Introduction

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Taren Grom, Editor

NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.

The Pulse of the Industry By Taren Grom This first annual PharmaVOICE Year in PreVIEW is designed to provide an overview of the challenges and trends expected to impact the life-sciences industry in the coming year and beyond. For this special forum, a distinguished list of more than 100 industry executives, representing an array of industry sectors, disciplines, titles, and areas of responsibility, shared their views and strategies on the following topics: business models, CDISC Study Data Tabulation Model (SDTM), drug development, financing, global issues, importation/price controls, innovation, intellectual property, marketing/promotion, medical education, Medicare, multifunctional teams, patient safety, regulatory, reputation enhancement, risk management, shareholder value, salesforces, supply chain, and technology. Mark J. Ahn, Ph.D. President and CEO, Hana Biosciences Inc., South San Francisco, Calif.; Hana is a biopharmaceutical company that acquires, develops, and commercializes innovative products for the treatment of unmet medical needs in cancer and immunological diseases. For more information, visit hanabiosciences.com. Michael J. Astrue. President and CEO, Transkaryotic Therapies Inc., Cambridge, Mass.; Transkaryotic Therapies is a biopharmaceutical company with a focus on developing products for the treatment of rare diseases. For more information, visit tktx.com. Lee Babiss, Ph.D. VP, Preclinical Research and Development, Roche, Nutley, N.J.; Roche is a leading healthcare company. For more information, visit rocheusa.com. Kevin Barnett. Senior VP, Managed Markets Practice, Campbell Alliance, Raleigh, N.C.; Campbell Alliance, a specialized management consulting firm serving the pharmaceutical and biotechnology industries, helps clients develop strategic and operational plans, as well as improve the efficiency of their internal operations. For more information, visit campbellalliance.com. Pat Barrett. VP, Integic Corp., Chantilly, Va.; Integic is a provider of software applications and business-process management solutions, connecting legacy environments to online business. For more information, visit integic.com. Dr. Beh Swan Gin. Director Biomedical Sciences Group, Singapore Economic Development Board, Singapore; The Singapore EDB is the lead agency that plans and executes strategies to sustain Singapore as a compelling global hub for business and investment. For more information, visit sedb.com. Angel Biaggi. VP, Marketing, STADA Pharmaceuticals Inc., Cranbury, N.J.; STADA Pharmaceuticals, a wholly owned subsidiary of STADA Arzneimittel AG, is a pharmaceutical company specializing in the marketing of generic and branded pharmaceutical products for the U.S. market. For more information, visit stadausa.com. (Note: The views expressed in this forum by Mr. Biaggi are his and do not necessarily represent the views of STADA Pharmaceuticals or its affiliates.) Jeffrey O. Boily. President and CEO, Rogers Medical Intelligence Solutions, New York; Rogers Medical Intelligence Solutions provides trusted information and insights on the latest medical and clinical research worldwide. For more information, visit rogersmis.com. Michael W. Bonney. President and CEO, Cubist Pharmaceuticals Inc., Lexington, Mass.; Cubist is a biopharmaceutical company focused on the research, development, and commercialization of anti-infective products for unmet medical needs. For more information, visit cubist.com. Jay A. Bua. President and CEO, Ascend Therapeutics Inc., Herndon, Va.; Ascend Therapeutics is an emerging biopharmaceutical company engaged in the research and development of therapeutic products for transdermal delivery. For more information, visit ascendtherapeutics.com. John J. Campbell. CEO, Campbell Alliance, Raleigh, N.C.; Campbell Alliance, a specialized management consulting firm serving the pharmaceutical and biotechnology industries, helps clients develop strategic and operational plans, as well as improve the efficiency of their internal operations. For more information, visit campbellalliance.com. Laura Carabello. Director, iTrials, Provisio Inc., Nashville, Tenn.; iTrials, a service of Provisio, is a trial-enrollment service. For more information, visit itrials.com. Geert Cauwenbergh, Ph.D. Chairman and CEO, Barrier Therapeutics Inc., Princeton, N.J.; Barrier Therapeutics is a pharmaceutical company focused on the discovery, development, and commercialization of pharmaceutical products in the field of dermatology. For more information, visit barriertherapeutics.com. Richard Chamberlain. President, Chamberlain Communications Group Inc., New York; Chamberlain Communications is a full-service public-relations agency. For more information, visit chamberlainpr.com. Paul D. Cottone. Chairman, President, and CEO, Odyssey Pharmaceuticals Inc., East Hanover, N.J.; Odyssey Pharmaceuticals is a specialty pharmaceutical company, and a wholly owned subsidiary of PLIVA Inc., focused on key therapeutic categories, including urology, respiratory, and metabolic disorders. For more information, visit odysseypharm.com. (Note: As this issue went to press, Mr. Cottone is no longer with Odyssey Pharmaceuticals; Wayne Yetter has assumed the titles of president and CEO.) Gregg Dearhammer. Director, Biometrics, Kendle International Inc., Cincinnati; Kendle is a global CRO delivering clinical-development solutions to help the world’s biopharmaceutical companies maximize product life cycles and grow market share. For more information, visit kendle.com. Donald L. Drakeman, Ph.D., J.D. President and CEO, Medarex Inc., Princeton, N.J.; Medarex is a biopharmaceutical company focused on the discovery and development of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases. For more information, visit medarex.com. Edward L. Erickson. Chairman, President, and CEO, Immunicon Corp., Huntingdon Valley, Pa.; Immunicon has developed a platform focusing on cell-based and molecular diagnostic products for monitoring cancer. For more information,visit immunicon.com. Scott Freedman. President, MonitorForHire.com, Conshohocken, Pa.; MonitorForHire.com is a leading Web-enabled resource management company providing qualified, regional independent clinical monitors to the pharmaceutical, biotechnology, medical-device, and contract research industries. For more information, visit monitorforhire.com. Paul E. Freiman. President and CEO, Neurobiological Technologies Inc., Richmond, Calif.; Neurobiological Technologies is a biotechnology company engaged in the business of acquiring and developing central nervous system-related drug candidates. For more information, visit ntii.com. John Freshley. President and CEO, Genetics Squared Inc., Ann Arbor, Mich.; Genetics Squared is an emerging biotechnology company whose mission is to advance the clinical development of therapeutics and to rescue failed drugs by discovering novel diagnostics that predict disease progression and patient response. For more information, visit genetics2.com. Aaron Graham. VP and Chief Security Officer, Purdue Pharma L.P., Stamford, Conn.; Purdue Pharma, and its independent U.S. associated companies, are known for their pioneering research on a principal cause of human suffering: persistent pain. For more information, visit purduepharma.com. J. David Haddox, DDS, M.D. VP, Risk Management and Health Policy, Purdue Pharma L.P., Stamford, Conn.; Purdue Pharma, and its independent U.S. associated companies, are known for their pioneering research on a principal cause of human suffering: persistent pain. For more information, visit purduepharma.com. Paul Hamelin. President and Chief Operating Officer, AlgoRx Pharmaceuticals Inc., Secaucus, N.J.; AlgoRx is a privately held, emerging pharmaceutical company focused on the development and commercialization of products to treat pain. For more information, visit algorx.com. Dennis Hurley. VP, Latin America, Kendle International Inc., Cincinnati; Kendle International is a global CRO delivering clinical-development solutions to help the world’s biopharmaceutical companies maximize product life cycles and grow market share. For more information, visit kendle.com. Bob Karczewski. Executive VP, Director of Client Services, HealthSTAR Communications Inc., Woodbridge, N.J.; HealthSTAR is a healthcare marketing services network. For more information, visit healthstarcom.com. Thomas Kempisty. Senior VP, Strategic Business Development, HealthEd, Clark, N.J.; HealthEd is an agency devoted to creating and implementing integrated patient- centered marketing campaigns that focus on driving consumer behavior through educationally relevant strategies and tactics. For more information, visit healthed.com. Faiz Kermani, Ph.D. Budgets, Proposals, and Marketing Executive, Business Development, Chiltern International Ltd., Slough, United Kingdom; Chiltern International has extensive experience running clinical trials from Phase I to Phase IV across a broad therapeutic range. For more information, visit chiltern.com. Douglas M. Kolodny-Hirsch, Ph.D., MBA. VP, Business Development, Chesapeake PERL Inc., College Park, Md.; Chesapeake PERL is a privately held, protein-manufacturing company whose PERLXpress platform technology overcomes major barriers presented by cell-based systems. For more information, visit c-perl.com. Carol Kovac. General Manager, IBM Healthcare and Life Sciences, Somers, N.Y.; IBM Healthcare and Life Sciences brings together IBM resources, including IT, deep industry insights, and research expertise to help clients develop and deliver safer, more affordable, and more effective diagnostics, drugs, and medical care. For more information, visit ibm.com/industries/healthcare. Steven A. Kriegsman. President and CEO, CytRx Corp., Los Angeles; CytRx is a biopharmaceutical research and development company focusing on the area of small molecules and ribonucleic acid interference (RNAi). For more information, visit cytrx.com. Rich Levy. Consultant; Mr. Levy has more than 20 years of experience as a healthcare advertising executive. For more information, e-mail rlevy11462@aol.com. Steven Levy. Managing Director, Business Development, Fletcher/CSI, Williston, Vt.; Fletcher/CSI provides customized, targeted, primary competitive and market intelligence to the world’s healthcare community. For more information, visit fletchercsi.com. Warren P. Levy, Ph.D. President and CEO, Unigene Laboratories Inc., Fairfield, N.J.; Unigene is a biopharmaceutical company engaged in the research, production, and delivery of peptide drugs. For more information, visit unigene.com. Ted W. Love, M.D. CEO, President, and Director, Nuvelo Inc., Sunnyvale, Calif.; Nuvelo is a biopharmaceutical company dedicated to the discovery, development, and commercialization of treatments for acute cardiovascular indications and cancer. For more information, visit nuvelo.com. Merrill Matthews, Ph.D. Resident Scholar, Institute for Policy Innovation, Lewisville, Texas; Institute for Policy Innovation is a nonprofit, nonpartisan public policy think tank. For more information, visit ipi.org. Pamela McNamara. CEO, CRF Inc., Waltham, Mass.; CRF, with global headquarters in Helsinki, Finland, provides electronic patient diaries and multichannel data capture for clinical trials. For more information, visit crfhealth.com. Michael Muyot. President, Tracer Analytics, New York; Tracer is an independent supplier of strategic financial intelligence. For more information, visit traceranalytics.com. Kristine Nash-Wong. Marketing Manager, HealthMedia Inc., Ann Arbor, Mich.; HealthMedia is a technology and health management company that builds and delivers individualized, one-to-one consumer solutions for the pharmaceutical/medical-device market, the healthcare market, and organizations focused on disease management. For more information, visit healthmedia.com. Michael Owings. VP, Quality and Regulatory Compliance, Phase Forward, Waltham, Mass.; Phase Forward is a provider of integrated data management solutions for clinical trials and drug safety. For more information, visit phaseforward.com. Bruce A. Peacock. President and CEO, Adolor Corp., Exton, Pa.; Adolor is a biopharmaceutical company specializing in the discovery, development, and commercialization of novel prescription pain-management products. For more information, visit adolor.com. Mark S. Perlotto. Executive VP, Chief Marketing Officer, Adair-Greene Healthcare Communications, Atlanta; Adair-Greene offers a full range of services tailored to meet each client’s individual needs, all geared either toward successful product introduction or the creation and maintenance of a competitive advantage for products already on the market. For more information, visit aghealthcare.com. David S. Rosenberg. Associate Director, Marketing, Pain and Critical Care, aaiPharma Inc., Wilmington, N.C.; aaiPharma is a science-based pharmaceutical company focused on pain management. For more information, visit aaipharma.com. (Note: As this issue went to press, Mr. Rosenberg is no longer with aaiPharma; he is now with the newly merged company of UCB Pharma and Celltech.) Kathryn Roy. VP, Marketing, Phase Forward, Waltham, Mass.; Phase Forward is a provider of integrated data management solutions for clinical trials and drug safety. For more information, visit phaseforward.com. Brent Saunders. Senior VP, Global Compliance and Business Practices, Schering-Plough Corp., Kenilworth, N.J.; Schering-Plough is a global science-based healthcare company. For more information, visit scheringplough.com. David R. Savello, Ph.D. Executive VP and Chief Technology Officer, Cardinal Health Inc., Dublin, Ohio; Cardinal Health has a broad suite of products and services that help improve quality, safety, and efficiency all along the chain of care. For more information, visit cardinal.com. Richard Schuerger, Ph.D. Practice Executive, Sales Practice, Campbell Alliance, Raleigh, N.C.; Campbell Alliance, a specialized management consulting firm serving the pharmaceutical and biotechnology industries, helps clients develop strategic and operational plans, as well as improve the efficiency of their internal operations. For more information, visit campbellalliance.com. Jim Scozzie, Ph.D. Senior VP, BioEnterprise Corp., Cleveland; BioEnterprise is a business formation, recruitment, and acceleration initiative designed to grow bioscience companies. For more information, visit bioenterprise.com. Matthew Shanahan. Chief Marketing Officer, Teranode Corp., Seattle; Teranode is an innovator in design automation for the life-sciences industry, providing software that accelerates decision making, collaboration, and compliance. For more information, visit teranode.com. Nigel Sheail. Global Head, Acquisitions and Strategic Alliances, Pharma Partnering, Roche, Nutley, N.J.; Roche is a leading healthcare company. For more information, visit rocheusa.com. David L. Stern. VP, Marketing, Metabolic and Endocrinology, Serono Inc., Rockland, Mass.; Serono, with corporate headquarters in Geneva, Switzerland, is a global biotechnology company. For more information, visit seronousa.com. Destry J. Sulkes, M.D. Managing Director, Eastern Region, Medsn, Jersey City, N.J.; Medsn, with corporate headquarters in Culver City, Calif., is a medical-education company that designs and implements highly interactive and traditional media-educational programs for pharmaceutical, medical-device, biotechnology, and healthcare organizations. For more information, visit medsn.com. Scott Szwast. Sector Marketing Manager, UPS Supply Chain Solutions, Alpharetta, Ga.; UPS Supply Chain Solutions has resources to manage every aspect of global supply chains, from transportation management to logistics and distribution to customs brokerage and international trade services. For more information, visit ups-scs.com. Brad Thompson, Ph.D. Chairman, President, and CEO, Oncolytics Biotech Inc., Calgary, Canada; Oncolytics Biotech is a biotechnology company focused on the development of Reloysin, its proprietary formulation of the human retrovirus, as a potential cancer therapeutic. For more information, visit oncolyticsbiotech.com. W. Leigh Thompson, Ph.D., M.D., Sc.D., FACP, FCCM. President and CEO, Profound Quality Resources Ltd., Charleston, S.C.; Profound Quality Resources is a worldwide scientific consulting firm. For more information, call 843-577-8936. (Note: Dr. Thompson also was a former Professor of Medicine at CWRU, Indiana University; former Chief Scientific Officer at Eli Lilly; and former President and Honorary Life Member of SCCM.) Thomas Tillett. President and CEO, RheoGene Inc., Norristown, Pa.; RheoGene, a wholly owned affiliate of the University of Pittsburgh Medical Center, is the source for advanced products, applications, and technologies that regulate gene expression for the development of safe and effective therapeutics. For more information, visit rheogene.com. Nancy Turett. President and Global Director Health, Edelman, New York; Edelman is an independent public relations firm. For more information, visit edelman.com. Gary Tyson. VP, Clinical Development Practice, Campbell Alliance, Raleigh, N.C.; Campbell Alliance, a specialized management consulting firm serving the pharmaceutical and biotechnology industries, helps clients develop strategic and operational plans, as well as improve the efficiency of their internal operations. For more information, visit campbellalliance.com. Robbert P. Van Manen. Worldwide Technical Director, Phase Forward, Waltham, Mass.; Phase Forward is a provider of integrated data-management solutions for clinical trials and drug safety. For more information, visit phaseforward.com. Thomas Wicks, Ph.D. VP of Regulatory Affairs, Odyssey Pharmaceuticals Inc., East Hanover, N.J.; Odyssey Pharmaceuticals is a specialty pharmaceutical company, and a wholly owned subsidiary of PLIVA Inc., focused on key therapeutic categories, including urology, respiratory, and metabolic disorders. For more information, visit odysseypharm.com. Michael K. Wilhelm. CEO, Director, and Founder, ImmuneRegen BioSciences Inc., Scottsdale, Ariz.; ImmuneRegen Biosciences is a biotechnology company engaged in the research and development of applications using modified substance P, a naturally occurring immunomodulator. For more information, visit immuneregen.com. Scott Wilhoit. VP, Managed Markets, Biovail Corp., Mississauga, Ontario; Biovail is a fully integrated pharmaceutical company engaged in the development, manufacturing, marketing, licensing, and distribution of pharmaceutical products primarily in North America with a primary focus on cardiovascular disease, central nervous system disorders, and pain management. For more information, visit biovail.com. Marcus Wilson, Pharm.D. President, HealthCore Inc., Wilmington, Del.; HealthCore, an independent subsidiary of WellPoint Health Networks, is a full-service pharmaceutical research and consulting firm that provides outcomes research and conducts clinical trials for new medicines. For more information, visit healthcore.com. Kleanthis G. Xanthopoulos, Ph.D. President and CEO, Anadys Pharmaceuticals Inc., San Diego; Anadys discovers, develops, and commercializes novel small-molecule medicines for the treatment of chronic viral infections and bacterial infections. For more information, visit anadyspharma.com. Gregory P. Young. President and CEO, NeoPharm Inc., Lake Forest, Ill.; NeoPharm is a biopharmaceutical company engaged in the research, development, and commercialization of drugs for the treatment of various forms of cancer. For more information, visit neophrm.com. Jerome B. Zeldis, M.D., Ph.D. Chief Medical Officer and VP of Medical Affairs, Celgene Corp., Warren, N.J.; Celgene is a pharmaceutical company with a focus on the discovery, development, and commercialization of small molecules for cancer and immunological diseases. For more information, visit celgene.com.

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