Useful Advices - Business

We all are project managers. Some of us manage projects like vacations or reunions, while others run implementations of new software systems, consolidation divisions of companies, launch new 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

roducts, or build buildings. While the scale changes for different kinds of projects, and complexity changes as more people are affected and involved; at the core there are questions you can a

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

Examples of combination products may in

nswer to help get any project off to a better start.

Here are seven of those questions you should ask (and answer!) when initiating a project:

1. What can I do at this early stage to increase

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

the likelihood of project success? This question gets you thinking about the key things to do now. Often at the beginning, especially of big projects, people focus all their effort on plannin

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

g. While planning is certainly important, sometimes there are actions other than “to plan” that need to be done early.

2. What skills will I need to complete this project, and who are the rig

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

Combination pro

ht people for the team? Seldom can we do it alone – and on big projects this question will get asked several times during the course of the project. Getting the right people with the right sk

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

lls on your team is critical and needs to be done as soon as you can.

3. How do I influence and persuade these people to be committed to this project? It is one thing to identify the people y

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

ou want on your team. It is another to help them understand why you want them, the roles they can play, and influence them to choose to be involved when they have other competing interests and

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

opportunities. Even in a corporate setting where people can be placed on or assigned to a team, we need to think about how we will gain their commitment, involvement and passion in the projec

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

outcomes.

4. What are the major deliverables for this project? A key part of any project plan is to outline what the outcomes will be. Answering this question is a critical part of your pro

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

ject planning, and sometimes overlooked as people focus only on the final end results, not considering the major deliverables along the way.

5. What are the major steps in my project plan? Ac

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

Following aspects would a

tually that is the question you want to answer, but isn’t where you want to start. Start by brainstorming on – “what are all the things that will need to be done in this project?” Don’t worry

dd to the challenges in developing combination products:

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

that you won’t think of all of them – you’ll think of more later! Get down on paper everything that you can think of first, and then ask the second question – “what are the major steps?” From

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

your big list you will be able to identify the key steps and then group the other steps “inside” the major steps.

6. How detailed does my plan need to be at this stage? Think about the compl

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

exity of the project, the number of people involved and the skill and experience of those people. All of these factors (and potentially many more) can play into the decision of how detailed to

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

make your plan. Make your plan detailed enough that people are clear on the deliverables and know what is expected of them by when. Perhaps the plan will need greater detail later and you wil

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

Professional from academic institutions, pharmaceutical industries, health care indust

l leave that to team members responsible for those components or maybe you need to develop that detail up front. This is one of the things you should be considering and balancing at the start

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

of the project.

7. What can I do at this early stage to ensure fewer risks and obstacles during the course of the project? Think about the end of the project for a few minutes. Imagine today

.

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

what obstacles, stumbling points and hurdles have had to be beaten to get to this successful completion. Then step back and ask yourself how you can eliminate the obstacles, bridge the roadblo

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

Companies that provide selfless information through particip

cks, and clear the hurdles now. This is one of the best uses of your time at the start – to take steps to reduce or eliminate these things, before they can occur to stall or delay your project

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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