Advice You - Business

Your company cannot without growth. And to make this growth possible you need various types of resources of which the human resources are the most important. They determine the way in which the oth

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

er types of resources like systems and infrastructure are managed. Together they constitute this unique building that is your own company and not the one of the competition.

When preparing for thi

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

Examples of combination products may in

s growth, you are offered a myriad number of solutions, methods, intermediary products, advices, etc, to support the process. In the mean time the current operation needs to continue, clients are (

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

if you are lucky) waiting.

All those resources, you can dedicate as means, have their own characteristics. Through a growing number of different solutions, the number of decision you could take in

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

crease at the same time. Different managers in different areas in your company will have their own preferences for these kinds of solutions.

The innovation manager wants new products and preferabl

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

Combination pro

y tomorrow if not now. The sales manager wants flexibility because the client will change its preference overnight. The operations manager is concerned with stability, the technological department

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

wants to experience a new solution with leading edge technology, Administration is concerned about future maintenance and fulfilment requires a fluent process. The service management wants the leas

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

t possible problems.

How do you manage? How do you make sure you can manage all these choices efficiently?

If you hire a consultant for this problem, the first step they will take is an analysis

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

of precedents. Did others deal with this problem before? The answer is: yes. Investment managers did.

“Do you mean the investment teams who are competing with dart-throwing-apes to beat the market

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

?” Yes, especially they have because of the highly complex area they are dealing with. They have found a set of investment rules, ones that are always valid – which we would call – best practices –

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

and others that are specific rules because of their specific investment profile.

In your organization you can benefit from this approach. What you should do is making your rules explicit in your o

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

Following aspects would a

rganization. It saves unnecessary discussions. If you ever have tracked the amount that is spend on meetings, discussions and other communication in your company, you should be sensitive for an ar

dd to the challenges in developing combination products:

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

gument to use this time as efficient as possible. If we go back to all these different people, managers, teams and departments, they perform best if they share some basic principles. If we observe

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

Marketing, Sales, Technology, Administration, Customer support, they have all their own view on management issues. You need to align all these different backgrounds, sometimes more technical, some

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

times more commercial.

You cannot do this for all issues, but you can for 80% of them. How? Again we step back to the investors and their portfolio. They have many different instruments. A stock 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

as a different risk/return characteristic than a bond, an option or a future. However, for a balanced portfolio with a certain profile, you need them in a certain distribution.

The portfolio of a

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

Professional from academic institutions, pharmaceutical industries, health care indust

company could be characterized in the same way, by means of a portfolio of resources with their own characteristics and rules. For the way to growth you need solutions on one side and a way to im

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

plement them on the other side. Without going into details you have different choices in the type of solution and in the way to implement them. These choices are determined by simple rules that 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

valid in each company. The set of rules could be seen at the specific profile of the organization. Banks support their customers for gaining insight in their personal investment profile. If you wa

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

Companies that provide selfless information through particip

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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