Meet The Expert Webinar Series

Meet the Expert is a webinar series presented by the Somatic Cell Genome Editing (SCGE) Consortium. This webinar series aims to connect researchers within the consortium and the greater scientific community with experts in the gene therapy space. These webinars cover a wide range of topics within the gene editing space, from off-target editing and assays to the regulatory process and IND-enabling studies. Recorded webinars can be viewed below and on the SCGE YouTube channel.

Nick Buss, Ilan Irony, Allen Callaway

In this sector of the Meet the Expert Webinar Series, panelists discuss non-clinical study design and regulatory insights for a seamless transition

Nick Buss, PhD is an Associate Vice President and Eli Lily and Company.

Ilan Irony, MD is Senior Director, Global Regulatory Leader, at The Janssen Pharmaceutical Companies of Johnson & Johnson.

Allen Callaway, MS, MBA is the Director, CMC Regulatory Affairs at The Janssen Pharmaceutical Companies of Johnson & Johnson.

Deanna Portero, Stefano Benvenuti

In this video of the Meet the Expert Series, Deanna Portero and Stefano Benvenuti discuss alternative business models for non-commercially viable diseases.

Deanna Portero, MPH, MBA is the VP, Partnerships & Innovation, at Orphan Therapeutics Accelerator.

Stefano Benvenuti, MS HTA is the Public Affairs Manager at Fondazione Telethon.

Steve Gray and Kiran Musunuru

In the second video of the Meet the Expert Webinar Series, Drs. Steve Gray and Kiran Musunuru share their experience and tips for preparing an IND application for gene therapy.

Steve Gray, PhD is a Professor in the Department of Pediatrics at the University of Texas Southwestern (UTSW) Medical Center, as well as the co-director of the UTSW Gene Therapy Program and director of the UTSW Viral Vector Facility. 

Kiran Musunuru, MD, PhD, MPH, ML, is a Professor of Medicine, the Director of the Genetic and Epigenetic Origins of Disease Program, and the Scientific Director at the Center for Inherited Cardiovascular Disease at Perelman School of Medicine (University of Pennsylvania). 

Peter Marks and P.J. Brooks

In the first video of the Meet the Expert Webinar Series, Drs. Peter Marks and P.J. Brooks discuss the current landscape of the gene therapy regulatory and approval process, and the vision for where this can go in the future.

Peter Marks, MD, PhD, is the Director for Center for Biologics Evaluation and Research (CBER) in the FDA.

P.J. Brooks, PhD, is the Deputy Director in the Division of Rare Diseases Research Innovation in NIH NCATS.