Ferran Barrachina, PhD
Director, Analytical and Therapeutic Development @ Gameto
About
Ph.D. in Medicine and Harvard-trained biotechnology leader with expertise in therapeutic development, CMC strategy, and analytical development for biologic and cell-based therapies.Currently serving as Director of Analytical and Therapeutic Development at Gameto, leading cross-functional programs advancing first-in-class therapies for reproductive and menopausal health. My work spans therapeutic strategy, translational development, IND-enabling activities, analytical development, and clinical-stage CMC execution.Proven track record advancing novel hiPSC-derived therapeutics from preclinical development through late-stage clinical readiness, including securing the first FDA-cleared IND for an hiPSC-derived cell therapy entering Phase 3 clinical trials in the United States.Extensive experience across:• Therapeutic Development• CMC Strategy & Execution• IND-Enabling Programs• Analytical Development & Validation• Potency Assays & QC Frameworks• Regulatory Submissions• Cell Therapy• CRO/CDMO Oversight• Translational Research• Cross-Functional Team LeadershipScientific contributor and co-author of peer-reviewed publications in Cell Stem Cell, PNAS, Cellular and Molecular Life Sciences, Human Reproduction, and other high-impact journals.Passionate about building transformative therapies that improve reproductive and women’s health outcomes.Languages: Spanish, English, Italian, CatalanUS Permanent Resident / Green Card Holder
United States
New York
Research
Board Level, Program Leadership, Therapeutic development, CDMO oversight, Potency assay, Analytical Methods Development, Cell Therapy, CMC development, Assay Development, Quality Control, Regulatory Filings, Investigational New Drug Application (IND), CRO Management, Mentoring, Strategy, Good Manufacturing Practice (GMP), Project Management, Biomarker Discovery, Processes Development, Mass Spectrometry
Experience

Director, Analytical and Therapeutic Development
Манхэттен, NY
Leading analytical and therapeutic development activities for Gameto’s therapeutic programs focused on reproductive and menopausal health. Key responsibilities and achievements include: • Leading a $10M cross-functional therapeutic development program advancing first-in-class cell therapies and a programmable vaginal ring platform for hormone delivery in menopausal health. • Leading development strategy across analytical, translational, and IND-enabling activities supporting progression from preclinical development through clinical readiness. • Oversaw analytical development for IND-enabling programs, including establishment of potency assays and QC frameworks for identity, purity, safety, and product conformance. • Contributed to regulatory strategy and authored CMC/Analytical and Nonclinical sections supporting the first FDA-cleared IND for an hiPSC-derived cell therapy entering Phase 3 clinical trials in the United States. • Managed external CRO/CDMO collaborations and analytical testing programs supporting clinical manufacturing and release. • Direct supervisor and mentor to multidisciplinary scientific teams across analytical development, therapeutic development, and translational sciences. • Co-authored multiple peer-reviewed publications demonstrating clinical advancement of hiPSC-derived therapeutics for reproductive medicine.

Senior Scientist
Манхэттен, NY
Gameto is a biotechnology company using cell engineering to develop therapeutics for diseases of the female reproductive system. Its lead program, Fertilo, is a therapeutic for IVF and egg freezing, aiming to make the process shorter, safer and more effective. Led translational and preclinical development activities supporting the Fertilo program, including: • Led preclinical studies evaluating efficacy, safety, and mechanism of action of cell therapy candidates in both in vitro and in vivo models. • Designed and executed translational studies using transcriptomic and proteomic profiling, molecular and cell-based assays, and advanced imaging approaches to characterize therapeutic function and mechanism. • Supported development of translational endpoints and quality target product profiles aligned with CMC and clinical development objectives. • Authored technical reports, data summaries, and contributed to regulatory documentation supporting IND-enabling activities.

Board Member
Estados Unidos
Serving on the Board of Directors of the TramutoPorter Foundation, supporting initiatives focused on health equity, compassionate leadership, education access, and global humanitarian impact. Contributing to programs that improve healthcare access and educational opportunities for underserved communities, promote human rights, and support future leaders through mentorship and scholarship initiatives. www.tramutoporterfoundation.com

Board Member & Treasurer
Boston, Massachusetts, United States
The Association of Spanish Scientists in the USA (ECUSA) is a non-profit organization with +3,000 members that aims to promote the role of science in society, and help Spanish science professionals established in the USA by organizing networking and science communication events, career development opportunities, and expanding science diplomacy skills.

Postdoctoral Research Scientist in Medicine
Boston, Massachusetts, United States
• Conducted preclinical drug target validation of immune modulators to prevent autoimmune diseases, kidney transplant rejection, and/or immune cell infiltration following kidney injury in collaboration with major pharmaceutical companies. • Explored the molecular basis of mucosal immunity in the urogenital tract to identify new diagnostic/therapeutic targets for male infertility and kidney injury. • Uncovered the role of Regulatory T cells (Tregs) in maintaining sperm tolerance and male fertility (Barrachina et al., PNAS, 2023). • Discovered novel mechanisms leading to immunological infertility and identified new targets for immuno-contraception (Barrachina et al., Cellular and Molecular Life Sciences, 2022).

Research Scientist
Hospital Clínic, IDIBAPS, Universitat de Barcelona
Discovered novel molecular protein biomarkers and therapeutic targets in male infertility using proteomics (LC-MS/MS) and protein-based assays: • Identified proteomic alterations of sperm and seminal plasma from infertile patients • Revealed epigenetic deregulations in oncological patients with testicular cancer • Characterized the protein composition of the sperm chromatin • Uncovered the role of extracellular vesicles (exosomes) of seminal plasma to shed light on their therapeutic application. • Initiated and maintained cross-departmental collaborations within the Departments of Urology, Pathology, Andrology, Genetics, and Assisted Reproduction at the Hospital Clinic of Barcelona. • Established research collaborations with laboratories in the United States, France, and Italy.

Graduate Teaching Assistant
Department of Biomedical Sciences, Faculty of Medicine
Graduate teaching assistant for Genetics at the Faculty of Medicine, University of Barcelona (Spain), for the BSc degrees in Medicine, Biomedical Sciences, and Biomedical Engineering, teaching over 153 h. The teaching activity was carried out under the grant "FPU Fellowship, Training program for Academic Staff" from the Government of Spain.

Research Scientist
Hospital Clínic, IDIBAPS, Universitat de Barcelona
• Characterized the nuclear proteome of human spermatozoa and detected epigenetic alterations. • Identified histone post-translational modifications and their expression pattern in human spermatogenesis. • Studied of the nuclear proteome conservation.

Research Internship
Hospital de Bellvitge, Universitat de Barcelona
• Used zebrafish as an experimental model of the Megalencephalic Leukoencephalopathy disease. • Genetic manipulation, genotyping, selection of fluorescent transgenic cell lines and brain microsurgery.
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