Management TeamAdvaxis 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
Mr. O’Connor was appointed Advaxis’s President and Chief Executive Officer in August 2013 at a time when the company had limited cash reserves, was burdened with significant debt, and, due to its status as an “ OTC Company,” had few options for securing the necessary financing to remain solvent. Undeterred, Mr. O’Connor executed a turnaround strategy rooted in an understanding of the potential of Advaxis’s Lm-LLO immunotherapy technology platform. From leading Advaxis’s uplisting to Nasdaq, to assembling the company’s executive team, to securing high-profile collaboration agreements with Merck, MedImmune and Incyte Corporation, Mr. O’Connor has successfully transformed Advaxis financially, clinically and operationally, providing a strong balance sheet that has enabled the company to advance one of most diverse and active immunotherapy pipelines in the industry.
Mr. O’Connor’s career is highlighted by more than 15 years of executive, legal, and regulatory experience in the biopharmaceutical industry, including senior leadership positions at ImClone Systems and PharmaNet. During his tenure 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® and played a key role in resolving numerous issues facing the company, including extensive licensing negotiations, in advance of its sale to Eli Lilly in 2008.
Mr. O’Connor’s career in the pharmaceutical and healthcare industry began with his appointment to general counsel of PharmaNet. While at PharmaNet, Mr. O’Connor was instrumental in building the company from a start-up contract research organization into an established world leader in clinical research. Prior to PharmaNet, Mr. O’Connor was a criminal prosecutor in New Jersey and gained leadership experience as a Captain in the U.S. Marines, serving in the Persian Gulf in 1990.
David J. Mauro, MD, Ph.D.
Executive Vice President, Chief Medical Officer
Dr. Mauro brings more than 14 years of experience in oncology drug development to Advaxis where, as Chief Medical Officer, he is responsible for leading the development of the company’s Lm-LLO immunotherapy platform and overseeing its multiple clinical programs including those in HPV-associated cancers (cervical, anal and head & neck), HER2 over-expressing tumors (breast, gastric, and osteosarcoma) and prostate cancer. Additionally, Dr. Mauro is a driving force in the advancement of Advaxis’s checkpoint inhibitor combination strategy where his expertise in PD-1/PDL-1 combination studies is instrumental in the ongoing success of programs involving Advaxis’s Lm-LLO platform and Merck’s approved PD-1 inhibitor, KEYTRUDA® (pembrolizumab), MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, and Incyte's investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360).
Before joining Advaxis in October 2014, Dr. Mauro served as Executive Director, Section Head Oncology Clinical Development at Merck & Co. where he was involved in the strategic oversight and tactical implementation of the clinical development and translational science for multiple programs within the oncology portfolio, including KEYTRUDA® (pembrolizumab). Prior to Merck, Dr. Mauro was Director at Bristol-Myers Squibb (BMS), where his responsibilities included Erbitux Medical Strategy and Oncology Early Development. While at BMS, he was responsible for all life cycle management activities for Erbitux, as well as medical affairs related activities.
During his career, Dr. Mauro has participated in multiple FDA submissions and approvals, including three successful new drug applications for Erbitux, Sprycel® (dasatinib) and Sylatron™ (peginterferon alfa-2b), and two PMA filings for EGFR PharmDx and KRAS Companion Diagnostics. Dr. Mauro received his BS in biochemistry from Cornell University and his MD, Ph.D. in pharmacology from Temple University School of Medicine. He completed his residency training at the National Cancer Institute, National Institutes of Health.
Gregory T. Mayes
Executive Vice President and Chief Operating Officer
As Executive Vice President and Chief Operating Officer, Gregory T. 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’s immunotherapy platform and technologies from Merck, 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 bio-pharmaceutical 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 dollar 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 B.S. degree from Syracuse University cum laude where he was recognized as a Remembrance Scholar and he earned a J.D. degree 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 I to IV. Dr. Petit joins 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 B.S. from Indiana State University.
Sara Bonstein, MBA
Senior Vice President and Chief Financial Officer
Sara Bonstein joined Advaxis in March 2014 as the Chief Financial Officer, Senior Vice President. Sara 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, Sara 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, Sara 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 ten monoclonal antibody cancer therapeutics, including Erbitux, a cancer treatment with over $1.5 billion in annual sales. Prior to joining ImClone, Sara 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. Sara is a 2004 graduate of Johnson & Johnson's Financial Leadership Development Program. She holds a BS in Finance from The College of New Jersey and an MBA from Rider University.
Chris L. French, MBA
Vice President Regulatory and Medical Affairs
Ms. French has over 20 years of regulatory, scientific and medical affairs experience in start-up, midsize and large pharmaceutical companies. She has held management positions in medical affairs, regulatory affairs, scientific communications, drug development, and business development. Chris joined Advaxis in 2011 from Bristol Myers-Squibb where she was US Director of Oncology Scientific Communications and medical strategy lead in US Oncology Medical Affairs New Products. Prior to BMS, Chris was the Senior Director of Program Management at MGI Pharma; Vice President of Regulatory and Scientific Affairs at Aesgen and the Director of the Dermatology Business Unit at Atrix, Inc. Earlier Chris was a research scientist and manager of technology transfer at the Mayo Foundation for Medical Education and Research. During her career Chris has managed over 60 technology transfer projects, 30 drug development programs and has been responsible for filing nearly 30 ANDAs, four NDAs and contributed to an additional 12 NDAs in multiple therapeutic areas.
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, Chemical Engineering from Stevens Institute of Technology and a Master of Science, 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-LLO cancer immunotherapy 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 I through Phase III 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 I through Phase III 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.
Fred J. Frullo
Vice President, Regulatory Affairs
With more than 20 years of experience in the biopharmaceutical industry, Mr. Frullo is well versed in the development of global regulatory strategies for the supervision, review and assembly of pharmaceutical product submission and coordination with global health authorities to obtain approvals. As Vice President, Regulatory Affairs, Mr. Frullo oversees regulatory submissions for the company's Lm-LLO cancer immunotherapy clinical programs, including ADXS-HPV, ADXS-PSA and ADXS-HER2, as well as combination studies involving complementary immunotherapy technologies. Mr. Frullo leads the development and submission of all regulatory documents on behalf of Advaxis to the appropriate health agencies and coordinates joint submissions with Advaxis's strategic partners. Mr. Frullo is responsible for leading Advaxis's global regulatory strategy and serves as the primary liaison between the company and the global health authorities.
Before joining Advaxis in May 2015, Mr. Frullo served as the Vice President, Regulatory Affairs at Onconova Therapeutics, Inc., where he developed global regulatory strategies for early development projects and liaised with the FDA and European Health Authorities.
Prior to that, Mr. Frullo was the Director, Global Regulatory Strategy at Bristol-Myers Squibb, where he was responsible for maintaining regulatory compliance for the oncology portfolio of marketed products and providing global regulatory strategy support for both Life Cycle Management Teams and Early Development Teams. Mr. Frullo's career in regulatory affairs is comprised of executive positions at several prominent pharmaceutical companies, including Pharmacia Corporation, McNeil Consumer Healthcare and Johnson & Johnson. Mr. Frullo holds a BS in biology from Ohio University.