Getting Ahead in mRNA Vaccine Development with an Experienced CRO Partner
mRNA technology is promising, and working with a partner experienced in mRNA-based vaccines and therapeutics can help accelerate your clinical development in an ever-changing competitive landscape. Keep reading to learn the benefits of having a proficient clinical development partner on board.
mRNA technology shows great promise for preventing and treating a wide range of indications, including infectious disease, cancer and metabolic disease. This flexible platform is in its infancy in terms of the number of approved products; however, mRNA is expected to dominate the vaccine space in the coming years thanks to its streamlined development process and demonstrated success in the response to COVID-19.
mRNA technology is exciting, and its products hold great promise in the field of public health. But with new technology comes unique regulatory considerations, which are complex and require direction from a partner that is proficient in bringing these products to market.
Working with a partner experienced in mRNA-based vaccines and therapeutics offers access to deep expertise that will help accelerate your clinical development in a rapidly evolving and competitive market.
The benefits of operating with an innovative and experienced CRO partner
Working with a novel technology can create unexpected demands at any stage of development. A dedicated contract research organization (CRO) partner with a track record of support for innovative products will approach these challenges with an experienced and forward-looking mindset. They are effective guides for both vaccine and drug developers and government leaders.
An experienced CRO partner can offer a deep bench of experts with technical expertise in clinical and nonclinical development, regulatory processes, and study execution.
- Safety profile characterization: A CRO with long-standing experience in safety oversight for mRNA vaccine trials allows for trend analysis over time and better characterization of safety profiles for these products. Additionally, this experience helps inform future trial design from a safety perspective.
- Regulatory consultation: Understanding regulatory requirements and combining the need for innovative clinical development approaches can have a significant impact on your development program. Partnering with a CRO that has extensive knowledge of global regulatory requirements — and experience integrating that knowledge into an innovative approach from the early onset of a clinical development program — will have a lasting impact on your program, resulting in faster development timelines and approvals.
- Nonclinical consultation: Development of mRNA vaccines requires specialized expertise in designing nonclinical programs to support expedited clinical development and, ultimately, market approval. A team of pharmacologists and toxicologists with experience designing and managing nonclinical studies and awareness of evolving regulatory guidelines and agency expectations is critical for success — not only for first-in-human studies, but throughout the development process and registration.
- Chemistry, manufacturing and controls (CMC) consultation: Using a platform technology for the development of mRNA vaccines provides an efficient means of production without arduous manufacturing and testing processes experienced with traditional viral vector- or protein subunit-based vaccines. Given the unique nature of the product characteristics, manufacturing process and potential for rapid deployment (as seen during COVID-19 mRNA vaccine development), developers will need to overcome significant regulatory and pre-clinical testing challenges. To this end, CMC consulting with an experienced CRO partner can help define a stable formulation and relevant controls of manufacturing processes, which are essential for product approval.
- Specialized storage and handling considerations: Handling and transport of vaccines stored at ultra-cold temperatures requires careful logistical planning and the use of specialized equipment at the site level. A CRO partner with a proven track record of logistical expertise is critical to successfully developing products with unique transportation and storage considerations.
Working with a partner familiar with end-to-end development of mRNA vaccines better positions sponsors for success, ensuring rapid timelines are met at all stages of clinical development and accurate advice is provided to overcome manufacturing and regulatory hurdles.
Our vaccine capabilities and experience by the numbers
- More than six years of mRNA study experience across Phases I-III, including more than 68 mRNA studies — the vast majority being vaccine trials.
- More than 30 years of vaccine experience, from pre-clinical to post-licensure.
- 2,000+ staff with vaccine experience, and the first CRO to stand up a dedicated vaccine unit.
- Over 220 vaccine studies completed in the past five years, encompassing more than 127,000 participants.
- Dedicated vaccine sciences laboratory with more than 30 years of development and testing of vaccine assays, over 600 scientists, a dedicated R&D team and 90,000+ square feet of laboratory space.
- Vaccine network of 1,000+ priority network sites in 90 countries and 32 depots across the globe for product and logistics management.
- Near real-time data access and trend analysis to enable proactive study management.
The PPD™ clinical research business of Thermo Fisher Scientific provides end-to-end, full-service vaccine development capabilities and is recognized as a market leader in the mRNA technology space. We accelerate mRNA vaccines and therapeutics from discovery through clinical development and commercialization, with a comprehensive portfolio of products and services proven to meet critical process, scale, quality and regulatory needs.
Our extensive experience in the vaccine and mRNA space has imparted in-depth knowledge of each step of clinical development, from research and discovery to post-approval studies. This experience translates to advanced knowledge of mRNA vaccines and therapeutics, including safety oversight and trial design, clinical and nonclinical regulatory consulting, and CMC consulting, as well as commercialization and production considerations. With this advanced experience, we guide sponsors while expediting and accelerating their clinical development.
Successful clinical development also requires mutual trust between thoroughly invested partners, which is key to a winning sponsor-CRO relationship. We pride ourselves on our collaborative, can-do mindset that proved critical to bringing one of the first mRNA vaccines to market.
Spotlight: Strategic Collaboration with Moderna Therapeutics
In 2020, Moderna publicly stated that Thermo Fisher Scientific’s PPD clinical research business, its dedicated CRO partner, was “essential to the successful execution of the COVE study” that resulted in authorization of the Spikevax® COVID-19 vaccine. This culminated in the PPD clinical research team winning consecutive ViE Awards for best CRO in 2021 and 2022, and the Citeline Award for best clinical research team, alongside Moderna, in 2022. The nature of this trusted partnership allowed for seamless communication and execution between established teams.
In February 2022, Thermo Fisher Scientific announced a long-term strategic collaboration with Moderna to continue expanding manufacturing capacity and applications of mRNA technology. We will continue to support Moderna’s mRNA platform and pipeline, further deepening our expertise in the mRNA space.
Speaking from experience
When choosing a CRO partner, companies must evaluate multiple factors, including trust, specialized technical and regulatory knowledge, and clinical trial infrastructure. Working with a development partner that has proven experience in the space of mRNA vaccines provides an edge to optimize all these factors at once.
An experienced partner like the PPD clinical research business of Thermo Fisher Scientific enables biotech, pharmaceutical and government leaders to save time and resources when developing mRNA-based vaccines and therapeutics, and, when necessary, rapidly address unmet or urgent public health needs.
Additional contributors: Brendt Stier, senior consulting director, Gary Klaich, director, regulatory affairs, Duu-Gong Wu, executive director, regulatory affairs, and Elena Whitley, senior director, regulatory affairs
Check out our experts’ discussion in American Pharmaceutical Review on how mRNA technology has ushered in an exciting new chapter of medicine.