Advaxis has assembled a world class management team with extensive expertise and a successful track record in drug development and commercialization of cancer immunotherapies.
Daniel J. O’Connor
President, Chief Executive Officer and Director
Daniel O’Connor is President, Chief Executive Officer and Director of Advaxis, Inc., a Princeton-based clinical stage biotechnology company that is developing cancer immunotherapies. As CEO, Mr. O’Connor has led the transformation of Advaxis into a leading cancer immunotherapy company.
Mr. O’Connor has 20 years of executive, legal, and regulatory experience in the biopharmaceutical industry, including senior leadership positions at ImClone Systems and PharmaNet, now known as Inventiv Health. At ImClone, Mr. O’Connor served as senior vice president, general counsel, and secretary where he supported the clinical development, launch, and commercialization of ERBITUX® (cetuximab) and helped resolve corporate issues, including extensive licensing negotiations, in advance of its sale to Eli Lilly in 2008. While at PharmaNet, Mr. O’Connor was part of the senior leadership team that expanded the company from a start-up contract research organization to a world leader in clinical research. Previously, Mr. O’Connor was a criminal prosecutor in Somerset County, New Jersey and a Captain in the U.S. Marines, serving in the Persian Gulf in 1990.
In 2015, Ernst & Young named Mr. O’Connor Entrepreneur of the Year® in New Jersey. He serves as an advisor to the Dean of the Penn State University’s Dickinson School of Law and is a member of the Board of Trustees of BioNJ. Mr. O’Connor is a lifelong resident of New Jersey, growing up in Westfield and currently residing in Pennington with his wife, Kathleen O’Connor, and their three sons. He has served on the Hopewell Valley Regional School Board and enjoys coaching youth sports.
Gregory T. Mayes
Executive Vice President and Chief Business Officer
As Executive Vice President and Chief Business Officer, Mr. Mayes plays an integral role in the implementation of Advaxis’ growth strategy and business development efforts. Since joining Advaxis in October 2013, Mr. Mayes has been instrumental in identifying and negotiating several partnership and clinical trial collaboration agreements, including combination studies involving Advaxis’ Lm Technology™ platform and technologies from Merck & Co., Inc., MedImmune and Incyte Corporation as well as cultivating a growing base of institutional shareholders.
Mr. Mayes’ career is highlighted by more than 20 years of biopharmaceutical experience. Prior to Advaxis, Mr. Mayes was an Executive Vice President at Dendreon, the leading pioneer in the field of immuno-oncology research and development, where he served as a member of the Executive Committee. Previous to Dendreon, Mr. Mayes was President and General Counsel of Unigene Laboratories, Inc. where he primarily led out-licensing efforts for the company’s novel oral peptide drug delivery platform.
From 2004 to 2010, Mr. Mayes served as Vice President, General Counsel, and Chief Compliance Officer at ImClone Systems Corporation, a wholly owned subsidiary of Eli Lilly. During his tenure at ImClone, Mayes supported the clinical development and commercialization of ERBITUX® (cetuximab) and contributed significantly to activities that resulted in Eli Lilly’s $6.5 billion acquisition of ImClone in 2008.
As Senior Counsel at AstraZeneca Pharmaceuticals from 2001 to 2004, Mr. Mayes provided a wide range of legal services in connection with the development and commercialization of five approved products in the company’s oncology portfolio. Earlier, Mr. Mayes worked in private practice at Morgan Lewis LLP, a national law firm. He earned his Bachelor of Science from Syracuse University cum laude where he was recognized as a Remembrance Scholar and he earned a Juris Doctorate magna cum laude from the Temple University School of Law where he was the Articles Editor on the Temple Law Review.
Robert G. Petit, Ph.D.
Executive Vice President and Chief Scientific Officer
Dr. Robert Petit has 23 years of experience in all medical and scientific aspects of pharmaceutical development. He has led programs in discovery, translational development and intellectual property development and has designed and conducted U.S. and international clinical evaluation programs from Phase 1 to 4. Dr. Petit joined Advaxis from Bristol-Myers Squibb where he was the U.S. Medical Strategy Lead for the ipilimumab program, Director of Medical Strategy for New Oncology Products, and Director of Global Clinical Research. Prior to joining Bristol-Myers Squibb, Robert served as Vice President of Clinical Development at MGI Pharma and also at Aesgen Inc. His scientific focus has been to develop immunologic based therapies with a particular emphasis on immunologic oncology treatment. Robert has had significant FDA experience and has contributed to five NDA/BLA filings. Dr. Petit has a doctorate from the Ohio State University College of Medicine and a Bachelor of Science from Indiana State University.
Sara Bonstein, MBA
Senior Vice President and Chief Financial Officer
Ms. Bonstein joined Advaxis in March 2014 as the Chief Financial Officer, Senior Vice President. Ms. Bonstein has a decade of financial leadership experience in the life sciences industry with Eli Lilly & Company, ImClone Systems and Johnson & Johnson. While at Eli Lilly & Company, Ms. Bonstein was a Six Sigma Champion and Black Belt, leading multiple projects relating to clinical research, project management, finance, manufacturing and commercial sales. Prior to her Six Sigma role, Ms. Bonstein held positions of increasing responsibility at ImClone (which was acquired by Eli Lilly in 2008) including Director of Finance where she led all budget and forecast activities for preclinical, clinical and manufacturing research and development, spanning over 10 monoclonal antibody cancer therapeutics, including ERBITUX® (cetuximab), a cancer treatment with over $1.5 billion in annual sales. Prior to joining ImClone, Ms. Bonstein was a financial analyst at Johnson & Johnson in both the Ortho McNeil Pharmaceuticals and Ortho Biotech Divisions of the company where she managed gross-to-net analysis and calculation for approximately $1.1 billion of pharmaceutical product sales. Ms. Bonstein is a 2004 graduate of Johnson & Johnson’s Financial Leadership Development Program. She holds a Bachelor of Science in Finance from The College of New Jersey and a Master of Business Administration from Rider University.
Senior Vice President and Chief Operating Officer
Mr. Duke joined Advaxis in October 2016 as Senior Vice President and Chief Operating Officer. He brings more than 20 years of life sciences experience to the Advaxis team, and is responsible for leading operations with a focus on overseeing clinical development programs and managing early commercial planning activities. Prior to joining Advaxis, Mr. Duke was Vice President, Global Commercial Operations at Amicus Therapeutics, Inc. where he played a lead role in the build out of the international business to support the successful launch of Galafold™ (migalastat), which was granted full approval by the European Commission in 2016. Mr. Duke was one of the first employees at Amicus and held several leadership roles in program/alliance management, medical affairs and commercial planning for 10 years.
Mr. Duke also served as Executive Director, International Commercial Operations for NPS Pharma where he led several strategic business planning initiatives and helped to establish NPS International to support the ex-US commercialization of Revestive® (teduglutide) and Natpar® (rhPTH[1-84]). He received his MBA from the Wharton School, University of Pennsylvania, his MPH from the University of Medicine and Dentistry of New Jersey, and a Bachelor of Science in Chemical Engineering from Rutgers University.
Vice President, Manufacturing
Mr. Pujols served as Executive Director, Technical Operations for Merck, Sharp & Dohme (MSD), the UK subsidiary of Merck & Co., Inc. As Executive Director, Technical Operations, Mr. Pujols led a team responsible for technical support and global supply of reliable, compliant and cost competitive biologics, vaccines and pharmaceuticals. Highlighting his success at MSD, Mr. Pujols was instrumental in spearheading partnerships with several key stakeholders and executing strategies that ensured the realization of opportunities, business continuity, innovation and financial results. Mr. Pujols also spent nine years with Merck & Co. at the beginning of his professional career.
Prior to MSD, Mr. Pujols spent seven years at MedImmune where he held positions of increasing responsibility, most recently serving as Director Clinical Manufacturing Operations, Research & Development. In this position, Mr. Pujols managed a team of development scientists and engineers responsible for scale-up, tech transfer and manufacture of pipeline biopharmaceuticals for global clinical trials. Previous to MedImmune, Mr. Pujols served as Manager, Global Technical Operations for Schering-Plough prior to its merger with Merck.
Mr. Pujols holds a Bachelor of Engineering in chemical engineering from Stevens Institute of Technology and a Master of Science in chemical engineering from Columbia University.
Thomas W. Hare
Vice President, Clinical Operations
Mr. Hare brings to Advaxis more than 28 years of experience in the biopharmaceutical and CRO industries overseeing the management of global commercial and clinical operations, data management, outsourcing and medical writing groups. As Vice President, Clinical Operations, Mr. Hare oversees clinical operations for the company’s Lm Technology™ clinical programs.
Before joining Advaxis in May 2015, Mr. Hare served as Vice President, Drug Development Operations for Incyte Corporation. He joined Incyte in January 2003 and was responsible for the strategic growth and development of a team that planned, implemented and managed Phase 1 through Phase 3 multinational clinical trials in cancer immunotherapy and cancer inflammation.
Prior to Incyte, Mr. Hare was Director of Operations at PRA International (now PRA Health Sciences), where he was responsible for forecasting of project revenue, costs and resources, performing financial analysis to insure contract compliance, developing metrics to measure quality, and managing a team responsible for the on-time and in-budget completion of Phase 1 through Phase 3 clinical trials. Previous to PRA International, Mr. Hare served as Vice President, Clinical Operations Division for Premier Research and as Clinical Manager/Senior Clinical Scientist for Bristol-Myers Squibb. Mr. Hare received a Master of Science in exercising physiology and biomechanics from the University of Delaware.
Robert W. Ashworth, Ph.D.
Vice President, Regulatory Affairs
Dr. Robert Ashworth has over 30 years of pharmaceutical industry experience spanning chemistry research and regulatory affairs. During the course of his career, he has made significant contributions to the FDA approvals of 12 new drugs. His drug development and regulatory experience includes small molecules, therapeutic proteins and antibodies. He joined Advaxis from NPS Pharmaceuticals Inc., where he served as Vice President, Global Regulatory Affairs and spearheaded the global approval of drugs for rare diseases. Prior to that, he had similar roles at Otsuka Pharmaceutical Development and Commercialization, Inc. and Biovail Corporation. Earlier in his career, he held positions of increasing responsibility at Forest Laboratories Inc., BASF Pharma (Knoll) and Ciba-Geigy Corporation.
Dr. Ashworth holds a doctorate in organic chemistry from the Massachusetts Institute of Technology and a Bachelor of Science in chemistry from St. John’s University.