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Who you are as a writer has grown from your life experiences, your passions, your soil. Your fertilizing and weed pulling, your garden. Your writing won't be like anyone e

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

lse's nor will your career or daily routine. This may appear self-evident, but we all compare ourselves to others, especially the best-selling writers. We want to be like

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

Examples of combination products may in

hem: successful, book in the front of the store, great story tellers. So we think we need to emulate them, their routine, their stories, and their style. But we are not th

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

m; we didn't come from the same root stock, soil or climatic conditions.

To grow the unique writer within, we need to look inward, and then take steps to cultivate our wr

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

ter self. Use the following questions and tips as guides.

Question #1: Where do you come from? What is your background, family, education, your dreams, your cultur

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

Combination pro

l influences, that thing that happened to you, that thing you overheard, those family expectations, the whispers of your imagination? Be specific, be general, be wacky, be

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

curious about yourself.

Question #2: What kind of writing do you want to do and do now, and why--what is your true motivation? Know why you write and don’t take th

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

first answer you come up with as the only answer. Dig deeper, listen harder, be truthful with yourself.

Question #3: What is your voice, your style, and what are

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

our strengths, your weaknesses as a writer? You are on a voyage of discovery and affirmation. Accept who you are. You are beautiful.

Tip #1: Goal Setting. S

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

t reasonable goals for yourself, challenging enough to keep you interested and motivated. And attainable so that you can actually have progress.

Tip #2: Trackin

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

. Grow discipline day by day, word by word, page by page. Track your progress. “Winners keep score,” a friend of mine said, a successful small business owner. Tracking

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

Following aspects would a

increases awareness and encourages accountability. The biggest bonus is that it signals your subconscious that you mean business: writing is not a whim but a daily habit t

dd to the challenges in developing combination products:

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

at you are coaching yourself on.

Tip #3: Compassion. Above all be gentle, have compassion for the writer within, the writer you are growing, whether you are

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

starting out, or have been at this for years. Treat yourself no differently, especially if you’re having a bad day, week, or month.

Tip #4: Trouble-shooting.

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

Are there unhelpful pests—other people’s thoughts, ideas, beliefs that are not your own, or fatigue, overwork, not enough play—invading your garden? You can change many t

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

ings that affect adversely your writer within—learn to say “No”. Get out and do something new, something to expand your heart, mind or soul. Do you need to move your body

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

Professional from academic institutions, pharmaceutical industries, health care indust

o counteract an overactive mind?

Tip #5: Patience. The garden does grow itself. We don’t stand by it every minute of every day and say, “Go roses! Go lavend

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

r! Grow!” It happens organically, because of the proper conditions—the soil, the sun, the rain, and the seed. We shape the garden by our hand. We care. We nurture. Regular

.

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

y. As with gardening, so with writing. Honestly, why do you write? Could you not write? Probably not. In that case, make peace with yourself, and write. But be gentle. Pla

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

Companies that provide selfless information through particip

ts do not grow faster if you pull on them. That would kill them. The most you can do is write regularly, with compassion, with awareness, and don’t give up.

Happy Writing

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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