LSL Web-Exclusive Content

  1. 3 Questions To Save Time And Reduce Stress When Reviewing A CDMO MSA
    4/9/2019

    Whether because of unfamiliarity or lack of resources, master service or supply agreement (MSA) execution can be time consuming and difficult. 

  2. FDA’s First DSCSA Warning Letter — A Closer Look
    3/11/2019

    The FDA issued the first warning letter related to the DSCSA amendments to the FD&C Act. This article takes a look at this warning letter and explains why pharma manufacturers should care.

  3. Include CDMOs In “Drugs, Money And Secret Handshakes”
    3/8/2019

    “Drugs, Money, and Secret Handshakes” is one hundred power-packed pages from author Robin Feldman, the Arthur J. Goldberg Distinguished Professor of Law at the University of California Hastings. Feldman provided Outsourced Pharma  a pre-publication copy of the book. Here’s part one of my review.

  4. Biosimilars Pipeline Shows Remarkable, Sustained Growth
    3/7/2019

    The biosimilars pipeline is progressing rapidly and continues to grow, with more products and more organizations involved. This article reviews the current biosimilars development pipeline and progress. 

  5. Raising The Bar: The Silver Lining Of FDA Commissioner Gottlieb’s Exit
    3/7/2019

    It was the announcement many have been dreading — but expecting — for several months now. Dr. Scott Gottlieb, 23rd Commissioner of the FDA, announced his decision to step down after 663 days (22 months) on the job. The news is sure to raise concerns for many. But I think the biggest surprise is how equally sad thought-leaders within the agency will be to say goodbye.

  6. FDA Form 1572 And Non-U.S. Clinical Trials: To Complete Or Not To Complete?
    2/28/2019

    As Bob Dylan sang many years ago, “For the times they are a-changin,”1 could be the motto of drug development. Regulations, requirements, and enforcement practices have changed, and industry professionals strive to maintain awareness in order to be compliant. As the number of clinical trial site locations outside of the U.S. has increased — driven by untapped populations, faster recruitment, and lower costs,2 — the challenges have added up. Regionally, the required or anticipated documentation and enforcement of those requirements has changed over time. One document that has recently garnered attention is the FDA Form 15723 and specifically its use by non-U.S. investigators.

  7. 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.

  8. 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.

  9. 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.   

  10. 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.