Advice You - Business

Over the years I have been asked by many of the attendees in my management seminars, “

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

What are the common traits of successful managers?” The list is too long for any arti

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

Examples of combination products may in

cle for this website but I would like to share with you what I believe are the most im

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

portant twelve. Yes there are many others, keep in mind this is just a summary to sti

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

mulate your thinking.

Why not evaluate yourself on each to determine where improvemen

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

Combination pro

might have a positive impact on your management style, as well as the performance and

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

productivity of your employees. The list is in no particular order of importance.

1.

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

The ability to foster a trusting corporate culture.

2. The ability to communicate wi

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

th integrity and effectiveness.

3. Adequate and timely advance planning.

4. Effectiv

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

e and timely decision making.

5. The ability to lead, as well as manage.

6. The abil

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

ty to maintain organizational, as well as individual, accountability.

7. The willingn

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

Following aspects would a

ess to continue to learn and develop new skills and attitudes.

8. The ability to eval

dd to the challenges in developing combination products:

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

uate issues, challenges and opportunities with maturity and insight and see reality (w

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

hat is) rather than seeing what is with blinders or ego.

9. The willingness and coura

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

ge to invite dissent, objections, disagreement, creativity and new ideas.

10. The wil

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

ingness and skill to create a positive motivational environment.

11. The ability to o

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

Professional from academic institutions, pharmaceutical industries, health care indust

perate with creativity and vision in a changing environment.

12. Understanding what p

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

eople really need and want in order to be effective, productive and happy.

There are

.

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

numerous other traits of effective and positive managers and leaders – but I will bet

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

Companies that provide selfless information through particip

that most of them will in some way fall under the umbrella of one of the above twelve

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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