BIO From The Editor and Guest Columns

  1. What To Expect From A Remote Inspection -- & How To Navigate It 7/23/2021

    Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.

  2. Developing A Cure For Diabetes Type 1 7/21/2021

    Ulf Hannelius, Ph.D. is leading a charge at Diamyd Medical with a singular mission: curing type 1 diabetes. The Business of Biotech caught up with him for deep dive into the company’s progress.

  3. Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation 7/21/2021

    A robust human factors process has become critical to product optimization and market competitiveness for medical devices and drug delivery devices, but not all companies have the resources, funding, or time to conduct such user studies. This article from Genentech's head of human factors engineering examines the three major categories of evaluation that you should consider, the pros and cons of each, and how to select study participants.

  4. The 8-Step Checklist To Write Effective Investigation Reports 7/16/2021

    It’s always best to prevent the need to investigate a non-compliance, but if you experience a non-compliance, it’s necessary to quickly and effectively perform an investigation. The investigation report needs to be clearly understandable to anyone reviewing the report, and hopefully you'll also learn enough to make sure the non-compliance doesn't recur.

  5. What’s Behind BridgeBio’s 30+ Drug Candidates? 7/15/2021

    Chief Business Officer Michael Henderson, M.D. opens up on the innerworkings of academic partnerships that are driving an unusually high pipeline of therapeutic candidates across a broad range of modalities in the rare genetic pediatric disease space.

  6. FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products 7/14/2021

    At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.

  7. Patent Transparency For Biologics & Biosimilars: The Revamped Purple Book 7/12/2021

    The FDA recently updated the “Purple Book” — a database containing information about all licensed biological products — to include, for the first time, patent information relating to biologics as well as FDA regulatory exclusivity information.

  8. Genesis Of A Gene Therapy Manufacturing Giant 7/9/2021

    Columbus, Ohio is seeing rapid growth in biotech, anchored by more than half a billion dollars recently invested into gene therapy ventures Andelyn Biosciences, AmplifyBio, and the newly formed hybrid CDMO and therapeutics development company Forge Biologics. Forge CEO Timothy J. Miller, Ph.D., shares the story.

  9. Cell Therapy Production To Clinical Administration: Addressing The Gap 7/9/2021

    Cell therapy manufacturing teams and cell therapy clinicians aren’t talking to each other, and when they do, they’re often speaking different languages. What’s the industry doing to fill the gap between therapeutic production and clinical administration, and what kind of talent does it require?

  10. How To Enhance “Operational Learning” In Biopharma 7/9/2021

    According to conventional wisdom in biopharma, operational learning is derived from existing practices, including inspections, audits, deviation investigations, and gemba walks. What is often missing is the necessary understanding of the “how.” This article provides advice, as well as lessons learned from Takeda and Biogen.