EDITOR'S DESK

  • Top 5 Biosimilar Developments Of 2016
    Top 5 Biosimilar Developments Of 2016

    In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.

Health Canada’s Unique Approach To Biosimilar Regulation

Health Canada recently released its revised guidance document on biosimilar submission requirements. Though the revisions were primarily “clarifications,” not major policy changes, some of these amendments provide a glimpse into the more unique aspects of Canada’s relationship with biosimilars.

The Case For Moving The EMA To Ireland

Relocating an organization as large as the EMA, which employs upwards of 1,000 people in London, will be no easy feat. As such, IDA Ireland, an agency that supports companies in Ireland and promotes foreign direct investments in the country, is working to compile information on why Ireland would be a good location for the EMA.

Congress Takes On Biosimilars

During an interview at a briefing held by The Atlantic and The Biosimilars Council, Senator Bill Cassidy of Louisiana presented some valuable insights into where he believes more work needs to be done to ensure biosimilars’ market success.

FDA Stresses Scientific Alignment, Not Harmonization For Global Biosimilars

In most cases, the biosimilar guidelines put forth by all the major regulatory agencies are quite similar. But there are some differences that can challenge companies looking to have their biosimilars approved in these different countries. 

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GUEST CONTRIBUTORS

  • The Role Of Human Performance Tools & Just Culture In Biopharma Operations
    The Role Of Human Performance Tools & Just Culture In Biopharma Operations

    The behavior of the people within an organization can be the least predictable part of the business. While the pharmaceutical and biotech industry has been successful in incorporating lean and Six Sigma principles to increase operational and system efficiency, there has been a lack of similar gain demonstrated when dealing with human behavior and human error.

  • U.S. DoD Opens Advanced Biologics Manufacturing Facility For Private, Public Use
    U.S. DoD Opens Advanced Biologics Manufacturing Facility For Private, Public Use

    The U.S. Department of Defense recently opened the Medical Countermeasures Advanced Development and Manufacturing (MCM ADM) facility — the first dedicated advanced manufacturing facility capable of developing and making biological (and small-molecule) products to protect service members who may be exposed to biological weapons or natural threats. 

  • An Analysis Of FDA FY2016 Drug GMP Warning Letters
    An Analysis Of FDA FY2016 Drug GMP Warning Letters

    This article presents a detailed summary of the drug GMP warning letters issued by FDA in FY2016, as well as a comparison of trends in this area since FY2013. Monitoring publicly available enforcement actions and trends as part of a comprehensive GMP intelligence program is crucial, because FDA expects firms to monitor these actions and correct similar deficiencies at their site(s).

  • 4 Major Trends In Pharmaceutical Packaging

    There are few better places to learn more about the state of an industry than a trade show. This past November’s Pharma EXPO, co-located with PACK EXPO International 2016 at Chicago’s McCormick Place, offered a firsthand look at some of the changes and new trends that are shaping the drug industry — including new serialization technologies and inspection technologies. Additionally, new processing equipment is being developed to handle the novel biological formulations and personalized medicines that are becoming more prevalent in today’s market. This article will discuss some of the important industry trends I observed on the show floor.

  • Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare

    If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity.

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BIOPROCESSING WHITE PAPERS

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INDUSTRY INSIGHTS

  • Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies
    Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies

    There are many reasons to be excited by the science being presented at this year’s American Society for Clinical Oncology meeting. The data presented at a special section on Saturday morning opened the door to a future when tumor genetics and biomarkers will change the way we think of about cancer treatment. As a physician working in clinical development, there is also the excitement around intriguing new questions that when answered could lead to life-saving treatments unimaginable just a decade ago. 

    More than 2,000 people packed into a cavernous conference hall at 8 a.m. on Saturday – demonstrating the high level of shared interest in emerging immunotherapies.  

  • 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.

  • The Multivariate World Is Expanding For Research And Industrial Data Analysis
    The Multivariate World Is Expanding For Research And Industrial Data Analysis

    The field of chemometrics has been around for quite some time now and has played its role in both research and industrial environments. While the multivariate research toolbox is well established and ever increasing, its industrial counterpart is only beginning to see widespread use in the last decade.

  • How Big Data Is Transforming Pharmaceutical Manufacturing
    How Big Data Is Transforming Pharmaceutical Manufacturing

    Pharmaceutical manufacturers now have the ability to analyze massive amounts of quality, environmental, and IoT-generated factory data, which enables them to build end-to-end process controls — resulting in higher-quality products, more predictability, more efficient manufacturing, and faster time to market.

  • Integrating Quality Control Tools Into Print Workflow Automation Solutions
    Integrating Quality Control Tools Into Print Workflow Automation Solutions

    For print professionals, the complexities of labeling and packaging can present numerous challenges. Ask any member of a prepress department and they will tell you that artwork must be right the first time and every time. Even a simple mistake has the potential to be catastrophic, resulting in product recalls, fines, write-offs and potential lawsuits.

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LIFE SCIENCE INDUSTRY EVENTS

cGMP Compliance - Understanding The Top Drug Enforcement Trends January 24, 2017
1pm-2:30pm EST, Online Training
The Investigational New Drug (IND) Submission - Tips to Win the First Time January 25, 2017
1pm-2:30pm EST, Online Training
Data Integrity - Detecting & Mitigating Risk January 26, 2017
1pm-2:30pm EST, Online Training
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TRAINING COURSES

cGMP Compliance - Understanding The Top Drug Enforcement Trends January 24, 2017
1pm-2:30pm EST, Online Training
The Investigational New Drug (IND) Submission - Tips to Win the First Time January 25, 2017
1pm-2:30pm EST, Online Training
Data Integrity - Detecting & Mitigating Risk January 26, 2017
1pm-2:30pm EST, Online Training
More Upcoming Courses