Project Orbis is an initiative launched in 2019 by the Oncology Centre of Excellence at the FDA (US Food and Drug Administration). The goal of the initiative is to leverage the existing scientific and regulatory partnerships between international regulatory authorities to provide a framework for concurrent submission and review and facilitate faster patient access to innovative cancer therapies with a high medical need across multiple countries.
The Countries currently collaborating with the FDA in Project Orbis are Australia, Canada, the UK, Singapore, Switzerland, and Brazil. During the first year, (June 2019 to June 2020), a total of 60 oncology products were reviewed resulting in 38 approvals.
Project Orbis is not an approval path that a company can apply for. Instead, the FDA, the coordinator of the initiative, selects a promising novel oncology program and invites the company to participate. When this happens, even if you are taken by surprise, you can still be prepared.
NDA has supported several companies through their Project Orbis international filings and during this webinar Claudia Reichle will provide a closer look at Project Orbis and what you should think about if you are offered the possibility to take part.
This webinar will be of special interest for any company developing innovative oncology products aiming for accelerating their market access or approval.