Advice Pool - Relationships

Helllloooo...it...is...VERY...NICE...to...MEET...you!

I stood, transfixed, trying to wrap my mind around the scene.

My mother was meeting Mike for the first time, after hearing about him for many years. Mike Schwass: national speaker, publ

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

ished author, coach, therapist, namesake for the high school Blackhawks MVP award...and quadriplegic.

Maybe it was the wheelchair height that threw her. Some innate, hard-wired grandma response that kicked in when she bent at the waist auto

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

Examples of combination products may in

atically signalling to her brain that she must be talking to a six year old.

My...daughter...speaks...very...HIGHLY...of...you!, she boomed.

I winced. Oh God, please don't start trying to use sign language. Mike just smiled and chatted wit

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

her and making no attempt to run his wheel chair over my toe, cruelly denying me any chance of satisfying my urge to scream. Now, I know that my mom didn't even realize what she was doing and I have heard enough stories from my years of wor

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

ing in rehab to know that she is not the first person to clump several disabilities into one big crazy pile. I remember hearing other wheelchair (w/c) bound adults telling me that waitresses in restaurants sometimes ask their spouses what th

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

Combination pro

person in the w/c would like to eat, apparently assuming they could not order for themselves. And for some reason people often do feel compelled to speak loudly, more slowly and to use simpler words with folks in wheelchairs. People just ge

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

different when faced with people who do not fit the norm for them. This can happen with any readily apparent disability. An amputee friend of mine once told me how bummed he was when he went to a handicapped accessible beach. It was the fir

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

st time he did not clear an area by taking off his prosthetic leg. Clearing a private area for himself was a phenomenon virtually guaranteed on the typical "able bodied" beach.

Even Mike has told me of times he has been avoided while shoppi

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

g, denied levels of customer service that the rest of us would consider to be meeting the most minimal standards.

When I would hear stories like this I guess I always felt like I was hearing about the world "out there". The "out there" wher

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

people sometimes just don't know any better, were uneducated or uninformed about such things, lacked awareness, or empathy, or just don't know how to cope with things they didn't understand and maybe feared. Where people sometimes were well

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

intentioned but misguided and where others were just plain mean.

And "out there" implies that there is an "in here". Somehow, I guess I thought that through osmosis or virtue of a blood relationship or friendship that everyone in my univers

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

Following aspects would a

would just know everything. That Mike would just be my Mike to everyone...the smart, funny, aware, cool guy I know him to be.

But here I was, in my own backyard, with my own mother, God love her, and all I could do was stare in disbelief a

dd to the challenges in developing combination products:

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

d pray that Mike would run into my shin really, really hard. Almost like I had this idea in my head that nothing awkward or bad or even innocently misguided would happen to him under my protective bubble and that somehow I had let him down a

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

d deserved some punishment.

Please understand I do not want to disrespect or embarrass my mother. She's got a very good heart and I know she was delighted to meet Mike. Further, I hope it does not sound like I think he needs a mother hen a

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

round him or that I do not think he can handle life or that I am infantilizing him in someway. Nothing could be further from the truth. It is just that it is so hard to see someone you care about having to deal with so much in life without

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

break and I would like to run interference for him, to give him islands of "don't worry about a thing, I've got you covered" when I can. And when I do something ridiculous like spill something on him or nearly flip him in his chair when tak

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng a turn to fast in his van, I feel like I've broken a promise. Maybe just a promise I made to myself on his behalf, but a promise nonetheless. But, no matter what, he always takes our human failings in stride.

Maybe that's it. It's his gr

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

ce in the middle of our blunders, insensitivities and blindspots that always blows me away. He's a bottomless well of forgiveness and understanding.

Up until now I haven't had that temperment. I haven't been able to tap into that immediate

.

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

race. When I get annoyed it takes me some time to shake things off. I get there eventually, and a heck of a lot sooner than I used to. It wasn't until the next day when my brother addressed a butter knife at the dinner table with "Helllooo..

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

Companies that provide selfless information through particip

it's VERY NICE TO MEET YOU" that I could laugh. And in that moment of laughter I forgave my mother her dorkiness. And most of the time I can forgive my own.You are right about the power of "Amazing Grace", Michael. Yours amazes me every time

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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