Advice You - Business

I have to admit that I’m starting to slow down a bit. I am definitely in my final career – and quite comfortable w

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

orking a 40 hour schedule. I even take a day off here and there to golf/ bike/ ski, although I’m thinking of selli

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

Examples of combination products may in

ng my windsurfing equipment .

For the past two years I have been looking for a spot in paradise to retire to in fi

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

e years or so - and I think I found it!

I have been traveling all over the Western US looking for the perfect spo

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

t to retire. But my idea of retiring is not the same as my Dad’s - and then again, maybe it is. Let me explain.

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

Combination pro

y Dad had a pre-WWII high school education. He worked in government service for 30 years. He grumbled about his jo

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

b the whole time – that is until the last few years. In his last assignment, he finally found a role that made him

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

happy.

He was mentoring a group of programmers as they built a new system for the state of Pennsylvania. They wer

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

e clueless about Health and Human Services. They really needed somebody that new how the system should work – he l

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

ved it. Then he hit mandatory retirement age and they kicked him out.

My Dad wasn’t a dummy. He knew that he had

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

a good deal, but he really missed his job. He never moved from Harrisburg, PA. For years, he made a monthly visit

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

Following aspects would a

to his old department, to visit the folks he trained.

Now - I never did anything the same way as my Dad. I went

dd to the challenges in developing combination products:

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

o Carnegie Mellon. I spent some time as an over educated ski bum and I traveled a lot before I settled down. As a

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

management consultant, I worked all over the world. I moved from company to company and even started a few, but I

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

ade a mountain top on the coast of California my home base.

But, guess what? My dad and I ended up in just about t

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

he same place after all.

I now own my own business and I work with a solid network of business professional. I sp

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd most of my time mentoring and consulting with entrepreneurs and business owners. My role is remarkably similar t

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

o my Dads – but there is nobody that can kick me out.

I just returned from two weeks in Kauai. My bride and I had

.

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

a great time in one of the loveliest places in the world. But toward the end, I was really ready to get back to my

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

Companies that provide selfless information through particip

office. Unlike my Dad – I am looking forward to my working retirement in paradise – doing more of the same that is

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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Advice You - Retiring in Paradise

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