Advice Pool - Business

A few years ago I worked with three other coaches to facilitate a program for a medium-sized financial services company. The company was started several y

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

ears earlier by their up-and-coming CEO and is still privately held. Our program was built around the topic of internal communications. This company has a

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

Examples of combination products may in

lways had a great outward appearance to its customers, but internally there was much room for improvement. We hoped to tag on to some additional work th

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

re, including coaching for their managers and above as well as additional group facilitation.

The CEO liked the work we did, but regarding any future busin

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

ess with his company, he left all negotiating with us in the hands of his company president and the training manager. These two individuals did not get

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

Combination pro

long well with one another and I sensed that the training manager was looking for another job (which turned out to be true).

The president of the company

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

was a very young woman. Because she was so young, I thought that the CEO could have been more directive with her regarding internal matters. "This is a

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

woman who could really use a coach," I thought to myself as I observed her during our program day. At the time, she was also getting national media expos

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

re as an expert in her field, which I sensed she enjoyed (but I was not so certain that she was ready for all that came with national exposure).

Recently

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

, I read a piece of news with her name in it. The piece said that she attended a dinner in Hollywood at which many people from the entertainment industry

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

mostly directors and producers, plus a few actors) were also in attendance. During the evening she made some remarks from the podium, a few of which raise

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

Following aspects would a

d the hair on the backs of the necks of some attendees.

It seems she didn't quite do her homework regarding her audience for that evening. In her remarks

dd to the challenges in developing combination products:

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

, she defended the actions of a personal friend of hers in the entertainment industry who several people in the audience believe bilked them out of thousa

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

ds of dollars.

I think it's a lesson that anyone who is placed in a high leadership position at a relatively young age will benefit greatly from honest

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

coaching that guides them through potential landmine fields without invoking any to explode.

It would have behooved the CEO of that organization to have

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

brought in a coaching plan, which would have provided leadership development for several leaders, without singling out the young president. In the

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

Professional from academic institutions, pharmaceutical industries, health care indust

news piece I mentioned, his company name was also in print, as his president is always mentioned as being the president of the firm when she is called o

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

n as an expert in her field.

Whether a company leader is quite young or is simply in a fairly new position (even if they have a lot of experience already

.

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

, getting a business coach to navigate the waters for about six months is a good way to make certain that embarrassing surprises don't happen. Rather, wit

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

Companies that provide selfless information through particip

h this type of focused leadership development you get what you need to guide your decision making in the right direction.

© 2006 Borgeson Consulting, Inc

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.advicepool.org.ua/article/22358/advicepool-Youthful-Company-President-Commits-Faux-Pas-in-Hollywood.html">Youthful Company President Commits Faux Pas in Hollywood</a>

BB link (for phorums):
[url=http://www.advicepool.org.ua/article/22358/advicepool-Youthful-Company-President-Commits-Faux-Pas-in-Hollywood.html]Youthful Company President Commits Faux Pas in Hollywood[/url]

When it comes to electricity, small and medium size enterprises can never assume they are getting a good deal. In fact, it's safe to say that - as the market stands today - businesses should assume the opposite is true, and that they are being taken for a ride by the 'big six' energy providers.

The keys to effective improvisation are the same as the keys to success in just about any other area of life, including business.

Making money on eBay, for most people seems like an ideal solution to giving up the daily grind of working for somebody else, and taking control of your future. But how much room is there really in the marketplace. I have no doubt that a select few power sellers have mastered the formula for making profits, and are able to generate above average incomes. But how easy is it to do this, and is there room for everyone?

Tags

Links

Advice Pool - Youthful Company President Commits Faux Pas in Hollywood

Related Articles: