Cases - Business

My mother has Alzheimer’s. She’s been in a nursing facility since February of 2005, and she’s more or less bed ridden. One of the many negative effects of Alzheim

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

er’s is rapid memory loss to the point family members’ names are forgotten and some members get forgotten altogether. Another symptom is life regression—that is wh

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

Examples of combination products may in

ere the person mentally and emotionally backtracks from their current age back to birth. The average person afflicted with Alzheimer’s has a life expectanc

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

y of roughly seven years from the time of initial diagnosis. Luckily, our family still has some time to share with mom, but the inevitable is always loomi

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

g. It’s truly a gut-wrenching experience for both the patient and loved ones. If I were to guess as to where my mom is in her regression, I’d estimate her to be s

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

Combination pro

omewhere in the neighborhood of her early twenties to late teens. She’s 78 years old so you can imagine the transgression and what it means.

Early in my mother’s

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

career she worked for the telephone company as a switchboard operator. Today, as we know, phone calls are connected electronically with no human intervention requi

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

red. In my mom’s mind, she “works” at the nursing facility, but she’s very interested in finding another job. One of the recommendations experts give when interac

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

ing with an Alzheimer’s patient is to play along with them wherever they are in their own little world. They don’t know any better so correcting them only creates

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

tension and frustrates both parties. My mom asked me if I thought she could go back to working for the telephone company as a switchboard operator, and I informed

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

her that those jobs have been replaced by computers and electronic machines so she’d have to find something else for “employment.” When asking her what she thought

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

Following aspects would a

she might be good at and enjoy, she seemed rather concerned in answering me “I have been so busy focusing on my life and doing my day-to-day stuff, I haven

dd to the challenges in developing combination products:

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

t paid attention to what’s going on around me or what’s even out there.” That’s when it clicked for me.

Many of us that don’t have any debilitating disea

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

ses (yet) do the very same thing mom spoke of even though she didn’t realize she was delivering an “ah ha!” moment for me. We all get caught up in our day-to-day l

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

ives to the point we don’t look around to see what’s going on and truly pay attention. I believe many companies suffer in an analysis paralysis conundrum. When th

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

e consequences begin to seriously impact the organization, it’s often too late to make a change because the downward spiral has picked up too much momentum to rever

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

Professional from academic institutions, pharmaceutical industries, health care indust

e course. Alzheimer’s works much the same way, but there is only hope for a cure—nothing in terms of a bonafide cure yet. There is a “cure” for the business commu

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

nity, and it’s a very simple one—pay attention! I mean really pay attention to the world around you and readily implement changes before the “disease” hits<

.

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

/strong> instead of waiting and reacting. Pro-activity prevents obsolescence.

I know my mom fully understood technology advances before Alzheimer’s started to sev

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

Companies that provide selfless information through particip

erely restrain her, but she delivered a nice reminder to me to pay attention to my surroundings in a very innocent way during our time together tonight. Thanks mom

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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Cases - Learning a Simple Lesson from an Alzheimer's Patient

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