Summit for Clinical Ops Executives

Total Page:16

File Type:pdf, Size:1020Kb

Summit for Clinical Ops Executives Organized by Register Today! FINAL AGENDA 7th Annual February 23 - 25, 2016 | Hyatt Regency Miami, Miami, FL Back in SUMMIT FOR CLINICAL OPS EXECUTIVES Miami! February 23-24 February 24-25 Global Site Selection, Feasibility Assessment, Improving Site-Study Activation and Performance Operations and Site Management Patient Engagement, Enrollment and Retention through Enrollment Planning and Patient Recruitment Communities and Tech Clinical Trial Forecasting and Budgeting Managing Outsourced Clinical Trials Implementing Risk-Based Monitoring (Part 1) Implementing Risk-Based Monitoring (Part 2) Clinical IT Strategy and Governance Clinical Data Technology and Integration Managing Late Stage Research, Observational Leveraging Existing Data for Clinical and Studies and Registries Observational Research Symposia - February 23-24 Managing Biomarker-Driven Clinical Trials NEW Clinical Research Statistics for Non-Statisticians NEW Event Features BEST 12 Conferences Clinical Informatics News Best Practices Awards P R S 2 Plenary Keynote Sessions Dedicated Exhibit Hall Hours & A E C T I C Networking Functions 3 Short Courses RAC RAC RAC P T P T P T T IC T IC T IC S E S E S E Interactive Breakout Discussions 2 New Symposia E S E S E S B B B 2 n 0 1 o i 2 2 4 t 0 E 0 R H n 1,000+ Industry Leaders Expected in 2016 1 E o e 1 E 4SCOPEsummit.comn M 4 N W I N N o r a b l e N O M I PREMIER SPONSORS Event-at-a-Glance Monday, February 22, 2016 Pre-Conference Short Courses (Optional, Separate Registration Required) 1. Implementing Social Media, Digital 3. Views and Conversations on 4. Developing Your Custom Strategy for Marketing and Other New Strategies Risk-Based Monitoring Requests for Proposals (RFPs) through for Patient Recruitment to Final Contract Welcome and Networking Happy Hour on the Riverwalk hosted by CHI, DrugDev and Praxis SITE PROJECT REAL WORLD BIOMARKER MONITORING DATA STATISTICS ACTIVATION RECRUITMENT MANAGEMENT EVIDENCE TRIALS Tuesday, February 23, 2016 CONFERENCE 1A CONFERENCE 2A CONFERENCE 3A CONFERENCE 4A CONFERENCE 5A CONFERENCE 6A SYMPOSIUM 7A SYMPOSIUM 8A AM & Global Site Selection, Enrollment Planning Clinical Trial Implementing Clinical IT Strategy Managing Late NEW NEW PM Feasibility Assessment, and Patient Forecasting and Risk-Based and Governance Stage Research and Managing Clinical Research and Site Management Recruitment Budgeting Monitoring (Part 1) Observational Studies Biomarker-Driven Statistics for Non- Clinical Trials Statisticians Wednesday, February 24, 2016 CONFERENCE 1A CONFERENCE 2A CONFERENCE 3A CONFERENCE 4A CONFERENCE 5A CONFERENCE 6A SYMPOSIUM 7A SYMPOSIUM 8A AM Global Site Selection, Enrollment Planning Clinical Trial Implementing Clinical IT Strategy Managing Late NEW NEW Feasibility Assessment, and Patient Forecasting and Risk-Based and Governance Stage Research and Managing Clinical Research and Site Management Recruitment Budgeting Monitoring (Part 1) Observational Studies Biomarker-Driven Statistics for Non- Clinical Trials Statisticians CONFERENCE 1B CONFERENCE 2B CONFERENCE 3B CONFERENCE 4B CONFERENCE 5B CONFERENCE 6B SYMPOSIUM 7A SYMPOSIUM 8A PM Improving Site-Study Patient Engagement, Managing Implementing Clinical Data NEW NEW NEW Activation and Enrollment and Outsourced Risk-Based Technology and Leveraging Existing Managing Clinical Research Performance Retention through Clinical Trials Monitoring (Part 2) Integration Data for Clinical and Biomarker-Driven Statistics for Non- Communities and Tech Observational Research Clinical Trials Statisticians Thursday, February 25, 2016 CONFERENCE 1B CONFERENCE 2B CONFERENCE 3B CONFERENCE 4B CONFERENCE 5B CONFERENCE 6B SYMPOSIA SYMPOSIA AM & Improving Site-Study Patient Engagement, Managing Implementing Clinical Data NEW PM Activation and Enrollment and Outsourced Risk-Based Technology and Leveraging Existing JOIN JOIN Performance Retention through Clinical Trials Monitoring (Part 2) Integration Data for Clinical and Main Sessions… Main Sessions… Communities and Tech Observational Research Stay Connected Join the Clinical The Intro-Net offers you the opportunity to set up meetings with Trials Ops @SCOPEsummit selected attendees before, during and after this conference, Executives group allowing you to connect to the key people that you want to meet. This online system was designed with your privacy in mind and is only available to registered session attendees of this event. 2 | SCOPE Summit for Clinical Ops Executives SCOPEsummit.com Sponsors Premier Sponsors: Corporate Sponsors: Corporate Support Sponsors: SCOPEsummit.com SCOPE Summit for Clinical Ops Executives | 3 Sponsorship, Exhibit and Lead Generation Opportunities CHI offers comprehensive sponsorship packages which include presentation Lead Generation opportunities, exhibit space and branding, as well as the use of the pre- and Obtain more targeted, qualified leads within post-show delegate lists. Sponsorship allows you to achieve your objectives before, life sciences with CHI’s Lead Generation during, and long after the event. Any sponsorship can be customized to meet your programs. We will mine our database of company’s needs and budget. Signing on early will allow you to maximize exposure 800,000+ life science professionals to your to qualified decision-makers. specific needs. We guarantee a minimum of 100 leads per program! Opportunities include: Agenda Presentations Invitation-Only VIP • Whitepapers • Web Symposia Showcase your solutions to a guaranteed, Dinner/Hospitality Suite • Custom Market Research Surveys targeted audience. Package includes a 15 Sponsors will select their top prospects • Podcasts or 25-minute podium presentation within from the conference pre-registration list for an the scientific agenda, exhibit space, on-site evening of networking at the hotel or at a choice branding and access to cooperative local venue. CHI will extend invitations and marketing efforts by CHI. deliver prospects. Evening will be customized according to sponsor’s objectives i.e.: Breakfast & Luncheon Presentations • Purely social • Focus group Opportunity includes a 30-minute podium • Reception style NEW presentation. Boxed lunches are delivered into • Plated dinner with specific conversation focus the main session room, which guarantees audience attendance and participation. A limited Exhibit New Product Showcase number of presentations are available for sponsorship and they will sell out quickly. Sign on Exhibitors will enjoy facilitated networking Exhibitors have the opportunity to showcase early to secure your talk! opportunities with 900+ qualified delegates. their new product. CHI will promote your new Speak face-to-face with prospective clients product with the following: and showcase your latest product, • NPS displayed in prime location in service, or solution. the exhibit hall • NPS logo displayed on the conference Additional opportunities are available for sponsorship, including: website • Game Card • Hotel Room Key • Padfolios • Your company logo, booth number, • Mobile App • User Group Meeting • Lanyards website, and product name included in the • Cell Phone Charging Station • Footprint Trails • Totebags (SOLD) Program Guide • Focus Group • Program Guide Advertisement • Multiple pre-show marketing campaigns sent to our targeted database (including one overall product update campaign To customize your participation at this event, please contact: emailed to 100,000+ prospects and pre-registered delegates) Ilana Quigley • Product/service description (30 words) in Senior Business Development Manager a press release announcing product Cambridge Healthtech Institute launches at the event T: 781-972-5457 E: [email protected] Current Sponsors and Exhibitors (as of September 25, 2015) Acurian CPI MakroCare Rho Advanced Clinical CSSi MBM Productions International RxTrials, Inc. AMC Health Cytel, Inc. MDC Partners Sidus BioData Anolinx DaVita Clinical Research Medidata Society for Clinical Research Sites (SCRS) Barrington James DrugDev Medpace Stiris Research BBK Worldwide Elite Research Network, LLC MMG Synexus Clinical Research Limited BioClinica Inc EMSI NCGS The Patient Recruiting Agency (TPRA) Blinded Diagnostics Exostar OmniComm Systems ThreeWire Chexx Inc. Frenova Renal Research Patient Advertising Guru Total Clinical Trial Management Chiltern Intl Ltd GoBalto PerkinElmer UBC Citeline Greenphire PharmaSeek Veeva Systems Inc. ClinEdge Healthcare Point Pharmica Consulting Y Prime Clinerion Ltd HealthiVibe, LLC PharPoint Zynapsys, LLC Clinical Ink Imperial Clinical Research Services (DAC) Phlexglobal Inc Clinical SCORE IMS Health Phoenix Software International CluePoints Infinata/BioPharm Clinical Platinum Research Network, LLC CMED Clinical Services IntegReview IRB PRA Health Sciences Compliance Insight, Inc. Intralinks Praxis 4 Comprehend| SCOPE Summit Systems for Clinical Ops Executives Langland Quintiles SCOPEsummit.com * Pre-Conference Short Courses Monday, February 22, 2016 | 2:00-5:30 pm Join your colleagues for more in-depth, focused learning at an SC3: Views and Conversations on Risk-Based Monitoring informational and interactive Short Course. Choose one of the Short Andy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Courses below for three hours of instruction and discussion in a Ingelheim Ltd. Mireille Zerola, Clinical Data Management Expert, Boehringer Ingelheim Ltd. small group setting. Get your questions answered, network with Mary Mills, President, CRA Consultant, Mary Mills, LLC colleagues, and share ideas. Ellen Kelso, Executive
Recommended publications
  • The Scientific Organizing Committee Gratefully Acknowledges the Pharmaceutical and Biotechnology Industry for Their Generous Support of WCBP 2019
    The Scientific Organizing Committee gratefully acknowledges the pharmaceutical and biotechnology industry for their generous support of WCBP 2019: Strategic Diamond Program Partners F. Hoffmann-La Roche Ltd. Genentech, a Member of the Roche Group Strategic Platinum Program Partners Amgen Inc. Biogen MedImmune, A member of the AstraZeneca Group Strategic Gold Program Partners Eli Lilly and Company Merck & Co., Inc. Novo Nordisk A/S Pfizer, Inc. Strategic Silver Program Partner Sanofi 1 Gold Program Partner Bill and Melinda Gates Foundation Silver Program Partners BioMarin Pharmaceutical Inc. Bristol-Myers Squibb Company GlaxoSmithKline Jazz Pharmaceuticals Bronze Program Partner Seattle Genetics, Inc. Friend of CASSS Janssen R&D, LLC 2 The Scientific Organizing Committee gratefully acknowledges the Program Partners and Exhibitors for their generous support of WCBP 2019: Diamond Program Partners Agilent Technologies Catalent Pharma Solutions Eurofins Pharma Discovery Services ProteinSimple, a Bio-Techne brand Thermo Fisher Scientific Waters Corporation Platinum Program Partners BioAnalytix SCIEX Bronze Program Partner Bruker Corporation 3 The Scientific Organizing Committee gratefully acknowledges the Exhibitors for their generous support of WCBP 2019: Exhibitor Partners 908 Devices Inc. NanoImaging Services Agilent Technologies New England Biolabs Associates of Cape Cod, Inc. Postnova Analytics Inc. BioAnalytix Inc. Pressure BioSciences Inc. Bruker Corporation Protein Metrics, Inc. Catalent Pharma Solutions ProteinSimple, a Bio-Techne brand Charles River Laboratories ProZyme, A part of Agilent Covance, Inc. RedShift BioAnalytics, Inc. Cygnus Technologies Rockland Immunochemicals, Inc. Envigo SCIEX Eurofins BioPharma Product Testing SGS Life Science Services Eurofins Pharma Discovery Services Shimadzu Scientific Instruments, Inc. FortéBio - Biologics by Molecular Devices Thermo Fisher Scientific GE Healthcare Life Sciences U.S.
    [Show full text]
  • The Impact of Secondary Innovation on Firm Market Value in the Pharmaceutical Industry
    The Impact of Secondary Innovation on Firm Market Value in the Pharmaceutical Industry By: Maitri Punjabi Honors Thesis Economics Department The University of North Carolina at Chapel Hill March 2016 Approved: ______________________________ Dr. Jonathan Williams Punjabi 2 Abstract This paper analyzes the effect of the changing nature of innovation on pharmaceutical firm market value from the years 1987 to 2010 by using U.S. patent and claim data. Over the years, firms have started shifting focus from primary innovation to secondary innovation as new ideas and new compounds become more difficult to generate. In this study, we analyze the impact of this patent portfolio shift on the market capitalization of pharmaceutical firms. After using firm fixed effects and the instrumental variable approach, we find that there exists a strong positive relationship between secondary innovations and the market value of the firm– in fact, we find a stronger relationship than is observed between primary innovation and market value. When focusing on the different levels of innovation within the industry, we find that this relationship is stronger for less-innovative firms (those that have produced fewer patents) than it is for highly- innovative firms. We also find that this relationship is stronger for firms that spend less on research and development, complementing earlier findings that research productivity is declining over time. Punjabi 3 Acknowledgements I would primarily like to thank my adviser, Dr. Jonathan Williams, for his patience and constant support. Without his kind and helpful attitude, this project would have been a much more frustrating process. Through his knowledge of the industry, I have gained valuable insight and have learned a great deal about a unique and growing field.
    [Show full text]
  • United States Securities and Exchange Commission Form 10-K Shire Pharmaceuticals Group
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ፤ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 1999 អ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 0-29630 SHIRE PHARMACEUTICALS GROUP PLC (Exact name of registrant as specified in its charter) England and Wales (State or other jurisdiction (I.R.S. Employer of incorporation or organization) Identification No.) N.A. East Anton, Andover, Hampshire SP10 5RG England (Address of principal executive offices) (Zip Code) 44 1264 333455 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of exchange on which registered American Depository Shares, each representing Nasdaq National Market 3 Ordinary Shares, 5 pence nominal value per share Securities registered pursuant to Section 12(g) of the Act: None (Title of class) Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ፤ No អ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the Registrant's knowledge, in definitive proxy or information statements incorporated by reference to Part III of this Form 10-K or any amendment to this Form 10-K.
    [Show full text]
  • Dyax Corp. 300 Technology Square Cambridge, MA 02139 617 225-2500
    Dyax Corp. 300 Technology Square Cambridge, MA 02139 617 225-2500 www.dyax.com Other Offices Dyax SA, Liege, Belgium ADVANCING NOVEL THERAPEUTIC PRODUCTS Dyax Corp. Annual Report 2003 Corporate Information Dyax Achievements 2003 Dyax Goals 2004 Directors Executive Officers and Stock Listing Henry E. Blair Key Employees Common stock has been traded on the Nasdaq Stock Market Advances in Clinical Development Clinical Development Chairman, President and Henry E. Blair* under the symbol DYAX since our initial public offering in Milestones Chief Executive Officer, Chairman, President and August 14, 2000. DX-88/Hereditary Angioedema Dyax Corp. Chief Executive Officer DX-88/Hereditary Constantine E. Stephen S. Galliker, CPA* The following table gives the quarterly high and low sales G Completed 9-patient Phase II trial, met primary endpoints Angioedema Anagnostopoulos, Ph.D. EVP Finance and prices of our common stock for the last three years. G Genzyme Corporation joined Dyax as joint venture partner Managing General Partner, Administration and G Complete Phase II 2001 2002 2003 G Gateway Associates, LP Chief Financial Officer Completed 3 of 4 dose cohorts in 48-patient Phase II EDEMA1 trial EDEMA1 study High Low High Low High Low G Susan B. Bayh, J.D. Lynn G. Baird, Ph.D.* Initiated Phase II EDEMA2 trial G Periodically observe James W. Fordyce SVP Development First Quarter $20.94 $6.56 $11.38 $3.10 $2.25 $1.52 G Orphan Drug designation granted in U.S. and Europe effects of repeat dosing in Phase II EDEMA2 Managing Partner, Robert C. Ladner, Ph.D. Second Quarter $19.99 $6.81 $ 4.68 $3.20 $4.90 $1.67 Fordyce & Gabrielson, LLC SVP and Chief DX-88/On-Pump Open Heart Surgery (CABG) study Third Quarter $21.24 $6.05 $ 4.20 $1.65 $7.50 $2.58 Mary Ann Gray, Ph.D.
    [Show full text]
  • 2016 Medicines in Development for Rare Diseases a LIST of ORPHAN DRUGS in the PIPELINE
    2016 Medicines in Development for Rare Diseases A LIST OF ORPHAN DRUGS IN THE PIPELINE Autoimmune Diseases Product Name Sponsor Official FDA Designation* Development Status Actemra® Genentech treatment of systemic sclerosis Phase III tocilizumab South San Francisco, CA www.gene.com Adempas® Bayer HealthCare Pharmaceuticals treatment of systemic sclerosis Phase II riociguat Whippany, NJ www.pharma.bayer.com ARA 290 Araim Pharmaceuticals treatment of neuropathic pain in patients Phase II Tarrytown, NY with sarcoidosis www.ariampharma.com ARG201 arGentis Pharmaceuticals treatment of diffuse systemic sclerosis Phase II (type 1 native bovine skin Collierville, TN www.argentisrx.com collagen) BYM338 Novartis Pharmaceuticals treatment of inclusion body myositis Phase III (bimagrumab) East Hanover, NJ www.novartis.com CCX168 ChemoCentryx treatment of anti-neutrophil cytoplasmic Phase II (5a receptor antagonist) Mountain View, CA auto-antibodies associated vasculitides www.chemocentryx.com (granulomatosis with polyangitis or Wegener's granulomatosis), microscopic polyangitis, and Churg-Strauss syndrome * This designation is issued by the FDA's Office of Orphan Products Development while the drug is still in development. The designation makes the sponsor of the drug eligible for entitlements under the Orphan Drug Act of 1983. The entitlements include seven years of marketing exclusivity following FDA approval of the drug for the designated use. Medicines in Development: Rare Diseases | 2016 1 Autoimmune Diseases Product Name Sponsor Official FDA
    [Show full text]
  • An Emerging National Resource for Clinical Research and Your Healthcare Partner in Personalized Medicine Innovation
    An Exclusive Membership Look into Colorado To visualize improving the world around us Fisher Scientifi c, part of Thermo Fisher Scientifi c, the world leader in serving science, is pleased to have the opportunity to partner with the Colorado BioScience Association and act as primary supplier of laboratory products, safety supplies, equipment, chemicals, reagents and a host of services. Fisher Scientifi c understands today’s challenging environment and has capabilities that align with CBSA’s strategic goals going beyond just providing products to o ering Colorado BioScience Association members access to customized programs to fi t their specifi c needs from start-up to scale-up. 1.800.766.7000 • Fax: 1.800.926.1166 • www.fi shersci.com 2 BIOSCIENCECOLORADO 2014-2015 Litho in U.S.A. 13_0280 JJ/KJ COLOR ADO 2014-2015 Drawing People & Data Together to Benefit Human Health 10 22 26 14 6 CONTENTS 06 Mobile Health in Colorado: Where “Big Data” Sparks Big Ideas 10 Biodesix Harnesses Machine Learning and Analytics to Tackle Multivariate Diagnostics 14 Bioscience in Colorado Continues to Shine with U.S. Senator Michael Bennet 16 Color ado Life Science Assets: A Sophisticated Repertoire of Clinical-Stage Therapeutic, Device and Diagnostic Products 22 Webb-Waring Biomedical Research Program 26 F ound in Translation: Rocky Mountain Lions Eye Institute Translational Research Programs Focus on Innovative Treatment of Eye Diseases 30 Connecting the Dots: Tech Transfer Offices Connect Research and Marketplace to Stimulate the State's Economy 33 Colorado by the Numbers: Financing and Acquisitions 36 Grant Programs: Innovation Engines 48 Colorado Bioscience Industry Directory 2014-2015 BIOSCIENCECOLORADO 3 We Know Workforce elcome to the Colorado BioScience Association’s eleventh anniversary edition of Bioscience Colorado.
    [Show full text]
  • Immunocore and Medimmune Announce New Collaboration to Conduct Immuno-Oncology Combination Trials in Melanoma
    PRESS RELEASE – IMMUNOCORE LIMITED Immunocore and MedImmune announce new collaboration to conduct immuno-oncology combination trials in melanoma (Oxford, UK, 16 April 2015) Immunocore Limited, a world-leading biotechnology company developing novel biological drugs to treat cancer and other diseases, and MedImmune, the global biologics research and development arm of AstraZeneca, today announced that they have entered into a second collaboration. Under the terms of the agreement, Immunocore will conduct a Phase Ib/II clinical trial combining MedImmune’s investigational checkpoint inhibitors MEDI4736 (anti-PD-L1) and/or tremelimumab (anti-CTLA-4) with IMCgp100, Immunocore’s lead T-cell receptor based investigational therapeutic, for the potential treatment of patients with metastatic melanoma. MedImmune has an exclusive relationship with Immunocore for the development of IMCgp100 in combination with MEDI4736 and/or tremelimumab, and will have first right of negotiation for the future commercial development of these combinations for tumours expressing gp100. Immunocore and MedImmune will collaborate to establish a dosing regimen for IMCgp100 combined with MEDI4736 and/or tremelimumab, as part of the Phase Ib study. The Phase II study will assess the safety and efficacy of the different combinations. The companies have a pre-existing research collaboration and licensing agreement, announced in January 2014, to develop novel cancer therapies using Immunocore’s Immune Mobilising Monoclonal T-Cell Receptor Against Cancer (ImmTAC) technology. “We are pleased to expand our partnership with Immunocore, a leader in the discovery and development of novel T-cell receptor-based drugs, to include this combination clinical trial in melanoma,” said Dr. Ed Bradley, Senior Vice President and Head of the Oncology Innovative Medicines unit, MedImmune.
    [Show full text]
  • The Future of Biomanufacturing
    THE FUTURE OF BIOMANUFACTURING WELCOME TO A PLACE THAT DELIVERS. HEADER 2 | BIOMANUFACTURING WELCOME TO EUROPE’S MOST SIGNIFICANT CLUSTER OF BIOMANUFACTURING. Liverpool City Region is home to the world’s biggest pharmaceutical players. It is also one of the world’s longest established biomanufacturing centres, chosen by the UK government in the 1940s for the largest penicillin manufacturing plant in the world. Major companies continue to build on this long-tradition and reinvest in new world-class facilities. Our formula for pharma manufacturing success is clear. Liverpool City Region sits at the centre of the UK’s chemical engineering industry; is part of a major centre for health and life sciences and is driving the advanced manufacturing sector through digital innovation. The convergence of these assets has a catalytic impact on the availability of the science, technology and engineering talent that underpins biomanufacturing. Most importantly though, a committed partnership of local organisations is supporting existing manufacturers and the wider supply-chain, through programmes to invest in the infrastructure, facilities and skills that the sector needs to succeed. Welcome to your future-proofed business location. BIOMANUFACTURING | 3 M65 M 6 SEFTON M 6 2 6 6 M M 6 1 M58 62 M M 6 GLASGOW M602 EDINBURGH M MANCHESTER 5 7 M 6 GLOBAL 0 TRADE KNOSLEY ROUTES ST. HELENS 0 6 M NEWCASTLE LIVERPOOL M 62 6 15 M 10 11 M62 12 14 13 HALTON LIVERPOOL CITY REGION LEEDS 56 MANCHESTER HULL M 1 AIRPORT MANCHESTER 7 RIVER 4 M MERSEY 2 9 5 8 SHEFFIELD IRRAL 5 3 3 M LIVERPOOL JOHN 6 LENNON AIRPORT NOTTINGHAM AL CAN 6 SHIP STER CHE MAN BIRMINGHAM 6 M5 CARDIFF BRISTOL LONDON PLYMOUTH SOUTHAMPTON 4 | BIOMANUFACTURING M65 M 6 SEFTON M 6 2 6 6 M M 6 1 M58 62 M M 6 M602 M MANCHESTER 5 7 M 6 GLOBAL 0 TRADE KNOSLEY ROUTES ST.
    [Show full text]
  • Medimmune Delivering the Next Wave of Scientific Innovation
    MedImmune Delivering the next wave of scientific innovation Bahija Jallal, Executive Vice President, MedImmune Building on the fundamentals Next wave of science 1 – MedImmune MedImmune has a 25+ year history in biologics; pioneering scientists are still driving discoveries today RespiGam 1996 2002 Gail Wasserman, PhD Mike McCarthy, MD, MPH, MS Tris Vaughan, PhD 1998 Biopharmaceutical Dev. Infectious Diseases / Vaccines Antibody Discovery & Pennsylvania State Uni. U. Maryland University College Protein Engineering Montclair State Uni. Georgetown U. School of Med. 2011 University of Toronto University of Leeds 1998 2003 2006 JoAnn Suzich, PhD Mark Schenerman, PhD Hong Jin, PhD Infectious Disease / Biopharmaceutical Dev. Infectious Diseases / Vaccines Cornell University Vaccines Purdue University University of Florida Northwestern Uni. 2009 2012 Glasgow Uni. 2 – MedImmune MedImmune continues to attract world class scientists with strong expertise in areas of interest Yong-Jun Liu, MD, PhD Jack Ratchford, MD Head of Research Neuro-Immunology Baylor Research Institute Chief Scientific Johns Hopkins U. School of Medicine Officer and Director of Immunology Columbia U. College of Physicians and Research Surgeons David Howe, MD Jacob Wesley, PharmD, MS Autoimmunity Oncology Cornell University Johns Hopkins University University of Toronto University of Maryland Edinburgh U. Medical School Brett Hall, PhD Eliezer Katz, MD Translational Science - Oncology Neuro-Inflammation West Virginia University U. of Massachusetts Medical Center Ohio State University
    [Show full text]
  • Shire: a Focused Global Pharmaceutical Company Focusing on a Bright Future Shire Pharmaceuticals Group Plc the Shire Mission
    Shire Pharmaceuticals Group plc Annual review and summary financial statement 2003 Shire: a focused global pharmaceutical company Focusing on a bright future Shire Pharmaceuticals Group plc The Shire mission Our mission is to become the leading company in meeting the needs of the specialist physician. We want to achieve this by developing and Contents 01 Financial highlights marketing products of the highest quality 02 Chairman’s statement 04 Chief Executive Officer’s review for the treatment of serious diseases, 06 Product portfolio 07 Product development pipeline which are treated by medical specialists. 08 Operating review 22 CSR: Corporate and social responsibility 24 Financial review We aim to provide high quality and effective 28 Board of Directors 30 The Executive Committee products that enhance the health and 32 Directors’ remuneration report 44 Corporate governance quality of life of people around the world statement Financial Statements and contribute to the long-term business 48 Statement of Directors’ responsibilities – Report of success of our Company, to the benefit independent auditors 49 Consolidated balance sheets 50 Consolidated statement of all our stakeholders. of operations 51 Consolidated statements of changes in shareholders’ equity We are driven by the needs of all our 52 Consolidated statements of cash flows stakeholders: patients, their families and 53 Notes to the consolidated financial statements 87 Five-year review caregivers, doctors and medical specialists, 88 Summary financial statement 93 Notes to summary employees and partner companies, the financial statement community in which we live and work and, Other 94 Shire head office and main operating locations of course, our shareholders.
    [Show full text]
  • Medimmune Advancing Science for Better Health
    MedImmune Advancing Science for Better Health Annual Report 2005 On the Cover SCIENCE, TECHNOLOGY AND INNOVATION ARE AT THE HEART OF MEDIMMUNE’S RESEARCH AND DEVELOPMENT EFFORTS, HELPING TO PROVIDE THE ADVANCES IN MEDICINE NEEDED FOR PATIENTS. FROM LEFT TO RIGHT, SUSAN WILSON, RESEARCH MANAGER I, WENDY WHITE, SENIOR SCIENTIST I, FRAN PALMER-HILL, RESEARCH MANAGER I, AND JOANN SUZICH, SENIOR DIRECTOR, MOLECULAR BIOLOGY AND BIOCHEMISTRY, ARE MEMBERS OF THE ORIGINAL TEAM AT MEDIMMUNE WHO PIONEERED THE DEVELOPMENT OF VIRUS-LIKE PARTICLE TECHNOLOGY IN THE MID-1990s THAT IS NOW INCORPORATED INTO HUMAN PAPILLOMAVIRUS (HPV) VACCINES IN DEVELOPMENT AT GLAXOSMITHKLINE (GSK). THIS HPV VACCINE TECHNOLOGY IS AN EXAMPLE OF OUR CONTINUING PRODUCT DEVELOPMENT PROCESSES THAT, WE BELIEVE, MAY RESULT IN SCIENTIFIC ADVANCES IN OTHER AREAS, SUCH AS INFLUENZA VACCINES AND THE TREATMENT AND PREVENTION OF RESPIRATORY SYNCYTIAL VIRUS (RSV). Financial Highlights (in millions, except per share data) 20051,2 20042 2003 20023,4 20014 CONSOLIDATED STATEMENT OF OPERATIONS DATA Total Revenues $1,244 $1,141 $1,054 $ 853 $ 621 Gross Profit 884 758 703 589 443 Research & Development 385 327 156 148 83 Net (Loss) Earnings (17) (4) 183 (1,098) 149 Diluted (Loss) Earnings Per Share (0.07) (0.02) 0.72 (4.40) 0.68 CONSOLIDATED BALANCE SHEET DATA Cash and Investments $1,472 $1,706 $1,900 $ 1,423 $ 778 Total Assets 2,780 2,564 2,795 2,188 1,237 Long Term Debt, including current portion5 506 507 682 218 10 Total Shareholders’ Equity 1,571 1,675 1,699 1,677 1,044 1 Includes charges for acquired in-process research and development (IPR&D) in connection with the Company’s acquisition of Cellective on October 14, 2005.
    [Show full text]
  • Sensitivity Analyses of Time to Adjudicated Attacks in the N
    Sensitivity analyses of time to adjudicated attacks in the N-MOmentum study: P1652 a randomized, placebo-controlled, double-masked trial in patients with neuromyelitis optica spectrum disorder Bruce AC Cree,1 Jeffrey L Bennett,2 Ho Jin Kim,3 Brian Weinshenker,4 Sean J Pittock,4 Dean Wingerchuk,5 Kazuo Fujihara,6 Friedemann Paul,7 Gary Cutter,8 Romain Marignier,9 Ari Green,10 Orhan Aktas,11 Hans-Peter Hartung,11 Fred D Lublin,12 Maureen A Mealy,13 Jorn Drappa,13 Gerard Barron,14 Soraya Madani,13 Dewei She,13 Daniel Cimbora,13 William Rees,13 John N Ratchford13 and Eliezer Katz,13 on behalf of the N-MOmentum Study Investigators 1UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA; 2University of Colorado, School of Medicine, Anschutz Medical Campus, Aurora, CO, USA; 3Research Institute and Hospital of the National Cancer Center, Seoul, South Korea; 4Mayo Clinic, Rochester, MN, USA; 5Mayo Clinic, Scottsdale, AZ, USA; 6Department of Multiple Sclerosis Therapeutics, Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; 7Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité – Universitätsmedizin Berlin, Berlin, Germany; 8University of Alabama at Birmingham, Birmingham, AL, USA; 9Lyon University Hospital, Lyon, France; 10UCSF Weill Institute for Neurosciences, Department of Neurology and Department of Ophthalmology, University of California San Francisco, San Francisco, CA, USA; 11Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; 12Icahn School of Medicine at Mount Sinai, New York, NY, USA; 13Viela Bio, Gaithersburg, MD, USA; 14Viela Bio, Cambridge, UK INTRODUCTION Figure 3.
    [Show full text]