Contributing Editors

  1. What Value-Based Reimbursement Means For Drug Development

    Pharmaceutical reimbursement historically has largely been a process of first determining the efficacy and safety profile of a therapy and then deciding its ultimate coverage level based on its price. But now, payers are taking a cue from their European peers and beginning to do the sophisticated number-crunching and cost-effectiveness studies to take a more holistic approach to drug coverage.

  2. Using Risk-Based Thinking To Manage Nonconformances And Deviations

    Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system (QMS) is the integration of risk-based thinking. While the concepts of risk-based thinking and management are not new, previous practice was more reactionary, primarily focusing on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.

  3. 7 Surefire Ways To Motivate A Life Science Consultant

    Consultants play a significant role in the pharmaceutical, biopharmaceutical, vaccine, and medical device industries. They are experienced resources in crisis situations; when new facilities are being installed; under circumstances requiring technical expertise; and during regulatory emergencies, remediations, consent decrees, and other planned and unplanned situations. Problems often occur between clients and consultants, and both contribute to them. Motivational enablers/drivers increase the probability that a project will be completed successfully, provided the consultant acquires their own motivational abilities coupled with experience that meets the project requirements.

  4. Emerging Best Practices For Contamination Management In Pharmaceutical Manufacturing

    Despite quality audits and third-party oversight, contamination of prescription and over-the-counter (OTC) pharmaceutical products is still prevalent. This is despite the adoption of cGMP practices, SOPs, risk mitigation methods, and metrics such as key performance indicators. We evaluated various emerging practices to overcome contamination issues. Novel batch concentration tests and dedicated capacity utilization have proven to overcome the source of contaminants. For technology adoption in continuous manufacturing, which is unclear in terms of compliance, the FDA Emerging Technology Team could be used for advisory oversight.

  5. Big Data Vs. Small Data: What’s The Proper Prescription For You?

    This article will explain what Big Data and small data are, build your fluency with the benefits and risks of each, and provide recommendations to improve our data-rich future.

  6. When And How To Implement Data Integrity Practices In The Product Development Lifecycle

    Data integrity is frequently discussed in many industries. It is more formally defined within the life sciences industry through regulation (e.g., current good manufacturing practices [cGMPs], good laboratory practices, good clinical practices, the application integrity policy) and in guidance documents from health agencies, including the FDA and WHO. These regulations set the expectations for companies to ensure data integrity and traceability by establishing and monitoring the effectiveness of their quality systems.

  7. Tech Transfer Project Management Best Practices

    When I first became a project manager, it did not take long to realize the pain associated with a lack of resource availability and cross-functional cooperation. This includes a lack of direct project support from functional areas and having the project work low on their priority lists. There simply had to be a better way for the teams to succeed.  A few years later, I became a PMP (project management professional) and then grew into the manger of project management role.

  8. Best Practices For Managing Clinical Supply Inventory

    It is critical to maintain patients on drug supplies during clinical trials, both for the success of the study and for the health of the patient. In this second part of this series on ensuring adequate drug supply, we will look at some specific strategies for successfully managing the clinical supply inventory.

  9. Pharma 4.0: A New Framework & Process For Digital Quality Management

    A little over 10 years ago I wrote an article urging our industry and the FDA to truly embrace the 2004 FDA guidance and the shift to scientific understanding as a basis to ensure product quality, safety, and effectiveness. Up until this landmark guidance, the industry had operated under the assumption that inspection and testing could ensure the suitability of products for the marketplace. The quality struggles related to the rapid global expansion of the supply chain revealed the foresight of this fundamental change, which opened a way forward to remaining competitive while ensuring safe and efficacious products.

  10. Data Integrity & Your Contract Manufacturer — Common Pitfalls To Avoid

    Francis Goodwin, director of the FDA’s Division of Drug Quality II, Office of Manufacturing Quality, Office of Compliance, spoke about enforcement trends at the Parenteral Drug Association (PDA)/FDA Regulatory Conference in September. He addressed warning letters, import alerts, and regulatory discretion activities. Let’s focus on warning letters, where the top concerns he presented were data integrity and contract manufacturing. His presentation identified that more than five warning letters issued in 2017 were issued to firms operating in this space, either as contracted facilities, product owners, or both.