Contributing Editors

  1. The EU’s Biopharma Industry Can Deliver More With IDMP Data Standards 12/17/2021

    Promises abound in the IDMP software industry about the vast transformation potential of data-driven processes beyond pharma regulatory exchange. Biotechs, unencumbered by legacy systems and processes, could blaze a trail. This article provides the steps to take now.

  2. Using System Risk Structures To Evaluate COVID-19 Pandemic Risks 12/15/2021

    This article's discussion demonstrates how system risk structures (SRS) can be used to understand complex risks and how SRS might be applied to understand the very complex risk landscape of the COVID-19 pandemic. It includes analysis of risk of personal infection, risk of disease progression or spreading, risk of vaccination, and more.

  3. The Pharmacological Treatment Pipeline For Traumatic Brain Injury 12/13/2021

    There is significant unmet need for traumatic brain injury therapies, leading to increased R&D efforts to discover new treatment approaches. Back Bay Life Science Advisors analyzed the clinical pipeline for new molecular entities at the proprietary level for TBI treatment to better understand the development landscape.

  4. The 4 Ways AI Implementation Is Changing The Future Of Precision Medicine 12/10/2021

    Part 1 of this two-part series examined how recent advances in for oncology diagnosis and treatment preview the full potential of precision medicine. This article, Part 2, shares insights on the 4 challenges the industry must overcome before individualized healthcare can be fully realized.

  5. Bioprocess Facility Design — Layout Rules And Configurations 12/9/2021

    The adoption of single-use systems (SUS) is allowing for a shift to smaller and more flexible facilities. This article explores modern facility design options and configurations, and best practices for building a facility around SUS process technology.

  6. Tips & Tricks For Risk Facilitators Conducting Remote Sessions 12/8/2021

    When the pandemic hit, the tools normally available to a risk facilitator during a working session were gone. This article presents some of the challenges encountered and learnings from that adjustment and recommends tips for risk facilitators in the hybrid work environment that has emerged from the pandemic.

  7. Principles And Concepts Of System Risk Structures For Understanding & Managing Risks 12/6/2021

    A truly effective risk analysis method for the biopharma industry should provide insights to and understanding of the fundamental properties and attributes that underlie every type of risk. This article describes how system risk structures (SRS) can be used to understand and manage both simple risk situations as well as complex risk landscapes quickly and efficiently.

  8. Regulatory Intelligence: It’s More Than Just Compliance 12/3/2021

    Every pharmaceutical company is under pressure to monitor the changes that are taking place in the regulated landscape and respond to them accordingly. Regulatory intelligence activities include collecting, evaluating, and analyzing various pieces of information to position your company for success.

  9. 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.

  10. How To Enable Your Quality Risk Management Lifecycle 11/29/2021

    The topics covered in this article represent some of the common risk management pain points and mechanisms to overcome these challenges, focusing on the foundation of quality risk management (QRM). This includes using consistent terminology, determining risk strategy, implementing QRM, and the advantages of early implementation.