GUEST COLUMNISTS

• An Introduction To Biopharma Facility Design & Layout

  This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.

• COVID-19 Spurs Growth Of China’s Domestic Bioprocessing Suppliers

  Just as the U.S. and European bioprocessing supply systems have seen more robust growth than ever before, China’s domestic demands for single-use bags, cell culture media, and purification resins are all on the rise. BioPlan’s Top1000Bio database of global bioprocessing facilities has tracked industry capacity and employment growth over 15 years. 

• A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk

  In Part 1 of this 2-part series, the authors presented a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. This method can be applied to any medical therapy, and this article (Part 2) provides a very relevant and contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.

• A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I

  This article introduces a novel model of benefit-risk by taking a bottom-up approach using the _risk of the therapy_ and comparing it to _risk of no therapy_ to quantify risk and benefit with the same scale. This overview is relevant not only to the pharmaceutical and biotech industries, but also the medical device industry.

• Is A SPAC The Right Option For Your Emerging Biotech?

  As biotech and emerging pharma companies weigh their options for raising capital, the popularity of the special purpose acquisition company (SPAC) has surged, with a 175% increase in announced SPAC M&As seen between 2019 and 2020. This article examines the considerations you should make when weighing if a SPAC is the right option for your company.

• Forging A New Path Forward in Manufacturing Genetic Medicines

  While the past decade’s focus on scientific advances has accelerated the advancement of genetic medicines, including gene and cell therapies, manufacturing is vital to product quality, safety, efficacy and clinical trial and commercial supply. In the case of adeno-associated virus (AAV)-based gene therapy and gene editing product development, manufacturing is no simple task. As the industry advances these genetic medicines, manufacturing is also ramping up, and with it optimization and efficiencies of scale. Since the industry is still maturing, and manufacturing know-how is often kept proprietary, companies must learn, adapt, and master novel innovations as well as challenges on their own.

• 3 Reasons Why Medtech & Digital Healthcare Companies Should Consider Direct-To-Cloud Connectivity for IoMT

  A critical part of the digital health ecosystem, wireless connectivity is a key enabler for medical devices that can be used by patients at home and on the move. For example, connected drug delivery devices enable pharma companies to offer remote monitoring, while wearable sensors enable continuous remote diagnostics. This article explains 3 reasons why you should consider direct-to-cloud connectivity for your product.

• Is The FDA About To Reclassify Your Drug Product As A Device?

  Until Oct. 8, 2021, the FDA is seeking public comment on its plans to transition some drugs to device status. The agency's intended implementation will affect not only new products meeting both drug and device statutory definitions in connection with the approval process but also existing products on the market that may have been improperly classified as drugs.