Subjects - Business

Polar bears are known for fierceness and lack of natural predators, although wolves and walruses can kill them. Feeding primarily on seals, the hungry bear featured i

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

n a recent episode of Planet Earth, happened on larger prey. Outweighed by the Atlantic walruses, with tusks that can reach three feet long, the Polar bear sought to

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

Examples of combination products may in

uzzle, push and pry his way past a mother to her calf, despite added protection from the walrus group.

Repeatedly, the bear bit the neck and body of the walrus. But

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

rayish-brown skin, up to two inches thick, protected her from the Polar bear's honed claws and teeth. In the end, the bear lost more than that battle. Alone, exhauste

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

and unable to kill any of the hundred or more clustered walruses nearby, he ultimately starved.

This interaction of the bear and the walrus reminded me of workplace

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

Combination pro

predators. You know the ones. Coworkers who knock others down for sport, trivializing successes, throwing stones at accomplishments, and ridiculing initiative as bro

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

n-nosing.

Coworker predators celebrate your missteps and failures, offering public jabs as a way to ward off contenders. Their caustic teeth of jealously, and jagged

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

claws of success-envy, can painfully hit their mark in a forum fraught with public scrutiny. Their messages can derail projects, reputations and careers. They tear do

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

n others as a way of building themselves up, trading potential substance and significance for sarcasm and snide remarks.

I've encountered my share of workplace preda

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

tors, attacking, biting, and clawing others to hinder success. They deliver reasons you won't, can't or shouldn't try something, and their negative predictions cast d

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

ubt shadows.

Early in my career, I was cowered by the seeming strength of workplace predators, retreating into more neutral positions or second-guessing my thinking.

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

Following aspects would a

The thinness of my confidence skin, soft and vulnerable, was an easy target for them. Their attacks made me question my abilities, direction, and contributions, at ti

dd to the challenges in developing combination products:

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

es feeling like they might even succeed in breaking my spirit or pushing me from the environment.

But I finally realized their attacks came as a result of my compete

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

nce, success, and achievement. As my confidence grew, so did thicker skin, and it became easier to withstand their attacks.

Workplace predators are not winning at wo

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

king, since people who are never tear down or attack others, even if their livelihood depends on it. Instead, people who are winning at working are like walruses, dev

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

loping their protective thick skin in a group oriented approach. They do that through teamwork, results, quality and self-esteem, growing denser skin with each succes

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

Professional from academic institutions, pharmaceutical industries, health care indust

, achievement, and accomplishment.

Unfortunately, here's the reality - when you're winning at working, you're going to have to deal with workplace predators. So, get

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

yourself ready. Develop behaviors that repel and weaken their antics. Grow the thickest skin possible by your consistent performance, trust, integrity, and achieveme

.

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

t. Cement your strength with persistence, determination and passion.

Then, when they strike, practice Thomas Jefferson's words, "Nothing gives one person so much adv

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

Companies that provide selfless information through particip

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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