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I’ve been a proponent of diversity throughout my life. This has manifested in a variety of ways, in both my personal life and career. Often "diversity" is used to connote a particular ratio of the two gen

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

ders or racial representation. I have a broader definition of "diversity."

In my view, diversity encases many more attributes than gender and skin tone, and a celebration and/or honoring of those differenc

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

Examples of combination products may in

es. Many attributes are used to sort people out, to place them in categories, often with ideas of better or lesser. Physical ability, general appearance, cultural background, birth language, economic con

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

ition, religious orientation, sexual preference, and countless other attributes are used in addition to gender and race.

Many years ago, I was consulting with someone who was responsible for a corporate-w

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

ide diversity plan. My involvement in the diversity plan itself was slight; I was doing some of what is called "shadow consulting" for this project, but I was more actively consulting on some of my client’s

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

Combination pro

other projects.

As my client (a white, able-bodied male), was working with the senior management of the corporation (predominately white, able-bodied males), I was pleased to feel the sincerity of this gr

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

oup to create an authentically diverse company. Insights were expressed in the workshops. Genuine plans of action were embraced. And then it was time for implementation……

At one point in my conversati

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

ons with my client during the implementation, I blurted out a realization: oh my gosh, they don’t understand that the "diverse" population will be different! And that realization has presented itself ove

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

and over again as I’ve remained a consultant with this company. So often, those in power are trying to get the diverse-other to be just like them! They hire someone who is different and feel pleased wit

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

h themselves to add to the diversity balance, and then try to mold that diverse-other into being the same as the majority.

Just the other day, I had a consultation with a high-level woman in this same com

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

any, providing me with a fresh example. She told me that once again (for the seventh, tenth, twentieth, who knows? time) her male boss has given her feedback on something that can only be considered "styl

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

Following aspects would a

e" in the way she approaches making presentations. While her boss has one opinion, many others compliment her on this style and try to emulate it. Here’s the suggestion I made for her response when he nex

dd to the challenges in developing combination products:

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

t gives her this feedback, which undoubtedly he will.

Her attitude must be upbeat and friendly, so please imagine that demeanor with these words, as there is no sarcasm nor defensiveness. "Well, I offer an

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

alternative. I AM an alternative. Each time you’ve given me that feedback, I’ve taken it seriously. I’ve considered and experimented with different approaches. But here’s something you might not be aw

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

are of: each time I make a presentation, people give me very positive feedback — people I know as well as people I don’t know. In a company as big as ours, I think it’s important that we all get to see d

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

fferent styles because some people relate more to me, while others relate more to _____, and still others relate more to ____. We’re all different, which I think is wonderful." (The ____ are names of speci

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

Professional from academic institutions, pharmaceutical industries, health care indust

fic persons in their company who have different presentation styles from her and from each other.)

A "Diversity Plan" usually contains general ideas, broad concepts, and well-intended actions. However, t

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

hat "different person" sitting in front of you is very specific. The platitudes of the general ideas need to be practiced in kindness and curiosity and flexibility in real-time conversations. Think of wh

.

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 a different interaction it would be between these two persons, if the boss were curious about how she saw her style, or if he engaged with her to understand and accept her differences. But, instead, he

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

Companies that provide selfless information through particip

wants her to conform and be like him — the exact opposite of honoring diversity.

So, if you embrace the idea of diversity, remember, when you are face to face with the diverse others, they will be different

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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