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

  • How To Catalyze & Sustain Continuous Improvement In Pharmaceutical Operations
    How To Catalyze & Sustain Continuous Improvement In Pharmaceutical Operations

    While other industries have learned from the principles of quality and statistical control methodology, (bio)pharma has been slow on the uptake. This article proposes tactic designs that utilize collaboration tools to facilitate Kaizen/continuous improvement in quality management systems (QMSs).

  • Integrated Delivery Networks & The Future Of Drug Development
    Integrated Delivery Networks & The Future Of Drug Development

    Integrated delivery networks (IDNs) were among the earliest adopters of Medicare accountable care organization (ACO) programs. The Centers for Medicare and Medicaid Services (CMS) releases results specific to these programs on an annual basis, creating opportunities for new drug development.

  • 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

    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

    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.

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BIOPROCESSING WHITE PAPERS

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INDUSTRY INSIGHTS

  • 5 “No-Cost Strategies” For Your Laboratory Project
    5 “No-Cost Strategies” For Your Laboratory Project

    The list is a guide to identifying practical strategies and making a project successful from inception to the operations and facility life-cycle by incorporating more science into less space, reducing utility usage, and using innovative concepts.

  • Reducing Upstream Processing Scale-Up Risks Using QbD
    Reducing Upstream Processing Scale-Up Risks Using QbD

    Upstream process must be robust to ensure high batch success rates with a low risk of contaminations and minimal variations in cell growth performance.

  • From Outsourcing To Partnership
    From Outsourcing To Partnership

    A recent survey by the Economist Intelligence Unit questioned biopharma industry leaders about their plans and concerns for the future. Along with excitement over expanding into novel therapies and emerging markets, they expressed serious concerns about risk mitigation. To combat risk, they raised the potentially contradictory options of building internal capacity and using outside experts. We spoke with Sebastien Ribault – Director of the MilliporeSigma BioDevelopment Center – to get his take on this duality and how it’s changing the nature of partnership.

  • Tips On Downstream Purification Processes
    Tips On Downstream Purification Processes

    Once protein purification work surpasses a certain scale in terms of volume, a measured and step-wise development of the bioseparation process is vital.

  • Implementing A Total Quality Strategy In Life Sciences
    Implementing A Total Quality Strategy In Life Sciences

    According to over 200 life sciences companies surveyed, the number one challenge in speeding products from R&D to patients is quality management, which may surprise many executives that have spent the past decade focused on other issues like validation, regulatory, or supply chain.

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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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