MEET OUR TEAM OF EXPERTS
EXECUTIVE LEADERSHIP
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Deb Autor
CHIEF EXECUTIVE OFFICER
Deb Autor has over 30 years of experience in regulatory, legal, and business strategy, including serving as Deputy Commissioner of the FDA and leading global regulatory functions at AstraZeneca and Mylan. Before FDA, Deb was a Trial Attorney at the U.S. Department of Justice, where she was first chair for dozens of civil and criminal cases under the FD&C Act and other consumer protection statutes. She is Chair of the FDA Alumni Association, expert advisor, board member and decorated government leader educated at Harvard, Kellogg, BU, and Columbia.
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Michael Singer, Ph.D.
EXECUTIVE CHAIRMAN
Michael Singer has 30 years of leadership experience in finance, investments and operations in the healthcare industry. He has been a founding CEO of a traumatic brain injury medical device company navigating through 7 FDA clearances and tens of millions of dollars of DoD research contracts and venture financing. He was President of Revolution Health investments, an executive at Microsoft, a CFO who took a VC-backed medical device company public before selling it, and an M&A and healthcare investment banker. He has founded or been first investor in multiple companies and has served on both public and private Boards. Michael holds a Ph.D. from LSE.
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Ben Eloff, Ph.D.
HEAD OF CLIENT DELIVERY & QUALITY
Ben Eloff brings over 20+ years of experience in medical product regulation and innovation. Former FDA/CDRH Deputy Director of Epidemiology, co-author of FDA Guidance on Use of Real-World Evidence, and Director of Innovation and KidneyX program for HHS. He ensures client satisfaction with every project, leveraging his extensive experience to provide efficient and innovative solutions. Ben holds degrees in Biomedical and Electrical Engineering.
OUR TEAM
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Thom Mezak
Senior Manager Business Operations
Thom Mezak has over 10 years of experience in quality systems, business operations, and project management in the Life Sciences sector. He specializes in regulatory compliance, resource planning, and tailored consulting solutions. A certified Project Management Professional (PMP), he holds an MBA from the University of Washington and a Biochemistry degree from Western Michigan University.
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Brit Valdez-Nava
RA/QA SPECIALIST
Brit Valdez-Nava has extensive experience managing FDA regulatory filings, developing drug and device quality management systems (QMS), and overseeing GMP operations. She previously managed cellular/gene therapy manufacturing quality operations and consulted for medical device companies. She holds a master’s degree in Regulatory Science from Johns Hopkins University.
SELECTED EXPERTS
Regulatory & Quality
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Dick Chiacchierini, Ph.D.
30+ years with FDA, former Director of CDRH’s Biostatistics Division
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Mike Davis, MD, Ph.D.
Former FDA Clinical Team Leader with experience developing psychedelic drugs; psychiatrist and pharmacologist
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Clare Elser, DrSc
20+ years as a Quality & Regulatory Executive with Genentech, Novartis, and Merck
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Maxine Fritz
Former FDA Investigator, expert in drugs and biologics GMP, pre and post approval support, enforcement and remediation
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Dan Hanley, MD
Director, BIOS Clinical Trial Coordinating Center, Johns Hopkins School of Medicine. Recognized expert in brain injury research, extensive PI experience in vast array of neurological trials
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John Hedberg
35+ years of FDA and Industry experience; former FDA Investigator, expert in clinical research solutions and healthcare technology
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Dan Klassen
37+ years of experience in CMC, QMS, regulatory affairs, compliance and remediation for drugs, biopharma, biotech, and biosimilars – SGE on FDA Pharma Advisory Committee
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Rene Kozloff, Ph.D.
30+ years of experience in clinical study design, implementation, operations, and analysis; former researcher at NIH National Institutes of Neurology; Child Health and Human Development; Drug Abuse; Mental Health; and Alternative Medicine Studies
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Joann Pfeiffer, DrSc
25+ years as a Clin-ops, Regulatory Executive, former Director of ASU Regulatory Science Program
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Radhika Rajagopalan, Ph.D.
30+ years of FDA and Industry experience in drug policy, regulatory, CMC, INDs, NDAs, ANDAs
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Robert Ruff
Former FDA Investigator, Medical Device Lead Auditor, and expert in GMP, QSIT and MDSAP
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Neil Sankar, MD
30+ years drug development strategy for therapeutic oncology drugs, NDAs and registrational studies
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David Schoneker
43+ years of regulatory strategy experience in excipients, food additives and color additives used in drug development
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Rick Thompson, Ph.D.
Former Director of Johns Hopkins Translational Institute; expert in all aspects of statistical analyses from study design to publication
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Joe Toerner, MD, MPH
25+ years of FDA experience directing drug and vaccine development, expert in regulatory, policy and safety evaluations
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Domenic Veneziano
Former FDA Investigator and ORA Director of Import Operations
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Marc Walton, MD, Ph.D.
30+ years of FDA and Industry experience in drug development strategy and regulatory science
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Dawn Wydner, RN
Former FDA and Industry expert in medical device and drug compliance; GMP, GCP, GLP and BIMO inspections and training
Military Health
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Tom Thomas, MD, DDS, FACS
Major General, U.S. Army (Retired), former President of the Uniformed Services University, 30+ years of service as a physician healthcare executive, former Director of Healthcare Operations and Chief Medical Officer for the Defense Health Agency
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Chris Priest, FACHE
Colonel, U.S. Army, Senior Executive Service (Retired), former Deputy Director of Defense Health Agency and former Chief of Staff, drove healthcare optimization in military facilities and oversaw TRICARE, clinical ops, and clinical lab compliance
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Greg Giddens
Potomac Ridge Consulting
35+ years in VA and DOD overseeing large scale programs, driving strategy, fostering relationships across government, including the White House and Congress, former Principal Executive Director for the VA Office of Modernization
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Stacy Vasquez
Potomac Ridge Consulting
30+ years serving Veterans and their families, improving access and quality of military healthcare, former Veteran and CEO of two highly innovative Veterans Affairs Health Care Systems, expert in civil rights laws affecting military service
Reimbursement
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Judy Rosenbloom, FASE
JR Associates
Payer Solution Expert and former Clinical Operations Manager and Health Practitioner
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Jo Ellen Slurzberg
JR Associates
Coverage, Coding, and Payment Expert; former Industry Senior Reimbursement Leader