LSL Web-Exclusive Content

  1. An Analysis Of 2017 FDA Warning Letters On Data Integrity

    Enforcement of failures in data integrity and data governance began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. While the FDA is not the only health authority that identifies these issues in inspections and enforcement actions, its transparency ensures the data is available.

  2. What’s The Right Pricing Strategy For Cell And Gene Therapies?

    At the BIO-Europe Spring Conference in Amsterdam in March 2018, CRA hosted a special program where attendees from biotech, Big Pharma, healthcare provider/payer groups, and patient associations were asked to share their views on pricing strategies for innovative medicine, including cell and gene therapies. More than 60 attendees responded to a series of questions about drug pricing, with a focus on cell and gene therapies, and their responses were captured live through an instantaneous voting system during a panel session.

  3. 4 Strategies To Thrive In The Competitive & Tech-Driven Biopharma Landscape

    The industry will see a mixture of new emerging trends and an evolution of historical trends heavily influenced by technology innovation and AI. The next year promises to be an exciting one that will strengthen the position of some existing leaders and elevate some new companies focused on building forward-looking platforms that will deliver future innovation and growth.

  4. The Impact Of Regulatory & Analytics Evolution On The Biopharma Industry

    This two-part article explores the use of various tools and the emergence of intelligent solutions in the industry.The first part provides an overview of how technological advancements and data analytics are critical in enabling regulators and the life sciences industry. 

  5. Launching A Hospital Product: A Guide For Pharmaceutical Companies

    While hospital drug expenditures represent a substantial market for the pharmaceutical industry, manufacturers face an increasingly complicated market environment.

  6. 6 Ways Biosimilar Companies Should Engage State Governments

    In my previous article, I argued that biosimilar companies must engage states as partners for successful U.S. market access. This article accepts that premise and also assumes interchangeability will occur at the federal level. My goal is to provide insights, along with several solutions for biosimilar companies to engage local politicians and patients in a manner that is mutually beneficial. This analysis is based on reading and assessing all 38 of the local statutes addressing biosimilars and my prior experience proposing statutes for local legislatures.

  7. 5 Proposed Solutions To FDA For Optimizing Clinical Trials

    Lupus is a complicated imbalance of the immune system with a spectrum of manifestations that vary from patient to patient and may change in the same person over time. This complexity makes treatment development challenging.

  8. What Is GDPR’s Effect On Medical Devices?

    The EU’s General Data Protection Regulation (GDPR) will go into full effect on May 25, 2018 — as will penalties for non-compliance. While most of the GDPR affects the back end of medical device data handling, the Cloud, Databases, and transportation of data, some of the GDPR affects software on medical devices themselves:

  9. This is Your Captain Speaking: 5 Keys to Leadership in Tough Times

    Sitting comfortably aboard a full commercial flight, ready to depart from Boston’s busy Logan Airport, I hear the captain’s calm and assured voice issued from the cockpit.

  10. Patient Recounts Reimbursement Challenges

    One area of patient centricity that might be getting overlooked is patient reimbursement. When patients travel to clinical sites for treatment, how much of their own money are they required to shell out? Are they being promised reimbursement for those expenses? And, if so, how long is it generally taking for them to receive the funds?