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Chapter 15: Global Regulatory Strategy
Regulatory decisions can affect the time-
to-market, label claims and reimbursement
directly and, consequently, a new product’s sales,
profitability and contribution to business results.
Therefore, it is critical regulatory professionals
understand the organization’s business strategy
to plan the product development and postau-
thorization activities within this framework and
as members of a multidisciplinary global team
planning an integrated product strategy.
Early sponsor development of a Target
Product Profile (sponsor TPP) by the multidis-
ciplinary team establishes key product attributes
and provides an opportunity to consider financial
factors and build a sophisticated financial model
to develop anticipated business outcomes. It
also will assist in determining the break-even
point at which no further development should
be undertaken, as the business outcomes will
not be positive, and product divestiture may be
considered. Ultimately, companies should seek
improved patient outcomes compared to existing
therapies and, if these are positive, it is likely the
product also may provide financial return.
Note, a sponsor TPP should be differen-
tiated from a formal regulatory TPP prepared
in accordance with FDA guidance1 and serving
as a format for sponsor discussions with the
regulatory authority. The relationship between
the two types of product profiles is important,
as a sponsor TPP will guide the formal TPP
and development plan, contributing to overall
business objectives.
A sponsor TPP may include optimal and
acceptable label claims compared to currently
available products and competitors in develop-
ment. Similarly, it may articulate an acceptable
safety profile and risk-benefit analysis, as well as
Figure 15-1. Multidisciplinary Product Development
Regulatory
Business
Finance
Marketing
Manufacturing Clinical Medical
Safety
Health
Outcomes
Target Product Profile
and Integrated Product
Strategy
Chapter 15: Global Regulatory Strategy
Regulatory decisions can affect the time-
to-market, label claims and reimbursement
directly and, consequently, a new product’s sales,
profitability and contribution to business results.
Therefore, it is critical regulatory professionals
understand the organization’s business strategy
to plan the product development and postau-
thorization activities within this framework and
as members of a multidisciplinary global team
planning an integrated product strategy.
Early sponsor development of a Target
Product Profile (sponsor TPP) by the multidis-
ciplinary team establishes key product attributes
and provides an opportunity to consider financial
factors and build a sophisticated financial model
to develop anticipated business outcomes. It
also will assist in determining the break-even
point at which no further development should
be undertaken, as the business outcomes will
not be positive, and product divestiture may be
considered. Ultimately, companies should seek
improved patient outcomes compared to existing
therapies and, if these are positive, it is likely the
product also may provide financial return.
Note, a sponsor TPP should be differen-
tiated from a formal regulatory TPP prepared
in accordance with FDA guidance1 and serving
as a format for sponsor discussions with the
regulatory authority. The relationship between
the two types of product profiles is important,
as a sponsor TPP will guide the formal TPP
and development plan, contributing to overall
business objectives.
A sponsor TPP may include optimal and
acceptable label claims compared to currently
available products and competitors in develop-
ment. Similarly, it may articulate an acceptable
safety profile and risk-benefit analysis, as well as
Figure 15-1. Multidisciplinary Product Development
Regulatory
Business
Finance
Marketing
Manufacturing Clinical Medical
Safety
Health
Outcomes
Target Product Profile
and Integrated Product
Strategy