Advice You - Business

When dealing with outsourcing, you know how complex it is. So you want best-practices. Unfortunately ther

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

e aren’t too many around.

But isn't there another experience you might learn from?

Yes. Insourcing. Tha

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

Examples of combination products may in

is what we have been doing a lot in the past. And still.

The make-buy-or-outsource-decision is very wel

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

documented. We are in the trend where MAKE is still replaced by BUY. So there are many packages you can

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

uy at any level (of which ERP – Enterprise Resource Planning and CRM – Customer Relationship Management a

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

Combination pro

e the most "important" ones).

What was this experience? Besides the fact that many projects exceed time

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

nd money targets, these organizations have learnt that tailor-made-solutions are no longer present. They

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

are replaced by a market standard. Yet there are many standards. There are four to five main suppliers in

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

each area, so there are (talking about largecaps) about five solutions to choose from.

How did you make

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

hat choice in the past? An important feature of this insource process is that external resources are do

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

ng the job. They have built the system (although it was finished when you bought it). So basicly, those h

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

Following aspects would a

man resources are to cooperate with you internal human resources.

How do these resources match? The fit

dd to the challenges in developing combination products:

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

etween the external company and your internal organization is one of the critical success factors. Rather

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

than the solution itself, you are dealing with external resources that are implementing part of your proc

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

ess. All by means of the package.

Once you have bought the software package (ERP, CRM) it is no longer a

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

out the solution (only) but about the characteristics of the resources of the supplier. How well do you g

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

Professional from academic institutions, pharmaceutical industries, health care indust

t along with each other? What principles do they apply and how do these rules match with your own organiz

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

tional values?

If you have dealt with these kinds of insource projects, you have already faced a big dea

.

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

of outsourcing (and its complexity). A simple assessment on style differences between your companies wil

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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Advice You - Outsourcing And What You Can Learn From Previous Insourcing Experiences

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