Guest Columns

31. A Phased Approach To Adopt In-Line Monitoring & Real-Time Release 10/26/2022

    The biotech plant of the future will use in-line monitoring (ILM) and real-time release (RTR), which includes process technology, operational systems, facility design, and construction innovations that will increase capacity and enable efficient processes. This article is a guide to adopting that vision.

32. Jump-Start Your Next CDMO Outsourcing Project With This Checklist 10/25/2022

    Why does it take so much time between awarding a CDMO contract and initiating of the first activities at the CDMO? Once a project is granted, there are activities that you as the sponsor company can perform before, at, and after the traditional kickoff meeting for best success.

33. Autonomous Supply Chain Planning Is Within Reach 10/19/2022

    In a fast-paced industry constantly innovating — from personalized medicine to health wearables — life sciences companies must be prepared to adopt transformative technologies that can help them meet the demands of the future of medicine. Autonomous supply chain planning is not science fiction; it's here, and it's now. Building a practical road map will help.

34. Pharma 4.0 Software Methodologies In Biopharma And Medical Devices 10/10/2022

    The life sciences industry has been using computer software testing methodology to validate software that is categorized to be GxP in alignment with the principles of good automated manufacturing practices and Industry 4.0 standards. This article discusses the methodologies of computerized system validation, computer software assurance, and the Agile approach.

35. Tips For Your Virtual Meetings With The FDA 10/7/2022

    It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.

36. FDA User Fee Programs Reauthorized: FDA’s CBER Is A Clear Winner 10/6/2022

    Last minute, squeaky clean! After years of planning, negotiation, and input, the user fee reauthorization bill was passed and signed into law on the very date that the programs were scheduled to sunset. This article sums up the key takeaways, CBER's reorganization with new product-specific offices, and more.

37. Life Sciences RIM: Modernization & Moving Ahead 9/28/2022

    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.

38. Pharma Process Validation: Initial Conclusions Are Often Deceptive 9/26/2022

    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.

39. 6 Best Practices For Biopharma Talent Management In 2023 9/23/2022

    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.

40. 3 Strategies For Small & Midsize Biotechs To Launch Drugs Successfully 9/21/2022

    Small and midsize biotechs can no longer rely on traditional commercial models. Launching new drugs is one of the most critical phases in the product life cycle, and often these entities’ entire existence depends heavily on a successful rollout. This article shares trends and three strategies for success.