Key Recent, Relevant Publications & Conferences

HIGH-IMPACT JOURNAL PUBLICATIONS

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

PROFESSIONAL SOCETIAL JOURNAL PUBLICATIONS

 

Hybrid Concepts International (HCI)’s Dr. Michael Mendicino Leads Publication Effort for ISCT Committee

 

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

 

 

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

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

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

  • ARM 2019: Legislative fly-in (participant on Capitol Hill)

  • ISCT 2019: Regulatory Impact on Timing of Global Commercialization of Cell & Gene Therapies; Strategies for Commercialization track organizing committee (member)