In November 2006, CONRAD and the Alliance for Microbicide Development sponsored a meeting entitled, "Biomarkers for evaluating vaginal microbicides and contraceptives: Discovery and early validation." This meeting was held in Reston, Virginia, and was funded in part by the Bill and Melinda Gates Foundation and the United States Agency for International Development. The goals of the meeting were to: 1) Review the current status of biomarkers in vaginal product research; 2) Assess how emerging technologies might be applied to the microbicide field; and 3) Encourage innovation and collaboration among a broad spectrum of researchers within and beyond that field. Three main areas were discussed: 1) Biomarkers of semen exposure; 2) Biomarkers of cervicovaginal inflammation; and 3) Biomarkers of HIV/STI infection. The meeting was attended by 85 representatives from 42 institutions (government, academia, industry), and received accolades for bringing together a new and diverse group, addressing cutting edge research (view list of meeting attendees).
Note: Selected presentations are available below. We will post additional presentations as they become available.
BIOMARKERS FOR EVALUATING VAGINAL MICROBICIDES AND CONTRACEPTIVES: DISCOVERY AND EARLY VALIDATION
Session 1: Background
Chair: Sam Niedbala, Lehigh University
Discussant: Thomas Moench, Reprotect, Inc.
Discovery of new biomarkers and assay development
Harsukh Parmar, AstraZeneca
Preclinical and clinical studies for biomarker validation
Sudhir Srivastava, National Cancer Institute
The search for biomarkers to support drug discovery and development of anticancer drugs as a model
Juan Leal, Exelixis, Inc.
Session 2: Biomarkers of Semen Exposure
Chair: Susan Ballagh, CONRAD
Discussant: Johan Melendez, Johns Hopkins University
Known and potential biomarkers of semen
Michael Coppola, ContraVac, Inc.
Review of known markers (PSA, Y-chromosome DNA) - lessons learned
Maurizio Macaluso, Centers for Disease Control and Prevention
Efforts to develop new biomarkers - e.g., proteomics
Andrezej Kulczycki, University of Alabama at Birmingham
Challenges to implementing biomarkers of semen exposure in clinical trials
Christine Mauck, CONRAD
Semenogelin assay and markers of product use
Robin Maguire, Population Council
Session 3: Biomarkers of Cervicovaginal Inflammation
Chair: Carolyn Deal, National Institute of Allergy and Infectious Disease
Discussant: James Cummins, Southern Research Institute
Mucosal immunity in the human female reproductive tract: the basics
John Fahey, Dartmouth Medical School
Cellular and molecular mechanisms of mucosal inflammation (part 1)
Cellular and molecular mechanisms of mucosal inflammation (part 2)
Bruce Horwitz, Brigham & Women's Hospital
Models and biomarkers for preclinical evaluation of microbicide safety
Gustavo Doncel, CONRAD
Session 4: Biomarkers of Cervicovaginal Inflammation (continued)
Chair: Deborah Anderson, Boston University
Discussant: Ken Mayer, Brown University
Biomarkers of vascular permeability and leukocyte infiltration in the vaginal mucosa
Radiana Trifonova, Brigham & Women's Hospital
Development of biomarkers predictive of microbicide safety
Betsy Herold, Mount Sinai Medical School
Challenges to implementing biomarkers of inflammation in clinical trials
Sharon Hillier, Magee-Womens Hospital
Session 5: Biomarkers of HIV/STI Infection
Chair: Robin Shattock, St. George's Hospital Medical School
Discussant: Jim Turpin, National Institute of Allergy and Infectious Disease
Mucosal markers of HIV infection
Stuart Turville, Population Council
Novel adenovirus vector-based vaccines for HIV-1
Dan Barouch, Harvard University
Surrogate markers of HIV mucosal uptake
Scott McCoombe, Northwestern University
Development of clinical biomarkers predictive of microbicide efficacy
Betsy Herold, Mount Sinai Medical School
Assessment of sexually transmitted co-infections
Sam Niedbala, Lehigh University
