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Undertaking any project, whether in-house or in partnership with a professional services firm, entails risk. Project risk is defined as any area of concern that could p

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

revent a project from achieving all of its benefits. Project risk requires careful management and involves identification, assessment, and mitigation. It is important

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

Examples of combination products may in

at the beginning of any project to go through the risk identification process. Not all project risks are obvious. When identifying risks, look for areas in the project

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

that are based on:

1. insufficient or unreliable data,
2. insufficient preparation,
3. inadequate resources, or
4. lack of control.

Some areas to pa

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

y close attention to are:

• Requirements identification
• Involvement of project sponsorship
• Level of project management experience
• Third-party invo

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

Combination pro

lvement
• Political/cultural environment
• Change control procedures and management
• Complexity of the technology

Risk identification is only the first

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

step. Risks need to be assessed to quantify and prioritize them according to their impact on the project. Keep in mind significant professional judgment is required du

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

ing the assessment process to quantify the magnitude of potential negative impact and to develop risk control measures. The assessment process should determine the (1)

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

likelihood of the risk occurring, (2) range of outcomes, (3) estimated timing of the risk, and (4) the frequency with which it will occur. It should also determine 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

warning signs of the risk that will forecast that the occurrence of the risk is imminent. The prioritized risks provide the basis for establishing Project Success Facto

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

rs (PSFs). Specific action plans are developed to address each PSF. For example, assume that required key policy changes are a high risk. An action plan must be develop

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

Following aspects would a

ed to:

• Focus on thorough and frequent communications
• Implement a steering committee structure
• Obtain strong support for the project team from executive

dd to the challenges in developing combination products:

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

management
• Stress the benefits of the project
• Identify training needs early

Once risks have been identified and assessed, mitigation plans should be dev

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

eloped. The plans document what the response will be when a risk event occurs. Keep in mind a mitigation plan might be to do nothing to mitigate the risk. The need is t

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

accept that a risk exists and be prepared to deal with the consequences when and if it happens. This type of action plan typically applies to low priority/minimal proj

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

ect impact risks. A mitigation plan should outline Plan B for the project area impacted by the risk. Knowing what Plan B is prior to having to execute it will greatly r

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

Professional from academic institutions, pharmaceutical industries, health care indust

educe the probability of increasing the negative impact of the risk event or causing other unknown risks to occur.

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

cmctraining.org/projectmanagement.asp">project management process means choosing and implementing risk-control strategies that work. Identifying, assessing, and dev

.

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

eloping mitigation plans are not one-time events. These processes need to occur throughout the life of the project. As the project progresses and project risk changes o

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

Companies that provide selfless information through particip

ccur, documentation resulting from the identification, assessment, and mitigation planning processes need to be updated.

The risk management process must be continuous

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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