Major Pharma Clinical Case Studies from Amgen, AstraZeneca, GSK, Intermune, Cephalon Inc, Sunesis Pharmaceuticals and Dartmouth Medical School during 1st Quarter ExL Pharma Programs

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NEW YORK, Dec. 11 // -- ExL Pharma brings in the New Year with a variety of educational and networking opportunities addressing the leading issues facing the pharmaceutical industry in 2008. These market-derived events target executives in Clinical, R&D, Regulatory, Medical Affairs and Marketing from large to small pharmaceutical, biotech, device and medical technology companies.

    Listed below are details on some of the featured events and highlights from those conferences:

    January 14-15, Arlington, VA

    3rd Clinical Data Disclosure Summit -- Implementing and Maintaining

    Compliant Trial Registries and Results Databases for Drugs, Biologics and

    Medical Devices The passing of the FDA Amendments Act changes clinical data disclosure requirements for all companies conducting clinical trials. Dr. Brett Koplow of Patton Boggs details the specifications of this federal legislation with regards to clinical disclosure and the evaluates the potential consequences of violation. GlaxoSmithKline's Dr. Craig Metz, Vice President, Center of Excellence for Drug Development shares GSK's Experience with Clinical Research Transparency, specifically the ramifications of Avandia's publicly disclosed data. The ICMJE present on their specific clinical registration requirements in order to publish in medical journals. In addition hear AstraZeneca, Genentech, Novo Nordisk. NIH, Abbott, Tap Pharmaceuticals, Medtronic and J&J share their thoughts, opinions and experiences on turning clinical data into a public commodity.

    January 14-15, Philadelphia, PA

    Utilizing Biomarkers to Determine Optimal Dose

    ExL Pharma is proud to announce their Utilizing Biomarkers to Determine Optimal Dose conference taking place January 14-15 in Philadelphia where the industry will gather to speak about predicting drug response, reducing risk of adverse events and increasing drug efficacy. Hear case study examples from Roche Diagnostics, Novartis, MedImmune Inc, Wyeth, and Eisai and join the industry's leading authorities on Dose Selection, Dose Estimation, and Molecular profiling applications to discuss experiences, strategies and best practices for working with Biomarkers to Determine Optimal Dose.

    February 4-5, Annapolis, MD

    2nd Clinical Research Billing & Budget Compliance

    With new speculation on forthcoming billing guidance's, the 2008 Clinical Research Billing and Budget Compliance is the leading event that brings together both clinical research providers and the research sponsors to discuss all of the pressing issues. This event brings together unique legal/regulatory perspectives and never before heard case studies on how to maintain compliance with these ever changing guidance's and on how to create new operational efficiencies in your clinical research.

    February 11th - 12th, Tampa Bay, Florida

    Lean Six Sigma for Pharmaceutical R&D -- Providing Presentations for

    Different DMAIC Phases -- Define, Measure, Analyze, Improve, Control

    Research and Development areas of pharmaceutical companies have had success applying Lean Six Sigma methodologies to their process improvement projects. Elimination of defects, defining cost-saving potential, and enhancing cycle times are all byproducts of Lean and Six Sigma process enhancements. Hear from Centocor's Process Management Team -- Patrick Hopkins and Sheila Smith will discuss Lean Implementation in an R&D Lab and specifically the Six Keys to managing change. Keith Russell, Director of Enhancing Product Delivery at AstraZeneca will discuss Improving R&D Processes and Systems using Lean Six Sigma. In addition, hear Wyeth, Amgen, JMP, GlaxoSmithKline, and CLG share their experiences and lessons learned using Lean and Six Sigma methodology within Clinical R&D processes.

    February 11-12, Tampa, FL

    Direct to Docs

    Physician Targeted Marketing and Sales Strategies: Exploring Tactics and

    Strategic Solutions It's no surprise that doctors are harder to reach now than ever before. That's why ExL Pharma's Direct to Docs conference is the perfect alternative for Physician Marketers looking for proactive solutions without dwelling on redundant data and facts. Packed with industry-led case studies from key leaders such as Genentech and AstraZeneca, this event provides pharmaceutical marketers with the latest tools and methodologies currently in use by industry peers to access and build meaningful relationships with physicians.

    February 21-22, Miami, Florida

    7th Successful Compliant Investigator Initiated Trial Programs

    Register today for the premier conference in the industry on Investigator Initiated Trials taking place on February 21-22, 2008 at the Hyatt Regency Miami located on the scenic Miami River. New topics such as Determining Fair Market Value and How FDA Views IITs to Avoid Major Pitfalls, along with Case Studies from Pfizer, Takeda, Baxter, Medtronic, Millennium and Wyeth will provide valuable information and networking opportunities. Coinciding with the conference, ExL is also proud to host the inaugural meeting for IISRA, the Investigator Initiated Sponsored Research Association which will take place on the afternoon of Day Two. Conference attendees will able to reap the benefits of the conference and the newly formed IIT association designed to shape best practices and future guidelines.

    February 25-26, Philadelphia, PA

    2nd Annual Search Engine Marketing for Pharmaceuticals

    Following the successful meeting last February, the 2nd SEM brings together leading eMarketing and Interactive Agency executives that work in the pharmaceutical sector to discuss the new strategies and tactics needed for a successful search campaign. Our distinguished faculty includes speakers from AstraZeneca, Eli Lilly, Bayer-Schering, Google, IBM, The Federal Trade Commission, Medtronic, Daiichi-Sankyo, Sepracor and more.

    February 25-26, Philadelphia, PA

    3rd Data Monitoring Committees/DSMBs Conference -- Evaluating Trial Safety

    and Efficacy through Independent Examination of Interim Clinical Data

    Renowned DMC/DSMB experts Dr. David DeMets, Professor & Chair of the Department of Biostatics and Medical Informatics at the University of Wisconsin and Dr. Susan Ellenberg, Professor of Biostatistics and Associate Dean of Clinical Research at the University of Pennsylvania join the speaking faculty of ExL Pharma's 3rd DMC conference, taking place February 25-26 at the Loews in Philadelphia. Dr. Chuck Shear, Vice President of Cardiovascular- Metabolic Development and Leader of the Torcetrapib Program at Pfizer, describes the Torcetrapib case study and the sponsor's view on trial termination based upon DMC recommendation. Also hear from senior-level executives from Novartis, GSK, Eli Lilly, Cytel, Applied Clinical Intelligence, Icon and more share on working with DMCs/DSMBs to ensure drug safety and efficacy in clinical trials.

    March 10th - 11, Miami, Florida

    Latin America Clinical Trials -- Achieving Regulatory Harmony to

    Facilitate Patient Recruitment

    The only event in the US where senior-level executives from regulatory agencies, IRB's, healthcare institutions and pharma companies discuss vital issues for running clinical trials within Latin America. Featuring topics such as the Examination of Latin America Regulatory Requirements with perspectives from the Regulatory Agencies of Brazil and Argentina, ANVISA and ANMAT. Also, Enrique Isola from Novartis will discuss specific successes and difficulties in the implementation of clinical trials in Latin America over the last decade and Elaine Rahal from BMS will discussion specific patient recruitment, retention and abandonment issues. Featuring viewpoints from Astrazeneca, ANVISA, Novartis, ANMAT, St. Jude's Children Hospital, Bristol Myers-Squibb, PAREXEL, Brazilian Society of Pharmaceutical Medicine, RBS, Roche, and the national ethical committee of Brazil, RPS, and CONEP.

    March 10-11, Philadelphia, PA

    Post-Approval Drug Surveillance

    ExL Pharma is proud to announce their Post-Approval Drug Surveillance conference taking place march 10-11 in Philadelphia. This is the only event that will cover strategies for developing and improving safety, effectiveness, value and quality of products post-approval. Hear case study examples from Amgen, Pharmanet Inc, Astrazeneca, and Vertex Pharmaceuticals and join the industry's leading authorities on Drug Surveillance and Regulatory Affairs to discuss experiences, strategies and best practices for working with Post approval plans to strengthen your safety and surveillance program.

    To view our full list of upcoming conferences and webinars and details on our expert speaking faculties or to REGISTER, Log onto:

    *Please mention Registration Code: EXL1211 when registering

    About ExL

    ExL Pharma, a division of ExL Events, Inc., is an emerging leader in developing innovative, educational events that serve the healthcare community and allied professionals. Behind our diverse conference portfolio, our experienced team conducts extensive market research and targeted outreach. The results translate into innovative, high-quality conference events designed to exceed the dynamic informational needs of the healthcare community.
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