Since 1981, Mrs. Gaby L. Anthonijs B.M., M.Sc. gained experience in the international pharmaceutical industry and the medical device industry and held several management positions a.o. at Yamanouchi Europe (for 4 yrs in R&D and MAE), for 6 years in R&D at Janssen Pharmaceutical (a division of Johnson & Johnson), for 2 years at Vitatron (a daughter of Medtronic) and 2 years at Farma Research (a full service CRO with a phase I unit). She has worked across a broad range of functions in both early and late phase drug development. Since August 2007, she is Associated Director Clinical Pharmacology at the Exploratory Department of Astellas Pharma Europe R&D. In her current position, she is responsible for the day-to-day management of the clinical operations and staff within the Clinical Pharmacology (CP) section of the Early Development Department (EDD) of Astellas. She has to ensure state of the art operational clinical pharmacology input to the European or Global clinical pharmacology study programs of Astellas projects to provide high quality data for development in Exploratory Medicine [Phase 0 to Proof of Concept (PoC)] and development in Clinical Pharmacology (Phase I between PoC and registration) within budget whereby optimal use of Clinical Pharmacology Research Management (CPRM) resources and budgets in EDD is required.

Larry A. Blankstein has over twenty years experience in pharmaceutical and biotechnology drug development. He received his Bachelor of Science degree from Rutgers University and his Ph.D. degree in Biology from Wesleyan University in Middletown, CT. He completed four years of post-doctoral research as a Leukemia Society of America Fellow at Tufts Medical School in Boston, MA., where his research examined genetic regulatory mechanisms involved in the transformation of normal cells to a neoplastic state. Prior to joining Genzyme as a Senior Director of Clinical Research in 2002 he was an Executive Director of Program Management at Quintiles. Dr. Blankstein has held positions as Manager of Immunodiagnostics Product Development at Ciba-Corning Diagnostics developing clinical immunoassays, Director of Life Science Research and Development at Millipore, Inc. developing cell biology and genetic analysis products, and Director of Project Management at Seragen, Inc. where he was responsible for the project management of Seragen’s lead oncology product, Ontak® to treat cutaneous T-cell lymphoma. He has experience in developing drug strategies and managing projects from product conception through process development, pre-clinical and clinical studies to filing with the FDA. In addition, while at Genzyme he has been involved in a number of mergers and acquisitions activities.

Dr Drees obtained his PhD in molecular genetics at the University of California at San Francisco at the height of the genetic engineering boom. He worked in Germany for the next 12 years in the pharmaceutical industry, setting up a Phase I medical writing group, developing the corporate documentation standards, and leading several regulatory submission teams, among other activities. He served as the President of the European Medical Writers Association in 1997 and as Editor-in-chief of The Write Stuff, the Journal of the EMWA from 1998 to 2004. He is currently a Managing Director of Trilogy Writing & Consulting GmbH. He is a frequent speaker on medical writing and other scientific communication topics for Management Forum and Prescription Pharma Services, and as an on-site trainer for pharmaceutical companies and other organizations including the WHO. He has appeared on German radio and television programs as an expert in gene technology and medical writing.

Leigh Hanif has over 10 years in-house experience, with the last 5 as in-house counsel for the pharmaceutical industry. Leigh originally trained as a Barrister, specialising in contract/commercial law and tax. Her practice emphasizes clinical work, procurement, joint ventures, company and commercial matters as well as supervision of major litigation and dispute resolution, risk management and compliance issues.

Dianne Kikta received her PhD in Medical Sciences, with an emphasis in Physiology and Pharmacology, from the University of South Florida, College of Medicine, in 1979. She completed a National Institutes of Health-funded post-doctoral fellowship at the University of Florida, College of Medicine, in Cardiovascular and Endocrine Physiology, in 1983 and then continued her academic career as a Research Scientist at the Bockus Research Institute, at the Graduate Hospital of the University of Pennsylvania. Dr. Kikta was also an Adjunct Assistant Professor in the Department of Physiology at the University of Pennsylvania, College of Medicine. In 2000, Dr. Kikta obtained an MBA from Villanova University, College of Commerce and Finance. In 1988, Dr. Kikta left academia and joined Wyeth Research as a Clinical Writer. She has held positions of increasing responsibility, and is currently Vice President, Global Clinical Strategic Resourcing at Wyeth. In this capacity, she is responsible for providing strategic oversight of opportunities for flexible resourcing for the clinical organization to meet objectives efficiently, especially through offshoring and outsourcing. Throughout her professional career, Dr. Kikta has been involved in innovation and change initiatives. At Wyeth, specifically, she has been involved in some capacity with most change initiatives within the clinical research organization over the past 10+ years—most recently as the sponsor for an initiative to determine how to work more effectively 24/7. Through this initiative, a novel approach to expanding into India, allowing the clinical organization to achieve more in a 24-hour period and thus eliminating significant bottlenecks in the clinical development process was implemented through a successful partnership.

After completing her study of Genetics with a diploma (M.Sc.) thesis in Biochemistry from the University of Vienna she continued to do basic research at the Institute of Biochemistry of the University of Vienna where she also held a University teaching position. Subsequently, she joined a group at the IMP (Research Institute of Molecular Pathology) to work on molecular aspects of developmental biology. In addition to her study she graduated with a diploma from a Management College (in Economics) which was of great help for her first position in the pharmaceutical industry as Clinical Research Associate with the CRO Quintiles. She then moved on to do international project management at the headquarter of Sandoz and is now Clinical Project Manager at the European headquarter of Baxter Innovations GmbH where she manages international clinical trials.

Clare Morgan is Director of Industry at the UK Clinical Research Network (UKCRN), leading the NIHR Clinical Research Networks to establish and support collaborations and effective processes between industry, UKCRN and key stakeholders, in order to facilitate commercial clinical research in the UK. Clare joined UKCRN from her role as Deputy General Manager of the Dementias & Neurodegenerative Diseases Research Network (DeNDRoN) at Newcastle University, where she was responsible for the development, strategic planning, organisation and performance management of the commercial and non-commercial research portfolio. Clare also brings significant project management experience of commercial clinical trials to the role, gained through positions in both a CRO and a Pharma company. Prior to her career in clinical research, she spent two years at the University of Bristol as a post doctoral researcher. Clare graduated from Newcastle University with a PhD in Immunology, from the University of Sunderland with a degree in Biomedical Sciences and is a Professional member of the Institute of Clinical Research.

Dr. O’Neill has to date more than twenty years varied experience in pharmaceutical R&D working in both pharmaceutical companies and contract research organizations (CROs). He joined the Clinical Quality Assurance department at Hoffmann-La Roche in 1992 where he is now responsible for the quality management oversight of external service providers used in Clinical R&D programs. During his time with Roche Dr. O’Neill has conducted more than 150 GXP qualification or in-process audits of service providers world-wide. He is certified by the internationally recognized Institute for Quality Assurance as a Principal Quality Management Systems 2000 Auditor, is a Fellow of the Royal Society of Medicine, and a member of the British Institute of Regulatory Affairs, and was also awarded a diploma in Pharmaceutical Medicine by the Swiss Association of Pharmaceutical Professionals.

Dr. Otte brings has more than 27 years of industry experience and joined Amgen in 2007 as vice president, Global Development Operations and is responsible for clinical operations activities associated with Phase 2-4 clinical studies. He joined Amgen from Pfizer, where he served as senior vice president, Worldwide Development Operations for six years. At Pfizer, he was responsible for phase 1-4 clinical trial operations worldwide. Prior to joining Pfizer, Dr. Otte was chief operating officer, Clinical Studies and Healthcare Research, at Innovative Clinical Solutions, Ltd., one of the largest clinical site management organizations in the U.S. Previously, he was vice president, Medical Research for Zeneca Pharmaceuticals, and also held several positions of increasing responsibility at PAREXEL International Corporation, both in Europe and in the U.S. Dr. Otte began his career as Medical Advisor for Solvay Duphar in the United Kingdom, where he spent 10 years, eventually overseeing the company’s European Clinical Research organization. Dr. Otte received his medical degree from the Welsh National School of Medicine in Cardiff, United Kingdom.

David Passov, ClinStar’s President and COO, was born in Estonia when it was part of the Soviet Union. He attended Tartu University Medical School in Estonia prior to moving to the US in 1993. He received a degree in biology from Boston College and following short basic science research tenure at Massachusetts General Hospital’s neuroscience department entered the biopharmaceutical industry in 1996. Since that time, he has held positions in clinical operations, project management, market research, business development and commercial operations at various small and large US-based CROs. Mr. Passov also received an MBA from the Executive MBA Program at the Northeastern University (Boston, MA) in 2002. He joined ClinStar in 2005. Mr. Passov is a native Russian speaker and spends about 75 percent of his time in ClinStar’s offices in Russia and Ukraine.

Pasi is working in Global Clinical Development Affairs at Actelion overseeing the Actelion’s clinical development finances globally. In his role Pasi believes that by implementing a clear outsourcing strategy by using different outsourcing models based on the characteristics of the development program is the right way to reduce costs and gain organizational efficiency. During last 6 year Pasi has been witnessing the exponential growth of Actelion’s clinical programs and the challenges it has brought to outsourcing of clinical activities. The changing environment in recent years has put an increased pressure on an efficient management of the growing number of outsourcing vendors and emphasis on quick adaptation of new outsourcing models.

Dr. Pojasek oversees global clinical development activities for Solace Pharmaceuticals including all activities related to SLC022, a glial cell modulator compound entering Phase II clinical trials for neuropathic pain. Prior to joining Solace, Dr. Pojasek was a Senior Associate at PureTech Ventures where he was part of the founding Solace team. At PureTech, Dr. Pojasek was responsible for identifying and reviewing early stage life science technologies as well as for founding and providing interim management for PureTech portfolio companies. Dr. Pojasek received his BA in Molecular, Cellular and Developmental Biology at the University of Colorado, Boulder and his PhD from the Biological Engineering Department at MIT.

Throughout his career, Doug has been working to secure value on 2 important ways: collaborating effectively within the business and building effective external relationships in complex spend categories. Doug currently leads procurement activities across the global Clinical Development organisation in AstraZeneca. During the past 18 months he led the provider selection and contract implementation for the outsourcing of AZ's Clinical Data Management activities. Previously, Doug has held a wide range of senior procurement roles, including Head of Purchasing for Global Marketing, Global Category Leader for Conferences and Events and Global Lead Buyer for IT Procurement. Before joining AZ in 1997, Doug worked in the Aerospace Industry, working in both procurement and sales roles at different times.

Dr Paul Quinn is currently Senior Clinical Program Director at Shire Pharmaceuticals based in Basingstoke, UK. In his role Paul is accountable globally for the design, delivery of all Phase II – IV clinical studies sponsored by Shire Pharmaceuticals. The Shire model is to outsource the execution of studies to CROs and the Clinical Programs group is responsible for the oversight and management of these clinical CROs. Prior to his current role Paul worked in Clinical Development at Pfizer as a Director. Here he was responsible for the design and delivery of Phase 2b and Phase 3 trials in both Irritable Bowel Syndrome, Overactive Bladder and Sexual Health. This culminated in the successful filing of darifenacin (Enablex) for the treatment of Overactive Bladder. Paul has also pioneered the use innovative trial designs and technologies including electronic data capture and electronic patient diaries to ensure optimal delivery of clinical trials. Paul has both a degree in Pharmacology and Physiology from Manchester University and a PhD in Physiology from the University of Leicester.

Dr. Adam Ruskin has developed over 50 clinical protocols in a wide array of therapeutic areas, leading to 1 IPO and 2 company buy-outs. He has developed efficient design methodologies which reduce study cost and time and has been a leading industry speaker for over 15 years. He now is President of FocusMonitors.com., your staffing solution for your clinical trial needs. Prior to this, Dr. Ruskin has lead in the global strategic development and outsourcing for several pharmaceutical and biotech companies and a large CRO.

Rikke Winther has worked in the CRO and Pharmaceutical industry for the past 15 years and has experience from Clinical R&D, Business Development and Contract/Outsourcing Management. During the last eight years she has built up, and is now heading up the Outsourcing Management function primarily within all pre-clinical and clinical functions at Lundbeck. Rikke is involved in the entire process from CRO selection through RFP development, negotiations and finalisation of contracts and Work Orders. Furthermore, Rikke is contributing to the development of Lundbeck’s future outsourcing strategies and is highly focused on Vendor management and optimised relationships. Prior to her employment at Lundbeck, Rikke worked for five years within analytical research and Clinical Development in hospital settings and the pharmaceutical industry, respectively. This was followed by four year of employment in an International CRO where she held positions as International Project Manager in Europe followed by setting up the first South East Asia office working as Business Development Manager and local Manager.