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Portfolio management is challenging, but it’s also exciting. Some people prefer to

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

have their portfolios managed by a professional. However, it’s not impossible to ma

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

Examples of combination products may in

age your own portfolio. It just takes time and a basic understanding of the process

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

Portfolio management involves 6 steps in an ongoing process.

1. Deter

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

ine Objectives/Constraints
2. Formulate a Strategy
3. Design an Investm

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

Combination pro

ent Policy
4. Implement Asset Allocation
5. Monitor Performance
6

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

Evaluate Performance

As an ongoing process, it is the responsibility of the

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

portfolio manager (whether that’s you or a professional) to go through the process

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

beginning at “Determine Objectives and Constraints”) and upon reaching the “Evaluat

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

e Performance” stage, start again.

Why is it an ongoing process? Because life is n

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

t static. People move, they change jobs, they get married, they get divorced, they

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

Following aspects would a

et remarried, they have children, they make large purchases, they make wise decisio

dd to the challenges in developing combination products:

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

s, they make unwise decisions, they are faced with windfalls and tragedies. Each of

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

those (and many, many other) events will affect how they manage their portfolio.

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

very individual has different needs and wants. The first step to successfully manag

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

your investment needs is to identify them by drafting an investment plan. This pla

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

Professional from academic institutions, pharmaceutical industries, health care indust

should state your goals. It is simply a mission statement of what you endeavor to

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

achieve. Be as specific as you can, so that you can determine what to invest in, an

.

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

how your portfolio will be structured to realise your dream.

We will review the 6

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

Companies that provide selfless information through particip

steps in our upcoming series of articles and I really hope you will benefit from it

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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