IF YOU DON'T HAVE ARTICLES IN PRESS WHEN YOUR PRODUCT DEVELOPMENT TEAM SUBMITS ITS NDA, YOU ARE ALREADY LATE.
Getting an article published in a well-respected peer review journal generally takes a year or more, and your
successful product launch depends on having a whole series of articles--not just one.
Peer-review publications in respected medical journals put a solid foundation under your educational and promotional materials. The data they contain provide credible source material, and the opinions of respected authors will influence the opinions and practices of their peers.
Your Marketing Team has put a great deal of research and thought into product positioning, key messages, and appropriate target audiences. The marketers surely have also considered the timing of message dissemination. Product-related publications should appear in the literature at the right time. And they should be consistent with promotional and educational efforts. How do you make sure that this happens?
A publication plan should be an integral part of the overall marketing plan, strengthening the product profile with target audiences. The timing should likewise mesh with the rollout of the key messages in other media. This means that you need to develop a strategic approach to publication planning.
Gather All the Information You Can
Whether you are the one developing the publication strategy or whether you are commissioning an agency to develop the strategy, the starting point is information. This information will come from many sources. The checklist that follows may help you find as much relevant information as is currently available.
GET INFORMATION FIRST
The Marketing Team:
Target audiences, Positioning statement, Marketing objectives, Major competitors, Budget parameters
The Clinical Researchers:
The clinical development plan (studies completed, under way, or planned), Key product benefits, Problem areas in the studies or the product profile, Abstracts and posters that have already been presented
The Regulatory Group:
The Clinical Investigators' Brochure, The NDA Summary Draft Prescribing Information (and expected indications, including likely contingency scenarios), Regulatory issues (red flags)
The Medical Literature (and the Internet):
Your product's publications, Competitive publications, Your product's meeting abstracts and poster handouts, Competitive product meeting abstracts and poster handouts, Usual medical practice (standard of care), Key journals (and audiences) for the competition, Influentials in the field, Key messages of competitive products, Important medical meetings
What Do You Want to Say to Whom?
You may want to start developing your strategy by making a list of all your key communications objectives. As you do this, you'll notice that not every communication objective may be important for every key audience. For example, a primary care audience may be most concerned about efficacy, safety, and ease of prescribing. A managed care audience may be most concerned about overall cost savings and good outcomes. A nursing audience may be most concerned about patient satisfaction and quality of life.
Furthermore, your key communications objectives are likely to be different during different stages of your product launch. The communications objectives will be influenced by whether you wish to
- Create a need for a new kind of product
- Create dissatisfaction with an entrenched product
- Create new treatment paradigms
- Teach new approaches to treating or monitoring
- Get pivotal trial data disseminated quickly
- Generate published articles that your professional representatives can carry
- Create anticipation for and confidence in an untried product
These factors will also influence the timing of each article. Before the launch, publications that create a need for your product may be your most important priority. These can take the form of review articles by experts in the field (eg, Reduced Quality of Life for Patients Living With Rough Elbows); create discontent for existing competitors (eg, Nonadherence to Regimens That Treat Rough Elbows); and create anticipation for the new product (eg, Management of Rough Elbows in the 21st Century and Beyond). At launch, you will want articles that focus on the efficacy and safety of the new product and its advantages versus the competition. Later you may want articles that suggest expanded uses for the product. If your product turns out to be a market leader, you may want articles that increase the diagnosis rates of the condition it treats and that increase desire to treat.
Ideally, the timing of the articles will be different for different audiences. You'll want the academic specialists to read about your product long before the launch, because they are likely to influence their colleagues as they lecture and teach. Many of them may already know about your product because they were investigators in one of the pivotal trials that support the NDA. At launch you are more likely to want to educate potential prescribers, pharmacists, and nurses.
For each communications objective, you will be able to list one or more key messages. For example, if your communications objective is "To convince physicians that 'Newium' is a more cost-effective choice than 'Oldium,"' a key message might be that patients taking Newium have fewer doctor visits than patients taking Oldium. You can set up your strategy as a grid, with a list of your key messages down the side and a list of your target audiences across the top. It
might look something like the table below.
| |
Audience |
| Message |
Derms |
PCPs |
Nurses |
Managed Care Influentials |
| A. Rough elbows are a serious but
underdiagnosed problem |
6 mos prelaunch |
6 mos prelaunch |
|
|
| B. Newium's unique mechanism of action is
elbow-specific |
6 mos prelaunch |
|
|
|
| C. Newium is highly effective in controlled
studies |
Launch --> 1 y
postlaunch |
Launch --> 1 y
postlaunch |
Launch --> 1 y
postlaunch |
Launch --> 1 y
postlaunch |
| D. Newium is easy for patients to use |
|
Launch --> 1 y
postlaunch |
Launch --> 1 y
postlaunch |
|
| E. Patients taking Newium have fewer doctor
visits |
|
|
|
Launch --> 1 y
postlaunch |
Within this framework, you can then decide how many articles you need (and can afford) for each audience and which key messages each article will communicate.
Conceptually, your grid has 3 dimensions, because the ideal timing of your publications varies with the audience and message. You may also decide to weight one
audience--eg, dermatologists--more heavily because you anticipate that per capita prescribing will be higher for this audience.
Unfortunately, you do not have total control of timing, for several reasons. For each of your key audiences, you will find a limited number of major medical meetings that can serve as venues for posters or podium presentations. You'll need to be aware of deadlines for abstracts well in advance so that you don't miss these opportunities as they come up. You may find that the timing of important meetings does not necessarily coincide conveniently with your launch date or that your abstract is not accepted to the meeting you have targeted. And meetings aren't the only problem in trying to schedule publications. The time from acceptance to publication of an article varies widely, even in the same journal. If your article is not accepted to the first journal you target, it may be delayed for months. Still, you need to set target publication dates and do the best you can to meet them.
|
Publication Scheduling |
| Quarter |
Q1 |
Q2 |
Q3 |
Q4 |
Q1 |
Q2 |
Q3 |
Q4 |
| Dermatologists |
| Article 1 |
X |
X |
|
O |
|
|
|
|
| Article 2 |
X |
X |
|
|
O |
|
|
|
| Article 3 |
|
X |
X |
|
|
|
O |
|
| Article 4 |
|
|
X |
X |
|
|
|
O |
| PCPs |
| Article 5 |
X |
X |
|
|
O |
|
|
|
| Article 6 |
|
X |
X |
|
|
|
O |
|
| Article 7 |
|
|
|
X |
X |
|
|
O |
| NPs |
| Article 8 |
|
|
|
X |
X |
|
|
O |
| PAs |
| Article 9 |
|
|
|
X |
X |
|
|
O |
| Pharmacists |
| Article 10 |
X |
X |
|
|
|
|
O |
|
X = Preparation
Time
O = Publication date
If your budget constraints were such that you could afford to support a total of only 10 publications in the launch year, your articles and time lines might look something like the chart above. Preparation times for meeting abstracts are, of course, shorter than the time needed for full articles.
Pick the Right Journal for the Job
Your choice of journal is driven by your objectives. For your pivotal trial data, the ideal journal would usually be the top journal for the relevant specialty audience. For our hypothetical rough elbow treatment, this would be
Journal of the American Academy of Dermatology (JAAD). However, the highly credible specialty journals often have low acceptance rates and long lead times from submission to publication
(~33% acceptance and ~10 months to publication for JAAD). If you need the article sooner, you may have to sacrifice high credibility for speed, in which case you might consider a journal like the
Archives of Dermatology, which has an acceptance rate of 46% and generally takes about 7 months to publish.
If you have limited field force resources calling on a particular specialty of interest (for instance, primary care), you may be most interested in a journal with very wide circulation to that specialty. For example, you might consider
Postgraduate Medicine, which has a circulation of approximately 133,000. If your article is intended for distribution by your field force and at your meeting booth, the journal's target audience and circulation are not as important, so you can consider fast, limited circulation, high acceptance rate
journals like Clinical Therapeutics. Among other important parameters to consider is whether the journal is indexed in PubMed. Indexing in this widely used search database will assure that your article can be readily accessed years after it was originally published.
A company that specializes in publication planning will have a journal database that can provide information that will enable you to target the appropriate journal for your needs. For example, the Project House journal database (PHRED: PH Ranking and Evaluation Database) has 30 fields of information, including:
-
Circulation
-
Target audience (specialty)
-
Credibility (and IMPACT factor)
-
Acceptance rates
-
Time from submission to publication
-
Author guidelines
-
Acceptance of unsolicited reviews
-
Willingness to publish supplements
-
Journal contact information
-
Journal guidelines
-
Society affiliation
-
Whether indexed in PubMed
Be aware that acceptance rates are always in flux. Journals, particularly controlled circulation ("throwaway") journals, have a target ratio of advertising to editorial matter (often in the range of 50:50). If advertising falls off, the journal will slim down, leaving less room for articles. This increases the competition for space in the journal and lowers acceptance rates. This has happened across the board in recent years.
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