Top Adding - Real Estate

The holidays are rapidly approaching and I’ve managed to do most of my Christmas cards and gifts on time this year! I still have a few to go, but for me most of the pre-holiday madness is over. It is now time t

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

o focus on a strategic plan for next year and I’m actually going to take a day out of “regular” work to get it done.

I’m going to go week by week, all 52 of them, for 2007. On the plan will be my goals for the

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

Examples of combination products may in

Year, the Quarters, the Months, and the Weeks. I’m taking a top-down approach that will ultimately drive my daily activities. And I will include plenty of vacation time! As I contemplate this process, I can se

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 that I’m going to have to get very good at several things:

1. Delegating - You have to “let go” to grow.

2. Following Up - While you do have to let go, you don’t “assume” that what you give to others will be

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

done the way you want it, when you want it. Accountability is a key to successful delegation.

3. Flexibility - No plan is perfect, nor does it survive the first play of the game (to mangle a football analogy).

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

Combination pro

Plans need room to adjust to changing conditions, so setting aside “update time” is critical to the process.

4. Measurement - As mentioned in #3, a plan is a living thing and needs to be reviewed constantly to

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

see if you’re on track to meet your goals. A plan without measurement is only a dream.

I’ve never done this before in this manner, so I’m planning on using some visual aids. One of them will be one of those de

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

sktop calendars … actually a couple of them. I’m going to use one to do the initial planning, so I can scribble, scratch out, take notes, and make changes. I’ll copy the final plan to the other one when I’m don

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

e marking up the first. I’m also going to use colored pens to clearly mark certain types of activities. When I’m done I’m going to post it on the wall, so everyone can see it. That way, we can literally be on

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

the “same” page. I think I’ll also use some kind of thermometer-type graphics or a series of bar charts to visually express key elements of the plan and the progress we make.

What about you? What will you do,

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

besides enjoy a really excellent vacation with your family in some great ski area or warm tropical setting, to further your goals during the holiday down-time? This might be a good time to approach your commerci

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

Following aspects would a

al real estate investment program in the same manner.

• You can set up some categories of things to do, like “Real Estate Education,” “Property Analysis Tools,” ”Days Driving Neighborhoods,” “Commercial Properti

dd to the challenges in developing combination products:

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

es Owned,” “Net Equity,” etc.

• Write down where you want to be in each category at the end of 2007.

• From there, break each category down by Quarter and work backwards to see where you’d have to be to reach t

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

hat goal by Year’s end.

• Now do the same process by Month to see what you have to do to hit each Quarter’s goal.

• Break your Months into Weeks and repeat the process. I suggest setting aside time in your pla

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

n each month to review your progress and allow for adjustments in the plan.

• Now take a single Week and write down what you have to do each Day to hit a Week’s goal.

• These become your “Important-High Priorit

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” activities … not to be confused with the Urgent ones that you think you have to do ahead of everything else.

• The Final Step is to set aside time during every day to spend time on these “Important” activitie

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

Professional from academic institutions, pharmaceutical industries, health care indust

s. This is time when no one can find you, the cell phone goes off, the GPS is dropped in a drawer, and the Radar is silent. It doesn’t have to be a long time … as little as 15 minutes, really. And it has to be

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

done consistently.

This process is called “Chunking Down.” If you do this, and really, really focus on setting aside that special time for your “Important-High Priority” activities every day (OK … we’ll allow

.

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

you some flexibility!), you have to succeed. It’s a wonderfully simple process and if combined with easy to see visual references, it will catapult you to success in whatever you choose to accomplish. This appl

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

Companies that provide selfless information through particip

ies to commercial real estate investing, as well as your personal life. Consistency and focus is an unbeatable combination. I’m looking forward to implementing this process in 2007 and I hope that you will, too

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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