Clinical Advisory Board

Robert Holloway, M.D.

Chairman

Medical Director, Gynecologic Oncology, AdventHealth Cancer Institute, Orlando, Florida.

 

Dr. Holloway is the principal investigator for VIRO-15 and has served on several committees of the Society of Gynecologic Oncology (SGO), including its Board of Directors. He is a Fellow of the American College of Surgeons and founding member of the Global Robotics Institute at AdventHealth, Orlando.  Dr. Holloway has authored or coauthored more than 100 peer-reviewed articles. Dr. Holloway completed medical school at Vanderbilt University Medical Center, residency at University of Alabama, Birmingham and fellowship at Georgetown University Hospital.

Robert L. Coleman, M.D.

Gynecologic Oncology, Chief Scientific Officer, US Oncology Research, The Woodlands, Texas.

 

Dr. Coleman currently serves on the Board of Directors of Gynecologic Oncology Group and is a Director of GOG-Partners.  In addition, he has served as President of SGO and as a Council member and Secretary Treasurer for the International Gynecologic Cancer Society, for which he is President-Elect (2020-2022). Dr. Coleman has authored or coauthored more than 300 peer-reviewed articles. Dr. Coleman completed medical school at Creighton University School of Medicine, residency at Northwestern University Medical Center, and gynecologic oncology fellowship at the University of Texas MD Anderson Cancer Center. He served as Professor and Ann Rife Chair in Gynecology at University of Texas, M.D. Anderson Cancer Center and Executive Director, M.D. Anderson Cancer Network Research until April 2020.

Alberto A. Mendivil, M.D.

Co-Director, Gynecologic Oncology, Hoag Memorial Hospital Presbyterian, Newport Beach, California.

 

Dr. Mendivil, site principal investigator for VIRO-15, serves as Co-Director, Gynecologic Oncology and Complex Pelvic Surgery, Hoag Hospital.  He has authored or coauthored more than 40 peer-reviewed publications and has been the principal investigator or site sub-investigator on 20+ clinical trials. Dr. Mendivil received his medical degree from the University of Utah School of Medicine and completed internship and residency training in Obstetrics and Gynecology at the University of California, Irvine, and fellowship training in gynecologic oncology at the University of North Carolina, Chapel Hill.

Thomas J. Herzog, M.D.

Deputy Director of the University of Cincinnati Cancer Institute and Vice-Chair of Quality and Safety for Obstetrics and Gynecology, University of Cincinnati College of Medicine Cincinnati, Ohio.

 

Dr. Herzog is Secretary Treasurer and Associate Director of the GOG Foundation.  In addition, he has served on the leadership board or council of SGO, the Foundation for Women’s Cancer, Board of Governors for the American College of Surgeons, American Board of Obstetrics and Gynecology, and International Gynecologic Cancer Society. Dr. Herzog has authored/co-authored 290+ peer-reviewed articles. Dr. Herzog graduated from the University of Cincinnati College of Medicine and completed his residency at Good Samaritan Hospital in Cincinnati and a fellowship in gynecologic oncology at the Washington University School of Medicine, St. Louis, MO.

David M. O’Malley, M.D.

Professor and Division Director, Ohio State University Comprehensive Cancer Center – James Cancer Hospital & Solove Research Institute, Columbus, Ohio.

 

Dr. O’Malley is the clinical trial advisor/lead for ovarian cancer within GOG Partners, a committee member for the NCI Gynecologic Cancer Steering Committee’s Ovarian Task Force and the NRG Oncology (Ovarian Cancer and Developmental Therapeutics Groups), and a panel member of the national Comprehensive Cancer Network Guidelines for Ovarian Cancer.  He has authored 130+ peer-reviewed publications. Dr. O’Malley received his medical degree from the Wayne State University School of Medicine, and completed his residency at Case Western Reserve University (MetroHealth) and the Cleveland Clinic Foundation, and gynecologic oncology fellowship at Yale University.

Expanded Access Policy

Outside of our clinical trials, we may provide physician-requested expanded access to its investigational products under limited situations. The request for access to a Genelux investigational drug will be considered only if all the following criteria are met.

 

  • The patient has a serious or life-threatening disease or condition with no comparable or satisfactory alternative therapies
  • The patient is not eligible for or unable to participate in a clinical trial
  • The investigational drug is currently in clinical development with sufficient evidence of safety and effectiveness for patient’s specific condition
  • A benefit-risk analysis suggests that the benefit from using of the investigational drug outweighs the known or anticipated risks based on evolving clinical data
  • We have adequate supply of investigational drug

 

If the investigational drug is approved by a regulatory agency for commercial use, including provisional approval, existing expanded access programs will be phased out or modified accordingly.

 

Patients interested in seeking an expanded access to a Genelux investigative drug should talk to their physician. All requests must be made by the patient’s treating physician by email at EAP@genelux.com. We will, in general, acknowledge receipt of a request for expanded access within five business days. We may ask for more detailed information to fully evaluate a request.

 

The request for access to an investigative drug can only be considered if the requesting physician agrees to obtain applicable regulatory and ethics committee approvals. We may deny access if the treating physician cannot guarantee an appropriate storage and handling of the investigative drug, which typically requires a temperature controlled deep freezer and follows Biosafety Level 2 safety procedures and precautions. The treating physician must agree to comply with regulatory obligations, including safety monitoring and reporting.

 

For more information on expanded access from the FDA, click here.