PHARMA OUTSOURCING ARTICLES

  •  What Outcomes-Based Contracting Means For Drug Development & Drug Pricing
    What Outcomes-Based Contracting Means For Drug Development & Drug Pricing

    The mounting public outcry over drug prices — fueled by dramatic increases in cost for a few high-profile, older, life-saving drugs — has put intense pressure on the pharmaceutical industry to lower list prices and curtail price increases or face government controls.

  • The Small Pharma–CDMO Marriage: How We Can Make It Even Better
    The Small Pharma–CDMO Marriage: How We Can Make It Even Better

    Unlike Big Pharma, which may outsource internally developed processes and formulations, small and midsize pharma/biotech firms are dependent on contract development and manufacturing organizations (CDMOs) for much of their product development and GMP manufacturing activity.

  • Timeline And Developmental Activities When Resources Are Limited
    Timeline And Developmental Activities When Resources Are Limited

    It is increasingly rare that early-stage compounds or platform technologies are acquired without demonstration of clinical effect. Many years ago you could get funding for an idea, a piece of data, or a novel platform. With little exaggeration, funding could be generally raised as long as there was promise and the ability to tell a story, or until the concept was fully disproven.

  • For Outsourcing, Make Sure Your Risk Management Is Redundant
    For Outsourcing, Make Sure Your Risk Management Is Redundant

    Many biotechnology and pharmaceutical companies are struggling with what I call the “sourcing dilemma”: How do I achieve redundancy in my supply chain while keeping costs down and incentivizing my primary suppliers — whether internal or external? Redundancy is expensive, it consumes precious time and resources, and it distracts your team from driving all-important development milestones.

  • Guidance & Predictions From New Outsourcing Advisory Board Members
    Guidance & Predictions From New Outsourcing Advisory Board Members

    The following are new leaders on the Outsourced Pharma Editorial Advisory Board, and they’re not hesitant to provide bold analysis on outsourcing drug development and manufacturing.

  • Are CMOs Sufficiently Serving Biotechs?
    Are CMOs Sufficiently Serving Biotechs?

    In the summer of 2016, Louis Demers brought his outsourcing experience — including at a J&J company and Genentech — to the newly created role of director of development and manufacturing outsourcing at XOMA, a drug discovery and development company with a portfolio of innovative therapeutic antibodies. His mission: Turn this historically self-reliant biotech into a reliable outsourcer.

  • Outsourcing 2017: Countries, Costs, & Some Concerns
    Outsourcing 2017: Countries, Costs, & Some Concerns

    A renewed crossing into Asia or U-turn back to Europe and the U.S.? Thoughts of capacity and costs running over filling your head these days? Perhaps some of the following comments from Outsourced Pharma editorial board members will help answer some of the questions you have regarding outsourcing in 2017.

  • An Outsourcing Challenge: Creating A Knowledge Base With Legacy Value
    An Outsourcing Challenge: Creating A Knowledge Base With Legacy Value

    At risk of speaking about an overdiscussed topic, knowledge management continues to be a challenge at the interface between sponsors and CDMOs.

  • Pharma Industry Lacks Consensus On Key Attribute Of A Sponsor-CMO Relationship
    Pharma Industry Lacks Consensus On Key Attribute Of A Sponsor-CMO Relationship

    Over the past several decades, the practice of outsourcing has evolved from transactional, client-vendor relationships where cost savings were the primary focus, to preferred provider relationships with pre-vetted companies to start up projects quickly and then to relationships more strategic in nature to gain access to technologies, skills, or expertise not possessed in-house.

  • Harmonizing Quality Management Systems In Early Drug Development
    Harmonizing Quality Management Systems In Early Drug Development

    Today, most biopharma development programs include the support of a contract service provider (CSP) for everything from early development contract research to commercial manufacturing and analytical support. The factors that drive the decision to engage a CSP for commercial manufacturing are many, and there are multiple collaboration elements that impact organizations’ ability to work together effectively.

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