Sponsor, the primary contact for FDA, can propose an application for Project Orbis once topline results are available from the registrational clinical trial(s). Selection of applications for Project Orbis is coordinated by FDA, and initial queries received by RHA are referred to the FDA. Project Orbis expansion considerations include the addition of more countries and management of more complex applications.
Participating countries have signified a strong commitment for continuation and growth of the program. Across the program, the median time-to-approval was similar between FDA (4.2 months, range 0.9–6.9, N = 18) and the POP (4.4 months, range 1.7–6.8, N = 20). The median time gap between FDA and Orbis submission dates was 0.6 months with a range of −0.8 to 9.0 months. New molecular entities, also known as new active substances, comprised 28% of the received marketing applications. In the first year of Project Orbis (June 2019 to June 2020), a total of 60 oncology marketing applications were received, representing 16 unique projects, and resulting in 38 approvals. While FDA serves as the primary coordinator for application selection and review, each country remains fully independent on their final regulatory decision. Project Orbis leverages the existing scientific and regulatory partnerships between the various RHA under mutual confidentiality agreements. Current Project Orbis partners (POP) include the regulatory health authorities (RHA) of Australia, Brazil, Canada, Singapore, and Switzerland. Project Orbis aims for concurrent submission, review, and regulatory action for high-impact clinically significant marketing applications among the participating partner countries. Orbis Clinical will retain its brand name as a division of PharmaLogics Recruiting until the remainder of this year, at which point only the PharmaLogics brand will remain.įounded in 2003, PharmaLogics Recruiting maintains a US headquarters in Quincy, Massachusetts, and a European headquarters in Basel, Switzerland. It was acquired in 2017 by private equity firm Webster Equity Partners (formerly Webster Capital), whose healthcare staffing portfolio also includes Cirrus Medical Staffing, a national provider of travel nurse and allied staffing, and travel nurse staffing firm Emerald Health Services, which Webster acquired last year. PharmaLogics is a $13 million company it has 90 employees and averages nearly 400 placements per year.In 2019, the FDA Oncology Center of Excellence launched Project Orbis, a global collaborative review program to facilitate faster patient access to innovative cancer therapies across multiple countries.
The $15 million company averages 100 contractual assignments per year with 20 employees and two offices. Orbis Clinical was owned by Maxim Health Services.įounded in 2004 and based in Woburn, Massachusetts, Orbis Clinical provides onsite or remote teams for a range of services, including drug safety/pharmacovigilance, clinical operations, regulatory affairs, quality assurance, biometrics, medical affairs, and scientific/nonclinical.
The transaction closed April 6 terms were not disclosed. The acquisition enables PharmaLogics to provide all life science functions in both permanent and temporary placement. PharmaLogics Recruiting, a provider of recruiting solutions for life sciences companies worldwide, acquired Orbis Clinical, a life science contract staffing and consulting firm.
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