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.

More From Our Editors

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.

More From Guest Contributors

BIOPROCESSING WHITE PAPERS

  • Securing The Brand Packaging Workflow

    Packaging represents the brand for each product. Shiny surfaces, vibrant colors and immersive designs all serve a purpose to capture the attention of consumers on crowded retail shelves.

  • Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing

    White paper on the risks related to bioburden downstream processing and the solutions available to mitigate these risks. Topics covered include improvements in raw material quality, equipment design, chromatography resin properties, and ways of working.

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • The 5 Common Printed Packaging Errors And How To Prevent Them
    The 5 Common Printed Packaging Errors And How To Prevent Them

    This article examines the five most common sources of printed packaging errors, why they’re likely to occur, and suggestions on how to prevent them.

  • Keeping Your Cool When Storing Purified Protein
    Keeping Your Cool When Storing Purified Protein

    The study of proteins and their function is central to understanding biology, but separating and purifying single proteins from complex mixtures is hard work. After investing the time to purify your target protein using various chromatography methods, losing your protein integrity because of improper storage would be devastating. Good storage conditions are particularly important if you need your protein for several downstream studies. You might need to store your preparation for an extended period of time, and some experiments require that the protein retain its original structure, binding affinity or enzymatic activity. Here we discuss some quick and simple suggestions relating to concentration, additives, sample size and storage temperature to consider when storing your protein for future use.

  • Changes To The Opioid Labeling Regulation
    Changes To The Opioid Labeling Regulation

    FDA is revising warnings and safety information for immediate-release (IR) opioid labeling. The goal is to inform doctors better about the risks of opioids and how to prescribe these drugs safely.

  • Divergent Approaches To Stem Cell Regulation
    Divergent Approaches To Stem Cell Regulation

    Cell-based therapies are a challenge to regulators because they involve withdrawing cells from a patient’s bone marrow, blood or adipose tissue, growing cells in vitro, and then administering in some form the expanded cells population back into the patient.

  • Building An Effective Manufacturing Supply Chain For Biopharma
    Building An Effective Manufacturing Supply Chain For Biopharma

    Precipitated by the need to support a global client base, the challenge to have a robust manufacturing supply chain is more crucial than ever to a company’s survival.

More Industry Insights

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
More Industry Events