Description:

Translating Early Research Concepts to Human Therapies: Navigating Preclinical Development of Cell and Gene Therapies

Cell and gene therapies (CGT) represent advanced treatments that can address the root cause of diseases at the cellular and genetic level. Many CGTs have delivered stunning efficacy in previously untreatable diseases, ranging from hematologic malignancies to rare monogenic disorders. While the field has grown rapidly in the past decade, CGTs face unique challenges that make product development difficult and expensive compared to other biologics. In nonclinical testing, standard approaches used to evaluate product safety in small molecules, proteins, and medical devices do not always apply for CGTs. In manufacturing, CGTs rely on living cells and heterogeneous precursors, making them more complex to produce with higher development costs and timelines. Here in this talk, I will provide key strategies that therapeutic developers use to navigate these unique challenges in nonclinical testing and manufacturing of CGT products.

Christina Fuentes is a Senior Consultant with Dark Horse Consulting Group. Christina provides strategic and tactical support for cell and gene therapy clients ranging from non-profit organizations, research institutes, start-ups, large pharmas, and investment firms. Christina has also written several papers and regulatory guidance documents on technical and regulatory considerations for viral vector and gene editing based products.

Christina earned her BS in Biomedical Engineering at Northwestern University and her PhD in Bioengineering at UC Berkeley. As an undergraduate, Christina worked on bioinspired gold nanorods for photothermal cancer ablation. During her doctoral work, Christina developed adeno-associated viral (AAV) vectors encoding a self-inactivating CRISPR/Cas9 system to reduce off-target genome editing. Christina also engineered a thermoresponsive hydrogel for scalable stem cell manufacturing. Christina is a recipient of the NSF GRFP, Siebel Scholars, and GEM Young Alumni Award.

Outside of consulting, Christina enjoys spending time outdoors and trying out new restaurants and bakeries around Chicago.