EDITOR'S DESK

  • FDA Emphasizes Regulatory Flexibility In Biosimilar Reviews
    FDA Emphasizes Regulatory Flexibility In Biosimilar Reviews

    A study recently published in the BJCP go a long way toward providing a clear example of what regulatory flexibility looks like in the EMA. But where does the FDA, which got a late start with biosimilars, stand in terms of regulatory flexibility today?

How To Prepare Your Biosimilar Company For Interchangeability

While attending a recent biosimilars conference, I heard few clear opinions about whether interchangeability will be a beneficial strategy for biosimilar makers. However, in an interview, Pankaj Mohan, CEO of pure-play biosimilar company Oncobiologics, offered a very straight-forward perspective.

3 Lessons From The GPhA Biosimilars Council Conference

This inaugural conference touched upon many of the topics one would expect, including reimbursement, interchangeability, naming, the global markets, and IP challenges. But I felt three overarching topics were particularly worthy of being singled out.

Biobetters: How Much Competition Should Biosimilar Makers Expect?

In the last few weeks, news stories have surfaced reminding the biosimilar industry that biobetters are alive and, for the most part, well. Overall, there are upwards of 500 biobetters in development worldwide. But should the biosimilar industry really be concerned about biobetters quashing the use of biosimilars?

The Norwegian Biosimilar Phenomenon: From Biosimilar To “Biogeneric”

Following the recent Amgen and Sandoz FDA advisory committee meetings, which focused heavily on concerns about “non-medical switching,” Dr. Steiner Madsen’s often frank discussion on how switching contributed to biosimilar uptake in Norway provides reassurance and best practices for global biosimilar makers.

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GUEST CONTRIBUTORS

  • 10 Critical Components Of A Successful Global Drug Development Plan
    10 Critical Components Of A Successful Global Drug Development Plan

    We use plans every day to help us arrive at our desired destinations.  Pilots utilize flight plans prior to take off — although they have flown to their destination perhaps hundreds of times before, they nevertheless reviews and follows a flight plan. Likewise, ship’s captains also file plans and chart courses. Road maps provide guidance on how to drive from point A to point B, though today most people rely on electronic global positioning systems (GPS) to assist with navigation.

  • Best Practices For Measuring System Quality For Drug-Device Combination Products
    Best Practices For Measuring System Quality For Drug-Device Combination Products

    Combination product development is a complex matter governed by different areas of regulatory oversight. In my previous article, we discussed which current good manufacturing practice (cGMP) requirements apply when drugs, devices, and biological products are combined, and the typical pitfalls to avoid when doing so.

  • Opioid Crisis Pushing Changes To U.S. Chronic Pain Drug Market
    Opioid Crisis Pushing Changes To U.S. Chronic Pain Drug Market

    With the U.S opioid analgesic addiction and overdose crisis showing no signs of relenting, change is coming fast for manufacturers of chronic pain drugs.

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BIOPROCESSING WHITE PAPERS

  • 5 Misconceptions About Global Shipping Of Temperature-Sensitive Products

    It’s no secret that drug development has undergone explosive global growth over the last decade. But is there a secret to moving time- and temperature-sensitive products seamlessly across the globe? What are the critical considerations for global specialty logistics — and how do they differ from country to country? Let’s explore five misconceptions about shipping internationally.

  • MVM Resistance Through Genetic Engineering

    Contamination in the manufacturing process can be a rare but catastrophic event costing a company millions per contamination in clean-up costs along. This does not include any loss of revenue due to missed product sales or the impact to the patient population due to loss of drug supply. Even with the use of animal origin free and animal component free systems, there have been recorded contaminations of CHO cells by Minute Virus of Mice (MVM) also called Mouse Minute Virus (MMV).

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • ULD Air Cargo Containers - Quality versus Redundancy – Where’s the Argument?
    ULD Air Cargo Containers - Quality versus Redundancy – Where’s the Argument?

    In the engineering and manufacturing process, we think of a system failure backup as ‘redundant’.   However, in many cases, the development, installation and use of redundant systems can backfire and produce less, not more, reliability.

  • Value Takes Center Stage Amid Excitement Over New Data At Annual Oncology Meeting In Chicago
    Value Takes Center Stage Amid Excitement Over New Data At Annual Oncology Meeting In Chicago

    The world’s leading cancer experts gather today in Chicago for the American Society of Clinical Oncology 51st meeting to explore topics in one of healthcare’s most complex and rapidly evolving therapeutic areas.

    It’s too early to say if there will be any big surprises this year, but looking over the weekend’s schedule, it is obvious that the conference discussion will largely center around pharmaceutical companies developing and launching novel immunotherapies that are changing the landscape in cancer care. This year’s conference also will highlight the companion topics of precision medicine and predictive diagnostics for finding the right patients for these advanced and costly treatments.    

  • The Building Blocks Of A Successful Drug Delivery Device
    The Building Blocks Of A Successful Drug Delivery Device

    Creating a successful drug delivery device requires the seamless integration of the biological or pharmaceutical regulatory requirements with the device regulatory requirements. There are several factors that need to be considered in order to do this, all while ensuring the patient is kept at the center of the design.

  • What Does 'Room Temperature' Mean In Pharmaceutical Storage?
    What Does 'Room Temperature' Mean In Pharmaceutical Storage?

    For those products where ‘room temperature’ storage is a requirement, there is a continuous and ever-increasing demand from a wide variety of regulators for manufacturers to ensure the efficacy of products, previously thought not to need temperature control during transportation, storage and distribution. 

  • As Largest Precision Medicine Trial in Oncology Launches, Questions Remain for Industry
    As Largest Precision Medicine Trial in Oncology Launches, Questions Remain for Industry

    Over the last few days at ASCO, multiple studies have shown the remarkable potential of matching cancer therapeutics to specific gene mutations, demonstrating that we are truly entering an age of personalized medicine in oncology. Despite all of the promise, the conference discussions also covered many questions yet to be resolved – by academic centers and pharmaceutical companies, doctors, patients and those of us working in the lab.

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LIFE SCIENCE INDUSTRY EVENTS

BioNetwork West 2016 October 5 - 7, 2016
Laguna Niguel, CA
Pediatric Clinical Trials: Special Considerations and Requirements October 6, 2016
1pm-2:30pm EDT, Online Training
Biosimilars: Preparing For Opportunities And Challenges October 11, 2016
1pm-2:30pm EDT, Online Training
Airflow Visualization Techniques and Practices October 11 - 12, 2016
Bethesda, MD
Medical Device Design Controls 101 – A Practical Crash Course October 12, 2016
1pm-2:30pm EDT, Online Training
More Industry Events

TRAINING COURSES

Pediatric Clinical Trials: Special Considerations and Requirements October 6, 2016
1pm-2:30pm EDT, Online Training
Biosimilars: Preparing For Opportunities And Challenges October 11, 2016
1pm-2:30pm EDT, Online Training
Medical Device Design Controls 101 – A Practical Crash Course October 12, 2016
1pm-2:30pm EDT, Online Training
The Top Method Validation Mistakes – And How to Avoid Them October 14, 2016
1pm-2:30pm EDT, Online Training
More Upcoming Courses