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TIPPA News
The International Publication Planning
Association Newsletter
Volume 1, Issue 1
Inside TIPPA News
Publication Planning Conference News
Zelnorm Publication Planning Practices Detailed
Legal Issues in the Dissemination of Published Information
How Should Pharma Handle the Blogging Phenomenon?
Clinical Trials Registries Update
Takeaways from May’s Publication Planning Conference
More than a hundred publication planning professionals gathered in Washington D.C. for Pharmaceutical Education Associates’ 3rd Annual Publication Planning & Execution Excellence conference this May 16-18. The conference featured intensive study workshops and a two-tracked program that covered a myriad of current topics in the publication planning arena.
Zelnorm Publication Planning Best Practices Detailed
Among the highlights was a case study presented
by Jodie Sherman, MPH, Global Publications/Communications Manager,
Gastroenterology at Novartis Pharmaceuticals, about instituting
improved publication procedures based on her work in reforming the process
for Zelnorm. Zelnorm was voted Best Practices for Publications at Novartis
and Ms. Sherman was asked to head up a steering committee to institute her
team’s process company-wide.
Just a few of the problem areas inherent in the old process included a
time-consuming, twenty-person review process; publication manager as driver;
an unclear strategy in selecting authors and final submission by an agency.
Ms. Sherman commented that the process could literally drag on for years!
Some of the critical elements of Zelnorm’s transformation were:
|
Ø |
Streamlining the core publications team |
|
Ø |
Initiating trial steering committees |
|
Ø |
Adhering to simpler review policies for abstracts and manuscripts |
|
Ø |
Instituting reasonable timelines and holding the team accountable |
|
Ø |
Establishing firm guidelines for internal and external authorship and ensuring their application |
In addition, an ongoing process of evaluation,
gap analyses and an annual face-to-face meeting with all of the key players
ensure continued success.
Jodie presented a sample timeline of the revised process, templates for
direction and accountability and detailed some of the new policies and
procedures. Four rules for internal as well as external authorship were
offered based on industry guidelines.
Legal Issues in the Dissemination of Published Information
Attendees gave rave reviews of Alan Minsk’s
presentation on legal issues relating to publications and medical journals.
Among the key issues discussed were:
|
Ø |
Dissemination of off-label (i.e., unapproved) information |
|
Ø |
Promotion or commercialization of an investigational new drug as safe and effective (e.g., recruitment vs. seeding and scientific exchange vs. promotion) |
|
Ø |
Lack of fair balance in presentation of a drug product’s benefits and risks (i.e., false or misleading information). |
Mr. Minsk reminded the crowd that “there is no
safe harbor protection for disseminating false or misleading information”
and that “investigators, speakers, PR firms, and marketing partners are all
held to the same standards as the company,” when acting on the company’s
behalf.
Mr. Minsk also gave many practical tips on reducing legal risk including:
|
Ø |
You may report study or scientific findings (all information—good and bad) but don’t promote or commercialize an investigational product |
|
Ø |
Be careful about symbols, logos, or graphics that can also get a company into trouble with intended use issues |
|
Ø |
Have an internal review procedure for all disseminated materials and train/audit to ensure compliance |
Mr. Minsk also reminded attendees that
disclaimers or qualifying statements are helpful, but won’t eliminate risk
if the whole promotion, when viewed in full and in context, is violating the
law.
A lively panel featuring Frank Rodino,
Churchill Communications; Peter Clark, Librapharm/Current Medical
Research & Opinion; George Lundberg, Medscape General Medicine, WEBMD;
Marie McVeigh of ISI Thompson and Barbara Cohen of Public
Library of Science discussed the opportunities available in open-access
publishing. Panelists emphasized that “open access publishing” still
includes—by their definitions—peer review, and is not a publication “free
for all.” Trends and growth projections for open-access publishing were
discussed as well.
Publication Planning Goes Undercover at the International Spy Museum!
Attendees gathered for a unique cocktail reception at the International Spy Museum after the first day of the conference. Admission to the museum was complimentary, and attendees viewed exhibits such as “Introduction to Espionage” “Spies Among Us” and “War of the Spies” following cocktails. The exhibits were truly worth seeing. For more information, go to www.spymuseum.org.
How Should Pharma Handle the Blogging Phenomenon?
Weblogs, commonly know as blogs, are rapidly
gaining momentum and acceptance as credible marketing strategies. Companies
are using blogs as customer relationship tools, for branding reinforcement,
product ideology testing and for creating a public relations buzz.
A blog can be a powerful communication tool and can be used to harm or help
the pharmaceutical industry. These days reporters at major news
organizations pay close attention to bloggers who often “break” major
stories before the traditional media does! Pharmaceutical PR people,
marketers, and especially CEOs should take a cue from the media and lurk in
the “blogosphere” to learn about public sentiment toward the industry and
specific products. Whether your company is ready to embrace blogging or is
just interested in keeping tabs on blogs, you need to understand the
essential basics of blogging, including the public’s perception of what a
blog should be.
And, as blogs enter the mainstream business world, marketers are faced with
how to impose a formal structure on blogs including format/strategy,
metrics/goals and ROI. If blogging is a legitimate strategy for your
company, do you know how to leverage this new media to complement your
existing online and offline marketing strategies?
Stay tuned for more information from TIPPA on the pharmablogging phenomenon!
‘…an increasing number of companies have come to see them [blogs] as the next great public relations vehicle—a way for executives to demonstrate their casual, interactive side.
More PR Than
No-Holds-Barred on Bosses, Corporate Blogs
Amy Joyce, Staff Writer, Washington Post, Saturday March
19, 2005; Page A01
‘The blogs give us what we call a corporate handshake with consumers, a bond of loyalty and mutual trust that’s different than the typical selling relationship…’
Mr. Gary Hirshberg, Chief Executive,
Stonyfield,
Blogging Becomes A Corporate Job; Digital ‘Handshake’?
Sarah E. Needleman, Careerjournal.com, WSJ, May 31, 2005,
Page B1
Update on Clinical Trial Registries
At Pharmaceutical Education Associates’ Clinical Trial Registries: Working Through Disclosures and Compliance Challenges, held June 9 in San Francisco, Annetta Beauregard of Eli Lilly and Company provided delegates with an interesting comparison of the registry requirements of ICMJE with proposals from WHO and PhRMA, reproduced here:
|
Disclosure Requirements |
ICMJE |
WHO |
PhRMA |
|
1. Unique Trial Number |
X |
X |
X |
|
2. Registration Date |
X |
X |
X |
|
3. Secondary IDs |
X |
X |
X |
|
4. Funding Source(s) |
X |
X |
X |
|
5. Primary Sponsor |
X |
X |
X |
|
6. Secondary Sponsor |
X |
X |
X |
|
7. Responsible Contact Person |
X |
X |
X |
|
8. Research Contact Person |
X |
X |
X |
|
9. Brief Title of Study |
X |
X |
X |
|
10. Official (reg.) Title |
X |
X |
X |
|
11. IRB Review |
X |
X |
X |
|
12. Condition |
X |
X |
X |
|
13. Intervention(s) |
X |
X |
|
|
14. Key Inc./exc. |
X |
X |
X |
|
15. Study type |
X |
X |
X |
|
16. Start date |
X |
X |
X |
|
17. Target Sample Size |
X |
X |
|
|
18. Recruitment Status |
X |
X |
X |
|
19. Primary Outcome |
X |
X |
|
|
20. Secondary Outcome |
X |
X |
|
Ms. Beauregard noted that there are only four
potential “sticking points” of disagreement between the organizations about
what must be included in a register, primarily due to pharmaceutical
manufacturers’ concerns regarding proprietary information. Ms. Beauregard
also provided a detailed look at LillyTrials.com, her company’s trials
webpage.
There was much discussion at the conference regarding the July 1, 2005 ICMJE
deadline for registering clinical trials. It was noted that if your study
starts after July 1, and you want your study considered for publication by
one of the ICMJE journals, you must post the required fields at initiation
of the trial, which speakers agreed was most commonly 21 days after the
first patient visit. This includes trials for conditions that are “severe
and life threatening.” By September 13, 2005, however, all trials (including
those that started before July 1, 2005) must be registered in order to be
considered by the ICMJE journals.
About TIPPA: The International Publication Planning Association
The International Publication Planning
Association (TIPPA) is an industry-run association. Our mission is to foster
excellence in medical publications and communications within the
biopharmaceutical industry by providing a foundation from which industry can
stand together to organize thoughts, present recommendations and ethical
guidance. In addition TIPPA provides practical strategies for developing,
implementing and executing an effective publication and communication plan
as a critical component of the clinical biopharmaceutical development
process. Our aim is to help biopharmaceutical communication executives and
their agencies produce ethical and targeted publications and clinical data
throughout the product lifecycle.
To contact TIPPA, email
Tracy@publicationplanningassociation.org, or
Lori@publicationplanningassociation.org or visit us at
www.publicationplanningassociation.org.
Win-win Investigator
Initiated Study Programs
July 19-20, 2005-Sheraton University City Hotel, Philadelphia, PA
Critical Issues in Clinical Trial Registries and
Registers
September 22-23, 2005-Sheraton University City Hotel, Philadelphia, PA
The 4th Annual Conference on Off-Label Usage
September 26-27, 2005-the Park Hyatt, Philadelphia, PA
Maximizing the Effectiveness of Medical Liaison
Team Capabilities
October 18-20, 2005-Sheraton University City Hotel, Philadelphia, PA
For more information on these events, call 1-800-686-2276 or go to
www.publicationplanningassociation.org.
If you have a colleague who is interesting in joining TIPPA or receiving TIPPA’s Newsletter, please email us at either address above!
Call for Papers!
If you have an article you’d like to see
published on the TIPPA website, please submit it for review to
Lori@publicationplanningassociation.org.