Phone: +44 141 899 0081

Meet our Advisors

Our expert advisors are available to assist our clients with general business and specific project needs.

Dr Xavier Luria

Medical & Regulatory ExperT

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    Dr. Xavier Luria is a consultant on drug development and drug regulation. He was Head of Safety and Efficacy at the European Medicines Agency (EMA) during 2005-2012, and previously held leadership positions in the biopharmaceutical industry for more than eighteen years, covering international clinical development, pharmacovigilance, biostatistics and medical affairs. At EMA, Xavier worked closely with CHMP, the highest regulatory committee in EU, and other regulatory bodies and committees. In addition to Dr. Luria’s specialties in internal medicine, pharmaceutical medicine and biostatistics (Autonomous University, Barcelona), he has developed expertise in several specific therapeutic areas. Xavier has also completed a postgraduate qualification in clinical pharmacology, drug development and regulation (Tufts University School of Medicine, Boston). He is a recognized expert on regulatory systems and benefit-risk assessment (modelling, development and methodologies).

Prof. Peter O’Shaughnessy

Preclinical Expert

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    Prof O’Shaughnessy graduated with a BSc in Pharmacology from the University of Glasgow in 1976 and a PhD from the University of Bristol in 1979. After a post-doctoral period at the University of Michigan he became a Lecturer in Anatomy at the University of London before moving to the University of Glasgow in 1993 to take up a Lectureship in Physiology and Pharmacology at the Veterinary School. He was awarded a Personal Chair in 1998 and until recently was the Head of Department of Preclinical Sciences at the Veterinary School. Peter maintains a highly active research group and in the past five years has been awarded grants worth over £2 million from the BBSRC and Wellcome Trust. His particular areas of research expertise are in Reproductive and Developmental Biology with an emphasis on the mechanisms of gonadal development. He sits on the Editorial Board of 3 journals. During the past ten years Peter has been Head of a commercial GLP-status laboratory at the University of Glasgow and has prepared expert reports in both human and veterinary medicine. He has assisted pharmaceutical and biotechnology companies with strategic and technical preclinical advice for regulatory submissions.

Dr Leon
Hooftman

Medical Expert

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    Leon is currently Chief Medical Officer (CMO) at Synthon Holdings, an innovative Dutch biotechnology company, and was previously CMO at Chroma Therapeutics in the UK. Before joining Chroma he was Head of Clinical Development at Celltech Group plc, a FTSE 250 biopharmaceutical company. Prior to this he was Director of Clinical Science for Oncology/ Immunology at F.Hoffmann La Roche, where he built up extensive experience of biotechnology development programmes, including Rituxan (lymphoma), and CellCept (transplantation). Dr Hooftman qualified in medicine in 1984, from the University of Utrecht, the Netherlands. He trained in surgery and transplant medicine in Holland, the UK and USA and holds a MD and BSc in medical sciences of Utrecht University. He joined the industry in 1991. [/

Gerry MacKay

Management Consultancy & Business Advisor

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    Gerry has had a long and distinguished career in the Biopharmaceutical industry and is currently CEO of BioOutsource, a specialist CRO based in Glasgow, UK. Focusing on the Biotechnology and Biosimilars segments of the market, the company has witnessed rapid growth during the last 4 years under Gerry’s leadership, and has worked with around 150 clients across all geographies. Previously Gerry ran several businesses for Millipore in Europe, Asia and North America. Gerry has led several merger and acquisition projects during his career. He graduated in Biochemistry from the University of Glasgow in 1983.

Gillian Watson

Management Consultancy & Finance Advisor

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    Gillian has an impressive pedigree in corporate finance, strategy and business development. Her career began with Morgan Stanley in London and later in Hong Kong. She then worked for Standard Chartered Asia Limited before leaving to attend business school. Thereafter she joined the power and energy sector in the UK and continental Europe where she held senior management positions relating to management, company strategy and business development. She was Director of Corporate Strategy for Endesa SA, one of Spain’s leading utility businesses, before returning to Scotland from Madrid in late 2006. In 2007, she was appointed CEO of Giltech Ltd, a privately-owned life sciences company, where she developed a focused strategy, steered a board reorganisation and raised both equity and grant financing for product development. She is currently leading projects in the renewables sector for ES Noble. Gillian also serves on the Boards of Scottish Enterprise, Scotland’s economic development agency, and Martin Currie Global Portfolio Trust. She was previously Vice Chair of the Board of Ayrshire & Arran NHS. Gillian has an honours degree in Mathematics from Edinburgh University and an MBA from INSEAD in France.

Esteban Guardia Santisteban

Founder and CEO of PLASMIA

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    Esteban is the Founder and CEO of PLASMIA, a Biotech company based in Barcelona (Spain). PLASMIA is focused on development of novel and generic pharmaceutical products through industrial bio-catalytic procedures. A practising physician, Esteban gained his degree at the University of Navarra, He also holds a MBA from the Instituto de Empresa in Madrid. Esteban has significant experience in Licensing and Business Development with various companies, notably including Almirall. He was the founder and CEO of the start-up company FARMATEC, a pharmaceutical company based in Barcelona, and is currently assessor and Board Member for Pharmaceutical and Medical companies.

Mark Turner

Regulatory, In-Licensing & Business Development Expert

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    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.

Tao Toni Chen

Asian Market
Advisor

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      Tao (Toni) started his professional career in China and continued it in Germany, where he lived and worked for 20 years with Henning Berlin GmbH/Brahms AG. He was in charge of different processes in development and manufacturing of biopharmaceuticals (such as cell line development, upstream/downstream process, formulation development, scale-up) and immune-diagnostics products. In Germany, he earned the Dipl.-Ing. in Bioengineering and the MSc. in International Technology Transfer Management. In China, he was 7 years as VP at the Chinese biopharma company, Pacific Meinuoke, and then 2 years as VP Business Development China at the German healthcare company, AMP Biosimilars AG/Biosilu Healthcare AG.”

Andrew Fox

Regulatory & Biotechnology
Expert

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    Andrew Fox is Senior Director, Regulatory Affairs at Onyx Pharmaceuticals and leads their European and Middle East, Africa, Russia and Turkey regional regulatory team based in the United Kingdom. He has previously held regulatory positions with Amgen, Warner Lambert and Sanofi Pasteur vaccines with regulatory experience in Europe, the United States and in several Emerging Market countries. Andrew has worked in Regulatory Affairs for nineteen years, working almost exclusively with biologics and biotechnology products. He has broad experience in technical and regulatory aspects of the manufacture and control of biologicals and in clinical development for a variety of therapeutic areas including vaccines, rheumatology and oncology. Andrew has worked extensively on scientific and technical aspects of regulatory policies and guidelines for biologics and biosimilars. He has been an industry member of the World Health Organization working party on standards for approval for biosimilar medicines, testified to the World Health Organization on naming criteria for biologics/biosimilars and has been a lead technical contributor to multiple policy discussions with regulators and legislators in the United States, Canada, Europe, Japan and Australia.