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April 26, 2012

Webinar Series
Innovative Analytical Approaches to Expedite Product Development

Part 1: Strategies to Speed Follow-on Biologicals to Market

Speakers for this Event:
  • Dirk Reitsma, M.D., vice president, global product development, PPD   Learn More
  • William Bakewell, Ph.D., associate director, biopharmaceutical services PPD, cGMP
        laboratory   Learn More
  • Steven Becht, Ph.D., research and development senior research scientist PPD, cGMP
        laboratory   Learn More
  • Strategies to Speed Follow-on Biologicals to Market

    In biosimilars product development (also known as follow-on biologicals), the most successful companies will be those who are able to streamline their analytical, clinical, and regulatory timelines in order to expedite commercialization. One strategy is to extensively characterize the biosimilar in a head-to-head comparison with the FDA-licensed product. A successful demonstration of similarity can reduce the scope of the clinical phase.

    Unlike traditional small molecule generics, biosimilars are complex, high-molecular-weight, three-dimensional proteins. Small differences in the manufacturing process can result in significant differences between the biosimilar and the innovator drug; these differences may alter the safety and efficacy profile of the drug. As a result, the characterization studies needed for a biosimilar go beyond what is needed for a small molecule generic or the typical battery of analytical methods one might perform for stability or release for a biopharmaceutical product.

    This presentation will address strategies and the analytical testing considerations that help speed the process for getting a follow-on biological product to market.

    This webinar is Part 1 of a series on Innovative Analytical Approaches to Expedite Product Development.

    Part 1 - Archive available - see bottom of webpage
    April 26, 2012
    Strategies to Speed Follow-on Biologicals to Market
    Part 2
    May 10, 2012
    Timely and Thorough Extractables/Leachables Evaluations to Expedite Regulatory Approval
    Part 3
    May 24, 2012
    Impurity Identification Using Two-Dimensional LCMS
    Part 4
    June 7, 2012
    Accelerating to Phase I Clinical Trials for All Dosage Forms
    THIS PROGRAM IS INTENDED FOR:
    • Chief Scientific Officers, Principal Scientists, VPs and Directors of Research and Development
    • Chief Medical Officers, Medical Directors
    • VPs, Directors of Technical Operations
    • VPs, Directors of Purchasing

    For large and medium pharma and biotech companies

    ABOUT OUR SPEAKERS

     

    Dirk Reitsma, M.D., vice president, global product development, PPD

    Dirk Reitsma, M.D., is vice president and head of oncology global product development at PPD. He established and leads the company’s biosimilar services development group, which brings together cross functional, global expertise and resources in the development of large molecule biologic drugs.

    Dr. Reitsma has extensive clinical development experience, having joined PPD from MedImmune, where he served as vice president of clinical development since 2004. At MedImmune, he led the company’s active clinical oncology programs in biologics and oversaw the expansion of its oncology clinical development department. Dr. Reitsma’s experience also includes serving as vice president of clinical affairs and medical director at Antigenics, and as associate director and senior clinical research physician in oncology at Novartis Pharmaceuticals. Earlier in his career, he was associate director, clinical research head, clinical section, at Bionetics Research, Inc. and medical advisor in the medical research department at Organon International, Inc. in Rotterdam, The Netherlands.

    Dr. Reitsma received a bachelor’s degree in science from the Medical Faculty of Rotterdam and a medical degree from Erasmus University in The Netherlands.

     

    William Bakewell, Ph.D., associate director, biopharmaceutical services PPD, cGMP laboratory

    As associate director of biopharmaceutical services for PPD’s cGMP labs in Middleton, Wis., William Bakewell manages a team of scientists and provides oversight and review of method development and validation and stability testing projects. He works with clients on proposals, contracts, laboratory investigation reports and final project reports.

    Before joining PPD, Bakewell held positions of increasing responsibility with another CRO, progressing from associate scientist to senior director of biotechnology. With more than 17 years in the biotechnology field, Bakewell is experienced in ligand binding techniques, cell biology and chromatographic, electrophoretic and quantitative analysis. He also has proven expertise in method development and validation to support characterization, release and stability studies for biopharmaceutical products under cGMP.

    Bakewell earned a doctorate degree in toxicology from the University of North Carolina - Chapel Hill, bachelor’s degree in biology from North Carolina State University and an associate’s degree in medical technology from the United States Air Force. He is a member of the American Association of Pharmaceutical Scientists. His roster of publications and professional presentations demonstrate a wide range of expertise with relevance to multiple therapeutic areas.

     

    Steven Becht, Ph.D., research and development senior research scientist PPD, cGMP laboratory

    As a senior research scientist in PPD’s cGMP lab in Middleton, Wis., Steven Becht manages the bio-molecular mass spectrometry (MS) group, including business development, revenue projection and tracking, and proposal development functions. He is responsible for evaluating new methodologies and technologies to support business growth of the group. Since joining PPD in 2002, Steven also has held positions as research and development scientist and senior research scientist.

    Throughout his career, Steven has gained extensive experience in the medical microbiology field, including project management, routine analysis, research and development and business development and become skilled in active pharmaceutical high performance liquid chromatography method development, high resolution mass spectrometry and biological fluid analysis for pharmaceutical compounds. In addition to his experience at PPD, he has worked as a research and development microbiologist with Trek Diagnostic Systems and chemist for Wisconsin Analytical and Research Services.

    Steven earned a doctorate degree in medical microbiology and immunology as well as bachelor’s degrees in biochemistry and molecular biology from the University of Wisconsin – Madison.

    OUR XTALKS PARTNER FOR THIS EVENT

    PPD is a global contract research organization (CRO) providing discovery, development and lifecycle management services. With offices in 45 countries and more than 11,500 employees worldwide, PPD has conducted clinical trials in over 100 nations, and we have worked with all of the top 50 pharmaceutical companies.

    PPD is a leading provider of chemistry, manufacturing and controls (CMC) laboratory services for all phases of drug development and follows current Good Manufacturing Practices (cGMPs). Our cGMP laboratories provide fully integrated product and analytical development services ranging from early characterization through commercial release and stability. Our highly qualified cGMP lab staff works with large and small molecules, including active pharmaceutical ingredients (API), drug products, inhaled products and other medical devices. With more than 200,000-square- feet of cGMP laboratory space, we have locations in Athlone, Ireland; Middleton, Wis.; and Wayne, Pa., to meet our clients’ needs.

    For more information, visit www.ppdi.com.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

     
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