In Partnership with:

Co-Sponsor:

Keynote Lecture: 

Bruce L.Levine, PhD

Barbara and Edward Netter Professor in Cancer Gene Therapy, Perelman School of Medicine, Univ. of Pennsylvania; Founding Director of the Clinical Cell and Vaccine Production Facility (CVPF)

From Innovation to Translation to Patients:The Future of Genetically Engineered T-Cells for Human Therapeutics

Keynote Lecture: 

Kyle Kolaja, PhD, DABT Fellow, ATS

Scientific Vice President, Therapy Area Head, Cell Therapy Safety and Head of Specialty Toxicology Labs at Bristol-Myers Squibb

Nonclinical Safety Assessment of Chimeric Antigen Receptor T Cell (CAR T) Therapies

Jason DelCarpini, PhD

Director, Bioanalytical and Molecular Assays @ Moderna Therpeutics

Harmonizing NAb Sample Testing and Reporting: Key Insights from the White Paper

Alka Dwivedi, PhD

Co-founder of ImmunoACT & Research Fellow @ National Cancer Institute (NCI)

Journey of India's First CAR-T Cell Therapy and its Global Impact

Melanie M. Eacho, PhD, RAC

Director, Division of Cell Therapy 1, Office of Cellular Therapy and Human Tissue CMC, Office of Therapeutic Products @ FDA/CBER

title TBA

Salvatore Iovino, PhD

Sr. Director, Head of Bioanalytical & Biomarker Sciences, Editas Medicine

Advanced Bioanalytical Strategies to Determine PK and Biodistribution of Cell and Gene Therapy Products

Daniel Kirouac, PhD

Vice President, Quantitative Systems Pharmacology @ Metrum Research Group

Making Drugs from T Cells: Mathematical Model-Informed Design and Deployment of Next Generation T Cell Therapies

Qingcong Lin, PhD

President of Medicilon USA Corp

CMC Aspects of ASO Manufacturing

David Williams, PhD

VP & General Manager @ BioAgilytix

Bioanalytical Strategies for Cell Therapies: Current Considerations

Hardik Mody, PhD

Principal Scientist, Clinical Pharmacology @ Genentech

Clinical Pharmacology Considerations in the Development of Allogeneic Cell Therapies - Opportunities & Challenges

Mohammad Shadid, PhD, MBA

Vice President, Translational Sciences @ Korro Bio

Translational Development of the GbGm Vector for Sickle Cell Disease: Assessing Safety and Efficacy from Preclinical Models to Humans

Indrajeet Singh, PhD

Senior Director, Group Lead, Clinical Pharmacology @ The Janssen Pharmaceutical Companies 

Role of Clinical Pharmacology in Efficient Development of CAR-T Cell Therapy: From FIH Starting Dose Selection to RP2D and Beyond

Gabriela Hernandez-Hoyos, PhD

Senior Scientific Director @ Bristol Myers Squibb

Regulatory Expectations and Safety Concerns with CART and Next Generation CART Programs

Helen-Marie Dunmore, MSc, ERT

Senior Director @ Certara

Navigating the Regulatory Landscape of Cell Therapies: Nonclinical Considerations 

CMC -  Panel Discussion 

Andy Lin, PhD

VP, Global Head of Individualized and Cell Therapy Development @ Genentech

Tamara Monesmith, PhD

Senior Vice President of Technical Development @ Editas Medicine 

Matt Silva, PhD

CEO, Emit Imaging

Cryo-Fluorescence Tomography: Transformative 3D Imaging to Monitor Gene and Cell Therapies

Sebastian Guelman, PhD

Senior Principal Scientist, Bioanalytical Sciences @ Genentech 

Comprehensive Bioanalytical Cellular Kinetics Strategy for Adoptive T Cell Therapies

Simon Bornschein, PhD

CEO & Co-Founder @ Coding Bio, UK

AI-Driven Approaches to Enhancing CAR Design

Johannes Stanta, PhD

Global Director Molecular & Cell Biology @ Celerion

Overcoming Host Rejection in Allogeneic Adoptive Cell Therapy: Engineering Strategies for Persistence and Efficacy

 Tamara Monesmith, PhD

Senior Vice President of Technical Development @ Editas Medicine

CMC Development for Cell and Gene Therapies for the Treatment of β-Hemoglobinopathies