Guest Columns

  1. Improving Outsourcing Relationships
    8/15/2019

    ISR research indicates that proactive communication between sponsors and CMOs in these three areas will help to improve outsourcing relationships. Data comes from ISR’s Development and Commercial Outsourcing Models market research report.

  2. What Organizational Design Says About Your Commitment To Data Integrity
    8/8/2019

    Understanding how to be appropriately staffed and being prepared to explain any perception of inequity could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.

  3. 3 Critical Areas To Review In Strategic Site Selection
    8/8/2019

    Have you ever put off doing something you knew needed to be done, even though you had the ability and money for it?  Think exercising, getting a will or going to the dentist (hopefully you have dealt with at least the latter).  In the same way, many study sponsors put off aggregating and utilizing key intelligence on their previously used investigator sites for use in future strategic site selections. At times, there will be unique reasons for engaging with a certain investigator site or the need to use research-naive sites. However, if previously used sites will be considered for a new study, it is vital to review some key information for a truly strategic site selection process.  Let's take a look at some of these key, yet often forgotten, areas.

  4. Asia Bioprocessing Capacity Trends: Overall Growth, But Cell Therapy Shortages Loom
    8/8/2019

    Overall, the growth in Asia’s bioprocessing capacity, particularly in China, has been impressive, albeit from a low baseline. Capacity growth over the past five years has been over 20 percent annually. New facility construction and expansions reflect the demand for biologics for domestic consumption, while other facilities are beginning to develop manufacturing strategies for GMP production for major markets, with capacity involving commercial-scale stainless steel and single-use bioreactors.

  5. Does A Phase 1 Virtual Biopharma Company Need A cGMP Quality System?
    8/7/2019

    Virtual pharmaceutical/biotech companies often receive conflicting advice regarding the need to establish an internal cGMP quality system. Either they’re told “you need an extensive set of cGMP SOPs” or “you don’t need any cGMP SOPs at all.” Which advice is correct?

  6. U.S. Bone Repair Devices: Trochanteric Grip Market Stalls, Cerclage Cables Take Off
    8/7/2019

    Approximately 75,000 procedures were completed in 2018 using cerclage cables and trochanteric grips, devices used in the repair of broken or surgically altered bones. This procedure volume is increasing every year.

  7. Standard Of Care And The Internet Of Medical Things
    8/6/2019

    During the American College of Cardiology annual meeting in March, researchers from Stanford University, Apple Inc., and other academic centers unveiled the Apple Heart Study, a first-of-its-kind large-scale study involving more than 400,000 members of the general population (iPhone and Apple Watch owners). The goal of the study was to identify users with a potentially lethal irregular heart rhythm called atrial fibrillation (AF).

  8. 4 Important Things To Consider Before Developing A Drug Delivery Device
    8/6/2019

    This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development.

  9. LATAM Medtech Leaders Podcast Summary Series: Part 1
    8/5/2019

    This article is the first in a series drawing on highlights from the LATAM Medtech Leaders podcast, with guests imparting advice on topics like commercialization strategy in Latin American markets, pricing, and more.

  10. Understanding Medical Diagnostic Method Patent Eligibility
    7/31/2019

    Until this area of unsettled law is more fully developed, it will be important to include practical implication details in medical diagnostic patents to maximize the flexibility to claim inventions in multiple ways.