One of the key elements of all stages of drug development is communications.1,2,3 Whether in preclinical development, during clinical trials, or post-approval, including marketing and commercialization, developers have significant internal and external communication needs. Although the trends are "digital, digital, digital," the COVID-19 pandemic created an environment where workers were leaning on screen time and digital communications more than ever, which is resulting in what some have dubbed "digital fatigue."4 The upshot is that print is not dead and is an important component of any drug development communication strategy.
Broadly, you can break the drug development life cycle into three areas: preclinical, clinical and post-approval. Each category has overlapping needs for internal and external communications that can benefit from a single-source vendor.
Preclinical is simply all drug development activities prior to human clinical trials. There is a broad range of materials in this category, both technical and business-related, that bleed into the clinical category. John Sullivan, National Account Manager at FedEx Office, says, "We help biopharma companies produce many protocols, such as regulatory binders, patient and physician recruitment materials and multi-part NCR forms."
Those are only a few of the print documents used by biopharma companies during preclinical development. There are numerous examples of internal communications, technical publications, investor communications, and materials used to recruit participants for clinical trials.
Although digital communications are a significant component of any of this work, there is still a significant need for print. In terms of clinical trial recruitment, print materials, including direct mail, are important in reaching participants and potential participants in order to communicate with them in the ways they want to be reached.
Clinical Trials & Approval
Clinical trials often require sponsor companies to interact with physicians, participants and various healthcare workers at multiple sites, and in many cases in multiple regions or countries. Print communications can include journal publication, clinical trial protocols, internal findings and various business-related materials such as press releases and investor communications.
Not only do external communications require regulatory compliance but they also need to reflect the strategic branding of the sponsor company. FedEx Office, for example, offers strategic consulting for its print and digital communications services.
Kevin Kaiser, National Account Manager with FedEx Office, says, "When talking about strategic use, such as the use of variable data, we can adjust, for example, the image and the message for each piece of direct mail that goes out to potential trial participants. And our response rate on direct mail is in the 40% to 60% range, depending on how you target that message and your strategy to the type of participants you want in your trial."
If all goes well, and a drug is approved for use by regulatory authorities, sponsor companies will be in the position of launching and marketing their new drug. This requires a significant level of branded marketing materials that go to physicians directly or via sales reps and to potential patients through a number of channels, including direct mail.
Sullivan notes that FedEx Office has multiple e-commerce platforms that can be deployed for customers. "One, for example, is print-on-demand, and this helps our customers catalog all of their communication materials on an easy-to-order online platform. So if there's any change in ownership of information throughout the life cycle of the clinical development program, those materials reside in that platform which helps make it easy for people to continue to order the materials while protecting the brand."
Product Direct Mail
A large pharmaceutical company uses FedEx Office for direct mail services to manage their customized patient assistance programs. This helps make certain drugs more affordable for patients with limited prescription drug benefits. The customers' account managers were using their own office printers to print and mail custom direct-to-patient program communication programs but were overwhelmed by the manual process. In addition, branding guidelines were at risk due to the color inconsistency between copiers.
With their platform, FedEx Office received a spreadsheet of names and addresses of patients through a secure online portal. The customer communications were printed and mailed by FedEx Office, freeing up valuable time for the account managers to run their patient assistance programs more efficiently.
Biopharmaceutical companies have ongoing and extensive needs for print and digital communications throughout the drug development life cycle. FedEx Office provides strategic consulting services as well as several technology platforms that can provide companies with a centralized approach to any and all digital and print communications.
To learn more about how FedEx Office can help your business communicate important messages through print, visit fedex.com/businesssolutions today.
1. Settleman J and Cohen RL. Communication in Drug Development: "Translating" Scientific Discovery. Cell. 2016;164(6):11010-1104. https://www.cell.com/cell/comments/S0092-8674(16)30200-8
2. Best Practices for Communication Between IND Sponsors and FDA During Drug Development: Guidance for Industry and Review Staff. U.S. Food and Drug Administration. December 2017. https://www.fda.gov/files/drugs/published/Best-Practices-for-Communication-Between-IND-Sponsors-and-FDA-During-Drug-Development.pdf
3. Pitts PJ. Can We Talk? Rethinking FDA Communications With Drug Developers. Health Affairs. December 23, 2019. https://www.healthaffairs.org/do/10.1377/hblog20191219.487362/full/
4. Douglas E. Feeling drained? You may have 'digital fatigue.' Human Resources Director. May 20, 2021. https://www.hcamag.com/ca/specialization/mental-health/feeling-drained-you-may-have-digital-fatigue/255616