BIO From The Editor and Guest Columns

  1. The 8 Key Takeaways For FDA Inspections In The Food And Drug Omnibus Reform Act 2/7/2023

    With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on Dec. 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and more.

  2. Antibody-Drug Conjugates: Increasing Investment In R&D And Partnerhip 2/1/2023

    DeciBio’s Antibody-Drug Conjugates 2023 Industry Survey points to progress in ADC development. Respondents anticipate lower regulatory, financial, and R&D barriers as the technology matures. Senior Life Science Expert Joe Daccache, Ph.D. gave us an insider's look at the numbers.

  3. After Decades Of Biomanufacturing Workforce Development, What’s Next? 2/1/2023

    We have seen exponential growth of the biotech industry in recent decades. Companies have struggled to find qualified workers. To close that workforce gap, we need to leverage the lessons from successful biomanufacturing training programs and consider new approaches.

  4. 4 Focus Areas To Modernize Your Cleaning Validation Strategy 1/30/2023

    The traditional outlook on cleaning validation might look inexpensive and safe, but it can lead to serious problems in the long run. To modernize your cleaning validation strategy for 2023, here are four areas to focus on.

  5. What's True Of Mice ≠ What's True Of Men 1/27/2023

    After losing his mother to pancreatic cancer, entrepreneur Alex Blyth launched an immuno-oncology company that’s developing a novel allogeneic cell therapy. The company, LIfT BioSciences, recently received a shot in the arm when it was accepted into Johnson & Johnson Innovation’s JLABS network.

  6. Can JP Morgan Help San Francisco? 1/25/2023

    My first in-person JP Morgan Healthcare Conference was great for business. It also left me wondering what the world's toniest healthcare conference is doing for the health of its ailing host city.

  7. 6 Strategies To Protect Your Biologics Supply Chain In 2023 1/25/2023

    Instead of automating everything — which costs a lot and doesn't solve every problem — drug makers should focus on building scalable, need-specific supply chain operations. This article discusses supply chain resilience strategies biotech companies can reasonably control.

  8. How Do Cell & Gene Therapy Requirements Differ Between FDA & EMA? 1/24/2023

    This article examines the similarities and differences between how the FDA and the European Medicines Agency (EMA) approach cell and gene therapies. Where do the regulatory perspectives align and where do they diverge?

  9. Considerations For Microbial Enumeration Methods When Working With CDMOs 1/23/2023

    In microbial enumeration testing, the product-specific interferences are addressed during method development. The execution can vary between laboratories. This article examines general considerations, membrane filtration, and the pour plate method.

  10. A Personal Case For Drug Repurposing 1/20/2023

    Amidst the dealmaking and spectacle of the 41st Annual JP Morgan Healthcare Conference, a bright and personal light was cast on the value of a different kind of collaboration: drug repurposing. There’s a deep vein of patient benefit sitting on pharmacy shelves, and Michael Fajgenbaum, M.D. wants to tap it.