Write You - Writing and Speaking

Dear Santa:

Every week I promise myself and my friends that I will start writing my book. And every week something happens that stops me. I

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

have so many commitments. I am so busy. I just get overwhelmed so I get nowhere with my book writing. Can you help me? Oh, I know you are

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

Examples of combination products may in

busy checking your list twice and packing those toys for the kids, but the greatest gift you can give me is advice. Here is my list…

1.

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

Give me a working title for my non-fiction book. I get stuck with a creative idea for my title. It prevents me doing some serious writi

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

ng. Wait a minute! It’s coming to me. “How to…” Yes, I’ll start the title with “How To” and follow it with a super solution to a problem.

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

Combination pro

That will get me started. I can always change it later.

2. Help me identify the purpose of my book. Is it to make money, promote m

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

y business, become recognized as an expert in my field, to provide information that my Reader is anxious to know? Yes, I want to be rich and

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

amous yet I think that providing solutions to my readers’ problems is the most important criteria that I could offer them.

3. Who is my R

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

eader? Friends keep asking me who is the audience for my book? I think everyone can benefit from my book. Well, that may be true but I’

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

ve been told I need to narrow it down—“find my niche” they say. Hey! I’ve got a great idea. I’m going to the bookstore. I will find

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

the section that would carry my book and review the books that are close or have the same subject as mine. I will read the inside and back c

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

Following aspects would a

overs. That might help me find my niche. It will also give me some ideas on how to present my book—even if it’s an e-book I will learn how t

dd to the challenges in developing combination products:

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

o promote my book.

4. Help me set a date to start writing my book. This is b-i-g. I just can’t get started. I don’t know why. I k

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

eep on telling myself I’m too busy. Yet, I want to write my book. What is stopping me? I got it! Can you give me an appointment book
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
for Christmas? That’s the answer—I’ll make an appointment with myself everyday or almost everyday to write for 20 minutes or more. In fact,
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
I can block off some weekends and promise to write one chapter on those two days. The new year’s coming soon and I WILL start writing. I pr
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
omise to review my appointment book every day and stay committed to my writing schedule.

Santa you are amazing. I haven’t even sent you my l
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
etter and you’ve answered all my questions. Thanks a lot. Oh, don’t forget to send me the appointment book so that I can mark a date and tim
.

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
e each day to write. I promise I will check it twice.

I’ll write to you next year about how to publish and market my book. Or I may finish
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
my book in 90 days then I’ll have to write to the Easter Bunny for advice. Merry Christmas to you and a Happy Writing New Year to all writers

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Tags

Links

Write You - A Letter to Santa: Help Me Write My Book

Related Articles: