Main Subject - Business

Over the next few years, Gen Yers will enter the workforce in ever-increasing numbers. Gen Yers entrepreneurial spirit makes them self-reliant yet camar

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

aderie oriented attuned a community environment. The influx of Yers will usher in a variety of new learning and performance expectations as well as chal

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

Examples of combination products may in

lenges that will affect how a company manages its employees. For the first time in modern history, the workforce will encompass four separate generation

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

working side by side. The Silent Generation (born 1933-1945), Baby Boomers (born 1946-1964), Generation Xers (born 1965-1976), and Generation Yers (bor

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

n 1977-1998).

Traditional management styles has been hierarchical top down. The Yers will push companies to morph not bottom up but into a new style of

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

Combination pro

collaborative humanism. Within the collaborative humanistic workplace, all employees regardless of diversity are seen as naturally hard working, loyal

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

committed to what they do and have something valuable to contribute. All employees, regardless of status, are recognized as unique, possessing rights a

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

nd needs as human beings, and that respect, curiosity, recognition are immutable. Collaborative humanism will extend beyond the workplace requiring comp

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

anies to embrace their responsibility in global social and environmental concerns. Also, a ‘success’ obligation to its employees in terms of providing

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

earning opportunities and work-life balance.

Making the leap into the collaborative humanistic workplace requires shared values. Shared values must be

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

adopted not only between management and its employees but amongst all employees as well. Not cozy mission or vision statements for the benefit of custom

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

Following aspects would a

ers; but a holistic organizational pledge of trust and truth that is practiced daily through identifiable mutual gains. Stephen Covey, author 7 Habits o

dd to the challenges in developing combination products:

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

Highly Effective People®, states “An empowered organization is one in which individuals have the knowledge, skill, desire, and opportunity to personall

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

y succeed in a way that leads to collective organizational success.” Productivity, innovation and profit are intertwined in and propagated through coll

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

aborative shared values.

Shared values are identified and communicated through the principals of perception. Acknowledging these principals will allow

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 flexibility for multi-generational employees to collaborate working side by side. In your workplace, what are the principals of perception practiced

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

Professional from academic institutions, pharmaceutical industries, health care indust

?

• Do you acknowledge no two people see things the same way? Do you embrace the value of this diversity?
• Do you recognize each person has a rig

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

ht to think, feel, and see things based on their own experiences? Do you support a free speech non-judgmental workplace?
• Do you acknowledge a pe

.

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

son gains new perspectives only through new experiences? Do you encourage creativity, risk-taking and multi-tasking opportunities?
• Do you acknowl

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

Companies that provide selfless information through particip

edge perception accounts for individual differences and workplace disputes? Do you have a conflict management or grievance program within your workplace

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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