E Pluribus Unum – The Future of Medical Writing
By Andrew Kusmierczyk, Scientist, CMC, Cardinal Health Regulatory Sciences
Publication plans. Journal articles. Conference abstracts. Investigator brochures. INDs. NDAs. BLAs. MSL slide decks. Scientific platforms. Educational materials for HCPs. Talk tracks. Visual Aids. Patient Education Brochures. Leave Behinds. Objection handlers. Sales Aids. Posters, E-blasts. Focus groups. Advisory boards.
Ask anyone in the pharmaceutical industry to identify a common thread among these and the answer will most likely lead to medical writing. Indeed, the ability to communicate scientific information to diverse audiences (regulatory bodies, researchers, health care providers, the general public, etc.) underpins the success of a pharma company’s development, regulatory and commercialization efforts. And ensuring strong, yet nimble, medical writing capabilities are available when called upon underpins the success of drug development companies, big and small.
However, there is another common thread among these items that may not be immediately apparent: they are frequently outsourced to multiple providers.
It is not uncommon for one vendor to handle pre-approval regulatory writing, another vendor to develop a scientific platform and publication plan, a third vendor to handle promotional and educational materials, and so forth. This “multi-vendor model” has been the preferred model for quite some time. However, a landscape shift is happening which will benefit not just medical writing vendors that rise to the challenge but, more importantly, the pharmaceutical companies that they serve – and ultimately patients.
Medicines are becoming more complex
“An average of 54 new active substance (NAS) launches per year are expected over the next five years and two-thirds of launches will be specialty products, lifting specialty share of spending to nearly 50% by 2023 in most developed markets.”1
This quote is one way to illustrate the landscape shift toward increasingly complex medicines. Product complexity will have a considerable impact on the ability of pharmaceutical companies to:
- Expertly communicate their research findings;
- Efficiently navigate the rapidly evolving regulatory terrain; and
- Effectively develop promotional and educational materials.
All of these activities are essential to achieving regulatory approval and delivering a successful product launch.
As complexity grows, the pharmaceutical industry will become increasingly focused on their core competency of drug research and development – and will rely more heavily on outsourced partners for non-core capabilities, such as medical writing. While increased reliance on teams of strong, highly credentialed, responsive service providers to assist with publication, regulatory, and promotional strategies is an exciting opportunity for the medical writing industry, it is also an opportunity that the multi-vendor model is poorly positioned to meet.
Moving beyond a multi-vendor model
As medicines and the science behind them become more complex, it will become more challenging for pharmaceutical companies to find multiple vendors that each possess the right set of subject matter experts (SMEs).
Moreover, because it is siloed, the multi-vendor model carries with it several built-in inefficiencies, including:
- Procedural inefficiencies due to duplication of billing, project management activities, and other administrative functions;
- Cultural inefficiencies that stem from having to acclimate your team to different corporate cultures, operating practices, data/information management systems of each vendor you contract with; and
- Scientific inefficiencies because information cannot flow freely between vendors, due to legal and IP issues. For example, since a regulatory vendor and a publications vendor don’t talk to each other, a rapid and coordinated response to the release of the next slice of clinical data is not easily accomplished.
Companies that can provide “one-stop-shop” medical writing solutions across the product lifecycle will offer their pharmaceutical clients much more value than is currently realized through the multi-vendor model. The value-adds include:
- Expertise under one roof. There is no concern about having to search for separate companies, each with an appropriate set of SMEs.
- Operational efficiency. Cost savings are realized from reducing the inefficiencies described earlier (i.e. billing, project management, administrative, etc.).
- Scientific efficiency. When a single vendor handles multiple medical writing aspects, information can flow freely between multiple teams as everything is under a single legal and IP protection framework. For example, the pharmaceutical client can rest assured that the vendor can deliver on regulatory strategy because the vendor has also been handling the client’s scientific publications and therefore knows the product and the science inside and out.
- Value pricing. A pharmaceutical company can take advantage of a more favorable cost structure when it is able to bundle medical writing services with a single vendor.
As medicines become more complex, the ability to coordinate medical writing across multiple functions (regulatory, publications, promotional, educational, etc.) will provide much needed scientific continuity and consistent messaging. Pharmaceutical companies, big and small, that are willing to move beyond the multi-vendor model will realize improvements in efficiency and cost savings.
At Cardinal Health, we accept that the landscape is shifting and welcome the opportunity to develop innovative solutions for our pharmaceutical clients via our Cardinal Health Specialty Solutions (CHSS) business. Contact us to learn more about our integrated medical writing team.
- “The Global Use of Medicine in 2019 and Outlook to 2023”. The IQVIA Institute. January 29, 2019 (https://www.iqvia.com/insights/the-iqvia-institute/reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023)