Industry Insights

  1. How Recent Regulatory & Payer Developments Impact U.S. Biosimilar Access

    In this second installment of a three-part series, industry stakeholders discuss recent developments in the U.S. marketplace from both the regulatory and payer viewpoints, with an emphasis on how these may lead to opportunities for biosimilar manufacturers.

  2. Are You Spending Too Much On Lifecycle Costs?

    Risk-based testing has been in play for several years now.  By design, there is a significant opportunity to avoid many lifecycle costs without creating an adverse impact to quality or processes.  These cost-saving opportunities may not be obvious at first glance, but upon a closer look, they can offer real and tangible savings.

  3. How Many Team Members Does It Take To Determine The Study Status?

    Sitting on one of those long, painful, study status update calls recently, I was reminded of the famous light bulb joke. You know the one: “How many engineers (lawyers, politicians, etc.) does it take to change a light bulb?”  I was both flabbergasted and frustrated that, after 45 minutes, the project manager was still wading through status updates from a myriad of CRO and vendor partners and CRAs — just to figure out where the study was from a site activation and enrollment standpoint.  

  4. Developing Triple-Combination Immunotherapies: Lessons Learned From HIV

    Our body’s immune system appears to be the most effective therapy to fight cancer—more so than chemotherapy, radiotherapy, or any other anti-cancer therapy currently available. However, the immune system is only effective if it can detect cancer cells.

  5. Is Blockchain The Solution To Drug Traceability?

    A few short months ago, the word “blockchain” was seldom mentioned in supply chain circles. Now, it’s not uncommon to be asked what your blockchain strategy is within those same circles. What has changed is its successful use and blockchain platforms adding functionality.

  6. 7 Steps To Properly Navigate An Event Investigation

    All information is good information during an event investigation (EI). It is important that the EI is not performed in a bubble — that it is completed in a safe, blameless environment where the community follows specific steps and procedures, and is focused on finding a root cause of a problem rather than conducting a witch hunt. 

  7. Sampling Preparation & Execution Best Practices For Environmental Monitoring

    The process of establishing a defendable environmental monitoring (EM) sampling plan during performance qualification of a new facility can be broken into six phases. This article will discuss the sampling preparation phase and sampling execution phase.

  8. One And Done: How Bad Is The PI Turnover Problem?

    It’s ruefully referred to throughout the clinical trial industry as the “one and done” phenomenon, and it’s a problem that has plagued us for years. The term refers to physicians and other medical professionals who jump into a trial to assume the duties of principal investigators (PIs). Unfortunately, many are completely or relatively inexperienced in clinical trials; they’ve taken on the role of PI in hope of adding a new revenue stream to their practice or boosting their academic credentials.

  9. Outsourced Manufacturing Considerations For M&A Technical Due Diligence

    When an acquirer purchases a product’s manufacturing rights, that company not only acquires a formula but also a manufacturing process. The manufacturing party can be a pharma company or a CMO.

  10. Address Rare And Respiratory Diseases And Improve Clinical Success With Metabolomics - Part 5

    Breathing is an involuntary reflex action and one of the most basic yet important functions that the body performs. However, for millions who suffer from chronic lung problems and respiratory disease, a single breath is never taken for granted. Certain respiratory diseases are the leading cause of death in the US and include chronic lung problems, such as asthma, bronchitis, and emphysema. In addition, heart attack and accident victims, premature infants, and people with cystic fibrosis and lung cancer suffer from respiratory problems.