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Resume
Profile
Consultant with 8 years of experience as a Community Member on NIH's Institutional Review Board and as a Patient Representative on External Data Monitoring Committees for pharmaceuticals conducting Muscular Dystrophy research, who leverages background as an attorney and a Federal official specializing in disability policymaking, advocacy, compliance, and enforcement – as well as experience gleaned from decades living with a significant disability – to effectively and substantively represent the interests, health, safety, and welfare of clinical research subjects.
Consulting Experience
2021 - Present
Member, External Data Monitoring Committee, Edgewise Therapeutics
Serve as a voting member and patient representative on the External Data Monitoring Committee responsible for the review of safety and efficacy in clinical trials related to Becker Muscular Dystrophy and Duchenne Muscular Dystrophy. Activities include, but are not limited to:
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attending and actively participating in the open and closed sessions of both regularly scheduled and ad hoc E-DMC meetings;
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evaluating safety and efficacy data presented in sponsor reports and Tables, Listings, and Figures (TLFs);
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reviewing initial and follow-up Suspected Adverse Reaction Reports (SUSARs);
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conducting relevant background research to gain greater familiarity with medical concepts and terminology;
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making suggestions for protocol amendments as appropriate;
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raising issues that are of unique concern to, or have a potential detrimental impact on, trial subjects; and
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engaging meaningfully with fellow E-DMC members (physicians and statistician), the Clinical Research Organization (Medpace), and the sponsor; and
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participating in discussions underlying formal E-DMC recommendations to the sponsor.
2016 - Present
Community Member, Institutional Review Board, Office of Human Subjects Research
Protections, National Institutes of Health (NIH)
Since 2019, have served as a voting member on the intramural IRB, which has responsibility for the protection of the rights, welfare, and safety of human subjects in hundreds of NIH clinical trials. From 2016 to 2019, served in the same capacity on NIH’s Combined Neurosciences Institutional Review Board. Activities include but are not limited to:
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participating in an average of 2 IRB meetings per month;
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engaging meaningfully with fellow IRB members;
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evaluating annual continuing review submissions for reported events and other study developments that might lead to changes in risk-benefit determinations;
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conducting relevant background research on a wide variety of medical conditions and proven and potential treatments;
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reviewing study modifications proposed by investigators;
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raising issues and asking questions that represent the perspectives of subjects who are in vulnerable populations and/or who may lack relevant medical knowledge; and
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reviewing informed consent and assent documents, recruitment materials, and other study documents and tools that study participants engage with, to ensure that content is readable and understandable to laypersons outside the medical community.
2015 - Present
Member, External Data Monitoring Committee, Pfizer, Inc.
Serve as a voting member and patient representative on the External Data Monitoring Committee responsible for the review of safety and efficacy in clinical trials related to Duchenne Muscular Dystrophy. Activities include, but are not limited to:
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attending and actively participating in the open and closed sessions of both regularly scheduled and ad hoc E-DMC meetings;
-
evaluating safety and efficacy data presented in sponsor reports and Tables, Listings, and Figures (TLFs);
-
reviewing initial and follow-up Suspected Adverse Reaction Reports (SUSARs);
-
conducting relevant background research to gain greater familiarity with medical concepts and terminology;
-
making suggestions for protocol amendments as appropriate;
-
raising issues that are of unique concern to, or have a potential detrimental impact on, trial subjects; and
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engaging meaningfully with fellow E-DMC members (physicians and statistician), the Clinical Research Organization (currently WCG and, for a now-closed trial, Parexel), and the sponsor; and
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participating in discussions underlying formal E-DMC recommendations to the sponsor.
Legal and Policy Experience
2014 - Present
Senior Compliance Specialist, Office of General Counsel, U.S. Access Board
Investigate complaints alleging violations of accessibility standards issued under the Architectural Barriers Act of 1968 (ABA), which requires Federal buildings and facilities to be accessible to individuals with disabilities. Activities include: conducting required legal analyses and research; reviewing architectural plans; determining if allegations constitute violations of the standards; ensuring that violations are addressed via corrective action; engaging with senior-level and junior-level staff at various Cabinet agencies and the U.S. Postal Service; drafting correspondence and reports; and providing training to agencies and the public.
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Disclaimer: The consulting activities described in the previous section of this resume are performed strictly: in a personal capacity (not in any official government capacity); while off-duty and on leave from government employment; and as an employee of Mario Damiani Consulting L.L.C. As those consulting activities relate solely to clinical research, they have absolutely no connection to or conflict with the work of the U.S. Access Board and the current Federal employment described here.
2006 - 2014
Policy Advisor, Office of Disability Employment Policy (ODEP), U.S. Department of Labor
Conducted development, research, analysis, technical assistance, training, and
dissemination of national disability employment policy, with a primary focus on
employment-related supports (e.g., reasonable accommodations, assistive technology, facility accessibility, transportation, and housing) for workers with disabilities. Policies supported the recruitment, hiring, retention, and advancement of individuals with disabilities in the public and private sectors.
2003 - 2006
Attorney-Advisor, Office of General Counsel, District of Columbia Department of Health
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Investigated complaints alleging violations of professional standards by physicians,
nurses, psychologists, and other medical or health practitioners, and made legal
recommendations to the applicable licensing board (e.g. Board of Medicine, Board of Nursing).
2002 - 2003
Law Clerk, District Columbia Office of Bar Counsel (now the Office of Disciplinary Counsel)
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Investigated complaints against attorneys alleged to have violated standards of professional conduct; evaluated allegations; made oral and written recommendations regarding violations and sanctions; and assisted in prosecutions.
2001 - 2002
Law Clerk, Chambers of the Senior Judges, District of Columbia Court of Appeals
Served as one of four law clerks to the Senior Judges of the Court and conducted legal research, reviewed trial records, attended oral arguments, briefed judges, and wrote bench memoranda and draft opinions in appeals in a variety of civil and criminal cases.
Publication
2018
Mary K. Colvin, James Poysky, Kathi Kinnett, Mario Damiani, Melissa Gibbons, Janet Hoskin, Scott Moreland, Christina J. Trout, Norbert Weidner; Psychosocial Management of the Patient With Duchenne Muscular Dystrophy. Pediatrics October 2018; 142 (Supplement_2): S99–S109. 10.1542/peds.2018-0333L.
Languages
English, Spanish, Italian
Education
1995 - 2001
The Catholic University of America, Washington, DC
B.A./J.D. Joint-Degree Program
Juris Doctor, Columbus School of Law, May 2001​
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Moot Court Associate
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Member, Thurgood Marshall American Inn of Court
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Participant, 2001 National Environmental Law Moot Court Competition
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Legal Intern, Office of the United States Attorney for the District of Maryland, Southern Division (Greenbelt, MD)
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Legal Intern, Office of the State's Attorney for Montgomery County (Rockville, MD)
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Legal Intern, Office of the State’s Attorney for Prince George’s County (Upper Marlboro, MD)
Bachelor of Arts (Summa Cum Laude), Politics, School of Arts and Sciences, May 1999
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Member, Phi Beta Kappa
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University Scholar, Honors Program (completed sequences in Humanities, Classical Philosophy, and Social Sciences)
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Dean’s List
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Representing the interests of patients in clinical research.