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Subjects - It's Not What You Do; It's What You Do After You've Done It
So how did you do? Really. No "nicey nicey" banal comments please on how it was "great". What really worked - and why? And what really didn't work - and why not? What role did you have? In the success? In
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
the failures?
After a project or an event, it's rare that anyone, either individually or as a team, sits down to reflect on what has unfolded.
Ironically, the learning from an event comes primarily from t
After a project or an event, it's rare that anyone, either individually or as a team, sits down to reflect on what has unfolded.
Ironically, the learning from an event comes primarily from t
; 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
he debrief rather than from the event itself. That's worth repeating because it is so profound and so often overlooked: the learning from an event comes primarily from the debrief rather than from the event
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
itself.
It's a delicate art to conduct a retrospective that's powerful and useful and not a destructive critique.
Most of us don't bother with a post-event analysis. But even when we do, they can be pain
It's a delicate art to conduct a retrospective that's powerful and useful and not a destructive critique.
Most of us don't bother with a post-event analysis. But even when we do, they can be pain
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
fully horrible affairs: a combination of passive-aggressive politeness with no one willing to mention the "dead moose" (or "dead elephant" or "dead kangaroo", depending on your country of origin) that is in
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
the room. (For those unfamiliar with the phrase, we're talking about the thing that's big and rotten and getting in the way of everything).
An After Action Review (AAR) is focused primarily on learning and
An After Action Review (AAR) is focused primarily on learning and
ucts have become life saving products for the pharmaceutical companies who doesnt have many innovative molecules in their product pipeline and have been inc
building community. It is founded on two related principles:
This is not to judge success or failure (and hence apportion blame) but rather the focus is on what can be learned for moving forward.
The
This is not to judge success or failure (and hence apportion blame) but rather the focus is on what can be learned for moving forward.
The
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
re's a belief (what Norman Kerth calls the Prime Directive) that regardless of what's discovered, the participants understand and truly believe that everyone did the best job they could, given what they kne
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
w at the time, their skills and abilities, the resources available, and the situation at hand.
With that in place, there are five simple and profound questions to ask.
1. What did you intend?
This can
With that in place, there are five simple and profound questions to ask.
1. What did you intend?
This can
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
be a simple restatement of your objectives. What were you trying to achieve?
2. What happened?
This is useful for just getting a sense of what really happened. You can rest assured that your perspective
2. What happened?
This is useful for just getting a sense of what really happened. You can rest assured that your perspective
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
of events is only one of the versions.
The objective here is to collect both "the facts" (such as costs, number of people involved, figures, etc) and differing opinions on what worked and didn't work, wh
The objective here is to collect both "the facts" (such as costs, number of people involved, figures, etc) and differing opinions on what worked and didn't work, wh
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
at circumstances influenced what happened, and other factors.
When commenting on others' roles, capture specific behavioural events (what they did, what they said) rather than your conclusion about what
When commenting on others' roles, capture specific behavioural events (what they did, what they said) rather than your conclusion about what
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
they did (X did a poor job because...).
3. What can we learn about it?
There will be different levels of learning here, from the very specific ("don't wear Brand X socks - they give you blisters") to th
3. What can we learn about it?
There will be different levels of learning here, from the very specific ("don't wear Brand X socks - they give you blisters") to th
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
e more abstract ("this project wasn't close enough to my life purpose for me to be motivated").
Don't forget to ask here "what did we do well that we need to discuss or else it will be forgotten?" It's v
Don't forget to ask here "what did we do well that we need to discuss or else it will be forgotten?" It's v
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
ery easy to jump to "the mistakes". It's most powerful to start with what's been working.
Capture also "what still puzzles us?" You won't be able to figure everything out. Be explicit about what it is th
Capture also "what still puzzles us?" You won't be able to figure everything out. Be explicit about what it is th
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
t still is a mystery.
4. What should we do differently next time?
This is powerful because it plants seeds for the "next time" conversation. Without these seeds, we default back to a collective memory o
4. What should we do differently next time?
This is powerful because it plants seeds for the "next time" conversation. Without these seeds, we default back to a collective memory o
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
f "this is how we do things around here" which most often does not capitalize on the collected wisdom.
5. What should we do now?
There may well be actions to take right now: things to do, people to conn
5. What should we do now?
There may well be actions to take right now: things to do, people to conn
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ect with.
As with all actions, set up accountability: what will be done, by whom and by when.
Something to Practice:
Look back on a recently completed project or event. It might be a family holiday. It
As with all actions, set up accountability: what will be done, by whom and by when.
Something to Practice:
Look back on a recently completed project or event. It might be a family holiday. It
.
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
might be a project at work. It might be a date with your girlfriend or boyfriend. Thinking about what happened, write down your answers to these five questions:
What did you intend?
What actually happene
What did you intend?
What actually happene
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
d?
What did you learn?
What will you do differently in the future?
What should you do now?
If you're feeling bolder, invite the others involved in the process and have the conversation with them as well
What did you learn?
What will you do differently in the future?
What should you do now?
If you're feeling bolder, invite the others involved in the process and have the conversation with them as well
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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