LSL Web-Exclusive Content

  1. A Technology Roadmap For Today’s Gene Therapy Manufacturing Challenges
    4/18/2019

    The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has published technology roadmaps addressing needs and gaps in three key product areas: gene therapy, antibody-dug conjugates, and vaccines. The roadmaps were developed with the collaborative input of industry, academic, and government experts. This article highlights technology opportunities for gene therapy manufacturing.

  2. Inside FDA's Proposed Program To Establish Voluntary Quality Standards
    4/17/2019

    The FDA’s CDER recently released draft guidance aimed at the development and recognition of voluntary consensus standards for pharmaceutical quality.

  3. How Will USPTO Guidance Revisions Impact Biosimilars?
    4/16/2019

    Since 2012, patent stakeholders in the U.S. have faced remarkable uncertainty in the evaluation of patent subject matter eligibility under 35 U.S.C. 101, particularly in the application of the Supreme Court’s Alice/Mayo1 test by the United States Patent and Trademark Office (USPTO). 

  4. 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. 

  5. What Is the Current State Of BREXIT, And What Happens Next?
    4/3/2019

    The United Kingdom’s plan to leave the European Union has devolved into a mess of shifting deadlines and what-ifs. Here, Zaid Al-Nassir breakdown for medtech leaders has been updated to include events taking place through April 11, 2019.

  6. 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.

  7. 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.

  8. 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. 

  9. 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.

  10. 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.