Pharmaceutical Outsourcing Q3 2023 - 16

CLINICAL TRIALS
Most Significant Risk Factors
for Emerging and Mid-Market
Biopharma Companies -
Costly Clinical Trial Delays
Dr. Harsha K Rajasimha, MS, Ph.D.
Founder
Jeeva Informatics Solutions Inc.
Co-Authored by Dr. Padma Rammoorthy
In 1820, a group of physicians, driven by concerns regarding the
quality and reliability of medicines, set up and released the first United
States Pharmacopeia (USP). This pioneering publication included
formulas for preparing 217 drugs deemed the most extensively
researched and comprehended during that period.1
In 1906, the
original Food and Drug Act was passed by Congress. The foundation
of the FDA's current regulatory functions can be traced back to
this act, which prohibited the interstate trade of adulterated and
misbranded food and drugs. Although the agency was not officially
named the FDA until 1930, this pivotal law marked the beginning of
the FDA's modern regulatory efforts. Over the course of the century,
the FDA has implemented multiple safeguards to assess and approve
investigational new drugs.2,3
Various Phases of the Drug
Approval Process
In the early stages of preclinical development for a new drug, the
primary objective of the sponsor is to assess the product's safety
profile for initial human use and evaluate its pharmacological activity
to justify further development. Once a product is identified as a
potential candidate, the sponsor shifts their focus towards gathering
the required data and information to demonstrate that the product
poses minimal risks to humans in limited, early-stage clinical studies.
The role of the FDA becomes significant at this stage, as the product
transitions into an Investigational New Drug (IND).
Any investigational drug undergoes a three-phase process before
potential approval for commercial use. After submitting the IND
application, the sponsor must observe a 30-day waiting period
during which the FDA reviews the IND to ensure the safety of research
subjects. Clinical trials then commence, marking the drug's initial
testing on humans. These clinical trial phases evaluate the drug's
dosage, safety, and efficacy.
Phase one which can last for several months, involves testing the IND
on 20 to 100 healthy volunteers or individuals with a specific disease
or condition. This phase primarily focuses on safety and dosage.
Around 70% of drugs progress to Phase Two. In Phase 2, several
hundred participants are involved, providing further safety data.
Phase 2 duration ranges from several months to up to two years, with
approximately 33% of drugs advancing to the next phase.
The last crucial stage preceding drug approval is Phase 3. In this
phase, researchers conduct studies to determine whether the
product provides a treatment benefit to a specific population. Phase
Pharmaceutical Outsourcing | 16 | July/August/September 2023
Pharmaceutical Outsourcing Q3 2023

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