Executive Management

Mr. David L. Barthel – CEO

 

Mr. David L. Barthel is an experienced executive leader in the healthcare and medical device space with the proven ability to straddle the worlds of large corporations and early-stage businesses. Mr. Barthel founded The SmartPill Corp. and led the company as CEO & President until its acquisition by medical device giant, Medtronic. Mr. Barthel successfully took The SmartPill company, developing an innovative ingestible sensor-based capsule for diagnosing GI motility disorders, from its initial patent through the entire product development process, raising more than $70 million in multiple funding rounds. Mr. Barthel led his team through multiple clinical trials, manufacturing, FDA approval, commercialization and successful insurance reimbursement.  After the acquisition by Medtronic, Mr. Barthel joined the company as Area Vice President, GIH Southeast Division.

 

Most recently, Mr. Barthel was CEO of Health Logic Interactive Inc. and its wholly owned Subsidiary, My Health Logic Inc. In less than a year, Mr. Barthel led the Company from an initial patent pending technology with proof-of-concept data to building an IP portfolio and further advancing its lab-on-chip technology platform. Mr. Barthel was responsible for implementing product and software development partners, the preparation of an FDA pre-submission, leading discussions with several potential strategic partners, integrating a strong clinical and business team-based culture, and the establishment of a diverse Scientific Advisory Board.

 

Mr. Barthel also has relevant P&L and senior leadership experience as a Managing Director for Henry Schein’s Orthopedic Surgical Instrumentation business, as an Area Vice President for the Southeast Division for Medtronic GIH in Atlanta, GA and as Vice President, SmartPill for Given Imaging in Duluth, GA.

 

Mr. Barthel earned a Bachelor of Arts Degree from St. Norbert College in Depere, Wi and an MBA from Lake Forest Graduate School of Management in Lake Forest, Il.

Steven Brooks, MD, MBA, FACC – Chief Medical Officer

 

Dr. Brooks was appointed as Executive VP of Medical and Regulatory Affairs, Chief Medical Officer on December 1, 2020. Dr. Brooks is currently the principal of Brooks Medtech, LLC, a medical technology consulting firm. Dr. Brooks has more than 20 years in medicine and industry supporting the commercialization of medical innovation, including medical devices, mHealth, drugs, biologics and combination products. Dr. Brooks’ interests include evidence development, clinical trial design and execution, regulatory and reimbursement strategy and healthcare market strategy.

 

Previously Dr. Brooks was an Interventional Cardiologist at University of Maryland Medical Center and private practice, and then a Medical Officer at the United States Food and Drug Administration (FDA) for six years in Center for Devices and Radiological Health (CDRH) in the Division of Cardiovascular Devices.

 

Dr. Brooks has held positions with the life science consulting firms NDA Partners, Popper & Company, and Sage Growth Partners. He is CMO for Global Interconnect and is the Senior VP of Medical Sciences and Regulatory Affairs for Vita Therapeutics. He previously held the positions of CMO for CardioCube, LLC and VP of Regulatory Affairs and Health Economics for Ablative Solutions.

 

Dr. Brooks achieved his M.D. degree at the University of Pittsburgh School of Medicine, and Residency, Cardiology and Interventional Cardiology Fellowships at University of Pittsburgh Medical Center. He received his MBA from the Johns Hopkins Carey School of Business in the Business of Medicine Program, and a B.A. at Duke University.

Catherine J. Pachuk, Ph.D. – Executive Vice President, Chief Scientific Officer

 

Dr. Pachuk has more than 25 years of research and development leadership experience in the pharmaceutical and biotech sectors with expertise in both drug, device and vaccine development with significant experience in nucleic acid based therapeutic platforms including ASO, RNAi and nucleic acid-based vaccines. Her key areas of therapeutic focus are viral diseases including Hepatitis B, Hepatitis C, metabolic disease, HCC and indications associated with Ischemia Reperfusion Injury. She was involved in advancing multiple product candidates into the clinic and market including several first-in-man compounds. She received her Ph.D. in molecular virology from the University of Pennsylvania where she studied the molecular biology of coronaviruses. She also has a dual Regulatory Affairs Certificate from RAPS (Regulatory Affairs Professional Society) in medical devices and pharmaceuticals.

 

Following a post-doctoral fellowship at SmithKline Beecham, she joined Apollon, Inc. to develop programs in oligonucleotide-based therapeutics, and subsequently DNA-based vaccines for both viral and oncology indications. Following the acquisition of Apollon, Inc. by Wyeth-Ayerst Research in 1998 she continued to direct several vaccine programs, which resulted in several plasmid-based vaccine products being advanced into clinical trials. During this time, Dr. Pachuk worked with FDA’S CBER division in the drafting of a “Points to Consider” document regarding considerations for administration of plasmid DNA compounds in humans. In 2001, she co-founded Nucleonics, a biotech focused on the development of RNAi-based therapeutics, one of which was advanced into clinical studies in Chronic Hepatitis B patients. Until April 2008, she was VP of Preclinical Research. Dr. Pachuk then went on to lead biology and preclinical development efforts for Pfizer’s oligonucleotide therapeutic programs (ASO and siRNA) in the areas of oncology and metabolic disease and was a member of the Executive Leadership Team. Dr. Pachuk also has significant experience in nucleic-acid delivery and has led nucleic acid-delivery and formulation development programs for ASO, plasmid-based therapeutics, and siRNA at Apollon/Wyeth Vaccines, Nucleonics and Pfizer. Dr. Pachuk also was responsible for obtaining more than $1.8 million in government and private grants.

 

Dr. Pachuk is currently a Scientific Advisory Board member for Ocugen, Inc. where she advises on the development of a COVID-19 vaccine and is currently an invited expert curator for the American Society of Microbiology’s COVID-19 research registry. She is also an adjunct faculty member at both Florida Atlantic University and Baruch Blumberg Institute.