LSL Web-Exclusive Content

  1. Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis
    2/28/2019

    When SMEs, management, and others gather to perform a risk assessment or a root cause analysis on a failure, they’re sure to achieve the desired outcome, right? Perhaps for a simple risk assessment or investigation, but success is not very likely for one that is even moderately complicated. That’s where a skilled facilitator is needed.

  2. Big Data And AI In Pharma Development And Manufacturing: An Inside Look
    2/27/2019

    Artificial intelligence and Big Data have the potential to lower the cost and time of drug trials, to better determine patient outcomes with established drugs, and to better design new drugs.

  3. Two Biosimilar Policies Raise Questions About Reimbursement Consistency
    2/25/2019

    In the first of this two-part article, I’ll discuss two current policies that could impact biosimilars in the U.S. — in particular, coding evolutions and the pass-through status debate — and some of the yet-unanswered questions they raise about reimbursement consistency between biosimilars and their reference products.   

  4. Medicare's International Pricing Index — Biosimilar Stakeholders Weigh In
    2/19/2019

    Can use of the Medicare IPI achieve lower drug costs? The consensus is still out. However, it will almost certainly change the way biosimilar manufacturers will have to think about pricing their agents. And it could raise further questions about the wisdom of a biosimilar pipeline for some drug makers.

  5. Why Data Integrity Is Impossible Without A Quality Culture
    2/19/2019

    For successful establishment and sustainability of a quality culture, “the mindset and behavior... must start at the top and be emulated by individuals at all levels and in all functions within the company.”

  6. 4 Tips For Overcoming Common Clinical Trial Recruitment Challenges
    2/19/2019

    The current approach to clinical trial recruitment is prolonged, costly, and inefficient and often causes major delays and challenges for research across multiple disease states. The vast majority (85 to 90 percent) of studies in the U.S. experience significant delays in recruitment and enrollment. Nearly one-third of trials under-enroll, and only 7 percent meet their target enrollment number on deadline.

  7. How To Write An Effective Validation Master Plan
    2/6/2019

    A validation master plan outlines the principles involved in the qualification of a facility, defining the areas to be validated, and provides a written program for achieving and maintaining a qualified facility.

  8. What Is Skinny Labeling — And Will It Work For Biosimilars?
    2/5/2019

    “Skinny labeling” refers to the practice of follow-on drug manufacturers seeking approval for some but not all the indications for which the branded drug has been approved. In the small molecule drug world, it has been a successful strategy for generic drug makers to get around the brand’s follow-on “new use” patents that keep the brand from falling off the “patent cliff” long after the expiration of the original patents. This strategy is starting to be used in the biosimilar realm.

  9. Patient-Centricity: Lessons Learned From A Career Inside (And Outside) Big Pharma
    2/4/2019

    Today’s clinical trial partner is tomorrow’s post-approval patient. They are the experts who can shape a program over time, be a voice during the regulatory approval process, and provide insight on what other patients hope to find in a therapy.

  10. An Analysis Of FDA FY2018 Drug GMP Warning Letters
    2/1/2019

    This article presents a detailed summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements. This allows manufacturers and sponsors to identify new trends in the focus of FDA inspectors and to act to address or justify similar situations at their own firms.