale adoption of innovative cervical cancer screening and treatment tools – and is on track to reach one million women by 2022, despite COVID-19;
  • The French government’s L’Initiative facility, implemented by Expertise France, will announce a reinforcement of the support, including operational research, to countries with high comorbidity and coinfection of HIV and HPV-associated cancers.”

    https://www.who.int/news/item/17-11-2021-global-leaders-call-for-cervical-cancer-elimination-on-day-of-action

Coronavirus (COVID-19) Update: November 16, 2021

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Coronavirus (COVID-19) Update: November 16, 2021

November 16, 2021: “The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • On Monday November 15, 2021 the FDA took several important actions intended to support ongoing nationwide COVID-19 testing efforts.

    These actions are aimed at further increasing access to accurate and reliable tests, particularly COVID-19 diagnostic tests that can be performed at home or in places like doctor’s offices, hospitals, urgent care centers, and emergency rooms without having to be sent to a central lab for testing.
    The FDA:
    • Reissued the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).
    • Issued a new Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests developed by laboratories for Serial Testing.
    • Reissued the EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests.
    • Revised the Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) to update references to the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.
    • Updated the FAQs on Testing for SARS-CoV-2.
  • Testing updates:
    • As of today, 422 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs).

      These include 293 molecular tests and sample collection devices, 90 antibody and other immune response tests and 39 antigen tests. There are 66 molecular authorizations and one antibody authorization that can be used with home-collected samples.

      There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 10 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
    • The FDA has authorized 19 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 685 revisions to test EUA authorizations.”


      https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-november-16-2021

Pfizer Completes Acquisition Of Trillium Therapeutics

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Pfizer Completes Acquisition Of Trillium Therapeutics

November 17, 2021: “Pfizer Inc. announced the successful completion of its acquisition of Trillium Therapeutics, a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer.

As Trillium becomes part of Pfizer, it brings an impressive portfolio that includes biologics that are designed to enhance the ability of patients’ innate immune system to detect and destroy cancer cells.

Its two lead molecules, TTI-622 and TTI-621, block the signal-regulatory protein α (SIRPα)–CD47 axis, which is emerging as a key immune checkpoint in hematological malignancies.

TTI-622 and TTI-621 are novel SIRPα-Fc fusion proteins that are currently in Phase 1b/2 development across several indications, with a focus on hematological malignancies. Both molecules are also being tested to evaluate clinical potential in solid tumors.

“We are proud to bring Trillium’s leading scientific talent and pipeline into Pfizer,” said Chris Boshoff, MD, PhD, Chief Development Officer, Oncology, Pfizer Global Product Development.

“Today’s announcement combines Pfizer’s research and global development capabilities with Trillium’s innovative discoveries, allowing us to accelerate breakthroughs that change patients’ lives.”

Hematological malignancies are cancers that affect the blood, bone marrow, and lymph nodes.

This classification includes various types of leukemia, multiple myeloma, and lymphoma. More than 1 million people worldwide were diagnosed with a blood cancer in 2020, representing almost 6% of all cancer diagnoses globally.

In 2020, more than 700,000 people worldwide died from a form of blood cancer.

Additional Transaction Details

Pfizer has completed its acquisition of all outstanding shares, warrants, options, and deferred share units of Trillium not already owned by Pfizer for $18.50 per share, in cash, representing an aggregate purchase price of approximately $2.22 billion.

The acquisition was completed by way of a statutory plan of arrangement under the Business Corporations Act (British Columbia) and, as a result of the acquisition, Trillium became a wholly-owned subsidiary of Pfizer.

In connection with the acquisition, Trillium’s common shares will be delisted from the Nasdaq Capital Market. Trillium’s common shares will be delisted from the Toronto Stock Exchange on or before November 19, 2021.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-completes-acquisition-trillium-therapeutics

New analyses of two AZD7442 COVID-19 trials in high-risk populations confirm robust efficacy and long-term prevention

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New analyses of two AZD7442 COVID-19 trials in high-risk populations confirm robust efficacy and long-term prevention

November 18, 2021: “New data from the AZD7442 COVID-19 PROVENT prevention and TACKLE outpatient treatment Phase III trials both showed robust efficacy from a one-time intramuscular (IM) dose of the long-acting antibody (LAAB) combination.

In an analysis of the ongoing PROVENT trial evaluating a median six months of participant follow-up, one 300mg IM dose of AZD7442 reduced the risk of developing symptomatic COVID-19 compared to placebo by 83%.

About 2% of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine.

This includes people with blood cancers or other cancers being treated with chemotherapy, patients on dialysis, those taking medications after an organ transplant or who are taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis.

The AZD7442 PROVENT trial is the first Phase III trial prospectively designed to evaluate a monoclonal antibody for pre-exposure prophylaxis of symptomatic COVID-19, with targeted inclusion of high-risk and immunocompromised participants.

More than 75% of PROVENT participants at baseline had co-morbidities that put them at high risk for severe COVID-19 if they were to become infected, including people who are immunocompromised and may have a reduced immune response to vaccination.

There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with  AZD7442 at either the primary or six-month analyses.

In the placebo arm, there were two additional cases of severe COVID-19 at the six-month assessment, for a total of five cases of severe COVID-19 and two COVID-related deaths.

An exploratory analysis of the TACKLE outpatient treatment trial, in patients with mild-to-moderate COVID-19, showed that one 600mg IM dose of AZD7442 reduced the risk of developing severe COVID-19 or death (from any cause) by 88% compared to placebo in patients who had been symptomatic for three days or less at the time of treatment.

A total of 90% of participants enrolled in TACKLE were from populations at high risk of progression to severe COVID-19 if they became infected, including those with co-morbidities.

In both PROVENT and TACKLE, AZD7442was generally well tolerated. No new safety issues were identified in the six-month analysis of PROVENT.

Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK and AZD7442 principal investigator, said: “These compelling results give me confidence that this long-acting antibody combination can provide my vulnerable patients with the long-lasting protection they urgently need to finally return to their everyday lives.

Importantly, six months of protection was maintained despite the surge of the Delta variant among these high-risk participants who may not respond adequately to vaccination.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “AZD7442 is the only long-acting antibody with Phase III data to demonstrate benefit in both pre-exposure prophylaxis and treatment of COVID-19 with one dose.

These new data add to the growing body of evidence supporting AZD7442’s potential to make a significant difference in the prevention and treatment of COVID-19.

We are progressing regulatory filings around the world and look forward to providing an important new option against SARS-CoV-2 as quickly as possible.”

Full results from PROVENT and TACKLE will be submitted for publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting.

On 5 October 2021, the Company announced that it had submitted a request to the US Food and Drug Administration for Emergency Use Authorisation for AZD7442 for prophylaxis of COVID-19. 

AstraZeneca has agreed to supply the US Government with 700,000 doses of AZD7442 if granted an Emergency Use Authorization by the FDA, and has agreements to supply to other countries.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/new-analyses-of-two-azd7442-covid-19-phase-iii-trials-in-high-risk-populations-confirm-robust-efficacy-and-long-term-prevention.html

Sanofi invests $180 million equity in Owkin’s artificial intelligence and federated learning to advance oncology pipeline

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Sanofi invests $180 million equity in Owkin’s artificial intelligence and federated learning to advance oncology pipeline

November 18 2021: “Sanofi announced today an equity investment of $180 million and a new strategic collaboration with Owkin comprised of discovery and development programmes in four exclusive types of cancer, with a total payment of $90 million for three years plus additional research milestone-based payments.

Owkin, an artificial intelligence (AI) and precision medicine company, builds best-in-class predictive biomedical AI models and robust data sets.

With the ambition to optimize clinical trial design and detect predictive biomarkers for diseases and treatment outcomes, this collaboration will support Sanofi’s growing oncology portfolio in core areas such as lung cancer, breast cancer and multiple myeloma.

To accelerate medical research with AI in a privacy-preserving way, Owkin has assembled a global research network powered by federated learning, which allows data scientists to securely connect to decentralized, multi-party data sets and train AI models without having to pool data.

This approach will complement Sanofi’s emerging strength in oncology, as the company’s scientists apply cutting-edge technology platforms to design potentially life-transforming medicines for cancer patients worldwide.

“Owkin’s unique methodology, which applies AI on patient data from partnerships with multiple academic medical centers, supports our ambition to leverage data in innovative ways in R&D,” said Arnaud Robert, Executive Vice President, Chief Digital Officer, Sanofi. 

“We are striving to advance precision medicine to the next level and to discover innovative treatment methods with the greatest benefits for patients.”

Sanofi will leverage the comprehensive Owkin Platform, in order to find new biomarkers and therapeutic targets, building prognostic models, and predicting response to treatment from multimodal patient data.

Sanofi’s investment will support Owkin’s development and goal to grow the world’s leading histology and genomic cancer database from top oncology centers.

“Owkin’s mission is to improve patient’s lives by using our platform to discover and develop the right treatment for every patient,” said Thomas Clozel, M.D., Co-Founder and CEO at Owkin. 

“We believe that the future of precision medicine lies in technologies that can unlock insights from the vast amount of patient data in hospitals and research centers in a privacy-preserving and secure way.

This landmark partnership with Sanofi will see federated learning used to create research collaborations at a truly unprecedented scale. The future of AI to transform how we develop treatments is incredibly bright, and we are proud to partner with Sanofi on this mission.”

This collaboration agreement will allow Sanofi to work closely with Owkin in identifying new oncology treatments across four cancers.

“We look forward to working with our colleagues at Owkin to analyze data from hundreds of thousands of patients,” said John Reed, M.D., Ph.D., Global Head of Research and Development, Sanofi.

“Sanofi’s investment in the company includes a three-year agreement that will help discover and develop new treatments for non-small cell lung cancer, triple negative breast cancer, mesothelioma and multiple myeloma.

This partnership will help accelerate our ambitious oncology program as we advance a rich pipeline of medicines to address unmet patient needs.”

About Owkin

Owkin is a French American startup that specializes in AI and federated learning for medical research. It was co-founded in 2016 by Dr Thomas Clozel M.D., a clinical research doctor and former assistant professor in clinical hematology, and Dr Gilles Wainrib, Ph.D., a pioneer in the field of artificial intelligence in biology.

Owkin has recently published groundbreaking research at the frontier of AI and medicine in Nature Medicine, Nature Communications and Hepatology.

The Owkin Platform connects life science companies with world-class academic researchers and hospitals to share deep medical insights for drug discovery and development.

Using federated learning and breakthrough collaborative AI technology, Owkin enables its partners to unlock siloed datasets while protecting patient privacy and securing proprietary data.

Through sharing high-value insights, the company powers unprecedented collaboration to improve patient outcomes.

Owkin works with the most prominent cancer centers and pharmaceutical companies in Europe and the US.”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-11-18-07-30-00-2336966

Pfizer Seeks Emergency Use Authorization For Novel COVID-19 Oral Antiviral Candidate

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Pfizer Seeks Emergency Use Authorization For Novel COVID-19 Oral Antiviral Candidate

November 16, 2021: “Pfizer Inc. announced it is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID™ (PF-07321332; ritonavir), for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death.

This submission to the U.S. Food and Drug Administration (FDA) includes clinical data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) interim analysis. Rolling submission of non-clinical data for PAXLOVID was initiated with the U.S. FDA in October 2021.

If authorized or approved, PAXLOVID would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2 that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness which can lead to hospitalization and death.

“With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options.

The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world.”

Pfizer is seeking EUA for PAXLOVID based on positive results from the EPIC-HR interim analysis, which enrolled non-hospitalized adults aged 18 and older with confirmed COVID-19 who are at increased risk of progressing to severe illness.

The data demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death from any cause in patients treated with PAXLOVID compared to placebo within three days of symptom onset, with no deaths in the treatment group.

Similar results were seen with within five days of symptom onset. Treatment-emergent adverse events were comparable between PAXLOVID (19%) and placebo (21%), most of which were mild in intensity.

At the recommendation of an independent Data Monitoring Committee, and in consultation with the U.S. FDA, Pfizer ceased further enrollment into the study due to the overwhelming efficacy demonstrated.

Rolling submissions have commenced in several countries including in the United Kingdom, Australia, New Zealand and South Korea, with planned submissions to other regulatory agencies around the world to follow.

Pfizer has begun and will continue to invest up to approximately $1 billion of its own funds to support the manufacturing and distribution of this investigational treatment candidate.

Additionally, Pfizer has signed a voluntary licensing agreement with the Medicines Patent Pool (MPP) to help expand access, pending regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.

About PAXLOVID (PF-07321332; ritonavir)

PAXLOVID is an investigational SARS-CoV-2 protease inhibitor antiviral therapy.

It was specifically designed to be administered orally so that it can be prescribed at the first sign of infection or at first awareness of an exposure – potentially helping patients avoid severe illness (which can lead to hospitalization and death), experience a decreased symptomatic period, or avoid disease development following contact.

PF-07321332 is designed to block the activity of the SARS-CoV-2-3CL protease, an enzyme that the coronavirus needs to replicate.

Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of PF-07321332 in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

PF-07321332 inhibits viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, PF-07321332 did not demonstrate evidence of mutagenic DNA interactions.

If authorized or approved, PAXLOVID will be administered at a dose of 300mg (two 150mg tablets) of PF-07321332 with one 100mg tablet of ritonavir, given twice-daily for five days.

Our Commitment to Equitable Access

Pfizer is committed to working toward equitable access to PAXLOVID for all people, aiming to deliver safe and effective antiviral therapeutics as soon as possible and at an affordable price.

If authorized or approved, during the pandemic, Pfizer will offer our investigational oral antiviral therapy through a tiered pricing approach based on the income level of each country to promote equity of access across the globe.

High and upper-middle income countries will pay more than lower income countries.

Pfizer has also begun and will continue to invest up to approximately $1 billion of its own funds to support the manufacturing and distribution of this investigational treatment candidate, including exploring potential contract manufacturing options.

It has entered into advance purchase agreements with several countries and has initiated bilateral outreach to approximately 100 countries around the world.

Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for PF-07321332; ritonavir to help expand access, pending regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.

About the Phase 2/3 EPIC-HR Study Interim Analysis

In July 2021, Pfizer initiated the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) randomized, double-blind study of non-hospitalized adult patients with COVID-19, who are at high risk of progressing to severe illness.

The primary analysis of the interim data set evaluated data from 1,219 adults who were enrolled by September 29, 2021.

At the time of the decision to stop recruiting patients, enrollment was at approximately 70% of the 3,000 planned patients from clinical trial sites across North and South America, Europe, Africa, and Asia, with 45% of patients located in the United States.

Enrolled individuals had a laboratory-confirmed diagnosis of SARS-CoV-2 infection within a five-day period and were required to have at least one characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19.

Each patient was randomized (1:1) to receive PAXLOVID or placebo orally every 12 hours for five days.

The scheduled interim analysis showed an 89% reduction in risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset (primary endpoint); 0.8% of patients who received PAXLOVID were hospitalized through Day 28 following randomization (3/389 hospitalized with no deaths), compared to 7.0% of patients who received placebo and were hospitalized or died (27/385 hospitalized with 7 subsequent deaths).

The statistical significance of these results was high (p<0.0001). Similar reductions in COVID-19-related hospitalization or death were observed in patients treated within five days of symptom onset; 1.0% of patients who received PAXLOVID were hospitalized through Day 28 following randomization (6/607 hospitalized, with no deaths), compared to 6.7% of patients who received a placebo (41/612 hospitalized with 10 subsequent deaths), with high statistical significance (p<0.0001).

In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID as compared to 10 (1.6%) deaths in patients who received placebo.

The review of safety data included a larger cohort of 1,881 patients in EPIC-HR, whose data were available at the time of the analysis.

Treatment-emergent adverse events were comparable between PAXLOVID (19%) and placebo (21%), most of which were mild in intensity.

Among the patients evaluable for treatment-emergent adverse events, fewer serious adverse events (1.7% vs. 6.6%) and discontinuation of study drug due to adverse events (2.1% vs. 4.1%) were observed in patients dosed with PAXLOVID compared to placebo, respectively.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-seeks-emergency-use-authorization-novel-covid-19

FDA Authorizes Marketing of Virtual Reality System for Chronic Pain Reduction

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FDA Authorizes Marketing of Virtual Reality System for Chronic Pain Reduction

November 16, 2021: “The U.S. FDA authorized marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral methods to help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain.

“Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life,” said Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health.

“Pain reduction is a crucial component of living with chronic lower back pain. Today’s authorization offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain.”

Chronic lower back pain, which is defined as moderate to severe pain in the lower back lasting longer than three months, is one of the most common chronic pain conditions in the U.S. Chronic pain may inhibit mobility or daily activities and has been linked to anxiety and depression, poor perceived health or reduced quality of life and dependence on opioids.

Current treatment plans for chronic lower back pain often include, among other options, prescription and over-the-counter pain medications, exercise, steroid injections, surgery and transcutaneous electrical nerve stimulation.

Cognitive behavioral therapy (CBT) may be used to reduce the burden of chronic pain and increase function through an emotional, cognitive and behavioral approach to shift negative beliefs held by patients about the relationship between their pain and movement.

EaseVRx employs the principles of CBT and other behavioral therapy techniques for the purpose of reduction of pain and pain interference.

The prescription device, which is intended for at-home self-use, consists of a VR headset and a controller, along with a “Breathing Amplifier” attached to the headset that directs a patient’s breath toward the headset’s microphone for use in deep breathing exercises.

The device’s VR program uses established principles of behavioral therapy intended to address the physiological symptoms of pain and aid in pain relief through a skills-based treatment program.

These principles include deep relaxation, attention-shifting, interoceptive awareness–the ability to identify, access, understand and respond appropriately to the patterns of internal signals—and perspective-taking, distraction, immersive enjoyment, self-compassion, healthy movement, acceptance, visualization, knowledge of pain and rehabilitation.

The EaseVRx treatment program consists of 56 VR sessions that are 2-16 minutes in length, which are intended to be used as part of a daily eight-week treatment program.

Each session incorporates elements of the aforementioned principles to provide the user with skills to achieve relief and reduction in the interference of pain in daily activities.

The FDA evaluated the safety and effectiveness of EaseVRx in a randomized, double-blinded clinical study of 179 participants with chronic lower back pain who were assigned to one of two eight-week VR programs: the EaseVRx immersive 3-D program or a control 2-D program that did not utilize skills-based CBT methods of treatment.

After enrollment in the trial, participants were followed for a period of 8.5 months total, including a two-week baseline assessment period, an eight-week VR program, a post-treatment assessment, and follow-up at one, two, three, and six months after completion of the program.

At the end of treatment, 66% of EaseVRx participants reported a greater than 30% reduction in pain, compared to 41% of control participants who reported a greater than 30% reduction in pain. Furthermore, 46% of EaseVRx participants reported a greater than 50% reduction in pain compared to 26% of control participants.

At one-month follow-up, all participants in the EaseVRx group continued to report a 30% reduction in pain and at the two- and three-month follow-up marks, the 30% reduction in pain remained for all outcomes with the exception of pain intensity.

In contrast, the control group reported a reduction in pain below 30% at one-, two-, and three-month follow-up for all outcomes.

To evaluate the effectiveness of EaseVRx, at the end of the eight-week program, participants were asked to rate the following outcomes on a 10-point scale, with 10 being the greatest value: pain intensity, pain interference on activity, pain interference on mood, pain interference on sleep and pain interference on stress.

On average, participants experienced a decrease in pain intensity of 1.31 points over the eight weeks of treatment.

Participants also reported a decrease in pain interference for all measured outcomes that ranged from .95 points to 1.27 points down from their respective scores at the start of treatment.

No serious adverse events were observed or reported during the study. Approximately 20.8% of participants reported discomfort with the headset and 9.7% reported motion sickness and nausea.

EaseVRx was granted Breakthrough Device designation.

To qualify for such designation, a device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.

The FDA reviewed EaseVRx through the De Novo premarket review pathway, a regulatory pathway for low-to moderate-risk devices of a new type.

Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type.

This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

EaseVRx is manufactured by AppliedVR.”

fda.gov/news-events/press-announcements/fda-authorizes-marketing-virtual-reality-system-chronic-pain-reduction

Two billion doses of AZ’s COVID-19 vaccine supplied to countries across the world

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Two billion doses of AZ’s COVID-19 vaccine supplied to countries across the world

November 16, 2021: “AstraZeneca and its partners have released for supply two billion doses of their COVID-19 vaccine to more than 170 countries across every continent on the planet in the last 11 months.

Approximately two-thirds of these have gone to low- and lower-middle-income countries, including more than 175 million doses delivered to 130 countries through the COVAX Facility.

This milestone comes just over 18 months after AstraZeneca and Oxford University formed their landmark partnership for the global development and distribution of a not-for-profit COVID-19 vaccine for the world, and less than 12 months after its first emergency authorisation in the UK.

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “Our vaccine has played a key role in tackling the biggest public health emergency of our lifetime: an estimated million lives saved, 50 million infections prevented, two billion doses delivered.

The numbers are remarkable, and I’d like to thank everyone who put their lives to one side to help in this incredible endeavour.

While much of the world still has to be vaccinated, and there is still much more to do, today is a proud day and testament to what can be achieved when we all work together.”

Professor Sir Andrew J Pollard, Director of Oxford Vaccine Group, said: “This is a proud moment and tribute to the efforts of researchers who developed and tested the vaccine, manufacturing staff who continue to work tirelessly to make it, logistics teams who ship it to clinics in every corner of the earth, armies of vaccinators who get it in our arms, and the public who have been with us since the first clinical trial dose on 23rd April 2020.”

To date, COVID-19 Vaccine AstraZeneca (ChAdOx1-S [Recombinant]) is estimated to have  helped prevent 50 million COVID-19 cases, five million hospitalisations, and helped save more than one million lives.

From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.

AstraZeneca continues to engage with governments, multilateral organisations and collaborators to ensure broad and equitable access to the vaccine.

Notes

COVID-19 Vaccine AstraZeneca
COVID-19 Vaccine AstraZeneca (ChAdOx1-S [Recombinant])was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

The vaccine has been granted a conditional marketing authorisation or emergency use in more than 90 countries. It also has Emergency Use Listing from the World Health Organization, which accelerates the pathway to access in up to 142 countries through the COVAX Facility.

COVID-19 Vaccine AstraZeneca is known as Vaxzevria in Europe. Under a sub-license agreement with AstraZeneca, the vaccine is manufactured and supplied by the Serum Institute of India under the name COVISHIELD.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/two-billion-doses-of-astrazenecas-covid-19-vaccine-supplied-to-countries-across-the-world-less-than-12-months-after-first-approval.html

Vertex Receives CHMP Positive Opinion for KAFTRIO® in Children With Cystic Fibrosis

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Vertex Receives CHMP Positive Opinion for KAFTRIO® in Children With Cystic Fibrosis

Nov. 12, 2021: “Vertex Pharmaceuticals Incorporated announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for the label extension of KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor, for the treatment of cystic fibrosis (CF) in patients ages 6 through 11 years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

“Today marks an important milestone for the treatment of children with CF in Europe. If approved, KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor will offer physicians a new treatment option for these young patients to help combat this life-shortening condition as early as possible,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex.

“The clinical data for ivacaftor/tezacaftor/elexacaftor plus ivacaftor in people with CF ages 6 through 11 with eligible CF genotypes demonstrated improvements in lung function, sweat chloride and respiratory symptoms and a safety and tolerability profile consistent with that observed in patients ages 12 years and older,” said Professor Marcus A. Mall, M.D., Head of the Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine at Charité University Medical Center Berlin. “This medicine has already made a big impact on the lives of eligible people ages 12 years and above in Europe. The CF community is now looking forward to it being available for younger patients too, to enable treatment as early as possible in life.”

About Cystic Fibrosis

Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 83,000 people globally. CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands, and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF, and these mutations can be identified by a genetic test. While there are many different types of CFTR mutations that can cause the disease, the vast majority of people with CF have at least one F508del mutation. CFTR mutations lead to CF by causing the CFTR protein to be defective or by leading to a shortage or absence of CFTR protein at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus, chronic lung infections and progressive lung damage that eventually leads to death for many patients. The median age of death is in the early 30s.

About KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in A Combination Regimen With Ivacaftor

In people with certain types of mutations in the CFTR gene, the CFTR protein is not processed or folded normally within the cell, and this can prevent the CFTR protein from reaching the cell surface and functioning properly. KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor is an oral medicine designed to increase the quantity and function of the CFTR protein at the cell surface. Elexacaftor and tezacaftor work together to increase the amount of mature protein at the cell surface by binding to different sites on the CFTR protein. Ivacaftor, which is known as a CFTR potentiator, is designed to facilitate the ability of CFTR proteins to transport salt and water across the cell membrane. The combined actions of ivacaftor, tezacaftor and elexacaftor help hydrate and clear mucus from the airways.

KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor is approved in the European Union for the treatment of cystic fibrosis (CF) in patients ages 12 years and older who have at least one copy of the F508del mutation in the CFTR gene.”

https://investors.vrtx.com/news-releases/news-release-details/vertex-receives-chmp-positive-opinion-kaftrior-0

WHO releases new toolkit to support quality HIV testing services

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WHO releases new toolkit to support quality HIV testing services

November 16, 2021: “WHO has released a new toolkit to enable countries to accelerate their ongoing efforts to fully adopt WHO guidelines and transition to new HIV testing algorithms.

In 2019, in response to changing epidemiology, WHO recommended countries adopt a standard HIV testing strategy with three consecutive reactive tests for an HIV-positive diagnosis to ensure quality services as countries move toward and achieve the UNAIDS 95-95-95 targets.

The guidance also highlighted the need to introduce dual HIV/syphilis rapid diagnostic tests (RDTs) and to phase out older testing technologies, including western blotting methods.

Many countries have since taken up this WHO guidance.

For example, in the WHO African Region, compliance to HIV testing strategies increased from 8% in 2014 to 71% in 2021. However, gaps remain.

More than a dozen countries use western blotting methods that hinder same day diagnoses and immediate access to ART and PrEP.

Also, many settings have yet to fully transition to WHO’s recommended testing strategy or integrate dual HIV/syphilis RDTs into testing algorithms for pregnant women and key populations.

Speaking at the African Society of Laboratory Medicine Conference, 2021, Anita Sands from WHO’s Department of Regulation and Prequalification said, “WHO encourages national programmes to use verified national algorithms with quality-assured products, including the offer of dual HIV/syphilis RDTs and efforts to phase out western blotting methods.

Such shifts are feasible and will enhance HIV testing quality, enable people with HIV to start treatment quickly, and people with substantial risk to scale-up access to PrEP.”

Fifteen low- and middle-income countries have already begun using elements of the toolkit to improve testing.

Dr Abderrazzack Adoum, Coordinator, Chad National HIV, Hepatitis and STI Programme, says, “Verification of HIV testing algorithms are important for identifying multiple assays that can be used to provide high quality and flexibility of testing algorithms.”

The toolkit has also been helpful with bringing innovative approaches for both HIV and syphilis into national planning.

“The evidence generated informed our final algorithms and plans for integrating the dual HIV/syphilis tests in antenatal care,” says Jean De Dieu Anoubissi, Chief of Research, Cameroon National AIDS Council.

Delivering correct results is one of the WHO “5Cs” and a core principle for all HIV testing services and essential to achieving global prevention and treatment goals.

WHO expresses thanks to the countries and international experts who supported the development and review of this toolkit.

As WHO celebrates the achievements of many countries making progress toward the 95-95-95 targets, the toolkit’s efforts to operationalize existing WHO recommendations to achieve quality HIV testing services are timely and will become increasingly important.”

https://www.who.int/news/item/16-11-2021-who-releases-new-toolkit-to-support-quality-hiv-testing-services

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