Jonathan Helfgott, MS
Senior FDA regulatory and clinical strategist with 20+ years of experience guiding medical products and technologies through high-stakes regulatory decision points.
Jonathan Helfgott brings deep expertise in FDA regulatory strategy, clinical development planning, and market access across medical devices, digital health, diagnostics, and biopharma. He has advised organizations on complex FDA pathways, evidence generation, and strategic Agency engagement; particularly for emerging and novel technologies where precedent is limited and regulatory decisions carry material risk.
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.
Dr. David Schodin brings deep expertise at the intersection of FDA regulatory strategy, molecular diagnostics commercialization, and complex life sciences transactions. He has advised executive teams on regulatory positioning, intellectual property strategy, partnering, and market access; particularly for novel diagnostic technologies where regulatory pathways, reimbursement, and deal structures must be aligned early to mitigate risk.
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. Michael Marcarelli brings deep expertise in FDA regulatory policy, bioresearch monitoring, and clinical investigation oversight, informed by senior leadership roles within the Agency. He has advised on regulatory strategy, compliance risk, and clinical research execution; particularly for programs navigating complex Investigational Device Exemption (IDE) requirements and scrutiny around sponsor and investigator conduct.
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.
Dr. Tom Colonna brings deep expertise in FDA regulatory strategy, scientific evaluation, and legal analysis across medical devices, biologics, pharmaceuticals, dietary supplements, food products, and biomedical software. With dual training in molecular biology and law, he has advised executive teams, law firms, and global manufacturers on regulatory pathway strategy, submission development, enforcement risk, and Agency engagement; particularly in complex or precedent-setting matters where scientific and legal considerations must be tightly aligned.
Dr. Ara Khachaturian, PhD
Expert clinical strategist with 30+ years of experience guiding neuroscience and public health programs through complex research, policy, and evidence-generation decision points.
Dr. Ara Khachaturian brings deep expertise in epidemiology, biomedical research strategy, and advanced data modeling applied to neurological disease and public health. He has advised research institutions, policymakers, and scientific organizations on evidence generation, population-level disease modeling, and translational research strategy; particularly for complex neurodegenerative conditions such as Alzheimer’s disease where clinical, epidemiological, and policy considerations must align.
Dr. Adam Kaplin, MD PhD
Industry and academic clinical strategy expert with 25+ years of experience guiding neuropsychiatric and CNS therapeutics through high-stakes FDA development and review decision points.
Dr. Adam Kaplin brings deep expertise in clinical development and translational neuroscience across biopharma and CNS drug programs. As a physician-scientist and former FDA medical reviewer, he has advised executive teams on regulatory pathway strategy, clinical trial design, endpoint selection, and Agency engagement; particularly for complex neuropsychiatric indications where evidentiary standards and safety considerations require careful alignment.
Anis Rahman, MS
Software validation and quality system expert with 15+ years of experience guiding medical devices, in vitro diagnostics, and digital health technologies through high-stakes FDA and global regulatory decision points.
Anis Rahman brings deep expertise in FDA regulatory strategy, quality systems, and global market access across IVDs, medical devices, and emerging diagnostic technologies. He has advised executive teams on U.S. and international regulatory pathway strategy, evidence planning, QMS implementation, and health authority engagement; particularly for novel diagnostics and device platforms navigating evolving regulatory frameworks.
Penny Rassmusen, MS
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.
Penny Rassmusen brings deep expertise in regulatory affairs, quality systems, and operational compliance across medical device development and commercialization. She has supported organizations ranging from early-stage innovators to global manufacturers, advising on regulatory pathway strategy, submission development, audit readiness, and cross-functional coordination required to operate effectively within FDA and international regulatory frameworks.
Joshua Anzaroot
Cybersecurity expert at IEEE with 20+ years of experience guiding cybersecurity, testing, and certification programs through complex federal compliance and assurance frameworks.
Joshua Anzaroot brings deep expertise in regulatory and certification strategy across the Testing, Inspection, and Certification (TIC) sector, with a focus on federal cybersecurity and assurance programs. He has advised technology companies and service providers on certification pathways, compliance planning, and assessment strategy across multiple U.S. government frameworks. His work frequently involves aligning technical implementation with regulatory requirements to enable efficient certification and market access.
Dr. Anupama Kumar, MBBS PhD
Clinical and scientific expert with 15+ years of experience guiding CNS and neuroimmunology programs through complex clinical development and regulatory decision points.
Dr. Anupama Kumar brings deep expertise in clinical trial design and execution across neuroimmunology and psychiatry. She has led multidisciplinary teams in translating scientific innovation into structured development programs, advising on protocol design, endpoint strategy, regulatory alignment, and operational rigor; particularly for therapeutics targeting complex neurologic and psychiatric disorders.
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. Zaven Khachaturian brings deep expertise in neuroscience research strategy, biomedical policy, and large-scale program development focused on Alzheimer’s disease and the neurobiology of aging. He has advised government agencies, research institutions, and global health organizations on scientific strategy, research infrastructure, and evidence development, particularly for complex neurodegenerative diseases where coordinated national and international research efforts are required.
Alexander Phillips
Regulatory specialist supporting FDA regulatory submissions and clinical development programs across medical devices and emerging healthcare technologies.
Alexander supports regulatory filings, clinical development activities, and quality system alignment throughout the product development lifecycle. His work includes preparation and management of regulatory documentation, clinical trial operational support, and coordination of compliance activities that support inspection readiness and regulatory traceability.
Zoe Posner
Research and clinical development analyst with experience supporting biomedical research programs, translational science initiatives, and emerging therapeutic innovation.
Zoe Posner brings a strong foundation in molecular biology and translational biomedical research, with experience contributing to large-scale research initiatives focused on cancer biology and therapeutic resistance. Her work centers on analyzing complex biological data, supporting research program execution, and translating laboratory insights into structured scientific development frameworks.