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Social Articles - The World of Writing: According to Authors Dave and Lillian Brummet
Question:
What was it like as new authors in the publishing world?
Answer:
As free-lance writers of informative articles, we had no prior experience with book publishers. We did a lot of research and were aware of some basic contract and publishing procedures, yet there were many things we were not prepared for. For instance, there was the
What was it like as new authors in the publishing world?
Answer:
As free-lance writers of informative articles, we had no prior experience with book publishers. We did a lot of research and were aware of some basic contract and publishing procedures, yet there were many things we were not prepared for. For instance, there was the
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
book cover design
to conceive of - which our good friend Brian McAndrew
created. The back cover text had to be developed, an
author's bio written, photos to have taken and lists of nearly
2 hundred contacts to sort out. The marketing research took
weeks to do, but it resulted in a 12-page plan to ease our
way. Then there were formal things
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
like dealing with the
Library of Congress and Copyrighting. For instance, copies
of the book had to be sent to the Library of Congress at our
expense. There are rules to be aware of as well. The rights
for free use (using quotes from other people) is so gray that
we opted out of including this kind of text. Unfortunately, that
meant more
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
editing. We were disappointed because there
were some very good quotes that would have added a great
deal to the book.
Question:
What were some publishing experiences or unexpected turn of events?
Answer:
While Lillian was browsing the Internet looking up information on other publishers, she came upon Publish America's website. It inspir
Question:
What were some publishing experiences or unexpected turn of events?
Answer:
While Lillian was browsing the Internet looking up information on other publishers, she came upon Publish America's website. It inspir
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ed her to send a query in on the
spot. Within 3-days we received a request for a sample
manuscript. Now, these publishers only accept 20% of the
thousands of queries that cross their desks, so we were
excited to have such a good response in a very short time.
Unfortunately, we were also relocating our home from one
part of town to another,
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
finishing a garden year and working
as well. Time was short and stress was high. We got that
sample manuscript off in a timely fashion, however, and we
received an acceptance within a few days. The heady
sensation of signing the 7-year contract flew by us in a blur.
Question:
What time and resources do we put in for promoting the book?
A
Question:
What time and resources do we put in for promoting the book?
A
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
nswer:
Every day we put in 2-6 hours into some aspect of the book. The Internet has proven to be a powerful tool where an immense amount of information can be found from newsletters, publishers, forums and authors. Every on-line communication we have is an opportunity to plug our book by simply attaching an auto signature. We developed pr
Every day we put in 2-6 hours into some aspect of the book. The Internet has proven to be a powerful tool where an immense amount of information can be found from newsletters, publishers, forums and authors. Every on-line communication we have is an opportunity to plug our book by simply attaching an auto signature. We developed pr
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
motional materials (flyers, mini-posters, large posters,
bookmarks, labels) and, of course, galleys and sample
packages for editors and booksellers. Most importantly, we
had a great website built for us by Brian McAndrew of
Beyond Graphix.
Question:
What did you learn in researching the book?
Answer:
We thought we were committed to the con
Question:
What did you learn in researching the book?
Answer:
We thought we were committed to the con
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
cept of the book
in our lives, but when researching and writing this book we
found we became much more motivated, more committed
and more informed about waste reduction.
Question:
As a writer, what have you learned about staying organized or motivated?
Answer:
Having a plan of action for every project is vital. Every project should have
Question:
As a writer, what have you learned about staying organized or motivated?
Answer:
Having a plan of action for every project is vital. Every project should have
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
an outline starting from the title through to the
end. There should also be a market plan laid out. Who are
you marketing to? How you are going about it? What will you
do first? These are the most important tools of a writer. Most
people think of a writing career being one where you have
lots of leisure time and creating with words. On the c
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ontrary,
most of the time is spent marketing and organizing projects.
For instance, we might write an article and query it to a
market. That market may take a few days to get back to us,
but it may also be as long as a year before we hear from
them. That article is idle and we do not get paid until after it
is published. A writer may have
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
hundreds of pieces of their
work at various stages of writing and marketing at one time.
They need to know where it is and its status, at a glance. We
use the Excel program to take care of this. For the book,
plans were indispensable. The market plan alone is a book
in itself and will take us years to complete. That is normal,
actually. A
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
writer must spend much of their time promoting
the book for years after publication in order to keep sales
happening. Unfortunately, promotion and writing time are
unpaid hours in the meantime.
Question:
When do you write?
Answer:
We have to do a bit of juggling to manage our business, day job and writing career with some kind of balance.
Question:
When do you write?
Answer:
We have to do a bit of juggling to manage our business, day job and writing career with some kind of balance.
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Usually,
We work as a team, though we write separately and then
conglomerate and edit the work together. Because we
share one computer, this can be a bit of a juggle. Dave
works shift work so when he is at work or sleeping Lillian
will use the computer to research and promote.
Question:
What is your professional background?
Answer:
Dave
Question:
What is your professional background?
Answer:
Dave
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
nd Lillian began their (paid) writing career working as
staff writers at Openminder Newsletter where they
experienced the harried pace of getting several articles and
even feature or interview articles ready for a by-weekly
deadline. It was our start in the writing world and plunged us
head-first into the community, interviewing unique and
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
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
enterprising people. The concept of Trash Talk was already
developed and this market snatched up the column
immediately. When Openminder closed shop, we started a
free-lance career. Our articles have since appeared in a
variety of magazines including Seeds of Diversity, Country
Connection and ISKRA.
Question:
Have you won any awards or co
Question:
Have you won any awards or co
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ntests?
Answer:
Yes, Dave has recently won first prize in the Nature category of BC Cottage Magazine's 2004 Photo contest. Lillian has won several editorial awards for her poetry and has had her work published in 5 hardcover anthology books of poetry through contests.
Question:
What is the most important lesson in your writing career?
Ans
Answer:
Yes, Dave has recently won first prize in the Nature category of BC Cottage Magazine's 2004 Photo contest. Lillian has won several editorial awards for her poetry and has had her work published in 5 hardcover anthology books of poetry through contests.
Question:
What is the most important lesson in your writing career?
Ans
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
wer:
Research. If you know something is coming up, research it and make a plan of action well ahead of time. If we did not start the market plan and develop a plan of action and estimated schedule soon after finding out the manuscript was accepted, we would have never been ready for the myriad of work ahead of us, much of which is time-sens
Research. If you know something is coming up, research it and make a plan of action well ahead of time. If we did not start the market plan and develop a plan of action and estimated schedule soon after finding out the manuscript was accepted, we would have never been ready for the myriad of work ahead of us, much of which is time-sens
.
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
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
itive.
Doing it right is essential - there is but little chance to make
an impression with a reviewer, reader or publication. Even
with the best of preparation you will be caught off guard or
unprepared. Don't sweat it too much if you make a mistake.
Think of it as a lesson.
Question:
Have you any advice for new writers?
Answer:
We hate
Question:
Have you any advice for new writers?
Answer:
We hate
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
to sound redundant, but again, do your research.
Join forums and research the previous messages for
several months ago. You will find many novice questions
are thoroughly answered with many different people
contributing ideas and opinions. Always research your
market and query them in a professional manner before
sending a finished product
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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