Executive Summary
Marilyn Julien is a global regulatory CMC specialist with more than 25 years directing chemistry, manufacturing, and controls strategy for biologics and small molecule products. She began at Schering-Plough Research Institute as an analytical development scientist, validating chromatographic methods for drug substances and finished dosage forms, then moved into regulatory affairs, a path that lets her read a development report and a health authority question with equal fluency.
Her industry record spans Celgene, ImClone Systems, Bayer HealthCare, Kedrion Biopharma, and BeiGene. At Celgene she was the company’s first and only regulatory CMC manager for biologics, independently carrying a portfolio of monoclonal antibodies, antibody-drug conjugates, fusion proteins, and gene therapy, and leading the company through its first biologics IND from the pre-IND meeting package to the Study May Proceed letter. At Kedrion she guided a Phase 4 comparability protocol for a plasma-derived bulk drug substance technology transfer, from initial strategy through FDA approval. At BeiGene she built global regulatory CMC strategy for early development biologics and set the Module 3 templates behind their INDs, IMPDs, and CTAs.
As a Senior Partner at Bracken, Marilyn develops global regulatory CMC strategy and oversees regulatory documentation across dosage forms, for innovative and generic products at every stage of development. Clients engage her when a program needs CMC documentation that anticipates what the agency will ask, before the question arrives as an information request, a phase-inappropriate comment, or a clinical hold.
Areas of Expertise
Regulatory CMC Strategy
Global CMC development strategy for innovative and generic products, small molecule and biologic, across every dosage form and stage of development.
IND, IMPD & CTA Submissions
Authoring, coordination, and compilation of investigational dossiers and their amendments for FDA and ex-US health authorities, plus the CMC section of briefing documents.
eCTD Module 3 Authoring
Module 3 template design and implementation, NDA and BLA quality sections, DMFs, and training technical teams on eCTD structure and U.S. submission standards.
Comparability Protocols & Amendments
Comparability protocols for commercial products and comparability amendments for development products, including technology transfer of bulk drug substance through approval.
FDA & EMA Meetings
Type B and Type C meeting packages, EMA scientific advice, and the strategy and content of responses to health authority questions and information requests.
Drug Lifecycle Management
Post-approval change control and regulatory disposition, supplements and EU variations, annual reports, and assessment of manufacturing changes for global filing impact.
