Consultancy to the Biotech, Pharmaceutical and Drug Delivery Industries
Bioedge Pharma Consultancy provides the services of the highly experienced drug development manager Dr Rod Baker C.Chem, MRSC to the biotech, pharmaceutical and drug delivery industries. In particular the company specialises in taking new molecules from late stage research to phase I and phase II clinical trials.
The objective of Bioedge Pharma Consultancy is to provide a professional and flexible service customised to meet the needs of the client. Projects can be undertaken at the offices of the client or from our premises in Buckinghamshire.
Both short and long-term appointments are welcomed, whether this is part of a project or managing a complete programme.
Experience and Background
Prior to the formation of his own consultancy business Rod was Vice President of Development & Operations of the Oxfordshire start up company Avidex (aquired by MediGene AG in September 2006) for eight years, Head of Pharmaceutical Technology in British Biotech for five years and Pharmaceutical Formulation Manager in a privately owned dermatology company for five years. As a result Rod has substantial experience in:
- Developing both small molecules and proteins from late stage research into Phase I clinical trials and through to the market place
- CMC, especially formulation development as well as manufacturing of API and drug products, product characterisation and clinical trial supplies
- Outsourcing pre-clinical, CMC and clinical activities through selection and management of contract research organisations
- Establishing and managing 'virtual' development teams
- Due diligence activities in both funding and licensing deals
- Establishing start ups
Furthermore Rod understands the challenges and pressures faced by small companies and the culture and approach required to produce results in such an organisation.
Phone: 01296 771126
E-mail: info@bioedge.co.uk
Attributes
- Over thirty years experience in drug development
- High degree of commercial awareness
- Used to working under pressure and to demanding timelines and budgets
- Results orientated
- Well networked with pharmaceutical and biotech companies and contract manufacturers
- Excellent organisational skills and attention to detail
- Open minded, hard working and enthusiastic
- Good negotiating skills through many years of outsourcing and managing contractors
- An understanding of corporate activities as underpinned by acting as company secretary for eight years and being involved in several funding rounds and acquisitions
- Has worked with start ups as well as established companies and understands the differences in culture required to achieve results.
Services Offered
Managing CMC activities and specialising in:
- Formulation development
- Developing insoluble molecules
- Outsourcing pre-clinical, CMC and clinical activities through selected contractors
- Establishing and managing 'virtual' development teams
- Preparing for and undertaking due diligence activities
- Strategic management support
- Manufacturing and clinical trial supplies of both small molecules and proteins
- Product characterisation
- Problem solving in early drug development
- CMC data compilation for regulatory submissions
- In-licensing and technology transfer of projects
- Establishing new teams, facilities and infrastructure, especially for start ups
Bioedge Pharma Consultancy Limited