GaeaOÜ is an agile full-service CRO in Phase I – III, IIT in all of Europe, with partners in the USA and Australia Read more Agile full-service CRO Commissioned by Sponsors, Gaea Trial Acceleration identifies and addresses the issues at sites, that are blocking their enrolment Read more Trial Enrolment Accelerator The GaeaOÜ CEO will work in-house at a company to define the clinical strategy and execute it with the company’s choice of CRO Read more Clinical Trial Planning
clinical
Clinical Services
- Phase I-III and IIT in all Europe, Australia and USA with partner.
- Project Management including all providers
- Site Feasibility
- Site Selection
- Regulatory
- Contracts
- Study Start-Up
- Screening Eligibility Assessment
- Consent, and Assent in incapacitated patients
- Monitoring
- Biostatistics
- CRF design, Data Management
- Safety Management
- Central and PK Labs Management
- Drug Safety Monitoring Board (DSMB | IDMC) set up and Management
- Medical Monitoring
- Quality Assurance
- Clinical Reports
- Investigator Meeting Organisation
- Patient Recruitment
Nigel Goodman, CEO: some work history that led to Gaea
I grew up in commercial in Roche big pharma for many years. I was committed and passionate for the success of the company, but I experienced at first hand the issues from suboptimal clinical development.
In my experience through the 80’s and early 90’s in Roche HQ, oncology clinical trials were not well designed and executed, “compassionate use” was resultant regulatory dossiers were poor and so products were too late to be early in the drug class. Roche Affiliates were despairing of the HQ output. The result was obvious in declining revenue and the company was slipping down the global rankings and risked exiting the Top 10.
In my last four years in Roche in the early 90’s, when Amgen was a partner, I proposed that we move from their silo-based drug development to the principles of the “Thriving on Chaos” (Tom Peters) through creation of a venture team.
I was given Pharma Board approval and led what we named the Amgen-Roche Venture Team to bring Neupogen® (Filgrastim, G-CSF) from end of Phase II to all Roche and Amgen markets
In four thriving- on- chaos- years, the small team worked in a very complex partner relationship: Amgen HQ and affiliates – Roche HQ – Roche affiliates, taking filgrastim through two Phase III trials, through production in Roche, through regulatory as one of the first drugs through the centralised EU regulatory process, through pre-commercialisation against GM-CSF, and through national regulatory with 80 national launches by launch year plus four years .
Neupogen has changed the delivery of conventional chemotherapy, it is revolutionising high-dose chemotherapy, and made peak sales of $4 billion a year, to be a driver of the growth of Amgen.
We had to set the goal of being first CSF to market that could not be missed, and with the addition of the highest quality at the core of all we did, as to hit the time goal and fail on quality or not meeting market need would be a fail.
We were budget rich and resource poor. We worked as a small cross-functional team: everyone who joined made a personal commitment to the team as it was not about our own enrichment – we avoided working in a box called a job description – we worked without a CRO – we used experienced resources we could contract.
So, what has changed?
COVID 19 has shown that we live and work in ever more volatile, uncertain, complex and ambiguous times.
There is still the fashion for patient centricity, but many protocols are of necessity with tightly defined inclusion criteria.
Despite ubiquitous outsourcing, and with many companies selling enrolment database solutions, increasing numbers of trials enrol slowly and with high patient dropout rate”.
Despite only nine CROs running ~60% of all outsourced clinical research, there isn’t an obvious increasing efficiency in the development process.
Many trials are competing for a limited number of patients…
It’s an environment of rapidly increasing numbers of clinical trials chasing few patients willing to join more than 5000 trials were open with immuno-oncology drugs (as mono therapy and combination immune oncology) in 2020