February 10,2003,Park Hyatt San Francisco — San Francisco European Regulatory Affairs: An InDepth Review of Registration Procedures in the European Union This Drug Information Association training course will cover the evolu tion of the registration systems available for approval of products since Jan uary 1995 in the European Union. Detailed review will be offered on cen tralized, mutual recognition, and national procedures and practical examples of product types suitable for each procedure will be discussed, as will the impact of the European Commission’s interpretation of Article 7A and Article 9. Other issues that impact successful regulatory strategy in Europe, such as Harmonization of Summary of Product Characteristics,Article 11 and Arti cle 12, Pharmacovigilance, and Supplementary Protection Certificate for patents will be described. The workshop will provide practical advice on how to file applications for the marketing authorizations in the European Union for staff involved in International Regulatory Affairs. Regulatory strate gy that affects commercial,business, and licensing arrangements will be of importance to those responsible for business development. For more information, contact Dori Browning, Jenna Hannum, or Susan McLaughlinat 2154426100,email [email protected],or visit www.dia home.org. February 1011,2003,Coronado Island Mar riott — San Diego Cardiovascular Drug Discovery and Development Summit Researchers in the cardiovascular field will convene to discuss the latest efforts in drug discovery and clinical development for the next generation of therapeutics. Sponsored by Strategic Research Institute,highlights of the meeting will include“Clinical Development of Crestor,”by AstraZeneca;“Nuclear Receptor PPAR in Macrophages Results in Reduced Inflammatory Response and Atherosclerotic Lesion,” by The Salk Institute; and “Inhibition of ApoB100 with Antisense Technology as a Therapeutic Strategy for the Treatment of Hyperlipidemias,”by Isis Pharmaceuticals. The list of presenters include: AstraZeneca,BristolMyers Squibb, Eli Lilly & Co., Millennium Pharmaceuticals, Pharmacia Corp., Procter & Gamble Pharmaceuticals, Atherogenics,Collateral Therapeutics,CV Therapeutics, Isis Pharmaceuticals, Myogen,Sequenom,Texas Biotechnology,Purdue Univer sity, The Salk Institute, Scripps Research Institute, and Southwestern Medical Center. For more information, contact Jon E. Liong, at 2129670095, ext. 243,e mail [email protected],or visit www.srinstitute.com. February 1821,2003,Four Seasons Hotel — Boston Postgraduate Course in Clinical Pharmacology,Drug Development,and Regulation The Tufts Center for the Study of Drug Development is offering a four day course in clinical pharmacology,drug development,and regulation.The program,presented in collaboration with the Drug Information Association, will provide an indepth overview of drug development and regulation and focus on practical,theoretical, and technical issues. This program is intended for clinical pharmacology, clinical develop ment, marketing, and research and development professionals, as well as regulators, physicians, attorneys, consultants, and others working with the researchbased drug industry. For more information, contact Ellie Cleary, Tufts Center for the Study of Drug Development,at 6176362173,email [email protected],or visit csdd.tufts.edu. February 2021,2003, Wyndham Emerald Plaza — San Diego Inflammation in Drug Discovery and Development The world inflammatory disease research community and BristolMyers Squibb, Novartis Pharmaceuticals, R.W. Johnson, AstraZeneca, and Amgen will convene at this year’s Inflammation in Drug Discovery and Develop ment event. The conference, which will consist of seven inflammatory compound presentations, will explore in detail the research efforts to discover and develop safer and more effective therapies for rheumatoid arthritis and other inflammatory diseases, as well as programs intended to discover next generation antiinflammatory drugs. The conference is organized into four main sections: Novel AntiTNF Pro teins andSmallMolecule Inhibitors;Advances in IL1,Gamma Interferon,and IL2 Biologics; Novel B Cell, T Cell and Receptor Modulators; and Additional Approaches for Novel AntiInflammatory Drugs. For more information, contact Ed Drilon, Strategic Research Institute, 2129670095, ext. 233, email [email protected], or visit www.srinsti tute.com. February 2428,2003,Wyndham U.S.Grant — San Diego AntibodyWorld Summit This series of four related antibody meetings promises to be one of the most comprehensive industry information,business devel opment, and networking extravaganzas ever offered on this topic. Spon sored by Strategic Research Institute, the meeting will consist of four events: AntibodyDiscovery andPreclinical Drug Development,February 2426;Anti body Clinical Development and Marketing, February 2426; Trends in Anti body DealMaking and Financing, February 2728; and Macromolecule Pro duction and Economics,February 2728. The summit features more than 100speakers,dozens of exhibits,and will draw more than 600 attendees.Research advances, emerging therapeutics, new technologies, antibody marketing, clinical cost optimization, produc tion economics, largescale manufacturing,partnering and financing topics, intellectual property, and the latest in the clinical pipeline are some of the summit highlights. For more information, contact Mark Alexay, Strategic Research Institute, at 2129670095, ext. 251,email [email protected],or visit www.srin stitute.com. February 2426,2003,Hyatt Regency Penn’s Landing — Philadelphia Regulatory I: The INDPhase Drug and biological products are the focus of this Drug Information Association training course.The objectives of the session are to provide an understanding of the role of regulatory affairs within the phar maceutical industry, an understanding of the role of the FDA regulators, the ability to plan,design,and organize an IND,and an understanding of how to communicate with the FDA effectively. The course is designed for people with a background in preclinical research,clinical research, or academia who have just entered the area of regulatory affairs and have zero to six months of experience in regulatory affairs. This course also will be beneficial to those who are in clinical research, data processing,biostatistics,basic research,project management,andmar keting, who would like to gain a better understanding of the regulation of investigational new drugs and biologics. For more information, contact Dori Browning, Jenna Hannum, or Susan McLaughlin at 2154426100,email [email protected],or visit www.dia home.org. 10 February 24 February 24 February 10 February 18 February 20 February ONTHECALENDAR 80 F e b ru a r y 200 3 PharmaVOICE February 2528,2003,Harvard School of Public Health — Boston Building Clinical and Administrative Trust:Advance Your Mission and ImproveYour Margin The first day of the conference will focus on two critical issues in trust: medical errors and privacy/HIPAA. Both issues will be explored as causes of distrust and significant areas of strategic opportunities in quality improve ment.The second day will address the central role of care providers in build ing trust in the healthcare system, including presentations about the role of physicians and others on building (or eroding) trust, a case study on the ethics of trust, and a dialog among the faculty on building clinical trust. For more information, contact Marilyn Barker at 6173848676, email [email protected], or visit www.hsph.harvard.edu. February 2627,2003,Hyatt Regency Hotel — Irvine, Calif. Investment In Innovation:A Preview of EarlyStage MedicalTechnology Companies Medtech Insight LLC is the host of the Investment In Innovation confer ence — a forum for senior executives in the medical device and investment community to preview earlystage medical technology companies in need of funding, acquisition, and/or strategic partnership. The twoday event will showcase more than 50 innovative, emerging medical startup companies who will present to an audience of 300 senior executives, representing the top medical technology and investment firms. Presenting companies repre sent a wide range of emerging medical technology markets, in the fields of cardiology and cardiovascular surgery, orthopedics and spine surgery, endo scopic surgery, drug delivery, and stroke management. For more information, contact Scott Pantel at 7145965353, email [email protected],or visit www.medtechinsight.com. March 24, 2003,Walt Disney WorldYacht and Beach Club Resort — Orlando,Fla. MarketingResearch to Support OutoftheBox Marketing The Pharmaceutical Marketing Research Group’s 2003 Spring Confer ence will feature two keynote speakers: Seth Godin, author of Permission Marketing,and Laura Ries, who recently coauthored with her father, Al Ries, The Fall of Advertising and the Rise of PR. The conference will feature a dynamic program over two days. On the first day, content will focus on the topic of “e” (electronic media) initiatives, and the second day will examine publicrelations programming in the pharmaceutical industry. Both days will offer practical information on the marketing research necessary to support such innovative approaches to marketing. For more information, contact Stephanie Reynders, CLT Meetings Inter national, at 4076289700, email [email protected], or visit www.pmrg.org. March 1718,2003 — Washington,D.C. Healthcare Best Compliance Practices Forum The Best Practices process is an established peerreview pro cess identifying best practices in key compliance areas. Identified best prac tices are presented at the forum,the only national event in whichhealthcare leaders, top government officials, compliance professionals, and legal and academic experts meet in to address practical compliance concerns. For more information, contact Daniel R. Reardon, Health Ethics Trust/Council of Ethical Organizations, at 7036837916, email [email protected], or visit www.corporateethics.com. March1819,2003,Hyatt Regency Hotel — Princeton,N.J. 4th Annual Multicultural Pharmaceutical Marketing,Media,and PR Thenextwave for DTCandOTC advertisers is to get ahandle on the surg ing multicultural market opportunity.This forum will help uncover new mar ket opportunities to reach consumers from ethnic groups with purchasing power who need both treatments and health education for diseases such as CAD, cancer, diabetes, and HIV/AIDS. Effective multicultural marketing can help pharmaceutical brands build longlasting relationships with a growing base of multicultural consumers. For more information, contact Rupa Ranganathan at 2129670095, ext. 252,email [email protected], or visit www.srinstitute.com. March 19,2003,Lehigh University, College of Business and Economics — Bethlehem,Pa. Pharma R&D Productivity:Concerns and Viable Solutions Answers to questions regarding declining R&Dproductivity canbe found at the “Pharma R&D Productivity: Concerns and Viable Solutions”conference. Hosted by the Martindale Center in the College of Business and Economics at Lehigh University,the conference will present avariety of views fromindus try leaders as to the causes and available solutions to meet this problem. Opening remarks from Dr. Frank L. Douglas, chief scientific officer and execu tiveVP for drug innovation and approval at Aventis SA,will set the tone for the conference. Attendees can look forward to engaging dialog from several noted speakers and perspectives from industry consultants Deloitte & Touche and Ernst and Young. For more information, contact Rosemary Krauss, Martindale Center, 610 7584771, or email [email protected]. March 2425,2003,Hilton La Jolla Torrey Pines Hotel — La Jolla, Calif. siRNA in Drug Discovery and Development Small interference RNAs (siRNAs) have gained much attention in drug discovery and development due to their powerful ability in selective gene silencing. The Small Interference RNA Conference and Exposition will these address issues such as: what are the challenges and hurdles in siRNA indus try? How will big pharmaceutical companies integrate and utilize the tech nology in accelerating drug development? Howwill smaller biotech compa nies specialized in siRNAs make creative deals and partnerships? What are the bottlenecks in realizing commercial value? What are intellectual property landscapes? The event will feature senior executives from large pharma and biotech as well as siRNA therapeutic companies, reagent companies, and functional genomic companies. For more information, contact Mark Alexay, Strategic Research Institute, at 2129670095, ext. 251, email [email protected], or visit www.srin stitute.com. March2628,2003,Washington Hilton &Towers — Washington,D.C. 6thNational HIPAA Summit The HIPAA Summit conference series provides a road map to under standing the complex requirements of federal and state law and illuminates strategies for compliance. The summit will provide the most uptodate information on the status and construction of the HIPAA regulations through presentations of regulators from the Department of Health and Human Services. There will be indepth analysis of the healthcare privacy and security laws of a number of states, as well as a focus on practical case studies from the field, featuring presentations by leading privacy, security, and compliance officers. For more information, contact Paul Tunnecliff at 8006844549, email [email protected], or visit www.hipaasummit.com. ONTHECALENDAR 24 March 26 March 19 March 18 March 2 March 17 March PLANNINGAHEAD 25 February 26 February 81 PharmaVOICE F e b ru a r y 20 03 March 31 April 2, 2003,Gaylord Palms Resort — Kissimmee, Fla. 12thAnnual Partnership withCROs and Other Outsourcing Providers Conference Dr. David Kessler, one of the most visible commissioners of the FDA in recent history, will discuss new drug approval processes in his keynote address at the 12th Annual Partnerships with CROs and Other Outsourcing Providers Conference. Organized by the Institute for International Research, the conference delves into outsourcing and the development of effective clinical partnerships, and is the place where pharmaceutical outsourcing leaders meet to facilitate change and drive results.The event is expected to attract more than 100 exhibitors and 700 clinical development experts. The event provides an educational and networking forum to promote building and maintaining effective partnerships between pharmaceutical and biotechnology companies and their clinical development outsourcing providers. New sessions for 2003 include: . CRO market snapshot:perspectives on growth trends; . CRO/PhRMA initiatives and impacts on industry; . Controlling the drivers in the escalating costs of healthcare; . Opportunities and challenges resulting from industry consolidation. Three new tracks also are planned that will address strategic planning and market assessment;screening, selecting,and contracting;and postcon tract management. For more information,contact MattGodson at 2126613500 ext.3225,e mail [email protected], or visit www.iirusa.com. March 31April 2, 2003,Jacob K.Javits Convention Center — NewYork International Pharmaceutical Industry Congress The International Pharmaceutical Industry Congress will feature four events: Interphex, PharmaIT Expo and Summit, Pharmaceutical Contract Services and Outsourcing Exposition andConference,andDrugScience and Technology Summit.Each event will feature a program developed for phar maceutical industry professionals by the industry’s most respected educa tion providers. The Interphex conference, produced by ISPE, the Society of Life Science Professionals, will address manufacturingrelated issues such as process technologies, packaging, validation, and FDA regulations. The Pharmaceuti cal Contract Services and Outsourcing Symposium, also produced by ISPE, will provide the skills needed to manage the outsourcing process. The PharmaIT Expo conference, produced by the Insti ute for Interna tional Research, will provide insights on the use of information technology to optimize pharmaceutical business and scientific processes.The Drug Sci ence and Technology conference is produced by Reed Business Informa tion’s Scientific Group. For more information, contact Lisa Tully at 2033537035, email [email protected], or visit www.pharmacongress.net. April 26,2003,La Fonda Hotel — Santa Fe, N.M. Society for Academic CME Spring Meeting For more information,contact Melinda Steele,Texas Tech Uni versity Health Sciences Center,at 806 7432226,email melinda.steele@ttuh sc.edu, or visit www.sacme.org. April 34,2003,HotelIntercontinental Chicago — Chicago BIO MidAmericaVenture Forum Conference Bio MidAmerica Venture Forum Conference is a new regional venture conference for the financial communities and biotechnology companies in America’s heartland. The conference will showcase the Midwest’s most promising seed,early and latestage biotechnology products and platform companies. The states involved in this collaboration include Iowa, Indiana, Illinois, Michigan, Minnesota, Missouri, Ohio,and Wisconsin. In addition to exposing the Midwest biotechnology scene to premier venture capital firms in the local region, the conference also will bring a national audience comprising the most prestigious firms. These firms will havetheopportunity to review topoftheline lifesciences companies from all over America. There will be workshops highlighting trends in the financial markets and biotech companies. For more information and to register, log onto www.bio.org/midameri ca/2003. April 2730,2003,Sheraton NewOrleans — New Orleans The Health Care ComplianceAssociation’s Compliance Institute 2003 This event is one of the most comprehensive compliance conferences designed to meet the needs of today’s healthcare compliance officers and staff. The meeting will feature multiple HIPAA and compliance sessions, an expert faculty, developing industry immersion sessions, and will feature ses sions on the latest compliance information on the hottest topics and cur rent events. Speakers will include policy makers, enforcement officials, prac ticing lawyers, and active compliance and privacy officers. For more information, contact Erin O’Donnell at 8885808373, email [email protected],or visit www.hccainfo.org. May 56,2003,Grand Hyatt — NewYork Therapeutic Insight 2003 The third annual global pharma and biotech industry confer ence is devoted to strategies for identifying, developing, and dominating therapeutic franchises. The conference includes two days of networking, plenary and breakout sessions for executives in licensing and business development, strategic planning, corporate development, and portfolio and franchise manage ment. For more information, contact DefinedHealth at 9739212850, or visit www.definedhealth.com, or contact Communitech Market Intelligence at 9142457764, or visit www.cmius.com. September 811,2003,Chicago Hilton and Towers — Chicago The 14th AnnualConference of the National Task Force on CMEProvider/Industry Collaboration For more information, contact Regina Littleton at 3124644637 or visit www.amaassn.org/go/cmetaskforce. September 2224, 2003,Marriott WardmanPark — Washington,D.C. 2nd Annual EmergingTechnologiesand Healthcare Inno vations Congress The congress provides healthcare industry executives with an indepth conference convening clinicians, healthcare industry executives, technology thought leaders, and vendors.These executives will address the impact and promise of technology and innovation on the future of healthcare. The forum and trade show will address the relevance and role of a wide range of issues, including Webenabled business processes and medical devices, the telecommunications convergence, and advances in medical and bioinformatics. For more information,contact Rachael Scheinman at 8042257422, ext. 212, email [email protected], or visit www.tethic.com. ONTHECALENDAR 2 April 8 September 22 September 5 May 3 April 27 April 31 March 31 March
