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(V) Assets

It’s time to take a look at your assets, current assets (those expected to be used in a year or less) need to be re-examined quarterly, fixed assets (those over a year) should 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

e dealt with at a minimum annually, semi-annually if you have the time and you purchase a fair share of fixed assets within a year. What you want to look for here is the return on assets. H

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

Examples of combination products may in

w are your assets contributing to making a profit? If they are not or if the number is lower then the industry average you may have to consider purchasing new assets. Check each fixed asset

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

against its accumulated depreciation, is its useful life nearly depleted? Your accountant made an assumption for how long that particular asset would be useful, chances are that asset may s

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

ill be able to provide years of production to come, so this is not a rule of thumb, but simply a way of determining whether a course of action needs to take place.

Included in your assets

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

Combination pro

re your receivables. Review your credit policy; examine your customers and clients. Is your bad-debt expense too high? Are you allocating too much write-off? This is the second biggest canc

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

r to cash flow (sales is number one, if you don’t make a sale, you have no cash, period). Re-examine who you extend credit to, do they continuously pay late? If you have a large quantity of

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

write-offs it may be time to consider collections, or factoring (selling your receivables at a discount).

(VI) Liabilities

This section is really fairly simple. You want to watch your deb

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

load carefully. Too much means too high interest expense, and too low could mean you’re not expanding your company, a sign of stagnation. Watch you current ratio, and the quick ratios. The

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

’re a good gauge of your use of cash, and receivables collection.

(VII) Strategy

Every year at the beginning of the fiscal year you should be meeting with key member of your team to discu

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

s strategy for the year ahead. This should actually be the final meeting about strategy setting as it should have been started six months ago. Everything from day one of the fiscal year on

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

Following aspects would a

hould be monitoring your strategic implementations.

It’s time to review your goals, short-term, intermediate, and long term strategies. Where is your company headed, and where does it sit

dd to the challenges in developing combination products:

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

ompared to your competitors. It’s a great time to break out SWOT and begin reviewing. Is your company headed in the right direction? Where are your products in their life cycles? Do you nee

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

to add a line, diversify your business, and acquire a competitor or a business in another market? Or is it time to get bought out?

(VIII) Your Team

Your support staff is a crucial part o

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

your business. Do not neglect them. They need to be led, nurtured, reviewed, given direction, given vision, and in some cases let go. Firing is difficult and letting an employee go could l

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

ad to a legal battle. Do not let this affect the decision to release an employee because they fail to meet standards, expectation, and code of conduct. Morale can be weakened by a “bad appl

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

Professional from academic institutions, pharmaceutical industries, health care indust

” why let them spoil your bunch.

Take the time to review each staff member, or at least key members and allow managers to review others. Motivation to work harder, smarter, and more creati

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

ely doesn’t always get solved by waving more green in front of them. Some employees desire different incentives, take the time to get to know what makes them tick, you may find that a key s

.

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

aff member may want to take half-days on Friday as an incentive, and you had planned to offer them an equity position. You may save yourself some money.

Also consider nurturing their gifts

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

Companies that provide selfless information through particip

and talents, look into professional development. Seminars, books, tools, courses, training, and certifications can lead to a better staff. Pour into them, and they’ll pour into your company

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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