About Us

    The concept of Pharmaceutical Quality by Design, as articulated by FDA in 2008, advances a smarter approach to drug development, one that examines risks over the entire life cycle of any drug and encompasses, not only finished drugs, but APIs, excipients, drug delivery forms, analytical methods and packaging.

    This Web site will focus exclusively on the key concepts of Quality by Design as they apply to both biopharmaceuticals and small molecule drug development, focusing on the definition of critical quality attributes, critical process parameters and the design space, the use of process analytical technologies (PAT) and risk assessment.

    The end goal is improving technology transfer, eliminating patient safety and environmental risks, quality problems, expensive and redundant testing and documentation, and product failure.

    Writing for this website are a number of expert practitioners within the pharmaceutical industry, as well as global regulators, independent consultants, academics and technology providers. They will share best practices that are being applied today, and also visions of how drug development will work in the future, as QbD methodologies, new technologies and approaches are used to advance a smarter and less wasteful approach to drug development.

    Our Editorial Advisors:

    Ali Afnan
    John Avellanet
    Prabir Basu
    James Blackwell
    Bikash Chatterjee
    Jim Cheney
    Emil Ciurczak
    Alistair Gillanders
    Ajaz Hussain
    Jason Kamm
    Girish Malhotra
    Russ Somma
    Alicia Tebar Perez
    Sam Venugopal

    Contact Us
    Tonia Becker
    Phone: 630-467-1300 ext. 455

    Agnes Shanley
    Phone: 630-467-1300 ext. 410

    Paul Thomas
    Senior Editor
    Phone: 630-467-1300 ext. 326

    Michele Vaccarello Wagner
    Senior Editor, Digital Media
    Phone: 630-467-1300 ext. 463

    Sales Contacts:
    Jeanne Freedland
    Digital Sales Specialist
    Phone: 630-467-1300 x325

    Matt O’Shea
    Associate Publisher
    Phone: 630-467-1300 x373

    Polly Dickson
    Account Manager
    Phone: 630-467-1300 x396