{"id":1468327,"date":"2026-05-06T04:30:00","date_gmt":"2026-05-06T08:30:00","guid":{"rendered":"https:\/\/www.statnews.com\/?p=1468327"},"modified":"2026-05-06T01:50:42","modified_gmt":"2026-05-06T05:50:42","slug":"fda-turmoil-felt-at-gene-therapy-conference-europe","status":"publish","type":"post","link":"https:\/\/www.statnews.com\/2026\/05\/06\/fda-turmoil-felt-at-gene-therapy-conference-europe\/","title":{"rendered":"Even at a meeting in Rome, FDA shifts are top of mind for gene therapy field"},"content":{"rendered":"<p>ROME \u2014 When Tim Hunt, who leads an organization for cell and gene therapy makers, reached for some reasons for optimism for the jittery field at a conference here last week, he highlighted the recent approvals of rare disease treatments from the likes of Rocket Pharmaceuticals and <a href=\"https:\/\/www.statnews.com\/2026\/04\/23\/trump-drug-price-deal-regeneron-mfn-negotiations\/\">Regeneron Pharmaceuticals<\/a>.<\/p>\n\n\n\n<p>There was one other headline he touted as potentially promising: \u201cFDA vaccine chief to leave the agency again.\u201d<\/p>\n\n\n\n<p>The allusion to Vinay Prasad \u2014 the Food and Drug Administration\u2019s top regulator of gene and cell therapies as well as vaccines until <a href=\"https:\/\/www.statnews.com\/2026\/03\/06\/fda-vinay-prasad-controversial-cber-director-leaving\/\">his departure from the agency last week<\/a> \u2014 was an indication that even at this event, designed to emphasize the opportunities and roadblocks the sector faces in Europe, it couldn\u2019t escape the decisions that are coming from 4,500 miles away.<\/p>","protected":false},"excerpt":{"rendered":"<p>Cell and gene therapy makers met in Rome to discuss the field&#8217;s outlook in Europe. One main topic of conversation: the FDA.  <\/p>\n","protected":false},"author":24,"featured_media":1468351,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"stat_display_restriction_not_latest":false,"stat_featured_image_caption":"The view over Rome, the site of the Alliance for Regenerative Medicine's recent Meeting on the Med.","stat_featured_image_nocrop":false,"stat_featured_image_focal_point":{"x":0.5,"y":0.5},"stat_article_wordmark_img":[],"stat_article_wordmark_url":"","stat_article_wordmark_height":"125px","stat_article_wordmark_enable":false,"stat_article_subheadline":"Agency\u2019s rejection rate for cell and gene therapies doubled since 2024","stat_paywall_restrict":true,"footnotes":"","stat_article_enhanced_byline":"","stat_article_newsletter_id":"","stat_article_header_color_scheme":"","_yoast_wpseo_primary_category":3292,"stat_paywall_move_flag":0},"categories":[3292],"tags":[1246,294,666,209192,5393],"authors":[159],"class_list":["post-1468327","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biotech","tag-drug-development","tag-fda","tag-policy","tag-rare-disease","tag-stat-plus"],"featured_image_src":"https:\/\/www.statnews.com\/wp-content\/uploads\/2026\/05\/GettyImages-2206886813-1024x683.jpg","coauthors":[{"avatar":"<img width=\"80\" height=\"80\" src=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/andrew-j-avatar-small-1-80x80.png\" class=\"avatar\" alt=\"Andrew Joseph\" loading=\"lazy\" sizes=\"auto, (min-width: 625px) and (max-width: 767px) 719px, (min-width: 768px) and (max-width: 899px) 835px, (min-width: 900px) and (max-width: 1023px) 635px, (min-width: 1024px) and (max-width: 1199px) 803px, (min-width: 1200px) and (max-width: 1439px) 994px, (min-width: 1440px) 982px, 576px\" decoding=\"async\" srcset=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/andrew-j-avatar-small-1-80x80.png 80w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/andrew-j-avatar-small-1-328x328.png 328w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/andrew-j-avatar-small-1-500x500.png 500w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/andrew-j-avatar-small-1-640x640.png 640w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/andrew-j-avatar-small-1-576x576.png 576w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/andrew-j-avatar-small-1-160x160.png 160w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/andrew-j-avatar-small-1-645x645.png 645w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/andrew-j-avatar-small-1.png 700w\" \/>","display_name":"Andrew Joseph","author_page":"https:\/\/www.statnews.com\/staff\/andrew-joseph\/","first_name":"Andrew","title":"Europe Correspondent","bio":"Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at drewqjoseph.71.","email_address":"andrew.joseph@statnews.com","email_url":"mailto:andrew.joseph@statnews.com","twitter_url":"https:\/\/x.com\/DrewQJoseph","twitter_handle":"@DrewQJoseph","facebook_url":"","linkedin_url":"","web_url":"","bluesky_url":"","bluesky_handle":""}],"stat_card_curation":{"image_id":1468351,"title":"","excerpt":"","video_id":0,"disable_topic_image_curation":false},"template_inline_styles":{"global_styles":":root{--wp--preset--aspect-ratio--square: 1;--wp--preset--aspect-ratio--4-3: 4\/3;--wp--preset--aspect-ratio--3-4: 3\/4;--wp--preset--aspect-ratio--3-2: 3\/2;--wp--preset--aspect-ratio--2-3: 2\/3;--wp--preset--aspect-ratio--16-9: 16\/9;--wp--preset--aspect-ratio--9-16: 9\/16;--wp--preset--color--black: #000000;--wp--preset--color--cyan-bluish-gray: #abb8c3;--wp--preset--color--white: #FFFFFF;--wp--preset--color--pale-pink: #f78da7;--wp--preset--color--vivid-red: #cf2e2e;--wp--preset--color--luminous-vivid-orange: 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var(--wp--preset--color--gold-20) !important;}.has-gold-10-color{color: var(--wp--preset--color--gold-10) !important;}.has-skin-70-color{color: var(--wp--preset--color--skin-70) !important;}.has-skin-60-color{color: var(--wp--preset--color--skin-60) !important;}.has-skin-50-color{color: var(--wp--preset--color--skin-50) !important;}.has-skin-40-color{color: var(--wp--preset--color--skin-40) !important;}.has-skin-30-color{color: var(--wp--preset--color--skin-30) !important;}.has-skin-20-color{color: var(--wp--preset--color--skin-20) !important;}.has-skin-10-color{color: var(--wp--preset--color--skin-10) !important;}.has-black-background-color{background-color: var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-background-color{background-color: var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-background-color{background-color: var(--wp--preset--color--white) !important;}.has-pale-pink-background-color{background-color: var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-background-color{background-color: var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-background-color{background-color: var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-background-color{background-color: var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-background-color{background-color: var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-background-color{background-color: var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-background-color{background-color: var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-background-color{background-color: var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-background-color{background-color: var(--wp--preset--color--vivid-purple) !important;}.has-teal-50-background-color{background-color: var(--wp--preset--color--teal-50) !important;}.has-grey-10-background-color{background-color: var(--wp--preset--color--grey-10) !important;}.has-grey-80-background-color{background-color: var(--wp--preset--color--grey-80) !important;}.has-grey-40-background-color{background-color: var(--wp--preset--color--grey-40) !important;}.has-teal-10-background-color{background-color: var(--wp--preset--color--teal-10) !important;}.has-blue-70-background-color{background-color: var(--wp--preset--color--blue-70) !important;}.has-blue-60-background-color{background-color: var(--wp--preset--color--blue-60) !important;}.has-blue-50-background-color{background-color: var(--wp--preset--color--blue-50) !important;}.has-blue-40-background-color{background-color: var(--wp--preset--color--blue-40) !important;}.has-blue-30-background-color{background-color: var(--wp--preset--color--blue-30) !important;}.has-blue-20-background-color{background-color: var(--wp--preset--color--blue-20) !important;}.has-blue-10-background-color{background-color: var(--wp--preset--color--blue-10) !important;}.has-teal-70-background-color{background-color: var(--wp--preset--color--teal-70) !important;}.has-teal-60-background-color{background-color: var(--wp--preset--color--teal-60) !important;}.has-teal-40-background-color{background-color: var(--wp--preset--color--teal-40) !important;}.has-teal-30-background-color{background-color: var(--wp--preset--color--teal-30) !important;}.has-teal-20-background-color{background-color: var(--wp--preset--color--teal-20) !important;}.has-forest-70-background-color{background-color: var(--wp--preset--color--forest-70) !important;}.has-forest-60-background-color{background-color: var(--wp--preset--color--forest-60) !important;}.has-forest-50-background-color{background-color: var(--wp--preset--color--forest-50) !important;}.has-forest-40-background-color{background-color: var(--wp--preset--color--forest-40) !important;}.has-forest-30-background-color{background-color: var(--wp--preset--color--forest-30) !important;}.has-forest-20-background-color{background-color: var(--wp--preset--color--forest-20) !important;}.has-forest-10-background-color{background-color: var(--wp--preset--color--forest-10) !important;}.has-green-70-background-color{background-color: var(--wp--preset--color--green-70) !important;}.has-green-60-background-color{background-color: var(--wp--preset--color--green-60) !important;}.has-green-50-background-color{background-color: var(--wp--preset--color--green-50) !important;}.has-green-40-background-color{background-color: var(--wp--preset--color--green-40) !important;}.has-green-30-background-color{background-color: var(--wp--preset--color--green-30) !important;}.has-green-20-background-color{background-color: var(--wp--preset--color--green-20) !important;}.has-green-10-background-color{background-color: var(--wp--preset--color--green-10) !important;}.has-lime-70-background-color{background-color: var(--wp--preset--color--lime-70) !important;}.has-lime-60-background-color{background-color: var(--wp--preset--color--lime-60) !important;}.has-lime-50-background-color{background-color: var(--wp--preset--color--lime-50) !important;}.has-lime-40-background-color{background-color: var(--wp--preset--color--lime-40) !important;}.has-lime-30-background-color{background-color: var(--wp--preset--color--lime-30) !important;}.has-lime-20-background-color{background-color: var(--wp--preset--color--lime-20) !important;}.has-lime-10-background-color{background-color: var(--wp--preset--color--lime-10) !important;}.has-yellow-70-background-color{background-color: var(--wp--preset--color--yellow-70) !important;}.has-yellow-60-background-color{background-color: var(--wp--preset--color--yellow-60) !important;}.has-yellow-50-background-color{background-color: var(--wp--preset--color--yellow-50) !important;}.has-yellow-40-background-color{background-color: var(--wp--preset--color--yellow-40) !important;}.has-yellow-30-background-color{background-color: var(--wp--preset--color--yellow-30) !important;}.has-yellow-20-background-color{background-color: var(--wp--preset--color--yellow-20) !important;}.has-yellow-10-background-color{background-color: var(--wp--preset--color--yellow-10) !important;}.has-peach-70-background-color{background-color: var(--wp--preset--color--peach-70) !important;}.has-peach-60-background-color{background-color: var(--wp--preset--color--peach-60) !important;}.has-peach-50-background-color{background-color: var(--wp--preset--color--peach-50) !important;}.has-peach-40-background-color{background-color: var(--wp--preset--color--peach-40) !important;}.has-peach-30-background-color{background-color: var(--wp--preset--color--peach-30) !important;}.has-peach-20-background-color{background-color: var(--wp--preset--color--peach-20) !important;}.has-peach-10-background-color{background-color: var(--wp--preset--color--peach-10) !important;}.has-plum-70-background-color{background-color: var(--wp--preset--color--plum-70) !important;}.has-plum-60-background-color{background-color: var(--wp--preset--color--plum-60) !important;}.has-plum-50-background-color{background-color: var(--wp--preset--color--plum-50) !important;}.has-plum-40-background-color{background-color: var(--wp--preset--color--plum-40) !important;}.has-plum-30-background-color{background-color: var(--wp--preset--color--plum-30) !important;}.has-plum-20-background-color{background-color: var(--wp--preset--color--plum-20) !important;}.has-plum-10-background-color{background-color: var(--wp--preset--color--plum-10) !important;}.has-grey-70-background-color{background-color: var(--wp--preset--color--grey-70) !important;}.has-grey-60-background-color{background-color: var(--wp--preset--color--grey-60) !important;}.has-grey-50-background-color{background-color: var(--wp--preset--color--grey-50) !important;}.has-grey-30-background-color{background-color: var(--wp--preset--color--grey-30) !important;}.has-grey-20-background-color{background-color: var(--wp--preset--color--grey-20) !important;}.has-beige-70-background-color{background-color: var(--wp--preset--color--beige-70) !important;}.has-beige-60-background-color{background-color: var(--wp--preset--color--beige-60) !important;}.has-beige-50-background-color{background-color: var(--wp--preset--color--beige-50) !important;}.has-beige-40-background-color{background-color: var(--wp--preset--color--beige-40) !important;}.has-beige-30-background-color{background-color: var(--wp--preset--color--beige-30) !important;}.has-beige-20-background-color{background-color: var(--wp--preset--color--beige-20) !important;}.has-beige-10-background-color{background-color: var(--wp--preset--color--beige-10) !important;}.has-gold-70-background-color{background-color: var(--wp--preset--color--gold-70) !important;}.has-gold-60-background-color{background-color: var(--wp--preset--color--gold-60) !important;}.has-gold-50-background-color{background-color: var(--wp--preset--color--gold-50) !important;}.has-gold-40-background-color{background-color: var(--wp--preset--color--gold-40) !important;}.has-gold-30-background-color{background-color: var(--wp--preset--color--gold-30) !important;}.has-gold-20-background-color{background-color: var(--wp--preset--color--gold-20) !important;}.has-gold-10-background-color{background-color: var(--wp--preset--color--gold-10) !important;}.has-skin-70-background-color{background-color: var(--wp--preset--color--skin-70) !important;}.has-skin-60-background-color{background-color: var(--wp--preset--color--skin-60) !important;}.has-skin-50-background-color{background-color: var(--wp--preset--color--skin-50) !important;}.has-skin-40-background-color{background-color: var(--wp--preset--color--skin-40) !important;}.has-skin-30-background-color{background-color: var(--wp--preset--color--skin-30) !important;}.has-skin-20-background-color{background-color: var(--wp--preset--color--skin-20) !important;}.has-skin-10-background-color{background-color: var(--wp--preset--color--skin-10) !important;}.has-black-border-color{border-color: var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-border-color{border-color: var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-border-color{border-color: var(--wp--preset--color--white) !important;}.has-pale-pink-border-color{border-color: var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-border-color{border-color: var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-border-color{border-color: var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-border-color{border-color: var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-border-color{border-color: var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-border-color{border-color: var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-border-color{border-color: var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-border-color{border-color: var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-border-color{border-color: var(--wp--preset--color--vivid-purple) !important;}.has-teal-50-border-color{border-color: var(--wp--preset--color--teal-50) !important;}.has-grey-10-border-color{border-color: var(--wp--preset--color--grey-10) !important;}.has-grey-80-border-color{border-color: var(--wp--preset--color--grey-80) !important;}.has-grey-40-border-color{border-color: var(--wp--preset--color--grey-40) !important;}.has-teal-10-border-color{border-color: var(--wp--preset--color--teal-10) !important;}.has-blue-70-border-color{border-color: var(--wp--preset--color--blue-70) !important;}.has-blue-60-border-color{border-color: var(--wp--preset--color--blue-60) !important;}.has-blue-50-border-color{border-color: var(--wp--preset--color--blue-50) !important;}.has-blue-40-border-color{border-color: var(--wp--preset--color--blue-40) !important;}.has-blue-30-border-color{border-color: var(--wp--preset--color--blue-30) !important;}.has-blue-20-border-color{border-color: var(--wp--preset--color--blue-20) !important;}.has-blue-10-border-color{border-color: var(--wp--preset--color--blue-10) !important;}.has-teal-70-border-color{border-color: var(--wp--preset--color--teal-70) !important;}.has-teal-60-border-color{border-color: var(--wp--preset--color--teal-60) !important;}.has-teal-40-border-color{border-color: var(--wp--preset--color--teal-40) !important;}.has-teal-30-border-color{border-color: var(--wp--preset--color--teal-30) !important;}.has-teal-20-border-color{border-color: var(--wp--preset--color--teal-20) !important;}.has-forest-70-border-color{border-color: var(--wp--preset--color--forest-70) !important;}.has-forest-60-border-color{border-color: var(--wp--preset--color--forest-60) !important;}.has-forest-50-border-color{border-color: var(--wp--preset--color--forest-50) !important;}.has-forest-40-border-color{border-color: var(--wp--preset--color--forest-40) !important;}.has-forest-30-border-color{border-color: var(--wp--preset--color--forest-30) !important;}.has-forest-20-border-color{border-color: var(--wp--preset--color--forest-20) !important;}.has-forest-10-border-color{border-color: var(--wp--preset--color--forest-10) !important;}.has-green-70-border-color{border-color: var(--wp--preset--color--green-70) !important;}.has-green-60-border-color{border-color: var(--wp--preset--color--green-60) !important;}.has-green-50-border-color{border-color: var(--wp--preset--color--green-50) !important;}.has-green-40-border-color{border-color: var(--wp--preset--color--green-40) !important;}.has-green-30-border-color{border-color: var(--wp--preset--color--green-30) !important;}.has-green-20-border-color{border-color: var(--wp--preset--color--green-20) !important;}.has-green-10-border-color{border-color: var(--wp--preset--color--green-10) !important;}.has-lime-70-border-color{border-color: var(--wp--preset--color--lime-70) !important;}.has-lime-60-border-color{border-color: var(--wp--preset--color--lime-60) !important;}.has-lime-50-border-color{border-color: var(--wp--preset--color--lime-50) !important;}.has-lime-40-border-color{border-color: var(--wp--preset--color--lime-40) !important;}.has-lime-30-border-color{border-color: var(--wp--preset--color--lime-30) !important;}.has-lime-20-border-color{border-color: var(--wp--preset--color--lime-20) !important;}.has-lime-10-border-color{border-color: var(--wp--preset--color--lime-10) !important;}.has-yellow-70-border-color{border-color: var(--wp--preset--color--yellow-70) !important;}.has-yellow-60-border-color{border-color: var(--wp--preset--color--yellow-60) !important;}.has-yellow-50-border-color{border-color: var(--wp--preset--color--yellow-50) !important;}.has-yellow-40-border-color{border-color: var(--wp--preset--color--yellow-40) !important;}.has-yellow-30-border-color{border-color: var(--wp--preset--color--yellow-30) !important;}.has-yellow-20-border-color{border-color: var(--wp--preset--color--yellow-20) !important;}.has-yellow-10-border-color{border-color: var(--wp--preset--color--yellow-10) !important;}.has-peach-70-border-color{border-color: var(--wp--preset--color--peach-70) !important;}.has-peach-60-border-color{border-color: var(--wp--preset--color--peach-60) !important;}.has-peach-50-border-color{border-color: var(--wp--preset--color--peach-50) !important;}.has-peach-40-border-color{border-color: var(--wp--preset--color--peach-40) !important;}.has-peach-30-border-color{border-color: var(--wp--preset--color--peach-30) !important;}.has-peach-20-border-color{border-color: var(--wp--preset--color--peach-20) !important;}.has-peach-10-border-color{border-color: var(--wp--preset--color--peach-10) !important;}.has-plum-70-border-color{border-color: var(--wp--preset--color--plum-70) !important;}.has-plum-60-border-color{border-color: var(--wp--preset--color--plum-60) !important;}.has-plum-50-border-color{border-color: var(--wp--preset--color--plum-50) !important;}.has-plum-40-border-color{border-color: var(--wp--preset--color--plum-40) !important;}.has-plum-30-border-color{border-color: var(--wp--preset--color--plum-30) !important;}.has-plum-20-border-color{border-color: var(--wp--preset--color--plum-20) !important;}.has-plum-10-border-color{border-color: var(--wp--preset--color--plum-10) !important;}.has-grey-70-border-color{border-color: var(--wp--preset--color--grey-70) !important;}.has-grey-60-border-color{border-color: var(--wp--preset--color--grey-60) !important;}.has-grey-50-border-color{border-color: var(--wp--preset--color--grey-50) !important;}.has-grey-30-border-color{border-color: var(--wp--preset--color--grey-30) !important;}.has-grey-20-border-color{border-color: var(--wp--preset--color--grey-20) !important;}.has-beige-70-border-color{border-color: var(--wp--preset--color--beige-70) !important;}.has-beige-60-border-color{border-color: var(--wp--preset--color--beige-60) !important;}.has-beige-50-border-color{border-color: var(--wp--preset--color--beige-50) !important;}.has-beige-40-border-color{border-color: var(--wp--preset--color--beige-40) !important;}.has-beige-30-border-color{border-color: var(--wp--preset--color--beige-30) !important;}.has-beige-20-border-color{border-color: var(--wp--preset--color--beige-20) !important;}.has-beige-10-border-color{border-color: var(--wp--preset--color--beige-10) !important;}.has-gold-70-border-color{border-color: var(--wp--preset--color--gold-70) !important;}.has-gold-60-border-color{border-color: var(--wp--preset--color--gold-60) !important;}.has-gold-50-border-color{border-color: var(--wp--preset--color--gold-50) !important;}.has-gold-40-border-color{border-color: var(--wp--preset--color--gold-40) 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