Executive Management

Thomas Zindrick, J.D. - President and Chief Executive Officer

Mr. Zindrick has served on our Board of Directors and has been President and CEO since 2014, and also serves as a member of the Board of Managers of V2ACT Therapeutics LLC.

 

Tom is an accomplished senior executive with diverse experience in life sciences companies. From 1993 to 2009, Tom held positions of increasing responsibility at Amgen, Inc., including Vice President, Associate General Counsel and Chief Compliance Officer. Prior to joining Amgen, Tom was an attorney at The Dow Chemical Company.

 

Tom currently serves as Executive Chairman of Aeromics, Inc., a clinical-stage pharmaceutical company developing products for the control of edema (brain swelling) in ischemic stroke. He previously served on the board of directors of Amitech Therapeutic Solutions, Inc. from 2011 to February 2021 and DNX Biopharmaceuticals, Inc. from November 2014 to March 2020.

 

Tom received his J.D. from the University of Illinois College of Law and a B.A. in Biology from North Central College in Naperville, Illinois.

Paul Scigalla, M.D., Ph.D. - Chief Medical Officer

Dr. Scigalla is a physician and medical researcher with more than 30 years of clinical development experience across multiple therapeutic areas. As head of Clinical Research for nephrology, oncology and bone metabolism at Boehringer Mannheim GmbH, now Roche Diagnostics GmbH, he was responsible for the preclinical and clinical development of erythropoietin and approval of ibandronate for the treatment osteoporosis and bone metastases. He later served as Head of Global Development Therapeutics and Executive Vice President at SUGEN, Inc., responsible for the clinical development of multiple receptor tyrosine kinase inhibitors, including sunitib (Sutent®) and as Vice President Research Oncology, Pharmacia/Pfizer, Inc. in Bedminster, New Jersey. Since August 2003, he has served as a consultant to several pharmaceutical companies in US, Japan and Europe. Dr. Scigalla received his medical training from the University of Humboldt and was appointed Professor of Medicine from the University of Heidelberg in 1992.

Tony Yu, Ph.D. - Vice President, Clinical Trial Operations

Dr. Yu has more than19 years of experience in biotech/biopharma industry, with expertise in oncology and biologics drug research and development.  Dr. Yu conducted the initial key scientific research that led to the formation of Genelux Corporation and was the Company’s first employee.  Dr. Yu has served as our Vice President of Clinical Trial Operations since January 2010, and has supervised the successful completion of seven human cancer clinical trials and one  canine cancer trial in the US/Europe. Previously, he served as our Associate Vice President of Preclinical Research & Business Development from 2008 to 2010. He was an adjunct faculty at UCSD Moores Cancer Center.  Dr. Yu has published more than 40 research articles in peer-reviewed journals and holds more than 20 granted US patents.  He is a member of the American Society of Clinical Oncology.  Dr. Yu received a B.A. in biology from the University of Utah and a Ph.D. in anatomy and biochemistry from Loma Linda University.

Joseph Cappello, Ph.D. - Vice President, Pharmaceutical Development

Dr. Cappello has served as Genelux Corporation’s Vice President of Pharmaceutical Development since November 2012 and General Manager of Genelux CMF (Commercial Manufacturing Facility) since September 2018.  Over three decades, Dr. Cappello’s career has spanned pharmaceutical and medical device development, R&D, regulatory affairs, GMP manufacturing, clinical study design and management and academic research.

 

In 1988, Dr. Cappello co-founded the start-up biotechnology company Protein Polymer Technologies Inc., based on technology he co-invented, which later transitioned to a public company. In his role as Vice President, Research and Development and Chief Technology Officer (CTO), he conducted R&D, product development, GMP manufacturing and clinical development, managing multiple multi-center clinical trials.  In 2010, he became an adjunct Professor of Pharmaceutical Sciences at the University of Utah with research interests in matrix assisted drug delivery using bioabsorbable materials, a position which he retains today.  He served previously as Director/General Manager of the Biological Test Center for B. Braun Medical, Inc., where he managed a GLP/GMP organization conducting safety and analytical studies for new pharmaceutical development.

 

Over his career, Dr. Cappello has authored more than 70 scientific publications in peer reviewed journals and holds 19 U.S. Patents.  Dr. Cappello earned his Ph.D. in Biological Chemistry from the University of Cincinnati, College of Medicine, and his B.S. in Molecular and General Genetics from the University of California, Davis.

Qian Zhang, M.D., Ph.D. - Associate Vice President, Research

Dr. Zhang joined Genelux Corporation as one of the founding scientists in January 2003. She served as Director of Molecular Biology for five years, responsible for design and engineering of protein expression constructs, tumor targeting, immune modulation, imaging, radiation sensitizing, and oncolytic viral therapy. She extensively investigated the genomic, proteomic and host expression profiles of various vaccinia strains, including Olvi-Vec(GL-ONC1), the leading product in the pipeline. She has had increasing responsibilities since 2008 as Associate Vice President of Medical Regulatory Affairs, serving as the regulatory contact in preparing and submitting regulatory documents, ensuring GMP product testing in accordance with FDA and EMA requirements, reviewing clinical protocols for regulatory compliance and quality assurance, and developing and evaluating laboratory SOPs for testing of clinical samples.

 

Dr. Zhang has authored more than 40 scientific publications in peer reviewed journals and holds numerous U.S. Patents. She earned her Ph.D. in Physiology and Molecular Biology and Master’s in Public Health (MPH) from Loma Linda University, and her Bachelor’s in Medicine from Qingdao University Medical College (aka Qingdao Medical College), China (ACEI certified to be equivalent to the first professional degree of Doctor of Medicine). She practiced for five years in Internal Medicine with emphasis on Cardiology and Geriatrics.

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.