Advice You - Business

Imagine you’re landing on the beach in war and I guess we could say you are like those poor unfortunate souls, the Cuban Freedom Fighters (if you’re old enough to remember that one) who landed down there during the Bay o

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

f Pigs and were slaughtered because in the last minute, maybe hours, President Kennedy withdrew his support.

In the change wars going in across the land people aren’t killed but careers are, everyday. Let me explain the

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

Examples of combination products may in

connection. When you start a change war you have to have a team and you have to give that team support. Every leader of course says they will, but in reality, just as in the Bay of Pigs, it is often withdrawn at a critic

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

l moment.

A case in point was a few years ago when I was Vice President of one of America’s high flying companies my boss started a change war. Now the politics in this tech giant (who thought they had no politics) woul

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

rival Washington on their best day. Our CEO was from Europe so his former business unit over there could do no wrong and when they did you’d better turn your head quick. Well, that wasn’t my style.

My boss had some bad

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

Combination pro

blood with the supply chain folks from over there so he told me to lead the change wars and take no prisoners, including in Europe. Now I’d been around the block a time or two and had my share of limbs sawed out from und

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

er me so I worked hard at making sure he and the CEO were aligned with the changes. At every step of the way my boss assured me of his support with a straight face and with zesto. The CEO was less than straightforward bu

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

that was normal for him.

Over the course of more than a year my team worked to study, analyze and present the case to close a massive, high tech warehouse that was an albatross around the neck of the organization. The

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

attle included studies by my folks and two major big league consulting houses. In every case the answer was close it … the savings was in the tens of millions of dollars. In each case the European team found some little

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

ssue to delay the inevitable.

Our manufacturing counterparts over there also reported in to my boss and their influential leader was behind us one thousand percent. I climbed further and further out on the limb of the c

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

ange tree, looking over my shoulder mind you but being assured every step of the way that this was a slam dunk.

The day came for the final decision. By now relations with the European crew were out of cold war status an

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

Following aspects would a

d downright nasty. But hey, it wasn’t my idea, I was just asked to lead the charge. But the wear a tear on me and my staff was pretty high. We’d need a break after this one for sure. When the meeting came I wasn’t invite

dd to the challenges in developing combination products:

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

. Now that is one big red flag.

You’ll recall at the beginning I said my boss had some real bad blood with the supply chain head in Europe. So did the European manufacturing manager. When the dust settle the supply chai

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

manager agreed to a move to a new site being opened in his home country in Europe, what a punishment for what he did, and the European manufacturing manager got a promise of a plumb new position over manufacturing and s

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

pply chain, a new combined organization. And my boss was happy because he had ‘paid back’ his nemesis in Europe.

Now all the money and time and pain that we spent driving the changes never paid off. My boss in the end h

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

d been holding the saw all along and I didn’t see it. I’d only been with the organization two years at this point and the rest of the players in this charade had been there for years. In the end it was like many had warn

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

Professional from academic institutions, pharmaceutical industries, health care indust

ed me, the CEO protected his own in Europe and my boss was a weasel.

But here is the principle, I call it Air Cover. When you send your troops to battle in the change wars be there and keep your word, provide air cover

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

hen the shooting starts. My team and I took a hit on this one because when the going got tough my boss went for compromise to get what he wanted, ultimately to have his nemesis removed rather than do what was right and c

.

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

ose the facility saving the company and its stockholders millions of dollars.

Air Cover, thinking through the changes and being willing to go to the wall in support of your troops once you send them to battle. Leaders t

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

Companies that provide selfless information through particip

day are failing in record numbers when it comes to this in organizations. If you want to lead successful change you keep your word, in other words – your words match your deeds. Anything less is awful, its not leadership

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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