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DRUG: DISCOVERY - DEVELOPMENT - DELIVERY


Contents:

Drug Discovery Volume 6
Drug Development Volume 4
Drug Delivery Volume 3


Drug Discovery Volume 6

Welcome to Drug Discovery
Stephen Minger
Head of Cell Technology, Research & Development, GE Healthcare
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Research and Development Challenges – The Next Decade
Steve Arlington
Global Leader, Pharma R&D Practice, PriceWaterhouseCoopers
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Pharma Innovation – A Challenge Facing the Industry and an Opportunity to Boost Productivity
Jan M Lundberg,1 Anders Ekblom2 and Simon King3
1. Executive Vice President, Discovery; 2. Executive Vice President, Development; 3. Vice President, Human Resources R&D, AstraZeneca
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Is the Future of Big Pharma Biotech?
Nafees N Malik
Analyst, Healthcare Investment Banking, Barclays Capital
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Towards Integrated Web-based Tools in Drug Discovery
Shirley Louise-May,1 Barry Bunin1 and Sean Ekins1,2
1. Collaborative Drug Discovery, Burlingame; 2. Collaborations In Chemistry, Department of Pharmaceutical Sciences, University of Maryland, and Department of Pharmacology, Robert Wood Johnson Medical School, University of Medicine & Dentistry of New Jersey
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Pluripotent Stem Cell Procurement for Drug Discovery
Clara Cavelier1 and Franz-Josef Müller2,3
1. Senior Product Manager, Cell Biology, HAMILTON Bonaduz AG; 2. Zentrum für Integrative Psychiatrie, Kiel; 3. Center for Regenerative Medicine, The Scripps Research Institute, La Jolla
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Automated Cell Handling Systems in Drug Development
Roland Durner
Director of Market Management, Tecan Schweiz AG, Maennedorf
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Activation of Endogenous Stem Cells in the Brain – A Novel Approach to Central Nervous System Disease
Lilian Wikström
Head of Research, NeuroNova AB
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Application of Translational Biomarkers in the Development of Antibody-based Therapeutics
Mohammad A Tabrizi1 and Hamza Suria2
1. Vice President, Pre-clinical Development; 2. Vice President, Corporate Development, AnaptysBio Inc.
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Brain-selective Oestrogens – Do We Need Them and How Do We Find Them?
Vladimir K Patchev
TRG Women’s Healthcare, Global Drug Discovery, Bayer Schering Pharma AG, Berlin
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From Hit to Lead – Speeding Up Techniques in the Chemistry Laboratory
Matteo Colombo and Ilaria Peretto
NiKem Research
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Novel Organotins as Antitumour Agents
Angela Alama,1 Bruno Tasso,2 Federica Novelli2 and Fabio Sparatore2
1. Tumour Genetics, Lung Cancer Unit, National Institute for Cancer Research, Genoa; 2. Department of Pharmaceutical Sciences, University of Genoa
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Blood–Brain Barrier Penetration
Hinnerk Boriss
Sovicell GmbH, Leipzig
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Maximising Drug Discovery by Simplifying Scale-up and Production
Katrin Åkerlindh1 and Shivan Ahamparam2
1. Global Product Manager, Speciality Gases; 2. Market Segment Manager, Fine and Speciality Chemicals and Pharmaceuticals, Linde Gas Division
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Drug Development Volume 4

Welcome to Drug Development
Ira Spector
Vice President, Global Development Operations, Wyeth Pharmaceuticals
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Collaborative Models in the Pharmaceutical and Biotechnology Sectors
Bruce M Pratt
Vice President, Science Development, Genzyme Corporation
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The Committee for Advanced Therapies at the European Medicines Agency and the Advanced Therapies Certification Procedure
Patrick Celis1 and Elisa Pedone2
1. Head, Scientific Secretariat, Committee for Advanced Therapies; 2. Scientific Administrator, Quality of Medicines Sector, European Medicines Agency
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Patient-reported Outcome Measurement – US Food and Drug Administration Regulatory Concerns
Päivi H Miskala, Laurie B Burke, Dianne L Kennedy, Elektra Papadopoulos and Ann Marie Trentacosti
Study Endpoints and Label Development, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration
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Process Validation During Clinical Development of Biological Medicinal Products
Siegfried Schmitt
Principal Consultant, PAREXEL
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Paediatric Drug Development and Clinical Pharmacology
Pravin R Jadhav, Gilbert J Burckart, Lawrence Lesko and Jogarao VS Gobburu
Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA)
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Clinical Scenario Evaluation – A Framework for Evaluating Competing Development Strategies
Norbert Benda,1 Michael Branson,2 Willi Maurer3 and Tim Friede4
1. Senior Expert Statistical Methodologist, Clinical Advanced Statistical Solutions, Novartis Pharma AG; 2. Global Head of Clinical Advanced Statistical Solutions, Novartis Pharma AG, Basel; 3. Senior Biometrical Fellow, Novartis Pharma AG, Basel; 4. Associate Professor of Medical Statistics, Warwick Medical School, University of Warwick
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Optimising Clinical Research via Standardisation – The Clinical Data Interchange Standards Consortium Protocol Representation Model
Lisa Chatterjee,1 David Gemzik,2 Arthur Gertel,3 Diane Wold,4 Julie Evans,5 Rebecca Daniels Kush6 and Joyce Niland7
1. Vice President, Healthcare Data Standards, Digital Infuzion; 2. Vice President, Implementation Services, Medidata Solutions Worldwide; 3. Vice President, Strategic Regulatory Consulting, Medical Writing and Quality Assurance, Beardsworth Consulting Group, Inc; 4. Director, Data Standards, GlaxoSmithKline; 5. Senior Director, Technical Services, Clinical Data Interchange Standards Consortium; 6. President and CEO, Clinical Data Interchange Standards Consortium; 7. Chair, Division of Information Sciences, Edward & Estelle Alexander Chaired Professor, Beckman Research Institute, and Associate Director for Information Sciences, City of Hope Cancer Center
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Assessing the Downstream Impact of Protocol Design Complexity
Kenneth A Getz
Tufts Center for the Study of Drug Development, Tufts University School of Medicine
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Accelerating Clinical Research – India’s Six Senses
Gopal Pai,1 Anand Eswaraiah2 and Kshama Shrinivas3
1. Head, Operations and Business Strategy; 2. Head, Clinical Development; 3. Executive, Business Development,
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Challenges in the Development of New Antiretroviral Drugs for the Treatment of HIV/AIDS
Jayvant R Heera1 and Elna van der Ryst2
1. Pfizer Global Research and Development, New London; 2. Pfizer Global Research and Development, Sandwich
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Impact of Dose Selection Strategies on the Success of Drug Development Programmes
Zoran Antonijevic
Senior Director, Center for Statistics in Drug Development, Quintiles, Inc.
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Drug Delivery Volume 3

Welcome to Drug Delivery
Bozena Michniak-Kohn
Professor of Pharmaceutics, Ernest Mario School of Pharmacy, Director, Laboratory for Drug Delivery, NJ Center for Biomaterials
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The Role of Molecular Imaging in Drug Delivery
Gang Niu1 and Xiaoyuan Chen2
1. Molecular Imaging Program at Stanford, Department of Radiology, and Bio-X Program, Stanford University School of Medicine; 2. Laboratory of Molecular Imaging and Nanomedicine, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health (NIH)
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Biopharmaceuticals – Challenges and Opportunities Facing the Drug-delivery Industry
Jared Hahn
Technical Operations Manager, Drug Delivery/Pharmaceuticals, Technology Catalysts International Corporation
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The Competitive Landscape of Nanotechnology in Drug Delivery
Mark Bünger,1 David Hwang2 and Jurron Bradley3
1. Research Director; 2. Analyst; 3. Senior Analyst, Lux Research, Inc.
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Nanopharmaceuticals for Drug Delivery – A Review
Raj Bawa
President and Patent Agent, Bawa Biotechnology Consulting, LLC, Adjunct Associate Professor, Rensselaer Polytechnic Institute, and Founding Director, American Society for Nanomedicine
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Nasal Drugs to Treat Nasal Disorders
Michael S Benninger and Ryan M Manz
Head and Neck Institute, The Cleveland Clinic
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Transdermal Delivery of Biopharmaceuticals
Weiyong Li
Research Fellow, Johnson & Johnson Pharmaceutical Research & Development, LLC
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Oral Pulsatile Delivery Systems – Applications and Design Strategies
Andrea Gazzaniga, Alessandra Maroni and Maria Edvige Sangalli
Department of Pharmaceutical Sciences ‘P Pratesi’, Università degli Studi di Milano
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Advances in Inhalers for Paediatric Use
Mark L Everard
Department of Respiratory Medicine, Sheffield Children’s Hospital
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Aerosol Drug Development in a Post-Exubera World – The Immediate and Long-term Impact on Targeting Drugs and Biologics to and Beyond the Lungs
James B Fink
Scientific Advisor, Aerogen, Ireland, and Adjunct Professor, Division of Respiratory Therapy, Georgia State University
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