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Can Project Managers prevent projects from slipping?

Ask a techie to come up with a schedule for a specific list of activities, and more often than n

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

ot, he/she will present a fairly accurate estimate. Some activities might be underestimated, others overestimated, but overall, the plan will be fair

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

Examples of combination products may in

ly accurate.

However, something happens to these estimates between the time the techie writes them down and the time the Project Manager publishes a

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

aseline project schedule. That “something” is why projects slip.

Projects tend to slip for two reasons. Either Project Managers don’t account for d

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

erivative activities such as vacation days when planning the overall project schedule, or they simply succumb to the pressure from management to compr

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

Combination pro

ss the schedule.

The case surrounding derivative activities is well documented 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

ls20041207.htm">here or on The Project Mangler (www.projectmangler.com), so I won’t spend any more time on it. The case surrounding management pr

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

ssure is not.

Management Pressure

Assuming your techies have estimated each task and that you’ve considered derivative activities, your proje

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

ct schedule should be accurate. Aggressive, but realistic.

Now, present this schedule to the management team, and 8 times out of 10, the feedback yo

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

’ll get is “that’s too late”. Eight times out of ten, you’ll be asked to revise the schedule and shorten it.

Project Managers are all too familiar w

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

ith the project triangle. We know we can shorten a schedule by either (a) reducing the scope of the project, or (b) adding more resources to it. Unf

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

Following aspects would a

ortunately, management either hasn’t seen that triangle or, more likely than not, simply chooses to ignore it.

Consequently, Project Manglers who are

dd to the challenges in developing combination products:

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

more interested in pleasing upper management than keeping honest have come up with their own universal algorithm for shortening project schedules. Ta

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

ke the number of days that need to be cut from the schedule, divide it by the number of major milestones, and then deduct that number from the duratio

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

of each milestone. In other words, if a project comprising of 4 major milestones is estimated to last 6 months, but you need to reduce it by one mon

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

th, you’d take 20 days, and divide it by 4. Take the answer (5), and deduct it from the duration of each milestone. And voila! Works every time.

A

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

Professional from academic institutions, pharmaceutical industries, health care indust

d at the end of the project, either your techies save the day (by working evenings or weekends) or the project slips.

Conclusion

Can Project

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

Managers prevent projects from slipping? Absolutely. Just stop publishing overly optimistic schedules.

1. Get your techies to help estimate the dura

.

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

ion of each development task.

2. Add time to the overall project schedule to account for derivative activities.

3. Don’t succumb to pressure from ma

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

Companies that provide selfless information through particip

nagement

And last but not least…

4. Stick to the basic principles behind the project management triangle. In other words, don’t be a Project Mangler

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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