Main Subject - Business

How would like to be a great manager? I mean a really great manager? Of course we all would but what does a great manager look like? It was years ago when first stum

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

bled over a really great manager and boy I didn’t want to admit he was great. Let me explain.

It was 1970 and I was driving truck for my Father’s company, a small t

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

Examples of combination products may in

rucker with a hundred trucks serving the building industry. There wasn’t much money in the business, the margins were razor thin and hauling clay pipe, brick and ste

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 coils wasn’t too glamorous. The company had three terminals at this point, one in Chicago, one north of Philadelphia in Pottstown and the home terminal in Akron, O

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

hio.

I just wanted to learn the business so I spent some time as a mechanic and was now on the road with some long term drivers. All the drivers hated going to Pott

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

Combination pro

stown because the Terminal Manager there, Spencer, was as they termed, a real ball buster. Now I had heard from my father that he was the greatest guy to walk the ea

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

th. Umm?

Over the next two years I went in and out of Pottstown and Spencer, which was his last name but the name everyone knew him by, was always there when we ref

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

ueled. He’d come out, never in a particularly good mood, and make really small talk while he walked around the truck. If there was one dent or scrape that wasn’t the

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

re the last time you were in, you heard about it. You could say, Spencer was engaged.

When I started out I was talking trash about Spencer just like the other drive

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. My father would always respond, “Well, he always makes me money.” For my father, that was the overriding criteria. But as time went on I noticed something else. S

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

pencer’s drivers had been with the company for a long time. In Akron, the home terminal, they never made money, had high turnover and the place looked a wreck.

Over

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

Following aspects would a

the course of those two years it became apparent that Spencer indeed was doing something right. Then one day I realized in the office that he didn’t even have an of

dd to the challenges in developing combination products:

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

ice. He had the same amount of drivers working there doing the same volume of work as Akron and had less than half the support staff. And get this … he didn’t even h

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

ave an office or a desk. He just sat at the end of his dispatchers desk and long before it was popular he managed by wandering around. He knew the business better th

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

an anyone that worked for him.

Over the years I became friends with Spencer and a finer man you wouldn’t meet. I worked hard to understand what his ‘secret’ was and

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

you know what, I figured it out. He didn’t have a secret he just did three simple things:

1. He knew the business better than anyone who worked for him. More import

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

Professional from academic institutions, pharmaceutical industries, health care indust

antly they knew he knew.

2. He truly managed the place as if every dollar he spent was his.

3. He cared. He cared about the business, the people in it and my fathe

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

r, the owner.

Spencer became a dear friend and my ultimate example of what a great manager really is. It is rare today to find someone who fits the bill of ‘manager

.

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

like Ernest did. It took me a couple years to get over the fact that he didn’t have an office, let alone a desk. He didn’t have a lot of things but what he did have

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

Companies that provide selfless information through particip

was the ability to deliver the mail, as my Dad used to say. He didn’t have a lot of things but he did just get it done and that makes him a great manager.

Ed Kugle

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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