This week on The Genetics Podcast, Patrick is joined by Richard Wilson, Senior Vice President, Primary Focus Lead of Genetic Regulation at Astellas. They discuss where the gene therapy field stands today, diving into successes, persistent barriers, regulatory considerations, manufacturing strategies, and other reflections on important approaches to precision medicine drug development.
Show Notes:
0:00 Intro to The Genetics Podcast
00:59 Welcome to Richard
01:33 Current wins and challenges in gene therapy
07:13 The need for more open non-competitive data sharing and a clearer pathway towards reimbursement and incentivization
11:15 Building post-approval systems into the genomic medicine lifecycle
14:47 Rethinking evidence standards in rare disease trials, and the global push for regulatory and reimbursement alignment
20:28 Genetic medicine breakthroughs in central nervous system diseases
22:25 The challenges of starting clinical development with an end in mind
24:34 The need for careful analysis around endpoints, vector design, and delivery approaches
29:33 Navigating regulatory hurdles when making mid-program changes to vectors or payloads
31:16 Strategies for enhancing scalability and quality of gene therapy manufacturing
36:05 Exploring other delivery methods beyond AAV
39:32 Getting ready for the Timmerman Traverse and raising nearly $1M for Life Science Cares
43:48 A call to refocus on patients, partnership, and purpose in uncertain times
45:55 Closing remarks
Find out more
Astellas (https://www.astellas.com/)
Timmerman Traverse fundraising for Life Science Cares (https://timmermantraverse.blackbaud-sites.com/)
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