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I’ve been in the classroom for the past 29 years. During that time, I’ve had the opportunity to travel a lot with my choirs and bands. To prepare students for these trips, I had them le

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

arn my “mantra” concerning time ( I don’t know where I got it from, but I’ve been using it professionally and personally for over thirty years).

“To be early is to be on time,

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

Examples of combination products may in

to be on time is to be in late, and to be late is to be in trouble”. For those of my students who followed the “late” timing, they quickly found that late nig

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

ht running solved their problems. I also “left: my fair share of chaperones at the hotel for not being ready to leave. Sounds harsh? Maybe--- but, it does teach us lessons that can be m

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

oved into the presentation arena.

As a presenter, being early to a presentation is a “win-win” scenario for both you as the presenter and the audience. The following is a listing and e

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

Combination pro

planations of the benefits of being early to a presentation.

Benefits for presenter:

- You can check out the layout of the venue--- sometimes the ch

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

air/table layout of the room may not be what you desire

- You get a chance to check the lighting of the room--- the room itself may not reach the “specs” that were sent to you. Inste

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

ad of adjustable lighting, your room may have fluorescent lights only.

- The audience “goodies” may not be in place--- your audience will always appreciate water at the back of the ro

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

om. You may even want to provide mints or hard candies of some type.

- Set the room temperature. It will take time for the room temperature to adjust. You don’t want a room where you

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

can hang meat or feel that you’ve just gotten into a tanning bed.

- Focus on technology. If anything can go wrong, it will be technology. Does the slide show run, can the audience s

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

e the screen, does the projector work, is the microphone enough or too much for the room. This is the time where you test all of the elements. Run your presentation with the technology

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

Following aspects would a

to find any potential glitches

Benefits for Audience:

- The audience will have a better chance in seeing a successful presentation. Audience Advocacy contain

dd to the challenges in developing combination products:

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

s important concepts… design/deliver the presentation in the way you as an audience member would appreciate participating. “Prior preparation prevents poor performance”. Make each prese

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

ntation successful for the presenter and the audience.

- You’ll be able to “bond” with your audience as they enter the room. This interaction and “getting to know the audience” will

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

help create a positive rapport between the presenter and the audience.

To interject a “personal” learning moment about being early to a presentation site as a presenter… I recently pre

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

ented at the ASCD (Association of Superintendents and Curriculum Developers) convention in Anaheim, CA. Prior to the convention, we were to send in out requests for equipment for the ro

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

Professional from academic institutions, pharmaceutical industries, health care indust

om. Due to changes in airline carry-ons, I opted to rent a projector at the convention site (first mistake). When I got to the room, there was no LCD projector but an overhead projector

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

instead. By arriving early, I had an hour and a half to find an LCD projector and have it sent to the room. From that point, I went into normal preparation mode. Moral of the story---

.

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

if I hadn’t arrived early, the presentation would have still been delivered, but without the PowerPoint support materials. To this end, I’m a firm believer in living the mantra…

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

Companies that provide selfless information through particip

g>“To be early is to be on time, to be on time is to be in late, and to be late is to be in trouble”. I suggest you incorporate this into your “presentation lifestyle” as well

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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Businesses have a life cycle, just like everything else, and based on these different stages of growth business owners need to be mindful of the key aspects of their business requiring focus. The following is a summary checklist.

Reducing defects is a noble goal, but not at the cost of sacrificing sales growth. The bottom line is profits and with Six Sigma that can be lost in a fuzzy haze of measuring defects instead of profits.

Word of mouth marketing helps boost your sales considerably as the trust is at work in this case. Your customers trust you and some other people trust these customers. These customers when recommend your offerings to their people then they try out the recommendation without any apprehensions.

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