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A girlfriend and I were feigning lament over being unemployed one afternoon. One of us (I’m not confessing who) mentioned wanting a kick-back job that paid well. The kind of job where you work no more than eight hours and had some free time to catch up with coworkers. The kind of job where

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

you knew you could leave at 4:00 every day so you can catch the last half of The Ellen Show.

Don’t get me wrong. We are both hard working people. We aren’t saying that we don’t want to put much effort into our jobs. When we are at work, we work hard and we work smart. We just want to have

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

Examples of combination products may in

life outside of work. We want to be treated like human beings, not machines.

I don’t think it’s natural for human beings to operate like clockwork (i.e., arrive at 8:00 on the dot every day, take only a 60 minute lunch). Life happens. Sometimes we have a rough night sleeping and need an e

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

tra 30 minutes in bed. Sometimes you hit traffic and sometimes your cat throws up on the bed as you are about to walk out the door.

I don’t think it is reasonable to expect people to not socialize or interact much while working. I understand that we are there to conduct business. However,

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

e are interacting with other human beings, who unfortunately, tend to intrigue us. When we are doing business with someone, we want to know who we are working with, right? We want to know how they spend their weekends, whether they are married and have kids, where they bought those cute sho

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

Combination pro

s. Meetings should have a 30 minute buffer where people just chat and get to know each other.

Instead, we have a lunch hour. We’re supposed to cram all of our “catching up” and socializing in a 60 minute period. But, the lunch hour is an illusion. There are lunch meetings where you actuall

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

y discuss business. Somehow, people manage to schedule meetings (no lunch included) to run right over your expected arrival time at Baja Fresh. If they don’t manage to schedule them over your usual lunch time, they book you up all morning and all afternoon so you end up captive at your desk

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

doing the action items from your morning meetings and preparing for your afternoon meetings. And you don’t even have 15 minutes to gripe to a coworker, phone your spouse to say “I love you” or call the plumber to fix the kitchen sink. Oh, right. We’re supposed to do that over lunch.

Geez.

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

don’t even have a job right now but I’m getting woozy just thinking about it. I better go eat lunch now while I still can.

Anyway, it’s 1:00 now so you head off to three hours of poisoning by PowerPoint in the Gas Chamber Boardroom. By the time you stagger out of the conference room, it’s

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

4:00 and everyone who is smart enough to take public transportation is shuffling out of the office in a hurry. They can’t miss the bus/train/donkey – otherwise how on earth will they get home? You look around the office. It’s you and a bitter 20 year old receptionist who is bound to her des

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

until 4:59 (she cheats and leaves early).

You envy the receptionist. She makes $12.50 an hour but she gets to leave by 5:00. You have reports to send out, emails and voicemails to respond to (thanks to that 24 hour response “service level agreement” your manager loves) and action items up

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

Following aspects would a

the yin yang. You could let it wait until tomorrow, but your manager promised on your behalf that you could have five things done for first thing tomorrow morning. So you scowl, pout and swear a little before putting on your iPod to start the second half of your workday, called Overtime.

dd to the challenges in developing combination products:

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

our manager bounces happily out of her last meeting sometime around 8:00 and is happy to see you there; now she has company for the next few hours. You consider using the staple remover to stab holes in your wrists so you can bleed to death.

I figured out what the problem is. There is alwa

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

s going to be someone (usually under 30) who is willing to work like this. There are simply far too many people out there who don’t have spouses, kids, significant others, families, friends, hobbies, evening plans, a bus/train/donkey to catch, or any biological need for seeing daylight. Tho

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

e people are making everyone else look bad. We can’t compete with these people. They have all the time in the world, and they are just fine spending it all in one place - work.

I remember interviewing candidates for two positions our team had open. One was an entry level job, the other was

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

a senior level associate. The entry level candidates did the eager head nodding the whole time, said “yes!” to everything we asked, and didn’t flinch when we touched on working overtime. In fact, they nonchalantly responded with “overtime is fine” as if only an idiot would say anything else

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

Professional from academic institutions, pharmaceutical industries, health care indust

. We immediately hired two of the candidates for full time jobs + plenty of overtime.

Then we interviewed the senior level candidates. We didn’t get a chance to ask about overtime. They brought it up first, inquiring about “work life balance” and how that is handled in our organization. De

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

d silence followed. I must have blacked out at that point; I don’t recall how we responded (it was a panel interview). These candidates were cautious and were clearly evaluating US to see if we gave responses that fit into what they were looking for. We tried to hire four of the candidates

.

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

or full time work. Three offered to do part time contract work for us. The fourth accepted a full time job and is pretty upset about it now.

I just don’t think work should be that difficult. Show up in the morning, work your 7-8 hours as you see fit, and head home in time for Ellen. Build

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

Companies that provide selfless information through particip

elationships with your coworkers by doing a nice blend of business and socializing. Every job needs balance between work and life. Your manager should be kicking you out by 4:00 so you can enjoy some sunshine and catch an early yoga class. And if that doesn’t work, try public transportation

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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