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Big Pharma clinical R&D group wants FDA and EMA involvement

By Gareth Macdonald , 26-Sep-2012

Big Pharma group TransCelerate BioPharma plans to work with regulators and academics to address the bottlenecks that slow the clinical development of biologic drugs.

The organisation – whose members include Abbott, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, GSK, J&J, Pfizer, Genentech and Sanofi - was launched at a US tradeshow last week with the aim of speeding up the clinical research process.

In an email to Outsourcing-pharma.com interim CEO Garry Neil, formerly Corporate VP, Science & Technology, Johnson & Johnson, said: “Five initial projects have been selected for funding in the area of clinical study execution.”

These are: the development of a shared user interface for investigator sites; the mutual recognition of site training and qualification; work on a risk-based monitoring; clinical data standards; and a system for ensuring the supply of comparator drugs.

Outsourcing-pharma.com asked Dr Neil whether the industry needs organizations such as TransCelerate, given that all drugmakers want to develop products as safely and quickly as possible already.

Neil responded that: “There is widespread alignment among the heads of research and development (R&D) at major pharma companies that there is a critical need to substantially increase the number and quality of innovative new medicines, while eliminating inefficiencies that drive up R&D costs.”

He cited the group’s broad industry participation and funding as advantages, adding that the ability to standardized approaches to clinical trials of biopharmaceutical drugs will increase efficiency and benefit the industry as a whole.

We also asked if TransCelerate plans to involve regulators in its work on the basis that the differing rules governing clinical trials around the world can significantly extend timelines and slow the development process.

He said the group “will build on existing industry collaborations by facilitating involvement of industry alliances (CDISC, C-Path, CTTI), regulatory bodies (FDA, EMA), CROs and academic associations as appropriate.”

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