Planning early late broadly Product Success

c Develop a map for molecule progression c Organize corporate resources c Plan for multiple indications o Think international e Consider alternate drug delivery systems c Consider labeling expansion o Get the most out of your patent & defend it c Plan for follow-on molecules c Consider in-licensing or blocking strategy c Be prepared for competitive molecules c Be prepared for generic competition

What are best parameters among myriad of business & research data?

Opportunity (Product)

Resources (Budget & Staff)

Opportunity (Product)

Resources (Budget & Staff)

Sales (Market)

Summary Statistics

Risk

Sales (Market)

Summary Statistics

Risk

Fig. 2.27. Product Life Cycle Management

Fig. 2.28. Types of PPM Analyses finally some overall summary statistics to be elaborated later [22, 41].

In Figure 2.29, four opportunity and three sales analyses are listed. The opportunity analyses noted are compound ratings, product profile comparisons, safety versus efficacy bubble diagrams, and NMEs versus MOAs. First, compound ratings are used to help set priorities among the product candidates in a portfolio. The ratings engage the teams to individually score their product with a standardized list of properties or parameters for new products. Often, the set of decision criteria discussed previously are used (e.g., efficacy, safety, formulation utility, market size, sales potential, competition, patent status, probability of success, and cost of goods). Each criterion is scored on a 1 to 5 or 1 to 10 scale from worst to best or lowest to highest. These scores are highly subjective, educated opinions and must be defended by the teams in front of management. An inordinately high score will diminish the credibility of the team and hurt the product's chances of moving forward. The scores are summed and all the products are then compared with each other with a minimum score required for a product to advance. The scoring is not an answer in and of itself but offers two benefits; creates some degree of standardization across a portfolio and is intended to stimulate a good discussion of products across a portfolio leading up to decisions of go-no go.

A second opportunity analysis is for product profiling, which can be combined with sales forecasts to assess a product's range of possible future revenues. The product team will create three profiles, one that fits the most desirable product profile for that disease, these type of products, and optimal research outcomes for the company's product. The most desirable (ideal) profile is compared with a second profile for the most likely product profile with the company product's performance in research. Finally, sometimes a third profile for the least acceptable profile for the product is created. Market research takes these three profiles to groups of thought leaders and customers to evaluate the merits of the product and its potential use by itself and in comparison with competitors. Marketing then has to transform the written feedback into sales possibilities based on experience in this particular marketplace of products. Sales over time for about 5 years is

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