Guest Columns

  1. An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices

    This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part, we will discuss the needle-free PFS and the dual-chamber system.

  2. CAR T-Cell Therapies: Current Limitations & Future Opportunities

    Novel technologies to address areas left unaddressed by Kymriah and Yescarta have started streaming into the research arena. This article focuses on the barriers to widespread commercial adoption of the currently available CAR T cell therapies, and opportunities for developers of next-generation treatments.

  3. Danger Ahead: What Biotech Companies Need To Know About Leasing Space

    One of the most significant moves for a growing biotech or pharmaceutical company — sometimes considered as a graduation step — is the acquisition of property to conduct clinical trials and manufacture commercial products. In the first installment of this two-part series, we will explore what considerations companies need to make before they decide what type of property to pursue.

  4. FDA’s New Population Pharmacokinetics Guidance: What You Need To Know

    The FDA’s Population Pharmacokinetics Guidance for Industry draft calls for sponsors of new drug and biologics license applications to apply population PK analysis. This column covers the implications for drug and device manufacturers.

  5. Analysis: FDA’s Draft Guidance On Premarket Combination Products Review

    The new EU draft guidance Guideline on the quality requirements for drug-device combinations and U.S. draft guidance Principles of Premarket Pathways for Combination Products are the latest attempts by each body to adequately regulate combination products. In this two-part series, we examine the two guidances in detail, starting with the U.S. guidance.

  6. FDA Rapid Inquiry Program Takes Aim At Regenerative Medicine Compliance

    Regenerative medicine holds promise, though evidence to back claims about current therapies is underwhelming. The FDA's announcement of the Tissue Reference Group Rapid Inquiry Program returns our attention to the administration's regenerative medicine policy framework.

  7. Recovery Studies: Common Issues & Using Statistical Tools To Understand The Data

    This article explores some of the typical issues that may be encountered during recovery studies, and explains how the use of statistical tools for assessing recovery data can provide greater insight to guide decisions concerning recovery studies. 

  8. FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis

    This is the second part of a two-part article counting down the FDA’s top 10 most-common drug GMP inspection citations for the agency’s 2018 fiscal year (FY2018).

  9. Think A Quality Culture Doesn’t Affect Your Bottom Line? Think Again

    Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen. News of a pharmaceutical company receiving an FDA Complete Response Letter and Form 483 — citing data manipulation and breaches — drove this point home recently. Based on the FDA observations made in this case, there is clear evidence that components of a voluntary quality assurance (VQA) culture were missing.

  10. Does Blockchain Make Sense For The Cell & Gene Therapy Supply Chain?

    Understanding the impact and requirements for a clearly defined supply chain strategy and implementing this into the complex environment of cell and gene therapies is not a simple task. It requires dedication and participation from all the stakeholders across the development-to-delivery life cycle. All the details need to be defined, simulation models developed, and risk assessed — and remediation plans put in place.