Key Recent, Relevant Publications & Conferences

BOOK CHAPTER

Mendicino, M. and Weber, D. (2015) Regulatory and intellectual property considerations for therapeutic human stem cell-based regenerative medicine product development: a US perspective, in Stem Cells in Regenerative Medicine: Science, regulation and business strategies (eds A. A. Vertès, N. Qureshi, A. I. Caplan and L. E. Babiss), John Wiley & Sons, Ltd, Chichester, UK. ch6 

HIGH-IMPACT JOURNAL PUBLICATIONS

  1. An FDA perspective on preclinical development of cell-based regenerative medicine products. Bailey AM*, Mendicino M*, Au P*. Nat Biotechnol. 2014 Aug;32(8):721-3. * all corresponding authors

  2. MSC-based product characterization for clinical trials: an FDA perspective. Mendicino M, Bailey AM, Wonnacott K, Puri RK, Bauer SR. Cell Stem Cell. 2014 Feb 6;14(2):141-5.

 

PRESENTATIONS / PANELS / PARTICIPATION

  • Phacilitate 2015: Can we reach a consensus on what the definition of an MSC should be? (panel)

  • ISCT 2015: Cell-based Regenerative Medicine Products for Clinical Trials – Regulatory Trends, Challenges and Opportunities (Chair, presentation, and panel)

  • NIST 2015: Strategies to Achieve Measurement Assurance for Cell Therapy (panel)

  • ARM 2015: Legislative fly-in (participant on Capitol Hill)

  • IBC 2015: Considerations for Comparability at Progressing Stages of Product and Clinical Development (presentation); Strategies for Commercialization track committee (member)

  • Stem Cells at the Mesa 2015: Led the Scientific Public Forum (Chair)

  • CCRM Cell Manufacturing and Clinical Trials Workshop 2015: Considerations for Comparability at Progressing Stages of Product and Clinical Development (presentation); Regulatory panel (panel)

  • ISCT 2016: Standards Coordinating Body Public Private Partnership Initiative: Formation and Future Prospects (presentation); Strategies for Commercialization track committee (member)

  • ISCT 2016 (NA regional): Considerations for MSC Comparability from the Industry Perspective (presentation and panel)

  • Cell & gene Meeting at the Mesa 2016: Process Improvement and accelerated CMC Development Workshop (Co-Chair as ARM Science & Technology Committee Co-Chair; presentation) youtu.be/t05tD1UizHk; Standards Coordinating Body (SCB) on-site meeting (SCB presentation as President; panel)

  • CCRM Cell Manufacturing and Clinical Trials Workshop 2016: Approaches to improve the development of Cell & Gene therapies via regulatory science and advocacy (presentation)

  • Cell & Gene Therapy Congress 2016: Considerations for an effective BLA strategy for a Cell Therapy Product (presentation) youtu.be/SObD_o_zp68

  • ARM 2017: Legislative fly-in (participant on Capitol Hill)

  • ISCT 2017: Strategies for Commercialization track committee (member); Standards Coordinating Body Public Private Partnership Initiative (on-site meeting)

  • ARM 2018: Legislative fly-in (participant on Capitol Hill)

  • ISCT 2018: Strategies for Commercialization track committee (member); panelist on 21st Century Global Regulatory Impact with Divergent Markets on Commercialization