EDITOR'S DESK

  • Should Your Biosimilar Really Be A Biobetter?
    Should Your Biosimilar Really Be A Biobetter?

    A few months ago, Eagle Pharmaceuticals agreed to acquire Arsia Therapeutics.This move will help Eagle partner with biosimilar companies to turn biosimilar candidates into biobetters. As Eagle CEO Scott Tarriff describes, the company’s business model of reformulating and improving existing small molecules is well-suited to the biologics space — especially considering his expectations of how the biosimilar space will play out.

Celltrion: Data Transparency Imperative For Biosimilar Success

Over the past year, the biosimilar industry has developed two mantras: “education, education, education,” and “strategy, strategy, strategy.” But after my conversation with HoUng Kim, the head of the strategy and operations division for Celltrion Healthcare, I’d like to add another mantra to this list: “data, data, data.”

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.

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GUEST CONTRIBUTORS

  • Overcoming The Manufacturing Hurdles Of Cell & Gene Therapy
    Overcoming The Manufacturing Hurdles Of Cell & Gene Therapy

    A number of innovative cellular and gene therapies are in development, and R&D and investments in these fields are rapidly growing. Although the number of approvals and markets remain very small — negligible by the standards of the mainstream (bio)pharmaceutical industry — this is likely to change as the first clinical trials are successfully concluded.

  • 7 Steps To Navigate Six Sigma’s “Improve” Phase
    7 Steps To Navigate Six Sigma’s “Improve” Phase

    In this series, we’ve covered quite a bit of ground in providing a working understanding of Six Sigma and its DMAIC (Define, Measure, Analyze, Improve, Control) roadmap for problem solving and product/process improvement.

  • Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances
    Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances

    Over the past 10 years, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued new and revised regulations and guidances in an attempt to define, clarify, and modernize their requirements. Ideally, these documents would have aided industry in developing new products that take advantage of new technologies, given budget and personnel limitations in both the regulatory agencies and industry. And in fact, many of these documents have proposed or emphasized radical changes in strategy and operations, but unfortunately such changes are often met with skepticism and concern by industry.

  • Launching A New Drug In A Maturing Market — Lessons Learned From Recent COPD Entrants

    Chronic obstructive pulmonary disease (COPD), a global growth market worth well over $15 billion in the U.S. and EU5 in 2016, has long represented a lucrative opportunity for drug manufacturers. However, the proliferation of treatments and increasing number of generics have begun to limit the potential for emerging therapies. A review of the successes and stumbles of the newest class of drugs (LABA/LAMA fixed-dose combinations) illustrates broader lessons manufacturers should consider when launching into a rapidly maturing market.

  • Brexit, Trump, What Next? 6 Rules To Succeed In An Era Of ‘Brutal Disruption’

    Heard the latest? Elvis is alive and kicking and planning a comeback.  Only kidding … but who knows? After the events of 2016, anything is possible.

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BIOPROCESSING WHITE PAPERS

  • The Future of BioManufacturing

    The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.

  • Checklist For Multivariate Analysis Best Practice

    You are unlikely to create the final model in your first attempt. Use the power of multivariate analysis to select interesting samples based on the instrumental measurements before you put them through the lab.

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • Single-Use Technology And Sustainability: Quantifying The Environmental Impact
    Single-Use Technology And Sustainability: Quantifying The Environmental Impact

    As this shift to SUT continues, there is both an opportunity and an obligation to understand the sustainability impacts of that shift.

  • 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.

  • Understanding Analytical Method Validation

    During my years in analytical development science at biotechnology companies including Celera and Genentech, it became routine to develop analytical assays to test products such as proteins, monoclonal antibodies, recombinant protective antigen, DNA, RNA, etc. These tests were predominantly developed on high performance liquid chromatography (HPLC), mass spectroscopy (MS), DNA sequencers, and other state-of-the-art techniques.

  • Shift From Central Lab To POC
    Shift From Central Lab To POC

    As new technologies work to change the market space, this article takes a look at the market forces that are helping and hindering the shift to zero wait time for patient test results. Comprehensive analysis of both test settings allows for better understanding of the diagnostic landscape as it exists today, offering insight to both product and process innovations for your next generation product.

  • The Standardization Of Single-Use Components For Bioprocessing
    The Standardization Of Single-Use Components For Bioprocessing

    As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization. While the standardization discussion encompasses many topics (including how products are tested, assembled, etc.), components are a critical area for improvement. With so many ways to apply single-use and hybrid bioprocessing systems, organizations must take action to standardize equipment in order to streamline operations and help reach the full potential of the technology.

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LIFE SCIENCE INDUSTRY EVENTS

Communication With FDA: What Do We Say And How Do We Say It? February 23, 2017
1pm-2:30pm EST, Online Training
Laboratory Data Integrity: Current Expectations for OOS Result Investigations February 24, 2017
1pm-2:30pm EST, Online Training
CRO Oversight: Risk Assessment & Action Planning March 1, 2017
1pm-2:30pm EST, Online Training
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TRAINING COURSES

Communication With FDA: What Do We Say And How Do We Say It? February 23, 2017
1pm-2:30pm EST, Online Training
Laboratory Data Integrity: Current Expectations for OOS Result Investigations February 24, 2017
1pm-2:30pm EST, Online Training
CRO Oversight: Risk Assessment & Action Planning March 1, 2017
1pm-2:30pm EST, Online Training
More Upcoming Courses