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March 20, 2012

Challenges in Early Comparability Assessment of Biosimilars

Speakers for this Event:
  • J. Fred Pritchard, PhD, Vice President, Global Drug Development, Celerion    Learn More
  •     Introduction and Moderator

  • Raymond Farmen, PhD, Vice President, Global Bioanalytical Services, Celerion    Learn More
  •     Early Stage Studies of Biosimilars

  • Michael E. Placke, PhD, DABT, Senior Vice President and General Manager, Ricerca Biosciences    Learn More
  •     Preclinical Development Strategies for Assessing Biosimilar Comparability

    Challenges in Early Comparability Assessment of Biosimilars

    The success of biologically-derived drug products has driven the demand for “biosimilar” versions of these products to increase competition and reduce costs to patients and providers. However, these products are complex to manufacture. Once an apparent source of drug substance has been established it is critical to understand whether its safety, immunogenicity, pharmacokinetics and pharmacodynamics are comparable to the innovator product before proceeding to expensive multi-center patient studies.

    This webinar will address the key elements of early biosimilar development that provide the bridge between the manufactured product and the larger clinical studies needed to prove comparable efficacy and safety.

    THIS PROGRAM IS INTENDED FOR

    VPs, Directors, and Managers in the following areas:

    • PreClinical, and Clinical Research
    • Toxicologists
    • Pharmacologists
    • Bioanalysis Scientists
    • Medical Directors
    • Clinical Operations
    • Drug Development
    • Research & Development
    • Outsourcing

    Plus Presidents, CEOs, Chief Medical Officers and Chief Scientific Officers for pharmaceutical and biotech companies worldwide

    ABOUT OUR SPEAKERS

    J. Fred Pritchard, PhD, Vice President, Global Drug Development, Celerion

    As Vice President of Global Drug Development, Dr. Pritchard leads a global team of drug development and regulatory affairs experts, project management professionals and alliance managers that work actively with clients to bring their drug products efficiently through early clinical testing.

    Dr. Pritchard brings 30 years of drug development experience to his work, including pre-registration work on five currently marketed pharmaceuticals and several that are currently in clinical development. Leveraging his experience in leading international teams of scientists at large pharmaceutical companies, Dr. Pritchard founded and led a group of consultants and program directors within a full service CRO that collectively worked on nearly 40 integrated drug development programs, bringing several of these through IND into phase I and II clinical trials.

    Dr. Pritchard has given numerous invited lectures at scientific meetings and academic institutions and is an author on over 120 scientific publications and abstracts. He is the 2000 Alumni Fellow of the Penn State College of Medicine, and named one of nine "Notable People in Pharmaceutical R&D" by R&D Directions magazine in 2009. He currently serves on the Therapy Acceleration Program Committee for the Leukemia and Lymphoma Society (LLS), the LLS North Carolina Chapter Board of Trustees and the Executive Committee of the Research Triangle Park Drug Metabolism Discussion Group where he has been past Chair and Treasurer.

    Raymond Farmen, PhD, Vice President, Global Bioanalytical Services, Celerion

    As Vice President of Global Bioanalytical Services, Dr. Farmen leads one of the preeminent bioanalytical groups in the industry. In this role he is responsible for the bioanalytical groups in Lincoln, NE USA and Zurich, Switzerland. These groups offer exceptional expertise in both small and large molecule method development and sample processing in an extremely automated and compliant environment.

    Dr. Farmen comes to Celerion with over 30 years of experience in the contract research organization (CRO) and pharmaceutical industries. Prior to joining Celerion, he held executive positions at PharmOptima, a CRO that specializes in ocular research services; Eurofins AvTech Laboratories, a CRO that specializes in small and large molecule bioanalytical chemistry as well as QC testing and analysis of finished drug products and pharmaceutical ingredients; and Camargo Pharmaceutical Services, a CRO that provides scientific and regulatory oversight during the drug development process. Dr. Farmen also held leadership positions in bioanalytical sciences at MDS Pharma Services, Phoenix International Life Sciences, and Bristol-Myers Squibb.

    Dr. Farmen has in-depth knowledge of both large and small molecule bioanalysis, DMPK, regulatory strategies, and GLP/GMP regulations. He played a pivotal role at the Crystal City meetings which helped to shape the early regulatory landscape and guidelines for bioanalysis of pharmaceutical products.

    Dr. Farmen earned his doctorate in pharmacology from Indiana University and did post-doctoral research in Biochemistry at the Upstate Medical Center in Syracuse, New York.

    Michael E. Placke, PhD, DABT, Senior Vice President and General Manager, Ricerca Biosciences

    Dr. Placke is a seasoned pharmaceutical executive with over 28 years of pharmaceutical industry experience and direct scientific, technical and development responsibility for multidisciplinary pharmaceutical development operations. This has included Drug Safety and Metabolism (DSM) and Chemical Product Development (CPD) divisions in large pharmaceutical companies, private equity/venture-funded start-up firms and contract research organizations (CRO).

    Dr. Placke has led multiple organizations with operating budgets of over $40M and over 300 staff. He has technical and executive-level experience in both large and small specialty pharmaceutical companies developing drug product modalities including small molecule, biologics, vaccines, and respiratory drug products.

    Dr. Placke has a record of accomplishments in research and development of advancing drugs from late discovery through market registration. He has advanced leadership skills and expertise in scientific assessment of new pharmaceutical therapies and technologies with an emphasis on drug safety, non-clinical product development, and early clinical evaluation.

    Formally trained in experimental pathology and toxicology, Dr. Placke is board certified in general toxicology, and a recent director and officer of the American Board of Toxicology.

    OUR XTALKS PARTNERS FOR THIS EVENT

    Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to global clinical research (over 730 beds in Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, global bioanalytical services (discovery through late stage), and drug development services. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. For more information, visit http://www.celerion.com/.


    Ricerca Biosciences offers a comprehensive suite of discovery, preclinical and development services to support drug candidates from lead identification through IND on a global scale. Capabilities include molecular through in vivo screening and profiling, as well as radiochemistry, IND-enabling toxicology, API process chemistry and cGMP manufacturing of clinical and commercial API. Our experienced scientists deliver world-class expertise and services to help you shorten time to IND and bring molecules to the clinic faster. In addition to U.S.-based facilities in Concord, Ohio, and Bothell, Washington, Ricerca also has ISO 9001-certified facilities in Taipei, Taiwan, and Lyon, France. The Lyon and Concord facilities also hold certification from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). For more information, visit http://www.ricerca.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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