August 2024 SOCRA Source Journal - Journal - Page 36
The Clinical Development Plan
The Clinical Development
Plan (Table 2) is a roadmap to
generate clinical data to support
the Target Product Pro昀椀le, which
is used in developing regulatory
submissions. The sponsor
works toward the Clinical
Development Plan starting
in the 昀椀nal discovery phase.
Many of the components of the
Clinical Development Plan are
built after pre-clinical studies
when the sponsor has the 昀椀rst
protocol to study the drug in
humans in clinical development.
The Clinical Development Plan
highlights all of the work that
has been done to prepare the
drug for regulatory review for
marketing.
Table 3 highlights the role of
the Target Product Pro昀椀le, which
provides a full understanding
of what the drug does and
how it interacts with the human
body. It shows how the drug
compares to, and may be better
than, other marketed products,
and the safety of the drug for
human consumption.
The take-home message is that
CMC (chemistry, manufacturing,
and controls) is critical to the
success of a research program
for manufacturing a usable
form of the drug. Biologics
CMC teams often have as many
meetings with health authorities
as clinical teams. Changes to
manufacturing often impact the
clinical work and manufacturing
must be carefully monitored.
Formulation changes to the
route of administration (IV to
oral) or changes in excipients
may be necessary based
upon the clinical data that
are collected. Manufacturing
process changes may require
bridging studies.
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TABLE 2
The Clinical Development Plan
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Therapeutic opportunities:
o Target indication strategies from the Target Product Pro昀椀le
(Proposed) mechanism of action(s)
Pre-clinical development
Strategic imperatives:
o Goals
o Objectives
Overview of active protocols
Overview of past studies
Safety pro昀椀le
Pharmacokinetics/pharmacodynamics
Clinical pharmacology plan
Pediatric strategy
Potential drug-drug combinations
Approved indications
Market availability
Reimbursement status
Competitive landscape
New emerging technologies/assets
Summary of clinical response
Development launch timeline
Current therapeutic target patient 昀氀ow:
o Alignment with molecule development plan
TABLE 3
The Role of the Target Product Pro昀椀le
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SOCRA SOURCE © May 2024
Includes dosage form, presentation, formulation, strength,
shelf life, placebo, and product quality
Based on preclinical data, mechanism of action, literature,
other projects, platform, and experience
Includes claims about clinical ef昀椀cacy:
o How the product beats the standard of care and potential
competing products
Includes claims about clinical safety, including safe use:
o In special populations
o In combination with other products
De昀椀ned primarily by:
o Project needs (clinical strategy and commercial)
o Product understanding (research)
Joint effort between:
o Chemistry, manufacturing, and controls
o Clinical and research
o Primarily driven by clinical and pre-clinical/research