2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)
- Steven Piccoli,
- Devangi Mehta,
- Alessandra Vitaliti,
- John Allinson,
- Shashi Amur,
- Steve Eck,
- Cherie Green,
- Michael Hedrick,
- Shirley Hopper,
- Allena Ji,
- Alison Joyce,
- Virginia Litwin,
- Kevin Maher,
- Joel Mathews,
- Kun Peng,
- Afshin Safavi,
- Yow-Ming Wang,
- Yan Zhang,
- Lakshmi Amaravadi,
- Nisha Palackal,
- Sai Thankamony,
- Chris Beaver,
- Eris Bame,
- Thomas Emrich,
- Christine Grimaldi,
- Jonathan Haulenbeek,
- Alison Joyce,
- Vellalore Kakkanaiah,
- David Lanham,
- Kevin Maher,
- Andrew Mayer,
- Paul C Trampont,
- Laurent Vermet,
- Naveen Dakappagari,
- Catherine Fleener,
- Fabio Garofolo,
- Cynthia Rogers,
- Shabnam Tangri,
- Yuanxin Xu,
- Meina Liang,
- Manoj Rajadhyaksha,
- Susan Richards,
- Becky Schweighardt,
- Shobha Purushothama,
- Daniel Baltrukonis,
- Jochen Brumm,
- Elana Cherry,
- Jason Delcarpini,
- Carol Gleason,
- Susan Kirshner,
- Robert Kubiak,
- Luying Pan,
- Michael Partridge,
- João Pedras-Vasconcelos,
- Qiang Qu,
- Venke Skibeli,
- Therese Solstad Saunders,
- Roland F Staack,
- Kay Stubenrauch,
- Al Torri,
- Daniela Verthelyi,
- Haoheng Yan,
- Boris Gorovits,
- Rachel Palmer,
- Mark Milton,
- Brian Long,
- Bart Corsaro,
- Vahid Farrokhi,
- Michele Fiscella,
- Neil Henderson,
- Vibha Jawa,
- Jim McNally,
- Rocio Murphy,
- Hanspeter Waldner &
- Tong-Yuan Yang