Skead Consulting Limited provides CMC consulting services to biotechnology and pharmaceutical companies. We specialise in providing a "Virtual Pharmaceutical Factory" to our clients in order that they can execute their non-clinical and clinical development plans in a timely, cost effective and regulatory compliant fashion.

As Head of CMC, I am responsible for all process research, development and manufacturing activities for Cyclacel’s projects. There are 4 molecules in development, all for oncology indications, that span pre-clinical development to Phase 3. The key projects are sapacitabine, an oral nucleoside analogue, 2 cyclin dependant kinase inhibitors and a polo-like kinase 1 inhibitor. Working closely with the program managers, I help define overall project strategy by defining the CMC elements of each… Show more As Head of CMC, I am responsible for all process research, development and manufacturing activities for Cyclacel’s projects. There are 4 molecules in development, all for oncology indications, that span pre-clinical development to Phase 3. The key projects are sapacitabine, an oral nucleoside analogue, 2 cyclin dependant kinase inhibitors and a polo-like kinase 1 inhibitor. Working closely with the program managers, I help define overall project strategy by defining the CMC elements of each project. Therefore I have to prepare CMC budgets and project plans for each project, which are presented to the executive management team for approval and then implementation.In detail, key CMC activities include:• Manufacturing contracts and work orders• Development of the cGMP quality management system focussed on vendor oversight• Synthetic route and solid form selection• Formulation development (oral, parenteral and paediatric dosage forms)• Analytical method development, validation and stability studies• cGMP manufacture of API and drug products• Process development and validation• Packaging, labelling, storage and distribution• Preparation of Quality module of regulatory dossiers (IND, IMPD) and scientific advice meetings with agencies (FDA, EMA)• Intellectual property (process, formulation and solid form patents)• Due diligence Show less

As CMC Director, I was responsible for drug substance and drug product development and manufacture and CMC regulatory affairs. The lead program was remimazolam which is an ultra-short acting sedative/local anaesthetic. Remimazolam was just completing Phase 3 clinical trials for procedural sedation, so the focus of my work was on process validation and preparation of the Quality module of the marketing application (NDA). Paion was a virtual company so all manufacturing activities are outsourced… Show more As CMC Director, I was responsible for drug substance and drug product development and manufacture and CMC regulatory affairs. The lead program was remimazolam which is an ultra-short acting sedative/local anaesthetic. Remimazolam was just completing Phase 3 clinical trials for procedural sedation, so the focus of my work was on process validation and preparation of the Quality module of the marketing application (NDA). Paion was a virtual company so all manufacturing activities are outsourced to a network of CROs and CMOs. Show less

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As Head of Process Chemistry, I had responsibility for managing a department of PhD and graduate scientists. The role of the department was to pick up projects in lead optimisation and take them as far as the organisation required (typically Phase 2 manufacture). At any one time the department had resources to manage about 4 projects at varying stages of R&D. Key accountabilities were Research project support, route identification, solid form selection, process development, technology transfer… Show more As Head of Process Chemistry, I had responsibility for managing a department of PhD and graduate scientists. The role of the department was to pick up projects in lead optimisation and take them as far as the organisation required (typically Phase 2 manufacture). At any one time the department had resources to manage about 4 projects at varying stages of R&D. Key accountabilities were Research project support, route identification, solid form selection, process development, technology transfer to contract manufacturers for GMP manufacture and preparation of regulatory documents and patent specifications. Show less

As Head of Process Chemistry, I had responsibility for managing a department of PhD and graduate scientists. The role of the department was to pick up projects in lead optimisation and take them as far as the organisation required (typically cGMP manufacture for Phase 2). At any one time the department had resources to manage about 4 projects at varying stages of R&D. Key accountabilities were research project support, route identification, solid form selection, process development, technology… Show more As Head of Process Chemistry, I had responsibility for managing a department of PhD and graduate scientists. The role of the department was to pick up projects in lead optimisation and take them as far as the organisation required (typically cGMP manufacture for Phase 2). At any one time the department had resources to manage about 4 projects at varying stages of R&D. Key accountabilities were research project support, route identification, solid form selection, process development, technology transfer to contract manufacturers for cGMP manufacture and preparation of regulatory documents and patent specifications. I was a core member of the “Project Review Committee” which was responsible for the management of the portfolio of development projects.As a Group Leader in Process Chemistry at Chiroscience, I managed a team of Ph.D. and graduate chemists. Primarily, I was involved in the chemistry of the single isomer pharmaceutical programs, leading up to 3 projects at any one time. Examples of these projects include Dexaminoglutethimide, Chirocaine, Dexifosfamide, Verapamil and Etodolac, Show less