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Just Other Articles - When Good Companies Go Bad, Part 2 - Fear
Slipping revenues and eroding profits have continued long enough to get everyone’s attention. The major constituencies necessary to every enterprise: customers, lenders, vendors, shareholders, the Board of Directors, management and the rest of the work
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
force all know something is wrong.
Fear becomes a palpable force and constant companion. Customers fear the company will not be able to honor its commitments; the lender fears for his loan; the vendor fears he will not be paid; the shareholders fear l
Fear becomes a palpable force and constant companion. Customers fear the company will not be able to honor its commitments; the lender fears for his loan; the vendor fears he will not be paid; the shareholders fear l
; 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 of their investment; the Board and management fear failure, and; the rest of the workforce fears for its security and future.
As different as these legitimate concerns may be, fear results in certain common behavior:
1. It keeps us placing eve
As different as these legitimate concerns may be, fear results in certain common behavior:
1. It keeps us placing eve
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ts and people into categories (boxes)
2. It stops us from leading
3. It stops us from letting go of the past
4. It keeps habitual patterns in place
5. Feelings of failure and insecurity stop us from making necessary changes
6.
2. It stops us from leading
3. It stops us from letting go of the past
4. It keeps habitual patterns in place
5. Feelings of failure and insecurity stop us from making necessary changes
6.
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
It keeps us from reaching out for help.
Small and mini-cap companies with sales in the 5 to 50 million dollar range are more likely to fail for want of timely professional help, simply because they believe they cannot afford the cost of turnaround ser
Small and mini-cap companies with sales in the 5 to 50 million dollar range are more likely to fail for want of timely professional help, simply because they believe they cannot afford the cost of turnaround ser
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ices. This is particularly true for the mini-cap (sales 5-20 million) where management simply knows it cannot afford outside help.
Regrettably the concern about costs is often a mask to cover other fears concerning Crisis Manager Turnaround specialist
Regrettably the concern about costs is often a mask to cover other fears concerning Crisis Manager Turnaround specialist
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
:
1. The Turnaround Specialist does not KNOW the business. In many instances this is true. The Turnaround Specialist KNOWS crisis management and has highly developed negotiating and insolvency skills. As a practical matter he does not need to know how
1. The Turnaround Specialist does not KNOW the business. In many instances this is true. The Turnaround Specialist KNOWS crisis management and has highly developed negotiating and insolvency skills. As a practical matter he does not need to know how
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
to make widgets, he needs to know how to get the people who can make widgets to do so. He also needs to know how to organize and motivate staff, lenders and vendors to participate in the turnaround. There is no viable substitute for this experience.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
. The Turnaround Specialist does not understand or appreciate our corporate culture. True. Rather than being bound by the problems and constraints that your culture has developed, the role of the Turnaround Specialist is to bring order out of chaos.
3
3
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
The Turnaround Specialist has no heart. False. The Turnaround Specialist brings objectivity, focus and control to a chaotic situation. He has been retained to make the hard decisions others evade, avoid or defer. An experienced negotiator, the Turnaro
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nd Specialist relies upon truth, be it pleasant or otherwise, to forge necessary alliances with lenders and venders and to restore customer confidence in the organization. He will bring a fresh clinical objectivity to the business of survival with a vi
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
w to saving the good parts of the enterprise and many jobs. This creates the conditions necessary for the turnaround to succeed.
4. The Turnaround Specialist does not have to live with the effects of his recommendations. False. The Turnaround Speciali
4. The Turnaround Specialist does not have to live with the effects of his recommendations. False. The Turnaround Speciali
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
t is motivated by success, just like most people. He is responsible to the stakeholders that retained him and dependant upon succeeding for his own reputation and career to prosper.
The ancillary fears placed in perspective, we come back to cost. Simp
The ancillary fears placed in perspective, we come back to cost. Simp
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
y put, the cost of losing the opportunity for a successful turnaround is all that the enterprise has: money, assets, reputation, employees and any chance for a future. Fairly steep price to pay for ignorance and/or fear.
The all too common failure to
The all too common failure to
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
obtain quick intervention and specialized help from a Turnaround Specialist is costly. The longer the problems fester the weaker the enterprise becomes. The cost of recovery increases as the likelihood of successful recovery decreases.
The cost of any
The cost of any
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
turnaround attempt is threefold: time, effort, and money. Each of these is critical and all of them will be in chronic short supply until the effort is well under way.
While most turnarounds include staff reductions as a part of stopping the cash hemo
While most turnarounds include staff reductions as a part of stopping the cash hemo
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
rhaging, these job losses must be balanced against the absolute need for assistance in implementing the turnaround plan. The Turnaround Specialist is a catalyst in the process and must have the participation and assistance of each of the constituencies
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
for the turnaround to succeed. Accordingly any job losses will be kept to the minimum necessary; recognizing the vital role the work force plays in the company’s fight for survival.
Failure or a chance for recovery and success? Not really a tough ques
.
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
ion, is it? Regrettably it is one that many stakeholders in small and mid-cap companies do not answer until a crisis has further deteriorated and finances are even more constrained, thereby increasing the cost and reducing the probability for recovery.
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
A Crisis Manager retained early in the process is ultimately the best value. By working with an objective, skilled Turnaround Specialist a company can have the opportunity to achieve recovery and relentlessly pursue success.
©2007, Charles B. Van Duze
©2007, Charles B. Van Duze
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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