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The demand for leadership talent greatly exceeds supply. If economic growth continues at a modest 2 percent for the next 15 years, there would be a

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

need for one-third more senior leaders than there are today.

Baby boomers have already started to retire. Most large companies will have to scrambl

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

Examples of combination products may in

to meet gaps in senior leadership talent. Who will replace your retiring executives, and how will you keep your company's leadership pipeline full?

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

To make matters worse, the global and more dynamic economy of the 21st century requires executive talent with a more complex skill set:

*Greater

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

echnological literacy
*A sophisticated understanding of global marketplaces
*Multicultural fluency
*Relationship savvy, with exte

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

Combination pro

sive networks of alliances and stakeholders
*Leadership skills over a delayered, disaggregated and virtual organization

Succession Plannin

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

g in the 21st Century

In response to these challenges, organizations have a renewed interest in succession planning systems. While these system

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

functioned merely as replacement charts in the past, and were HR executives' function, there are two critical differences today, emphasizing:

1. L

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

adership development at all levels (not just senior executives)

2. Responsibility and involvement for leadership development within the work group,

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

with the person's manager and team members (and no longer an HR function)

Distinct Leadership Levels

Most development models fail to consi

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

er leadership requirements at all levels. As a person is promoted from line manager to business manager to functional manager, skills and requiremen

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

Following aspects would a

s change.

Companies mistakenly focus on leadership traits, styles and technical competence. They commit a major error when promoting successful ind

dd to the challenges in developing combination products:

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

ividuals without acknowledging required skill set differences at different levels of leadership responsibilities.

The Leadership Pipeline

H

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

ring gifted people makes sense as a tactic, but not a strategy. Companies need to build leaders, not buy them. Research and experience demonstrate t

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

at potential is not fixed.

The more people achieve, the more they learn. Their willingness to tackle new challenges increases. To capitalize on pot

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

ential, companies must define the true work requirements at each key leadership level. Succession planning systems must spell out what's needed to m

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

Professional from academic institutions, pharmaceutical industries, health care indust

ke a successful transition from one layer of leadership responsibility to the next.

Succession Planning to Fill the Pipeline

The following

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

ive-step plan will facilitate succession planning:

1. Tailor a leadership pipeline model to fit your organization's succession needs.

2. Clarify s

.

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

tandards for performance and potential, in your own language.

3. Document and communicate these standards throughout the organization.

4. Evaluate

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

Companies that provide selfless information through particip

succession candidates through a combined potential-performance matrix.

5. Review plans and progress of the entire pipeline frequently and seriously

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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