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Zintro ID: David-*****
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I am an experienced Senior Manager and Scientist with a comprehensive knowledge of scientific, commercial and pharmaceutical development within the Bioscience and Pharmaceutical industry. I have achieved extensive technical and business development experience through the successful management of product research and development programmes, working on both academic and commercial contracts. I possess excellent communication, influencing and inter-personal skills with an ability to work cross-functionally at all levels. Established ***** Ltd, an independent consultancy business in 2007, specialising in Pre-clinical Pharmaceutical Development.

 
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Principle Consultant Nov 2007 - Present.

1. Pharmaceutical Development, managing all development activities, including analytical method development, validation, stability studies and formulation, through to and including Phase1 clinical trials.
2. Academic Liaison and Innovation Management, identification and evaluation of academic research projects focussing on NCE potential. Development of new drug candidates through to “proof of concept”.
3. Preformulation 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”.
4. Patent portfolio management.
5. CMC management and preparation of IMPD documentation.
6. Identification and audit of CRO’s. Scale up chemistry, clinical trial supplies, toxicology and safety.
7. Technical transfer management
8. Advice and preparation of business plans.

STIEFEL LABORATORIES INC.
Head of Scientific Development 2001 –Nov 2006.
Head of Chemistry/Pharmaceutical Development *****
ICI/ZENECA LIFESCIENCE MOLESCULES *****
Analytical Science Group Manager
EARLIER CAREER HIGHLIGHTS
***** Research Analytical Manager for ICI Biological Products.

***** Senior Research Biochemist at the Centre for Applied
Microbiology & Research at Porton Down.

***** Research Associate – Department of Physiology, University
Of Cincinnati, Ohio, USA.

2004 – 2007 De Montfort University Masters in Law

***** University of Southampton Ph.D. Biochemistry

***** University of Birmingham BSc. Biochemistry

Chartered Scientist, Chartered Chemist and Fellow of the Royal Society of Chemistry.

In 2006 I was appointed a Visiting Professor to the School of Pharmacy at the University of Sunderland.

Interim contract (March 2009 to March 2010) Technical Manager/Consultant to Exova Ltd, advising on analytical chemistry and formulation development for their existing client base and introducing new clients and projects.

Pharmaceutical development consultant to Insense Ltd, developing a range of novel products for the treatment of psoriasis and fungal infections.

Interin contract as Head of Product Development with Pharmasol Ltd responsible for managing R&D projects from formulation through to Phase I. In this role I developed a range of novel sublingual formulations for the treatment of opioid addiction, pain management and osteoporosis. Subsequently managed the proof of concept clinical trial, prepared the business plan, managed the filing of two patents and represented the company at the MHRA.

Principle consultant to Sunderland Pharmaceuticals, a potential university spin-out. The most recent project involves the management of scale-up chemistry, preliminary toxicology and formulation for novel drug compounds.

Preparation of IMPD documentation for the University of Surrey Clinical Research Department.

Provided consultancy services to Alliance Boots, advice to their Technical Strategy Programme.

Discovery and development of a NCE for treatment of psoriasis. Management of the patent portfolio and preparation of business plan for submission to investors. Proof of concept funding was successfully achieved.

Preparation of technical development strategy for a natural product “cosmeceutical” company.

Advised Dermatology Company on the formulation of topical products for the treatment of a range of skin diseases.

Provided technical development advice to a start up company developing a drug for the treatment of acne.

Produced a development plan and managed the technical strategy for the formulation of a drug substance for the treatment of osteoporosis.

Managed on-site audit of CRO carrying out a bioequivalence study, interpreted data and prepared visit reports.

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