Clintrlmng: Pharmaceutical Project Management

Front 1

successful drug development is about what?

Back 1

translating science into an optimal
investment proposal that provides value to a variety of stakeholders and customers.

Front 2

What are the skills are needed to create a strong development strategy?

Back 2

1. establishing a strategy which recognizes who the
customers for new medicines are and addresses their needs
2. strong technical knowledge of drug
development and understanding of development risk management
3. understanding of the importance of the target product profile (TPP) as a strategic tool and the need for its continuous review throughout
development
4. understanding the life cycle management and that the commercial value of a product will be realized only by ensuring that the product benefits are fully
exploited

Front 3

Early Development Strategy

Improving Input Quality to Development

Back 3

The quality and quantity of preclinical data provided by discovery groups to support the development of a new compound is often suboptimal. Specific data gaps in a development proposal may exist for good reasons (e.g., obtainable but
will incur major delay) and can be addressed in development.

Front 4

What can be obtained from the non-clincal parties in development?

Back 4

- In each of the nonclinical development disciplines (chemistry, pharmaceutics, drug metabolism,
pharmacokinetics and toxicology) key pieces of data may be obtainable at modest cost and to aid in selecting the best development candidate.
- the payback in improved input quality to development will more than justify the effort

Front 5

What is the key strategic tool which guides drug development?

Back 5

The key strategic tool which guides drug development is the Target Product Profile (TPP)

Front 6

What is the TPP?

Back 6

The TPP describes the specifications of the product intended to be
introduced into the market [1]. It defines the required efficacy and side effect profile of the product, how it is supplied, how it is to be used, in which patient groups,
and for what purpose. It specifies the cost of goods and the time of market introduction. It is the key design template for creating the development plan. It defines the
performance requirements which enables the commercial organization to assess the market impact and estimate the commercial return.

Front 7

What is is essential to do regarding TPP?

Back 7

It is essential
to define a minimum TPP specifying the minimum performance for commercial viability. The expected product performance can also be defined alongside the
minimum TPP, and commercial forecasts can be provided for both. The specific attributes within the TPP constitute a package.

Front 8

What must be done if a change is made in one attribute?

Back 8

If a change is made in one attribute,
the whole TPP must be reviewed again to ensure that the impact of the change is fully understood. The TPP has to be set in a specific time frame for launch because
any change in schedule may result in an important change in the market environment, e.g., competitor launch

Front 9

What is the TPP dynamically effected by?

Back 9

The TPP is dynamically affected by internal and external factors. Internal factors can include clinical and nonclinical development findings. External factors include, for
example, new competitor clinical results just released. Therefore, the TPP is generally reset in development. The TPP is a contract between R&D and the commercial
organization.

Front 10

If the TPP
“contract” is to be changed, what must be done?

Back 10

If the TPP
“contract” is to be changed, this must be renegotiated and an endorsement for the new contract secured to ensure that further investment is justified