Guest Columns

11. Understanding Coding Standards In Medtech Development 5/11/2020

    While the adoption of coding standards in medical device development lags behind other industries focused on functional safety, such standards’ use is progressively increasing as their value in risk mitigation and efficient product development is recognized.

12. 2 Things Every Emerging Biopharma Needs To Know About Supply Chain 5/8/2020

    For clinicians on the front lines with potential effective therapies who are exploring how to develop new drug products, as well as development-stage companies looking to manage clinical supply chains and transform their organization for product launch, a basic framework is needed in order to integrate supply chain operation into a business strategy.

13. How Military Thinking Can Improve Pharma Decision Making Under Stressful Conditions 5/8/2020

    As a result of the COVID-19 pandemic, many companies are struggling to make both the decisions they would on any other day as well as those that are required in the current environment. This article explores what military decision-making practices can teach us about how to reach appropriate conclusions during the pandemic or other stressful conditions.

14. Introduction To Science- And Risk-Based Cleaning Validation Using ASTM E3106 & E3219 5/6/2020

    This article discusses some of the history that began the movement from compliance-based approaches to cleaning validation to the science- and risk-based approaches introduced in the American Society for Testing and Materials (ASTM) E3106 Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation and the ASTM E3219 Standard Guide for Derivation of Health Based Exposure Limits (HBELs).

15. How Will COVID-19 Impact Biosimilar Trends In The Top 5 European Markets? 5/5/2020

    It is undeniable that COVID-19 will have a significant impact on biosimilar uptake, particularly in European markets in which governments cover citizens' pharmaceutical needs and where the crisis will lead to an important reduction of available resources. However, it is difficult to assess the extent to which this will occur.

16. Creating A Roadmap For The Development And Manufacture Of Gene Therapies 5/4/2020

    The cell and gene therapy sector is in need of a similar revolution, but instead of a “standard gauge,” there is a need for clear, evidence-based industry standards and best practices for manufacturing these innovative technologies.

17. How To Adapt To Changing Single Parcel Testing Standards 5/4/2020

    Medtech manufacturers currently following the ISTA 2A package performance testing standard may wish to consider more modern standards that allow customization of some testing criteria to better evaluate real-world conditions of their packaging and distribution environments.

18. The Missing Links For A Strong Quality Culture: Skill Definition & Assessment 5/4/2020

    To build and sustain a strong quality culture, the organization must understand the critical skills needed to assure all employees can act in the patient’s best interest when making decisions on product quality and usability. 

19. Developing A Clinical Trials Strategy For A Post-COVID World 5/4/2020

    It’s becoming clear that we need proactive, collaborative planning and execution to mitigate the impact we’ll absorb when the pandemic loosens its grip on our industry, along with a significant effort to advance our virtual capabilities forward.

20. Should You List All Manufacturing Facilities In Your Drug Substance Application? Understanding The Supply Chain 5/1/2020

    In Part 1 of this two-part article, we will review the significance of listing facilities in a drug application — namely, how it connects the dots in the supply chain from a raw material manufacturer to the distributor, manufacturer, packager, wholesaler, pharmacy, and finally, the patient, helping to effectively manage supply chain integrity.