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Business Articles - Getting Involved in Global Development
Australia is blessed with an incredible pool of talent and experience, across a broad
range of industries, and it is this expertise that could provide significant and
sustainable benefits into the communities where a development initiative is
targeted.
The challenge for many firms and individuals wishing to participate in development activities is in
The challenge for many firms and individuals wishing to participate in development activities is 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
understanding the intricacies of the process to secure involvement.
Activities through agencies such as the Australian Agency for International
Development (AusAID), the World Bank and the Asian Development Bank, are usually
let through a public, competitive tendering process. Adding to this challenge is the
fact that in almost all cases, the proce
; 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
ss is different for each agency.
Myth that the development industry is different.
Well of course it is, as are all industries different clients, different products, different channels to market, different cultures, different environments, different risks etc.
What makes it the same is the need to ensure client needs are met, if not exceeded, and
Myth that the development industry is different.
Well of course it is, as are all industries different clients, different products, different channels to market, different cultures, different environments, different risks etc.
What makes it the same is the need to ensure client needs are met, if not exceeded, and
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
that products and services are as desired/needed, not imposed.
So how do you get involved? Is it luck? It is skill? Is it people, products or services?
All and more I am sure.
A key step often required is the need to demonstrate experience, understanding, value, sustainability of strategies etc to those assessing a tender.
Reality Check - Successful
So how do you get involved? Is it luck? It is skill? Is it people, products or services?
All and more I am sure.
A key step often required is the need to demonstrate experience, understanding, value, sustainability of strategies etc to those assessing a tender.
Reality Check - Successful
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
enders must be compliant to the requirements of the
request, must be price competitive, and need to find the balance between the
technical requirements of the response and the selling nature of the process.
One of the most important aspects of development initiatives is their ability to produce sustainable outcomes into the communities within which the
One of the most important aspects of development initiatives is their ability to produce sustainable outcomes into the communities within which the
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
activities take
place. Consequently, learning from past activities assists to shape the style of
future initiatives. For firms or individuals seeking participation, understanding how
such learning could modify development approaches is a critical step in determining
the type and level of involvement to target.
Fact learning from past activities
Fact learning from past activities
ucts have become life saving products for the pharmaceutical companies who doesnt have many innovative molecules in their product pipeline and have been inc
continues to shape future interventions.
The Development Market Today
The following points are some key observations about the directions [approaches] being taken in the provision of development assistance. These directions have the potential to impact on any strategy organisations and individuals might adopt to enter, maintain, or increase their inv
The Development Market Today
The following points are some key observations about the directions [approaches] being taken in the provision of development assistance. These directions have the potential to impact on any strategy organisations and individuals might adopt to enter, maintain, or increase their inv
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
lvement:
Funds are being diverted from government aid agencies to other government departments for sector-specific programs
There is a continuing trend to devolve more decision making to the offshore post of the donor country, away from the central headquarters
An increase in donor co-ordination and collaboration where, for example, the USA [
Funds are being diverted from government aid agencies to other government departments for sector-specific programs
There is a continuing trend to devolve more decision making to the offshore post of the donor country, away from the central headquarters
An increase in donor co-ordination and collaboration where, for example, the USA [
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
through USAID] and Australia [through AusAID] might align program
approaches to avoid duplication and other associated impediments, into a sector-
wide approach
A trend seeing more assistance being aligned to foreign policy where, for example, security and regional stability could influence aid disbursement
Bilateral donors are opening their market
A trend seeing more assistance being aligned to foreign policy where, for example, security and regional stability could influence aid disbursement
Bilateral donors are opening their market
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
s, allowing for individuals and
organisations to compete for once closed opportunities
There is an increasing trend for a move to larger activities, such as sector-wide approaches, as opposed to specific project interventions
Scale and global reach is likely to be an important criteria in winning and managing major programs
Relationships and ne
There is an increasing trend for a move to larger activities, such as sector-wide approaches, as opposed to specific project interventions
Scale and global reach is likely to be an important criteria in winning and managing major programs
Relationships and ne
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
works in country with donor representatives, recipient
governments, local organisations and development professionals are becoming
increasingly important.
Opportunity/Approach/Success Factors
Opportunities for involvement exist across a whole spectrum of activities, from short-term review/assessment activities in Australia, to short-term offshore as
Opportunity/Approach/Success Factors
Opportunities for involvement exist across a whole spectrum of activities, from short-term review/assessment activities in Australia, to short-term offshore as
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
signments for individuals or teams, to long-term offshore assignments for
individuals or teams, to overall project management which might include technical
inputs as well as sub-contracting of activities.
Organisations such as The Development Executive Group (http:// www.developmentex.com) are a valuable resource for individuals and firms to identify
Organisations such as The Development Executive Group (http:// www.developmentex.com) are a valuable resource for individuals and firms to identify
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
opportunities, individuals and potential partners. This Group provides a
range of free information and support services to individuals and companies,
including project information updates, a weekly development newsletter and
employment opportunities in the development sector.
An immediate key success factor is the consideration of which level of invol
An immediate key success factor is the consideration of which level of invol
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
vement
for a particular opportunity is likely to deliver the best result with the minimum of
risk for the organisation, the client, the stakeholders and the recipients of
support.
Many of the larger activities, such as programs, facilities and sector-wide approaches, often have sub-components that will be let out meaning the overall project man
Many of the larger activities, such as programs, facilities and sector-wide approaches, often have sub-components that will be let out meaning the overall project man
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
ging firm could be ineligible to perform the services within a sub-
component. The key principles to securing sub-component involvement is often
identical to that required to secure the overall project, as there will be a call for
tender using the same or very similar process to that used by the funding agency.
Consequently, all levels of involvement i
Consequently, all levels of involvement i
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
n the development arena are likely at some
point to require interested organisations/individuals to participate in a competitive
tendering round. This is often the case regardless of the size of the resultant
budget.
Reality Check - Tendering efficiency and effectiveness remains critical.
Tendering skills alone, while critical, are not the sole succe
Reality Check - Tendering efficiency and effectiveness remains critical.
Tendering skills alone, while critical, are not the sole succe
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
ss factor in fact
tendering well in the absence of other key activities/initiatives may prove
insufficient. Key considerations for success, in addition to compiling a winning
tender include:
Having the winning product the team, the approach, the methodology, and the response to the requirements of a tender
Ensuring advance positioning res
Having the winning product the team, the approach, the methodology, and the response to the requirements of a tender
Ensuring advance positioning res
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
arch, preparation, resources
Maintaining adequate promotion often the key here is relationships, and certainly past achievements
Being in the right place knowing the clients and stakeholders and having an international presence
Offering the right price must be competitive and offering value for money.
The tender response is often the most
Maintaining adequate promotion often the key here is relationships, and certainly past achievements
Being in the right place knowing the clients and stakeholders and having an international presence
Offering the right price must be competitive and offering value for money.
The tender response is often the most
.
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
challenging aspect (apart from
implementation of course), addressed by ensuring appropriate preparation and
analysis is conducted in advance. The tendering timeframe usually falls within a 4
8 week period and generally responses would be required to address key criteria
including the team, approach and methodology, management, and price.
Reality Ch
Reality Ch
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
eck - Preparation must commence prior to the public call for tender if a
realistic chance of success is to be expected.
These thoughts are by no means exhaustive, though they do cover some core principles relevant to successful business development and tendering approaches.
http:// www.meldunn.com.au
These thoughts are by no means exhaustive, though they do cover some core principles relevant to successful business development and tendering approaches.
http:// www.meldunn.com.au
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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