Main Subject - Business

"We're not going to that stupid meeting! They'll just feed us more BS." That was the overwhelming sentiment at a recent workshop I conducted f

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

or a worldwide company doing around $8 billion is sales. It was one colossal problem they had on their hands.

You see about a year ago now 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

e folks from the parent company came in and surprised even the VPGM of this division with the news they were moving the operation to Europe. W

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

hat you have to know is that this division is the core of the manufacturing business and has employees ranging in tenure from ten on the low s

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

ide to thirty plus years with the company. It was a shock.

What happened since the announcement was well, exactly, nothing. They hired a new

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

Combination pro

staff overseas and they were moving along but these folks based in the states were left hanging out to dry. They were originally told they'd a

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

ll have jobs at local subsidiaries ... but no information was forthcoming. Oh, they'd had meetings and HR was calling them 'Roundtables' but n

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

othing was coming out.

You see they were having 'get togethers' with pizza but they weren’t telling the troops anything. You can’t do that if

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

you're going to succeed at change. You have to communicate clearly, regularly and most importantly, truthfully. If you don’t know then tell 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

hem you don’t know. When there is a communication void it will be filled with something. If not from you, then the resisters will fill it up i

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

a heartbeat.

So remember ... when leading change you must communicate and you must include these three elements.

1. Clearly - that means in

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

Following aspects would a

simple straightforward terms tell them what you know and what you don’t.

2. Regularly - understand they don’t come for the pizza; they come

dd to the challenges in developing combination products:

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

to hear a status report on the changes taking place. Schedule them, make them important and say what you mean and mean what you say, as schedu

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

led.

3. Truthfully - do we need explanation? Don’t BS them, they know it. Tell them straight up what is going to happen.

The group I mentio

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

ned in the beginning weren’t referring to my workshop they were referring to the next 'Pizza Luncheon' on Monday after I left. They hadn’t hea

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

rd anything straight for months. That's all they wanted, to hear the truth.

I had to conclude my week with them by meeting with the Director

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

Professional from academic institutions, pharmaceutical industries, health care indust

of Human Resources.

He said, "Tell me straight up, how the people are doing?"

I started with this one. "Do you know that 100% of your people

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

do not want to come to your communications meeting on Monday?" He was flabbergasted. "Well, uh, why would they feel that way?"

Now that is

.

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

how far removed he was from reality.

"Well, Jose, let me break it to you ... all you ever tell them is BS and they know it."

Well, this guy

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

Companies that provide selfless information through particip

was breathing that really thin air at the top and never quite got it ... don’t let that be you. Communicate clearly, regularly and truthfully

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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A company’s board of directors can play an important role in determining the kind of funding a public offering receives. If going public is your goal, the selection of board members should be given especially careful consideration.

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