Guest Columns

  1. How To Ace Your Next CDMO Capabilities Audit
    6/18/2019

    A capabilities audit is an integral part of a sponsor's due diligence in vendor procurement. It is often the sponsor’s first exposure to a CDMO’s operations, and the primary objectives are to evaluate the facility, equipment, quality systems, and the expertise of each functional team in relation to the specific needs of the project.

  2. Developing Optimal Pharmaceutical Quality Control Strategies
    6/14/2019

    How can the industry improve the quality of its products? The first tactic could be to increase the frequency of vendor inspections, using internal quality control programs to inspect suppliers to assure compliance with the necessary supply agreements and adherence to appropriate manufacturing practices, including GMPs.

  3. Leveraging AI To Assess Clinical Trial Technologies
    6/13/2019

    As part of our ongoing series detailing an approach for the rapid assessment and prototyping of digital and other clinical trial technologies, we introduce here the use of artificial intelligence (AI) and machine learning (ML) to optimize clinical study design and execution. 

  4. Are Biopharma's Strong Pipeline Innovations Reaching Patients?
    6/13/2019

    The number of new chemical entities gaining FDA approval more than doubled from 2017 to 2018. Global R&D spending increased 3.5%. The pipeline is strong, but how many innovations are actually reaching patients?

  5. Latin America Offers Welcoming Entry Market Amid Tighter EU Regulations
    6/12/2019

    In the past, regulatory requirements that were laxer than U.S. rules made the EU almost a no-brainer as an entry market for many medtechs. However, the advent of the MDR and IVDR has tightened EU regulations and added implementation challenges. Are Latin American markets the answer?

  6. What To Do When Your CDMO Receives A Warning Letter
    6/11/2019

    You have just completed a full technical transfer to a CDMO for your commercial drug product. This has been a two-year program and you are gearing up to launch the opening campaign. Then, the regulatory team from the CDMO alerts you that it has been issued a warning letter by the FDA.

  7. How Amgen Is Taking An Adaptive Approach To Clinical Trials
    6/11/2019

    Clinical research is sometimes viewed as a box-checking exercise, where we run fairly cut-and-dried randomized, placebo-controlled studies based on long-established protocols. But things are actually changing very rapidly in the world of clinical development, which is by far the largest part of pharma R&D spending. We are on the threshold of a transformation that will allow us to dramatically accelerate the acquisition of useful knowledge, get new medicines to patients sooner, and expand their usage to new indications more quickly.

  8. Trends In Single-Use System Adoption In The Biopharma Industry
    6/10/2019

    Upstream bioprocessing at large and commercial scales is projected to be the fastest growing segment of the single-use equipment market as products now in development using SUS move up to commercial manufacturing. In addition, as cellular and gene therapies emerge, we will likely see SUS technologies created and adapted explicitly for these personalized applications.

  9. Understanding China’s Updated Overseas Inspections: A Q&A with Gert Bos and Michael Yan
    6/10/2019

    China’s National Medical Products Administration (NMPA) has stepped up overseas inspections in recent years, and manufacturers looking to market products in China must be prepared for potential visits from Chinese inspectors.

  10. 7 Tools For Breakthrough Quality And Performance In 30 Days
    6/7/2019

    In this sixth installment on the selection and use of quality improvement tools in your organization, Ben Locwin wraps up the series with a treatise on the 7 Tools of Quality.