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Digg It - People Issues in Project Management
Project managers are often assigned as proposal managers and asked to plan and put an estimate to arrive at an acceptable proposal during the project proposal stage; and upon winning the project to manage th
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 projects with little or no authority, dictated time frames and deliverables, and essentially told to just get the project done! The reality to remember is that project executions rarely fail due to technic
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
l problems but rather because of people problems.
Conflicting priorities, unclear expectations and roles, poor leadership, conflicts of interests, poor teamwork or lack of it, and little and no motivation a
Conflicting priorities, unclear expectations and roles, poor leadership, conflicts of interests, poor teamwork or lack of it, and little and no motivation 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.
ll lead to project failure. Addressing the people management problems we all face as project managers and the best way to do it will require us to at least understand the many types of people we potentially
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
eet and engage in project execution in the work place.
More and more focus is made to understand human work behavior and human personality these days simply because individual character types may be complem
More and more focus is made to understand human work behavior and human personality these days simply because individual character types may be complem
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
entary but potentially conflicting to one another too. Most teams must work together to a lesser or greater extent collaboratively in any project execution, organizations, and in work place. If the team orga
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
ization and operating practices can be constructed taking into consideration each individual’s strengths and weaknesses, this will have a positive influence on the project team with good chances for success.
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
Also interesting to note here is the result of a research I read which indicates that an ‘Apollo Team’ defined as the best and most talented people, when assembled in a project execution team will not be t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e best team you can expect in a project team simply because of the strong ego each team member tends to have and the strong likelihood that such team may compete rather than collaborate and support each othe
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
r.
In my view, we will never have a perfect project team nor should we dream of one, and in fact in most organizations that I have worked with and the many projects I have had privilege to handle, the proje
In my view, we will never have a perfect project team nor should we dream of one, and in fact in most organizations that I have worked with and the many projects I have had privilege to handle, the proje
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
t teams have almost always been assembled and planned during project proposal preparation stage. Though I may have some say for replacement to those who are no longer available for the project, I still think
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
my only chance to influence the project team is to build one, and together with the team, find a common identity sooner rather than later so I can cultivate the team work culture for all to collaborate to th
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
e same and aligned project objectives.
What I also managed to find out and observed in many instances is that nothing causes more friction between project management and line management than poor forward fo
What I also managed to find out and observed in many instances is that nothing causes more friction between project management and line management than poor forward fo
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ecasting of the project resource needs. Starting resource requirement has the benefit of time to prepare ahead during and after the proposal prior to start of project execution. But the many turns of events
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
during project execution and the changes in project scope can be an unexpected surprise to meet projects resource requirements.
In order to avoid unnecessary conflict, the project manager and his team must
In order to avoid unnecessary conflict, the project manager and his team must
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
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
learly specify their particular resource requirements to the line management at the outset, and keep functional management abreast of changes as they occur. In order to do this, they must develop a manpower
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
loading chart and resource mobilization plan in some detail at the beginning of the project and the follow on updates during project execution, and must clearly spell out any other resources that they will p
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
tentially need along the way to project completion.
Even with those efforts there is always a conflict of interest especially when the company is executing multiple projects and when new proposals preparati
Even with those efforts there is always a conflict of interest especially when the company is executing multiple projects and when new proposals preparati
.
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
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
on needs pop up out of blue, now and then along project execution, and or simultaneously. Particularly at the end of a project, it is essential that the project manager clearly defines well in advance when t
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
e team members are likely to be released and the functional management is equally informed. It is never acceptable for the project manager to retain his team on a week-by-week basis or in ‘Just in Case’ mode
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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