Main Subject - Business

When you first start your own business there never seems to be enough time. I certainly was no exception to this entrepreneurial mantra. What the truth really is; onc

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

e time is gone it can never be reclaimed. One of the reasons I got into business for myself was not only for a more affluent lifestyle but also to spend more quality

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

Examples of combination products may in

time with my family. However, what I quickly found in my first few months is, that all my time was used primarily to build my business and my family came second. The

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

daily up hill climb which required me to make a success of my business so I could deliver on my promises to my family blinded me to the fact that I was not living in

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

the present. That time was in reality passing me by and, by the time I did make the business a success my family might be too old to want to spend time with me. Somet

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

Combination pro

hing needed to be done to balance work and family.

What I chose to do to remedy the situation is volunteer to coach my son in baseball. Now, you are probably thinkin

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

g to yourself, how can I find the time? Easy! I had a baseball schedule that became integrated to my business schedule just as you would book any business appointment

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

Surprisingly for me at the time, with the rare exception, I made all my appointments.

The obvious benefit is I now had more time with my son but, I also had more ti

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

me with my daughter and my wife. We went to all the games together and enjoyed watching all the young boys play baseball. In the following years my daughter played ba

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

seball and both kids played soccer. We always had the time.

Now here is the not so obvious benefit, my company grew customers and suppliers to my business through my

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

contacts in baseball. As the years went on I became a coach for Double A baseball, then Triple A and then took over as a Manager of a Double A Team. This led to me s

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

Following aspects would a

itting on the Board of Directors of Rep baseball. In other words, my time commitment for volunteering increased. You would think my business would suffer. It didn't.

dd to the challenges in developing combination products:

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

One Sunday night at a Rep Baseball Board meeting we starting talking about all the coach/manager volunteers being in most cases in their own business. We deemed this

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

to be normal as we have more control of our schedule than someone who is in a job. And then it occurred to us that we are missing out on a great networking opportuni

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

y. Our Baseball Association had over 100 Managers, Coaches and Coach Assistants. We decided to have a Business card Swap Night.

The idea was well received and greatl

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

y attended on a Wednesday night at our Club House. Each person had 3 minutes to do their Elevator Pitch (A speech about you and your company that is short and to the

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

Professional from academic institutions, pharmaceutical industries, health care indust

point and equivalent in time to the ride on an elevator when someone ask you what you do for a living). All Business cards were left on a table and in a no pressure e

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

nvironment you could help yourself to a business card.

For me it was a boon to my business. I secured my second largest client and found new contractors who performe

.

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

d better at better pricing than my current contractors.

The lesson to be learned here is Volunteering has many benefits to your family, the rewarding emotional good

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

Companies that provide selfless information through particip

feeling of helping other children who may be in broken families and, needless to say, the success of my business.

Time cannot be reclaimed but it can be spent wisely

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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I always find it sad when I bump into someone and find out that they just lost their job. That is always unsettling. I can't help but empathize with their situation.

Contrary to popular opinion, business opportunities abound in all kinds of economies; you just have to know where to look for it. And sometimes, you should consider creating business opportunities instead of waiting for them to come knocking at your door.

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