<p>Biotech Outsourcing Strategies 2014</p> <p><em>Discovery/Early Development &amp; Clinical Outsourcing Tracks</em></p>

Dr Andy Merritt has held the post of Associate Director, Chemistry at the MRCT Centre for Therapeutics Discovery (CTD), the drug discovery arm of MRC Technology since the summer of 2009. In close collaboration with academic scientists, the CTD develops and subsequently prosecutes innovative drug discovery programmes emerging from academic research. Screening of a carefully constructed diverse compound library, targeted screening of selected structural motifs and in silico generated screening approaches all combine to provide good medicinal chemistry starting points, which in combination with structural information on targets can be utilized in medicinal chemistry optimisation strategies.

Prior to his current position Andy was a Director of Discovery Medicinal Chemistry at GlaxoSmithKline, a role which encompassed early lead discovery from screening campaigns plus global responsibility for outsource support for lead discovery chemistry and for the provision of molecular tools for target validation. He was at the forefront of the development and application of combinatorial chemistry and technologies to drug discovery, high throughput screening and hit to lead development from the initiation of the approach in the early 1990s. The use of outsourced resources to support early stage drug discovery in GSK was developed within his teams, building an operation spanning the globe and encompassing all aspects of chemistry services for early drug discovery. Prior to the 2001 merger to form GSK, as part of the GlaxoWellcome organisation he led interdisciplinary teams focusing on lead discovery and optimisation incorporating the development of new chemical technologies. Andy joined the former Glaxo organization as a senior medicinal chemist in 1988 following postdoctoral studies in the US, and initially worked on oncology and pain drug discovery programs, leading to one clinical candidate submission

Andy sits on the RSC Chemical Biology interface Forum Executive and the Chemistry World editorial board, and was for a number of years the European regional editor for the journal Combinatorial Chemistry and High Throughput Screening. He has been a regular undergraduate lecturer in pharmaceutical medicine at Imperial College, Warwick and Sussex universities, and was the industrial organiser for the RSC Medicinal Chemistry residential summer school between 1999 and 2005, and has returned as a lecturer in all subsequent summer schools.

Dr Steve Ludbrook has worked at GlaxoSmithKline (GSK) in the UK for over 15 years following his PhD. He has led numerous groups across the target validation to clinical candidate selection continuum, supporting a variety of therapeutic areas. Steve currently leads a group in the Biological Sciences division at GSK, supporting reagent supply, assay development and compound profiling predominantly during the target to candidate phase of drug discovery. A particular focus is to combine physiological knowledge with emerging enabling technologies, to deliver medium to high throughput primary cell-based phenotypic assays that better link clinical efficacy to cellular compound screening.

Stefan Jaroch studied chemistry at the University of Bonn and obtained his PhD from the Ludwig Maximilians-Universität, Munich, in 1993. After a postdoc at the University of California, Irvine, he joined Schering AG and worked as medicinal chemist from 1995-2000 in Berlin and from 2000-2001 at the US subsidiary Berlex Biosciences in Richmond, CA. From 2001-2007, he was director in the medicinal chemistry department in Berlin, and from 2007-2010 in the medicinal chemistry department of Bayer Schering Pharma in Wuppertal. In his 15 years of pharma research experience his main interests were in the areas of anti-inflammation and oncology research. He holds an honorary professorship at the chemistry department of the Philipps-Universität Marburg since 2008.

Since 2010, he focuses on collaborations with partners from academia, research institutes, pharmas, biotechs, and CROs. As Head of External Innovation Technologies he is responsible for partnering activities referring to early drug discovery assets, technologies, and services, also including open innovation approaches. 

Dr Paul Deutsch currently heads the Chemical Process Research & Development (CPR&D) department within BioPharmaceutical Process Development group (CMC development function) at UCB Pharma. Major activities within CPR&D include chemical route selection, process development and scaleup for material supplies for all NCEs in UCB’s portfolio, technology transfer and validation of processes, as well as major process lifecycle management initiatives. 

Paul received his BS in Chemistry from Lehigh University (Bethlehem PA, USA) and a PhD in Chemistry from University of Rochester (Rochester NY, USA).  He subsequently spent 13 years performing, coordinating and managing process development and scale-up activities for active pharmaceutical ingredients at several CMOs – Lonza, Aerojet Fine Chemicals, and Cambrex. This included efforts working with many big and medium pharma companies as well as startups, and ranging from tox supplies to clinical supplies to launch, for both innovator and generic molecules. 

Dr. Deutsch then added 8 years experience within pharma companies, initially working as Director API development and Manufacturing at DOV Pharmaceutical, where he was involved with all GMP API activities, before moving to UCB.

Rudolf Hausmann, originally from Kiel Germany, studied Pharmacy before his Ph.D. in Immunology. He has also a degree in Pharmaceutical Medicine from Basel University.

His career in the Pharmaceutical Industry started at Hoffmann La-Roche in Basel/Switzerland and he held different positions in Galenical Production, Formulation Development and Project Leadership. He worked on numerous development projects from pre-Phase-I up to launch.

2005 he started at Santhera Pharmaceuticals, a Biotech company near Basel/Switzerland, which is focussed on Development and Commercialization of new medicines against Neuromuscular Diseases. In his position as Head Technical Development & Operations he is responsible for Technical Development from Phase-I to Phase-III and commercial manufacturing & supply. He is also involved BD&L activities and has additional responsibilities as Project Leader.

Andy is currently Discovery and Development consultant for ProPharma Partners Ltd where he offers a broad range of consulting services including, medicinal chemistry, CMC project management and assisting small companies and academic groups in raising funding and establishing Research and Development Operations.

In a career spanning nearly 30 years, Andy has held senior technical and management positions in major pharmaceutical companies, emerging biotech companies and, most recently, small virtual pharmaceutical companies.  In his last two operational roles he was Head of Product Development at Altacor Ltd, an ophthalmic specialty pharmaceutical company; and previous to that was a co-founder and the Research and Development Director of Serentis Ltd, a virtual dermatology focused pharmaceutical company. In these two roles the business model was based on a low-risk approach to drug discovery and development drawing assets from both internal discovery programmes and in-licensing opportunities. Andy had responsibility for all technical operations including pre-clinical and clinical operations, CMC, quality and intellectual property (IP).

Andy is an experienced Medicinal Chemist, most latterly focused on the exploitation of new biology in old drugs and their templates.  At Arakis, he was instrumental in establishing a strong research platform based on the novel exploitation of old ‘drug templates’. He has pioneered approaches to leverage new IP and therapeutic opportunities from established drug templates either by reformulation or chemical modification.  Andy has experience of many therapeutic areas and is inventor or co-inventor of over 60 patent applications.

Andy has developed products as solid dose forms (including modified release), injectables, topical, inhaled, intra-nasal, sub-lingual and transdermal patches progressing programmes through to phase II proof of concept clinical studies.  Most notably he was involved in the phase II development of AD237, a long acting anti-muscarinic agent for the treatment of COPD.  This Arakis product was based on a strong re-profiling concept through collaboration with Vectura.  AD237 was out-licensed to Novartis and reached market approval in 2012.

Elena is a European Patent attorney with over 15 years experience in the pharmaceutical/biotech industry, both as a scientist and as an attorney.   She works as an independent Intellectual Property consultant.  She studied chemistry in her native Madrid, holds a PhD in organic chemistry from Imperial College, London, and performed post-doctoral research in France.  She has also worked as a research chemist in the pharmaceutical industry.  After qualifying as patent attorney she has worked in Intellectual Property within small and start-up pharmaceutical companies, both in-house and as an independent consultant.  She was also senior attorney and manager of the pharma and nutrition team at a firm of patent attorneys.  Her expertise includes IP due diligence, the analysis of portfolios for licensing and freedom to operate, along with strategic and risk assessment and patentability evaluations for new research projects.  She is particularly interested in the area of reprofiling of old drugs. 

Julie Warneck is a Director of Protogenia Consulting Ltd, which offers pre-clinical and early clinical development consultancy services to the pharmaceutical / biotech industry. Julie studied Biochemistry & Toxicology at University of Surrey, UK and has 25 years industry experience in pharmaceutical R&D spanning virtual biotech to mid sized Pharma.  Her career started in pharmacology and ADME at Enzymatix/Chiroscience/Celltech before joining Takeda Cambridge (previously Paradigm Therapeutics/Amedis Pharmaceuticals) as Biology Outsourcing Manager in 2002, and Serentis Ltd as Head of Pre-clinical Operations in 2007.  Julie has an established background in developing small molecules, peptides, and drug re-profiling opportunities in a variety of therapeutic areas including inflammation, pain, endocrinology, cancer adjunct therapy, ophthalmology, diabetes and dermatology.

In 2009, Julie set up her consultancy company to offer strategic, operational and project management support to the Pharma industry, focussing on virtual biotechs, academic spin-outs and MRC/Wellcome Trust grant funded project management.

Marcel Hogerheide earned his Ph.D. in the area of organometallic chemistry. After initially working in the area of hybrid coatings, he has held various Sales and Business Development positions with service providers to the Pharmaceutical industry for the last 14 years. He joined Hovione in 2011 as Sr. Business Development Manager, with a focus on new business development in Europe and Japan. He is currently Head, Account Management & Business Development, Europe & Asia Pacific for Hovione’s Custom Services Business.

A qualified chemist attracted out of the laboratory by the dark-side of business development and management where he has spent the last 25 years; over 10 years working at the Dudley, Newcastle chemical and pharmaceutical production site under its various names from Rhodia through to Shasun.

A career filled with the passion for manufacturing - especially the manufacturing of speciality and pharmaceutical chemicals in Great Britain. 

Duncan is an enthusiastic and accomplished medicinal chemist with extensive outsourcing experience, a 39 year proven track record with a Blue-Chip Pharmaceutical Company, and is the founder of Awridian Ltd.

Duncan has made significant contributions to numerous drug discovery projects, and is cited on many patents and publications including research areas such as prostaglandin agonists, histamine H2, opioids, angiotensin II and CCR3 receptor antagonists. He has been pivotal numerous lead generation projects gaining a unique insight into project and compound tractability. He has extensive outsourcing experience including projects to enhance screening collections, where he engaged with external partners to design, and synthesise appropriate compounds in a cost effective and timely manner. Duncan has recently published and presented on Open Innovation in Drug Discovery for which he is a strong advocate. He was a founder member of the DiscoverAssist™ Panel at the Stevenage Bioscience Catalyst.

Duncan formed his consultancy company (Awridian Ltd) in 2012, and is currently working with a range of international companies and UK academics.

Professor Neil Williams is Founder and CSO of KWS BioTest.  He brings a huge depth of expertise in preclinical drug discovery in immunology and infection, through 25 years working on academic and industry led programs. His positions have included Professor of Immunology and Head of Department at the University of Bristol and Chairman of the British Society for Immunology. He was also Founder of Aegis Pharmaceuticals Ltd (now Trident Pharmaceuticals Inc).

Professor Williams' expertise in drug discovery enables KWS BioTest to act as true partners for their many clients across Europe and the rest of the world.

Dr Minna Komu has a PhD in medical biochemistry and molecular biology, and MSc in economics and business administration. Her scientific background is in research groups from Finland & USA, and she has published in several high-profile journals, such as Nature. Currently Minna works at Admescope as a business development manager. Additionally to being responsible for the in vitro toxicology service portfolio and being involved in the development of the new cell based assays Minna looks after developing the Admescope business in Europe and USA.

Peter MacLennan has many years of research experience both in academia and pharmaceutical industry. He has been with ORION Clinical Services since 2001 – following the merger with SIMBEC Research he has taken on responsibility for Business Development across the group as a whole whilst retaining close links with the operational teams. Before joining ORION he worked for other CROs in business and operational roles and prior to that spent several years in the pharmaceutical industry with responsibilities in clinical development, selection and management of CROs and medico-marketing activities. He began his career in academic research with a PhD in Biochemistry at Dundee University and was a Lecturer at Liverpool University.

Roger Joby Bsc. CSi CertMgmt MAPM

An international project management consultant and educator in Project Management, with over 40 years experience in the pharmaceutical sector. Roger has worked for both Pharmaceutical companies in project management and outsourcing, and in CROs as head of clinical operations and in a number of senior positions in contracts and proposal departments.

Roger has also taken an active role in project management research collaborating with Professor David Bryde Liverpool JM University as well as being an active member of the planning and project control special interest group of the Association for Project Management(APM).

Over the last decade Roger has worked with a number of sponsor and supplier companies including MedImmune, AstraZenica, Boehringer Ingelheim, NovoNordisk, Solvay, Misubushi, Ono Pharma, Quintiles, Harrisons, CroMedica, and Bio Products Laboratory.

Susan Tio-Gaillard studied bio-medical sciences at the university of Leiden (Netherlands), followed by a nearly 2 years fellowship at the department of neurophysiology. In 1996 she obtained her PhD at the department of Medical Pharmacology at the Leiden Amsterdam Center for Drug Research, in the field of female reproductive neuro-endocrinology. Part of this research work was performed during a 1-year fellowship at the Rockefeller University, The Population Council, Center for Biomedical Research, New York, NY, USA.

After obtaining her PhD, Susan worked for 4.5 years in a CRO setting within Quintiles, followed by 5 years at Yamanouchi Europe as a European study manager.

Susan then joined Centocor BV (Johnson and Johnson) in 2005 where she worked as Clinical Research Manager. Closely working with the US, building and leading clinical teams in the field of oncology and GI, and line and people management were key activities.

Mid 2007 Susan took up the position of Associate Director Clinical Development, at Astellas Pharma Europe (merger of Yamanouchi and Fujisawa). Susan fulfilled the role of line / functional manager at Astellas in the Clinical department. Initially Susan managed (associate) study managers as well as clinical program managers, and since 2010, Susan is managing a group of clinical program managers, reporting into the global head in the US. Susan’s current role as Director Clinical Program Management at Astellas, Global Clinical Science, includes line-management , people management and development of a group of global clinical program managers who are accountable for ensuring implementation and execution of the clinical development strategy at the global program level including alignment and oversight of clinical studies (e.g., timelines, resources, budget, etc.) across internal and external stakeholders. This includes phase Ib - IV and post approval commitment and observational studies in the fields of urology, nephrology, pain, and infectious disease. Other key activities include vendor oversight activities, involvement in / leading global process improvement initiatives including business processes as well as processes that positively impact (global) collaboration and organizational cohesion. Furthermore, Susan is the urology / nephrology Clinical representative from a scientific  and operational perspective in the Therapeutic Area governance body.

Susan is a member of the Pharmaceutical Contract Management Group (PCMG) committee, and member of the PCMG steering committee organizing the 2014 PCMG annual conference.  

Amer completed his M.Sc in Pharmacology at Bradford University, Postgraduate studies in Medical Sciences at University College Hospital, Diploma in Biological Sciences from Salford University & Postgraduate Certificate in Clinical Research from Surrey University.  

Amer is a frequently invited speaker at international congresses and has presented and chaired at over 47 international congresses. He has over 23 years track record in the pharmaceutical industry (Clinical Development, Quality Assurance, Pharmacovigilance, Medical Information, & Medical Communications). For some time, he was the Assistant Editor for 11 Medical & Pharmaceutical journals. He contributed further to these disciplines by writing “The Pharmaceutical Medicine Dictionary” in April 2001 and “The Dictionary of Pharmacovigilance” in May 2004. He is currently writing his 3rd book, Dictionary of Clinical & Pharmaceutical Development.

Amer is currently the Global Head of GCP & GVP Quality Assurance at Acino Pharma AG. Prior to his current role, he was Director, Global Head of Quality Assurance & Audit Management at Merck Serono, Geneva, Switzerland. His previous positions include: Global Head of GxP (GCP, GMP, GLP and GPP) Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Auditor at Novartis Pharma Headquarters in Switzerland and he was the first Pharmacovigilance Compliance Coordinator of the Medicines and Healthcare products Regulatory Agency (MHRA).

In these roles, Amer conducted a vast number of audits including a spectrum of GCP, Pharmacovigilance, Clinical Laboratories, GLP, GCLP, GMP, Vendor, Protocol, Clinical Study Reports, Due Diligence, Fraud investigation and Databases audits. He is certified as a Lead Auditor by the International Register of Certified Auditors.

He served as an Executive Committee Member of International Society of Pharmacovigilance (ISoP) and the Good Pharmacovigilance Practice Committee of the British Association of Research Quality Assurance (BARQA), and is a member of the Society of Pharmaceutical Medicine, Associate of the Institute of Quality Assurance (IQA), DIA, Member of the Association of Clinical Research Professional (ACRP), and the Organization for Professions in the Regulatory Affairs (OPRA).

Dr Penelope (Penny) Ward is Chief Medical Officer at Topivert Pharma Ltd. She qualified in medicine from University Hospital London entering the pharmaceutical industry as a clinical research physician in 1991, after a clinical career in academic medicine and obstetrics and gynaecology. She has enjoyed an extensive industry career, including senior roles in both large pharma and small biotech companies. Her experience encompasses translational medicine, early and late stage clinical development, medical affairs, OTC switch and pharmacovigilance. Her work has resulted in the launch of several innovative medicines, small molecule and biologics, now used for the treatment of infection, inflammatory disorders, osteoporosis, neurological conditions, cancer and sexual and reproductive disorders. 

Tilo Hache obtained a degree in electrical engineering in 1998, and an MBA in 2011 from Hochschule Furtwangen University. In 1998, he joined F. Hoffmann-La Roche AG in Switzerland and took responsibilities as a system engineer, global project manager and global team lead for corporate IT service development until mid 2003. Since then, he has been working in Novartis Pharma AG, with increasing responsibility in various IT service management and sourcing management positions. Amongst others he was running the global PC environment with 95’000 seats and managing the commercial relationship of the largest IT outsourcing deal in the company.

In his 17 years of leadership experience in IT and sourcing, his main interest was in continuous improvement, and, in the last few years, in innovating the way drug development is done by injecting new technology.

Since 2013, he focusses on an innovation program in Novartis: Trials of the Future. In his role as a Global Category Manager for Innovative Technologies, he is supporting and running strategic projects to search, evaluate and implement new technologies from external partners.

Jean-Marie heads the Quintiles London Phase I Unit, including designing and delivering efficient Phase I studies and overseeing the performance of Early Clinical Development studies.  With a deep understanding of the market dynamics and drivers for corporate growth and innovation, he has helped develop services and alliances to address complex First-In-Human and Proof-Of-Concept studies in various patient populations.

With over 25 years' experience, Jean-Marie holds a PHD in Pharmaceutical Sciences and has a unique blend of strong scientific leadership and credibility together with outstanding management skills exercised in the Pharma, Biotech and Contract Research industry sectors. Recognized for his expertise in all stages of drug development, Jean-Marie has made a substantial contribution to scientific advancement in fields such as cancer, prostatic hyperplasia, alopecia and blindness treatments, pharmacology, pharmacokinetics and drug metabolism.

Richard joined Mitsubishi Tanabe Pharma in 2009 to set up and develop an Outsourcing and Contract Management function. He is currently responsible for Outsourcing Management of Phase I to III studies across EU and supporting the development of a Global Outsourcing strategy across the organisation, working closely with Japan and US affiliates. Since moving from the healthcare to Pharma environment in 1990, he held sales management and Brand Management positions with Ciba before moving to Clinical Development roles in CRO as well as Pharma. Richard is also the current Chairman of the Pharmaceutical Contract Management Group, founded in 1994 to support the development of professional standards and practices in clinical outsourcing across Europe.

Martin Knight is a Senior Director within the Operational Strategy & Planning group within Covance Development Services.  Martin has 27 years of experience within the pharmaceutical industry. Within his current role, Martin is responsible for the co-ordination of strategy development for new clinical studies awarded to Covance with a focus on General Medicine.

Martin obtained his degree in Pharmacology from the University of Manchester in 1987. Following graduation, he joined Wyeth Research (UK) as a Research Pharmacologist before moving into clinical research in 1990.  He joined Covance in January 1998 within the Periapproval Services Unit as Manager, Medical Research Group, where his responsibility was for supervising clinical operations for late stage drug development (phase IIIB/IV).  From November 1999 until February 2003, Martin assumed the role of Global Project Director where his main role centralised around European and Global programme management.  From February 2003 to November 2007, Martin held several senior positions within the Project Management Department with accountability for delivery all clinical studies for a number of defined clients.

Kieron Hall is Vice President of Business Development, EMEA for Quotient Clinical, the Translational Pharmaceutics company. Quotient is a leading UK-based early clinical development service provider. The unique Translational Pharmaceutics delivery platform co-locates and integrates clinical facilities with contract formulation development and clinical manufacturing capabilities. By bringing CMC and Clinical delivery teams together under one roof, Quotient slashes inefficiencies inherent in the conventional clinical ‘make-test’ paradigm achieving time savings of approaching 50% and significant associated cost savings. As a result of this, Quotient now performs more Phase I clinical studies than any other UK-based provider.

Steve recently joined Takeda in the UK as a Director of Clinical Science in the general medicine group. In this role he is responsible for pulling together development plans for products covering a diverse range of indications and leading the clinical development teams that execute these plans. Prior to joining Takeda, Steve spent a number of years working on challenging drug development projects in Zurich Switzerland and Amsterdam in the Netherlands. Whilst in Zurich, Steve was the Director for Global Project Management for the biosimilars development group at Mylan responsible for project and program management of a portfolio of eight biosimilar products.   In Amsterdam,  Steve was head of clinical operations at Amsterdam Molecular Therapeutics (now UniQure) designing and managing the execution of the pivotal study that led to the approval of Glybera, the Western Worlds first gene therapy product.

Paul Madeley, Ph.D., is an organic chemist with over thirty years’ experience of chemical synthesis. He has worked for three large companies (Boots, Courtaulds and Abbott Laboratories) and two biotech companies (British Biotech and OSI Pharmaceuticals) before setting up his consultancy company, Synth-Isis Ltd. Dr. Madeley has worked on over one hundred projects, comprising more than six hundred individual reaction steps; at scales ranging from a few grams to several metric tonnes.

In 1995, having worked as a pilot plant manager for five years with Abbott Laboratories, Dr. Madeley moved to virtual pharma and has been responsible for outsourcing more than two hundred manufacturing contracts. This involved development of template agreements and site visits for technical appraisal of potential manufacturers. He has visited more than fifty manufacturing sites in Europe and the US. He has acted as the CMC technical lead for a number of due diligence meetings on behalf of clients on more than twenty occasions; in which he presented the technical package for the API to potential investors. He has also undertaken due diligence examinations of potential in-licensing opportunities. Since setting up Synth-Isis Ltd in 2004, Dr. Madeley has worked with over twenty small biotech and emerging pharma companies, together with a number of service companies, and has prepared the chemistry sections of seventeen IMPDs and three INDs. This has included technical oversight of manufacture of the APIs.

Sandra has worked in the biopharmaceutical industry for nearly 17 years.  She began her career in the UK with 7 years in business development for Contract Research Organisations Syne qua non and PRA International.  Sandra then worked for 9 years in Switzerland in various strategic sourcing roles for Roche and Novartis.  She has worked in different outsourcing models for clinical development and medical affairs with increasing areas of responsibility.  In 2013 she set up her own outsourcing consultancy based in Switzerland which provides contracts and sourcing advice to biotech, device and pharmaceutical companies in Europe.  Sandra holds a BSc (Hons) Surrey University (UK), a Marketing Management Diploma (Australia) and is a member of Pharmaceutical Contracts Management Group, Swiss Association for Pharmaceutical Professionals and Chartered Institute of Purchasing. 

Roger Joby Bsc. CSi CertMgmt MAPM

An international project management consultant and educator in Project Management, with over 40 years experience in the pharmaceutical sector. Roger has worked for both Pharmaceutical companies in project management and outsourcing, and in CROs as head of clinical operations and in a number of senior positions in contracts and proposal departments.

Roger has also taken an active role in project management research collaborating with Professor David Bryde Liverpool JM University as well as being an active member of the planning and project control special interest group of the Association for Project Management(APM).

Over the last decade Roger has worked with a number of sponsor and supplier companies including MedImmune, AstraZenica, Boehringer Ingelheim, NovoNordisk, Solvay, Misubushi, Ono Pharma, Quintiles, Harrisons, CroMedica, and Bio Products Laboratory.

Dr. Frederik Beck has more than 20 years of experience from pharmaceutical and biotech companies. He is the CMC outsourcing manager at Zealand Pharma and has held this position for the past four years and has successfully completed 2 IMPD’s for two new chemical entities. As CMC outsourcing manager Dr. Beck is responsible for the outsourcing of all activities relating to clinical trials, both DS and DP. Prior to joining Zealand Pharma Dr. Beck worked for CMC Biologics as Project Director and as scientist/ project manager at Hexal. Dr. Beck received a Master of Chemical Engineering in 1992 from the Technical University of Denmark and an industrial Ph.D. from the University of Copenhagen in collaboration with DAKO A/S in 1999.

Sarah has a wealth of consulting expertise with particular focus on clinical development strategy, organisation design, change management, performance management and process optimisation. Since joining Quintiles, Sarah has led projects in clinical development transformation, quality management and audit readiness assessment, and safety reporting processes and governance.

Prior to Quintiles, Sarah worked for PriceWaterhouseCoopers and IBM, following a successful career at GSK.  Sarah has a BSc in Zoology and Pharmacology, an MBA and an MSC in Health Economics.

I joined GSK upon graduating in Chemistry in 1987 and have undertaken a variety of role within the R&D environment during my career to date, spanning research chemistry, quality assurance and development activities. The majority of my career has been spent in a technical role supporting procurement and I currently lead a multidisciplinary, global team developing outsourcing strategy and supporting service provision to support non-clinical R&D activities. In addition to my degree I hold a Diploma in Research Quality Assurance and an MBA.