I Suggest - Home and Family

“Be not forgetful to entertain strangers, for thereby some have entertained angels unawares.” The Bible

The third-biggest retailing holiday is one day away. Just behind Christmas and Father’s Day, Valentine’s Day will be celebrated by spending $13 billion on anythin

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

g heart-shaped, chocolate-flavored or rose-scented.

While never refusing dark chocolate nor snubbing floral deliveries, I’m just not into either this year. OK. Maybe I’m still into chocolate. My hubby will be out-of-town on Valentine’s Day, so it just won’t be a very big d

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

Examples of combination products may in

eal; it’ll be celebrated upon his return. But apparently, very few others feel the same way. A recent report by Kiplinger’s found that men out-spend women three to one, spending an average of $92. Last year, 175 million roses were produced for Valentine’s Day alone, more th

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

an enough for every adult in America to get one.

Frankly, I’ve never been one to fall wholeheartedly into the whole Valentine’s Day ritual. Don’t buy my hubby silk boxers with little hearts all over them; don’t question our marriage if he walks in the door sans roses. So r

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

ther than give you yet another creative take on the Valentine’s Day “holiday,” I’m going to brag about a fellow rocket mom.

My friend, Kim, rocket mom to four kids (all within five years) sent out via email an invitation to a “Chicken Soup for the Soul” luncheon at her hom

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

Combination pro

e. I had assumed that she was including her closest friends, but it turned out that she was inviting only those women who were serving in various caretaking—or shepherding—capacities at our church for her children. She wanted it to be casual; again, I assumed it was kind of

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

a “drop-in-as-you-feel-like-it” kind of a party. But instead, it was a sit-down affair, with homemade chicken soup, salad, rolls and home-baked cookies.

Kim made a conscious decision to make adult friendships a high priority in her life, and despite feelings of being over

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

whelmed, or of being intimidated by entertaining styles of some of her other acquaintances, she was inspired to do something simple, yet meaningful.

After a lovely afternoon of lunching with new and old friends, Kim presented us with Valentine’s goodies bags: chocolates ti

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

d with a pretty ribbon and a quote, each of us receiving something unique.

“I believe your quote will speak directly to you,“ Kim said as, one by one, we read our quotes and nodded, some of us with lumps in our throats, about the uncanny effect that this little ritual had

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

on us. (Sort of like opening a Chinese fortune cookie to discover what seems like a “fortune” written just for you, only better…)

When I reflect back on those memories which evoke the strongest sentiments, invariably they include those times when someone enveloped me into

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

her cocoon, wrapping me with simple things, like hot food, fresh coffee and undivided attention. When a girlfriend grabbed me for my birthday or for moving away or just after childbirth, to enjoy a warm meal surrounded by all the creature comforts of her home. Those special

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

Following aspects would a

times don’t come all that frequently, and so we remember them with special fondness. And so the older I get, the more convicted I become to practice hospitality to others when opportunities spring into my path.

This weekend, we had the opportunity to extend hospitality to

dd to the challenges in developing combination products:

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

a traveling drama troupe from Cape Cod. They were to perform the 15th century play, Everyman, in our town, before we got buried under the 26” of snow which hit the entire northeast corridor early Sunday morning. The team of eight needed three different homes in which to sta

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

y, and we offered ours as one of them. The plans took an obvious shift when we became stranded at home, as we sit on top of a mountain at the mercy of a private snow plower. So what we thought would be a weekend of entertaining for a couple of meals and a few warm beds turn

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

ed into a solid two days of long chats by the fire, a half-dozen pots of coffee and a few more times around the kitchen table than we had originally planned.

And we were all so blessed. One of the gentlemen whom we housed remarked: “I’ll bet in twenty years you’ll all look

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

back on this weekend and say ‘Remember when those three guys from the Cape came and stayed with us and we got stuck in the biggest snowstorm to have ever hit New England?’”

And of course, we all will.

There’s a game which is frequently played in adult discussion circles

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

Professional from academic institutions, pharmaceutical industries, health care indust

hich goes something like: “Write down the names of three Academy Award winners for Best Actress; write down the names of three Olympian gold-medal winners; write down the names of blah-blah-blah.” (You get the idea) It finishes by asking you to write down the names of three

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

teachers you had an impact on your life.

And of course, we can do that without batting our eyes.

Human connection. Extension. Intimate interaction. That’s what has impact. That’s what has meaning. Evokes the strongest memories. Conveys true love.

So on Valentine’s Day 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

his year, I will try to do those seemingly small yet powerful love acts that might, in some way, have eternal significance. Flowers? Chocolate? Yeah. They’re all great. But opening my door to a stranger. Giving my hubby and my kids undivided attention. Leaving simple gifts

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

Companies that provide selfless information through particip

on my children’s pillows. Writing a meaningful letter. Calling a long-lost friend. Following Kim’s example of hospitality. Those will be my inspirations for Valentine’s Day this year.

I hope you have a love-filled Valentine’s Day. In whatever form you think best defines it

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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