Advice You - Business

Your IT business is starting to grow. It’s still a bit quiet occasionally, but at other times you’re finding the workload a bit much. You don’t

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

want to employ someone full-time, but someone part-time for specific tasks, depending on their expertise, may be useful.

It is a good idea to ge

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

Examples of combination products may in

t together a team of subcontractors BEFORE you need them, with different skills. If you wait for the first project where you may need help, you c

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

ould find it will take too long to find the RIGHT subcontractor for the PROJECT.

Check the references of any subcontractors who apply. Contact I

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

T consulting firms they have worked for. They are representing your business. You also want to make sure you will not be spending more time fixin

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

Combination pro

g up their mistakes than if you did the work yourself. Remember, you are paying them. They need to be high quality.

When you have decided on the

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

subcontractor(s) you’re going to contract, get the paperwork done before you need them on a project. A contract between you and the subcontracto

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

r is essential and you should include a non-compete clause – you don’t want them stealing your business. A non-complete clause means that they mu

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

st represent your company in any contact with the client and not be trying to arrange future work with them.

But if you have any doubts about a

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

subcontractor, even if their resume is impressive, it is better to trust your gut feelings. You don’t want people who will make your business – a

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

nd your life – more difficult.

Negotiations of payment are crucial for the subcontracting arrangement to work well. You can either pay upfront o

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

Following aspects would a

r wait for the client to pay you. Perhaps if you pay upfront it may be a lesser amount. You will need to consider your cash flow situation. Be e

dd to the challenges in developing combination products:

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

specially careful of using a subcontractor for the first time. If they are reliable and their work is good you may able to trust them with an upf

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

ront payment.

Always agree upfront what you will pay the subcontractor, and get it in writing with both of you signing. You don’t have to tell t

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

hem how much the client is paying you. If you want someone with high quality skills and experience you need to be prepared to pay for it. Do some

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

research into what subcontractors are being paid. Work out if this will fit into your budget.

Have in writing exactly what you expect from your

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

Professional from academic institutions, pharmaceutical industries, health care indust

subcontractor. If they will be doing the same thing every time, make sure they have a copy at all times, and keep a signed copy on file. Also gi

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

ve them any project specific instructions, and obtain a signed copy from them.

You must maintain an active role with the client and keep in regu

.

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

lar contact. Keep a high profile and make it known you’re using subcontractors at the outset. Some clients may not like you outsourcing your work

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

Companies that provide selfless information through particip

, in which case you should either undertake the work yourself or not take it on at all.

Gregory Fitzgerald
http://www.getsomebodynow.com.au

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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