LSL Web-Exclusive Content

  1. 6 Ways AI Is Transforming The Life Sciences (Already)
    1/31/2019

    Most in the life sciences agree that artificial intelligence (AI) will reshape the sector from R&D through commercial. Although AI has only just left the starting gate, and most activity is in exploratory phases, some benefits are starting to emerge. And there are pockets of early adopters trailblazing new approaches and seeking a competitive edge.

  2. Champions Against Nonsense: A Better Way To Talk (And Think) About Quality
    1/30/2019

    This is the second of three articles focusing on an effort to address what appear to be systemic issues across quality departments. This article addresses how to reframe the way we view and discuss quality, how to better engage stakeholders, and an alternate view of how quality can add value to the company.

  3. Measuring The Financial Impact Of Remote (Digital) Clinical Trials
    1/29/2019

    Many companies are exploring ways to continue to innovate and bring novel drugs to patients while reducing the overall costs of drug development process. Enter… remote clinical trials.

  4. How Healthy Is The Biopharma Pipeline Heading Into 2019?
    1/28/2019

    This article analyzes key indicators of pipeline strength over the past three years, including R&D spend, new chemical entity approvals, and Phase 2 and Phase 3 development. 

  5. Understanding The Inspector General’s Critique Of The FDA Over Cybersecurity — And What It Means For Manufacturers
    1/28/2019

    This article examines a report issued by the Office of the Inspector General of the Department of Health and Human Services, resultant of an audit of the FDA’s internal processes to ensure cybersecurity in the postmarket phase of medical devices – as well as the FDA’s disagreements with the findings and what this means for manufacturers going forward.

  6. How Would Proposed Congressional Price Control Policies Impact Biosimilars?
    1/24/2019

     

    Sen. Bernie Sanders has introduced three bills aimed at reducing prescription drug prices, two of potential importance to biosimilar developers. This article discusses these cost-containment policies, as well as two other congressional initiatives to watch.

  7. Why This Biosimilar Initiative Is One To Watch In 2019
    1/16/2019

    When news came my way in early December that the Biosimilars Forum had established the Biosimilars Roundtable, which would be a working group comprising members of 40 different stakeholder organizations, I was thrilled.

  8. 5 Questions To Ask Your CDMO: #5 — What Is Your Employee Turnover?
    1/15/2019

    While it’s common to say a company has experience with a certain technology, it is the people at that firm who are able to utilize equipment and procedures in successful applications of technology.

  9. Are You The Weak Link In Your Own Pharma/Biotech Supply Chain? How To Find Out — And Fix It
    1/14/2019

    A team composed of nearly 70 FDA, pharma/biotech, and medical device leaders — spanning 39 organizations and five countries — have concluded that companies trying to get a handle on issues in their supply chains should focus less on their suppliers and more on themselves as the possible source of the problems.

  10. FDA Shutdown: Assessing The Potential Impact On Innovation And Public Health
    1/11/2019

    I am not an expert on immigration or building walls. I don’t pretend that I can totally understand the political strategy of either party at the high level of the government shutdown. But as someone very familiar with the FDA, I am growing increasingly concerned that the longer the government shutdown continues — dragging the FDA along with it — the greater the potential for harm to the public health.