Guest Columns

  1. Navigating The Regulatory Landscape For Therapeutic Radiopharmaceuticals 1/27/2020

    There have long been numerous global and local regulations for how nuclear materials are transported, compounded, monitored, and dosed for the purpose of diagnostic evaluation. These continue to be applicable for both diagnostic and therapeutic nuclear medicines. However, establishing therapeutic medical claims for nuclear medicines increases the list of regulations that must be followed.

  2. Biosimilar Litigation Review: BPCIA Cases Settled Or Dismissed In 2019 1/21/2020

    This is the second article in a four-part series on 2019 legal developments related to the biosimilar sector. Part 1 shared statistics regarding Biosimilars Price Competition and Innovation Act district court litigation and reviewed ongoing BPCIA district court cases. In Part 2, we turn our attention to BPCIA district court cases that were settled in 2019.

  3. Recommendations For Managing Complexity In Biopharma Operations 1/21/2020

    There's a tendency in biopharma operations to make things more complex than they need to be. More content in an SOP, additional signatures, new forms, and control loops don't necessarily equate to better.

  4. An Introduction To Agile Project Management For Pharmaceutical Outsourcing 1/21/2020

    Modern sponsor-CDMO partnerships must be agile and flexible, bringing together professionals from multiple disciplines to find solutions that increase efficiency.

  5. Non-Hodgkin’s Lymphoma CAR T-Cell Therapy: Where Do We Go From Here? 1/16/2020

    Following the success of Kite/Gilead’s Yescarta and Novartis’ Kymriah in treating relapsed or refractory diffuse large B-cell lymphoma, key players are pursuing therapies in earlier treatment settings and in mantle cell lymphoma, chronic lymphocytic leukemia, and follicular lymphoma.

  6. Prepared For Impending Changes To U.S. Biologics & Biosimilars Law? 1/16/2020

    Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.

  7. Biosimilar Litigation Review: Ongoing BPCIA District Court Cases To Watch 1/14/2020

    Biosimilars Price Competition and Innovation Act (BPCIA) litigants and Federal and district courts grappled with new issues in 2019. In Part 1 of this article series, we summarize BPCIA district court litigation and review ongoing court cases.

  8. 5 Supply Chain Questions Every Drug Company Should Know The Answers To 1/14/2020

    Part 1 of this two-part column raised the point that if you’re not happy with one or more of your suppliers, it may be because you haven’t clearly told them what you want, what your expectations are, and what is important to you. Here in Part 2, we explore five important questions that can serve as a brief checklist to help drug companies both figure out and communicate their expectations to suppliers and understand their suppliers’ expectations.

  9. Why You Need A World-Class Quality Culture — And How To Build One 1/13/2020

    The quality culture of the organization has a clear and direct impact on the ultimate quality of the product. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.

  10. 6 Important Elements Of The New STRONGER Patents Act 1/9/2020

    Over the past decade, patent reform has been an area of emphasis for Congress, with the passage of The America Invents Act of 2011 (AIA) and, more recently, the filing of a revised version of the STRONGER Patents Act in July 2019.