Biopharma Manufacturer Enhanced R&D & Clinical Study Procedure Efficiencies for Fast-Tracking Drug’s Availability
New York, NY, January XX, 2021 – The factors contributing to the FDA’s authorization of the BioNtech COVID-19 vaccine are many (LINK TO BIONTECH PRESS RELEASE), but much of the groundwork for its success was the company’s adoption of a range of new clinical development process enhancements that transformed its readiness to be able to create the vaccine at a far accelerated pace. Biopharma industry consulting firm TriRadial Solutions (www.triradialsolutions.com) collaborated with BioNTech to get them “rapid vaccine development-ready”.
BioNTech recognized that standard clinical drug development processes would not be sufficient to create and produce massive quantities of a vaccine in months for a devastating, quickly spreading global pandemic, so starting in early 2020 they worked with TriRadial Solutions to identify and implement clinical operations changes that would maximize the company’s ability to bring an effective vaccine to market as quickly as possible.
“We knew we had the scientific expertise to potentially produce a COVID-19 vaccine, but we needed to make sure that every aspect of our clinical work protocols and organization was at optimal preparedness to achieve that goal for a new study and trial model timetable that was never attempted before”, said __________, of BioNTech. TriRadial quickly identified clinical development process changes we needed to make to ensure we would meet vaccine study and production schedules needed to get control of the pandemic”, added _________.
TriRadial Solutions analyzed every aspect of the BioNTech clinical operations environment and recommended and helped implement best practice clinical productivity procedures that included: improving integration of U.S. and Europe clinical functions; securing new cost and oversight efficiencies with contracted CROs and vendors; implementing new drug development technologies and project management processes; recruiting additional domain expert clinical development resources. Together, these measures helped facilitate the company’s COVID-19 vaccine to market.
“It was an honor for us to have had the opportunity to work with BioNTech to help them remove any operational challenges to their laser-focused mission to bring a vaccine to market for combatting this COVID-19 pandemic”, said Geoff Garabedian, Founder and President, TriRadial Solutions. “Our collaboration will always be a highlight of our clinical process and operational organization optimization work helping biopharma enterprises around the world make the next therapy breakthroughs, “added Garabedian.
About TriRadial Solutions
TriRadial Solutions works with early-stage, small and mid-sized biopharma companies around the world to develop growth strategies and design people, process, and technology solutions to improve productivity. The firm’s metrics and data visualization solutions provide increased transparency to performance levers and help deliver predictable results.
TriRadial Solutions offers core/non-core assessments, global sourcing models and visualization tools that help organizations capture cost savings and access to innovations through strategic partnerships, while ensuring the transparency and oversight needed for success. The firm also provides targeted solutions that enhance regulatory compliance, while balancing productivity needs and the reality of operating in today’s highly outsourced environments.