LSL Web-Exclusive Content

  1. Cross-Lab Data Collaborations – The Future Of Immunotherapy?

    In January, UC San Francisco announced a research alliance with AbbVie, Amgen, and BMS supporting the collection and analysis of at least 500 tumor samples from more than 10 different forms of cancer to ultimately improve patients’ responses to cancer immunotherapy.

  2. What Outcomes-Based Contracting Means For Drug Development & Drug Pricing

    The mounting public outcry over drug prices — fueled by dramatic increases in cost for a few high-profile, older, life-saving drugs — has put intense pressure on the pharmaceutical industry to lower list prices and curtail price increases or face government controls.

  3. Are You Prepared For The Upcoming USP <800> Requirements?

    The United States Pharmacopeial Convention (USP) has developed a chapter on hazardous drug (HD) handling in healthcare, USP <800>, which will become effective on July 1, 2018. For facilities that handle hazardous drugs, there’s no time to waste in working toward compliance, because facility design/redesign and construction may be necessary to achieve it.  USP chapters numbered less than <1000> are requirements, not guidelines, in the United States, so compliance is necessary.

  4. The Small Pharma–CDMO Marriage: How We Can Make It Even Better

    Unlike Big Pharma, which may outsource internally developed processes and formulations, small and midsize pharma/biotech firms are dependent on contract development and manufacturing organizations (CDMOs) for much of their product development and GMP manufacturing activity.

  5. Examining FDA’s New Quality Agreement Guidance

    The new FDA guidance is a simple one, providing best practices and high-level insight into the components of a quality agreement. This article continues the discussion from Part 1, analyzing the elements that the agency indicates should be included in quality agreements — and explaining how FDA missed a chance to truly provide value to the industry.

  6. New Medicare Proposals Could Impact Biosimilar Competition

    In early January, both Pew and MedPAC presented several suggested changes to current Medicare Part B policy. Though these two organizations' proposals have their differences, the ultimate goal of both is to encourage competition between biosimilars and reference products, which would help with affordability for biologics.

  7. Pharma Off-Label, On-Label, And Free Speech

    The FDA gives manufacturers additional guidance for scientific communications, but is it much ado about a little?

  8. The Most Exciting Region In Asia For Pharma and Medical Devices

    With an economic potential still largely untapped, the Greater Mekong Region (GMR) should be front and center in the plans of any pharma, medical device, or biotech organization looking to expand its market in Asia.

  9. 5 Important Takeaways From The FDA's Revised Quality Metrics Guidance

    On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015). This article discusses the most significant differences between the two documents and what pharma manufacturers and CMOs should take away from these changes.

  10. Alternative Fact: Site Identification Is Not Critical To Clinical Trial Efficiency

    On the surface this may seem to have some validity, as sponsors and CROs often lack a transparent, evidence-based strategy for this task. Instead, they frequently rely on archaic paper-based or spreadsheet methods to identify sites across the globe with a reasonable chance of enrolling the contracted number of patients on schedule, and the ability to generate quality data.