Advice Pool - Business

Steve’s a pretty regular guy – wife, 4 kids in their blended family, 12+ years of engineering experience, a degree, mortgage, car payments, some debt… and feeling depressed because he waited to look till the end. Last time he tran

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

sitioned was 5 years ago for more money and he liked some of the people and it was simple…this time he’s heard some in his professional association have been looking for almost a year...and they weren’t lightweights. No wonder he’s s

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

Examples of combination products may in

weating.

Steve’s wife can’t figure out why he’s so moody and angry…she doesn’t understand that Steve has feelings of rejection from a company he had been loyal to for 5 years. He had poured heart and soul into his projects. Eve

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

n though he didn’t always agree with his manager’s direction, on a project he shepherded, he had been recognized for achievement. Gosh, only 2 years in and already a rising “star”.

In hindsight, Steve saw he had subtly butted heads

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

on how the team was treated by management and that he made suggestions that “his bosses’ way” was backward. Things began to slip. It was more real when he didn’t get a merit raise. He didn’t fathom the basic tenet that consistent

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

Combination pro

values with the management are fundamental to longevity. You see, Steve made an “easy” choice to compromise his work ethics and principles because he thought he was on the upside of lots of growth (money).

Choice #1 – Choose base

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

d on values – not only on personalities in the organization.

Now that his desk was cleared out, a few weeks to wind down was in order before he could mount the energy to start looking. After all, he deserved a break, didn’t he?

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

It gave him time to think over what went wrong…to concentrate, to brood over the calamity that landed on him because others hadn’t done their jobs. It simply wasn’t fair…Jesse, their 6 year old, couldn’t understand why “daddy just si

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

ts in the den and won’t play with me anymore…”

Choice #2 – You have power to choose your reaction to difficulty. It was business, not personal, and even if it was personal, so what, get some support, get some direction, get some

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

help to tackle this bump in the road and get on with life.

Steve’s wife finally pushed him to get his resume posted online…this is easy! What he didn’t know was the internet is only about 4% of the market and that less than 10%

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

of the companies who have posted have ever hired someone from the internet. He has complacently fallen into a deadly trap believing quantity will always yield quality positions!

Choice #3 – Choosing to get a career by coincidence

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

Following aspects would a

will seldom (read seldom as never) yield a role with expansive growth potential and long term satisfaction. It is not easy; it takes expertise, competitive edges of timing, better exposure and more powerful communications about capa

dd to the challenges in developing combination products:

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

city to win a position of your choice.

Eventually, Steve let a recruiter encourage him to “get his foot in the door” in a company a few states over. It was his only “egg in his nest” and a few steps back to where he had been 8-9

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

years earlier…and he’d have to leave Sundays and come back home Fridays since relocation wasn’t even offered. But what choice does he have – it’s been 11 months since he was let go and savings have dwindled and he’s tired of being a

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

tay-at-home dad.

Choice #4 – Choosing to take a job will only spiral down his career, his confidence, his perceived capability and his cash. Being talked into – that is recruited/sold – a cookie-cutter position versus taking a po

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

sition that has been engineered around him. There should be no question.

Well, Steve has gotten accustomed to the commute and his efficiency apartment and really looks forward to seeing his kids next weekend. The job is just th

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

Professional from academic institutions, pharmaceutical industries, health care indust

at – he’s surviving, but there’s no challenge…same-o every day. That recruiter called back to say he’s got another job like this on the East Coast – Steve hung up on him this time…about all the energy he could muster. Been feeling r

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

eally exhausted.

Choice #5 – Choosing to ignore his body cues of exhaustion only leads Steve to depression and powerlessness and feeling trapped again. Choosing to have proper rest, diet, exercise and balance of life invigorates.

.

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

Steve’s 17 month anniversary is coming up – he’s looking a little haggard from the day-to-day grind. It’s Friday, about 2 and Steve’s boss wants him to come to the conference room…and the HR person is there…

Choice #6 – S

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

Companies that provide selfless information through particip

teve can choose to run this cycle again…or choose to purposefully utilize his full potential by proactively marketing himself.

It’s Steve’s choice…it’s his career…it’s his life… Then, again, maybe it’s not Steve; maybe it’s you??

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 Pool - Just a Series of Choices

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