Nuventra is committed to helping bring new medicines to patients in need and providing the drug development community with relevant information regarding COVID-19. During a global pandemic, it is critical for organizations across the world, especially in the pharmaceutical and biotech industries, to work together to ensure public safety, contain the spread of the disease and develop vaccines or therapies that target the disease. If you have any questions or comments on any of our panel discussions, blogs, or services, please contact us.
Panel Discussions | Drug Development During COVID-19
Panel Discussion Part 1
During the first 45-minute session, industry experts discussed:
- Strategies for virtual drug development
- An overview of current guidances from the FDA
- Real examples of how drug development programs are adapting
- How the industry may be impacted by a global recession and social distancing
Panel Discussion Part 2
During the second 1-hour session, industry experts discussed:
- How labs are adjusting to the crisis
- FAQs from our clients and colleagues
- Regulatory impacts from a former FDA reviewer
- The latest impacts on ongoing and planned clinical trials from a Phase 1 site
Panel Discussion Part 3
During the third 1-hour session, industry experts discussed:
- Obstacles faced by many Sponsors when developing treatments for diseases outside of COVID-19
- Impacts of the pandemic on drug development programs, directly from Sponsors
- Trends our consultants are seeing in development from various clients
Strategies to Keep Drug Development Moving During COVID-19
With many studies now paused, cancelled completely, or in the early stages of restarting, this time offers a rare opportunity to re-evaluate your program and to pivot in the direction your data are suggesting. Here we will highlight strategies to help minimize delays and keep your program moving.
Learn how Nuventra can help you navigate these uncertain times and keep your program on track.
Developing Vaccines for the Coronavirus Disease (COVID-19) Outbreak
The question on everybody’s mind: when will we have a vaccine for COVID-19? Our latest blog post discusses the virus as well as a potential timeline for two vaccines and one antiviral therapy currently in development.
Nuventra is committed to do our part in fighting this global pandemic by helping Sponsors bring their COVID-19 vaccines and therapies to the general population as soon as possible.
Global Impacts of COVID-19 on Drug Development
Drug development has not been spared from the negative impacts of the COVID‑19 pandemic. We have assembled this post to highlight how the current pandemic is shaping the future of drug development around the world.
During this difficult time, it is important to consider what you can do now to strengthen your drug program for the future. Nuventra’s team of experts are here to support your needs and any activities related to strengthening your development program.
How Technology Makes Virtual Clinical Pharmacology Phase 1 Studies Possible
With the current COVID-19 pandemic, drug developers and researchers are searching for drug development strategies that limit human contact. For certain drugs and certain types of Phase 1 studies, a “virtual” Phase 1 trial might be possible.
Here we examine current solutions that could allow Phase 1 clinical pharmacology trials to be conducted as either partially virtual or completely virtual trials.
Understanding Vaccine Development & COVID-19
Scientists are continuing to search for a vaccine that can reliably prevent COVID-19. Discovering a vaccine to combat the virus is only part of the puzzle; large-scale production, ensuring proper dosing for efficacy, and addressing potential safety concerns remain significant hurdles.
Learn more about vaccine development for the virus, how vaccines work, and the importance of dosing and efficacy.
Statement in Response to COVID-19
As a company committed to helping our clients bring new medicines to patients in need, we have been closely monitoring the global spread of the novel coronavirus COVID-19.
At Nuventra, we are prioritizing the health and safety of our employees and clients. We are also committed to helping bring vaccines and treatments for the novel coronavirus to market as quickly as possible. Read our statement here:
How Can We Help?
An important resource Nuventra offers is bandwidth. With increased urgency to address the current outbreak, we have services to offer immediately. We can quickly support the development of a vaccine or treatment – from data analysis and pharmacometric modeling to help identify dosing paradigms to writing, programming and regulatory strategy.
We are offering the following services free of charge for any drug development program intended to prevent or treat the novel coronavirus:
- Review of clinical protocols
- High level drug development gap analysis
- General 30-minute Q&A to address any roadblocks or issues in the development of a vaccine or treatment with Nuventra drug development professionals (including former FDA reviewers)