Emerging biotech companies must master many challenges in bringing a product to market. Even the acronyms common to early development, like IND (Investigational New Drug Application), SAD (single ascending dose), and MAD (multiple ascending dose) imply that a company must know how their treatment impacts the body, how to analyze study results, and how to express their findings to regulatory authorities. The expertise of medical writers is valuable in helping an emerging biotech reach its drug development goals.
What expertise can PROMETRIKA’s medical writers offer to these companies?
Nearly 100% of the companies that PROMETRIKA Medical Writing has served in the last few years can be informally classified as small or medium. A small company has generally been in business only a couple of years, has 1 to 20 employees, and their first entity is not yet, or just barely, in human studies. A medium company has been in business 5 or more years, has a product approved or at least in phase 3, and usually has other products in the pipeline.
Not that budgets aren’t important in all companies but, particularly in small companies, pursuing funding is a continual effort. This may actually color their view of the value of medical writing or what documents and documentation are necessary. They may value a press release based on “first look” analyses of newly locked data – news that can generate the excitement that prompts further investments – over aclinical study report that seems irrelevant if funding is not available. Additionally, the volume and pace of regulatory processes may be mind-numbing to a naïve company, especially to scientists who could move more quickly to additional research in their own laboratories.
A young company may not have templates and formats for their documents; they may not have used consistent data quality standards. Often, the early clinical documents have been drafted or written by team members who may be subject matter experts but have no regulatory writing experience. The medical writer can create templates, and perhaps SOPs, alongside the needed document. Building on the scientific background provided by the sponsor company, the medical writer’s expertise can bring clarity of expression, consistency of terminology, and compliance with ICH formatting requirements to the documents filed with regulatory authorities during early drug development. A skilled writer may be able to develop these documents more efficiently than the company’s subject matter experts, saving money and freeing them to manage the drug development process.
Many small companies are collegial collaborations of experts in different disciplines, leading to a matrix management structure. They may make all decisions by consensus, which can work well or lead to inefficiency or disagreement. Some company team members may be unfamiliar with collaborating with a medical writer. Medical writers have valuable team leadership skills that help teams meet deadlines. The writer can offer to spearhead the establishment of a project plan with stated responsibilities, specific timelines for all team members, and a feasible workflow. By building strong relationships with all individuals, the writer can facilitate progress in the development of the document. The writer is especially skilled in helping team members align on document messaging by working to build consensus during round-table reviews.
When working with small companies, medical writers may be challenged to exceed their areas of expertise. For example, some small companies may seek a writer who has a deep background in regulatory and/or clinical operations, as a way to fulfill their needs and, possibly, save research funds. Experienced medical writers have learned about these areas but few would consider themselves experts in all these facets. Writers should be transparent about their knowledge base when working with these sponsors.
In summary, by filling the roles of writer, advisor, and project manager, medical writers are valuable collaborators with small biotech companies and help to improve the efficiency of the drug development process.
