Guest Columns

  1. The European MDR: Impetus, Impacts, And Current Status 6/3/2020

    This article explains the MDD’s shortcomings, details the MDR’s history, highlights expected transition timelines, describes the most significant changes, and discusses the anticipated impact on medical device markets. It has been updated through June 1, 2020. 

  2. 2 (Major) Impediments To Faster Biopharmaceutical Product Development 5/29/2020

    As pharmaceutical products have become more complex, many companies have become bogged down in accomplishing their primary mission of launching new products by complex regulatory requirements, convoluted management approaches, and inefficient resources and methods that add time and cost to moving new products from research to the patients.

  3. DSCSA, Blockchain, & The Pharma Supply Chain — Where Do Things Stand? 5/27/2020

    As the requirements for serialization and track & trace become more challenging to implement as we approach 2023, blockchain, by providing data integrity throughout the supply chain, becomes a more attractive solution to reducing the probability of errors occurring.

  4. A New Guide For Promotional Labeling And Advertising Of Biosimilar Products 5/26/2020

    This article will outline the central components of new FDA guidance on promotional labeling and advertising considerations for biological reference and biosimilar products. While such materials are overseen by the FDA, the article also explores an alternative method of challenging claims of misinformation and other forms of unfair competition that may impact the biosimilar space moving forward.

  5. MDR Delay Is An Opportunity To Excel, Not An Excuse To Relax 5/25/2020

    While the MDR date of application has been delayed a year, the Regulation’s final compliance date has not changed. This article discusses general concerns medical device manufacturers should keep in mind as they adjust to the new timeline, as well as four critical MDR factors to address (or revisit) moving forward.

  6. Identifying, Documenting, & Auditing Processes For Quality Management 5/25/2020

    Process results that are predictable and consistent can be achieved more effectively and efficiently when the activities are considered, managed, and understood as interconnected processes that function as a system.

  7. Put Your Continued Process Verification (CPV) Data To Work 5/22/2020

    Though the FDA’s process validation guidance has been in place for over a decade and other regulatory agencies (EMA, WHO, PIC/S) continue to accept the continuous process verification (CPV) concept, adoption has been slowed by the data governance, analytical capability, and technology challenges.

  8. Bioprocessing Hiring And Capacity Crunch On The Horizon 5/21/2020

    With a very healthy R&D pipeline of cell and gene therapies, we can expect multiple blockbuster products and various “orphan” niche products to be launched annually in coming years. As a result, the industry is heading for a capacity crunch.

  9. Cleaning Up The Systems Mess: A Phased Approach To Implementing Real Automation And EBRS 5/20/2020

    The biopharma industry uses the most sophisticated microbiological and genomic technology, and we experience waves of advancements in therapies driven by our computing and communications technology. So, why are we still drowning in 100-page paper batch records, books of SOPs on the plant floor, and paper documents being handled by operators?

  10. Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing? 5/19/2020

    This article will examine the relationship between improved continuous manufacturing (CM) and biosimilar development, paying particular attention to the reasons why biosimilars are especially promising candidates for CM development and innovation.