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 Should I Respond To This FDA Warning Letter? (And Other Compliance Questions Answered)
    How Should I Respond To This FDA Warning Letter? (And Other Compliance Questions Answered)

    Success in developing a drug product, medical device, or drug substance requires navigating the tradeoffs and decisions of today's complex global regulatory realm. Some of the most common questions about compliance concern dealing with the FDA 483 list of inspection observations, warning letters, and consent decrees following FDA regulatory action. [Online name] posed some important questions about warning letter responses and remediation — and other important regulatory issues — to Richard Aleman, VP of regulatory compliance at Pharmatech Associates. Aleman has an insider’s view on these issues, having spent 28 years at the FDA in both the field and headquarters organizations, specializing in biopharmaceuticals, drugs, and medical devices.

  • 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?

    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.

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15th Annual Global Forum September 25 - 29, 2017
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The HireLifeScience.com Career Fair 2017 September 26, 2017
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Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner September 28, 2017
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