Drug Discovery Featured Articles & Applications

  1. What’s The Role Of Intuition When Making QRM Decisions? 2/28/2022

    In Part 1 of this 2-part series, this author explained how to effectively set up your quality risk management (QRM) program for pharma and medical devices. In this article, he explains how to implement that program. For such a numbers-based field, there is still an important role for using your intuition to make QRM decisions.

  2. What Are Risk Appetite & Risk Tolerance In Pharma & Medical Devices? 2/23/2022

    This article describes and differentiates risk appetite and risk tolerance and discusses why these two concepts are foundational to how we make risk-based decisions in pharma and medical devices. Also covered are a spectrum for risk appetite, best practices for risk communication, and events and conditions that can shape risk appetite and tolerance.

  3. How To Set Up An Effective Quality Risk Management Program 2/16/2022

    The author of this article has taught courses on quality risk management (QRM) and its implementation as well as seen it in action in many companies. This article, Part 1 of a 2-part series, shares some of his observations and lessons learned in setting up an effective QRM program.

  4. Pharmaceutical Quality Compliance In 2022: Data Is Paramount 2/11/2022

    Pharma quality and compliance leaders must anticipate potential manufacturing issues before they happen by leveraging risk-based methodologies, continuously monitoring their systems, and tracking the profusion of data generated during the process. This article outlines the potential of data and analytics to improve quality performance.

  5. The Talent Shortage In Biopharma Demands A Creative Solution 2/2/2022

    The demand for new talent in the biotech industry was already reaching new heights before the COVID pandemic, and now it is even more obvious. Complicating the dilemma is the move toward Pharma 4.0. The industry will need talent that can operate in new business models that are more complex.

  6. Sex Matters… In Preclinical Drug Development? 1/18/2022

    In safety pharmacology studies investigating short-term side effects on physiological functions, the scientist is obliged to “consider” sex in the study design of animal models. This article also shares the differences in anxiety and depression in human males and females.

  7. Can Anti-TNF Treat Post-operative Cognitive Decline? New Clinical Research Investigates 1/6/2022

    People who suffer from post-operative cognitive decline can develop difficulty remembering things and performing daily tasks, and may possibly end up in nursing homes. There are no existing therapies. However, 180 Life Sciences believes it has a novel understanding of how to treat it.

  8. Using AI In Drug Discovery: The Latest Market Research 12/1/2021

    The deployment of AI-driven drug discovery in areas such as oncology, neurology, and cardiology reduces gaps in R&D for improved drug manufacturing processes and further helps in targeted manufacturing of drugs. These technologies are rapidly attracting pharma and biotech companies, CROs, and academics and research institutions.

  9. Inside Novome Biotechnologies’ Phase 1 Study of NOV-001 11/22/2021

    Novome Biotechnologies recently announced positive results from a Phase 1 study of orally administered NOV-001 in healthy volunteers. The Phase 1 study demonstrated the ability to safely colonize the human gut with a therapeutically engineered microbe and control its abundance via once-daily dosing of a prebiotic control molecule. Based on these results, Novome intends to commence a Phase 2a study to evaluate preliminary efficacy in patients with enteric hyperoxaluria.

  10. Your Operating Model Needs To Be As Innovative As Your Science: An Open Letter To CEOs And Boards Of Directors Of CGT Companies 11/10/2021

    Organizations should design their operating models to address the unique requirements of CGT products to get the most from their investment dollars.