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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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  • A CRO’s Role in Innovation

    It was once solely on the shoulders of Pharma/Biotech to produce all of our industry’s innovation.  However, we’re learning that

     

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  • Where is Today’s Innovation Bottleneck?

    Where is Today’s Innovation Bottleneck is the second installment of our 4-part series related to a recent statement issued by

     

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  • The FDA’s Shift from Gate Keeper to Enabler

    Most of us were shocked when Scott Gottlieb stepped down from his duties as the FDA Commissioner. He is largely

     

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  • What Can China Teach Us About CAR-T?

    What Can China Teach Us About CAR T is the final installment of our CAR-T series and discusses how China

     

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  • Taking CAR-T Therapy to the Next Level

    Taking CAR-T Therapy to the Next Level is Part 2 of 3 of our most recent CAR-T series.  The dialogue

     

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  • CAR-T Therapy: Are We Getting a Bargain?

    With cancer research and treatment evolving so dramatically over the past 10 years, we’re left thinking what will the next

     

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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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