Contributing Editors

31. Post-COVID Supply Chain Opportunities And Strategies For Biopharmas And CDMOs 3/30/2022

    For biopharma executives engaging with CDMOs, rethinking domestic manufacturing goes beyond supply chain evaluation. Leaders should address three main areas to holistically assess their global operating model.

32. Tips For Making Better Tech Decisions In Biotech Manufacturing 3/28/2022

    As startup pharmas, biotechs, and gene therapy companies, how do we strike the right balance between new technology ROI and its impact on P&L? This article discusses considerations and tips for adopting single-use technologies and deciding when to go digital.

33. Boosting Pipeline Acceleration With A Strategic Pharma/CDMO Relationship 3/25/2022

    Pharma portfolio managers and CDMOs should seek more strategic modes of working together. By coordinating with each other to change all your development and capacity "red lights" to green, and balancing operational efficiency and flexibility, you can accelerate your pipeline. Here's how.

34. Shared Qualification Audits: A Win-Win-Win Approach 3/23/2022

    Throughout the pandemic, the FDA has demonstrated more than ever the value of using a risk-based approach to inspectional activities, which must be embraced and mirrored in industry when it comes to supplier and vendor audits, especially by early-stage pharmaceutical companies.

35. CMC And Quality Considerations When Engaging Your CDMO 3/21/2022

    Before pursuing an outsourcing strategy, it is essential to define what processes will be kept in-house and where your CDMO partner will take the lead.

36. Betting The House: CDMO Selection For Emerging Pharma 3/18/2022

    How an emerging company selects a CDMO to produce materials for clinical trials and commercial production is like the high stakes of betting the house at a pivotal point in a card game. A good gambler knows how to assess the risks and odds to know when it's best to “bet the house.” Selecting the right CDMO can lead to successful clinical trials and rapid commercial growth.

37. FDA Seeks Public Comment On Quality Metrics Reporting Program 3/17/2022

    The FDA recently announced it is soliciting comments on changes to its previously proposed Quality Metrics Reporting Program. This article shares which primary metrics the FDA intends to collect data on as well as the FDA's questions for input. The comment period ends June 7, 2022.

38. Key Considerations For cGMP Building Conversions 3/16/2022

    As the life sciences workforce has increased, companies need more space to accommodate them. One emerging option is searching for buildings such as offices and warehouses and converting them into biopharma manufacturing facilities. However, not all conversion projects are as easy as you would hope. This article shares key considerations for such a project.

39. Biopharma Deal-Making In 2022: Key Trends 3/11/2022

    Strategic partnerships and alliances in biopharma have become an even more important means of accessing new capabilities. This article examines key recent trends in biopharma deal-making and M&A, and how those will inform related activities in 2022.

40. What’s All The Hype About mRNA Vaccinology? 3/7/2022

    The COVID-19 mRNA-based vaccine success is spurring a further stream of medicines to come. This article provides an overview of mRNA for those who aren't already working in the field, how mRNA is being used in vaccines, and how mRNA can be used for future developments.