Useful Articles - Writing and Speaking

When was the last time you picked up a pen and wrote a letter in long hand? Grainy, silky or just plain vanilla, I miss the feel of personal correspondence. In looking through some old photographs and family memorabilia, I came acro

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

ss a poem my mother sent me when I was working overseas. While holding the yellowed paper in my hands, I had an overwhelming sense of her presence. I wasn’t simply reading her words; I was hearing her voice.

Our family lived near t

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

Examples of combination products may in

he ocean and as a child I loved wandering off the beach and meandering along the boardwalk. On the back of a faded photo of a beach outing, my father had written in his unique calligraphic style, “We removed 13 splinters from Suzy’s

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

feet.” I immediately relived being carried off in my father’s arms to the first aid station where I ate enough Tootsie Rolls between wailings to overshadow any negative aspects of the foot surgery. And I remembered what a terrific sw

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

immer he was.

I still have my older brother Bobby's letter sent while he was waiting to be shipped out from Okinawa to Japan during World War II. The enemy was unyielding, the invasion force was huge and not many GIs were expecte

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

Combination pro

to survive the first wave on to the beaches. But true to his nature Bobby didn't want us to worry. His letter was upbeat with funny doodles. By the time we received the letter the U.S. had dropped atomic bombs on Hiroshima and Naga

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

saki signaling the end of the war. My brother went to Japan as an occupier, not an invader, and he lived to tell his story. These intimate moments are the stuff of life that connect us to each other; they give us a real sense of our

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

own history. For our Iraq and Afghanistan GI's, email is a blessing, but without the smell of the stationery.

Today we live in a no touch world. Send an electronic greeting card or an email, instant message a friend with all those

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

blah, blah acronyms— on to the next multi-task. We’re too busy for personal notes. It’s so much easier to be personally disconnected, while remaining impersonally connected to a faceless impersonal world. Not only has writing by hand

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

passed into history, sadly there is a definite disconnect between humans in all areas of life. We complain about the rudeness in our society, but it is precisely this disconnect—not having to look someone in the eye or confront t

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

hem on the phone—which encourages the rudeness. Never having to say I’m sorry is b–s. It lets us off the hook of responsibility for our actions. We’re too busy to be civil; we’re on to the next multitask.

Speaking of multi-tasking,

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

Following aspects would a

I saw a commercially successful young couple on television reveling in the fact that they each work 80 to 100 hours a week. They are so in love with their jobs they never take a vacation; they’re never without their cell phones and

dd to the challenges in developing combination products:

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

Blackberries. On trains, planes and automobiles, how many folks do you see that are not electronically tethered or otherwise digitally occupied? Ask them what color the flowers are and they cannot tell you.

Consider what hum

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

ans would look like millennia from now if hearing and seeing were the only senses that developed. We could “evolve” like the subject of a science fiction story I read as a child. Absent arms and legs, the protagonist was an enormous

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

brain with tiny holes for ears and eyes. That’s a bit of a stretch, but you get my drift. It’s easier to plug in and zone out rather than deal with the demands of 21st century life.

Technology frees us to sit back and let someone

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

else, or something else, do what our arms, legs and brains are naturally programmed to do. Unfortunately, while we are enjoying the remarkable attributes technology brings into our lives, we are being blindsided by the

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

Professional from academic institutions, pharmaceutical industries, health care indust

cum of society that use technology to lie, cheat, scam or lure our kids into places we don’t want them to go—for example, pornography. In an interview with serial killer Ted Bundy just before his execution he stated that unless soci

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

ety deals with pornography, “lots of kids…are going to be dead tomorrow.” Bundy told his interviewer that every killer he knew through the prison grapevine had been influenced in childhood by pornography. What a chilling thought.

T

.

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

chnology is moving faster than we can imagine. We can only hope the decades to come will bring more planet friendly ways of living with each other and our trains, planes and automobiles. Plugging in needn’t mean zoning out. It’s our

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

Companies that provide selfless information through particip

responsibility, our duty to be aware, be very aware of what is happening around us. The more aware we are the more apt we are to get the government we need and the quality of life we deserve.

“Simplicity-Courage-Humor-Soul”

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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