Useful Advices - Business

I got yelled at tonight. Not the type of yelling that someone does when you’ve done something to tick someone off, but the kind of yelling

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

that was a swift kick in the pants about something that I'm NOT doing.

I probably deserved it. I needed to hear it. But it made me edgy an

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

Examples of combination products may in

d I tried to make excuses.

Nope! That didn’t work. I continued to get the lecture.

Now I know you are all dying to know what I did that w

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

sn’t exactly right. Mary? Got yelled at? How DARE they?

Here’s what happened. Tonight my husband and I met out a friend from swimming and

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

a woman I set him up with on a blind date. Lets call him Bill. If you read the entry that he dances to his own tune, then you’ve met Bill.

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

Combination pro

In my book, he’s a consistent and dedicated swimmer. The lecture was about the fact that: I’M NOT.

I miss practice. I get there a tad lat

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

. And, I miss practice.

I told him I HAVE A LIFE. I have a child! I need my sleep!

He reminded me that I have a goal. I want to make nati

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

onals. I want to lower my time. I’m pretty close to doing it too.

So, here I am at 3 in the morning writing about the fact that I got yell

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

ed at. And I think it worked. I know he’s right and I’m going to change my schedule around a bit so I can make the practices more often. I

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

as going to about 3 a week instead of 4.

Earlier this week I dropped a note to friend who is an entrepreneur. He and his partner had a yel

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

ling match on the phone. I know them both well and they’re both working hard at building their business. They had a disagreement and I trie

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

Following aspects would a

d to help smooth over the conflict.

I got this email from my friend that I liked:

Mary: Thank you for your insight….Every tree that yield

dd to the challenges in developing combination products:

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

fruit must be shaken to get the best from the top.

So, I thought about it for a while and realized that the conflict did shake things up.

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

It got them both out of their comfort zone. It made them think about what really was the answer to their problem. Because they didn’t danc

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

e around the problem and play nice they were able to solve the issues more quickly.

I’m always the type that wants to avoid conflict. I th

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

nk that a lot of people are like me. Its easier to talk things out than yell and get to the bottom line. But I see how that works.

Now I’m

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

Professional from academic institutions, pharmaceutical industries, health care indust

not proposing that anyone else should go out and confront anyone just to be able to yell at someone, but I do think that honest confrontin

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

g can be exactly the thing to make someone step up to the plate, take ownership and pull their weight or change some sort of negative behav

.

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

or. It’s sometimes quicker than having discussion after discussion. It’s certainly more memorable. And sometimes, it can get you up at 3 in

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

Companies that provide selfless information through particip

the morning to blog about it!

But lets just SEE if it'll get me out of bed for 5:30am swim practice more times a week! I'm betting on YES

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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