Useful Advices - Business

• Make sure you have clear aims and objectives for the meeting – many meetings are held in

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

businesses for no better reason than that that’s what they’ve always done each month. 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

t’s just not effective.
• Make sure the meeting has an agenda and that this has been

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

issued to all participants in advance
• Make sure you have allocated a dedicated minu

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

te taker to the meeting and that that person understands their role
• If you have a l

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

Combination pro

arge number of participants make simple rules and list them before you start e.g. everyone

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

must put up their hand and be indicated by the chair before speaking (to stop people all

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

peaking at once.)
• If this is a follow-up or on-going meeting make sure that the fir

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

st point on the agenda is going through the action points listed on the previous minutes.

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

• If actions have not been carried out this may or may not be the time to find out w

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

hy. If there is a later point on the agenda that will explain why an action has not been c

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

Following aspects would a

arried out, state firmly that this point will be discussed on agenda point 5 (or whatever

dd to the challenges in developing combination products:

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

the relevant number is)
• Keep people on topic. It’s easy for discussions to become

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

impassioned and roam off to other topics. Firmly state that these issues will either be di

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

cussed later in the meeting or are not relevant to the meeting.
• Don’t lose your tem

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

per! It is vital that the chair keeps a cool head in order to maintain order in the meetin

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

Professional from academic institutions, pharmaceutical industries, health care indust

g.
• At the end of the meeting ask the minute taker if s/he has any points that need

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

clarifying. This gives the minute taker an opportunity to check details on the spot, and m

.

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

inutes can then be issued more quickly.
• Check the meeting minutes before issuing t

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

Companies that provide selfless information through particip

hem, or having them issued, to the other participants and any team members who were absent

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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It's a fact that smaller companies, by need and design, are more innovative, more flexible, more decisive, and faster to move than their larger brethren who are entrenched in operational processes and corporate procedures. Small companies are typically not led by career executives for whom every decision must be predicated by hours of meetings and mounds of documentation. Most small companies are led by their founders; men and women who were cut from an entrepreneurial cloth that has yet to fade. It is when a company grows to the point that the founder steps aside to make way for professional managers that the company loses its innovative nature and entrepreneurial flair.

Business administration school is a university-level institution that educates learners on such topics as accounting, finance, marketing, organizational behavior, strategy planning, and quantitative methods. Most business administration schools have experienced well-qualified faculties, and efficient managements. In 1881, the first 'collegiate business school' was founded in Wharton.

You sell more than one service or product, but you cannot assume that anyone knows about everything you have to offer - even your past clients! Here are some things you can do to assure that your prospects don't go elsewhere to purchase what you provide, simply because they don't know that you provide it.

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