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There are lessons that we learn as we go. Our mothers could have told us - but we would neither have believed them nor paid atte

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

ntion. Instead, they let us learn on our own.

In that spirit, let me share a few things I've learned about teleseminars.

1. Th

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

Examples of combination products may in

y can "see" you over the telephone line! No, they can't see your flip flops or your bad hair day. But they *can* see your smile

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

and your energy. So stand up, walk around, get excited! Smile into the phone, even when you're the only one in the room. The aud

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

ence is watching!

2. You're talking to "dead air" when you mute the line. This is generally a shock to most people on their fir

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

Combination pro

t teleseminar. And I've heard many of them unmute repeatedly just to be sure there is still someone listening. After all, it's l

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

onely in there, in the muted area all by yourself. Never fear. Your audience is still there - you just can't hear their breathin

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

.

3. Half the registrants won't show. They have good intentions when they sign up - especially for a "free" call. But things co

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

e up. Even when they have paid to be on the call, they get caught in traffic, company shows up unexpectedly, the dog has to go t

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

o the vet, the kids have soccer practice, the last episode of "24" is on. Things happen. It's incumbent on you, the organizer, t

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

remind them about the call - repeatedly. Then cross your fingers and "go on with the show."

4. You need to do the follow-up wo

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

Following aspects would a

k before the call. After the call you are stoked and pumped from the call - the last thing you want to do is take care of detail

dd to the challenges in developing combination products:

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

s! But the audio needs editing, the registration page has to change, email reminders have to go out, the transcript needs editin

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

, you need to set up the product in the shopping system, etc. There is just a lot to do! And if you haven't done most of it ahea

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

of time, you'll spend more time after the call than you did before. And that dilutes the excitement and leaves you less time to

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

enjoy the moment.

5. It takes 6 hands to do a teleseminar. You have to follow the call outline, check the recording levels, IM

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

Professional from academic institutions, pharmaceutical industries, health care indust

your guest, field questions via email and watch the clock. What to do? Get help! Hire someone to record the teleseminar. Ask som

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

one to handle the question emails for you and ask the questions on behalf of the audience. Add operator service to your line. Yo

.

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

u can't do this alone - unless you're a split personality or very talented.

Consider yourself forewarned about these lessons. B

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

Companies that provide selfless information through particip

t I'll know you weren't listening when on your next teleseminar you keep unmuting the line and saying 'Hello - anyone out there?

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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