Classification

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 February 2024

Retrieved on: 
Saturday, February 17, 2024

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Strangvac to implement the outcome of the MAH’s signal management process to add adverse reactions in the product information.

Key Points: 
  • The Committee adopted by consensus a positive opinion for a variation requiring assessment for Strangvac to implement the outcome of the MAH’s signal management process to add adverse reactions in the product information.
  • The respective target species were cattle, pigs and sheep (one product), chickens, and squirrel monkeys (one product each).
  • Concept papers, guidelines
    Quality
    The Committee adopted an annex to the Guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water on compatibility studies between veterinary medicinal products and biocidal products (EMA/CVMP/QWP/592906/2022) following close of public consultation.
  • The comments received during the consultation procedure were taken into account for the revision of the annex.

Drowning in ‘digital debt’? AI assistants can help – but we must use them carefully

Retrieved on: 
Friday, February 16, 2024

It refers to employees’ rights to refuse unreasonable after-hours contact from their employer.

Key Points: 
  • It refers to employees’ rights to refuse unreasonable after-hours contact from their employer.
  • Artificial intelligence (AI) assistants in the workplace are touted as a potential solution to this “availability creep”.

A crushing digital debt

  • It reveals that 57% of the average workday is spent on communications and 68% of respondents couldn’t find uninterrupted blocks of time to focus during the workday.
  • The origins of digital debt can be traced back to the “productivity paradox” from the late 20th century, where increasing technology investments had led to decreasing workplace productivity.
  • Left unattended, digital debt accrues “interest”, with damaging effects on both employee and employer.

AI assistants to the rescue?

  • But the capabilities of these AI assistants are fittingly at the intersection of digital debt, the deluge of data, and the right to disconnect.
  • In the broadest sense, generative AI (think ChatGPT) produces new and meaningful content in response to prompts from a human operator.
  • AI assistants generalise this capability for goal-oriented complex tasks.

A needy assistant that needs supervision

  • By learning from past data and not through lived experiences, it lacks factual knowledge of the world.
  • Therefore, the human using the AI must “peer review” all of the assistant’s output to avoid potential errors and misrepresentations.
  • In most workplaces where we are expected to “do more with less”, such needy AI assistants would create an additional layer of work.

The looming ethics problem

  • It is no secret AI also has an ethics problem, and this extends to AI assistants.
  • There are efforts to regulate AI based on the risks it poses, but the challenge is that the risk itself is dynamic.
  • For example, menial office tasks could go horribly wrong if politically sensitive, tone deaf or workplace-inappropriate content is produced and circulated by an AI.


Daswin de Silva does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Cryo-EM: Visualizing Biomolecules with High-Throughput Single Particle Analysis, Webinar Hosted by Xtalks March 6, 2024

Retrieved on: 
Thursday, February 15, 2024

TORONTO, Feb. 15, 2024 /PRNewswire-PRWeb/ -- The field of cryogenic electron microscopy (cryo-EM) exploded in popularity during the "resolution revolution" in the 2010s, leading to the 2017 Nobel Prize in Chemistry awarded to Jacques Dubochet, Joachim Frank and Richard Henderson "for developing cryo-electron microscopy for the high-resolution structure determination of biomolecules in solution." Cryo-EM techniques such as single particle analysis (SPA) now allow structure determination of biomolecules at resolutions previously only reached by X-ray crystallography. Cryo-EM offers many new possibilities as it does not require protein crystallization and allows structural determination of large protein complexes imaged in frozen solution or even in the cellular environment.

Key Points: 
  • The featured speaker will discuss the features of the JEOL CRYO ARM 200kV and 300kV cryo-TEMs.
  • Cryo-EM techniques such as single particle analysis (SPA) now allow structure determination of biomolecules at resolutions previously only reached by X-ray crystallography.
  • Register for this webinar to learn about innovative approaches in cryo-EM, including high-throughput single particle analysis and more.
  • Join Emmanuel Smith, Senior Application Specialist for Cryo-EM, JEOL USA, for the live webinar on Wednesday, March 6, 2024, at 2pm EST (11am PST).

Paradatec Launches New Analytics Module for AI-Cloud Platform

Retrieved on: 
Thursday, February 15, 2024

WILMINGTON, Del., Feb. 15, 2024 /PRNewswire/ -- Paradatec Inc., a market leader in AI-based document analysis technology for the lending and real estate industries, announced the availability of a new Analytics module that automatically compares system-of-record data from different systems with extracted and calculated data from source documents and datasets. Returning fully traceable and auditable results, the Analytics module in Paradatec's AI-Cloud platform improves overall data accuracy and flags unusual data, therefore enabling organizations to significantly reduce labor costs, improve the quality of their loan files, and enhance their fraud detection capabilities.

Key Points: 
  • Returning fully traceable and auditable results, the Analytics module in Paradatec's AI-Cloud platform improves overall data accuracy and flags unusual data, therefore enabling organizations to significantly reduce labor costs, improve the quality of their loan files, and enhance their fraud detection capabilities.
  • "Our new Analytics module is another example of our ongoing investment to deliver customer-requested practical, tangible innovation for our valued clients and the mortgage industry," said Neil Fraser, director of U.S. operations at Paradatec.
  • The Analytics module uses a flexible rules engine, allowing clients to augment Paradatec's rules with their own business rules for data comparison purposes.
  • Leveraging Paradatec's market-leading AI-based document classification, versioning and data extraction capabilities, the Analytics module uses data from multiple sources and automates data calculations and comparisons.

Bombardier Launches U.S. Technician Apprenticeship Program in Collaboration with WSU Tech

Retrieved on: 
Wednesday, February 14, 2024

During the two-year paid apprenticeship program, students will complete hands-on instruction at Bombardier Group’s Wichita site and in-class training at WSU Tech.

Key Points: 
  • During the two-year paid apprenticeship program, students will complete hands-on instruction at Bombardier Group’s Wichita site and in-class training at WSU Tech.
  • Their job classification will transition from apprentice to full-time A&P technician at Bombardier, expanding the company’s technician roster and enabling the growing delivery of timelier OEM maintenance services.
  • “We are pleased to deepen our roots in Wichita and the U.S. through the launch of this foundational program in collaboration with WSU Tech, a leader in aviation mechanic training in Wichita,” said Paul Sislian, Executive Vice-President, Aftermarket Services & Bombardier Strategy, Bombardier.
  • By training and hiring highly skilled technicians, Bombardier further showcases its commitment to developing its aerospace pipeline.

Sandvine Enhances its App QoE Portfolio with New Technologies and Solutions to Make it Easy for Network Operators to Know Their Network and Know Their Customers

Retrieved on: 
Wednesday, February 14, 2024

WATERLOO, ON, Feb. 14, 2024 /PRNewswire/ -- Communication service providers are continually challenged by ever-increasing volumes of OTT traffic, much of it encrypted and unmanageable. Sandvine recognizes the critical need for operators to know what's going on with application and content type usage in their networks, and with their customers and their devices.

Key Points: 
  • To help, Sandvine, the App QoE Company, is delivering several new technologies and solutions that will enhance its flagship application classification product, AppLogic, and deliver greater accuracy, speed, and value to customers.
  • Easy to Measure – Building on the 95% accuracy of its industry-leading application classification product, AppLogic , Sandvine is introducing App QoE Scoring , the world's most accurate depiction of real-time subscriber sentiment.
  • App QoE Scoring measures and scores a customer's satisfaction with an operator's network based on current application performance and quality of experience.
  • Using AI/ML propensity and prediction models, operators can now solve network problems often before the subscriber even realizes there is a problem.

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
Wednesday, February 14, 2024

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 5/12

      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 6/12

      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 11/12

      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 12/12

C.K. McWhorter Champions Women Investors As He Races Towards Billions

Retrieved on: 
Wednesday, February 14, 2024

McWhorter is leading the charge in championing women investors in the Luxury asset investment classification.

Key Points: 
  • McWhorter is leading the charge in championing women investors in the Luxury asset investment classification.
  • Drawing inspiration from legendary investor Warren Buffett, McWhorter sees the untapped potential and significant contributions women can make to the future of investment.
  • Recognizing the talent and expertise women bring to the table, McWhorter emphasizes the need for diversity in investment decision-making processes.
  • Acknowledging the complexities of interpersonal dynamics, McWhorter also recognizes that there have been challenging moments in collaborating with women investors.

1touch.io Launches Inventa 3.9 for Modern Hybrid Data Environments

Retrieved on: 
Wednesday, February 14, 2024

NEW YORK, Feb. 14, 2024 /PRNewswire/ -- This Valentine's Day, 1touch.io is redefining enterprises' relationship with their data by announcing the launch of Inventa™ 3.9, the latest enhancement to its flagship sensitive data intelligence platform. Inventa 3.9 leverages Contextual AI and machine learning to provide total visibility across all data sources, ensuring accurate identification and classification of sensitive data for complex, hybrid data environments. This update sets new data discovery, classification, and governance benchmarks across cloud and on-premises settings.

Key Points: 
  • Inventa 3.9 leverages Contextual AI and machine learning to provide total visibility across all data sources, ensuring accurate identification and classification of sensitive data for complex, hybrid data environments.
  • Coinciding with the launch, 1touch.io is introducing the 'Love Your Data' promotion, designed to help enterprises fully embrace Inventa 3.9 in cloud environments.
  • "With the complexity of today's data environments, enterprises demand solutions that go beyond conventional boundaries to ensure robust data protection and governance.
  • To commemorate the release of Inventa 3.9, 1touch.io is launching the 'Love Your Data' promotion to enhance cloud visibility.