Guest Columns

51. 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.

52. 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.

53. 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.

54. 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.

55. 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.

56. 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.

57. Biopharma Facility Modular Design & Construction: Key Considerations 9/12/2022

    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.

58. A Practical Guide To Navigate The EU's Revised GMP Annex 1 9/9/2022

    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.

59. 5 Steps To Avoid Mismanaging Biopharma Grant Funds 9/7/2022

    You've finally received the grant you need to make your biopharma business a reality. The tough part is over, right? Not exactly. If you mismanage your funds, you could end up on the government’s naughty list.

60. Replacing The MAC/MACO With The MSC: Rethinking How Cleaning Validation Limits Are Calculated 8/31/2022

    Two of the most commonly used terms used in pharmaceutical cleaning validation are the Maximum Allowable Carryover (MAC or MACO) and the Maximum Safe Carryover (MSC). This article provides the historical development of both terms and why we should replace the MAC/MACO with the MSC.