The global pharmaceutical market is estimated to be worth $1.6 trillion by 2020. With the development of each new drug, pharmaceutical companies will undergo intensive, highly-regulated clinical trial processes with a unique set of challenges. While pharma companies make substantial investments in drug development, the risk — in both financial and regulatory terms — are incredibly high. To put it in perspective, only 12% of new products are approved by the FDA after 10 to 15 years in development, resulting in an investment average of $2.6 billion with no guarantee a drug will go to market.
Of the small minority of drugs that do make it out of the testing and development phase by proving to be both safe and effective, very few achieve a positive return on investment (ROI) on the costs of their research and development (R&D).
Pharma companies are increasingly seeking solutions to mitigate the risk and manage the costs of the development process, particularly as they must cast a wide net in the clinical trials phase to gain an adequate patient population for studies. Additionally, more pharmaceutical companies are looking to conduct rare disease studies and require patients from multiple countries to ensure their results are well-tested and accurate.
Taking a more globalized approach can help broaden the reach and potential ROI of drug development, but it does require a team that can work internationally and understands the intricacies of the process.
Translation can play a key role in all stages of the drug development process — including R&D, clinical trials, go-to-market strategy and regulatory compliance. With translation support, organizations can benefit from a strategic advantage that allows them to broaden their reach, as well as protect their organizations’ investments.
By utilizing translation and localization services, organizations can overcome the substantial language challenges associated with successfully placing pharmaceutical drugs into the hands of the patients in need.
Tools such as 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, these companies can then use their in-house team to focus on increasing their chances of profitable returns on pharmaceutical drug creation and innovation.
Research and development
Clinical trials — in which patients using proposed drug therapies and medical devices are studied to ensure there is medical effectiveness — are a critical part of the R&D process; however, recruiting patients, especially in foreign regions, can be a challenge.
Many US pharma companies are turning to emerging markets to conduct multiphase 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 documents used to recruit trial participants in their native languages.
By communicating with 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. An international translation partner can enable pharmaceutical companies to leverage both linguistic and regulatory validation through specialist networks. These specialists can perform cognitive debriefing, which includes testing instruments used to assess patient safety during a study, as well as regulatory validation that uses clinicians in-market to ensure all phrases on packaging are in compliance with local regulations.
Reliance on compliance
In addition to executing safe clinical trials, pharmaceutical companies must also take necessary steps to ensure regulatory approvals across all markets where the drug will
be sold. This can be another hurdle as differences in regulatory approval requirements from market to market can lead to duplicative testing and clinical trial requirements, delays in product approval and higher costs to manufacturers.
Many regulatory agencies struggle to keep up with the volume of submissions that need to be reviewed in a timely and consistent fashion, creating enormous backlogs, approval uncertainty and market access delays. There may also be concerns related to the security and maintenance of confidential business information (CBI), such as clinical data that must be submitted for approval.
Translating drug instructions and labels for each market with 100% accuracy is essential to regulatory compliance. Every word and phrase needs to be translated with zero errors since this can become a hazard for the patients.
With that said, translation at this phase is simply not within most drug companies’ area of expertise. Most organizations are turning to multilingual clinical labels, which is a best practice for end-to-end localization management. This increasingly popular strategy delivers quality localization while enabling internal staff to stay focused on core tasks. When using this strategy, translation solutions such as regulatory validation can best be implemented.
Many pharma companies are partnering with translation and localization providers to support them through this labor-intensive process. At this stage, the stakes for accurate translation are of extreme importance. Regulatory approval will be stopped if drug labels and dosage instructions are not correct, which can significantly impact the company’s bottom line. Partnering with translation experts can cost-effectively supplement the language-skill gap for pharmaceutical companies and assist them in achieving regulatory compliance as efficiently and accurately as possible.
To market, to market
When a company finally does bring a drug to market, they have successfully overcome the development odds. Yet the risk of achieving positive ROI to offset development costs doesn’t stop there.
Drug companies only have ten years to market their products unchallenged by generic brands and strategic, localized marketing efforts are crucial during this stage to ensure maximum revenue flow while on patent. Companies willing to invest millions of dollars in marketing need their campaigns to be constructed in a way that is effective, targeted and localized to resonate with diverse audiences.
For many pharmaceutical companies, entering foreign markets can be particularly challenging. Each country has its own unique regulatory, marketing and reimbursement environments as well as government policies. Therefore, the strategy must evolve across each location.
Translating marketing content is essential for pharmaceutical companies to reach customers around the world with content that is both engaging and 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.
Taking a worldview approach
With local governments continuing to increase healthcare budgets worldwide, the number of clinical trials and new products being developed across multiple countries will consistently grow. To succeed in this increasingly globalized industry, pharma companies must be mindful of regional differences that may impact adoption, as well as adhere to diverse regulatory and ethical compliance mandates that continue to develop.
Pharmaceutical companies must take into consideration the many diverse audiences they serve from drug development and planning, to trials and eventually bringing their solutions to market. By taking a worldview approach to new drug development, organizations can achieve greater profitability and success, while bringing lifesaving solutions to the people who need them most.