Pharmaceutical Product Development
Mr. Butz is an experienced regulatory and product development strategist providing direction for the development, validation and marketing of Dx, CDx, medical devices and targeted therapeutics. He is skilled at developing regulatory strategy plans and coordinating FDA engagements throughout the product lifecycle including Pre-Submissions, Pre-INDs, Pre-RFDs and marketing applications. Mr. Butz has demonstrated leadership in providing project management, strategy, technical expertise and coordination oversight for Dx, CDx, medical device, and therapeutics projects. Leveraging more than 20 years of combined experience as a molecular and cellular biologist and product development specialist, Mr. Butz provides expertise and strategic leadership in precision medicine models and the co-development of biomarkers and CDx with therapies. In his current role, Mr. Butz chairs the cross functional MDD Working Group and supports PPD’s precision medicine initiatives.
Mr. Butz has progressive experiences in regulatory science, product development and quality requirements of Dx, devices, and therapeutic products having developed, led and managed many areas of compliance including submissions, QC/QA, manufacturing, and cGCP-compliant IVD clinical trials. He brings knowledge of cGxP, CLIA, 21 CFR Part 820, ISO 13485, and EU IVD Regulation 2017/746 to the development and commercialization of products, tests, assays, and processes. Mr. Butz has a broad and global perspective in Dx beginning as a molecular biologist and including experience in basic and applied research and assay development, optimization, and validation to support the development of molecular markers and biomarkers for Dx products.
Prior to PPD, Mr. Butz’s career included academic research (Cleveland Clinic Foundation, University at Buffalo), Dx industry experience (AMRESCO, Gentris, ParagonDx), and regulatory consulting (Vista Bioconcepts, Conatus Consulting). He holds an M.Sc. degree in Bioscience from Marshall University and a B.Sc degree in Natural Sciences from Muhlenberg College.
Wednesday, September 16, 2020
10:35 AM – 11:30 AM EDT