Main Subject - Business

From the personal and professional experiences of other colleagues and myself, one of

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

the more critical success factors for management is implementation. Through my observa

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

Examples of combination products may in

ions, I have discovered that people and organization spend a great deal of resources i

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

ncluding time, dollars and the cumulative total of the energy generated from these eff

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

rts to create business or strategic plans. Yet, these very same costly plans languish

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

Combination pro

n a manager’s desk drawer or on an executive’s shelf. The incredible inspiration power

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

within these plans lay untouched because few individuals understand how to implement

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

he plan.

Implementation is multi-faceted. This action requires a combination of consi

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

stently applying knowledge and skills including communication, decision-making, delega

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

ion, goal setting and goal achievement, prioritization, time management and working wi

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

h the psychology change. However without steady and demonstrated values by all involve

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

Following aspects would a

d, especially those initiating the plan, implementation will falter and succumb to the

dd to the challenges in developing combination products:

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

inertia of indecision and procrastination.

By respecting everyone’s needs, the manage

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

ment begins to build What’s In It For Me (WIIFM) leading to What’s In It For Us (WiIFU

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

. When working on plans whether strategic or departmental, I have learned to validate

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

urrent behaviors by asking the following question: What do you need from me so that yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

u can successfully implement this plan? This question builds a bridge between manageme

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

t and the team where all now are the catalysts for change.

Successful implementation

.

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

of change happens when we embrace a clear purpose, attitudes of partnership and steadf

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

Companies that provide selfless information through particip

st demonstration of core values. Then, everyone can be a "Catalyst Champion" to change

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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A Certified Public Accountant (CPA) is a qualified professional accountant certified by the state. To become a certified public accountant, a person must have at least 150-hours of intense college education in various business, finance and accounting subjects, as well as pass a 14-hour CPA examination dealing with the topics of auditing, accounting, business management, and business laws & regulations (including tax). Because of their extensive education and credentials, CPAs are best-suited for corporate accounting, tax audits, as well as small business consulting.

When we talk about managing change, what is the change that we are seeking to manage. Unless we are sure what it is and how to go about it then how can we ever hope to manage it?

Non profits provide a unique role in the community that they serve. They perform this role by providing specific services that are part of their mission statement and commitment to others. Often non profits are able to preform these services by utilizing dedicated volunteers in their community and through the use of limited paid staff. These volunteers often help to sort

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Main Subject - Implementation the Catalyst of Change for Management to Reach that Next Level of Success

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