BIO From The Editor and Guest Columns

  1. What These Two Mottos Must Mean For The Biosimilar Industry
    9/20/2017

    I recently attended the Association for Accessible Medicines (AAM) Biosimilars Council’s Leading on Biosimilars conference.In addition to the many tidbits of knowledge I took away from this event, two terms kept resurfacing throughout the conference I feel are worth delving into more deeply.

  2. Are You Prepared For The EU’s FMD Safety Features Delegated Regulation?
    9/13/2017

    The European Union’s (EU) Falsified Medicines (FMD) Directive 2011/62/EU amends Directive 2001/83/EC to safeguard public health by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines. It also introduces new rules to more rigorously regulate the supply chain.

  3. Pfenex’s New CEO Sizes Up Biosimilar Industry’s Future
    9/11/2017

    Newly-appointed Pfenex CEO, Eef Schimmelpennink, faces the challenge of determining how to adapt Pfenex to a constantly changing future. Though it's still very early in his tenure, Schimmelpennink highlights some areas he will keep in mind as he steers Pfenex's future biosimilars onto the market.  

  4. Validation Of Visual Inspection As An Analytical Method For Cleaning Validation
    9/11/2017

    It has never been clear whether visual inspection is reliable since it has never actually been validated. If it can be validated, then the use of this technique for release of equipment would be justified and might even be used in place of traditional swab methods, which take substantial amounts of time and resources to develop, validate, and perform.

  5. Using Trending As A Tool For Risk-Based Thinking
    9/8/2017

    Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. While the concept of risk management is 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.

  6. Can Biosimilars Increase The Profitability Of Generics Manufacturers?
    9/7/2017

    Generic drug prices are falling. For confirmation, look no further than the recent earnings reports from generic manufacturers and pharmaceutical wholesalers whose profits from distributing generic pharmaceuticals are also declining.

  7. Can New York City Lead In Life Sciences?
    9/7/2017

    New York City has long aspired to become a life sciences hub, but while the city seems to have all the elements necessary to foster such industry growth, it has continually fallen short of this goal. New York currently ranks a distant third behind both Greater Boston and the San Francisco Bay Area, and there’s some work to do if it hopes to catch up.

  8. A Life Cycle Management Approach To Developing A Supply Chain Strategy
    9/6/2017

    Adopting a life cycle management approach will assist in identifying risk factors and constraints and provide structure and control, with a clearly defined methodology to identify and mitigate risk.

  9. Biocontainment: An Intro To Control Levels & Practical Design Concepts
    9/4/2017

    The first part of our design discussion covers various processes and their applicable BSL levels, to understand the risk levels and what types of processes must be contained. Finally, we will provide some practical (and required) design and building concepts that must be integrated into the GMP process to satisfy the FDA and EU.

  10. State Of Serialization: Where FDA & The Pharma Industry Currently Stand
    9/1/2017

    Serialization in the pharmaceutical sector is a direct response to the problems of counterfeit, stolen, and gray-market drugs. There's been a huge incentive for counterfeiters to duplicate high-profit-margin products. According to the 2016 Brand Protection and Product Traceability Market Research Report from PMMI, the black market for counterfeit drugs is about $75 billion annually.