Innovation in excipients is important to optimize a drug formulation, but there are barriers to innovation, including regulatory barriers, which excipient manufacturers and users are seeking to address. Providing the latest developments and insights is Dave Schoneker, President of Black Diamond Regulatory Consulting, LLC, which specializes in providing regulatory and quality consulting in formulation development and excipient selection and use. Schoneker is a past Chair of the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas), a current Emeritus member of the IPEC-Americas Executive Committee, and current Chair of the Quality by Design/Composition Committee of IPEC-Americas, where he is involved with the development of regulatory, safety, excipient GMP, and supplier qualification-related guidelines to improve excipient acceptability, safety, and global supply chain security.

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