<p>Biotech Outsourcing Strategies 2012</p> <p><em>Discovery &amp; Early Development Tracks</em></p>

James Willson joined Shire Pharmaceuticals in September 2011 as a Senior Clinical Scientist

He holds a PhD in Neuropharmacology obtained at the University of Southampton in 2003.  After a brief postdoctural position again at Southampton University he left to begin a career in clinical research.

In 2004 James joined the Clinical Research Organisation ICON Clinical Research as a Clinical Research Associate.  In 2010, he became a project manager at ICON. While at ICON he worked on a number of global trials (with sites in EU, Americas, Asia Pacific) in various indications.

Currently at Shire Pharmaceuticals he is a study manager working on a large global programme of clinical trials.

Tamzin has worked for Lilly for 20 years in a variety of roles, starting in the analytical labs, progressing to be a project manager and most recently as part of the outsourcing group. In this role she is responsible for placing all phase I work outside of the US. In addition she is the relationship manager for the phase I strategic relationship with Covance. She has a degree and PhD in Chemistry.

Gareth is currently a Functional Sourcing Manager based at Pfizer UK, located in Walton Oaks, near Dorking in Surrey. Gareth has been involved in Clinical Research for over 20 years, working across a broad range of drug development programmes covering phases I-IV. Most of Gareth’s experience has been gained within the commercial arena of pharmaceutical companies, designing and implementing trials which have supported the development of some of the most well-known & commercially successful prescription medicines. As Director of the UK Clinical Research Group at Pfizer, Gareth has led that organisation through several significant organisational changes, including the integration with Wyeth. In his current role, Gareth has supported the implementation of an outsourced clinical operations partnership with Quintiles, involving the delivery of clinical trials across 30 countries globally.  Over the past 2 years, Gareth has led the complex transition of ongoing clinical trials between CRO partners, in order to achieve strategic organisational goals.

Peter MacLennan has many years of research experience both in academia and pharmaceutical industry. He has been with ORION Clinical Services since 2001 where he is responsible for Business Development, the company’s German Business Unit and the Data Management/Statistics team.  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.

Pia Sauer Larsen, R&D Outsourcing Manager, Clinical Outsourcing Management, LEO Pharma A/S

Pia Sauer Larsen – with 15 years’ experience in various roles related to Clinical Development, Pia is currently working in the R&D Outsourcing Function at LEO Pharma A/S, a leading global pharma company specialising in dermatology and critical care.

Previously Pia was working as Strategic Procurement management function at Genmab A/S, and in a DM role at Nycomed Denmark Aps mainly focusing on the relationship and outsourced DM services between DM CROs and the clinical teams and also spent more than 8 years in a Data Management Unit at a centralized imaging CRO and in the Danish Cancer Society. 

Kieron Hall is Vice President of Business Development, Europe for Quotient Clinical a leading UK-based clinical research organisation underpinned by the unique Translational Pharmaceutics delivery platform. Translational Pharmaceutics combines real time drug product manufacture with clinical testing within a single facility to enable data-driven early stage clinical progression.

Quotient Clinical, Quotient Bioanalytical Sciences and Quotient Chemistry & Metabolism deliver integrated pre-clinical and clinical programs to a global client base. Kieron will present a case study to illustrate how these groups combine to deliver enhanced decision-making data in an accelerated manner providing answers through innovation.

Dr. Laurent Spiess is Vice President, Business Development, Adaptive Clinical Trials at Aptiv Solutions and has been proactively engaged in promoting adoption of Adaptive Clinical Trials for the past seven years.  During this time, Laurent helped advance the clinical trial strategies of many large, multi-national Pharmaceutical companies as well as smaller biotechnology companies by assisting them in innovating and implementing adaptive trial methodology into their clinical development programs.  Part of Laurent’s personal approach is to form long-lasting professional relationships with Industry Executives and global Regulators to ensure that innovative Adaptive Clinical Trial methodology and execution solutions are widely promoted and routinely accepted.

 In addition to cultivating relationships with industry leaders and regulators, Laurent attends and presents at global Adaptive seminars for clinical development decision makers.  In 2010, Laurent chaired an adaptive conference and a round table aimed at defining French Adaptive Trial Guidelines which was attended by regulators, industry leaders and academic innovators.  French by birth but global in perspective, Laurent has spent over fifteen years working for US companies delivering software and services to the pharma industry in both Drug Discovery and Clinical Development. 

 Before joining Aptiv Solutions, Laurent spent several years coordinating the global sales efforts of Cytel’s flagship software product, East® for the design of Adaptive Trials. 

 Finally, Laurent’s impressive educational background began with a Ph.D. from Northwestern University where he studied Quantum Physics and continued on with a Post-Doctoral Fellowship at the University of Tokyo in Japan where he lived for 2 years.  Laurent speaks French and English fluently and can interact comfortably in Japanese. 

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.

Tacye Connolly BSc (Hons), MTOPRA

Tacye has worked in Regulatory Affairs for over 25 years. She has worked for Glaxo, Baxter Healthcare and Novartis, where she managed the biotechnology product area. She subsequently became a Regulatory Consultant, firstly with Innovata Biomed and then with Regulatory Resources Group. Tacye became a Director and owner of Regulatory Resources Group in 1999.

The majority of Tacye's work is now in project management and regulatory strategy for small and start-up companies and in training especially in relation to strategy and clinical aspects of regulatory affairs. She was a longstanding member of the TOPRA Introductory Course organising committee.

Steve Greentree is currently the Director Global Portfolio Management for
biologics at Mylan GmbH in Zurich Switzerland. His responsibilities include
portfolio, program and project management for the range of biosimilar
products in Mylan's development pipeline. As a relative newcomer to the
field of biosimilars he is particularly interested in the development and
application of standard portfolio and program management methods to support
this business model. In this position he applies the knowledge and
expertise gained from more than 25 years spent in a variety of drug
development positions in the pharmaceutical and biotechnology industry.

With over 25 years of clinical development experience within the pharmaceutical industry, Keith started his clinical research career working in the Clinical Pharmacology Unit of G D Searle in 1983, before moving on to manage European Phase II and III studies with G D Searle in gastroenterology.  In the late 1980’s Keith moved to Schering Plough as a Medical Research Associate in oncology and respiratory diseases.  Following a brief period at Amersham International, he joined Amgen in 1990 with responsibility for European Clinical Development in haematology/oncology from Phase I through to licensing.  Keith joined Roche in 2003 as Operations Project Leader where he planned, staffed and directed global clinical operations in haematology/oncology and rheumatoid arthritis, and then joined CeNeS in 2005 to work in the CNS area.  PAION UK Ltd took over CeNeS in 2008, where he is currently Director of Clinical Operations, based in Cambridge, UK.

Hugh is currently Head of Pharmacology at TPP Global Development, a virtual drug discovery company based in Edinburgh. Following 12 years in academic research in the UK & US he worked at Organon/Merck, Newhouse from 2001 to 2010 as Neurobiology Section Head, he managed a team of scientists (32FTE) working on psychiatry, neurology and pain projects and an equal resource allocated to outsourced activities. Also active on a range of teams from Neuroscience Lead Finding through Lead Optimisation to Early Clinical Development  programmes, Hugh was a member of the pre-clinical team responsible for supporting Asenapine’s (Saphris/Sycrest) registration by the FDA & EMEA. He holds an Honorary Professorship at the University of St Andrews is a serving member of BAP Council.

Sharon Grimster has 30 years’ experience in development of biological and small molecule pharmaceuticals.  Her career began in Guys Hospital London, where she developed new analytical methods for clinical research.  Sharon then spent 18 years at Celltech in a number of management roles in research, manufacturing and project management.  She subsequently joined the senior management team at  Antisoma, to lead project management, manufacturing, quality, regulatory, and business operations.  Sharon’s experience covers a range of therapeutic areas, including oncology, respiratory and autoimmune diseases.  In 2011, Sharon joined the senior management team at F-star to lead the development of bispecific antibodies generated from F-star’s modular antibody technology platform.

Sharon is passionate about Bioscience in the UK, having been the first chairman of the BioProcess UK steering committee, and a previous chair of the BIA manufacturing committee.

Anthony Walker PhD leverages 12 years of building and managing a biotechnology company together with over 12 years as a management consultant to the chemical, pharmaceutical and biotechnology industries.  His experience includes due diligence, technology/market appraisal, business planning, licensing, raising venture capital finance, and M&A. 

Prior to forming Alacrita, Anthony was CEO of Onyvax, a company he co-founded in 1997, raising over £35 million from blue chip life science investors including 3i and SR One.  Before that, he spent ten years as a management consultant, specialising in the pharmaceutical and biotechnology industries. He consulted to Big Pharma and biotech, and also produced Expert Reports for five IPOs. He is a non-executive director of Proteome Sciences plc.

Sarah studied for her BSc Agricultural Zoology at the University of Leeds.  Following 2 years as a study supervisor at  Huntingdon Life Sciences, she joined GlaxoSmithKline in 1989.  Originally based in Safety Assessment as a Study Director, Study Monitor and project team member supporting multiple therapeutic areas,  she also studied for an MSC in Biomedical sciences, followed by an MBA.   She obtained a role as a CRO manager in 2005 building on my scientific background to develop business acumen.  The transfer of this role into a cross functional group, scinovo, in 2009, has allowed her to develop a greater understanding of the other preclinical disciplines, as well as insight into external drug development .  As the Director, CRO Management (Biology) ,  she leads a team of CRO managers who outsource toxicology, bioanalysis and ADME studies in the development space.   The primary accountabilities of the CRO Management team are to evaluate, develop and manage GSK’s supply base (including for  R&D China) and the risk-management associated with outsourcing.  These are delivered through partnering with GSK lines and consolidation of  supply base into a global network of core suppliers. Working on behalf of  GSK’s  external collaborators as part of scinovo  has developed her knowledge into the wider world of medicines development and discovery outsourcing.

Alan Harris has worked in the Pharmaceutical industry for 38 years.  After starting out as a medicinal chemist at what is now GSK he soon moved into process R&D with Fisons, which later became Astra and AstraZeneca.  His experience covers process research, pilot plant management and project management through all phases of development.  Following the Astra Zeneca merger he managed the early development outsourcing group within Process R&D.  After leaving AZ in 2010 he formed Alacrity Pharma Associates with the aim of providing comprehensive CMC consultancy advice to small and virtual pharma companies as well as advising CROs on the development of their HSE and Quality systems. 

During the past 4 years Jens has been responsible for Pharmaceutical Cooperations with various external service providers and collaboration partners within Bayer Pharma´s pharmaceutical Development section. In this position he contributed to the implementation and refinement of Bayer´s sourcing strategy, bridged pharmaceutical scientific thinking with legal requirements and economic needs serving as central interface to the colleagues from Legal and Procurement. He is now responsible for the Development of Line Extension projects with external partners.

Jens has been with Bayer for 13 years holding positions in several CMC Development functions, such as Analytical and Formulation Development, including a one-year excursion to Quality Assurance.

He holds a PhD in Pharmaceutical Sciences of the Free University of Berlin and spent two years as post-doc at the Leiden/Amsterdam Center for Drug Research.