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Your Space - Do You Need A Corporate Reality Chcek?
In an age of accelerating change, it is critical that today’s organizations get and stay in touch with the reality of the marketplace and especi
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
ally within their own companies.
It is so easy, when bombarded with constant outside and inside pressures, to put important policy modification
It is so easy, when bombarded with constant outside and inside pressures, to put important policy modification
; 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
s, strategic plans and corporate agendas on the back burner while giving your full attention to putting out daily fires. Many of these daily cri
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ses are the natural result of a lack of attention to these very critical activities. There is always time to fix something, but never enough ti
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
me to do it right the first time. There is always money to fix something but never enough to do it right the first time.
I encourage you to ta
I encourage you to ta
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ke stock of the current perceptions, attitudes, philosophies, and a whole host of related issues within the culture of your organization both bo
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
ttom-up and top-down, as well as your customers and prospects.
For years, thousands of organizations, both large and small, have muddled throug
For years, thousands of organizations, both large and small, have muddled throug
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
h day after day with the curse of crisis management. Many of these seem to survive and a few succeed in spite of themselves. Day after day, they
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
shoot themselves in the foot, bandage it up and then shoot the other foot tomorrow.
They are like a train out of control, speeding down the tr
They are like a train out of control, speeding down the tr
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
ack with no clear destination, broken steering mechanism, worn brakes and with little focus on the real reason for their existence or the trip.
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
What are the symptoms and curses of this stressful management style?
1. Inconsistent or poor communication strategies, approaches or style.
2.
1. Inconsistent or poor communication strategies, approaches or style.
2.
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
Poor planning.
3. Inconsistent, inaccurate or non existent upward feedback from employees and /or the marketplace.
4. Excessive politics and
3. Inconsistent, inaccurate or non existent upward feedback from employees and /or the marketplace.
4. Excessive politics and
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
game playing.
5. Autocratic top-down management style.
6. A corporate culture that doesn't foster employee empowerment and sharing of informat
5. Autocratic top-down management style.
6. A corporate culture that doesn't foster employee empowerment and sharing of informat
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
ion.
7. Independent decision making without consulting the departments or people that are affected or must implement the decision.
8. Arroga
7. Independent decision making without consulting the departments or people that are affected or must implement the decision.
8. Arroga
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
nce or attitude of invisibility.
9. A greater concern for who said it rather that what is best for the health and success of the organization.
9. A greater concern for who said it rather that what is best for the health and success of the organization.
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
10. Lack of employee training and development.
11. Senior management that is out of touch.
12. Excessive employee or management hidden agenda
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
s.
13. Management incompetence.
14. Dual or conflicting messages from above.
15. Last minute orientations.
There are others causes, but in m
13. Management incompetence.
14. Dual or conflicting messages from above.
15. Last minute orientations.
There are others causes, but in m
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
y experience working with corporate clients from five million in sales to over forty billion for over thirty years - most will tend to fall in o
.
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
ne of the 15.
If your organization or any department or division tends to be run with a crisis management style you might want to look deeper i
If your organization or any department or division tends to be run with a crisis management style you might want to look deeper i
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
nto the culture or philosophy of the business to see where the cause of this costly and time consuming mindset is originating or being fostered.
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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