By Mark Aiello, Vice President and General Manager of Regulated Industries, Lionbridge
New drug development can be a lucrative investment for companies, and the global pharmaceutical market is worth $300 billion per year, according to the World Health Organization. Around the world more than 7,000 drugs are currently in clinical development. While pharma companies make substantial investments in drug development because of the potential for a high return on investment (ROI), the risk of failure is also high. The costly reality is that the majority of drugs never make it to the sales phase – only one in 10,000 will actually be brought to market. And of that small minority of drugs that do make it out of testing and development, only two out of 10 return revenues that equal or exceed research & development (R&D) costs.
With these daunting odds in mind, pharma companies are increasingly seeking solutions everywhere possible to mitigate risk and to manage costs, in order to optimize the development process and boost their chances for success. Translation as a business service is one such solution that plays a key role in all stages of the drug development cycle – including R&D, clinical trials, go-to-market strategy and regulatory compliance – to create a strategic advantage and protect their investments in drug development.
By using translation and localization solutions, organizations can overcome the massive language challenges associated with successfully getting their drugs into the hands of patients. Tools like integrators and digital software platforms can streamline the translation process for pharma companies, connecting them to language experts and allowing them to centrally manage content online for translation in multiple languages. With the help of highly accurate translation, pharma companies can ultimately devote their in-house team’s focus on increasing their chances of profitable returns on drug creation.
Research and development
In 2015 alone, pharmaceutical companies invested $58.8 billion in R&D, a 10.3 percent increase from 2014. One of the most critical phases of R&D is clinical trials where participants using proposed drug therapies and medical devices are studied to ensure medical effectiveness. But one of the biggest challenges in completing a successful clinical trial is recruiting these participants, especially in foreign countries.
Many U.S. pharma companies are turning to emerging markets to conduct multi-phase clinical trials because they offer a wider pool of candidates, with a higher likelihood of participation. To reach these populations, clinical affairs departments are using solutions to translate the myriad documents used to recruit trial participants in their native languages. By reaching trial participants in their own languages, companies can more effectively connect with their target participant group and recruit those that meet the study criteria. Translation services are a necessary tool for patient recruitment in these emerging markets and an essential solution for pharma companies to pass their drugs through the critical clinical trial phase of R&D.
A drug that makes it through the clinical trial phase has cleared a significant hurdle on its way to becoming marketable and profitable, however, pharmaceutical companies still must take necessary steps to ensure regulatory approval across all markets where the drug will be sold. Translating drug instructions and labels for each market with 100 percent accuracy is essential to regulatory compliance. Every word and phrase needs to be translated with zero errors since human lives and well-being are on the line. Translation at this phase is simply not within most drug companies’ area of expertise.
Many pharma companies are partnering with translation and localization providers to support them through this daunting process. At this stage, the stakes for accurate translation are extremely high. Regulatory approval will be halted if drug labels and dosage instructions are not correct, which can significantly impact the company’s bottom line. Translation experts can cost-effectively supplement the language-skill gap for pharmaceutical companies and assist them in achieving regulatory compliance as efficiently as possible.
Marketing and sales success
When a company finally does get a drug to market, they have successfully beaten the development odds. The risk still remains, however, of achieving a positive ROI. Drug companies have only 10 years to market their product unchallenged by generic brands via patent protection laws, which is a short timeframe to produce financial results. Intelligent and targeted marketing efforts are crucial during this stage, and drug companies invest significantly to get their drugs in front of potential consumers. Companies willing to invest millions of dollars in marketing need their campaigns to be constructed with effective, targeted content that will resonate with diverse audiences and grow brand value.
Translating marketing content is essential for pharmaceutical companies to reach customers around the world with engaging content that is locally relevant. By partnering with localization experts as part of a wider marketing strategy, pharmaceutical companies can ensure consistent brand messaging in language translation which increases their chances of making the sale during this final stage of the drug development process.
At every phase of drug development, the stakes are too high for pharma companies to manage every task in-house. As the regulatory and marketing landscapes continue to evolve, pharmaceutical companies must implement translation solutions to help them navigate the drug development process. Pharmaceutical companies that partner with localization experts at every stage of drug development will experience real advantages in achieving profitability and success.
Mark Aiello joined Lionbridge in 2016 as Vice President and General Manager of Regulated Industries, a high-growth business unit within Lionbridge’s organization. Prior to joining Lionbridge, Mark was most recently Vice President and General Manager, Virtual Data Room Solutions at RR Donnelley, leading that full-service SaaS offering from platform launch in 2008 to a $50 million business unit.