How The FDA Are Accelerating The Drug Development Process

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How The FDA Are Accelerating The Drug Development
Process
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• In the best interests of everyone, not just those
  suffering from a serious disease, when drugs are
  made available at a faster rate, everybody
  benefits, from patients to healthcare providers.
  Prior to a drug receiving approval, however, it
  must go through a detailed FDA review process,
  and naturally, this can time.With this in mind,
  the Food and Drug Administration have developed
  four distinct and highly effective approaches to
  help facilitate the rapid availability of drugs
• 1.Priority review
• 2.Breakthrough therapy
• 3.Accelerated approval
• 4.Fast track

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• Lets look at each of these in a little more
  detail
• Priority review
• This designation means that the FDA will aim to
  act on an application for approval within 6
  months, as opposed to the previous goal of 10
  months. When a drug is given a priority review,
  attention and resources are directed to the
  evaluation of applications for drugs that if
  they are given approval would significantly
  improve the safety or effectiveness of the
  treatment, diagnosis or prevention of serious
  conditions in comparison to other, standard
  applications.

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• Breakthrough therapy
• Designed to expedite the development and review
  of drugs that are intended to treat a serious
  condition, and which initial clinical evidence
  indicates that the drug may demonstrate a
  substantial improvement over other therapies
  currently available, breakthrough therapy speeds
  up their availability. While determining whether
  the improvement is significantly better may be a
  matter of judgement, generally speaking, the
  preliminary clinical evidence should demonstrate
  a clear advantage over existing therapies.

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• Accelerated approval
• Often, when studying a new drug, it can take many
  years to discover whether it has a real effect on
  a patients survival, feelings or functions, and
  when one is determined to have a positive
  therapeutic effect according to the context of
  the disease it is being used to treat, its
  described as being of clinical benefit. In
  1992, with this in mind, the FDA implemented the
  Accelerated Approval regulations, designed to
  allow drugs used to treat serious conditions in
  the absence of any other, to be approved based on
  a surrogate endpoint ultimately speeding up
  their approval.

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• Fast track
• This process is designed to facilitate and
  expedite the development and review of drugs for
  the treatment of serious conditions, and which
  fill a medical need that is currently not being
  met. Its main purpose is to get important,
  potentially lifesaving drugs to patients in need,
  quicker, and the fast-track process addresses a
  wide range of conditions deemed as serious.
• If the drug in question will have a positive
  impact upon a patient suffering from a serious
  condition, such as by improving their chances of
  survival, day-to-day functioning, or is based
  upon the premise that if left untreated, the
  condition will progress to a more serious one,
  then the fast-track process will be applicable,
  and its design and review can be sped up.

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• The FDA currently have their hands full with the
  ongoing pandemic and the growing need for a
  vaccine, and are exploring ways of exercising
  regulatory agility in new, innovative but most
  importantly safe ways.

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