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“WHOA GIRLS. DON’T BE AFRAID. SHE’S THE SAME AS YOU!”

The heifers stampeded across the pasture and right through the fence. There were posts popping, wires whining, b

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

ovines bellowing. I had not planned this rodeo.

I recently bought three groups of year-old heifers to graze the grass on our small farm, Ohlers’ Acres. Two groups were Black

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

Examples of combination products may in

ngus – totally black. When I turned them together, it was if they were long-lost cousins – immediate friends, even though they were from different farms.

Then I hauled in a he

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

fer from the third farm. This animal was yellowish with a white face. When I let her out of the trailer, the hullabaloo happened.

Through my years of working with cattle, I h

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

ave finally learned that once an episode like this starts, it is out of my control. Rather than cussing, swearing, and raising my blood pressure, I might as well sit, watch the

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

Combination pro

show, and see if I can learn something.

It occurred to me that this episode was about the same as watching the integration of a new child at a playground, a newcomer in a commu

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

ity, or a new member of an association or organization.

We may feel very comfortable with our own group, our own herd. We may not like everyone, but we know them and know what

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

to expect in our interactions. It is safe inside of our protected little pasture.

And then the newcomer arrives. We may attack, run, or hide because we are afraid.

“Afraid?

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

No way. I ain’t afraid of nothin’ or nobody.”

At a conscious level, we likely deny that we are afraid. At an unconscious level, we are afraid. We don’t know or understand t

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

e newcomer, so we avoid the person physically, verbally, and socially. Most times we are not consciously aware that we are doing it.

I don’t believe that most of us intentiona

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

ly want to be rude or hurtful to others. And yet, out of our fear, out of our lack of understanding, we may do just that to protect ourselves. We may ignore, resist talking, a

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

Following aspects would a

nd be just plain un-neighbourly.

I’ve been the newcomer many times, and I’ve also been part of the herd. Each role can be uncomfortable, and it can be exciting with a positive

dd to the challenges in developing combination products:

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

approach and attitude.

It takes an incredible amount of courage to be the newcomer and to strive to become one of the herd. There are so many new faces, attitudes, judgments,

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

nd perceptions to break through.

It also takes courage to break from the herd and to include the newcomer. I have found this move to be very rewarding and have gained many gre

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

at long-term friends this way.

Next time you become aware of a newcomer to your organization or neighbourhood, rise above the bovine brain and give this a-go:

- step aw

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

y from the herd, or your comfort zone, and approach the newcomer with a welcoming smile

- introduce yourself

- ask questions about his/her life (dreams, desires, passions, fam

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

Professional from academic institutions, pharmaceutical industries, health care indust

ly, etc.)

- listen intently with a genuine desire to learn about him/her

- refrain from talking about yourself, unless they ask and then only briefly

- offer to introduce him

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

/her to others in the group.

As humans, we like to feel valued, respected, and included. We like to be a part of the herd.

Consciously using these tips feels good for both pa

.

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

ties, and may inspire newcomers to become involved and committed to growing healthy organizations and communities.

We may have different skin, hair, spiritual and sexual prefer

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

Companies that provide selfless information through particip

nces. But at the core, our hearts work the same wonderful way.

Now excuse me. I have a lesson to teach in the pasture before the next load of heifers arrives.

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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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