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One of the things I really enjoy as a therapist is helping people learn how to handle stress. I often ask clients what a typical day is like for them, so I can understand what they are up against.

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

"Take me from getting up to going to bed" is one way I usually ask the question.

I've heard about some horrendous schedules. After listening to some people, the question changes from "How could y

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

Examples of combination products may in

ou feel so stressed-out?" to "How could you not feel so stressedout'?"

Of all the schedules I have heard about, I truly think the most stressful are those of women who have the dual careers of "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.

ofessional outside the home" and "professional mom" at home.

Notice that I haven't used the popular term "working mom." All mothers work.

Consider the words of Amy Grant from her song "Hats!"

"O

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

ne day I'm a lover, one day I'm a mother. What am I supposed to do? Working for a livin,' all because I'm driven, to be the very best for you."

She seems to have captured some of the angst and pre

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

Combination pro

ssure of the typical dual-career woman.

What a schedule!

Follow along with me as I describe the typical daily schedule of one dual-career mom.

• 5:30 a.m. Alarm goes off. Get up and get r

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

eady for work. • 6 a.m. Make kids' lunches and fix breakfasts.

• 6:30 a.m. Wake up kids, make sure they get bathed, dressed, fed and ready for school. Make sure oldest is at bus stop by 6:45 a.m.

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

• 7:15 a.m. Leave house, drop one kid off at school and the youngest at day care. Listen to the day-care worker tell about problem with your child yesterday.

• 8 a.m. Arrive at work.

• Noon. Do

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

errands on lunch hour.

• 3 p.m. Leave work to take one child to doctor's appointment.

• 4 p.m. Return to work.

• 4:15 p.m. Take call from oldest child who just got home and is checking in. Work

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

until 6 p.m. to make up for time off in afternoon.

• 6:15 p.m. Pick up kids at day care.

• 6:45 p.m. Arrive home, fix dinner, give baths, help with homework, get ready for the next day, get kids

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

in bed.

• 9:30 p.m. Time for self and to be with husband.

• 9:45 p.m. Fall asleep. Next morning get up and do it all over again.

Whew! It wears me out just to think about that schedule. In my c

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

Following aspects would a

onversations with dual-career women, several themes have emerged. Let's take a look at what is most stressful followed by some suggested solutions.

What is most stressful

• Juggling multip

dd to the challenges in developing combination products:

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

le schedules

• Finding quality time for everyone, including oneself

• Spending the weekend catching up instead of relaxing

• Coming home to cranky, hungry kids

• Exhaustion - physical, mental,

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

emotional

• Worrying if kids are well cared for while you are at your job

Solutions we have found together

• Get your partner to help.

• Make lists. This was one of the most common sugge

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

stions. Make lists of all the to-dos and appointments and commitments. Having them on paper not only organizes you, it can clear your head as well. One crucial key is to make sure your own needs ge

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

t on the list.

• Plan ahead. Cook several meals and freeze them. Plan outfits for a week, etc.

• Hire someone to help with cleaning. If you can't afford it, hire someone anyway, even if it's only

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

Professional from academic institutions, pharmaceutical industries, health care indust

once a year.

• Keep just one room of your home clean. Many people say this makes them feel less pressured.

• Get out your schedule book and make two appointments. One is for time completely to y

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

ourself. The second is with your spouse or partner. Protect these times as you would a business appointment or job interview. I learned this technique from my wife when she wrote her name down in m

.

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

y appointment book a few years ago. I got the message.

• Once a month, or with a similar regularity, pamper and indulge yourself in some way.

• Create realistic expectations and priorities for yo

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

Companies that provide selfless information through particip

urself. Consider what's more important, a clean house or time with your family. Well, that's what I've learned from the dual-career moms I know. I invite your comments, experiences and suggestions

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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