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The past few years have seen an increase in the number of petroleum mega projects being proposed and executed. Record oil prices have given rise to increasingly ambitious and complex international alliances in the

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

energy industry. These large, long term and capital intensive projects carry a great deal of cost and schedule risk which is very challenging to mitigate. We have found that some of this risk can be managed throug

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

Examples of combination products may in

an emphasis on accountability at all levels of the project organization. Results-based accountability strategies create clarity throughout these complex projects; they ensure that everyone from the senior managers

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

to casual labourers are working together for the same organizational goals.

Using a tool called an Accountability Agreement we start with the project’s owners or the management team to create a clear understanding

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

of the project deliverables and success factors. An Accountability Agreement is a document which asks each employee to clearly state the specific results that he or she is accountable for bringing about and the sup

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

Combination pro

ort he or she requires to get there. By using this tool, we get public commitment to the kind of working culture that will most likely lead to a successful project. What starts as a complicated combination of inter

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

sts, skills, and backgrounds is gradually transformed into a unified alliance with a clear sense of purpose.

Committing to organizational alignment makes a noticeable impact on all departments involved in a major

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

roject. In addition to operational functions, Accountability Agreements play a part in how people approach their jobs and the satisfaction they expect to receive in return. In a time when companies are in competit

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

on for talented people, having a clearly defined project culture can be a strong competitive advantage. Accountability agreements allow for employees to publicly state what they would like to receive in return for

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

chieving their stated goals. Job satisfaction can never be entirely guaranteed, but mutually agreeing upon expectations and positive consequences reassures employees that their efforts will be recognized. This ope

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

and reciprocal relationship enhances employee satisfaction and allows more key talent to be retained in the long term.

An Accountability Agreement distinguishes between operational accountabilities and leadership

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

Following aspects would a

accountabilities. These terms do not exclusively refer to employees working at the operational or leadership level. Rather, we use these terms to emphasize that all employees have accountabilities in their operati

dd to the challenges in developing combination products:

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

nal activities and their approach to leadership. Operational accountabilities refer to the specific results that an employee is expected to bring about. Some examples of operational accountabilities agreed to at t

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

e project management level are:

• “A safe work site”

or

• “A workable three-year business plan for construction”

Leadership Accountabilities refer to individual actions which make a direct impact on the organiz

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

tion’s culture and working relationships. Every individual involved in a project must be partially accountable for the strength of its business culture. Some examples of accountabilities that lead to the desired cl

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

mate for a successful project are:

• “A positive image of the company in all the communities where we build.”

or

• “Leadership behaviours that contribute to an entrepreneurial, high-performing work environment.”

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

Professional from academic institutions, pharmaceutical industries, health care indust

With a commitment to a strong organizational culture, the achievement of specific results, and the promise of recognition in exchange for individual initiative, the people side of the project has been set in motio

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

. Clear results-based accountability at this level creates the ‘north star’ for the rest of the project which makes it possible to orient new people to the project and helps to refocus efforts if and when things g

.

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

astray. With all accountabilities publicly available for all to see, finger pointing and blaming can finally be set aside.

Mega projects often begin with confusion and uncertainty as project managers struggle wit

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

Companies that provide selfless information through particip

an abundance of disparate resources. Through a commitment to results-based accountability, we have been able to transform this uncertainty into an unprecedented level of clarity, cooperation, and long term success

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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Machiavelli emphasized on building a strong organization structure where responsibilities and accountabilities are clearly defined and offender should be dealt with no mercy. As per him an organization or kingdom can be built on the support of either the people or the nobles.

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