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.

Service Lines Include:

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Click the Tabs Below for Case Studies, White Papers, and Articles

Case Studies
Articles
Blog
  • Portfolio Prioritization – Oncology

    Situation: A publicly traded Oncology company with 3 technology platforms and limited resources was in need of narrowing their focus. 

     

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  • Go-to-Market Strategy and Tactical Deployment Plan

    Situation: A privately held emerging biotech company, with an innovative cancer detection test, retained Kineticos to assist them in effectively

     

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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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  • 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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  • 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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  • Is the Funding Still There for Alzheimer’s Drug Development?

    With everything in drug development, you need to have the capital to drive clinical trials. Is the capital and funding

     

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  • The New Approaches to Solving Alzheimer’s

    Kineticos’ SVP of Biopharma, Kevin Hampton leads our panelists through a discussion on what is next in the Alzheimer drug

     

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  • Moving on From the Beta-Amyloid Hypothesis in Alzheimer’s

    Alzheimer’s Disease continues to be an enigma that cannot be resolved as the traditional beta-amyloid hypothesis has been failing over

     

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  • Regenerative Medicine Valuations: An Art or a Science?

    In the final installment of our Regenerative Medicine panel, Kineticos’ Chief Commercial Officer, Kevin Hampton, sparks a discussion surrounding how

     

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  • Clearing the Regulatory Backlog

    The latest installment of our Regenerative Medicine panel is a short exert related the regulatory pathway for cell and gene

     

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  • Regenerative Medicine Game Changers

    In our third installment of our Regenerative Medicine panel, our experts discuss their views on potential catalysts and disruptors for

     

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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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