Mr. Hobbs is an entrepreneurial senior executive with over 35 years of demonstrated success in profitable medical device and combination drug/device product business creation and growth, general management, sales and marketing, and product development.
He currently serves as a Visiting Scholar and Entrepreneur in Residence for the Translational Accelerator at Brigham and Women’s Hospital, Harvard Medical School. From July 2014 to January 2016, Mr. Hobbs served as the President and Chief Executive Officer of Antares Pharma, Inc., a specialty pharmaceutical and drug/device combination company focused on self-injection pharmaceutical products and technologies. From 2009 to 2013, he served as President and Chief Executive Officer of Delcath Systems, Inc., a specialty pharmaceutical and medical device public company specializing in cancer treatment.
Prior to Delcath, Mr. Hobbs served as President and Chief Executive Officer of AngioDynamics, Inc., a company he co-founded in 1988 as a division of E-Z-EM, Inc. which grew into a leading medical technology company and took public in 2004. Prior to starting AngioDynamics, Mr. Hobbs was Director of Marketing and Product Development at NAMIC; founder, President and Chief Executive Officer of Hobbs Medical, Inc.; and a Product Development Engineer at Cook Incorporated.
He also has served on numerous public and private company boards throughout his career. Mr. Hobbs received a B.S. degree in Plastics Engineering with a Biomaterials emphasis at the University of Massachusetts (Lowell).
Gary M. Onik, MD, while still in radiology residency training in 1982, at the University of California – San Francisco, described a brand new cancer treatment concept – a radiological procedure based on the possibility of image guided thermal tumor ablation (destruction). His new procedure demonstrated a brand new approach and novel techniques for destroying a tumor through freezing or heating and then leaving it in place to be removed by the body rather than by surgery.
This was the very first demonstration of its kind and with it Dr. Onik literally created an entirely new field of medicine around the concept of minimally invasive cancer tumor destruction and removal by normal bodily processes, rather than through surgical removal.
In 1982, using cryosurgical ablation under ultrasound guidance, he developed the first new potentially curative treatment for unresectable liver cancer patients. This work spawned the development of image-guided radio-frequency (RF) ablation of liver tumors, and subsequently the field of what is now a 4th branch of cancer treatment, called “Interventional Oncology”.
At the same time as his work on hepatic cancer ablation, Dr Onik. developed the instrumentation and techniques that allowed for the cryosurgical ablation of prostate cancer, which is now an accepted alternative to radiation and radical prostatectomy and the preferred treatment for patients with radiation-recurrent prostate cancer . His concept of “focal therapy” for prostate cancer, treating only the prostate tumor rather than the whole gland, similar to a breast lumpectomy, is now a major research and treatment initiative in all of the major prostate cancer centers in the world.
The 3D Prostate Mapping Biopsy, which he has pioneered, maps the exact location of the cancer in the prostate gland allowing safer and more efficacious treatment. (See video).
His most recent development of “Irreversible Electroporation” (IRE), embodied in the “NanoKnife”, is the first of its kind “non-thermal” tumor ablation modality, which is now being used to successfully treat inoperable pancreatic carcinoma. One recently published study indicated it can double overall survival time. This modality also promises effective treatment for other inoperable tumors including those of the head and neck and the brain.
After years of development and refinement leading to approval of the device, Dr. Onik is the physician with the most experience in the world using the NanoKnife, and is able to bring that experience along with the great breadth of his practice in tumor ablation to the treatment of recurrent prostate cancer.
The concepts and techniques he developed have had a major impact on the treatment of cancer patients throughout the world and his work has been recognized by awards given to him by major societies in both medicine and engineering.
In addition to his medical practice, Dr. Onik is an Adjunct Professor of Mechanical Engineering at Carnegie Mellon University, working closely with his colleagues to develop the next generation of cancer fighting technologies.
His latest work, using immunotherapy to treat metastatic cancer, offers hope those patients with literally no other options.
Mr. Gerardi is an entrepreneurial C-Level executive and a consummate financial strategist who partners with company leadership as a trusted adviser and plays a pivotal role in influencing strategy, planning and growth. He grasps the implications of critical issues and quickly formulates and implicates appropriate financial strategies and capital management solutions and controls with systems that drive organizational growth and expansion.
Mr. Gerardi started his career at FACTRON/Schlumberger as a Cost Accountant in 1986. He transitioned into the medical sector in 1987 as a Plant Controller at Mallinckrodt. In 1992, Mr. Gerardi joined AngioDynamics, Inc as the Chief Financial Officer. Throughout his 16-year tenure, he was pivotal in the rapid growth of the company. In 2004 he helped to spearhead an Initial Public Offering (IPO) of AngioDynamics that was subsequently recognized as one of the most successful IPOs of the year.
In 2008 Mr. Gerardi stepped down from AngioDynamics and joined Paradigm Spine as its VP and CFO. He continued to work within the orthopedic specialty in 2012, serving as VP and CFO to Knee Creations and Centinel Spine. From 2015 to 2018 Mr. Gerardi served as the VP and CFO of Genesis Global Healthcare, LLC. In 2015 he founded Fox Hollow Financial Consulting, partnering with companies as a trusted adviser, influencing strategy, planning and growth.
He received a B.B.A. in Finance in 1984 from SUNY Utica, followed by an MBA in International Business from SUNY Albany.
Dr. Condra is a senior scientific leader and educator with an extensive career in biomedical research, biotechnology and drug discovery (small molecule/biologics/vaccines), with experience ranging from target identification through post-marketing studies. He has broad and deep expertise in multiple scientific and technological areas, including: molecular biology, cell biology, molecular virology, biologics/therapeutic antibody discovery, and bacterial/viral genetics.
Prior to joining ImmunSYS, Dr. Condra was an Associate Professor of Pharmaceutical Biotechnology at the Temple University School of Pharmacy from 2012-2017. He taught an introductory immunology course for PharmD students and a graduate seminar in pharmaceutical biotechnology. He also engaged in several collaborative research projects as a member of the Moulder Center for Drug Discovery Research.
Dr. Condra spent the majority of this career in various leadership positions at Merck, most recently as Distinguished Senior Investigator and Head of Antibody Display Technology, Biologics Research. Over his 28-year tenure there, Dr. Condra grew to be an internationally recognized expert in HIV therapy and drug resistance. He is a prolific researcher, with 63 publications, 86 abstracts and 20 patents/patent applications to date. He is a highly sought after speaker and has delivered over 400 invited lectures throughout his career.
Dr. Condra completed his undergraduate studies at University of California, San Diego in Biology, followed by a Ph.D. in Biology from University of California, Riverside in 1979. In 1983 he completed his postdoctoral research on regulation of vesicular stomatitis virus (VSV) RNA transcription, replication & nucleocapsid assembly, in the laboratory of Dr. Robert A. Lazzarini at the National Institutes of Health (NIH).
Marlene Barton is a renowned expert in regulatory affairs and has significant experience in worldwide approvals and coordination of FDA panel meetings. Notably, Marlene assisted in the first drug-eluting stent approval in Japan, the first Brachytherapy system approval in the United states, and the first liquid embolic agent IDE approval for Neurovascular use in the United States which lead to PMA approval.
Marlene has been an active participant in the AdvaMed PMA & 510 (k) Working Groups since 1997, where she worked in conjunction with FDA to re-engineer their systems and develop numerous guidance documents. She was the PMA Working Group Chairperson for seven years. Marlene has also held significant roles in compliance efforts which led to resolution of a Corporate Warning Letter. This included her membership with the Office of Management and lead on several of the work streams (complaint handling, change management and non-conformances).
She has vast international experience, including her role as a representative for the Global Harmonization Task Force Study Group 1, as well as her work with FDA and Asia Pacific regulators to present the United States regulations at the time they were establishing new regulations in their countries.
Prior to joining ImmunSYS, Marlene served as the VP of Regulatory Affairs at Syntactx, where she was responsible for worldwide regulatory approvals for medical devices, combination products, biologies and drugs. Prior to Syntactx, Marlene was the Vice President of Regulatory Affairs for Cordis Corporation where she worked for 27 years on Endovascular, Neurovascular and Cardiology products. She left Cordis, a J & J company, in 2010 to start her own consulting company. During this time, she worked on various medical devices and combination products.
Marlene holds a Bachelor of Science in Geology from SUNY Binghamton. She is a member of the Regulatory Affairs Society and is Regulatory Affairs Certified (RAC).