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E-Folder - Managing Your Team (Part 6) - You Two Stop Fighting
Of course there's fighting, then there's fighting!
I would like to think that irritating bickering between individuals can be nipped in the bud promptly and quickly. Not a lot of sense in allowing it to continue, annoy other t
I would like to think that irritating bickering between individuals can be nipped in the bud promptly and quickly. Not a lot of sense in allowing it to continue, annoy other t
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
eam members, and end up with a non productive session and a non productive team.
However, I said "I would like to think"...
How much are the team's objectives contributing to this internal fighting? They may do,
However, I said "I would like to think"...
How much are the team's objectives contributing to this internal fighting? They may do,
; 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
but more often than not, the team setting is merely regarded as another opportunity by which this adversorial behaviour can be expressed and continue.
Both in our personal and business lives, we collect baggage and a lot of it,
Both in our personal and business lives, we collect baggage and a lot of it,
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
unfortunately, stays with us. Moreover, the personal and business items we've collected get confused and it is only natural that one set will have an adverse effect on the other and vice versa.
One all too common area where t
One all too common area where t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
his can manifest itself is in our working relationships within our company or organization.
Some one-on-one situations may be resolved quickly and no more is thought of it. Others, when left unchecked, can grow in seriousness
Some one-on-one situations may be resolved quickly and no more is thought of it. Others, when left unchecked, can grow in seriousness
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
significantly affecting the performance of those involved.
More importantly, it's not just the negative impact these situations have on those involved - look at the bigger picture - and the adverse effect it has on the performa
More importantly, it's not just the negative impact these situations have on those involved - look at the bigger picture - and the adverse effect it has on the performa
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
nce of the team and more - classic ripple effect.
Typical reasons may be...
Previous project team experiences - negative outcomes
Personal reasons
Unresolved situations in the workplace
Typical reasons may be...
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
>Promotion / Demotion
Internal or external departmental conflict
It's more likely that this less than desirable working relationship goes back way before the team was formed and, if left unchecked, will continue
It's more likely that this less than desirable working relationship goes back way before the team was formed and, if left unchecked, will continue
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
after the team has completed its assignment and moved on.
To me this is a classic NO-WIN situation.
Whatever the reason it seems that no real effort has been made to help these adversaries resolve the conflict or their
To me this is a classic NO-WIN situation.
Whatever the reason it seems that no real effort has been made to help these adversaries resolve the conflict or their
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
differences and enable them to move on. If the team leader doesn't know the root cause(s) how is he/she meant to deal with it? How does he/she keep the rest of the team motivated?
Knock On Effect...
Team members f
Knock On Effect...
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
eel like onlookers, bystanders
Fear of outcome if others get involved
May be seen as taking sides
Totally demotivated with progress not being made
Questioning why nothing is being done to
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
resolve it
Feelings get so strong other team members end up 'fighting' with the adversaries.
So, what's a team leader to do?
I would suggest that whether this adversorial behaviour happens in the workplac
So, what's a team leader to do?
I would suggest that whether this adversorial behaviour happens in the workplac
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 during normal day to day activity or within the confines of a project team, the ways forward are very similar.
The bottom line is the quicker this type of challenge is dealt with, the easier it will be to resolve it. As team
The bottom line is the quicker this type of challenge is dealt with, the easier it will be to resolve it. As team
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
leaders, we certainly have the responsibility to facilitate a postive change. However, the onus to change lies totally on the shoulders of the individuals involved...
Facilitate a private discussion between those involved.
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
Use a structured approach, do not be judgemental (you may not totally know the history), the only objective is to reach consensus and determine what steps they agree to take to move forward.
Prevention is the b
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
est form of cure. If it is at all possible, at the point of team selection, make sure adversaries are not selected to be on the same team.
If the team leader is not empowered to make that decision, it makes sense to
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
bring the individuals together before the first meeting and encourage them (insist) they reach an agreement as to how they will behave as a member of this team.
Additionally, establish the team's "ground rule
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s". These are the rules all team members agree to follow when they get together and, again, without pointing fingers, emphasis can be placed on disruptive behaviour not being acceptable.
Sadly, some situations may
.
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
be beyond the point of reasonableness and the team leader now has no alternative but to treat this as a serious performance issue. It is vital that the organization's policies and procedures are fully understood so that due car
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 is taken to facilitate a positive outcome. If the team leader is unsure, then he/she definitely needs to seek guidance within the organization.
Managing The Team (Part 7) will look at Why Can't We Stay on Track?.
Managing The Team (Part 7) will look at Why Can't We Stay on Track?.
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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