BIO From The Editor and Guest Columns

  1. Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine
    10/1/2019

    A race is being run to create the pharmaceutical manufacturing of the future and with Pharma 4.0, powerful market trends are shaping the running field.

  2. An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices
    9/30/2019

    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.

  3. FDA’s Woodcock: Biosimilar Development Promotes Future Of Better Biologics
    9/30/2019

    While some regulators may express skepticism that we’ll see major changes to the clinical component of the biosimilar development pathway, Woodcock’s DIA keynote exemplified what I found to be a strikingly different attitude about the future possibilities for biosimilar development.

  4. Abcentra Chief Looks Beyond The Clinical Horizon
    9/26/2019

    Why Bert Liang, M.D., Ph.D. obsesses over at-scale manufacturing and regulatory challenges from the outset of clinical trials. 

  5. CAR T-Cell Therapies: Current Limitations & Future Opportunities
    9/26/2019

    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.

  6. Danger Ahead: What Biotech Companies Need To Know About Leasing Space
    9/25/2019

    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.

  7. FDA’s New Population Pharmacokinetics Guidance: What You Need To Know
    9/23/2019

    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.

  8. Analysis: FDA’s Draft Guidance On Premarket Combination Products Review
    9/20/2019

    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.

  9. FDA Rapid Inquiry Program Takes Aim At Regenerative Medicine Compliance
    9/19/2019

    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.

  10. Recovery Studies: Common Issues & Using Statistical Tools To Understand The Data
    9/18/2019

    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.