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I + 41

Impact Scale: -2 Very poor, -1 Poor, 0 Neutral, +1 Fair, +2 Good, +3 Excellent

Impact Scale: -2 Very poor, -1 Poor, 0 Neutral, +1 Fair, +2 Good, +3 Excellent

Fig. 2.46. IND Benefits: PPM, P-8th paradigm & Leaders avoiding each pitfall from strongly disagree (-2), disagree (-1), neutral (0), fair (1), good (2), up to excellent agreement (3). A total score can be as low as -30 to as high as +45, and we would suggest that a high score at or above 20-30 indicates significant impact (overall at least good) on NDA/CTD process and approvals. These scores will be generated by the authors, and you as the reader can determine your own scoring. Pitfalls with the scores are found in the table in Fig. 2.46.

PPM should have certain strengths as can be observed by the five high scores for "planning," "paying attention," "not hiding something," "global thinking," and "choosing wisely." Subtotal score for impact of PPM on pitfalls is 28, a good score. Pitfalls scores for the organizational effectiveness model (P to the eighth power) are suggested to be fairly consistent across most of the pitfalls in avoiding them, without any particular single strength. The model has broad potential beneficial impact on all the various operations of R&D product development because the paradigm basically is intended to impact all the elements of product development to some extent. The subtotal score for use of the organizational model, P to the eighth power, is 27, also a good score by itself [43].

Leadership and specifically the model of leadership offered in this treatise can be scored on the 15 pitfalls in filing INDs/NDAs. The strengths that leadership offers for the pitfalls is suggested to involve particularly "paying attention," "hiding something," and "choosing wisely," plus favorably impacting six other pitfalls. Its subtotal score is 22, a reasonably good score. Then, when you combine all three operational and planning models (leadership, organizational effectiveness, and PPM), the total score for avoidance of failure with INDs/NDAs is suggested to be quite high, possibly 41 out of 45. The caveat is that the three models are fully implemented, operational, and running reasonably smoothly, as well as reassessed periodically to refresh and upgrade them.

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