In this podcast, we will explore the advantages of partnering with a Contract Development and Manufacturing Organization (CDMO) to navigate the journey from molecule conception to clinical trials, including the expertise, experience, and preparedness that a CDMO brings to the table.
The audience will gain valuable insights into crucial questions such as the optimal stage in the development process to engage with a CDMO, the necessary preparations for a successful collaboration, and whether a finalized molecule is required to initiate discussions with a CDMO.
Join Curia’s Director, Process Development Science, Scott Alderucci, who leads the process development group at Curia, a global CDMO offering CDMO expertise for biologics and small molecules.
Emily Heffernan of Arcadis explains how facility scale, equipment, containment, and quality testing differ across ex vivo cell therapy, viral vector, and mRNA-LNP manufacturing.
FDA expands Anktiva’s bladder cancer indication, Alvotech and Advanz submit a proposed Eylea 8 mg biosimilar in Europe, and Lilly reports new remission data for Omvoh in inflammatory bowel disease.
The FDA expanded ImmunityBio’s Anktiva plus BCG to include patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary-only tumors, extrapolating efficacy from the QUILT-3.032 carcinoma in situ cohort.
The FDA expanded Fast Track status for invikafusp alfa, Marengo Therapeutics’ TCR Vβ-targeting antibody-IL-2 fusion protein, from TMB-H colorectal cancer to TMB-H solid tumors regardless of tissue of origin.
Nathan Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
The FDA launches a new rare disease development initiative, BioNTech’s BNT113 misses a progression-free survival endpoint, and Viking Therapeutics begins Phase III trials of its oral obesity candidate.