The Future of Vaccine Research: the Evolving Global Landscape
In just over 2 years the vaccine development window has gone from 8-10 years to 260 days. Now the industry is looking at a 60-day turnaround target. Post-COVID-19 the sector is positioned to rapidly develop therapies across almost all therapeutic areas including infectious diseases, oncology, rare diseases, CNS, autoimmune diseases, and more.
Novotech recently brought together leaders in the vaccine sector to share lessons learned and what the future holds for vaccine development.
The panel comprised:
- Sushant Sahastrabuddhe, Associate Director General with the International Vaccine Institute, Korea.
- Paul Griffin, infectious disease physician and Clinical Director of Infectious Diseases at Mater Health Services, and Associate Professor at the University of Queensland Medical School.
- Babaji Yadav, Senior Consultant with Novotech Drug Development Consulting.
- Jenny Arellano, Novotech’s Director of Clinical Services in the Philippines.
The panelists agreed that COVID-19 has been the catalyst for massive change in vaccine development including rapid global trials, FDA approval processes, and advanced manufacturing solutions. Most importantly many of these new processes have been permanently adopted by Governments and regulatory authorities making new vaccine development faster and more responsive to health challenges.
They also said that the rapid development of mRNA technologies has been key to accelerated vaccine development, saying the plug-and-play approach offers a future of exponential growth at rapid speed and low cost.
The panelists noted that the future is already seeing new delivery systems including intranasal and patches, many of which offer at-home administration.
Partnerships in Development
A priority for vaccine development according to Jenny Arellano is the careful selection of partners with a strong footprint across the geographies, and expertise bandwidth to support the entire drug development program on a local and global scale.
Permanent Changes at Regulatory Authorities
Dr. Sushant Sahastrabuddhe said: “One positive point that we have seen during COVID-19 is the way the regulatory agencies showed flexibility in terms of reviewing the protocols, giving clear guidance to the manufacturers, developers, and governments, and having a very clear strategy in terms of how and when to license the products.”
Jenny Arellano said: Like the rest of the world, Asia Pacific regulatory bodies have also responded positively to rapid vaccine review processes. “The regulatory and ethics bodies quickly put an infrastructure for continued service to review clinical trial applications during the pandemic. Moreover, for COVID-19 in particular, regulatory authorities in Asia Pacific have actually opened the doors for rapid review and put in place, technical experts to support the review process.”
New approaches to clinical trials – remote monitoring
Dr. Sushant Sahastrabuddhe said until last year, “almost 75% of our research was on COVID-19 vaccine. Other vaccines got deprioritized. Now I think we are coming back to the vaccine priorities. We are diversifying, again on the diseases that are important for global public health.”
One of the new approaches to trial design that we will see more of in vaccine development is remote monitoring, she said.
“There are some sponsors, and some CROs like Novotech, who are using this option. I think during COVID-19, we realized that we can do much more by managing things remotely, as much as we were doing before.”
New Delivery Systems
Dr. Paul Griffin said: “I really think intranasal vaccines are going to be an important part of not only what we do with COVID, but other respiratory pathogens as well. There are some really good approaches that are progressing well through clinical trials with intranasal vaccines.
I also think that vaccines into the skin via patches are going to be a really important part of our strategy moving forward. They have a lot of really interesting properties including being stable at room temperature for long periods of time.”
Dr. Babaji Yadav said: “Platform technologies can certainly be used to leverage some of the clinical safety and efficacy data established with your prototype vaccines to support or accelerate the clinical development of your modified vaccines or subsequent vaccines. Platform technology is basically a machinery or a tool that effectively delivers an antigen, and enhances its immunogenicity.
From my experience here at Novotech where I am currently working with a number of clients, we have seen this approach being very well-accepted by regulatory agencies around the globe, for mRNA vaccines, DNA vaccines, even personalized cancer vaccines that used plasmid DNA or lipid nanoparticles as a platform technology.
USFDA actually also has published a guidance on public health emergency use of vaccines where they have stated that if you are developing a modified form of vaccine against a new viral strain, and as long as you keep the manufacturing process the same, then you can submit an abbreviated data package with just the pharmacology and immunogenicity studies with your modified vaccine without having to repeat concepts of toxicology studies, which may take time and it costs some money as well.”
Accelerating trials – Patient Recruitment
Jenny Arellano said: We know that the Asia Pacific region has more than 4 billion people, which represent 60% of the world’s population. There’s also a large number of treatment-naive participants or individuals. If you combine this with the presence of a heterogeneous population, it makes these characteristics attractive for vaccine trials. Couple this with also the research environment for vaccines requiring a large study population as well as a rich trial experience in these regions.
The region also offers a high success rate in recruitment delivery, high retention of participants in the clinical trial, and as such, high compliance to protocol-required visits. In parallel, the improvement in the regulatory landscape and increasing investment in trial infrastructure and the lower cost of running clinical trials, are all contributory factors in the attractiveness of the region for vaccine trials.
Novotech is the leading Asia Pacific-centered biotech CRO with global execution capabilities. Novotech has experience in ~100 vaccine trials across all phases of development and has established strong site collaboration with over 800 vaccine trial sites globally. Vaccine trials in Asia Pacific have grown 2x faster than the ROW at 15.7% CAGR between 2018 and 2022 and contributed the major share of ~40% of global vaccine studies from 2018 – 2022. China, Australia, India, Japan, and South Korea are the top locations for vaccine trials.
Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US, and Europe. Novotech has over 3,000 staff globally and 34 office locations across the US, Europe, and Asia Pacific.
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