Cases - Business

If transport industry is a game of soccer, there are sure signs that the goal posts are shifting*. (Note: for better viewing experience with appropriate colour highlights, plea

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

se refer to original article, url attached)

Goalpost #1:

Previous goal post (1996): LTA White Paper

We only started MRT operations in 1987. We cannot grow 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

comprehensive network over the next few years. However we will build up the network incrementally, properly sized to match our city of the future. Over a decade or two, the res

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ults will be significant and clearly visible. Our target is to have as high as percentage of trips on a quality public transport system as in Zurich, where 75% of trips into th

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

e city centre are by public transport.

Current goal post (2006): Speech by Raymond Lim, 23 Oct

The aim is to increase the proportion of trips taken on public transport during

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

the morning peak period from 63% today to at least 70% over the next 10 to 15 years.

Goalpost #2:

Previous goal post (2001): Speech by Mr Yeo Ch

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

eow Tong, 23 Oct

Provided the financial position of the Government remains strong, the plan is to increase the network from 90 km today to over 150 km in 2006, and to about 24

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

0 km by 2012. In the long-term rail masterplan, the network will reach over 500 km, which is more than five times today's coverage.

Current goal post (2007): Speech by Mr Mah

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

Bow Tan, 9 Feb

LTA will be evaluating other new lines as well as extensions to current lines in different parts of Singapore which are currently under-served by the RTS networ

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

k as part of the overall master plan. In the long term, we may need to at least double our rail network. (Author's note: current RTS network stands at 138km. Doubling rail netw

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ork will reach about 280km.)

Goalpost #3:

Previous goal post (1994): Basic Bus Service Standards (Public Transport Council, PTC)

a) At least 100

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

% of bus services to operate at headway of not more than 10 minutes during weekday peak periods (excluding pubic holidays), unless otherwise stipulated by the PTC.

b) At least

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

100% of residential bus services to operate at headway of not more than 15 minutes during off-peak periods, unless otherwise stipulated by the PTC.

Current goal post (2006):

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

Quality of Service Standards (PTC)

a) At least 80% of bus services to operate at headway of not more than 15 minutes during weekday peak periods (excluding pubic holidays), un

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

less otherwise stipulated by the PTC.

b) At least 85% of bus services to operate at headway of not more than 20 minutes during off-peak periods, unless otherwise stipulated by

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

the PTC.

Let me clarify that I am not against shifting goal posts per se (a.k.a refining the targets) because I totally appreciate that targets need to be adju

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

sted or refined due to change in commuters' expectations and other factors that could render them unattainable or unrealistic. However, my observation is that the goal posts we

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

re shifted without providing any rationale. And the best part of this saga? The new targets, which are of a lower standards, are hailed as the next great milestones to achieve.

.

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

* Shifting goal posts (v): changing positions or targets. Used by Prof S Jayakumar (Minister for Foreign Affairs, Singapore) in Jan 2003 to explain to Parliament on how Malay

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

sia repeatedly changed its positions in negotiation of water supply to Singapore. For more details on the shifting goal posts saga, click here (quote in point 11 of main text).

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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