Advice You - Business

Leadership in Troubled Times

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 first task of a leader is to keep hope alive. - Joe Batten

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

Examples of combination products may in

Leading an organization can be challenging, even when times are good. When times are troubled, it is even more important for leaders to come to the forefront and provide direction and inspiration. We face challenging times today with a weakened economy, layoffs, and intense scrutiny

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

of a mistrustful public sector. As leaders, now is the time to stand up for our beliefs.

I subscribe to a value based leadership theory that has as much

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

f not more relevance in our troubled times today than it has in the past. Leadership is about hope, vision, inspiration, communication, and trust. As a leader, you have the opportunity to provide vision and hope to those around. You have the opportunity to instill belief and restore trust to those who look

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

Combination pro

up to you. And you have the opportunity to build a bond with those around you that is forged under difficult circumstances and tempered with the steel of your own personal values and beliefs. I believe that this is true regardless of what level of leader you are. Whether you are a first line manager, or a C

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

EO your people are looking up to you for direction and inspiration. And they are looking to you to provide them hope.

Is that a tall order for a leader at

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

any level?

Yes. But this is what separates the true leaders from those people who are leaders only by title.

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

Text style="MARGIN: 0in 0in 0pt">I believe that Joe Batten is right when he states that the first task of the leader is to keep hope alive. I believe that the second task of a leader is to communicate that hope and vision to their e

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

mployees and their superiors in a way that builds trust and respect. With a strong foundation of values, a leader can inspire their people to achieve great things, produce fantastic results, and succeed while others around them fail. Without a values based foundation a "leader" may produce short term result

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

but will fail the test of time as employees, without any basis for trust and respect will look for any opportunity to better themselves and remove themselves from the realm of a valueless based leader.

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

Following aspects would a

nt-family: 'MS Mincho'">You do not lead by hitting people over the head -- that's assault, not leadership. Dwight D. Eisenhower (1890-1969) - Thirty- fourth President of the USA

dd to the challenges in developing combination products:

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

in 0in 0pt">Why is it that we hear about so many oppressive work environments, where the bosses belittle their employees, use the whip to produce results, and then discard anyone who questions their orders? When I read or hear about

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

"leaders" telling their employees that they "are lucky to have jobs at all", I cringe. For in reality, those are not leaders. Those are just the caretakers of companies that do not truly value their most precious asset .... the employees. These "leaders" violate the principles of value-based leadership and

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

will soon discover that their lack of true leadership, their lack of vision and hope, will result in their being abandoned when things improve.

He who thi

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

nks he is leading, but has no one following is only taking a walk. - John Maxwell " 21 Irrefutable Laws of Leadership"

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

Professional from academic institutions, pharmaceutical industries, health care indust

amily: 'MS Mincho'">Employees are the backbone of any organization. They, not you, make things work. They, not you, find creative solutions to complex problems. And they, not you, ultimately hold the key to your own personal success. For ultimately you are judged by your ability to

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

evelop, lead, and maintain strong teams that put the goals of the company ahead of their personal goals. And that only happens to employees who are inspired by, and trust in their leader.

.

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

Mincho'">If you want to know if you are truly a leader or not, look around at your team. Do they follow you because they want to? Because they are inspired by you? Because they believe in you? Or do they follow you because they have to.
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ZE: 12pt; FONT-FAMILY: 'Times New Roman'; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA">It is time to take a long, hard look in the mirror. Are you providing hope and inspiration to those around you? If not, when will you start.

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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