David, a scientist and senior manager by background, is an experienced pharmaceutical development and CMC consultant. David has a comprehensive knowledge of scientific, commercial and pharmaceutical development within the Bioscience and Pharmaceutical industry. David understands and has practical experience of MHRA, EMA and FDA regulatory processes.
David has extensive technical and business development experience acquired through the successful management of product research, development programmes and the manufacture of finished product.
He has been providing consulting service since 2007.
His services Include:
- Pharmaceutical Development, acting as Subject Matter Expert in the development and manufacture of small molecules and providing operational management of CMC activities. This includes managing all development activities, formulation, analytical method development, validation, stability studies and formulation, through to and including Phase lla clinical trials.
- Academic Liaison and Innovation Management, identification and evaluation of academic research projects focusing on NCE potential. Development of new drug candidates through to “proof of concept”.
- Pre-formulation and formulation development up to pilot plant manufacture within a GMP environment and production of clinical trial supplies to annex 13 of the “Orange Guide”.
- Patent portfolio management.
- Contract Manufacturing Organisations, identify and collaborate effectively to drive development.
- Identification and audit of CRO’s. Scale up chemistry, clinical trial supplies, toxicology and safety, analytical method development, stability trials.
- Technical transfer management
Clients include:
- Gaia Biotherapeutics Ltd
- London Pharma Ltd
- Mitovie Ltd
- Calculus Capital Ltd.
- Exova Ltd.
- Insense Ltd,
- Pharmasol Ltd
- University of Surrey Clinical Research Department.
Assignments activities have included scientific, technical and development advice and consultancy support related to drug development, independent scientific due diligence, interim management and the preparation of Investigational Medicinal Product Dossier documentation.
David possesses excellent communication, influencing and interpersonal skills and demonstrates an ability to work cross-functionally at all levels.
David is a Fellow of the Royal Society of Chemistry and a visiting Professor to the School of Pharmacy at the University of Sunderland.
If you would like to speak to David you can contact andrew.burns@georgejamesltd.com
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