EDITOR'S DESK

  • DIA Biosimilars Conference Reveals “More Questions Than Answers”
    DIA Biosimilars Conference Reveals “More Questions Than Answers”

    During the DIA Biosimilars 2017 conference, there were three topics of discussion that, arguably, could remove barriers to biosimilar development and advance it. But a phrase that was regularly used over the two days highlights one of the biggest issues standing in front of this industry: “There are more questions than answers.”

Pfizer’s Cultural Evolution To “Tell The Biosimilar Story”

Pfizer's Tracy Dianis presents a candid look into the cognitive and cultural transition that needed to occur in her own mindset, as well as within Pfizer, in order to embrace biosimilar development.

Biosimilar Regulatory Best Practices: Don’t Fear Exploration

In the first of this two-part article, Sandoz's Cindy Cao shares lessons learned from working with the FDA and reveals that there is still a lot of room for exploration and innovation in biosimilar development.

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.  

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GUEST CONTRIBUTORS

  • 7 Surefire Ways To Motivate A Life Science Consultant
    7 Surefire Ways To Motivate A Life Science Consultant

    Consultants play a significant role in the pharmaceutical, biopharmaceutical, vaccine, and medical device industries. They are experienced resources in crisis situations; when new facilities are being installed; under circumstances requiring technical expertise; and during regulatory emergencies, remediations, consent decrees, and other planned and unplanned situations. Problems often occur between clients and consultants, and both contribute to them. Motivational enablers/drivers increase the probability that a project will be completed successfully, provided the consultant acquires their own motivational abilities coupled with experience that meets the project requirements.

  • Emerging Best Practices For Contamination Management In Pharmaceutical Manufacturing
    Emerging Best Practices For Contamination Management In Pharmaceutical Manufacturing

    Despite quality audits and third-party oversight, contamination of prescription and over-the-counter (OTC) pharmaceutical products is still prevalent. This is despite the adoption of cGMP practices, SOPs, risk mitigation methods, and metrics such as key performance indicators. We evaluated various emerging practices to overcome contamination issues. Novel batch concentration tests and dedicated capacity utilization have proven to overcome the source of contaminants. For technology adoption in continuous manufacturing, which is unclear in terms of compliance, the FDA Emerging Technology Team could be used for advisory oversight.

  • The Complex Litigation Surrounding Remicade And Its Biosimilar Challengers
    The Complex Litigation Surrounding Remicade And Its Biosimilar Challengers

    Control of the Remicade and biosimilar market is being aggressively contested by Janssen, J&J, Celltrion, Hospira, and Pfizer. This article discusses the legal issues being decided in each of the federal court cases surrounding Remicade.

  • Big Data Vs. Small Data: What’s The Proper Prescription For You?

    This article will explain what Big Data and small data are, build your fluency with the benefits and risks of each, and provide recommendations to improve our data-rich future.

  • When And How To Implement Data Integrity Practices In The Product Development Lifecycle

    Data integrity is frequently discussed in many industries. It is more formally defined within the life sciences industry through regulation (e.g., current good manufacturing practices [cGMPs], good laboratory practices, good clinical practices, the application integrity policy) and in guidance documents from health agencies, including the FDA and WHO. These regulations set the expectations for companies to ensure data integrity and traceability by establishing and monitoring the effectiveness of their quality systems.

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BIOPROCESSING WHITE PAPERS

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • How To Avoid 5 LIMS Nightmares
    How To Avoid 5 LIMS Nightmares

    Analysts have estimated the failure rate of commercial laboratory information management systems (LIMS) to be as high as 60 percent with many of them failing to deliver original customer requirements after lengthy and expensive deployments.

  • Making Novel Therapies A Reality Part 1
    Making Novel Therapies A Reality Part 1

    Cell therapy, gene therapy, and RNA-based therapies. Right now, those are the classes of therapies we’re considering novel. If you look at it historically, ten years ago, recombinant proteins and monoclonal antibodies would have been novel therapies, but now they’ve become very much standardized. So now that bar has moved a little bit, and the novel therapies are really cell and gene therapies, and to a certain extent the RNA therapies.

  • Personalized Medicine - Diagnostics Will Lead The Way
    Personalized Medicine - Diagnostics Will Lead The Way

    We have been talking about Personalized Medicine for years. "Wouldn't it be better if the medicine that I was taking was designed just for me?" We all know that personalized medicine would greatly benefit individual patients. 

  • Tips For Performing Preparative Chromatography And Protein Purification
    Tips For Performing Preparative Chromatography And Protein Purification

    This articles provides some fundamental tips and tricks to preparative chromatography that will yield a pure sample preparation that will advance protein characterization studies.

  • Ensuring Bar Code Accuracy From Packaging To The Patient
    Ensuring Bar Code Accuracy From Packaging To The Patient

    For pharmaceutical companies, a barcode helps to assure the origins of the drugs, which in turn helps in minimizing the possibility of a genuine drugs being considered sub-standard or counterfeit.

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LIFE SCIENCE INDUSTRY EVENTS

Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings November 28, 2017
1pm-2:30pm EST, Online Training
The Top Method Validation Mistakes – And How to Avoid Them November 29, 2017
1pm-2:30pm EST, Online Training
Quality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle December 6, 2017
1pm-2:30pm EST, Online Training
Auditing Validated Computer Systems In A GxP Environment December 12, 2017
1pm-2:30pm EST, Online Training
Building An Effective GMP Training System: A Risk-Based Approach December 19, 2017
1pm-2:30pm EST, Online Training
More Industry Events

TRAINING COURSES

Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings November 28, 2017
1pm-2:30pm EST, Online Training
The Top Method Validation Mistakes – And How to Avoid Them November 29, 2017
1pm-2:30pm EST, Online Training
Quality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle December 6, 2017
1pm-2:30pm EST, Online Training
Auditing Validated Computer Systems In A GxP Environment December 12, 2017
1pm-2:30pm EST, Online Training
Building An Effective GMP Training System: A Risk-Based Approach December 19, 2017
1pm-2:30pm EST, Online Training
More Upcoming Courses