Weekly Digest: AI, Gene Therapy & Radioligand Theranostics (Sept 22

Artificial Intelligence

Date	Headline	Source	Summary
September 18, 2025	OECD Urges Responsible AI by Governments	OECD	Member countries encouraged to adopt frameworks for trustworthy AI in public services, strengthening transparency and accountability.
September 24, 2025	Invisible AI: The Silent Revolution	Electe / AIjourn	Survey shows 85% of Fortune 500 use invisible AI; warns only 1% feel “mature” in governance; calls for Minimum Viable Governance frameworks.
September 25, 2025	UN Launches Independent Scientific Panel on AI	United Nations	Open call for 40 experts to advise Global Dialogue on AI; aims to provide annual evidence-based assessments of risks and opportunities.

Gene Therapy

Date	Headline	Source	Summary
September 15, 2025	FDA Approves Vyjuvek Label Expansion	HCPLive	Label now covers DEB patients from birth, authorizes caregiver at-home application; may expand screening and follow-up capacity.
September 16, 2025	AAV-Olig001-ASPA Shows Early Benefit in Canavan (Phase 1/2)	Nature Medicine	MYR-101 intracranial dosing reduced CSF NAA (P=0.0008), improved myelination (P=0.0137) and developmental scores (P=0.0171) at 12 months.
September 21, 2025	AskBio Randomizes First Europeans in AB-1005 Phase 2 PD Trial	AskBio	AB-1005 (RMAT-designated) aims to slow Parkinson’s progression; trial will assess safety, tolerability and motor outcomes in Europe.

Radioligand Theranostics

Date	Headline	Source	Summary
September 8, 2025	Radiopharm Theranostics Day Newsletter	Radiopharm Theranostics	Highlights partnerships and milestones in precision oncology; previews new pipeline assets and MD Anderson collaboration.
September 22, 2025	RLT Sequencing & Novel Targets in Prostate Cancer	OncLive	Dr. Tagawa reviews optimal sequencing of PSMA-targeted therapies and emerging targets beyond PSMA to overcome resistance.

In Case You Missed It

Three Biggest AI Stories in September 2025 – California’s Frontier Model bill, Anthropic copyright ruling, Google AI Mode expansion.
AI & the Future of Pharmaceutical Research – Review of AI’s impact on drug discovery timelines and predictive modeling.
FDA Cell & Gene Therapy Public Meeting – Sept 18 session on leveraging prior knowledge in C> development.

This Week in Perspective

Looking ahead, FDA’s decision on next-gen PSMA radioligands (PDUFA target: Oct 1) and EMA’s first approval of an mRNA-based oncology vector are on the horizon. In AI, expect the first annual report from the UN Scientific Panel in November, which could shape global policy dialogue. Gene therapy watchers: CRISPR-based ophthalmology trials readout by year-end will guide pipeline prioritization.

Practical Workflow Tips

• For AI governance teams, adopt a “Minimum Viable Governance” approach: start with transparent model cards and incident-reporting protocols before scaling.
• In gene therapy trials, integrate remote-monitoring platforms to capture RWD for label-expansion submissions.
• Radioligand trialists should standardize lesion segmentation workflows using open-source PET/MRI co-registration tools to streamline multi-center analyses.