Medical Affairs-related scientific content publication planning takes countless people and several months of hard work to reach the point where the medical affairs team is ready to create a publication plan. Even during the publication process, MA teams need to keep stakeholders informed and work closely with researchers to ensure their data makes an impact.
Here are some of the key elements of the publication process and best practices for MA teams.
The changing role of medical affairs professionals means MA teams are more involved than ever. They need a seat at the table from the beginning of the development process all the way through publication. This makes them more informed about new therapies while allowing them to set timelines for promotion.
“As part of modern medical affairs organization, you should have involvement and ownership across the life cycle of assets, from early development to late stage planning,” writes Qasim Ahmad, head of medical affairs, Japan, for Novartis. “Either you are in field medical teams, medical advisors or MSLs (medical science liaison) role, you are the eyes and ears of the organization to the external world.”
Not only are MA teams actively involved in the publication process, but they work within all levels of the organization to promote the content. They meet with clinical communication agencies and PR firms that specialize in promoting the publication, along with internal staff members with the same goals.
“In most organizations, medical affairs representatives are now not only actively engaged in communicating medical information directly to opinion leaders, but also connecting with practicing physicians, payer medical directors and other decision makers,” writes the team at life sciences consulting firm CMK Select.
As you develop your publication plans, identify any blind spots within your organization. Where are your MA teams left out? What do you need to know?
In the same way that MA professionals need to be involved as key participants of product development, they also need to return the favor with greater communication and involvement of stakeholders.
“Building trust and relationships with colleagues is critical,” write Betsy Kitchens and Megan Hall, senior director of publication planning at Ultragenyx Pharmaceutical and head of medical communications at GRAIL, respectively. “One recommendation is to meet individually with key internal stakeholders to understand their prior publication experience. This should enable advocating for and educating on the publications role accordingly.”
When you listen to these stakeholders, even when their role in the testing and publication process is over, they can serve as both champions for your work and expert advisors. This makes the publication more effective and can drive better results. However, this is easier said than done. MA teams can sometimes be siloed from the rest of the pharmaceutical organization, while researchers prefer to leave the promotions to the experts outside of the lab.
“Oftentimes within pharma, the Commercial and Medical Affairs teams are truly a tale of two cultures – each with their own specific backgrounds and agendas,” says Chris Welsh, vice president of medical affairs at TGaS Advisors, a division of Trinity Life Sciences.
A recent survey by Trinity Life found 53 percent of medical affairs professionals felt they had a strong relationship with the commercial team; however, only 39 percent of commercial leaders shared those feelings. This highlights the gaps in communication and collaboration.
There is a third party that needs to be involved alongside MA teams and researchers: the writers. MA teams usually guide the publication writing staff. When managed poorly, these writers can feel isolated and confused about what they are promoting.
“A medical writer can be involved at both pre and postmarketing stages and also may be involved at the study level, including the authoring clinical study protocols, Clinical Study Reports (CSRs) and safety narratives,” writes Kate Forte, medical writer at biopharmaceutical services and clinical research organization Parexel.
Involving your MA teams in deeper parts of the research process means bringing your writing staff in as well. This applies to in-house workers as well as outsourced writing groups.
When your medical writers are included in the publication process, the lines should blur as to whether they are outsourced or in-house. If you want quality publications, then you need a writing staff that knows the information inside and out.
There are resources that medical affairs teams can tap into to strengthen their medical writing and publication plans. The Publication Plan is a non-profit resource for medical affairs professionals who want to improve their publications. They curate resources, share news stories, and provide opportunities to upskill and improve your know-how. This website is a good place to start to improve your publication strategy.
Historically, medical affairs professionals would create a publication and promote it in as many ways as they could. However, with the rise of new technology, digital marketing and unique presentation tools, your firm may need to reassess its efforts to learn what is most effective.
“We need to prioritize which activities have the biggest impact,” says Charlotte Kremer, EVP head of medical affairs at Astellas Pharma. “No organization has unlimited resources, so our success can also be defined by what we decide not to do.”
This applies both to the promotional efforts related to a publication and the data used to defend the product portfolio. It’s easy to overwhelm or confuse your audience with too much data. By selecting a few key points, you can create a meaningful message that sticks with those who engage with the material.
“Publication professionals are in a great position because they understand the data; and if they can connect the data to the overarching communication strategy, they become an invaluable member of the matrix organization,” says Eric Crown, scientific director at pharmaceutical and research development company AbbVie.
The promotions aspect is more important than ever. Your research firm and data team put so much effort into these trials, the last thing you want is for your publication to get ignored because there is other news elsewhere.
“It is important to remember that our desired audience is being hit with communications via multiple vehicles and channels,” write Stephen Casey and Michael Caso at Omni Healthcare Communications. “Contemporary audiences are not only bombarded by endless communications, but they now have the option to choose when and where they view those communications.”
The field of medical affairs continues to evolve and so will your publication best practices. Regardless of your trial or medical field, ethics need to be a key focus of any new data analysis strategy.
“Medical Ethics rests on four central pillars: autonomy, beneficence, non-maleficence, and justice,” write Cherie Hyder and Mitch D'Rozario, medical affairs at Biohaven Pharmaceuticals and medical science liaison at Genentech respectively. “An MSL who is knowledgeable about these principles, compared to someone who lacks this substantive knowledge, is better equipped to ask questions, apply good judgment based on knowledge and expertise, and recognize how and when to escalate a situation.”
This is where the International Society for Medical Publication Professionals comes in. The organization was founded for medical publication professionals and maintains a strong code of ethics for teams to follow. There is a code of ethics you can reference, along with various case studies that put this code into practice.
Medical affairs professionals who have worked in clinical trials for decades are still learning about publication practices in the modern era. Every year there seem to be new publication options and data practices for smoother analysis and presentation. However, by sticking closely to your key practices of communication, collaboration and ethics, you can maintain the reputation of your organization and publish meaningful reports.