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It has now well been accepted that the implementation of project management practices adds value to any organization. One recent study showed a 28% RO

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

I1 from project management initiatives in IT organizations. However, what is the reality in developing and following such practices? Are the returns o

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

Examples of combination products may in

investment so easily shown? What are the key steps or processes for these returns to actually occur? Experience and examples from the field, points

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

o the following critical steps in becoming a better project management organization.

Set clear goals and establish benchmarks. This al

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

ows the organization to prove the value of the PM investment as well as change practices to achieve higher returns. If your organization is lacking ha

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

Combination pro

d, historical numbers on projects there are other tools that can be used. Customer satisfaction forms can be used for evaluating success on previous p

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

ojects and can be continued for all future projects. Even if project baselines are missing (most likely), it is usually possible to find out when prev

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

ous projects were expected to start and finish and when they actually did - on a monthly or quarterly time frame. Select a sample size, record the acc

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

racy of the initial estimates and move on. You will have more accurate measures later in the process.

Don't start until you have strong, commit

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

ed sponsors. In the case of one government department, the primary sponsor was transferred shortly after the initial training program. The new

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

regime had their own ideas and despite pleas from the workers, the entire program was dropped. The sponsor in a pharmaceutical firm not only did the p

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

Following aspects would a

resentation at the kick-off meeting, she sat in on many of the trainings and demanded that all tools and techniques be used by staff This forced peopl

dd to the challenges in developing combination products:

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

to accept the new processes and once over that mental hurdle, quickly began to like and appreciate the processes. Without sponsor commitment there is

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

little chance for success.

Don't promise too much, too early. Putting in some basic processes and templates will often show early, posi

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

ive, results. However, depending on the organization, it may take longer than you hoped! Even organizations that focus on short projects (1-6 months)

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

end to take at least a year to see success. Why? People are usually in the process of working on, or finishing up, projects when the new systems come

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

Professional from academic institutions, pharmaceutical industries, health care indust

nto place. Therefore, it will be difficult for them to make many changes until that work is finished. To keep up enthusiasm, get people who are using

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

he new tools to speak up about their individual successes. In one recent example, a PM implemented shorter, problem solving meetings. His director and

.

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

team all had positive comments which allowed him to introduce other tools as well!

In summary, it isn't easy to get organizations to adopt new ways o

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

Companies that provide selfless information through particip

doing things. However, by setting clear and measurable goals, generating a team of supporters, and not promising the moon, positive change will occur

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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