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As a child growing up, one of the many life lessons instilled in me was to wash your hands before eating and after using the restroom. As a child I often played in the dirt and places where germs customarily manifested. Another lesson I lear

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

ned growing up was when introduced to new acquaintances always shake their hands. It is said to be a polite thing to do, and demonstrates a sign of friendly reception.

I can’t remember the first time I shook someone’s hand, but as an adult I have lea

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

Examples of combination products may in

rned the different handshakes I detest and those I most appreciate. It is frequently said that the handshake is a window into the personality. For example, on the phenomenal television show “Survivor” during the last episode the tribal council selects

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

he winner of the contest. Before the vote, seven remaining tribal members were given an opportunity to ask a question or make a statement to the remaining first and second place contestants.

In the heat of anger one tribal member named Susan verbally

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

lashed out at Kelly who had the deciding vote to cast her from the contest. Susan’s anger stemmed from an alliance that was broken as Rudy, Richard, and Kelly (the last three members) began to fend for themselves as the contest came to its season fina

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

Combination pro

e. But after the winner was chosen, the seven tribal members went to give their congratulatory hugs and handshakes. Of course Susan went over to shake hands with Kelly for placing second. While 40 million viewers watched, Kelly refused to shake Susan’s

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

hand. So what’s in a handshake?

Dr. Wade Horn, President of the National Fatherhood Initiative said, “The handshake establishes contact; it sends a message. If I am having an important meeting the handshake will tell me if the meeting was successful

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

” Dr. Horn went on to explain further that, “If there is a firm, tight, and strong grip at the end of the meeting then the meeting was successful. If not, then that person is disappointed and not pleased with some aspect of the meeting.” He closed by

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

saying “When someone shakes my hand and doesn’t let go then that’s too personal.”

But what does that say about billionaire and former presidential candidate Donald Trump? Mr. Trump, who does not like to shake hands, was met with some controversy when

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

efusing to shake hands on the 2000 presidential campaign trail. The New Republic reported that Donald Trump is “A germ freak. Trump has said he doesn’t want to touch the diseased masses. His campaign hands out half-ounce bottles of hand-cleaner, with

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

Trump’s web-site address taped to the necks.”

Evan Burfield, co-founder and Chief Strategy Officer for the Netdecide Corporation, said “It’s like driving on the highway. People do things that are so uncivilized, things that you they would never do in

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

Following aspects would a

person. It’s the same way in a corporation; there’s a protective layer that a handshake removes for a second. It lets you understand that you are talking with another person who needs to be treated like a person with trust, respect, and forthrightnes

dd to the challenges in developing combination products:

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

.”

Evan added that, “Today we are operating in a cross-gender environment. That man-to-man power struggle handshake doesn’t work with women. It’s a positive to have women involved with everything we do; it softens a lot of the male aggressive rituals.

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

” And speaking of rituals, the handshake has origins more anthropological than historical. Because they carried knives, spears, and rocks, when land was scarce and sacred males would extend their hand to show that they were not attempting to kill their

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

neighbor. To add to that, the classical Greeks were under the impression that the right hands were mysteriously connected to the heart.

The Greeks may not have been very far off point. The handshake is a symbol equivalent of a promise. It becomes a v

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

irtue of the word and value of the person extending it. It is an agreement sealed with honor before the lawyers get involved. The handshake is a very valuable tool and, since in business often the communication is one-to-one, it’s flexible and indicat

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

Professional from academic institutions, pharmaceutical industries, health care indust

s that an agreement has been reached on current dealings. It says that all information and intentions have been disclosed so that the value of the handshake is not diminished. The lesson here is that the handshake historically has carried symbolic imp

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

ortance. It is good to know what your handshake is worth. It’s your word and it says you can deliver on your promises.

Kevin Robertson, president of Vision of Life consulting firm said it best—“Today a man or woman is judged on their handshake, eye co

.

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

tact, and the display of confidence.” This is a far cry from the classical Greeks, or prehistoric man who when all they had to worry about being stabbed or hit with a rock. There were no lawyers and no contracts, just the bond of a man’s word.

The Le

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

Companies that provide selfless information through particip

sson

What’s in a handshake? The handshake encompasses trust, honor, and communications, follow through and follow up, and represent good faith negotiations. After all, the word of a man and woman still lies in the bond that they will ultimately create

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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