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But if you have what it takes you need to communicate that to the people that count – potential clients. And not just that you’re the b

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

est person for the job. You also need to be able to convince them to pay you a good but realistic fee for your services. After all, if

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

Examples of combination products may in

you’ve decided to go down the consulting road you want to be paid good money for it!

If you lack assertiveness or confidence you need

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

to do something about it. Counselling or courses are options. It always better if someone you know recommends a person or course that t

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

ey found to be helpful.

Before negotiating for work and a fair fee, you need to know what your goals are. Also you should know what a

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

Combination pro

fair fee is. Research is essential if you don’t have this information. Membership of the Australian Computer Society can be useful in d

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

etermining what rates to charge as well as providing many other benefits, go to https://www.acs.org.au/ictcareers/index.htm.

When appl

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

ying for a contract you need to communicate how you can assist the potential client to achieve their goals. That means you need to know

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

a lot about their organization. So spend some time to find out information about them. Websites are useful. But don’t be afraid to ring

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

the right person and ask questions. This would normally be the person advertised as the contact for the project; it could be the proje

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

ct manager or someone from HR. But find out their name if you don’t know it.

Once you’ve got the right person, arrange a meeting at a

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

Following aspects would a

mutually convenient time. It will probably be at their workplace. Be confident, assertive and prepared. Have pen and paper with you and

dd to the challenges in developing combination products:

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

take notes. But listen and look up periodically to let the client you’re interested in what they have to say. Ask questions about anyth

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

ing you’re not sure of. Be flexible. If you can think of a better and more cost-effective way of doing something say so. But the client

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

has the final say, so don’t push your opinions too far.

If you need to get back to them on something say so, and arrange a second mee

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

ting. You should avoid overcharging and undercharging and agreeing to unreasonable deadlines. If they are going to insist on deadlines

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

Professional from academic institutions, pharmaceutical industries, health care indust

hat are very difficult or impossible to meet, they may be “A Client from Hell” and you may be better off without their business.

At th

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

e end of the meeting summarize the main points and offer your proposal. They’ll either say yes, no or let’s meet again. Get any agreeme

.

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

nt in writing. A formal contract is often best. It’s probably best to get legal help with your first contract. Arrange another meeting

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

Companies that provide selfless information through particip

for the signing of the contract. Give them time to read it before they sign.

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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