GUEST COLUMNISTS

• FDA’s RTOR Program: Draft Guidance & Insights

  First launched in Feb. 2018 by the FDA’s Oncology Center of Excellence, the Real-Time Oncology Review (RTOR) program is intended to streamline the review process for oncology drug applications. This article summarizes the new guidance and reviews the performance of the program thus far.

• Is Phage Therapy Ushering In A Post-Antibiotic Era?

  Faced with the emergence of resistant bacteria, phage therapy, which uses bacterial viruses (bacteriophages) to treat bacterial infections, is emerging as one of the most credible alternatives to antibiotics.

• Life Sciences RIM: Modernization & Moving Ahead

  Life sciences companies are getting more strategic and ambitious about regulatory information management (RIM). This article shares four key findings from an industry survey and insights for moving ahead in today's world, including a look at advanced technology's role.

• Pharma Process Validation: Initial Conclusions Are Often Deceptive

  As a pharmaceutical consultant, this author has observed many pharma process validation outcomes. In this article, he provides insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of CMAs and CPPs.

• 6 Best Practices For Biopharma Talent Management In 2023

  The Great Resignation. Inflation and the rising cost of goods and services are compelling workers in a variety of industries to seek higher salaries. This is being acutely felt in the life sciences industry. We need to revolutionize how we're approaching talent management in pharma and biopharma in order to succeed in this environment.

• Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases

  Last year, Janssen Biotech and the University of Oxford established a collaboration to understand pathogenic pathways driving immune-mediated inflammatory diseases. They have been creating a cellular map of expressed genes and proteins. This article shares what the collaboration has accomplished so far.

• Biopharma Facility Modular Design & Construction: Key Considerations

  In facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain standardized modules and components reach, the wider the benefits.

• A Practical Guide To Navigate The EU's Revised GMP Annex 1

  The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is new and different, how to document your "known unknowns," and more. Quality risk management and a contamination control strategy will be key.