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    Nucleon, Inc

    Uploaded by

    Swati Arya
    Nucleon, Inc. was founded in 1985 to develop pharmaceutical products based on cell regulating factors (CRFs). By 1990 it had grown to 22 employees focused on researching CRF-1, which showed potential to treat burns and kidney failure. However, Nucleon lacked FDA-approved manufacturing facilities to supply CRF-1 for upcoming human clinical trials. It considered building a pilot plant, contracting manufacturing, or licensing production to another firm. The biotechnology industry was highly competitive, with over 200 firms developing similar technologies and large pharmaceutical companies pursuing internal R&D programs. Nucleon's strategy focused on selecting promising projects and collaborating with established pharmaceutical marketers.

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    Nucleon, Inc

    Uploaded by

    Swati Arya
    204 views5 pages
    Nucleon, Inc. was founded in 1985 to develop pharmaceutical products based on cell regulating factors (CRFs). By 1990 it had grown to 22 employees focused on researching CRF-1, which showed potential to treat burns and kidney failure. However, Nucleon lacked FDA-approved manufacturing facilities to supply CRF-1 for upcoming human clinical trials. It considered building a pilot plant, contracting manufacturing, or licensing production to another firm. The biotechnology industry was highly competitive, with over 200 firms developing similar technologies and large pharmaceutical companies pursuing internal R&D programs. Nucleon's strategy focused on selecting promising projects and collaborating with established pharmaceutical marketers.

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    Nucleon, Inc

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    Nucleon, Inc. was founded in 1985 to develop pharmaceutical products based on cell regulating factors (CRFs). By 1990 it had grown to 22 employees focused on researching CRF-1, which showed potential to treat burns and kidney failure. However, Nucleon lacked FDA-approved manufacturing facilities to supply CRF-1 for upcoming human clinical trials. It considered building a pilot plant, contracting manufacturing, or licensing production to another firm. The biotechnology industry was highly competitive, with over 200 firms developing similar technologies and large pharmaceutical companies pursuing internal R&D programs. Nucleon's strategy focused on selecting promising projects and collaborating with established pharmaceutical marketers.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    204 views5 pages

    Nucleon, Inc

    Uploaded by

    Swati Arya
    Nucleon, Inc. was founded in 1985 to develop pharmaceutical products based on cell regulating factors (CRFs). By 1990 it had grown to 22 employees focused on researching CRF-1, which showed potential to treat burns and kidney failure. However, Nucleon lacked FDA-approved manufacturing facilities to supply CRF-1 for upcoming human clinical trials. It considered building a pilot plant, contracting manufacturing, or licensing production to another firm. The biotechnology industry was highly competitive, with over 200 firms developing similar technologies and large pharmaceutical companies pursuing internal R&D programs. Nucleon's strategy focused on selecting promising projects and collaborating with established pharmaceutical marketers.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
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    Nucleon was a biotechnology company founded in 1985 that focused on developing cell-regulating factors, particularly CRP-1 which showed potential in treating burns and kidney failure. However, it lacked manufacturing facilities that met FDA requirements for supplying CRP-1 to clinical trials.

    Nucleon had no manufacturing facilities that adhered to FDA requirements, making it challenging to supply CRP-1 for clinical trials. It considered three options: building a new pilot plant, contracting manufacturing externally, or licensing production to another company.

    It was difficult to patent process technologies, and competitors could challenge patents granted. Companies also competed to establish strong patent positions on molecules and genetic sequences to attract investors and partners.

    Nucleon, Inc - Introduction

    Founded in 1985 by Dr. Alan Ball, to develop pharmaceutical products


    By December 1990, it had grown to 22 employees of which 18 were engaged in R&D
    It was a leader in cell regulating factors. It was operating in a highly competitive and high
    stake drug industry
    Its products were based on class of proteins called cell regulating factors (CRP)
    It had raised approximately $6 million in VC and received research grants worth $0.6
    million
    Focussed on researching ways to produce CRP-1 which had potential as a treatment for burns
    & kidney failure

    CRP-1 had been undergoing extensive


    experimentation and analysis, ready for human
    clinical trials.
    Nucleon had no manufacturing facilities adhering
    to FDA requirements, challenge of supplying CRP1 to the clinic.
    The problem

    1. Build a new 5000 sq-foot pilot plant with ample


    space capacity for Phases 1 & 2 of clinical trials
    2. To contract clinical manufacturing to an outside
    firm
    3. To license the manufacturing to another
    biotechnology company or to a pharmaceutical
    firm, covering manufacturing, clinical development,
    and marketing.
    Solutions : 3
    Options

    Strategy & Competition


    Competition in this industry was intense, over 200 firms were developing
    pharmaceutical technologies based on molecular biology & immunology
    Large pharma enterprises had extensive in-house biotechnology R&D
    programs as well as collaborative ties with new entrants
    Smaller companies were racing to establish a strong patent position to
    lure potential investors
    Biotechnology Development & Commercialization Strategies:
    All biotech companies started as R&D laboratories
    Vertically integrated into production or marketing

    Uncertainties with Biotechnology


    patent laws

    Companies might
    claim ownership of
    the molecule or the
    genetic sequence
    used to obtain it.

    Very few companies


    could afford to wait
    Difficult to patent
    for several years
    the process
    required to process
    technology used,
    an application &
    though the starting
    huge risks
    material & resulting
    associated in going
    molecule were
    ahead with
    original
    development before
    grant of patent

    It was possible for


    competitors
    challenge the
    patent grants
    anytime.

    Nucleon Strategies

    Firm
    survival
    Strategy
    Marketing
    Strategy

    To pick the right projects in first


    attempt
    To be present at the leading
    edge of scientific research
    Marketing was unaffordable,
    hence ally with established
    pharma companies having
    strong marketing distribution
    capabilities

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