Webinar: Building a robust FIH biologics regulatory CMC package

When you enter the clinical trial stage of your molecule’s development, you must prepare a dossier to support conducting the clinical research. A critical component of this dossier is the package of documentation that supports the chemistry, manufacturing, and controls (CMC) of your molecule. A robust CMC package provides health authorities with the information to assess the quality of material entering clinical trials. Inadequate CMC supportive evidence or insufficient detail can delay the go-ahead to enter the clinic. At the same time, unnecessary granularity can impact the lifecycle management of the dossier.

Join us to learn how to develop a robust first-in-human (FIH) regulatory CMC package for recombinant biological molecules by integrating the following activities into your project plan.

  • Progressively developing knowledge of the molecule’s critical quality attributes to justify the manufacturing and control strategy
  • Planning for continuing development
  • Identifying opportunities to enhance with scientific advice

Daniela Decina

Sr Director Affairs, Regulatory Affairs

Thermo Fisher Scientific

Daniela leads a team of regulatory professionals at Thermo Fisher Scientific that provide expertise in small molecule and biological drugs, solid oral and sterile injectable dosage forms and advances therapies across all product life cycle stages. She provides high-quality registration documentation, regulatory authority interactions support and strategic advice to customers through the regulatory services offerings. Daniela also supports development of regulatory chemistry, manufacturing, and controls (CMC) solutions for customers, in collaboration with the Pharma Services North American manufacturing network. She has a Master of Science in microbiology from University of Guelph, Ontario, Canada amd a Bachelor of Science in microbiology from University of Guelph, Ontario, Canada.

Michele Duggan

Sr Manger Regulatory Affairs

Thermo Fisher Scientific

Michele Provides regulatory expertise in biologics and small molecule drugs, solid oral and injectable dosage forms across all product life cycle stages as part of the North America Regulatory Affairs team. She supports development of regulatory solutions in collaboration with Thermo Fisher Scientific’s pharma services North American manufacturing network. Michele also provides high-quality submission documentation, Health Authority interactions support, and strategic advice through the regulatory service offerings. She has as Master of Science in Forensic Science from University of New Haven, Connecticut and a Honors Bachelor of Science degree in Pharmacology & Toxicology from University of Western Ontario, London Ontario, Canada.


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