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PharmaWrite at the 12th Annual Meeting of ISMPP


Compiled for you by PharmaWrite.

Publication steering committees (PSCs) are a vital industry tool that can help you facilitate communication and increase the effectiveness of your publications. PSCs can optimize the publication process by coordinating all publishing activity, establishing uniform expectations, and engaging authors in a fluid scientific exchange. This is crucial because some key opinion leaders, especially those coming from academia, may have limited knowledge about the complex and inter-related publication "ecosystem" - and as a result may harbor mistrust about pharmaceutical company influence on the publication process. PSCs can aid in overcoming some of these challenges.

When discussing the value of publication steering committees, it is also important to note that all publication planning is not the same across disease areas. Publication planning for oncology or rare diseases, for example, may differ widely from planning for drugs to treat diabetes or hypertension. Similarly, planning for orphan drugs and/or rare diseases can also be uniquely challenging.

At the recent 12th annual meeting of the International Society of Medical Publication Professionals (ISMPP), a panel discussion of industry experts described key tactics for establishing and conducting successful PSCs while also providing ways to overcome obstacles in assembling and driving PSC success. The panel included Jonathan Druhan (PhD, Director, Publications, US Medical Affairs, AstraZeneca); Grannum R. Sant (MD, FRCS, FACS, Medical Affairs Consultant, Photocure ASA; FormerProfessor and Chair, Department of Urology, Tufts University School of Medicine); and Anita N. Schmid (PhD, Associate Director, Global Scientific Communications, Celgene). The session was moderated by Bhakti Kshatriya (PharmD, Director, Publication Excellence, Global Scientific).

The panel shared their best practices for development and execution of successful PSCs in both the industry and academic setting and the benefits of establishing a PSC charter.

Industry Perspective
PSCs should be composed of motivated individuals who are willing to participate and offer opinions without remuneration. An ideal PSC is composed of 3-6 external members and 2-3 internal members. Early creation of PSCs (prior to final data release) is beneficial because it affords the opportunity for proactive publication plans, establishes clear communication regarding the obligation to publish and provides an opportunity for early discussions about authorship agreements. However this must be weighed against the uncertainty of data available for publication planning.

During the first year, the PSC should:

Publication steering committees may require a charter. A charter covers the PSC membership structure and establishes a clear set of expectations that all PSC members understand and agree to. It is typically broader than a contract which just covers the scope of work, duration of engagement, payments, service obligations, liabilities, etc. A PSC charter can build upon an existing Study Steering Committee (SSC) charter. It is beneficial because it acts as a catalyst for agreement. It helps drive the discussion about how the company and authors will work together, provides an opportunity to discuss company policy and compliance and sets up a governance process for publication planning and author selection.

Academic Perspective
At ISMPP, Dr. Sant discussed how PSCs are especially important in the world of academia where there have historically been a lack of knowledge about the complex and inter-related publication "ecosystem" and a suspicion of industry motives and practices. It is important for key opinion leaders to be educated on the responsibilities of a PSC, the role of publication professionals and medical writers, and publication guidelines such as GPP3, ICMJE, and EQUATOR.

For your convenience, and for your reference, the PharmaWrite staff has compiled a detailed meeting summary of the ISMPP event, including session descriptions, key takeaways, and valuable speaker comments and quotes. The summary includes valuable in-depth information, like the material presented here, on all of the topics discussed at ISMPP. Please fill out the form below to request this comprehensive summary.