BIO From The Editor and Guest Columns

  1. Where EDMS Fails: Data Integrity Pitfalls To Avoid In Metadata For Life Science Products

    When creating and managing electronic documents, document metadata deserves as much attention as document content. Firms that do so can improve compliance and even gain potential competitive advantage by realizing electronic documents (with appropriate metadata) as real business assets.

  2. Harnessing The Hype: Can AI And Other Tech Make Patients Better Faster?

    Artificial intelligence (AI), blockchain technology, predictive analytics, cloud computing, and speech and image recognition are the latest buzzwords across industries. Numerous companies are looking to inject these technologies into their operations, and a great deal of funding is pouring into related startups.

  3. How To Build An FDA Audit-Ready QMS — A Primer

    This article will address the expected roles of quality control and quality assurance, how these roles are related and how they are different, and how they must work together to create a sound quality management system (QMS).

  4. How The EU Influences U.S. Thinking On Biosimilar Interchangeability & Other Policies

    In part 1 of this series, we reviewed the relatively slow uptake experienced by biosimilars in the U.S. and speculated on the role pricing and contracting may play. Additionally, we examined how more vigorous uptake has been encouraged by the EU and how some of those policies appear to be migrating to the U.S. Here in part 2, we will highlight the meaning of the NOR-SWITCH trial results and how the EU’s view of biosimilars as therapeutic alternatives, rather than generics, has influenced U.S. policy.

  5. What’s New In MHRA’s Revised Data Integrity Guidance — A Detailed Analysis

    The Medicines and Healthcare Products Regulatory Agency (MHRA) published a revision to its 2015 Data Integrity Guidance, finalizing the draft revision published for consultation in 2016. The revision was a coordinated effort among the GCP, GDP, GLP, GMP, and GPvP inspection groups, reflecting a broad source of input.

  6. A Tale Of Two Annexes: Analyzing EMA’s Revisions To Annex 1 & 13

    A Tale of Two Cities by Charles Dickens opens with the famous line, “It was the best of times, it was the worst of times,” referring (in part) to the to conditions in the cities of London and Paris before and during the French Revolution. This parallels two annexes recently updated by the European Medicines Agency (EMA) — one avoids the turmoil (Annex 13), while the other undergoes major upheaval (Annex 1).

  7. Biosimilar Discounting & Contracting: What Can The U.S. Learn From Europe?

    Based on our research, the European Union (EU) is 10 years ahead of the United States with respect to biosimilar adoption. It is therefore unsurprising that the EU’s actions and policy decisions are having an impact on the U.S. market. In this two-part series, we will consider multiple facets of the EU’s influence. Part 1 will focus on payer coverage of biosimilars and the role of discounting and contracting. Part 2 will highlight the effects of the NOR-SWITCH trial results and how the EU’s view of biosimilars as therapeutic alternatives, rather than generics, has influenced U.S. policy.

  8. How An Emerging Biopharma Changed Its Supply Chain Methodology — And What It Learned

    When Trevena, Inc. needed to establish a supply chain for its lead compound, OLINVO (oliceridine injection) — a pain-management product expected to make the transition from clinical trial material to full-blown commercial manufacturing — executives at the emerging biopharma decided to try a new framework. Instead of simply relying on decades of collective experience in managing drug supply chains, they augmented that experience with a new set of tools developed by FDA officials and industry professionals under the Xavier University Supply by Design (SbD) Initiative.

  9. The Value Of Standardizing Risk Assessment Across Quality Systems

    Even with the additional effort required and increased complexity, focusing on risk assessment and risk management, and fostering a company culture of continually considering risk, can only improve our overall product quality and sharpen our ability to serve our patients and other stakeholders at the highest level.

  10. Using Lean Strategy To Improve Efficiency In Pharmaceutical QC Labs

    The QC lab is often seen as outside of the pharmaceutical production process, and, as a result, opportunities for improved efficiency and operational excellence are missed.