Social Articles - Writing and Speaking

You’ve written your book.

You’ve either sold it to a traditional publisher or you’ve decided to self-publish.

You know the book has the potential to become a bestseller.

Now... how do you make that

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

happen?

For the answers to these and other questions, I interviewed Nashville, Tennessee, book publicist Maryglenn McCombs. Here’s what I found out:

Q: What is a book publicist? What should authors

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

Examples of combination products may in

expect from a publicist?

A: Book publicists work with the media to generate awareness - both at a consumer and retail level - for a book. Publicists act as a liaison between the author or publisher

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

and the media. My job, as a publicist for a book, is to generate media coverage for a book or author.

As for what a client should expect, I think dependability and responsiveness are key. It is impor

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

ant that the publicist have strong media contacts, good writing skills and verbal skills and a general awareness or interest in the book's subject matter.

Q: Do you work on a project by project ba

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

Combination pro

is? I would assume, as a publicist, you like to build a relationship with each client to see results. How do you do this?

A: For the launch of a book, I work on a per project basis. There are special

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

circumstances where I will to take on a project for an agreed-upon number of hours per month, but these are typically for post-publication books that need a jump-start or other instances where an int

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

nsive campaign is not necessary.

And it doesn't happen overnight. As a publicist, I think it is extremely important to explain the process and timing of the campaign (i.e., when will the publicist pi

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

ch to print media? Radio? TV? Will they set up a book tour?) to the client on the front end. It is important to address a client's expectations, as well.

I like to keep my clients well aware of ev

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

erything I am working on, so I send reports detailing what has been done/who has been pitched, the status, and next steps. The client deserves to be completely in-the-know about the services being pr

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

vided. Effectively promoting a book is a process -- and it is one that requires lots of patience - both from the author and the publicist.

Q: Does the publicist write the press materials, or does t

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

Following aspects would a

e author have to do that?

A: I create all of my own press materials. Occasionally, clients will come to me with their own press materials, but I prefer to create releases, biographies, and other mat

dd to the challenges in developing combination products:

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

erials myself, as this is a great way to familiarize myself with the client, their book and message. I do ask that my clients supply digital photos of their headshots.

Q: How are publicists paid?

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

A: I work on a per project basis and am usually paid in monthly installments.

Q: How do you create a press kit for each client? What do you do with the press kit to promote your client?

A: I typica

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

ly keep the press kit as simple as possible -- a press release (not longer than one page), a biography, a fact sheet (just the details about the book, such as ISBN, trim size, price, etc.) and in some

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

cases, a tip sheet (a few succinct bullet points of what is in the book) If there is an interesting backstory to a book, I sometimes include a mock interview with the author.

The press kit is used

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

Professional from academic institutions, pharmaceutical industries, health care indust

or a number of things - soliciting reviews, providing background for interviews, etc. One client I currently represent is using the press kit I created for him to solicit speaking engagements.

Q: Do

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

all your clients live in Nashville? How do authors hire you?

A: I work with very few clients in Nashville. Right now, I have clients in London, New York, Massachusetts, Wisconsin, Texas, California

.

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

, Florida, Kentucky, and Ohio.

The first step is just to make contact -- email is the easiest way to reach me (maryglenn@maryglenn.com). Initially, it is helpful to know a little about the book, whe

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

Companies that provide selfless information through particip

it is expected to be released, etc. From there, I typically schedule a phone consultation with the author/publisher to discuss further and answer questions about how I work and the services I provide

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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