Christina Fuentes, Ph.D.

SENIOR CONSULTANT

Brings cutting-edge CGT experience in gene modification and AAV for in vivo therapies

About Christina

Christina Fuentes is a Bioengineer with experience in gene and cell therapies. Dr. Fuentes’ work with DHC clients has ranged from long-term embedded support to vendor management to technical lead from initial product design stages through to first-in-human/IND approval.

During her doctoral work, Christina also gained industry experience through a summer internship in the Antibody Engineering Department at Genentech. She conducted and analyzed experiments related to phage display screens of antigen-binding fragments. While interning, Christina was awarded a position in the Genentech Leader Intern Exchange Program (gLINX) where she met with senior leaders at the company to gain deeper knowledge about successful strategies for managing and leading teams and projects in the biotechnology industry.

Christina received her Bachelor’s in Biomedical Engineering at Northwestern University where she also has had hands-on experience in device development. In her Senior Capstone project, Christina worked in a team to build a wireless respiratory monitor for continuous measurement of respiration and detection of respiratory distress. Within a year, the project was taken from the initial brainstorming stage to human subject testing with IRB approval.

Christina is passionate about working collaboratively to develop solutions to unique challenges in the Cell and Gene Therapy field.

EXAMPLES OF RECENT WORK

  • Technical assessment on due diligence projects for investors considering buying into the CGT market
  • Embedded support from preclinical studies through to clinical lot release and IND approval.
  • Primary contact and technical lead, including vendor management
  • Regulatory writing and support including primary authorship on IND module 3

SELECTED PATENTS

SELECTED PUBLICATIONS

INDUSTRY EXPERIENCE

Dark Horse Consulting Group
Consultant
Associate Consultant

Genentech
Intern in antibody engineering department

CERTIFICATIONS

Multicultural Education Program and Restorative Justice Graduate Student Inclusivity Certificate Program, UC-Berkeley

OTHER NOTEWORTHY ACCOMPLISHMENTS

Dr. Fuentes co-authored the first externally-prepared proposed draft FDA guidance, on the topic of “Proposed DRAFT guidance for FDA Consideration: Testing of Adeno-Associated Viral (AAV) Vector-Based Human Gene Therapy Products for Empty Capsids During Product Manufacture.” The proposed draft guidance, which can be found in its entirety here, aims to offer a benchmarking goal in making a recommendation to establish a release criterion for empty AAV vector capsid impurity. The guidance was formally submitted to the FDA on May 15, 2022

Christina also co-authored a white paper titled “Beyond Empty and Full: Understanding Heterogeneity in rAAV Products and Impurities,” detailing the importance of product characterization  and heterogeneity in product-related impurities to improve product understanding and inform manufacturing strategy.

EDUCATION

University of California, Berkeley
Ph.D., Bioengineering and Biomedical Engineering

Northwestern University
B.S., Bioengineering and Biomedical Engineering

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