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Digg It - Create Your Methodology Based on a Standard Framework (Part2)
In the previous article I explained why it is a good idea to create a methodology based on a standard framework and highlighted the criteria to choose the most convenient one. In this article I will g
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
ive some tips for the adaptation and documentation of the methodology.
Understand the framework
Once a framework has been chosen it is time to start building the methodology. The first step is to a
Understand the framework
Once a framework has been chosen it is time to start building the methodology. The first step is to 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
Examples of combination products may in
cquire a general understanding of the framework, a holistic view of its components. You must have a clear idea of its scope and boundaries. It might be useful (if you already have some formal processe
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
in place) to carry out a mapping of your processes to the standard and perform a gap analysis. This is not necessary if you approach the project as a reengineering project, building the new processes
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
from the ground up.
Build a roadmap
Once you have a clear vision of the standard framework's scope and your current situation, you have to define where you want to get (the scope of your methodolo
Build a roadmap
Once you have a clear vision of the standard framework's scope and your current situation, you have to define where you want to get (the scope of your methodolo
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
y). This means that you must have a clear vision of your organization once the new methodology is in operation. You might find that some processes do not apply to your organization or are too sophisti
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
cated for your needs.
Be realistic. Take into consideration the resources you have available for the project and the timeframe. Be sure that this strategic vision is known by all people involved in t
Be realistic. Take into consideration the resources you have available for the project and the timeframe. Be sure that this strategic vision is known by all people involved in t
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
he project and understood and shared by the initiative sponsor.
Now you know where you want to get and the objectives of the project have been defined, it is time to plan how you are going to get the
Now you know where you want to get and the objectives of the project have been defined, it is time to plan how you are going to get the
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e. You can face the project in two ways:
Once-off delivery. The methodology is only only deployed once the full scope has been achieved. Incremental delivery. The methodology is deployed in several
Once-off delivery. The methodology is only only deployed once the full scope has been achieved. Incremental delivery. The methodology is deployed in several
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
iterations, each of which releases a set of processes.
Although the once-off approach can make sense when the scope of the change is limited, I believe an iterative approach increases the probabilit
Although the once-off approach can make sense when the scope of the change is limited, I believe an iterative approach increases the probabilit
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
of success of the project. Try to get some quick-wins by choosing for the first iterations those processes that add visible value or solve a known problems. You will learn with each release and apply
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
that knowledge in subsequent iterations.
Adapt and detail the processes
Standard frameworks are general purpose. In order to be useful to a wide and heterogeneous set of organizations they provide
Adapt and detail the processes
Standard frameworks are general purpose. In order to be useful to a wide and heterogeneous set of organizations they provide
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
best practices expressed in general terms. It is your task to convert that into actionable pieces of work. After understanding the process as described in the framework, you will have to determine how
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
you want it to be carried out in your organization's context, determine the roles that will be responsible of executing it, the tools that will be used to facilitate it and the documents, information,
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
objects, etc... that it must deliver.
Document the processes
Once the new processes are clear, they must be documented in order to facilitate their communication to the people that will be executin
Document the processes
Once the new processes are clear, they must be documented in order to facilitate their communication to the people that will be executin
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
them. The objective now is that the process is executed in the real world according to the new process definition. This can only be achieved through process understanding and buy in of the people wh
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
o carry out the process, and good process documentation is key for this.
Process can be documented in a wide variety of formats with several tools (from MS word to metoCube, a process documentation t
Process can be documented in a wide variety of formats with several tools (from MS word to metoCube, a process documentation t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ool developed by us at Nevant). Whatever format and structure you choose for your process documentation, always try to keep the following in mind:
Process documents must be easily accessible. If they
.
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
re not, people won't spend time searching for them.
Process documentation must be easily navigable. If people don't find the concrete piece of information they are looking quickly, they will probably
Process documentation must be easily navigable. If people don't find the concrete piece of information they are looking quickly, they will probably
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
desist or waste valuable time.
The tools and templates needed to carry out the work described must be easily accessible from the documentation. Complement textual process descriptions with diagrams
The tools and templates needed to carry out the work described must be easily accessible from the documentation. Complement textual process descriptions with diagrams
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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