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).
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).
Mr. Gago brings to this position over 30 years of experience nurturing, developing and building strong and lasting relationships with the international healthcare community. He has extensive experience on a global basis with industry business partners, ranging from component suppliers to clinical, training and marketing organizations.
Agustin brings a wealth of expertise in the fields of interventional oncology, cancer treatment systems/surgical devices, diagnostic cancer pharmaceuticals as well as cardiology devices and devices for vascular interventions.
Prior to joining ImmunSYS, Agustin held several executive-level positions, including: EVP/Chief Commercial Officer at InspireMD, Chief Commercial Officer at Delcath, Vice President of International Oncology Sales at AngioDynamics, and Vice President of International Operations at E-Z-EM Inc.
Over the years Agustin has built direct sales, distributor sales, marketing and distribution organizations, along with technical sales and marketing support units that were focused on the oncology and interventional oncology segments of the marketplace. He holds a B.S. in Business Management from Hofstra University.
Mr. Recinella has over 35 years of experience in medical devices and has taken numerous products from feasibility to commercialization. His experience covers a wide array of devices ranging from Class I to Class III and has included the development of implants, hardware and consumables. Most of his career has been spent in engineering (R&D and Operations) and project management, but he also has experience in product management, regulatory and clinical.
Dan started his career at Sarns (a division of 3M) where he was part of the team developing one of the first LVAD’s as well as consumables for open heart surgery procedures. From there he moved on to Mansfield Scientific, followed by AngioDynamics where he last served as Chief Technology Officer before leaving in 2011.
Most recently, Dan was at Veniti where he served as one of the executive level managers and led R&D, Operations, Clinical and Regulatory. He left Veniti after the company was successfully acquired by Boston Scientific last year. Dan holds a bachelor’s degree in Mechanical Engineering from the University of Michigan-Ann Arbor and an MBA from State University of New York-Albany.