Contributing Editors

31. Interacting With FDA During Biosimilar Development: From Initial Advisory Meeting To BLA 11/3/2020

    In Part 2 of this two-part article, we discuss what information is critical to support the sponsor’s argument that the proposed product is biosimilar to the designated reference product and when is it appropriate and at what level of detail it should be for each stage of interaction with the FDA.

32. Best Practices For Selecting & Implementing New Technology In The Life Sciences 11/2/2020

    Software tools and their supporting hardware can undoubtedly enable greater performance within your medical device, pharmaceutical, or biotech business. Regardless of the type of technology implementation, how you select technology and how you implement it are two critical factors for any organization.

33. Evaluating The Potential Impact Of Anti-BCMA Therapies In The Multiple Myeloma Space 10/30/2020

    There are more than 70 ongoing clinical trials in development investigating over 30 B-cell maturation antigen (BCMA) targeting agents, each utilizing innovative technologies and strategies such as antibody-drug conjugates, bispecific antibodies, and CAR T cell therapies. This article reviews three key anti-BCMA therapies in late-phase clinical development that are likely to impact multiple myeloma treatment.

34. How To Implement Continuous Process Monitoring Of Validated Processes 10/28/2020

    It is time to consider augmenting your validated pharmaceutical, medical device, and tissue production processes, including processing, packaging, and labeling, with continuous process monitoring to ensure continued compliance with established specifications and requirements if you do not want to be cited by the FDA.
    
     

35. Mammalian Biomanufacturing Industry Supply & Demand Trends 10/26/2020

    While capacity will increase over the next five years, demand for capacity, pandemic aside, will increase at a slightly faster rate, allowing for some short-term loosening of capacity constraints, but after 2024, capacity tightening may occur.

36. Biologics Manufacturing In China: Competition Heats Up 10/23/2020

    China is demonstrating clear investment interest in participating in global markets for both innovative biologics and biosimilars produced at GMP quality levels.1 These factors are creating a strong market environment for CMO services.

37. How FDA, MHRA, & Russia’s Drug Inspectorate Escalate Inspection Findings 10/21/2020

    Representatives from the Russian Federation State Institute of Drugs and Good Practices, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their processes for evaluating and escalating inspection findings to determine if regulatory action is needed.

38. COVID-19 Vaccine Manufacturing Challenges Spark Surge In Outsourcing Deals 10/19/2020

    As the pharma industry scrambles to develop one or more viable COVID-19 vaccines, the greatest hurdle to immunizing the world’s population is the manufacture of billions of doses in parallel. In response to this challenge, vaccine developers are signing an unprecedented number of outsourcing agreements with CMOs and other service providers.

39. A Quality Agreement Primer: What To Include & Who To Assign It To 10/16/2020

    Part one of this three-part series on quality agreements discussed identifying key risks in partnering with contract companies and working with vendors. Part two explored the regulations and enforcement activities associated with quality agreements. In this final part, we examine what to include in quality agreements and who should be responsible for the assigned tasks.

40. How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data 10/14/2020

    Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?