Main Subject - Business

Unless you present your convictions and positions with authority, people will walk all over you.

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

I heard a call where a rep had the sale in the bag. The soon-to-be-customer, grasping for any l

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

Examples of combination products may in

ast minute throw-in asked the rep, “How's 'bout you guys pick up the delivery on this?” I about

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

leaped out of my chair when the rep hemmed and hawed, then said, “Well, we're really not supposed

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

to do that.” Smelling blood, the customer spotted an opening: “Really not supposed to, but you

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

Combination pro

do on occasion, right?” “Uhhh, yeah, sometimes.” “What cases are those?” inquired the customer

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

“When we need to get an order.” The customer pounced. “OK. This is one of those situations. I'm

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

a new customer, and this is what you need to get the order. You can explain that to anyone who w

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

ould have to approve it, right?” “Yeah, I guess so.”

What caused this whole mess? Really. That'

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

s it. Really. The word, “really.” And the rep's hesitant tone of voice. When you know you have a

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

deal in hand, you're faced with a request that is 90% nonnegotiable, or if you have a position t

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

Following aspects would a

hat you feel deep down strongly about, it's imperative that you give the impression that your sta

dd to the challenges in developing combination products:

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

nce is rock solid. So what should this rep have said? Easy.

Prospect: “How's 'bout you guys pi

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

ck up the delivery on this?” “(sincere tone) Wish I could. (Matter of factly) Delivery is just g

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

oing to be $32 on this order. Which location do you want it shipped to?” Notice there's no apolo

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

gy for the shipping (“Well, shipping is a part of our cost and if we did it for you, whine, whine

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

Professional from academic institutions, pharmaceutical industries, health care indust

. . .”) It acknowledges the request, feeble as it might be, states a fact, the shipping price,

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

then gets on to the business at hand, deflecting the person's request. You could even use humor

.

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

. Act as if you didn't take the comment seriously, and they'll realize they weren't serious about

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

Companies that provide selfless information through particip

making it. Present your positions with conviction, and you won't have them challenged as often

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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Main Subject - Present Ideas with Conviction to Avoid Being Challenged

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