Introduction

Poniard Pharmaceuticals, a leading biopharmaceutical company specializing in oncology treatments, faced a significant challenge when it developed a new drug to treat kidney cancer. The innovative treatment contained precious metals and involved complex manufacturing processes. Poniard was seeking FDA approval of the drug, but because it was working with various providers of raw materials and equipment – including suppliers based in Germany – it needed help translating documentation to obtain the desired regulatory authorization in the United States. The company needed a reliable translation provider that could handle the entire translation process and help with its submissions to the FDA.

This case study explores how the partnership with GLS, a translation company specialized in pharmaceutical and other life sciences translations, enabled Poniard Pharmaceuticals to achieve its objectives with timely translations of technical documents, an end-to-end translation process, and 24/7 support.

Background

Poniard, a pharmaceutical company based in Seattle, was developing an innovative oncological therapy to treat kidney cancer. This form of cancer is one of the top 10 most common cancers in the United States, with more than 76,000 new cases diagnosed each year[1]. As part of its development effort, Poniard needed translations of documentation provided by German partners that supplied the company with key materials and equipment necessary for the development and production of its new treatment. However, Poniard had never worked with a translation provider before and was therefore not familiar with the translation process. Given the importance of its work, it was essential to find a partner that would be able not only to provide high-quality translations, but one that could offer end-to-end support for the entire translation process.

The problem

As Poniard ramped up development of its oncological treatment, it realized it needed to have a significant amount of documentation translated from German into English for submission to the U.S. Food and Drug Administration (FDA). The translations were critical to the company’s efforts to obtain approval for the drug. However, Poniard needed expert assistance with the translation process.

 

Poniard’s primary requirements included:

 

1. Accurate translation of complex documentation: Poniard’s success hinged on precise translations of the German documentation provided by suppliers of key materials and equipment used in the development and production of its treatment.

 

2. Adherence to industry-specific terminology: The pharmaceutical industry uses complex and specific technical terminology. It was imperative for Poniard to partner with a translation company that had subject matter expertise and in-depth knowledge of pharmaceutical terminology.

 

3. Timely delivery: Poniard’s development timeline was tight. It needed a translation partner capable of delivering high-quality translations with short turnaround times to ensure the success of its new drug.

The solution: a strategic partnership with GLS

After learning about GLS from an employee who had previously worked with the Seattle-based translation company, Poniard Pharmaceuticals met with the GLS team. GLS gave a detailed presentation of the translation process and how we could help Poniard. Poniard was impressed with GLS’s professionalism and chose to partner with us.

 

Poniard and GLS worked very closely together, with GLS serving almost as an in-house translation department for the pharmaceutical company. They came to rely on us for our decades of expertise in pharmaceutical translation. The partnership between Poniard and GLS was designed to address the specific challenges the pharmaceutical company faced as it developed its drug and sought FDA approval for it. Among other things, GLS helped Poniard in the following ways:

 

1. Specialized translation team: GLS had a team of linguists with expertise in the pharmaceutical industry, and specifically with oncology. The team’s in-depth knowledge ensured accurate translations of documents while adhering to industry-specific terminology.

 

2. Development of glossaries: Consistent terminology is essential, especially when complex technical terms are involved, as is the case in the pharmaceutical industry. GLS created a filterable, exportable, client-specific term base from scratch, ensuring the use of correct terminology in the English translations of the technical documentation generated by Poniard’s German suppliers.

 

3. Creation of the end-to-end translation process: As Poniard hadn’t established a process for handling foreign-language documentation yet, GLS provided a complete solution that met all of the pharmaceutical company’s needs. GLS took on all aspects of the translation process, from project management and translation to quality control and delivery. In this way, Poniard was able to focus entirely on developing its treatment, secure in the knowledge that its translations were in good hands, and its submissions to the FDA would be professional and high-quality.

 

4. 24/7 support: GLS was very responsive to Poniard’s needs, meeting with the company in person when necessary. Leveraging its extensive network of trusted freelancers, GLS was able to work on Poniard’s translations 24/7.

The results

The partnership between Poniard Pharmaceuticals and GLS yielded significant benefits and excellent results. This included:

 

• Accurate and compliant translations: GLS’s team of specialized translators delivered accurate and compliant translations of all documentation. This precision led to faster and more compliant regulatory submissions, ensuring a smoother approval process for Poniard.

 

• Successful quality process: GLS developed the entire process for handling translations at Poniard, which allowed the pharmaceutical company to maintain its focus on developing its drug treatment. The quality control process ensured that translations were accurate, compliant, and consistent.

 

• Close partnership: The successful collaboration with GLS led to a close partnership between the two companies. As Poniard Pharmaceuticals developed its treatment, GLS continued to support the company’s language needs, offering consistent quality and timely deliveries.

Conclusion

The strategic partnership between Poniard Pharmaceuticals and GLS exemplifies how effective language solutions can overcome complex linguistic challenges in the pharmaceutical industry. GLS’s specialized team of translators, project management expertise, and rigorous quality control process facilitated Poniard’s development of its oncological treatment.

With precise and compliant translations provided by GLS, Poniard successfully navigated the translation process and was able to focus on its research and development efforts. The success of this collaboration demonstrated the indispensable role of a reliable language partner in achieving successful results in the pharmaceutical industry.

 

How can GLS help you?

Launching new products can be a difficult process, especially in a complex field like the pharmaceutical sector. However, having a language partner that understands the intricacies of the materials can help overcome hurdles. GLS can provide you with the same benefits that it offered Poniard Pharmaceuticals – a deep understanding of complex technical material, fast turnaround times, and the highest level of quality and accuracy. Contact us to see how we can help you with your next translation project.

 

 

[1] https://www.urologyhealth.org/urology-a-z/k/kidney-cancer