Advice You - Business

Insane. That is what you would hear if you were to spend a day with me, and ask the people I work with what they think about their schedules. We praise ourselves on being doer

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

s and shakers, and on our no-nonsense, result oriented approach. But still most people spend enormous amounts of time in the office and when tiredness sets in and their outloo

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

Examples of combination products may in

k becomes a little less positive, they will confess that they can’t keep up.

Now… I have to confess something myself: I can keep up. I have more free time than anyone else. T

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

he truth is: I am the one who works the least in my office (and paradoxically the one with the best results)…

What is the secret?

One of my interests has always been acc

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

elerated learning. One day, I asked myself the following question: What is the fastest way to learn something? Well… the fastest way is NOT to learn it, I answered jokingly.

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

Combination pro

t first, I thought this was a nice theoretical answer, but with no application in the real world. Fast-forward a few months, and I am in charge of a big IT project. Pressure i

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

s coming from all sides (client, managers, developers …) There is so much to “do”, that there is objectively no way everything can be done, even by working 24 hours/day, 7 day

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

s/week.

This was actually a great situation to be in, because if there really is no way to do something, you are forced not to do it. And then the miracle occurs. The task yo

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

u thought you had to do, you do not do. And you survive. You realize the necessity of this task was just an illusion. Then you wonder what would happen if you did not perform

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

the next task. Again, you see the illusion. Soon, you wonder how you managed to spend so much energy on trivial things. And you enjoy free and playful time again.

Doing only

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

hat is really essential is more than enough (but this, you need to do better than anyone else – or at least, be perceived that way, and this is the subject for an entirely dif

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

Following aspects would a

ferent article).

Here are the master questions you need to use:

- Before doing something, ask yourself what would happen if you did not do it. If you can live with the c

dd to the challenges in developing combination products:

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

onsequences, do not do it. The real understanding you need to get to, is that you can live with far more consequences than what you presently think. There are really very few

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

things that you absolutely need to do. There are several good ways to deal with the emotional aspects of this approach, and if you are interested, let me know. I can explain v

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

ery concretely how I do this.

- If something really needs to happen, the second question is: Who could do this instead of me? Watch out with this one, because the sub questio

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

is: Is this person reliable? Does she have a track record of delivering fast and correct results on her own, or will I need to check her work? (Again, managing other people i

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

Professional from academic institutions, pharmaceutical industries, health care indust

s a separate topic which I will address in future articles)

- If no one else can execute the task, then the question is: What is the fastest way I can do this? How accurate d

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

oes it have to be to be “enough”? And the most important question: How can I manage other people’s expectations? How can I be perceived as having done an excellent job?

There

.

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

is a lot of power in those questions (and I will expand on them for people who are interested). Do this for everything until it becomes a habit.

Perfectionists (I used to be

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

Companies that provide selfless information through particip

one) will have a hard time with this. Until they see the benefits in their life… Trust me… There is no feeling like the one coming from doing nothing and being praised for it

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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If you have ever bought products outside of retail stores, you most likely know of the great deals that can be had from getting your items from overseas. You can get your products for a fraction of the cost. Most people are not aware that the items that they buy are usually imported, so they are not aware of the great savings they are missing out on. It can be hard for an individual to make purchases as such overseas, but for a businessperson, it can be a great asset that they can obtain quite easily.

Why should you care about my viewpoints? Good question - you don't know me - but obviously - You're confused and maybe even a bit fed up by your new assignment and it's lack of clarity... Typical ...

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