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As you climb higher and higher on that precarious corporate ladder, you'll eventually get to the point where you are depending on other people to get work done for a deadline you are responsible for. An example of this would be if you are leading a team doing

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

software design, and you are responsible of having all of the designs done by a certain date. You are responsible for the end result (all of the designs done), but you need your team to actually write the designs for this to happen. What happens if your tea

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

Examples of combination products may in

m doesn't make the deadline? Who gets the blame? This is a simple answer: You.

With this idea firmly in mind, how do you prevent missing a deadline? This is another simple answer, and yet many people don't follow it: Be proactive. What d

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

oes this mean? Well, I find that a good amount of the time a deadline is missed because the team lead does not check to see if their team is on track until the last minute. Finding out that three designs aren't going to be done the day before the deadline is

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

due is not going to do you any good, as it is too late to do anything about it. However, if in this same situation you were to check a week or two before the deadline was due, the outcome might be different. This is being proactive. For our

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

Combination pro

purposes, we can define it as taking action with enough time before your deadline is due to correct any problems.

The following are three things that you can do to be proactive on your projects as a team lead:

Have regular

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

meetings - Not just every once and awhile on the fly, but scheduled meetings. This means that your team knows that you have a meeting at a certain time on a certain day every week. For instance, you could have a 10:00 AM meeting every Monday to kic

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

k off the week and make sure everybody knows what they should be working on. Also, you could have a meeting at 3:00 PM on Friday to wrap up the week. You don't have to go overboard and have a meeting everyday (unless you're in really deep trouble), but I've

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

ound once or twice a week to be effective. Make sure that you have a structure to the meeting as well, and it's not just everybody standing around randomly talking. You need to conduct it and have a clear agenda when you go in for what you want to get out of

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

it.

Keep a tracking spreadsheet - This is another important organization tool: The tracking spreadsheet. Yes, it is a pain to maintain. However, it will save you from a lot of problems in the future. With this spreadsheet, you c

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

an see your team’s progress at a glance. This makes it easy to go into a meeting with them and ask questions about who is slipping or who is going to be ahead of schedule and why. This can save your deadlines by allowing people who are ahead of schedule to h

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

Following aspects would a

elp pick up the slack of those who are falling behind. Also, this is good for meetings with your boss so that you can give them an easy to understand overview of how your team is progressing. The key point to remember here is to make sure your tracking sprea

dd to the challenges in developing combination products:

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

sheet is up to date. It does you no good if you have one, and yet nobody has updated it for a week. If your team is responsible for updating, remind them to update at the end of everyday (or whatever works for you, I just find the end of the day to be effect

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

ive). If you are responsible for updating it, make sure you set aside a certain amount of time to do it everyday.

Check in individually - Even if you have regular meetings, you should have informal progress checks with each of your

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

team members. This doesn't mean that you have a schedule a specific time for this, this can be as simple as stopping by their cube and asking them how they are doing. This way you don't have to find out about a problem that happened on Tuesday at your regul

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

ar Friday meeting. By performing these progress checks, you relay a message to your team that you are right there with them in the trenches, and that you are there to help if they have any questions. Also, as stated above, this allows you to take action imme

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

Professional from academic institutions, pharmaceutical industries, health care indust

iately on a problem instead of having someone waste their time working on it for days at a time. Linking to the point above, if you find a change in someone's progress as you talk to them, update the tracking spreadsheet immediately after you get back to your

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

desk. This way you can see how that change is going to impact the rest of the team and your final deadline.

These are just three ways I've found that help me to be Proactive. There are probably lots of other ways specific to yo

.

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

ur work situation that can also help you out. A good way to think about your deadline situation is this: Whoever is holding you responsible for your deadline probably looks at your project as something of a black box. They don't want to know the fine detail

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

Companies that provide selfless information through particip

s, they just know what they want to see come out of it. With this in mind, you want to deal with any problems that arise inside that box, rather than outside of it, so that when your finished product comes out the end result is what this person is looking for

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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When dealing with foreign investors and franchising in another country often language and interpretation of word meanings can get clouded. Additionally tenses or gender of words can change what a sentence says or means in an agreement.

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