https://mbcbiolabs.com/wp-content/uploads/2025/03/Siren-Logo_Grey-Red.pngFrom the trenches - what it's like to submit your first data packet to the FDA in 2025At Siren, we are combining the promise of two transformative therapeutic technologies, AAV gene therapy and cytokine immunotherapy, into a single, powerful new treatment modality to fight cancer. Come hear from us about our experience transitioning from a Discovery to a Translational (& about to be Clinical) Stage company and what it's like to engage with the FDA right now. The intent of this time is to be maximally useful to our neighbor companies as we continue to learn from each other. We'll chat about Siren, share some firsthand stories and lessons learned, and close with an 'ask me anything'-style Q&A.Website → Our Speaker https://mbcbiolabs.com/wp-content/uploads/2025/03/Nicole-Paulk.jpgDr. Nicole PaulkDr. Nicole Paulk is the CEO, Founder, and President of Siren Biotechnology and has dedicated her career to advancing the field of gene therapy. Before founding Siren, Nicole held various leadership positions in academia and industry and most notably was an Assistant Professor of AAV Gene Therapy in the UCSF Department of Biochemistry & Biophysics before leaving to found Siren. Nicole has a unique lens into the current biotech environment as an advisor for numerous public and [...]

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