Jonathan Helfgott, MS
Dr. David Schodin, PhD JD
Dr. David Schodin, PhD JD
Senior FDA regulatory and clinical strategist with 20+ years of experience guiding medical products and technologies through high-stakes regulatory decision points.
Dr. David Schodin, PhD JD
Dr. David Schodin, PhD JD
Dr. David Schodin, PhD JD
Industry expert with 30+ years of experience guiding diagnostics, laboratory-developed tests (LDTs), and molecular technologies through high-stakes regulatory, transactional, and commercialization decision points.
Edmond Massuda, MS
Dr. David Schodin, PhD JD
Edmond Massuda, MS
Senior scientist with more than 20+ years of experience advancing biologics, vaccines, and diagnostic technologies through complex analytical and regulatory challenges.
Dr. Ara Khachaturian, PhD
Dr. Michael "Emeritus" Marcarelli, PharmD, MS
Dr. Michael "Emeritus" Marcarelli, PharmD, MS
Expert clinical strategist with 30+ years of experience guiding neuroscience and public health programs through complex research, policy, and evidence-generation decision points.
Dr. Michael "Emeritus" Marcarelli, PharmD, MS
Dr. Michael "Emeritus" Marcarelli, PharmD, MS
Dr. Michael "Emeritus" Marcarelli, PharmD, MS
Former Director of FDA CDRH's Division of Bioresearch Monitoring (BIMO) and head of the Investigational Device Exemption (IDE) program. 35+ years of experience guiding medical device programs through clinical investigations, compliance oversight, and high-stakes FDA decision-making.
Dr. Tom Colonna, PhD JD
Dr. Michael "Emeritus" Marcarelli, PharmD, MS
Dr. Tom Colonna, PhD JD
Senior FDA regulatory and clinical strategist with 30+ years of experience guiding medical devices, biologics, pharmaceuticals, software, and food products through high-stakes FDA regulatory decision points.
Penny Rassmusen, MS
Dr. Michael "Emeritus" Marcarelli, PharmD, MS
Dr. Tom Colonna, PhD JD
Senior FDA regulatory and device strategy expert with 30+ years of experience guiding medical device companies through 510(k) regulatory submissions, quality system implementation, and compliance in highly regulated environments.
Joshua Anzaroot
Dr. Zaven Khachaturian, PhD
Dr. Zaven Khachaturian, PhD
Cybersecurity expert at IEEE with 20+ years of experience guiding cybersecurity, testing, and certification programs through complex federal compliance and assurance frameworks.
Dr. Zaven Khachaturian, PhD
Dr. Zaven Khachaturian, PhD
Dr. Zaven Khachaturian, PhD
Senior Alzheimer's and clinical strategist with 40+ years of experience shaping national research programs and scientific policy for neurodegenerative disease and brain aging.
Dr. Norelle Wildburger, PhD
Dr. Zaven Khachaturian, PhD
Dr. Norelle Wildburger, PhD
Senior biotechnology strategist and translational scientist with expertise in therapeutic and diagnostic development, executive leadership, and commercialization strategy.
Dr. Patrick M. Moriarty, MD
Dr. Patrick M. Moriarty, MD
Dr. Patrick M. Moriarty, MD
Professor of Medicine at The University of Kansas Medical Center in Kansas City, Kansas. He has an extensive clinical background from his clinical trials, research, and peer review experience.
Todd Mayover
Dr. Patrick M. Moriarty, MD
Dr. Patrick M. Moriarty, MD
Data privacy and risk management expert. Investment guide, advising acquisitions and financing deals. Accomplished project manager with extensive background advising C-suites.
Zoe Posner
Sara Pezzini, MS
Sara Pezzini, MS
Regulatory and quality specialist with expertise in Software as a Medical Device (SaMD) products, 510(k) premarket notifications, and document management.
Sara Pezzini, MS
Sara Pezzini, MS
Sara Pezzini, MS
Regulatory specialist providing FDA regulatory support for medical device submissions and clinical research initiatives involving novel healthcare solutions.
Lev Schwartz, MS
Sara Pezzini, MS
Lev Schwartz, MS
Regulatory affairs associate supporting medical device clients through the FDA 510(k) submission process. Lev combines graduate training in regulatory affairs with experience in client outreach, business development, and project management.