LSL Web-Exclusive Content

  1. 5 Tips For Orphan Drug Development In A Price-Sensitive Payer Environment

    The first installment in this two-part series examined rising costs associated with orphan drugs and two related case studies. This second part provides actionable suggestions for developers.

  2. How To Create A Spirit Of Independence Among Your Team

    Welcome to the premier edition of Dr. Liz on Leadership! In my new, monthly Life Science Leader column, I will bring you practical tools and advice to help you, your team, and your organization thrive in today’s rapidly changing healthcare environment.

  3. Using Social Media To Build Patient Trust

    Understanding the proper role of social media is an important challenge for pharmaceutical companies when it comes to “connecting” with potential patients and building their levels of trust. In 2017, strategies that involve traditional mass media — such as TV and print ads — are far from dead; however, social media offers clear advantages to building recognition for a drug — and awareness of its efficacy — in ways that can be targeted to very specific audiences.

  4. Responding To Regulatory Inspection Observations: Do’s and Don’ts

    It’s Friday, it’s late, and you are just leaving for the weekend. The inspection you hosted two weeks ago remains a painful memory. The exit meeting didn’t go well — five major observations, all relating to your quality system. When your boss enters your office, you know it’s not to wish you a good weekend. 

  5. Pharma's Vital Interest In Tracking State Biosimilar Substitution Laws

    State lawmakers continue to spearhead legislative boundaries to automatic biosimilar substitution at a rapid clip across the nation, with 33 states and Puerto Rico having taken action and with bills pending in eight more states.

  6. Listening To Patients To Improve Clinical Trials

    There are so many challenges around designing clinical trials that it can often be difficult to decide where to focus your efforts and resources to improve the process. Based on our recent surveys of clinical trial participants, we see that early engagement with patients can change the course of a study for the better — and research shows it can directly impact the cost of conducting the trial as well.

  7. The Importance Of Options In Biosimilar Litigation

    A recent discussion amongst experts from Momenta, Eli Lilly, and Foley & Lardner highlighted the diversity of opinions surrounding Amgen v. Sandoz and other legal challenges in the space. But lurking underneath discussions of statutes and standards of evidence is biosimilar makers' desires for options to address the U.S.' rigid patent landscape.

  8. Seeking A Smooth Transition To The New EU MDR? (Then Start Complying Now)

    The new regulation has a word count nearly four times higher than its predecessor, the Medical Devices Directive (MDD), contains five more annexes, and uses the word “safety” 290 times, rather than just 40 times. 

  9. Cross-Stakeholder Collaboration: Advancing Research Through Common Protocol Templates

    In 2014, TransCelerate BioPharma launched an initiative dedicated to creating a common protocol template (CPT), with a vision of addressing the increasing complexity of clinical trial protocol development and supporting the pursuit of protocol quality through a practical, harmonized and adoptable approach. Several weeks ago, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) released a final version of its own common protocol template — noting that it was in alignment with TransCelerate’s CPT, specifically, the new enhanced technology-enabled edition. They, like TransCelerate, recognized that the clinical trial protocol deserved renewed attention and modernization.

  10. Making Last-Minute Serialization Preparations

    Starting on Nov. 27, 2017, pharma manufacturers are required to begin marking all saleable units and homogeneous cases of prescription drugs with a unique serial identification code, as stipulated by the Drug Supply Chain Security Act.