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"Is there a point here or are we just being beat by a blunt object?" One of my direct reports spewed that out like a bad dinner coming up after a night of drinking. It wasn’t the most p

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

olitically correct thing to say to the McKinseyite’s leading the meeting but it was effective. It was about like tossing a hand grenade on the table. It took place during the height of

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

Examples of combination products may in

ur change efforts at Compaq in the mid-nineties. Change was everywhere but nothing was changing ... we were in a meeting!

The number of meetings you experience will be in direct propor

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

tion to the rate of change someone is trying to drive. And the rate of meetings pick up in proportion to how far behind you are in the change process. As the rate of change increases so

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

do the number of participants in the meetings. Of course you can predict the effectiveness, as well, zero.

Compaq was into online scheduling. When I joined the company I was immediatel

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

Combination pro

y booked solid in meetings for three weeks. I asked Kelly, my Admin Assistant, what was with all the meetings? She said calmly, "Welcome to Compaq, where we're 'Meetings R' Us'. She was

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 kidding. After three weeks of really meaningless meetings I pulled myself from the online meeting program. You actually had to talk with me to get a meeting, a novel concept.

So wha

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

t can you do about it? Here are a few points that will save your sanity and a boat load of time.

1. Purpose: Every meeting must have an outcome stated upfront or you don’t go. Yea, you

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

ll probably have to sit through some boring meetings with your boss that have no purpose but beyond that ... demand a purpose up front. My boss at Compaq had ten hours of staff meetings

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

each week. They could have been done in two.

2. Attendance: Only those people should attend that have to present, approve, provide direct input to the process or perhaps are in traini

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

g. No one else should be there. One of my people at Compaq got computer scheduled to a meeting of thirty people who sat around talking for twenty minutes only to find out they were wait

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

Following aspects would a

ng on the person who called the meeting. My guy later found out he was scheduled to be at this meeting in error.

3. Time: When you start the meeting assign a timekeeper. Decide in adva

dd to the challenges in developing combination products:

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

nce how long it should take and don’t go over by one minute. On one consulting/turnaround gig we did the CEO routinely, as in every single meeting, came in and dominated the conversatio

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

causing a one hour meeting to run to three and four and many times they ran into the night. It was awful. No one but me would tell him (privately mind you), how rude it was to takeover

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

and dominate meetings and be so disrespectful of another’s time. He didn’t listen but I told him.

4. Subject: At the start of a meeting you assign a gatekeeper. That is the person 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

at tells the others, "You are off target, that's not the 'purpose' of this meeting. You've all been in meetings where you end up trying to solve world hunger and never get to the topic

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

Professional from academic institutions, pharmaceutical industries, health care indust

at hand. The Gatekeeper's job is to insure that doesn’t happen.

When you run a meeting, make sure those four things happen. Make sure there is a purpose, the right people are there, yo

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

adhere to the time and you stay on course. There is no other way to survive the tyranny of meetings during change.

The choice is yours. Do you want to waste your life in meetings or d

.

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

o you want to do something about it. It was so bad when I was at Compaq during my ten hours of staff meetings weekly, I wrote a small book. It's called A Dozen Things I Learned About Li

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

Companies that provide selfless information through particip

e as a Marine Sniper in Vietnam. It was fun. It was that or slit my wrists. My boss came by one time and said, "My you take a lot of notes." I smiled and said, "Yes Sir I do."

Ed Kugle

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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