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Organisations which fail to prioritise their projects and activities in alignment with their goals risk getting lost in a mire of directionless activity instead of taking a clear set of actions to reach a goal or goals.

Most organisations build an inventory

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

of projects and activities over time, which are not visible to the leadership team. Organisations need to periodically stop, take stock and prioritise the projects and activities they are undertaking against the goals of the organisation.

Symptoms, includi

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

Examples of combination products may in

ng incomplete projects, project cost overruns, operating cost blow outs, low customer satisfaction, low productivity and low morale are typical of organisations which are unable to prioritise their inventory of projects and activities.

In one organisation I

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

worked with, the competitive environment was tightening dramatically. The goals, which were set for the following twelve to eighteen months, related to managing the portfolio of products, services and customers to achieve a drastic cost reduction.

They had

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

an inventory of over two hundred discretionary projects and activities. That is, projects and activities outside of both the day to day business and those projects required to comply with internal or external regulations. Reviewing that inventory revealed l

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

Combination pro

ess than forty percent of the projects and activities were aligned to the goals. Further, less than fifty percent of the projects and activities were deliverable within the desired timeframe.

Effectively, less than twenty percent of the discretionary projec

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

ts and activities were aligned to their goals and timeframe. As a result, several projects were stopped completely, and many were postponed.

Key projects and activities, which delivered against the goals in the time frame required, were given additional res

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

urces and a shorter timeline for delivery.

The first, most difficult and most important task in a prioritisation review is to understand clearly what the organisation's goals are.

In the context of this article, goals are the few business outcomes that def

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

ine an organisation as being successful.

To achieve their goals all organisations create a number of projects and activities designed to deliver business improvement and execute a large number of day to day processes. The projects and activities have target

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

s and milestones and the processes have key performance indicators with associated targets and boundary values. Targets, milestones and key performance indicators are not goals.

In my experience, organisation's which have more than three major goals tend to

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

fail to deliver on any of them.

One reason is that it is difficult to articulate more than three goals without finding at the operating level, that the unintended consequence of one goal contradicts another goal. Even with three goals, it becomes difficult

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

Following aspects would a

at the operating level not be confused by the conflicting requirements of meeting each of the goals.

If the goals are clear, it is important to understand for each project or activity, what are the key deliverables and what support is required for delivery

dd to the challenges in developing combination products:

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

. In many cases organisations do not think deeply enough about what support is required for a project to deliver. The result from this lack of project planning is that the review of project against the organisation's goals is flawed from the beginning.

The

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

review itself is fairly simple if the goals are clear and all the tasks required to complete the projects and activities are well understood.

For each project or activity, evaluate its alignment with the goals. Be brutal. If it is not aligned with goals rat

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

it very low in a scoring range of 1-10.

Complete a second pass evaluating each project or activity on its likely completion date. If the completion date does not meet the time horizon required for the organisation to deliver against the goals, revise the p

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

roject, perhaps into shorter phases. If it cannot be revised, rate it very low.

A third pass evaluates the probability of successful completion. The evaluation includes an analysis of resource requirements compared with resource availability and of stakehol

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

Professional from academic institutions, pharmaceutical industries, health care indust

der support. The resources to be evaluated include, but are not limited to competent people, money, and technology.

Discard or revise those projects with a collective low total score.

Projects which survive the review must be planned. The aggregation of th

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

ose plans must be tested in ninety day or less blocks against the resource availability where common resources are being used across several projects.

By taking a ruthless approach to prioritising projects against the goals and resource availability of the

.

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

organisation, more projects are completed on time. The results for successful projects are higher productivity within both the project activities and the day to day processes.

For unsuccessful projects, a benefit often overlooked is the earlier realisation

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

Companies that provide selfless information through particip

that a project is going to be unsuccessful and the organisation is able to close it off and release resources for another project.

In either case, when it comes to projects and activities designed to improve the business, doing less most often achieves more

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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