Cristina Giachetti, Ph.D.
Founder and Principal Consultant
Cristina is an accomplished life sciences advisor with substantial experience and expertise in the Biotech and Healthcare industries, academic, and for-non-profit organizations. She has a proven track record of successful leadership managing complex programs and coordinating multidisciplinary groups. She applies her strong drive, creativity, and deep knowledge of the medical diagnostics industry and product development to help companies to move their ideas and technologies into successful products that advance the practice of health care today. She values strong working relationships and working environments that are open, creative, motivated, and aligned toward a common vision and challenging goals.
As noted below, previously, Cristina was Deputy Director for Diagnostics at the Bill and Melinda Gates Foundation, and before that she was Senior Vice President, Research and Development for the Diagnostics Division of Hologic, and Vice President, Research and Development for Gen-Probe.
During her career she delivered on key initiatives using an integrated strategic approach that resulted in numerous in vitro Diagnostics (IVD) products for detection, screening, and/or monitoring of infectious, genetic, and neoplastic diseases commercialized worldwide by Gen-Probe, Hologic, Chiron, Bayer, Siemens, Novartis, and Grifolds. Several of the products that she developed were recipients of prestigious awards, including the National Medal of Technology.
Cristina has authored multiple peer-reviewed publications in virology and diagnostics and has presented at many scientific meetings. She received her degrees in Clinical Analysis and Biochemistry from the University of Buenos Aires, and a Ph.D. in Biochemistry from the same university. She completed postdoctoral training in virology, molecular virology, and rapid viral evolution at the University of California, San Diego, Department of Biology and at the University of California, Irvine, Department of Microbiology and Molecular Genetics.
Previous Positions
Deputy Director, Diagnostics
Bill and Melinda Gates Foundation, Seattle WA
Established relations and collaborations with multiple organizations working in Global Health (CHAI, Unitaid, USAID, FIND, Afro-WHO, etc.) and with African governments to explore new approaches to deliver high quality clinical diagnostics services in Africa.
Led the diagnostics function supporting the Foundation’s objectives in Global Health for HIV, TB, Malaria, Neglected Tropical Diseases, Pneumonia, and Enteric Diseases, and formulated a strategy focused in the development of low-cost molecular and immunoassay platforms able to support multiple diseases.
Introduced best practices for diagnostics product development, such as the use of design control and the creation of an objective process to define and document product requirements.
VP & SVP, Research and Development
Hologic, Inc., Marlborough MA
Held managerial and budget responsibilities over Product Development, Clinical Affairs, Research Core Technology, and R&D Operations Support of the Diagnostics Division of Hologic.
Delivered on R&D strategy that resulted in more than half of the on-market molecular diagnostics revenue of Hologic in the areas of Women’s Health, Virology, Genetic Testing, Oncology, and Blood & Plasma Screening.
VP, Research and Development; VP, Development and Executive Sponsor of HPV program
Gen-Probe, Incorporated, San Diego CA
Similar responsibilities as above, and as Executive Sponsor of the HPV program for cervical cancer screening, led all functions involved in its execution, with direct reporting from Clinical Affairs, Regulatory Affairs, Program Management, Marketing, and Product Development. This $100M program concluded with the PMA approval of the APTIMA HPV assay and positioned Gen-Probe for sale to Hologic for 3.7 billion in 2012.
Senior Director, Product Development
Gen-Probe, Incorporated, San Diego CA
Directed development of tests for Blood Screening and Diagnostics for Women’s Health and Oncology, contributing directly to FDA CDRH clearances of APTIMA assays and FDA CBER approvals of Procleix assays resulting in sales growth that exceeded 15% each year.
Partnered with core teams and executives to streamline and improve product development processes and stablished technology stage gate process to focus research efforts and increase their value.
Director, Associate Director, Program Manager, Senior Program Manager, Blood Bank Product Development
Gen-Probe, Incorporated, San Diego CA
Created the organization responsible for all technical aspects of the development of nucleic acid-based assays for Blood, Plasma, Tissue, and Organ Donor Screening.
Led the development of the first CE marked and FDA licensed multiplex molecular test for blood and plasma screening and directly contributed to the establishment of Gen-Probe’s Blood Screening business. Currently more than half of the worldwide donations screened with molecular methods use the products developed by this group.
The technology improvement to blood screening was recognized in several awards, and the resulting enhancement in the safety of the blood supply awarded Gen-Probe the National Medal of Technology and Innovation presented by the President of the United States in 2006.
Staff Scientist, Senior Research Scientist
Genta, Inc., San Diego CA
Led a Papillomavirus antisense therapeutics project and evaluated feasibility of antisense technology against several other viral targets.
Designed novel oligomer backbones and discovered and patented active oligonucleotides in vitro.
Studied delivery of oligomers to skin.
Commercialized Products Worldwide
Procleix HIV-1/HCV multiplex assay and corresponding discriminatory assays on the Procleix System
Procleix WNV assay on the Procleix System and on the fully automated TIGRIS System
Procleix Ultrio assay for detection of HIV-1, HCV, and HBV and corresponding discriminatory assays on the Procleix System and on the fully automated TIGRIS System
Procleix HIV-1, HCV, and HBV Controls and Proficiency Panels
Procleix Ultrio Plus assay (with higher HBV sensitivity) and corresponding discriminatory assays on the TIGRIS System
Procleix Parvo B-19/HAV assay for plasma screening (in process QC) on the TIGRIS System
Procleix Dengue assay on the TIGRIS System (under IND use)
Procleix Ultrio elite assay for detection of HIV-1, HIV-2, HCV and HBV on the Panther System (ex-US only)
Procleix WNV assay on the Panther System (ex-US only)
Procleix HEV assay on the Panther System (CE only)
APTIMA HIV-1 RNA qualitative assay on the eSAS System
VERSANT (and APTIMA) HCV RNA qualitative assay on the eSAS System
APTIMA AC2 assay for detection of Chlamydia trachomatis and Neisseria gonorrhea on the TIGRIS system, claims for additional specimens
APTIMA CT assay for Chlamydia trachomatis detection on the TIGRIS system, claims for additional specimens
APTIMA GC assay for Neisseria gonorrhea detection on the TIGRIS system, claims for additional specimens
APTIMA Trichomonas vaginalis assay on the TIGRIS System
APTIMA HPV assay for cervical cancer screening on the TIGRIS system
APTIMA HPV-GT assay for detection of HPV-16, 18, and 45 on the TIGRIS system
APTIMA AC2 assay on the Panther system
APTIMA Trichomonas vaginalis assay on the Panther system
APTIMA HPV assay on the Panther system
APTIMA HPV-GT assay on the Panther system
APTIMA HIV-1 Quant Dx assay on the Panther system
PROGENSA PCA3 assay for prostate cancer risk on the eSAS system