GUEST COLUMNISTS

  • FDA Issues Final Rule On Intended Use For Drugs & Devices After A Complicated History

    On Sept. 1, 2021, the FDA’s final rule on intended use for drugs and devices became effective. The rule has a complicated history and has been the subject of controversy over the last 6 years. The final rule provides clarity to manufacturers, but many stakeholders are still unsatisfied with the evidentiary standard for determining intended use, perhaps forecasting legal challenges to the regulation.

  • How To Find & Manage Biotech Consultants Effectively

    The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.

  • What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively?

    When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?

  • 3 Successful Strategies For Protecting Your New Biopharma’s IP

    Intellectual property is the lifeblood of new biopharma entities. Patent protection is necessary to secure investment, to build a solid foundation with opportunity for future growth, and to establish viability within a highly competitive landscape. This article addresses key patent-related considerations for startups and small or early-stage players in the life sciences arena.

  • Best Practices For Raw Material Supplier Change Notifications: New BioPhorum Guidance

    Managing the large volume of supplier change notifications while safeguarding the continuity and compliance of a complex and tightly regulated supply chain is a resource-intensive task. To address the challenges, the BioPhorum Raw Material Variability Workstream has developed a guidance document designed to streamline the process without straying from essential and strict risk mitigation procedures.

  • Best Practices To Ensure Quality Of Raw Materials Used To Manufacture Therapeutic Proteins

    Across biologics, raw material quality is a key driver of product quality and consistency. This article recaps a recent U.S. Pharmacopeia (USP) workshop on the subject, including recaps of best practices and experiences shared by the FDA, Merck, Biogen, and more.

  • The 5-Step Checklist For A More Mature, Robust Quality Management System

    Whether you are preparing for a pre-approval inspection, have the corporate desire for continuous inspection readiness, or are engaged in a LEAN initiative to clean up and strengthen your quality management system (QMS), further maturing your QMS can be helpful to ensuring a robust, comprehensive, and compliant QMS.

BIOSIMILAR WHITE PAPERS

  • Strategies For Upstream Intensification

    Upstream intensification is one strategy that will enable the Facility Of The Future by significantly driving down costs through an increase in volumetric productivity. Read the white paper to learn more!

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BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS

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The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.

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