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All management is based on guiding principles; and the effectiveness of management derives from those principles. This is true whether the principles are appropriate or inappropriate, reasonable or unreasonable, consistent or inconsistent. Similarly, the derivative nature of management holds whether the guiding principles are vague or well-defined, followed faithfully or haphazardly, applied day-to-day by managers who are highly skilled or fundamenta

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

lly incompetent. Effective management, then, is a product of:

• Guiding principles that are appropriate, reasonable, and consistent;

• Managers who clearly understand the guiding principles, faithfully adhere to them, and who are fundamentally competent.

It follows from this that the effectiveness of an organization's management is a product of the Principle/People equation:

• Principles + People = Outcomes.

The guiding principles for an organiz

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

tion are a composite of underlying assumptions and values that define and direct management practice. 'Assumptions' in this context are beliefs that are held as 'true' without demonstrable proof. 'Values' are those conditions that are held to be inherently and intrinsically 'right.' From this perspective, then, guiding principles are true because they are true and right because they are right.

With the non-empirical, self-justifying nature of guidin

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

g principles in mind, an organization has its unique 'culture.' Here, 'culture' refers to the collective beliefs, values, and norms of the organization, where 'norms' are the standards for behavior and interaction within the organization. These standards are, of course, based on the organization's beliefs and values related to how the organization's people 'should' behave and interact both with each other and with people outside the organization. 'No

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ms' thus define correct and proper behavior.

When norms are understood as following from beliefs and values, the organization's culture can be summarized as its collective sense of;

• What is true,

• What is right,

• What is proper.

At an abstract level, an organization's guiding principles exist within its collective memory and current consciousness; but at a practical, functional level, those guiding principles reside within its people. Each p

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

erson is a carrier and a conveyer of the guiding principles that direct the organization's day-to-day activities and future 'outcomes.' Those 'outcomes' may be tangible or intangible but are, nonetheless, a product of the collective efforts of people who carry and convey the organization's guiding principles.

PRIDE

(P) Professionalism: An organization's achieving its desired outcomes is dependent on its people; so what people bring to the endeavor

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

akes a critical difference. They must be competent to fill their organizational roles. At a minimum, they must have knowledge, skills, and judgment consistent with their positions and responsibilities. In turn, they must apply their knowledge, skills, and judgment in the interest of achieving the organization's desired outcomes. To the extent that the organization's people do not have the requisite knowledge, skills, and judgment for their positions,

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

the organization, through its management, must assure that the needed training and skill development are provided for its people; and as people leave the organization, new people must be recruited who either have or can develop the requisite knowledge, skills, and judgment. Whatever the mechanism, the organization cannot achieve its desired outcomes unless and until the requisite knowledge, skills, and judgment are in place.

(R) Responsibility: Ass

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ming that the requisite knowledge, skills, and judgment are in place, the organization's desired outcomes will only be achieved to the extent that its people do the right things right, the first time, on time, every time. Simply having competent people in place is not sufficient in and of itself. Here, doing the 'right' things is not based on training and experience. Rather it is based on understanding and adhering to the organization's guiding princ

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

iples. It is doing that which is right from a value perspective. Doing the right things right, the first time, on time, every time means that the organization's people are consistently and conscientiously adhering to its guiding principles.

(I) Initiative: Competence plus adherence to guiding principles leads to initiative: people seeing what needs done and doing it because it needs done. Since the organization's people are competent, they are able

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

o see what needs done and have the requisite knowledge, skills, and judgment to do it. Since they adhere to the organization's guiding principles and are committed to its desired outcomes, they do that which needs done. Conversely, if the organization's people do not manifest initiative, there are organizational deficits requiring management intervention. That intervention must be directed to some mix of increasing the competence of the organization'

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

s people and increasing adherence to the organization's guiding principles. Increasing adherence to guiding principles, of course, must focus on increasing understanding and acceptance of that which is true, right, and proper from the organization's perspective.

(D) Directedness: The organization's people can be competent, do the right things, and manifest a high level of initiative and still not achieve the organization's desired outcomes unless th

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

re is a high level of Directedness: focus on attaining optimal outcomes for each situation or circumstance. These optimal outcomes are intermediate steps toward the organization's desired outcomes; and an absence of focus on them decreases the likelihood of achieving the organization's desired outcomes. Conversely, intense focus on intermediate outcomes increases the likelihood of achieving the organization's desired outcomes.

(E) Effectiveness: Wer

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

e the internal and external organizational environments static, professionalism, responsibility, initiative, and Directedness would be sufficient for achieving the organization's desired outcomes; and once people were successful with respect to the intermediate outcomes, they would only need to 'keep up the good work.' Management, then, would be little more than a 'maintenance of effort' process. However, both the internal and external environments c

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ange over time; and management is responsible for assuring a continuing fit between the organization and the external environment. Further, the organization's desired outcomes change over time. This change may involve completely different outcomes or changed standards for old outcomes. Whatever the change, yesterday's desired outcomes will not be the same as tomorrow's. It is, then, management's responsibility to keep the organization's people aligne

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

d with its changing outcomes. This is accomplished through doing what needs done, evaluating what was done, and doing it better the next time, while concurrently assuring continuous fit with changing internal and external environments and desired organizational outcomes.

The 'people' side of the principle/people equation requires continuous management of Professionalism, Responsibility, Initiative, Directedness, and Effectiveness in relation to chan

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ing, desired outcomes in concert with the organization's guiding principles. This leads to the conclusion that PRIDE is and must be the underlying guiding principle for effective management and for effective managers.

With PRIDE as their guiding principle, effective managers then strive to:

• Understand and further the mission of the organization.

• Define and maintain a rational, flexible Organizational Structure within which employees can functi

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

on with a minimum of administrative and bureaucratic control and interference.

• Provide clear, consistent Direction for employees, assuring each employee knows and understands what is expected of him and what behavior and action are acceptable and unacceptable.

• Maximize Personal Control for each employee over his work related environment and activities.

The critical strategies for achieving these outcomes are:

Cooperation: Emphasizing a helpfu

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

, supportive approach to relationships and activities.

Loyalty: Emphasizing working with employees by accommodating to special needs and interests and facilitating resolution of problems.

Caring: Emphasizing concern for and interest in the activities, successes, and problems of employees.

Sharing: Emphasizing talking with employees, reciprocal assistance, and mutual problem solving.

Respect: Emphasizing acceptance of employees' beliefs and values

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

, receptivity to employees' thoughts and ideas, and sensitivity to employees' feelings and interests.

Trust: Emphasizing giving employees the benefit of the doubt without blaming, accusing, or threatening.

Integrity: Emphasizing keeping commitments to and agreements made with employees.

Conflict Resolution: Emphasizing identifying, understanding, and working through conflicts and tensions among and between employees.

There you go and now you know

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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