Advice You - Business

Kevin was ready to get the day started. He only had one scheduled meeting all day, a real rarity. He was looking forward to a day in the office to catch up on calls, emails, filing, etc. As he walked out the

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

door of his home he slipped on some ice and broke his ankle. Kevin’s day just landed in a totally different direction than what he originally intended.

Julie woke up all set to get the week started. She was

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

Examples of combination products may in

xcited because she was ready to dig in and be a productivity maven. She had put a task list together and she was geared up to tackle it. Just as she knocked one item off the list and felt that she was just ge

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

tting on a roll she was interrupted. The interruption itself isn’t really important to this story – whether it was a colleague “dropping by”, a client calling, or her son’s school – the fact remains, her roll

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

as brought to a screeching halt.

Does this sound even vaguely familiar to you?

Many of us start out our days or our weeks very well intentioned, excited even, to be productive or make a dent in the “to-do” li

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

Combination pro

t. Occasionally, something unexpected happens. The unexpected event prevents us from being as productive as we would like to be. When this happens we have a number of choices. The choices are about how we th

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

ink, how we behave, what we do, and how we respond.

How do these unexpected incidents affect you? How do you behave when they happen? What do you think about when your productivity is directly impacted?

The

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

intent of this article is to highlight the choices we have when these situations arise. The more we are aware of the choices we have in unpredictable situations, the easier it is to identify a choice that make

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

the most sense in the moment.

Choice of No acceptance – We see children pick this choice quite often when something doesn’t go the way they want. They get frustrated, pout, and throw a tantrum over it. As

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

adults this is typically tempered a bit, but the same idea applies. It is a choice to be frustrated, anxious, and even pout about how the unexpected situation threw your plans for a loop. It is the choice to

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

ot accept that unexpected things or events can, and will at times, change our best laid plans. This often leaves us less productive and miserable doing what came up unexpectedly. Do you ever find yourself in

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

Following aspects would a

his choice? How long do you stay frustrated before realizing that it isn’t going to do you any good? Do you realize at some point that you should choose another path at least for your own sanity? While this

dd to the challenges in developing combination products:

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

is a choice, it’s not one I recommend.

Choice of Hesitated Acceptance - Outwardly there is acceptance that the day just took a big left turn. Inwardly we don’t let go of thinking about all that we wanted to

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

chieve and how it’s not getting done. We may be pondering when we’re ever going to have another day to be productive. The “perfect” productivity day still seems wasted even if we go through the motions of havi

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

g accepted the unexpected change we’ve been dealt. This is almost worse than “No acceptance” because your inward and outward self are being incongruous. Have you ever been here? What do you do when you reali

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

ze that what you’re saying and what you’re thinking are not synchronous?

Choice of Acceptance – Accepting that our day or our week is no longer going to be what we originally intended can help relieve the fru

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

Professional from academic institutions, pharmaceutical industries, health care indust

tration as we look to assess what must still get accomplished and when might we get back to the things put on hold. When circumstances in life are beyond our control identify how to make the best of it. Go wi

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

h the flow. Be ready to change direction with the new direction set. How often do you go with this choice right out of the gate? Is it difficult to get to a point of acceptance for you? What needs to happen

.

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

for you to be more accepting the next time your day is turned upside down?

For those few and fortunate souls who can change with the wind and adjust to new plans on the fly; more power to you. Don’t lose sig

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

Companies that provide selfless information through particip

t of this wonderful gift you have. When you see someone else struggling to accept unexpected circumstances, offer to assist them. Share how you think about it and what gets you to choose acceptance so quickly

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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Credit card processing costs can add up but cannot directly be passed on or down to customers. While business owners should include the cost to process credit cards when determining fees, they cannot surcharge customers for using credit cards -- at least in most scenarios.

Most Web 2.0 sites that will help you market your site will Only work if you make a conscious effort to share your resources. Think of it as traditional networking amplified and assisted by web tools. Realize, though, that the technical details of how to maximize social bookmarking, blogging, RSS, collaborative tools and widgets are all useless without the new underlying first rule of the Web.

Even professionals can say something they wish they didn't. It's even more important that executives and managers recognize the importance of what they say, how it may be interpreted and what to do if a mistake is made.

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Advice You - Best Laid Plans - Unexpected Events - and the Choices we Have

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