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January 14, 2013

Best Practices for Outsourcing Drug Development: The Human Elements of a Successful Relationship

Speakers for this Event:
  • Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories    Learn More
  • Thomas J. Wilson, Vice President of Quality, Synta Pharmaceuticals Corp.   Learn More

  • Most of us involved in outsourcing are familiar with the contractual and other practical considerations involved in selecting a CRO. But we also know that the heavy lifting occurs after the contract has been inked. In this webinar, industry experts on both sides of the sponsor/CRO relationship will delve into the human elements that can make or break development success.

    Learn how to dramatically enhance the value derived from outsourcing, without additional expense!

     

    WHO SHOULD ATTEND

    Pharmaceutical and Biotechnology companies, including VPs/Directors/Managers of

    • Research and Development
    • Product Development
    • CMC Operations
    • Technical Operations

    Anyone involved in the decision-making process for outsourcing drug development services, particularly analytical services

    ABOUT OUR SPEAKERS

    Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories

    Dr. Wayland Rushing is a technical expert in all aspects of Chemistry Manufacturing and Controls (CMC) program design, analytical development and regulatory submissions. Over his 12-year career, he has led CMC development programs for a wide array of biopharmaceuticals, including parenterals, inhalation drugs, and other pharmaceuticals with complex delivery systems.

    Dr. Rushing is a subject matter expert in HPLC and GC method development and validation, extractables and leachables program design and regulatory submission requirements; has drafted multiple IND and NDA submissions; and assists ABC clients in responding to FDA deficiency letters. Dr. Rushing currently serves on Parenteral Drug Association (PDA) advisory committees for Technology Transfer and Elastomeric Closures and Seals Defects.

     

    Thomas J. Wilson, Vice President of Quality, Synta Pharmaceuticals Corp.

    Mr. Wilson is the Vice President of Quality Assurance at Synta Pharmaceutical Corp. in Lexington, MA. He joined the company in November 2012 with over 21 years of industry experience in quality assurance and quality control as well as other areas related to chemistry, manufacturing, and controls (CMC). He has been heavily involved with the outsourcing of analytical services since 1998.

    Mr. Wilson established the quality departments and systems for Sepracor (from 1998 to 2006, now Sunovion), Orexigen Therapeutics (from 2008 to 2011), and Euthymics Bioscience (from 2011 to 2012). He also provided regulatory and CMC consulting while at Analytical Bio-Chemistry Laboratories from 2006 to 2008, and held quality and analytical positions at Mallinckrodt (now Covidien) and Granutec, a former subsidiary of Novopharm Ltd. Mr. Wilson received a B.Sc from Truman State University.

    OUR XTALKS PARTNER FOR THIS EVENT

    Established in 1968, Analytical Bio-Chemistry (ABC) Laboratories, Inc. is a Contract Research Organization that delivers a broad array of product development and analytical testing services to the pharmaceutical, biotech, animal health, and chemical industries. The company supports all stages of large and small molecule drug development with expert analytical support, custom synthesis and radiolabeling, environmental assessments and drug development consulting services.

    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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