Start / Cell & Gene: The Podcast / Regenxbios nina hunter ph d details the accelerated approval pathway for gene therapies

REGENXBIO's Nina Hunter, Ph.D. Details the Accelerated Approval Pathway for Gene Therapies

18 min • 17 februari 2022

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REGENXBIO's VP of Regulatory and Science Policy, Nina Hunter, Ph.D., shares potential solutions to gene therapies' regulatory roadblocks and why the accelerated approval pathway is so pertinent.

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Senaste avsnitt

Rethinking Large Animal Models in Gene Therapy with Novartis' Ralf Schmid, Ph.D.

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The Promise of Genome Editing with Caribou Biosciences' Rachel Haurwitz, Ph.D.

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Focus Areas For Cell Therapy With Bristol Myers Squibb's Stephan Krause, Ph.D.

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REGENXBIO's Nina Hunter, Ph.D. Details the Accelerated Approval Pathway for Gene Therapies

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REGENXBIO's Nina Hunter, Ph.D. Details the Accelerated Approval Pathway for Gene Therapies

Senaste avsnitt

Rethinking Large Animal Models in Gene Therapy with Novartis' Ralf Schmid, Ph.D.

Gene Therapy for Inherited Retinal Diseases with Opus Genetics' Dr. George Magrath

Extracellular Vesicle Breakthroughs with Aegle Therapeutics' Dr. Gloria Matthews

Bridging Development and Regulation in CGT with Halloran Consulting Group's Monika Swietlicka

Harnessing AI and Synthetic Biology for Cell Therapies with Generate:Biomedicines' Dr. Alex Snyder

Redefining Heart Failure Treatment with Precision Autologous Cell Therapy with BioCardia's Peter Altman, Ph.D.

CRI’s Response to NIH Cuts with Alicia Zhou, Ph.D.

Rethinking CGT Biotech Growth & Investment with Audrey Greenberg

Advancing Retinal Gene Therapy with Atsena Therapeutics' Dr. Kenji Fujita

Harnessing the Power of Cord Blood Tregs with Cellenkos' Dr. Simrit Parmar

CGT Manufacturing: Distributed & Digital with Deloitte Consulting's Omkar Kawalekar, Ph.D.

Inside Gene Therapies for Cardiac Care with Tenaya Therapeutics' Faraz Ali

The Future of Adenovector-Based Therapies with Precigen's Helen Sabzevari, Ph.D.

The Future of NK Cell Therapy for Autoimmune Disease with Artiva Biotherapeutics' Christopher Horan

Lessons in Automation with Roswell Park Comprehensive Cancer Center's Christopher Choi, Ph.D.

Can Gene Therapy Be the Solution for CHF with AskBio's Dr. Lothar Roessig

Inside a Dopamine-Restoring Cell Therapy for PD with BlueRock Therapeutics' Dr. Amit Rahkit

Globalization's Impact on Patient Access with ARM's COO, Rita Johnson-Greene

Improving TCR T-Cell Persistence and Efficacy with Adaptimmune's Dennis Williams

Live from ARM's Meeting on the Mesa with Kiji Therapeutics' Dr. Miguel Forte

Pioneering Next-Gen TCR Therapies in Solid Tumors with Neogene Therapeutics’ Carsten Linnemann, Ph.D.

Optogenetics for Vision Restoration with Ray Therapeutics' Paul Bresge

A New Approach to Genome Engineering with Tessera Therapeutics' Dr. Michael Severino

Scaling Allo with Allogene Therapeutics' Dr. Zachary Roberts

CGT Regulatory Update and Outlook with Dark Horse Consulting's Kimberly Benton, Ph.D.

Identifying Drug Development Opportunities for DMD with CureDuchenne

Tackling "The Delivery Problem" of Gene Editing-Based Medicines with Mammoth Biosciences' Lucas Harrington

TILs for the Treatment of Solid Tumors with KSQ Therapeutics' Micah Benson, Ph.D.

Synthetic Biology and Programmable mRNA with Strand Therapeutics' Jake Becraft

Developing an mRNA Therapy for DMD with Elixirgen Therapeutics' Aki Ko

The Current State of the Global Regulatory Landscape with ISCT's Dr. Bambi Grilley

Dr. Bruce Levine on ISCT and the Future of CAR-T

CGTs for HIV Suppression with Addimmune's Dr. Marcus Conant

Inside BlueRock Therapeutics' Parkinson's Disease Trial with Dr. Ahmed Enayetallah

Reducing the Disease Burden of AML with Vor Bio's Dr. Robert Ang

Reducing Toxicities in Allogeneic Cell Therapies with Orca Bio's Dr. Scott McClellan

Inside Cellular Rejuvenation Therapies for Age-Related Diseases with Life Biosciences' Sharon Rosenzweig-Lipson, Ph.D.

The Future of Rare Diseases with The Jackson Laboratory’s Rare Disease Translational Center's Cat Lutz

Inside Yescarta's Reduced Median Turnaround Time with Kite, a Gilead company's Christopher McDonald

Pricing, Value, And Access of CGTs With The Dedham Group's Jennifer Klarer, M.Sc.Eng.

Breaking Down Solid Tumors with Triumvira Immunologics' Dr. Paul Lammers

4 Keys to Allo in 2024 with Poseida Therapeutics' Kristin Yarema, Ph.D.

Cell Therapy For Corneal Endothelial Dystrophies With Aurion Biotech's Greg Kunst

Overcoming the Limitations of CAR T-Cell Therapy with Vittoria Bio's Nick Siciliano, Ph.D.

Gene Therapy Deals, Collaborations, & Partnerships with Astellas' Richard Wilson

The Promise of AAV Gene Therapy with REGENXBIO's Ken Mills

Inside 2023 Meeting on the Mesa with ARM's COO, Rita Johnson-Greene

The Future of Cell and Organ Transplantation in Treating T1D with Dr. Camillo Ricordi

In Vivo CAR T-Cell Therapeutics With Umoja Biopharma's Dr. Andrew Scharenberg

Inside Genome Editing with CBER's Dr. Peter Marks

The Future of CAR-T with Bristol Myers Squibb's Lynelle Hoch

The Promise of Genome Editing with Caribou Biosciences' Rachel Haurwitz, Ph.D.

Focus Areas For Cell Therapy With Bristol Myers Squibb's Stephan Krause, Ph.D.

The Intersection Of RNA, AI, And Synthetic Biology With Shape Therapeutics' Dr. Francois Vigneault

Inside Prime Editing with Prime Medicine's Dr. Andrew Anzalone

Navigating CMC Challenges with Parenteral Drug Association's Glenn Wright

An Interview with Dr. Usman "Oz" Azam

Targeting Oncogenic Drivers for Solid Tumor Cancers with Affini-T Therapeutics' Dr. Jak Knowles

TJU's Jefferson Institute for Bioprocessing's Impact on CGT with Parviz Shamlou

Computational Biology's Role In Gene Therapy With Kriya Therapeutics' Dr. Shankar Ramaswamy

The Near-Term Future of Exosome Science with Capricor Therapeutics' Dr. Linda Marbán

Inside the World's First-Ever Allogeneic Approval with Atara Biotherapeutics' Pascal Touchon

The Potential of RNA Exon Editing with Ascidian Therapeutics' Romesh Subramanian, Ph.D.

Automating Processes to Scale CGT Manufacturing with PA Consulting's Paolo Siciliano

The Why Behind In-House Manufacturing With Sangamo's Andy Ramelmeier

2023 Market Outlook with AdBio and ISCT's Miguel Forte

CMC and Scale Up with Mustang Bio's Robert Sexton

An Interview with Dr. Peter Marks

Inside NK and Macrophage Cellular Immunotherapies with Shoreline Biosciences CSO Dr. Robert Hollingsworth

The Future of iPSCs with BlueRock Therapeutics' CEO Seth Ettenberg

Manufacturing at the Point of Care with Orgenesis' CEO Vered Caplan

Capstan Therapeutics' CEO Laura Shawver on In Vivo Cell Engineering

PepGen's SVP Head Of Clinical Development On Delivery Of Oligonucleotide Therapies

BridgeBio's Chief Regulatory Affairs Officer Adora Ndu on PDUFA VII Reauthorization

Inside RNAi with Arrowhead Pharmaceuticals' Javier San Martin

Planning For Manufacturing Capacity With Kite Pharma's Will Junker

Commercialization Learnings with Novartis Gene Therapies' President Chris Fox

A Stem Cell-Derived Treatment for T1D