By Peter Deryncz
As a pharmaceutical company seeks to guide a new product from concept to commercial success, it must effectively harness an important tool: the scholarly research paper. A clear understanding of the roles an article can play and the challenges of maximizing its effectiveness are valuable knowledge for any pharma executive. Let’s first review the multiple roles a paper can play and then assess the challenges.
During the preclinical study phase, your company’s researchers will be navigating through the millions of articles that exist in support of the scientific process. After preclinical work, clinical trials are conducted and the publication-planning process accelerates, culminating in scholarly articles that will be submitted to peer-reviewed academic journals. Once published, they become a major part of your investigational new drug application (INDA) submitted to the FDA. If the FDA approves your product, the articles take on a new role as your marketing efforts begin. As witnessed by the growing importance of evidence-based promotions, there is no greater weapon in your sales representatives’ arsenal than research studies that can be effectively presented along with prescribing guidelines to the healthcare professionals (HCPs) with whom they meet. Being able to back up one’s claims for a medication with science — in addition to the promotional materials prepared by your marketing firm — is not only a good idea; it has become the chief method by which you can distinguish yourself from rival companies with competing drugs. It has also become one of the few ethical methods remaining to communicate with HCPs in light of the highly restricted code of interactions adopted within recent years.
Naturally, there are challenges linked to these uses of scientific articles, which are related to issues of compliance and business process. First, it is well known that an IND submitted to the FDA can easily run 10 or more volumes, largely consisting of reviews and copies of published studies of the drug in question. Assembling, transmitting, and managing this volume of materials is a major task for any pharmaceutical company, particularly with the new electronic common technical document (eCTD) format. It is vital for your bottom line that this task be completed in as economical a manner as possible and in a way that avoids unnecessary duplication of materials. Similar care must be taken when distributing key articles proactively through your sales force or digital marketing initiatives or reactively in response to medical information inquiries. Additionally, regulatory issues pertaining to good reprint practices (GRP) and copyright issues must be adhered to when articles are acquired and distributed.
The Value Of Content Repurposing
The good news is that your company need not go it alone in navigating these challenges; a company specializing in content repurposing can oversee much of this process. For example, with regard to the eCTD submission process, the content repurposer can process orders for articles either singly or in batches and procure them, ensure that the retrieved documents are digitally formatted to specifications, and oversee quality control and assurance processing. The service can also be tasked to report on the details of usage for every article requested by your company and assign a dedicated project manager to oversee the entire process.
Also, the content specialist can provide a streamlined method for obtaining reprints, ePrints, and single articles in a copyright-compliant manner. It can offer tools that make it easy to obtain and legally share these articles from secure online environments, via your customer relationship management (CRM) or inventory system, and a variety of other ways. Having access to single document delivery, for example, can provide your company’s scientists and researchers with copies of most articles you need in as little as a few minutes to a few hours—a significant advantage considering the costs for every day a new product is delayed in getting to market.
As we have seen, research papers are becoming the lifeline of life sciences. When written, published, compiled, and disseminated in effective ways, they can make the difference between successful or unsuccessful development and marketing efforts for your company’s new drug. Partnering with the appropriate content repurposing company can go far toward accomplishing these goals.