Expert Details

Expert in Pharmaceutical formulation, process development and manufacturing of products

Expert ID: 732555 United Kingdom

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Extensive experience in formulation design and manufacturing process development and optimization gained working for large, medium and smaller companies.Having worked on the development of a relatively large number of small molecules at all stages of development, Expert has gained specialist expertise on the application of various technologies for solubility enhancement and bioavailability improvement of both BCS Class 2 and 3 molecules. This includes both high and low dose API's. The development of amorphous formulation to improve solubility and bioavailablity while retaining physical and chemical stability through the use of polymeric materials.

Consultant details:
Provision of strategic and operational product development expertise in formulation development, process development and manufacturing at all stages of development ranging from pre-clinical to product commercialization. This is based on global product development experience gained within large, medium and smaller pharmaceutical companies and includes outsourcing product development activities and driving development projects at contract development and manufacturing organizations in Europe and the USA. It also includes preparation and review of regulatory submissions in support of global clinical studies and registration.

CMC Development of a number of small molecule drugs for infectious diseases and targeted delivery of molecules for treatment of lower bowel inflammatory disease. This included control of CMC budget for the management and scientific direction of outsourced development projects at Contract Development organizations as well as coordination of clinical supplies manufacturing and preparation and review of regulatory submissions

Education

Year Degree Subject Institution
Year: 1986 Degree: PhD Subject: Pharmaceutics Institution: University of Wales, Wales, UK
Year: 1997 Degree: MBA Subject: Marketing strategy and small business Institution: University of Warwick, UK
Year: 1982 Degree: BSc Pharamacy Subject: Pharmacy Institution: University of Brighton UK

Work History

Years Employer Title Department Responsibilities
Years: 2014 to Present Employer: Undisclosed Title: Consultant Department: Responsibilities: Provision of strategic and operational product development expertise in formulation development, process development and manufacturing at all stages of development ranging from pre-clinical to product commercialization. This is based on global product development experience gained within large, medium and smaller pharmaceutical companies and includes outsourcing product development activities and driving development projects at contract development and manufacturing organizations in Europe and the USA. It also includes preparation and review of regulatory submissions in support of global clinical studies and registration.
Years: 2010 to 2014 Employer: Shire Pharmaceutical Development Title: Senior Product Development Director Department: Global Product Developmrent Responsibilities: Member of the Global Pharmaceutical Sciences Leadership team with responsibility for defining strategic project and organizational objectives.
Leading/participating in Project Teams for new molecular entities and product line extension projects at all development stages.
Ensuring team is adequately resourced and with the right skill sets to support the virtual development model.
Supporting Pharmaceutical Sciences Department with expertise in preformulation, formulation and manufacturing process development of conventional and controlled release products including regulatory and analytical support. Areas of therapeutic focus included gastro-intestinal, haematology and pain indications. Prucalopride (Resolor) tablets for constipation were taken through to commercialization.
Identification and selection of contract development and manufacturing partners as well as preparation and approval of the required contracts.
Leading and supporting due diligence activities relating to the in licensing and out licensing of products.
Years: 2006 to 2010 Employer: LifeCycle Pharma Title: Vice President Department: CMC Responsibilities: Strategic and technical leadership of pharmaceutical and analytical development as well as technology development and outsourcing functions with direct reports including the heads of each of these groups. Main therapeutic focus areas for in house product development included oral products for organ transplantation and cardiovascular indications, developed using MeltDose® technology for increasing the solubility of poorly soluble drugs administered orally. The first product commercialised using this novel technology was Fenoglide® tablets in the US market. The second product developed for use in Phase 3 clinical studies and suitable for registration was a fixed dose combination product.
The third product developed was Tacrolimus tablets, which presented significant stability challenges when applying MeltDose® technology and these were successfully addressed with multiple tablet strengths being developed which were stable under room temperature conditions.
Extensive support was also provided for various early stage client NME projects. The business development group was supported in promoting the use of MeltDose® solubilisation technology for client projects involving BCS Class 2 actives. Additionally liquid loadable tablet technology was also being developed in-house for the delivery of liquids in tablet form.
Years: 2005 to 2006 Employer: Self Employed Title: Consultant Department: CMC Responsibilities: Consultancy work on projects related to formulation and process development as well as preparing CMC submissions for regulatory authorities using the extensive experience gained within the pharmaceutical industry.
Years: 2002 to 2004 Employer: Phoqus Pharmaceuticals Title: Director, Product Development Department: Product Development Responsibilities: Responsible for the formulation and analytical development groups within product development as well as providing technical support to the business development group. Advanced the application of novel electrostatic coating technology to oral drug delivery systems which were developed in collaboration with pharmaceutical companies including fast dissolve tablet technology, modified drug release and loading of tablets with low dose actives.
Years: 2000 to 2002 Employer: Janssen Pharmaceuticals Title: Director, Pharmaceutical Development Department: Pharmaceutical Development Responsibilities: Scientific management of the liquids formulation development group including sterile products. Also responsible for contributing to the definition and implementation of scientific strategy within pharmaceutical development.
In collaboration with the commercial and research groups, my group of scientists was responsible for the preparation and implementation of pharmaceutical development plans for new chemical entities as well as product line extensions and technology transfer to manufacturing facilities. To this end, the team obtained regulatory approval for the commercialisation of an anti-psychotic depot injection product (Risperidone).
Years: 1996 to 2000 Employer: DMV International Title: Applications Development Manager Department: Excipients Development Responsibilities: Collaboration with pharmaceutical companies and providing technical support to commercial personnel, focussing on the use of lactose for direct compression tableting as well as lactose for inhalation applications. Research activities within the group were focussed on improving direct compression lactose products and developing customised lactose products for use in dry powder inhalation systems. This included the characterisation and modification of critical particle properties to best match customer applications.

Also involved in leading a multifunctional project team responsible for establishing a brand new inhalation lactose development centre within DMV. This state of the art facility, included a dedicated GLP laboratory and operations facilities for manufacturing products under cGMP conditions (class 10,000 environment).
Years: 1993 to 1996 Employer: DMV International Title: Team Leader Department: Product Development Responsibilities: Responsible for new product development (CMC) on a global basis for allocated compounds consisting of NME's and product line extensions with direct responsibility for pharmaceutical and analytical resources. Development covered all phases from preclinical to post-marketing, including the full range of solid, liquid and novel dosage forms. Responsible for supporting the development of one particular NME (Ropinirole) commercialised as Requip tablets from early Phase I studies right through to MAA/NDA submissions including technology transfer to the final commercial manufacturing sites.
Years: 1991 to 1993 Employer: SmithKline Beecham Pharmaceuticals Title: Principal Scientific Officer Department: Product Development Responsibilities:
Years: 1988 to 1990 Employer: SmithKline Beecham Pharmaceuticals Title: Senior Scientific Officer Department: Product Developmrent Responsibilities: Responsible for European pharmaceutical development of allocated compounds. Extensive clinical/GMP manufacturing experience, technology transfers and project team representation.
Years: 1986 to 1988 Employer: R.P Scherer Ltd, Swindon Title: Development Pharmacist Department: Market led product development Responsibilities: Responsible for pre-formulation, formulation and process development of soft gelatin capsules. Also involved in the early development of “Zydis” freeze dried dosage forms for the oral administration of drugs.

International Experience

Years Country / Region Summary
Years: 1996 to 2000 Country / Region: The Netherlands Summary: Excipients develoipment for oral and inhalation applications
Years: 2000 to 2002 Country / Region: Belgium Summary: Development of liquid formulations
Years: 2006 to 2010 Country / Region: Denmark Summary: Product Development of poorly soluble actives

Career Accomplishments

Associations / Societies
Member of the General Pharmaceutical Council of Great Britain
Former Board member of the International Pharmaceutical Excipients Council (IPEC) Europe
Publications and Patents Summary
Number of publications made relating to direct compression of pharmaceutical excipients into tablets and more recently on the use of flash nanopreciptation technology for the solubility and bioavailability enhancement of poorly soluble actives.

Fields of Expertise

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