Subjects - Business

There is a lot of talk about leadership development but very little specific leadership skill training is available. It seems like success is

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

dependent upon surrounding yourself with the right people and hoping they have the skills necessary to do the job. Compassion often prevents

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

Examples of combination products may in

us from replacing those that don’t have the skills in a timely fashion and very little coaching and mentoring support is available within th

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

e company.

A sad commentary considering that team building and teamwork skills are critical to the effectiveness of the management team. Suc

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

cess of your management team can be defined by what they accomplish as a group. A synergy within the team that creates unity, clarity of dire

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

Combination pro

tion with a common purpose that is in alignment with strategic initiatives. This is the first prerequisite for your management team to make t

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

he Super Bowl and be effective. A common purpose and crystal clarity of goals and objectives are essential. Team building exercises must supp

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

ort the development of this clarity which includes responsibilities and accountability.

“Purpose is the driving force of all accomplishments

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

of greatness” -- Thomas Carlyle

What is your management teams real purpose? Do they all share the same response to that question?

Effecti

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

ve communication is the second prerequisite. This topic is discussed in every management book written because ineffective communication is ge

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

erally at least partially responsible for the majority of failures within any management team. The key to effective communication starts with

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

Following aspects would a

being able to listen effectively. In addition to listening skills, an effective management team must foster trust within the group, respect

dd to the challenges in developing combination products:

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

for each other and their abilities, an open honesty to be able to express opinions without fear and a feeling of camaraderie that breeds an a

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

tmosphere of sharing both credit for success and responsibility for failure.

Often times a Management Team Retreat or workshop can provide t

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

remendous dividends by energizing the group to such an extent that they could not only make the Super Bowl but win it as well. The following

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

ey components should be part of this development process.

• Leadership

Communication

Conflict recognition & management

Stress Aware

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

Professional from academic institutions, pharmaceutical industries, health care indust

ness

Delegation

Team Building

Coaching & Mentoring

• Organizational Effectiveness

- Optimizing Performance

- Vision & Values

- R

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

esults Focus

- Organizational Alignment

- Role Clarity

• Strategic Planning and Scenario Planning

The Process

Readiness Factors

T

.

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

he End Game

Does your management team need an effectiveness assessment with a personalized management team workshop designed to help them wi

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

Companies that provide selfless information through particip

n the Super Bowl? E-mail rick@ceostrategist.com if you would like to discuss a personalized assessment and workshop for your management team

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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Your Boss can make or break your career, which makes getting along with him an important part of your career tactics. However, not all bosses are created equal. In fact, some hardly seem human... so how do you deal with them? Do you need to bother?

Have we become workaholics? Are we so obsessed with making our mark in the professional world that we’re willing to sacrifice our personal lives and valuable sleep for it?

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Subjects - Can Your Management Team Make The Super Bowl?

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