New Product Development

The continuous innovation of new products is the cornerstone of pharmaceutical industry’s success and longterm viability.

What is a new product?

New consumer product New to the world (fax, DVD, VCR( New to the country New to the firm New category entry Product line addition )new icecream

flavor( Product improvement (lighter and faster(

New products according to degree of innovation: Breakthrough products (new to the

world( Pioneering Products (thinner portable

computer ( Adaptive products (2 in 1 hair shampoo

combination Imitative products ) me-too product(

FDA New Pharmaceutical Product Classification

Chemical type:

Treatment potential Priority review drug (P( is a drug that

appears to have therapeutic qualities that surpass available therapy.

Standard review drug (S) All nonpriority applications are considered standard applications.

Pharmaceutical R & D statistics

Drug Discovery Methods

The New Drug Development Process

Idea generation Idea screening Buisness analysis Development commercialization

Idea generation

Is based on the identification of unmet therapeutic needs. Based on large amounts of

epidemiological and therapeutic area market data

Pharmaceutical marketers select a therapeutic area with an unmet therapeutic need, a significant potential for sale

Then they construct a product target profile

The process of unmet needs analysis , target profiling, and profile based development is called label-driven development.

Idea screening

Business analysis

development

R & D Strategies

Proactive (continuous performance improvement)

Or

Reactive (responsive, defensive, imitative, and not truly pioneering )

Most experts agree that continuous performance improvement is the optimal approach for long term innovation and profitability