Bob Clay established his own regulatory consultancy practice through Highbury Regulatory Science in 2014. Prior to this he was VP Global Regulatory Affairs at AstraZeneca with responsibility for oncology, infection and personalised healthcare. He is a regulatory strategist with more than 30 years' experience in drug development.
Highbury Regulatory Science provides consulting support to small and mid-size growing biotech companies on regulatory and development strategies across a range of therapy areas and regions. We support programmes in new drug development, devices and diagnostics. We also provide management consultancy and board advisory services on organisational development and outsourcing key regulatory activities.
We have offices in London, Manchester and Dublin - but work with companies across the world - see Locations
Bob Clay presented at the Bionow Oncology & Precision Medicine Conference on November 15th 2023 on Regulatory Considerations for Precision Medicines for Rare Diseases
Bob participated in the TOPRA Summit in London on May 23rd 2019
Bob Clay was a presenter and panelist at an event organised by Hyper Recruitment Solutions - HRS on "Quality and Regulatory Considerations for UK Pharma/Biotech"
Bob Clay chaired the TOPRA CRED Navigating European Regulatory Procedures 22-23 March 2018, Utrecht and 12-13 March 2020, London
Bob Clay presented on "Novel clinical trial design and technology impact on regulatory advice and shape development of new medicines" at the Adaptive Designs in Clinical Trials meeting presented by SMi in London on April 9-10th 2018
TOPRA delivered training programmes at the Malta Medicines Authority in March for regulatory professionals. Bob Clay led several sessions on the one-day "Essentials" and two-day "Introductory" courses.
Check out our papers and conference presentations on our News page
Over 2022-23, we have supported a client in the submission of paediatric plans in the US and EU; and submission of their first phase 3 studies via the EU CT Regulation and meetings with regulators in Japan and China, leading to the successful start of a global phase 3 programme. We also supported the same client in fundraising activites to enable the development programme to progress towards marketing authorisation.
In 2021, we have supported various meetings with regulatory agencies, including FDA, MHRA and PEI; a new IND submission; a successful End of Phase 2 Meeting; EMA Scientific Advice; an MHRA Innovation Passport designation; the first approval of a novel antiviral; submission of a new Marketing Authorisation Application in the UK; and also various mentoring assignments with startup companies.
In 2020, we supported the submission of a marketing authorisation application for a novel antiviral; initiation of several clinical studies in various therapeutic areas, including potential SARS-CoV-2 treatments; a Paediatric Investigation Plan; a pre-IND and other FDA meetings; an EU Scientific Advice Procedure and various national agency meetings for clients across a range of therapeutic areas.
During 2017, two clients received positive CHMP Opinions - we provided support to the submission development and responses to questions raised during the review.
Following our preparation and support for a pre-IND meeting, our UK-based client successfully opened their first IND. We have supported continued interactions with FDA completing the end of phase 2 meetings and commencing phase 3 studies in 2020.
A US-based start-up recently opened its first IND and gained an orphan designation with our support.
We have supported clients in three other pre-IND meetings in different therapeutic areas at FDA during 2016-7.
Another client completed an FDA end of phase 2 meeting and plans to initiate Phase 3 studies in the second half of 2018.
Talk to us about the role of regulatory meetings in your development programme. Since 2017, we have managed IND amendments and following completion of the phase 1 study supported the design and submission of a phase 2 study to the IND. We have also led various meetings with regulatory agencies.
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