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Advice You - If You Need Surgery, Call in the Surgeon
When you need a heart by-pass, you call in a cardiologist rather than a general
practitioner. When you are in legal troubles, you consult a lawyer. When you have tax
problems, you seek advice of a tax consultant. Yet man
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
y troubled companies make the
fatal mistake of not approaching the right professional for help. Many try to get out of
their conundrum using the internal management. Others rely on their lawyers, auditors,
etc. These 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
oubled businesses need to bring in turnaround experts and specialists. In fact,
the management of some of these ailing companies behaves like a deer caught in the
headlights, petrified and totally clueless on how to move
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
forward.
As chief executives and chief financial officers fall from their grace over accounting irregularities and scandals, turnaround managers, with familiar titles such as chief restructuring officers, turnaround sp
As chief executives and chief financial officers fall from their grace over accounting irregularities and scandals, turnaround managers, with familiar titles such as chief restructuring officers, turnaround sp
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
cialists or artists, corporate doctors are taking charge
of distressed companies to get them up to speed again. In the US, troubled companies
such as WorldCom Inc, Enron Corp, Kmart Corp have appointed turnaround special
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
sts
to restructure their businesses. Since he Asian financial crisis, even Malaysia has enlisted
the use of professionals, armed with impressive credentials rather than political ties to
shake up the government-linked
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
companies. For instance, in 1998, the former premier
brought in the first batch of turnaround experts to head the Umno-linked companies and
asset management firm Danaharta.
Some of these turnaround experts who generally
Some of these turnaround experts who generally
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
have a background in business,
accounting, finance or operations are called in by the creditors or board of directors who
lose faith in the management. In most instances, these specialists have had a significant
experi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ence as a CEO, CFO, CIO or COO provide a sense of credibility and glimmer of
hope to the board, investors and creditors. . They are a special breed of talent, as they
have to be entrepreneurs, visionaries, redesign archi
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
ects and crisis managers all rolled
into one. They have to create resources out of liabilities, find opportunities where none is
apparent and travel down uncharted paths to fix “unsolvable” problems. In essence, they
h
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ve to create value by reinventing the company.
Unfortunately, no company seeking to turn around would run an advertisement that says: “Company not making money and need turnaround specialist. Send in your application.”
Unfortunately, no company seeking to turn around would run an advertisement that says: “Company not making money and need turnaround specialist. Send in your application.”
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
There are many ways of finding quality professionals to enable you to fix your business.
The first place to start looking for a turnaround specialist is to contact your banker,
lawyer, external auditor, large accounting
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
irms and various business chambers and
associations. Through their previous collaborations, these parties may have the contacts
of specialist with the requisite skills
Another way to find the turnaround specialist is to
Another way to find the turnaround specialist is to
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
contact those who understand the
company’s situation such as current employees, company’s board of directors and
advisors and associates. But one has to exercise care in the selection process. There are
many professio
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
als who profess to be turnaround specialists but are actually only
financial people who are preoccupied with cost-cutting measures. It takes much more
than mere cost cutting to turn around an ailing business. Certainly,
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
uch skills and
knowledge are important but it is only part of the answer.
Besides having actual turnaround experience, turnaround specialist needs to have a broad understanding of the industry. He or she needs some unde
Besides having actual turnaround experience, turnaround specialist needs to have a broad understanding of the industry. He or she needs some unde
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
rstanding of the industry.
Normally time is not on the side of the turnaround specialists to show results. Therefore
if he understands the industry it can facilitate and shorten the learning curve and quickly
bring in
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
usiness through his contacts.
The specialist also needs to have gone through adversity and shows track record of successfully turning around troubled businesses. Successful managers in healthy companies will not cut it
The specialist also needs to have gone through adversity and shows track record of successfully turning around troubled businesses. Successful managers in healthy companies will not cut 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
as they have not had to work with low-morale employees,
creditors screaming for payments and diminishing market share as clients switch to the
competitors.
Sadly, most of these restructuring experts are brought in too l
Sadly, most of these restructuring experts are brought in too l
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
te. As the restructuring
should have been carried out yesterday. Consequently, the success rate of turnaround is
very low.
Therefore, when you need surgery, call in the surgeon quickly. Do not delay as it can be fatal
Therefore, when you need surgery, call in the surgeon quickly. Do not delay as it can be fatal
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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