Main Subject - Business

Leadership skill development is accomplished on the job. People learn to be project managers by managing projects; people learn to recruit staff by recruiting staff; people learn to discipline staff by discipli

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

ning staff; and people learn to lead a team by leading a team.

When managers and leaders acquire these skills, they actually do most of their learning the first time that they complete such a management or lead

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

Examples of combination products may in

rship initiative.

Therefore, it is through undertaking challenging new projects that leaders learn. Their development and situational maturity grow as a result of doing something different and unfamiliar.

Joh

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

Dewey, in his wonderful book, “How We Think,” writes:

“The familiar and the near do not excite thought on their own account, but only as they are adjusted to mastering the strange and remote.”

B

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

siness management training and leadership development in a purely theoretical sense are therefore pointless. People think, learn and reinvent themselves by experiencing and doing new things. Within the busines

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

Combination pro

environment, successful corporate team building integrates the following key elements:

Provide the Leadership Development Experience

Leaders must be given a challenging task or objective that has been

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

identified as being of high importance in achieving a specific business result. The activity should present a new opportunity that the person has not encountered before.

By exposing the best people to these rol

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

s, they are more likely to rise to the challenge. This type of learning experience is effective because there is an element of the unknown and the stakes are high. Such tasks create a sense of urgency, raised

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

xpectations and a certain degree of tension that is motivating for aspiring leaders.

This is not to say that people should be left to sink or swim. They must be given the support and the resources required to a

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

hieve the task that has been set, by having them work alongside and with the best people in the business to increase the probability of their success.

Enrol the Right Supports

The potential leader shoul

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

be assigned to a manager who is a recognised high performer in terms of achieving results, managing himself or herself, and having the ability to lead with and through others. This will ensure that the best in

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

Following aspects would a

the business are learning from the best in the business.

In this ongoing process of learning, both the coaching manager and the person being coached are encountering new problems, gaining new insights and are

dd to the challenges in developing combination products:

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

eveloping new skills and competencies along the way. This exposure to the experience of another in undertaking real work is mutually invaluable and builds the capability of the business and the people within it.

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

Evaluate Success

Gains, in terms of milestones, must be recognisable, measurable and celebrated when they are achieved. Such recognition reinforces the winning cycle and encourages the person to achiev

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

and learn even more. When mistakes occur, they must be identified and talked about in an open and honest manner, addressed and fixed. This will also reinforce the ongoing learning experience and the positive n

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

ture of the achievements along the way.

Making Mistakes and the “Always Learning” Mindset

Some of the best learning comes from having made mistakes. Of course, these mistakes should not happen repeated

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

Professional from academic institutions, pharmaceutical industries, health care indust

ly, and the lessons learned from them must be incorporated into new ways of being and acting. Likewise, the enormity of certain mistakes can derail whole careers, so there is inherently a rider on the extent of

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

an acceptable level of mistake.

The whole process of learning on the job is premised on having a work environment that values, encourages and supports learning. Having an “always learning” mindset is critical

.

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

n absorbing information and then applying it in specific situations to achieve the desired outcomes and results.

This “always learning” mindset enables leaders to understand their strengths and manage and compe

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

Companies that provide selfless information through particip

sate for their own weaknesses. Mistakes and recognising them within a supportive environment assist leaders in coming to terms with a know-it-all syndrome and further enhance successful business career building

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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