Directors & Senior Consultants
Martin Jordan
MA Cantab mjordan@kinesysconsulting.com
After starting his biopharmaceutical career in Regulatory Affairs at Almirall in 1987, and thereafter in Palex (both Spain), Martin was head of EU Regulatory Affairs for Convatec (UK), a device subsidiary of BMS, responsible for lobbying the company position on wound care products during the development of the Medical Devices Directive 93/42 EEC.He subsequently joined the board of MTC Europe, the largest specialist medtech regulatory firm in the EU. He then set up and managed the European operations of Biomatrix Inc., a successful US biomaterials company subsequently acquired by Genzyme.He has significant regulatory and commercial experience with borderline & combination products as well as devices incorporating human and animal tissues, and a unique understanding of how the regulatory positioning of such products can help or hinder their commercial success.
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Mark Turner
Mark has over 21 years experience working in the industry primarily in Regulatory Affairs, In-Licensing and Business Development. Comprehensive knowledge of EU and International Regulatory Affairs, Process Development and Regulatory Operations in conjunction with new active substance, biotechnology, advanced therapies and generic product development. Expertise in due diligence, product life cycle management and global licence portfolio development. Specialties: Over 20 years EU regulatory experience including Centralised, Decentralised and Mutual Recognition/national licensing of MAA's, project management, due diligence, manufacturing compliance and technical transfer processes in EU. Global US/EU Project work. 11 years man-management/project leadership with teams of varying sizes. Therapeutic area experience in HRT, oral contraceptives, CNS, generics, cardiovascular, metabolic disoders and endocrinology, oncology, anti-infectives/fungals, liposomal technologies, and gastro-intestinal.
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Gerry McGettigan
BSc, B.A., Fellow of TOPRA gmcgettigan@kinesysconsulting.com
Gerry, a molecular biologist, has twenty five years' experience in the biotechnology and pharmaceutical industries, in regulatory affairs, clinical development and business development, and in various Non-Executive Director roles. He has worked with large and medium pharma companies (Almirall, Spain and Glaxo, UK) and was Regulatory & Scientific Affairs Director of The Liposome Company, a US biotechnology firm. He founded the European regulatory affairs and product development consultancy company, GMG BioBusiness Ltd, which was sold to a top 5 CRO in 2005. He also set up and was CEO of the Catalan biotechnology development agency, Biocat, based in Barcelona. Gerry has worked with many clients on projects ranging from early stage regulatory strategy and complex biotechnology products, to clinical development and registration of novel healthcare products. Gerry has excellent relationships with top level business, science and governmental executives. Gerry has invested in several biotech / pharma companies. Gerry is Non-Executive Director of Syntropharma and Biopta.
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Dr Graeme Deuchar
BSc Hons, PhD gdeuchar@kinesysconsulting.com
Graeme has over 15 years experience working as a biomedical research professional. Graeme's regulatory affairs experience with Kinesys is in a number of areas including biosimilars, scientific advice applications, CTAs and orphan product designations. He has also helped to design and now maintains the Kinesys Oncology & Orphan Products Database.As a researcher, Graeme has an impressive track record of developing and utilising preclinical disease models combined with imaging, in projects designed to improve understanding of disease mechanism and investigate novel diagnostic and therapeutic advances in areas of cardiovascular, pulmonary and neurological medicine.Graeme is a co-founder of a recently formed biopharmaceutical company, Aurum Biosciences Ltd where he advises on planning the current and future research and development programme required to support continued progression of the company's key technology through to a successfully translated product for acute stroke management. He is an integral member of the project management team responsible for development, regulatory and commercial planning.
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Jim McGuire
BSc Hons, MSc MTOPRA jmcguire@kinesysconsulting.com
Jim has over 20 years in pharma, biotech and medtech, with expertise in management, commercialisation, regulatory pathways, product and manufacturing development, project management and IP. Originally qualified and worked in clinical and molecular microbiology Jim was recently the CEO of an NHS spin-out, Clear Surgical Ltd, developing innovative surgical devices from concept to regulatory approval in Europe and USA, and enabling the products to enter the global market place. Jim was also responsible for raising capital for the company. He has held senior roles with Scottish Health Innovations, Aortech International, and Hydrosense Ltd. Jim has held Director roles in several companies including Clear Surgical Ltd, Omega Critical Care and the charitable organisation Timeout Club. He is currently CEO of Aurum Biosciences, a company developing novel pharmaceuticals for use in stroke and a number of different clinical indications. Jim was part of the Senior Management Team in Scottish Health Innovations Ltd, a technology transfer and product development company, with responsibilities to manage the company's activities nationally from an operational and strategic perspective, in particular a remit to finalise investment opportunities that would lead to new spin-out companies. As Product Manager within Hydrosense Jim set up their new laboratory and processes providing the capability to carry out in-house Feasibility, Design Verification and Validation studies. As Senior Scientist at Aortech Cardiovasular his role concerned the technology transfer of a novel polyurethane heart valve from initial proof-of-concept phase within academia to a commercially viable product manufactured following ISO and QSR (FDA) guidelines. Jim also co-ordinated ISO 10993 haemocompatibility studies and developed unique manufacturing processes and novel manufacturing equipment that increased yield, quality, and productivity. He was responsible for carrying out FMEA and Process Capability (Six-Sigma) studies to provide key input to product design leading to a change in design specification that significantly improved manufacturability. In addition to his experience as a Biomedical Scientist Jim also carried out characterisation and surveillance of Gram-negative antibiotic-resistant bacterial outbreaks using DNA purification, PCR, RFLP, Cloning, DNA Sequencing and PFGE. He also helped set-up the Scottish National MRSA Reference Laboratory.
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Sonia Ziouani Ammor
PharmD, MSc. sziouani@kinesysconsulting.com
Sonia is a pharmacist and has a MSc. in Market Access & Health Economics from Paris-Sud University in France. Sonia also has a MSc. in Immunology from Paris Descartes Faculty of Medicine in France and conducted pharmacology research at Montreal University in Canada. Sonia recently joined Kinesys Consulting, after a succession of roles in Clinical Trials, Regulatory Affairs, Health Economics & Market Access in pharmaceutical and biotechnology companies such as Novartis and Janssen. Sonia has special interests in Haematology/Oncology and Orphan products and has also worked in Biosimilars. Sonia’s role in Kinesys is as Regulatory and Market Access Consultant. She is based in Kinesys’ Glasgow, UK office.
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