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Thought Leadership Expertise

CMC Strategy

Parts 1 & 2 of DHC's Morse and Fiedorowicz on "Analytical Considerations for Gene-Modified Hematopoietic Stem and Progenitor Cell Tx"

Nate Manley and Sam Blackford co-author "Expanding the analytical toolbox..."

Proposed DRAFT Guidance for FDA Consideration:

Kim Benton on the Commissioner's National Priority Voucher (CNPV) Program

Our panel of former-FDA regulatory experts: a discussion

Is CGT Ready for Prime Time?

Manufacturing costs the ‘biggest threat’ to cell and gene therapies

Lunch & Learn takeaways (ATW23)

Katy Spink in Precision Medicine Online