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Biopharmaceutical Practice Regulatory

Our Regulatory services are designed to help biopharmaceutical companies to solve complex regulatory challenges, as well as reduce risk and expedite the development process, by applying a premier level of expertise to every client engagement.

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Case Studies
Articles
Blog
  • Diagnostics Partnering Support

    Situation: An emerging oncology diagnostics company was in need of a Business Development strategy and retained Kineticos to develop such

     

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  • Voice of Customer Study

    Situation: A joint venture between two European companies was looking to maximize the commercial potential of its automated plate reader

     

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  • Go-To-Market Strategy

    Situation: As a follow up to a pricing study, Kineticos was retained by a specialty laboratory to develop a comprehensive

     

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  • Oncology Commercial Assessment – Melanoma

    Situation: A clinical-stage oncology company with a potentially ground-breaking technology requested Kineticos to help determine which tumor type(s) had the

     

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  • Business Development & Licensing

    Situation: An innovative oncology diagnostics company retained Kineticos to assist in developing their pitch deck, as well as developing and

     

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  • Product Search

    Situation: A drug delivery technology company identified an opportunity to generate additional revenue by acquiring products to further develop and

     

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  • The Impact of I/O on Oncology Diagnostics

    Oncology Diagnostics Panel Session Kineticos recently hosted a panel with 3 industry veterans to gain insight regarding the nuances of

     

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  • Making Up for Unfavorable Reimbursement

    Oncology Diagnostics Panel Session Kineticos recently hosted a panel with 3 industry veterans to gain insight regarding the nuances of

     

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  • Can Diagnostics Keep Up with Pharma?

    Oncology Diagnostics Panel Session As the oncology landscape continues to grow and develop, the diagnostics developed and used will need

     

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  • Are We Truly Ready for AI?

    Immuno-Oncology Panel Session Kineticos recently tapped 3 industry veterans and Oncology experts to participate in a panel to discuss where

     

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  • Data is King!

    Immuno-Oncology Panel Session Kineticos recently tapped 3 industry veterans and Oncology experts to participate in a panel to discuss where

     

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  • Paying for Outcomes and Only Outcomes

    Immuno-Oncology Panel Session Kineticos recently tapped 3 industry veterans and Oncology experts to participate in a panel to discuss where

     

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  • How Metrics Can Help Identify and Solve Operational Challenges

    Article Preview As the sophistication of operational practices across life sciences increases; unfortunately, so do the difficulty and complexity of

     

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  • Growth by Acquisition in Life Sciences: Do You Have a Plan?

    Article Preview As the life sciences landscape continually changes, growth by acquisition has become increasingly common. Recent deals, such as

     

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  • R&D Revolutionaries: Why the Actavis/Allergan Deal Takes a Stand for Biopharma’s True Roots in Innovation

    James Forte of Kineticos takes an in-depth look at the recent Actavis/Allergan deal including the role R&D innovation played in shaping the deal’s outcome. Let’s be candid. It’s been awhile since any biopharma company was able to claim R&D as a core competency with a straight face. Biopharma’s R&D efforts have long been challenged, and rightly so given its output, but the Actavis/Allergan deal shows that the right investment in R&D can revolutionize a business. Could efficient R&D be the new definition of innovation?

     

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  • Driving Revenue and EBIDTA at CROs through Customer Loyalty

    Article Preview Determining customer satisfaction and loyalty is a difficult endeavor for most businesses. Traditional voice of customer surveys are

     

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  • Merck KGaA and Bayer Choose Opposite Strategies

    Article Preview Europe’s two largest chemical and drug conglomerates are changing course in starkly opposite ways. As reported in recent

     

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  • Next Generation Sequencing: Using Technology to Develop Mutually-Beneficial Partnerships

    Article Preview Arup Laboratories announced it will begin offering next-generation sequencing (NGS) based high resolution Human Leukocyte Antigen (HLA) genotyping

     

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