Discovery Research Articles

  1. Pharma Might Learn About M&A Integration From The CMO World 6/9/2014

    The urge to merge in the pharmaceutical industry has been strong in 2014. However, the ability to get a deal done and successfully integrate those that transpire is far from guaranteed. This might ring true particularly with the kind of high-profile deals we are seeing recently. Pharma might benefit from some insight into one such deal from the provider side of the business.

    This spring Jim Mullen became CEO of DPx Holdings B.V., formed in a $2.65 billion transaction combining JLL Partners’ assets Patheon and Banner Life Sciences, with Royal DSM’s Pharmaceuticals Products business. Mullen previously held the title of CEO of Patheon. This was a large deal in the service provider sector. In a recent interview with Outsourced Pharma, Mullen walked us through some of the key elements that allowed the deal to transpire.

  2. The Language Of Our Industry 4/21/2014

    True character and the quality of our thoughts are revealed in the way we talk about ourselves and the events in which we participate. We may purposely affect certain patterns of language, but the real thing is sooner or later uncovered.

     

    Or something like that. We also know we have to walk the talk, as the more succinct saying puts it. Considering specifically the language of the contract drug discovery, development and manufacturing industry, in a recent outsourcing survey conducted by contractpharma.com, 75% of respondents said that they would use the word “partnership” to describe their relationship with their contract service providers. That has to be good news for both pharma sponsors and the CROs/CMOs around the world, and points to an improvement in level of service delivered by the latter.

  3. Pharma Research & Development Analysis: CPhI Annual Report 4/7/2014

    CPhI, The world's leading pharamceutical networking evernt, with over 100,000 attendees globally - is now using its collective resourced to create Pharma Insight Reports, analyzing individual parts fo the pharma industry, as well as, creating the well respected and eagerly anticipated Annual Report featuring a global panel of experts. This CPhI Pharma Insights Report examines the current trends in evaluation, adoption and partnering solutions that have been implemented across the industry to drive greater innovations and cost efficiencies.

  4. Communicating R&D Innovations Early And Carefully 3/5/2014

    You would expect a room full of communications, marketing and public relations professionals to be exuberant in their discussion of how to deliver the company message across platforms and generally boast about their brands. While some of that did take place at the 3rd Annual Life Science Brand Reputation and Communications Conference in Atlanta (February 20-21), a lot of the discussion focused on FDA regulations and SEC concerns, and the checks and balances applied to patient, media and investor communications by internal legal and investor relations departments.

  5. Quality by Design: A CMO's Perspective On Gaining Knowledge Faster And Better 11/26/2013

    Although the phrase “QbD” has been thought of as a new or borrowed concept and discussed in terms of feasibility, many CMOs have been using these con-cepts, albeit perhaps not in a well-planned, cohesive manner.

  6. Poster: CMC For 505(b)(2) Applications 4/7/2010
    The Chemistry, Manufacturing, and Control (CMC) Section (Modules 2 & 3 of the Common Technical Document [CTD]) of any application to the FDA will be the cornerstone for demonstrating the quality of any drug product. A clear document that complies with the ICH Harmonized Tripartite Guideline per the ICH Steering Committee Meeting (9 Nov 2000) is instrumental to that process. By Lynn Gold, PhD, Ken Phelps, Kathryn Wekselman, PhD, RN, and Karen Seta-Aust, PhD, Camargo Pharmaceutical Services, LLC
  7. How PATs Improve Bioreactor Performance And Inline Monitoring

    Accurately monitoring process parameters and bioreactor performance while leveraging process analytical technologies can lead to strong improvements in productivity, quality, and process stability.

  8. Your World-Class Biopharmaceutical CDMO

    Rentschler Biopharma provides you a comprehensive expertise in the development of bioprocesses for therapeutic proteins. With our experience and our proven track record of a wide variety of proteins, we support you through all stages of the life cycle of your product.

  9. A Fully Integrated Toolbox For Therapeutic Protein Expression

    The GS Xceed® Gene Expression System is a comprehensive toolbox for development of biologics that has been used to develop not only monoclonal antibodies but also a wide variety of new molecular formats.

  10. Targeting Cancer With Therapeutic Antibodies

    Advancements in mAbs are paving the way for new antibody-based drugs for cancer treatment, making it essential for sponsors to accelerate early development and overcome production challenges.