On February 29th 2016, the 15th Annual International Publication Planning Association (TIPPA) meeting convened in San Diego, CA for two days to discuss the evolving challenges impacting on the publications community. The meeting had approximately 100 attendees, including delegates, speakers, and sponsors. A summary of the first day of the meeting is provided below. A summary of the second day of the meeting can be found here.

Day 1: Monday 29th February 2016

Implementing the new GPP3 guidelines

The meeting opened with a topical discussion on the Good Publication Practice 3 (GPP3) guidelines, published in August 2015 by the International Society of Medical Publishing Professionals (ISMPP). Donna Simcoe (Medical Publications Consultant, Simcoe Consultants, Inc.) began the session by giving a brief overview of the history of the Good Publication Practice (GPP) guidelines which were originally published in 2003 and updated in 2009 (GPP2). She explained that GPP publications are intended to provide guidance on how to “responsibly and ethically develop and publish manuscripts sponsored by pharmaceutical companies”. The newest publication, GPP3, offers additional guidance on interpreting International Committee of Medical Journal Editors (ICMJE) authorship criteria and improved clarity on section 6002 of the Affordable Care Act, more widely known as the Sunshine Act, which provides guidance on authorship and reimbursement. Currently, there are a number of supporting materials to aid in the interpretation of GPP3 on the ISMPP website and they are currently planning to develop additional training materials.

Dikran Toroser (Medical Writing Senior Manager, Amgen) went on to discuss authorship criteria and author number.  He noted that while there are a number of resources offering guidance for authorship, including the ICMJE guidelines and AMA manual of style, GPP3 specifically clarifies the “grey” areas of the ICMJE authorship criteria. However, he mentioned that the guidelines for author number are less clear and vary by resource; GPP3 recommends capping the author number at 10, however ICMJE is more flexible. Ensuing discussions revealed that many publication professionals agree that limiting the number of authors is not as important as following ICMJE criteria for authorship. This was echoed by the third panelist Monica Ramchandani (Global Biosimilars Development, Amgen) who noted that while Amgen does strive to follow the majority of the GPP3 guidelines, they prefer to be more flexible with author number, as outlined by the ICMJE guidelines. She also stated that Amgen disagrees with GPP3 on adding local presenters to encore bylines and instead follows ICMJE authorship guidelines. This point led to a lengthy discussion with the audience and while it was clear that views differed among the audience, most felt that significant author contribution was still the primary consideration.

Evolving best practices for working with authors – authorship and beyond

Chandra C. Abbott (Senior Manager, Scientific Communications, Sirtex Medical Ltd.) discussed best practices for forming and using publication steering committees, which is a group of authors and investigators whose ultimate goal is to help with the optimal dissemination of data on a product (usually from one or more clinical trials). In her experience, publication steering committees generally meet in-person and discuss topics such as publication ideas, identifying key audiences, and activity planning around manuscripts, key congresses and meetings. She emphasized the importance of meeting with the committee to enhance engagement and also recommended forming smaller working groups that convene periodically to discuss specific issues of interest (i.e. to help answer particular questions). For initial identification of the steering committee – as well as inviting principal investigators – the publication team may also take recommendations from experts in the field and from internal stakeholders.

Surendra Sharma (Global Medical Publications-Head, Alcon Laboratories, Inc.) covered good publication practices at Alcon. He stated that they strictly follow ICMJE guidelines for determining authorship. While they do not offer compensation for writing activities, they do offer medical writing editorial services. Additionally, while Alcon generally do not universally reimburse for conference attendance, there are exceptions, such as if the author had not planned to attend the conference where he/she is due to present. He stressed that exceptions were all evaluated on a case-by-case basis and underlined the importance of making the attendance stipulations clear to authors. It was apparent that a similar approach was taken by most companies and this was a popular topic throughout the conference.

Don’t be left behind – learn to evolve with the changing healthcare environment

Mike Smith (Managing Director, AlphaBioCom) spoke of the need for the pharmaceutical industry to evolve their communication strategies to include digital and social media to ensure greater dissemination of content. Though he acknowledged several barriers, such as regulations, lack of support in a conservative environment, and lack of media experts, he challenged the audience to think outside the box. For example, he suggested the inclusion of Quick Response (QR) codes on posters, which could link to an interactive poster presentation or to a poster with multiple language options. He also stressed the benefits of creating interactive communities on various platforms. To help with these strategies, he suggested that publications teams work closely with compliance teams to implement processes and procedures.

Publication planning department management in 2016 – one size does not fit all

This session was moderated by Welyn Bui (Executive Vice President, Scientific Communications, Meridius Health Communications). Panelists included Renu Juneja (Head of Medical Communications, MedImmune) and Surendra Sharma (Global Medical Publications Head, Alcon Laboratories, Inc.). Renu kicked off the session by discussing the evolving role of the medical writer. She estimated that only 60% of a medical writer’s time is spent on scientific content, while the other 40% is spent on “processes”. She stated that this is not a good use of time for MDs and PhDs and suggested the need for new roles to assist with publication management. These roles would be geared towards individuals who are detail-oriented and excel at following processes. She also noted that there is a move for more in-house writing teams and emphasized the benefit of having fully-integrated writers that are abreast of current conversations and strategy within the company. However, only about 25% of companies represented by the meeting attendees currently have in-house writers.

Renu and Surendra both contributed to a discussion centered on choosing the right journal for a publication. While impact factor and the top journal in a therapeutic area should still be considered, it was noted that other metrics are increasingly important, such as the ability to easily find the publication and to access it for free.

When asked where the publications teams will be in 3–5 years, Renu thought that publications teams would work more closely with corporate communications teams and that compliance issues would be less burdensome, allowing more time for scientific endeavors. She also hoped that time to publication would decrease to allow patients faster access to life-saving therapies. It was noted that most publishers have an option for rapid publication.

Clinical trial data transparency – data sharing and third party data inquiries

Debra Mayo (Vice President, Global Scientific Communications, Teva Pharmaceuticals) gave a very topical presentation on data transparency. She cited it as an opportunity to regain credibility with patients, but noted that there is still work to be done; currently only 57% of clinical trials are registered at clinicaltrials.gov, a US-based online registry. She encouraged publications teams to post data publicly, publish data in peer-reviewed journals, and provide public access to patient-level data. She also noted that several publishers now require public access to clinical trial data before they will consider publishing it.

In regards to data sharing, she encouraged companies to be proactive, indicating that sharing is not only a display of integrity, but is likely to improve patient outcomes. She stated that while there are disadvantages to data sharing, such as the release of ideas to competitors and impact on stock, data sharing will build trust, enhance patient care, offer new opportunities, and will ensure uniformity and equality.

Adapting to a more patient-centered approach to the scientific exchange

In this session, Richard White (Commercial Director, Oxford PharmaGenesis, Ltd.) discussed the need for the community to adopt a more patient-centered approach to publication practice. He encouraged the use of patient-reported outcomes (PRO) and emphasized that PROs are key to demonstrating healthcare value to stakeholders, such as payers, clinicians and regulators. He referenced studies that were successful in predicting clinical outcomes through PROs and went through the basic steps of developing generic- and disease-specific PRO instruments.

Mary Beth DeYoung (Global Publications Lead, AstraZeneca) then talked about the evolving role of the patient and the trend for increased patient involvement in the publication process. She mentioned that some journals, such as the British Medical Journal (BMJ), have implemented strategies to promote patient involvement and noted that there have been moves in the community to include patients in reviewing protocols, data interpretation and as authors on manuscripts. While concerns were raised, she encouraged publication professionals to keep an open mind and consider that patients are increasingly savvy. To become more patient-centered, she stressed the importance of speaking “human”, publishing open access, obtaining patient feedback prior to submission, and the importance of thanking patients.

Operating on a global scale – streamlining global publication strategies

Jack Yeager (Chief Scientific Officer, Sylogent) discussed the difficulty of operating on a global scale, particularly in regards to communication between departments and the increasing pressure to know and understand all metadata. He stressed the importance of having a centralized data source to maintain data consistency across the company. He demonstrated this by sharing cases of companies that publicly shared conflicting data and the resulting negative impact.

Additionally, he noted that pharmaceutical and device companies have an increasing number of regulations, particularly those concerning data transparency, more processes, shorter timelines, smaller budgets, and fewer resources.  While there were suggestions in previous discussions to “resource up”, he suggested that the better and more economic solution is to invest software to assist with theses challenges, such as those offered by Sylogent.

Publication strategies for rare disease and biosimilars

Robin LeWinter (Senior Director, Global Publications, Aegerion Pharmaceuticals) and Dheepa Chari (Director, US Scientific Communications, Novartis Pharmaceuticals Corporation) led the discussion on publication strategies for rare diseases by focusing on the unique challenges. Some of these challenges include the ease of identification of patients and the dearth of clinical trial data. They noted that often there is either no prior clinical data or data is from studies with a very small number of participants and no placebo. Additionally, the patient journey is very convoluted and diagnosis and treatment guidelines often differ or are outdated, further complicating the understanding of the disease. Publishing clinical trials can be challenging because the trials are often small, single-arm studies with limited audience reach. Because of these challenges, Dheepa stressed the importance of outlining the value proposition of the drug in each publication.

Monica Ramchandani (Global Biosimilars Development, Amgen) followed this discussion by presenting on the challenges of publishing data on biosimilars. First, she explained that the regulatory pathway for biosimilars is inverted compared to innovator biologics with limited clinical evaluation which ultimately produces less data. With biosimilars, the majority of efforts are spent on structural and functional characterization, followed by non-clinical and clinical assessments. Typically, there is one phase I study to demonstrate the pharmacokinetics/pharmacodynamics and no phase II study. Additionally, usually one confirmatory clinical study in one indication is conducted to compare the biosimilar to the reference product with respect to efficacy, safety and immunogenicity.

She explained that publications for innovator biologics/drugs also have different medical objectives, which traditionally focus on clinical and health economics and outcomes research. However, the primary objective for biosimilars is to communicate similarity of the proposed biosimilar to the reference product with respect to structural/functional characterization and safety, potency, and purity. Additionally, it is necessary to communicate on policy issues such as labeling, as well as switching patients over from the reference drug, etc.  She also noted that the type and extent of analysis done is sponsor-dependent and evaluation by regulatory agencies is done on a case-by-case basis; therefore, each biosimilar is unique and it is not possible to compare one biosimilar with another. All of these aspects present challenges in several areas, including educating internal and external stakeholders, sound study design and interpretation, and publishing in journals/congresses because of limited data and larger audience, which includes physicians and pharmacy directors, as well as scientists, payers, policy makers, regulators and other clinicians.

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By Brea Midthune, PhD

Supported by Aspire Scientific. Aspire Scientific is a boutique medical writing and publication planning agency led by professionals with at least a decade of medical writing experience and supported by PhD-educated writers and academics at the forefront of their specialist fields.