EDITOR'S DESK

  • What These Two Mottos Must Mean For The Biosimilar Industry
    What These Two Mottos Must Mean For The Biosimilar Industry

    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.

Pfenex’s New CEO Sizes Up Biosimilar Industry’s Future

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.  

The Evolving Landscape Of Biosimilar Risk Management Programs

In a presentation at the 2017 World Biosimilars Congress, Asif Mahmood, disease area safety and strategy lead at Pfizer, shed some light on global risk management strategies and the challenges of launching these programs.

The Evolution Of Russia’s Biosimilar Regulatory Pathway

In a recent article, I discussed the market opportunities and reimbursement system in Russia. But in addition to this snapshot of the market, my conversation with BIOCAD's Roman Ivanov highlighted how the Russian biosimilar regulatory system was established, as well as the challenges BIOCAD has faced during it evolution.

Russia’s Biosimilar Market At A Glance

After my discussion with BIOCAD's Roman Ivanov, it’s clear the Russian biosimilar market is a prime example of the positive impact biosimilars can have on a nation. However, Russia's biosimilar market has evolved quite differently than those of the EU and U.S.

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GUEST CONTRIBUTORS

  • Are You Prepared For The EU’s FMD Safety Features Delegated Regulation?
    Are You Prepared For The EU’s FMD Safety Features Delegated Regulation?

    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.

  • Validation Of Visual Inspection As An Analytical Method For Cleaning Validation
    Validation Of Visual Inspection As An Analytical Method For Cleaning Validation

    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.

  • Using Trending As A Tool For Risk-Based Thinking
    Using Trending As A Tool For Risk-Based Thinking

    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.

  • Can Biosimilars Increase The Profitability Of Generics Manufacturers?

    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.

  • Can New York City Lead In Life Sciences?

    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.

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BIOPROCESSING WHITE PAPERS

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INDUSTRY INSIGHTS

  • Biosimilar Developers Must Scale Mountains of Data
    Biosimilar Developers Must Scale Mountains of Data

    The U.S. FDA approved Sandoz’s filgrastim product, Zarxio, a biosimilar of Amgen’s Neupogen. This was a big step for the Agency, and one some feel was long in coming. The same product was approved for marketing in Europe six years earlier (under the name Zarzio).

  • Which Test Is Appropriate For Container Closure Integrity?
    Which Test Is Appropriate For Container Closure Integrity?

    Validation of container integrity must demonstrate no penetration of microbial contamination or gain or loss of any chemical or physical parameter deemed necessary to protect the product.

  • Which Laboratory Software Is The Right One For Your Lab?
    Which Laboratory Software Is The Right One For Your Lab?

    To ensure that your requests for specific software and systems receive full consideration, it pays to fully understand the types of lab management software available.

  • Applying QRM To The Change Control Process
    Applying QRM To The Change Control Process

    Since the publication of ICH Q9: Quality Risk Management in 2005 (1), there has been much written about the application of risk management to the production process, product development and validation (2–5). Relatively little has been published about its application to some of production’s supporting processes that comprise an important part of the pharmaceutical quality system (PQS).

  • Freezing Down Time In Bioprocessing
    Freezing Down Time In Bioprocessing

    Can high density cryopreservation allow biopharma manufacturers to buy back time? The answer is “yes” – and specialized media (both catalogue and customized) for perfusion processes are being designed for this purpose.

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LIFE SCIENCE INDUSTRY EVENTS

15th Annual Global Forum September 25 - 29, 2017
Chicago, IL
The HireLifeScience.com Career Fair 2017 September 26, 2017
Edison, NJ
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner September 28, 2017
1pm-2:30pm EDT, Online Training
Organizational Strategies for Reducing Human Error in GMP Environments October 3, 2017
1:00 - 2:30 PM EDT, Online training
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