Advice You - Business

Thirteen-year-old Gary woke up with anxiety. Today is the day, he thought. I have to bring it with me. Mom told me it was what I needed, so it must be okay, he assured himself. However, even that small

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

effort of self-assurance was not enough to calm the doubt that plagued his adolescent mind.

Gary quickly got ready, gathered all his schoolbooks, some change for lunch, and “it” – The Brown Bag. “Boy, th

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

Examples of combination products may in

is is heavy”, he thought. He didn’t remember it being that massive the night before. His mother calmly assured him everything was okay and encouraged him out the door.

Upon arriving at school, Gary becam

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 immediately self-conscious. Where are all the other brown bags, he thought? Did I miss something, he wondered? Out of fear of embarrassment, he darted to his destination. Now at his planned location,

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

Gary slowly pushed the door open as he made his way to make his delivery. He was given a task, a task that he was anxious to complete – to drop off the contents of the brown bag. The task was simple, plac

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

Combination pro

e the item in the brown bag on the table and walk away.

What Gary saw that day was a neatly stacked row of what appeared to be the smallest urine samples of his peers for the school’s annual health examina

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

tion – each small in size with the name of its owner. What was buried in his brown bag was the large mayonnaise jar his mother provided him the night before with his name in the boldest black font. Gary l

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

fted the behemoth sample from the bag, quickly turned his boldly printed name to face the wall, and walked away in utter horror as his sample glistened in the fluorescent light of the nurse’s waiting room.

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

He wasn’t intending to outdo his peers, but the size of his contribution was obviously far superior. It communicated passion for the project and diligence with the task. In all seriousness, the perceptio

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

n that day was that Gary approached the task with an extra level of seriousness or maybe a misunderstanding of instructions. Either way, he was judged by the size of his contribution, but that is a story f

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

or another day.

Gary learned a valuable lesson that day – in a world of judges, the game of life is all about perception. As humans, we all get judged for what we present to others and the world. The del

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

Following aspects would a

ivery of a presentation is just the same – it is all about perception.

Here are some tips to help develop a positive perception of you the next time you step up to the podium.

The Power of Silence<

dd to the challenges in developing combination products:

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

br> Sam Rayburn, former Speaker of the United States House of Representatives, once said, “No one has a finer command of language than the person who keeps his mouth shut.” The best way to begin any talk

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

is with silence. Silence builds anticipation. Silence demonstrates command. Silence is the strongest start.

Talk Like a Human Being
Generally, there are two kinds of speakers: the untrained

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

and trained. The untrained speakers often deliver presentations that are unmemorable, difficult to follow, and wasteful of one’s time. The trained speaker comes across as memorized, rehearsed, and unnatur

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

al. Both fail in that they don’t talk like a human being. They lack authenticity and a natural voice. Great speakers are conversationalists. They understand that they are unique, different, and have a s

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

Professional from academic institutions, pharmaceutical industries, health care indust

tory to tell. They aren’t untrained or trained, they are sincere with their delivery.

Focus on a Child It’s amazing how many presenters use
“business talk” that often leaves their audience gue

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

ssing, wondering, and confused. Great speakers know how to deliver messages that are clear, concise, and simple. Here’s a great rule of thumb: If an eight-year-old cannot recite your three main points at

.

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

the conclusion of your talk, you’ve delivered an unclear message. Keep it simple and you will keep it memorable.

The lesson here is that we live in a world full of judges. Keep your message concise. Ke

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

Companies that provide selfless information through particip

ep it clear. Keep it simple. And most importantly, be yourself. People will judge you. That is the fact of life. However, let them judge you for who you really are – not a poser, but an authentic voice

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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