Advice You - Business

Project management as a science and art is undergoing key transformations as a result of countless stori

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

es of failed projects, cost overruns, and canceling that project that took 2 years of your employee's li

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

Examples of combination products may in

es. Needless to say, these scenarios not only cost money, time, and lost opportunities, but also have a

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

onger term impact on the overall morale of a workforce.

Though there is no panacea to these inevitable

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

utcomes, it's important to take a look back on the cornerstones that define effective and success-prone

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

Combination pro

project management.

Ultimately project management like most disciplines, requires just that-discipline.

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

This discipline of mindset far outweighs any single tool, or management fad with a catchy name. The PMBO

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

or The Project Management Body of Knowledge is a good reference guide to begin, refocus, or sharpen you

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

project management mindset.

Here are some key attributes of the Project Manager mentality:

1. A solid

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

understanding and vigilant re-education in the discipline, the science, and the are of project manageme

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

t and it's key knowledge and practice areas.

2. The experience and wherewithal to not attack a project

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

Following aspects would a

ith everything and the kitchen sink and instead being able to pick out the appropriate tools for improvi

dd to the challenges in developing combination products:

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

g implementation and the planning of the project.

3. Understand the dynamics of a team, and serve as th

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

e glue that holds the members together.

4. The ability to incorporate the new methodologies with the ol

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

on the fly.

5. People, People, People! A knack for understanding how to communicate effectively with y

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

ur team members as it relates to project changes, overall progress, and transcribing the overall vision

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

Professional from academic institutions, pharmaceutical industries, health care indust

or the project throughout it's duration.

Overall the skills required to achieve the project manager men

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

tality are: being flexible, possessing strong oral/written communications, the ability to think strategi

.

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

ally and solve problems on your feet, team building and interpersonal skills, a sense of accountability

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

Companies that provide selfless information through particip

or yourself and your team members, and finally the technical credibility to lead the project in question

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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