Others - Writing and Speaking

Nobody likes feeling scared. Even if you're an adrenaline junkie who loves death-defying roller coaster rides and terrifying horror movies, you proba

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

bly don't like feeling personally threatened by something outside of your control. The actual sensation of fear can be more anxiety provoking than wh

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

Examples of combination products may in

atever you thought you were afraid of in the first place.

That's why when we get nervous or anxious before speaking in public, we don't like it. We

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

ontract and resist those feelings. We curse them. We take them personally, as if they are taunting us, punishing us for not being more confident and

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

self-assured.

Then we're horrified when huge, uncontrollable waves of anxiety hit us at the most inconvenient of times. Like right before we go on s

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

Combination pro

age to speak. But these huge, overwhelming tsunamis of fear are created by our consistent resistance to any feelings of fear. By pushing them away, w

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

e allow the energy of that emotion to build and build until it finds the crack of least resistance through which to explode full force.

So, what can

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

you do? Let me tell you. When you have a speech, or any anxiety-provoking event, coming up, and you start to feel nervous or scared, follow these thr

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

ee steps and notice how much better you feel.

Step One – Be With What Is
Whatever you are feeling, let yourself feel it. Imagine that you are a

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

huge container, like a deep bowl, and let those feelings and sensations be held in this expansive container that is you. Don't try to control your fe

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

elings or shrink them or make them go away. Rather, allow them to float and move through you.

Step Two – Lean Into It
Now, grab some paper and

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

Following aspects would a

a pen and write down what you are feeling, both the emotion (fear, anxiety, embarrassment, discouragement) and the actual sensations relative to thos

dd to the challenges in developing combination products:

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

emotions (tightness, pounding heart, pressure, heat). For example, "I feel this fear in my chest; it's a tightening, pulling sensation, a heaviness

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

pressing down on me."

Rather than push away whatever you are feeling, lean into it. Get curious. Feel what's there and write about it as you are fee

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

ing it. Don't wait until the feelings pass and then write. Be in the experience as you write.

Then, lean in some more. Ask yourself, "What am I afra

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

id of? What's going to happen? What is this (feeling) about?" See what answers come to you and write those down as well.

Step Three – Let It All Mov

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

Professional from academic institutions, pharmaceutical industries, health care indust

Through
Once you've written it all out, leave it on the page. Sit back and notice how you feel now. Notice the sensations in your body, the tho

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

ughts sifting through your mind. If you really leaned into it in Step Two, you are probably feeling a warm hum of energy throughout your body and a g

.

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

eater sense of ease.

The great advantage of this little 3-step process is that once you've done it, you can easily let any little waves of adrenalin

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

Companies that provide selfless information through particip

e just move through without holding on to them or pushing them away. Any sensations of fear are no big deal. You've released the fear the fear itself

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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