Advice You - Business

I worked for a respected pharmaceutical sales and marketing organization during years of rapid growth and expansion. The "driving rule" o

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

f behavior for this company was to "compete" and "perform" better than everyone else. This focus on competition drove the entire organiza

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ion to excellence as they used this strength to influence hospitals, governments and insurers to use their products and drove improvement

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

ithin the organization. Top performers were rewarded with many rewards and recognitions. Those who didn't perform were replaced with tho

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

se who would. This culture helped attract and develop people who were competitive and driven for success.

However, the industry began to

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

Combination pro

change. Cost constraints pressured private and public health providers to decrease costs, forcing change in the pharmaceutical business.

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

Teamwork, collaboration and partnerships with government, health insurers, and physician groups became more important.

As a result, senio

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

r management introduced a new set of values that included values such as, alignment, teamwork, collaboration, community, and respect for p

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

ople. However, the organization continued only to recognize and promote based only on performance and competition. While HR distributed

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

ilms, books and posters explaining the new values, most managers felt, as one once told me, that the definition of "respect for people" me

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

nt that "if employees don't "perform", we will "respectfully" fire them".

The old paradigm that brought prior success had changed, but th

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

Following aspects would a

e company was unable to change the internal culture to match the external drivers. Soon the company was unable to meet goals and frustrat

dd to the challenges in developing combination products:

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

on spread. The old culture became a liability to their success, but the old rewards stayed in place and no new awards for teamwork and col

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

aboration were put in place. It has taken this organization years to adapt to the new working environment. They still struggle developin

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

g teamwork and alignment over internal competition.

This is an excellent example of a needed culture shift that leadership did not drive

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

ast enough for the company to keep its competitive edge. Rewards and recognitions should have been changed more quickly in order to motiv

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

Professional from academic institutions, pharmaceutical industries, health care indust

te a change in behaviors. Also, the hiring and firing of employees should have been oriented to the new behaviors in order to bring peopl

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

e into the company whose values were in alignment with the new culture. This example also shows how difficult a dramatic change in cultur

.

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

can be for an organization. Upper management recognized they needed to change, but were not successful in communicating the need clearly

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

Companies that provide selfless information through particip

enough to the organization that behavioral change was needed for the company to continue to "compete" and "perform" in the new environment

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.adviceyou.org.ua/article/13892/adviceyou-Organizational-Cultural-Shift.html">Organizational Cultural Shift</a>

BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/13892/adviceyou-Organizational-Cultural-Shift.html]Organizational Cultural Shift[/url]

This article offers one take on the age-old question that plagues so many young people. Should you go on to college after high school, or move into the workforce.

In staffing terms, recruitment refers to the process of looking for and hiring new staff. Recruiters and hiring managers look for desirable people and whether or not you are desirable can go a long way to...

If you found yourself unemployed today, would you want the job you have now? Would you be eager to apply for it? What about your career as a whole? If you’d never worked in your current industry, would you consciously choose to work in it now?

Tags

Links

Advice You - Organizational Cultural Shift

Related Articles: