Updates in Cell and Gene Therapy: Current Trends and Operational Considerations

Jonathan Hogan, MD, Medical Director, Cabaletta Bio; Adjunct Associate Professor of Medicine, Division of Nephrology, University of Pennsylvania

Dr. Jonathan Hogan formerly a clinical trialist in glomerular disease at University of Pennsylvania, now at Cabaletta Bio as Medical Director where he is the clinical lead on their CD19 CAR T Cell Therapy (CABA-201) program for systemic lupus erythematosus.

Prior to joining Cabaletta Bio, Dr. Hogan served as the faculty at the University of Pennsylvania where he was the clinical director of the Penn Glomerular Center for seven years, and where he also started an onco-nephrology program. He was a site PI for multiple NIH- and industry-sponsored studies in glomerular disease. He also conducted original clinical research projects in glomerular disease and onco-nephrology, including work that led to him being a co-inventor for a chimeric autoantibody receptor (CAAR) T Cell therapy for PLA2R positive membranous nephropathy.

Dr. Hogan left academia for industry in 2021. He first joined Janssen as the Director of Clinical Research (immunology therapeutic area) and led a clinical program for lupus nephritis.

Barbara Gillespie, MD, MMS, FASN, VP and Therapeutic Head of Nephrology, Fortrea; Adjunct Professor, Division of Nephrology and Hypertension, University of North Carolina School of Medicine

Barbara Gillespie, MD, MMS, FASN, is a board-certified nephrologist who  has been collaborating with sponsors on renal clinical development, protocol design and execution since 2006.  She is  on the board of directors at the Kidney Health Initiative, a public-private partnership between the FDA and American Society of Nephrology. She also serves on several advisory boards including the NKF Patient Network (CKD Registry) Steering Committee and various NephCure Steering Committees. Dr. Gillespie has served as an associate medical director at a small local dialysis unit until recently.  She completed her internal medicine residency at the University of North Carolina and nephrology fellowship at Duke University.

Frederick Derosier, DO, Vice President and General Manager, Rare Disease, Advanced Therapies and Pediatrics Team (RAPT), Clinical Lead, Enterprise Cell and Gene Therapy, Fortrea

Dr. Frederick Derosier joined Fortrea in 2017 and has over 10 years of private practice experience (internal medicine) and more than 20 years of clinical development experience, primarily in neurosciences and rare diseases, in the pharmaceutical industry with large/mid-sized pharma and biotechs. Dr. Derosier’s experience broadly extends from translational/early phase development through product launch to late phase/post-marketing studies and lifecycle management. He provides medical/scientific leadership for clinical development programs involving rare diseases and/or advanced therapeutics at Fortrea.

Paulla Dennis, Senior Director, Rare Disease, Advanced Therapies and Paediatrics Team (RAPT), Fortrea

Paulla Dennis, Senior Director, is a leading member of the Rare Disease, Advanced Therapies, and Paediatrics Team (RAPT) at Fortrea. With over 24 years in the clinical research industry, Paulla has expertise in global phase I through IV rare disease and pediatric operational strategy and planning. She specializes in working within a team to align strategy, provide operational insights and develop unique solutions to common challenges for rare disease clinical trials. Paulla experience includes project management, clinical operations, and start-up at Fortrea; combined with 17 years’ direct site experience managing rare and pediatric clinical trials. Her experience includes executing trials in renal diseases, gene therapies as well as supporting a pediatric focused nephrology consortium during her tenure at a local pediatric hospital.