Advice You - Business

"Nothing great was ever achieved without enthusiasm." Ralph Waldo Emerson

I'm so excited. I got a cool new power point template with orange and yellow flames. It's n

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

ot too much (well, maybe it is), but I don't care. I like it.

So I transferred my regular presentation to the new template. I got some mesmerizing slide transitions like Ji

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

Examples of combination products may in

Edwards used (spinning boxes and such that the audience at Big Seminar were oohing and aahing about). My handouts were ready to go.

Then I find out -- they don't have a pr

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

ojector where I'm speaking.

Bummer.

So I freak out. I call my marketing buddies, who don't answer their phones (they're busy marketing). I dial up my mastermind group. No

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

o. I beg to borrow my ex -husband's projector and big 'ol screen to drag on the one day roundtrip flight. He says yes. I don't know how to set this up. Now my husband John u

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

Combination pro

ually goes with me. But since this is just one day, he opts to stay at home and take care of the kids. So I figure I can just figure it out and follow the manual (never mind

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

that techno geek John was unable to set this monster up at the last event and we had to borrow someone else's).

My flight is an hour so I'll have to go through security, t

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

ke off my shoes, get pat down by the female guard (those metal things are set so low now even my belly ring makes it beep) all while dragging around a 6 foot screen that wei

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

hs about 45 pounds, a projector, a laptop and a purse.

Hmmm. This isn't sounding like such a good idea.

Finally, I whine to John. But he's used to me making a big deal out

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

of little things. So he just waits for me to get a grip. Why is it so easy for him to not get mired in the details? Because he's good at seeing the view from 10,000 feet. H

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

's a big picture guy, while I'm stuck staring at blades of grass up close and personal.

Handouts. We nix the projector idea and decide on handouts instead. "Well, there can

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

Following aspects would a

t just be ANY handouts," I say!! "They have to be eye- catching and fancy. I want them spiral bound with a clear cover and black back. The front page should be color. Oh and

dd to the challenges in developing combination products:

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

they have to be ready by this weekend, John. Thank you very much."

"Lower the bar," he reminds me. He has an annoying way of remembering all the chunks of wisdom I

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

ell him then feeding them back to me. He reminded me that Tom Antion widely distributes a recording with some very bizarre background noises (that's a whole different story

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

'll tell you sometime). One of John Reese's most highly acclaimed articles is about writing "cr@p" for the internet. My gal pal, Alexandria Brown even told me sometimes thos

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 of us who care try so hard for perfection, we don't get anything done.

Lower the bar. That does NOT mean under-deliver. Far from it. All it really means is don't w

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

Professional from academic institutions, pharmaceutical industries, health care indust

rry so much about perfection. I say this for you as much as I say it for myself, because I know other people suffer from this same affliction. You are an expert in your fie

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

d, right? So just share that information and people will be able to improve their businesses. They don't need shiny covers on their handouts. They don't need eye-popping pow

.

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

er point presentations. All they need is information. Information given to them from a place of empathy for what their needs are. And your expertise. So I'm going to go to m

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

Companies that provide selfless information through particip

event and share some down and dirty information that will undoubtedly help them with their marketing and their businesses.

Lower the bar enough to step into your own power

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 You - Lower the Bar

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