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The Super Bowl is a game but, like sports in general, it offers useful life lessons that we can take with us . . . if we only look below the surface. As I wa

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

tched the game, I saw a number of things. How many did you see?

1. As I pointed out last year, winning is a team effort. That was never more obvious than th

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

Examples of combination products may in

s year when the Steeler offense was going no where for most of the first half and the SeaHawk offense was moving the ball almost at will. All of the focus pr

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

or to the game was on the offenses and, in particular, the match up between the quarterbacks. But Pittsburgh’s Roethlisberger started horribly, piutting pres

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

sure on the defense. Seattle moved the ball against the defense but could not “seal the deal” with points as John Madden said diuring the game.

In his post-

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

Combination pro

ame comments, Coach Cowher spoke about the team effort that went into winning, in particular the coaches who put in an enormous effort all season long to ada

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

t to the chages that kept occuring all season long.

Who are your coaches or are you trying to do everything by yourself? Champions take coaching from the st

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

aff who are able to look at their performance and offer good advice that the pro adapts to. Wouldn’t that be helpful in your career planning?

2. Excitement

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

s a great motivator; fear isn’t. Pittsburgh came out “jumpy” and unsettled. Penalties and poor execution on offense and on the defensive side of the ball alm

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

st put them in a big hole. Fortunately for them (but unfortunately for Seattle), each time Seattle moved the ball, the Steeler defense would hold. Pittsburgh

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

scored right before the half making the score 7-3. Seattle had dominated the play through most of the half but was trailing.

When you interview, it is OK to

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

Following aspects would a

be excited but arriving fearfully can cause you to make mistakes that can cost you the job you’re well qualified to perform. You don’t execute well on the i

dd to the challenges in developing combination products:

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

terview and you go home to explain what happened. It’s a horrible feeling.

3. Critical mistakes will keep you from winning. Seattle arrived as a team who ha

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

not turned the ball over for several weeks and left as a team that dropped passes, threw a critical interception, fmbled at a critical juncture, committed c

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

ostly penalties that cost them 14 points (or enough to win).

4. Try not to be predictable. The team that runs the same plays over and over again will be def

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

ated. Pittsburgh buried Seattle with an end reverse becoming an option pass touchdown to Hines Ward. In their playbook all season, they only ran the play onc

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

Professional from academic institutions, pharmaceutical industries, health care indust

all year.

5. Planning for next year started 72 hours after the teams left the field. That should be true oof how you start planning for your next career mo

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

ve. As someone once said, the person who gets ahead isn’t always the smartest and doesn’t always work the hardest . . . although those are great qualities to

.

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

have. The person who gets ahead is the one who remains alert to opportunity. Sometimes that’s within an organization; sometimes it’s outside of it.

Good luc

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

Companies that provide selfless information through particip

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 - Job Search Lessons from the 2006 Super Bowl

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