GUEST COLUMNISTS

• Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation

  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.

• The 8-Step Checklist To Write Effective Investigation Reports

  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.

• FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products

  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.

• Patent Transparency For Biologics & Biosimilars: The Revamped Purple Book

  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.

• How To Enhance “Operational Learning” In Biopharma

  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.

• Emerging Biopharma: Your Next 2 Geographic Markets To Tackle After The US

  While the majority of the world’s drug development and innovation are underwritten by the United States, emerging drug developers should not overlook these two major regions of the world that represent volume, profit, ingenuity, and growth. 

• Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances

  In the U.S., you're grappling with how to set up a fully interoperable electronic system for securing and tracing products across industry sectors per the Drug Supply Chain Security Act (DSCSA) by Nov. 2023. Here's how to navigate the key requirements, as well as the FDA's four new guidances on the subject released in June.

• 5 Foundations Of Lean Leadership For Pharmaceutical & Medical Device Professionals

  Every life sciences company, now more than ever before, is on a journey to provide greater returns to stakeholders by manufacturing products at better quality and lower cost, which is the aim of lean manufacturing. However, many people forget about the cultural and leadership aspects of lean, which at its foundation are responsible for the success or failure of a lean transformation.