Richard is a regulatory and development Consultant. Richard consults with clients on strategic regulatory issues facing their drug and biologic development programmes, with regularly stakeholder interactions to facilitate accelerated patient access. Richard has 30 years’ experience in development having worked in the biopharmaceutical and CRO industries and most recently leading Huron Life Sciences regulatory consulting.
Prior to Huron, Richard was a regulatory consultant for CROs PPD and Gregory Fryer Associates, managing global clinical trial submissions and lifecycle strategy with regular regulatory agency interactions. Richard was senior programme manager at SRA Global Clinical Development (formerly Origin Pharmaceutical Services and Constella), where he was responsible for leading global development programmes, providing strategic insight on early stage (nonclinical/clinical/CMC) development and quality management. Richard has also managed teams at Actelion and Axovan (Basel), and at Chiroscience (later to become Celltech/UCB).
Richard has a BSc (Hons) in Pharmacology and MSc in Toxicology and professional memberships include TOPRA where he is a consultant editor for Regulatory Rapporteur and has also authored 20+ peer-reviewed publications including patents.
Experience
- Providing strategic insight and operational regulatory support for development programmes
- Assessment and application of early global access strategies for products in rare disease and unmet patient need to accelerate authorisation and market access
- Leading high stakes interactions and negotiations with regulatory agencies (and HTA bodies). Representing the client at Scientific Advice (including US PIND and EU CHMP) strategy to implementation (liaising with the health authorities, drafting questions and creating briefing documentation)
- Designed and implemented development plans, including project scheduling, identification of key deliverables, study feasibility, risk analysis, contingency plans, setting milestones and budgets
- Leading global clinical trial submissions (first time applications and maintenance). Creating and gathering essential documents, negotiating with local affiliates and tracking health authority (and ethics committee) submissions to approval
Expertise
- Leading global phase I and III regulatory submissions strategy and implementation for the first biosimilar monoclonal therapeutic antibody (CT-P13) to gain EU Market Approval
- Managing regulatory submissions (orphan drug designation, protocol assistance and CTAs) for first novel gene-based therapy (sitimagene ceradenovec) to enter clinical development
- Regulatory supporting for a wide-range of start-up and SME biopharma including providing gap analysis with recommendations to successfully progress the project to FIH clinical trials, and then on through POC development to commercialisation
- Technical knowledge across various therapeutic indications, routes of administration, small and large molecules to facilitate lifecycle progression
- Internationally recognised as a compassionate use/managed access operations and strategy expert
Selected Clients include:
- Abbott Nutrition
- Actinium
- Alexion
- Apex
- Ark Therapeutics
- Autifony
- AZ
- BMS
- Celltrion
- Celtic Therapeutics
- Eisai
- Ferring
- Genmab
- Gilead
- Hermo Pharma
- Millennium
- Rhythm Pharma
- Sarepta
- SOBI
- Takeda
If you would like to speak to Richard you can contact andrew.burns@georgejamesltd.com
Free services supported by paid for services. If you or any of your contacts are considering engaging a recruiter, consultant or trainer we will welcome the opportunity to be considered.