MALCOLM BARTH, PhD

***** **** ***** · Rockville, Maryland 20853

Mobile: 301-***-**** · ad3pju@r.postjobfree.com

RESEARCH SCIENTIST · RESEARCH COMPLIANCE EXPERT · RESEARCH CONSULTANT

Skilled research scientist, educator and scientific protocol expert with extensive experience and a proven ability to improve research procedures and Institutional Review Board (IRB) standards. Leverages knowledge gained as a researcher, compliance expert and educator to improve techniques, develop and implement effective protocols and communicate robust safety procedures and best practice guidelines. Establishes and leads committees to guide research efforts. Implements and manages safety programs. Areas of expertise include:

Life Sciences · Biomedical Research · Research Compliance · Education · Bio-Safety · Research & Analysis

Consulting · Program Evaluation · Communications · Scientific Publications · Institutional Review Boards (IRB)

Policy & Procedure Development · Clinical Trial Protocols · Best Safety Practices · Immunology Research

Conflict Resolution · Secure Research Environments · Bio-Defense & Bio-Pharmaceutical Industries

PROFESSIONAL EXPERIENCE

Medical Writer, Neoimmunetech, Rockville, Maryland, November 2021- February 2024.

Key Duties:

• Develops study documents such as synopsis, Protocol, ICF, Study Plans, CSRs,, Patient Diaries,

DSURs, IBs, INDs, Study Reference binders, Clinical Data Review Plan, Clinical Database

specifications development, clinical abstracts, posters, and manuscripts, and SOPs

• Performs necessary literature searches for drafting document content

• Effectively communicates deliverables needed for clinical regulatory documents, writing

process, and timelines to other team members

• Responsible for QA/QC of the submission documents to support publishing process

• Supports or conducts sponsor quality monitoring/oversight visits to sites and/or CRAs

performance assessment in adherence to GCP, corporate SOPs and protocol as needed

Medical Writer, PSI, Rockville, Maryland, March 2021 – November 2021.

Key Duties:

Support Cancer Therapy and Evaluation Program (CTEP) at NCI

Write Letter of Intent response letters

Write summary notes of various scientific committee review meetings

Draft INDs, annual reviews, investigator brochures, agent-specific templates, write particular sections of an IND for a specific protocol, conduct literature searches, abstract scientific findings, and updating safety reports of adverse events

Clinical Data Manager, Axle Informatics, Rockville, Maryland, October 2020-December 2020.

Key Duties:

Provide expert knowledge and advice regarding Institutional Review Board (IRB) processes for new application submissions, amendments, and continuing reviews in accordance with 45 CFR Part 46 – Protection of Human Subjects, document compliance to the 2018 Common Rule, and FDA regulatory requirements.

Provide scientific and technical assistance and consultation regarding electronic systems for IRB submissions, approvals, and document updates for new and ongoing research studies.

Ensure that clinical research protocols, consent forms, Investigator Brochures and other clinical research documents are in compliance with applicable regulatory requirements defined by the Code of Federal Regulations (CFR) and Good Clinical Practice guidelines.

Work and coordinate with clinical research teams that include physicians, laboratory scientists, research nurses, pharmacists, regulatory personnel, and support staff in assessing electronic IRB system applications to meet Institute requirements.

Ensure that advice and actions of staff are consistent with NIH and Department of Health and Human Services (DHHS) goals and policies, as well as with applicable statutes, regulations, rules, and directives.

Review the development of database specifications, validation plans, and data management plans, ensuring alignment with case report forms, protocol, and safety data standards.

Implement data management and collection procedures for an electronic IRB process.

Review data management activities and recommend process improvements.

Maintain both ongoing and new IRB process changes with thorough documentation and communication updates.

Review IRB submissions in response to identified problems and resolve issues with recommended expert solutions in a timely manner.

Prepare reports summarizing clinical and research information obtained for the purpose of communication with the IRB.

Interface with NIH principal investigators, clinical laboratories, and outside contract laboratories to assess accurate data submissions and process applications are followed.

·Oversee clinical data management project timelines on multiple complex studies or programs.

Science and Regulatory Liaison Manager, STCube Pharmaceuticals, Gaithersburg, Maryland June 2020 – October 2020

I managed all science writing and research compliance activities for the company.

- initiated training program for Good Laboratory Practices and Animal Care./IACUC activities

- wrote SOPs

- Led search to obtain electronic lab notebook and Laboratory Information Management System

Organized meetings

- conducted analysis of research compliance activities with company

Science and IRB Writing Consultant – June 2019 – June 2020.

Writing scientific articles and IRB materials for submission to IRBs for review. This involved writing clinical protocols, informed consents, and streamlining submission of written materials to the IRB.

Science Consulting Group, Gaithersburg, MD- December 2018 – May 2019.

Science Writer – provide writing support summarizing NIH scientific conferences and teleconferences, EPA teleconferences, IRB minutes, and writing articles for NIH.

Key Duties:

• Provide detailed summaries of scientific conferences and teleconferences from recordings and notes.

• Research and write scientific articles for NIH.

• Interview scientists for articles.

Science/Education/IRB Consultant (Freelance) - April 2018 to December 2018.

Write clinical protocols, scientific articles, science blogs, and other medical writing. I also conduct online educational science tutoring and write educational materials.

Booz Allen Hamilton, Falls Church VA, May 2017 to March, 2018.

Senior Health Policy Scientist - Provide research oversight and compliance support, including processing reportable events and adjudicating cases of research misconduct. Provide guidance to institutions on matters related to human subjects’ protections and research integrity or misconduct. Contribute to policies and procedures relating to the human research protections and research misconduct. Maintain records as required by 32 CFR 219 and DoD policy. Develop and maintain training curriculum. Provide program support for an electronic management system, including developing and tracking deliverables, meeting logistics and minutes, and supporting training needs. Conduct audits and site visits in support of assurance oversight and renewal.

Key Duties:

• Provide comprehensive, timely, professional quality and fully documented reviews of research supported by the components of the USD P&R, including review and determinations for DoD intramural research and Human Research Protection Official Review for extramural research.

• Provide regulatory-based written -review of protocol life cycle actions following a R2O2-required format using standardized checklists. This may include, but not limited to, review of amendments/addenda, continuing review reports, reports of unanticipated problems and serious adverse events, reports of serious or continuing noncompliance, reports of research suspension/termination, protocol deviations, subject complaints, and final study reports and provide a professional quality written review.

• Support the government in conducting reviews of assurance requests and site visits, including reviews of standard operating procedures (SOPs) and Institutional Review Board (IRB) records.

• Provide consultation to assist institutions under USD P&R oversight in electronic IRB system submission and use, including training and helpful hints for using the online system, tracking milestones and general system updates, providing research oversight guidance and information.

Freelance Life Sciences and IRB Consultant December 2015 – May 2017.

Written scientific review articles and helped clients submit to their research to IRBs for review. This involved writing clinical protocols, informed consents, and streamlining submission of written materials to the IRB.

Metabiota, Silver Spring, Maryland, February 2015 – June 2015.

Compliance Manager/Research Collaborator – responsible for all aspects of research compliance within Metabiota, Inc. and facilitates client-sponsored research activities in partner countries.

Key Duties:

• Administer all research compliance activities within Metabiota, Inc.

• Lead purchase and implementation of new research software to streamline compliance procedures.

• Draft SOPs that specify new research compliance procedures and establish a QA/QC program of internal researcher audits.

• Conduct training various research compliance regulations and issues for company personnel and researchers.

• acts as a technical resource and collaborate for client-sponsored research activities in partner countries, facilitating developing research projects and working with partner nation scientists to develop work plans and research project materials including, but not limited to, oversight review applications and forms, training materials.

Freelance Consultant for Rose Li Associates, Bethesda, Maryland May 2014 – September 30, 2014.

Evidence Curator – work as part of a team to build a cancer database and treatment classification system.

Key Duties:

• Create Innovation entries on the RLA Share point site, classify treatments, review the best evidence, assess PubMed records, review clinical trial results, gather drug patent and launch data, and identify issues.

• Science Writer at Education and Health: New Frontiers NIH Conference in Washington, DC, June 2014

Kelly Government Solutions, Bethesda, Maryland, October 2013 – May 2014

Kelly Services® is a strategic government staffing provider and business partner to the federal government and its key suppliers, including prime and set-aside business contractors.

Health Science Policy Analyst - work with staff on the oversight and management of the Public Health Emergency Research Review Board (PHERRB). This work was supporting the NIH Office of Intramural Research

Key Duties:

Acts as liaison between the 12 Institutional Review Boards (IRBs) of the NIH Human Research Protection Program (HRPP) that currently serve as the PHERRB; ensures that these IRB.s have model generic protocols in place to respond to emergencies quickly.

In the event of a public health emergency, works with the designated NIH IRB(s) to respond to the emergency; ensures that resources, staff and consultants are made available to support the IRB(s) and, in case of multi-site protocols, that reliance (authorization) agreements are in place, or a waiver from the need for a reliance agreement has been obtained.

Develop and write policies and standard operating procedures (SOPs); analyze national and international guidelines, regulations and guidance documents; identify issues related to public health emergencies; establish and evaluate processes.

Establishes appropriate forms, tracking tools and instructions for use by other organizations throughout the country.

Provide outreach regarding public health emergencies with non-NIH biomedical research organizations and Federal government departments.

Collaborates with staff on the coordination, development and IRB review of different types of protocols in areas of biomedical and behavioral research, health services research and public health research for immediate implementation in the event of a public health emergency.

Identifies legal barriers to implementation of protocols throughout the United States, in the event of a public health emergency; works with DHHS Office of General Counsel and the DHHS Secretary to obtain any necessary Secretarial waivers to ensure prompt implementation of protocols in response to a public health emergency.

General Dynamics IT Fort Detrick, Maryland, August 2013 – October 2013

A top tier integrator of mission-critical IT systems.

Human Research Protection Scientist: Support the Human Research Protection Program of the U.S. Army by reviewing extramural protocols and acting as a subject matter expert on Human Research Protection.

Key Duties:

Serves as an expert in the area of human subject protections and compliance in the execution of research.

Plans; organizes; and conducts audits, reviews, investigations, and analytical studies.

Prepares, analyzes, and interprets a variety of documentation and ensures correct application of intended guidance.

Generates complex and comprehensive reports and documents for internal organizational use and for external agencies.

Evaluates protocol development, institutional regulatory review (SRC, IRB, IBC, RSC, etc.), and post-approval conduct of research providing feedback to each constituency in the form of written reports.

Reviews and audits proposed and active clinical research studies; interpret research regulations and identify investigator compliance with regulations and requirements relative to clinical settings.

Alliance Biosciences, Inc. (Freelance Consulting)

· November 2011 · Conducted one day training session on Biosafety principles and Institutional Biosafety Committees at Rosalind Franklin Medical School on November 28, 2011 in Lake Forest, IL. Researched, prepared and delivered presentation.

· June 2012 · Conducted a three hour webinar on Biosafety Principles and Institutional Biosafety Committees to University of Hawaii research and biosafety staff.

• November 2012 • Lead writer for two white paper proposals submitted to Defense Threat Reduction Agency for funding consideration.

• January 2013 – June 2013 • Conducted business development activities identifying and meeting with various contracting and technology companies to form alliances for proposal submission for government contracts.

CONSOLIDATED SAFETY SERVICES (CSS), Bethesda, Maryland (NIH Campus) · June 2013 – July 2013 (Part Time Instructor – one course)

A consulting company combining the rapid advances occurring in technology with a fundamental understanding of scientific principles to promote and ensure a healthier and safer environment.

Laboratory Safety Instructor: Support the laboratory safety training of NIH internship students with instruction on general laboratory safety, chemical safety, and biosafety.

Key Duties:

• Provide laboratory instruction orally and with demonstrations of equipment in general laboratory safety,

chemical safety, and biosafety.

• Administer pretests and post tests on subject material to students.

• Assess student knowledge deficiencies and provide remedial training if necessary.

• Provide feedback to NIH client on course content.

TOEROEK ASSOCIATES, Lorton, Virginia, Feb 2012 - Nov 2012

Provider of specialty analysts and services to the Federal Government in National Security and Environmental Protection.

Biology Science Liaison: Support new and ongoing biological programs in partner countries for the Cooperative Threat Reduction program, including science oversight of construction activities, development and implementation of scientific improvements, and conference support.

Key Duties:

Provide oversight and review for new and ongoing integration projects/contracts in assigned partner countries.

Collaborate with US-based Principal Investigators and other stakeholders on projects specific to assigned country.

Prepare Statements of Work for solicitation of proposals.

Review Statements of Work (SOWs) for the entire program and/or country specific work.

Prepare recommendation memos and white papers for technical and other program concepts.

Support government country managers and other stakeholders in meetings, correspondence, and other program documents.

Review Cooperative Biological Research (CBR) and Threat Agent Detection and Response Activity Project (TAP) proposals.

Provide technical conference support, including participant identification and invitation, vetting presenters, venue and facility selection and evaluation, abstract and poster review, logistics, and talking points for side meetings.

ALION SCIENCE AND TECHNOLOGY CORP., McLean, Virginia, March 2011- Feb 2012

Total technology and operational solutions provider serving the Department of Defense, civilian government agencies and commercial enterprises worldwide.

Senior Human Research Protection Analyst: Evaluated Navy command IRB meeting minutes and protocol reviews. Analyzed assurances issued to Navy command with IRBs. Visited Navy research facilities onsite and reviewed all facets of IRB operations, conducting audits and detailed reviews of research protocol files and IRB records. Developed headquarters-level policy drafts for Navy Headquarters.

Key Accomplishments:

Identified compliance issues in protocols and assurances that will be used to advise command for assist visit.

Made key contributions to government client efforts with subject matter expertise that improved research.

ANALYTIC SERVICES, INC., Arlington, Virginia · 2009-2011

Public service institute that provides objective studies and analyses to aid decision-makers throughout the national security, homeland security and public safety communities.

Senior Research Analyst (Corporate Site Jan 2011 – March 2011): Constructed a model for biodefense framework architecture to help key decision makers in event of an incident with bioweapons.

Key Accomplishments:

Helped to define the various elements of a government response to a bio-event.

Mapped elements of government response and architecture to Homeland Security Presidential Directives (HSPDs) and other official guidance documents.

Offered subject matter expertise for medical countermeasures and their deployment for various possible types of a bio-event.

Senior Human Research Protection Analyst (Client Site Jan 2009- Jan 2011): Review Air Force human subject research protocols at the headquarters level and draft policies for the research oversight program. Conduct detailed analysis of assurances issued to Air Force research facilities with Institutional Review Boards (IRB). Inspect and audit Air Force IRB operations and onsite activities. Complete scientific reviews of science grant applications, including molecular biological proposals, for Air Force project funding.

Key Accomplishments:

Improved IRB promotion of human subject protection by providing expert advice on sound principles and best practices.

Stabilized institutional knowledge and offered needed subject matter expertise in a challenging environment created by high staff turnover and shortage of specific professional skills.

Significantly increased professionalism of office and audit procedures by creating policy documents and providing research compliance guidance.

Increased specialized knowledge of genome wide association (GWAS) studies in humans through attending specialized conference on the subject which allowed me to propose procedures for the review of human subject research protocols using this technology in our office.

ALION SCIENCE AND TECHNOLOGY CORP., McLean, Virginia · 2008-2009

Total technology and operational solutions provider serving the Department of Defense, civilian government agencies and commercial enterprises worldwide.

Oversight and Monitoring Coordinator: Evaluated Navy command IRB meeting minutes and protocol reviews. Analyzed assurances issued to Navy command with IRBs. Visited Navy research facilities onsite and reviewed all facets of IRB operations, conducting audits and detailed reviews of research protocol files and IRB records. Developed headquarters-level policy drafts for Navy Headquarters.

Key Accomplishments:

Led successful audit of Navy command HRPP program, identifying areas for improvement and creating policy addressing scientific review of protocols.

Made key contributions to government client efforts with subject matter expertise that improved research.

LOYOLA UNIVERSITY CHICAGO, Chicago, Illinois · 2005-2008

Leading university and research facility dedicated to the pursuit of knowledge in the service of humanity.

Compliance Manager: Led IRB and all related functions, supervising a staff of 2. Served as Chair of Institutional Biosafety Committee (IBC), forming the group, establishing IBC policies and coordinating the campus biosafety program. Led Institutional Animal Care and Use Committee (IACUC) and oversaw all related functions. Played key role as administrator of Laboratory Safety Committee and Chair of Radiation Safety Committee. Selected and deployed software package to document and manage IRB, IACUC and IBC activities. Forged productive relationships with faculty.

Key Accomplishments:

Ensured 100% of faculty were covered under approved biosafety protocols.

Established policies and procedures for successful functioning of biosafety program.

Streamlined office procedures to comply with IRB human subject research protection directives.

ADDITIONAL POSITIONS

LOYOLA UNIVERSITY CHICAGO · 2007-2008 · Adjunct Faculty Member: Taught genetics to premedical and biology students, providing night-time lectures for Department of Biology. Assisted students with coursework and provided advice on studies. Developed and delivered lectures. Created course curriculum.

WESTERN IRB · 2004-2005 · IRB Regulatory Analyst: Analyzed and assessed clinical research protocols, evaluating for scientific validity and compliance with federal human subject protection standards and advising sponsors and study sites on compliance issues. Served as regulatory advisor at Board meetings and issued letters to clients regarding Board decisions. Researched issues and protocol deviations and authored regulatory opinions, focusing on issues involving blood and tissue banks as well as immunological protocols. Analyzed HIPAA language and informed consent issues to ensure compliance. Prepared conflict of interest reports.

UNIVERSITY OF SOUTHERN CALIFORNIA · 2003-2004 · IRB Program Specialist: Analyzed and reviewed clinical research protocols, assessing for scientific validity as well as adherence to federal human subject protection standards. Edited and prepared strike-through copies of informed consent documents. Created action letters and reviewed minutes of IRB meetings.

ALFRED E. MANN INSTITUTE · 2003 · GLP Laboratory Manager (Regulatory): Established effective laboratory protocols. Wrote and organized documentation and calibration protocols. Supervised students.

LOS ANGELES TRADE TECH COMMUNITY COLLEGE · 2002-2004 · Lecturer: Taught microbiology and biology courses on a part-time basis.

LOYOLA MARYMOUNT UNIVERSITY · 2001-2002 · Visiting Lecturer in Science Education: Developed environmental science and science education courses and delivered lectures via Natural Science Program.

VARIOUS HIGH SCHOOLS · 1997-2001 · Teacher: Developed curriculum and taught college preparatory chemistry at Mary Keppel High School, Bellflower High School and Hart High School in California.

SCIENTIFIC RESEARCH · 1993-1997 · Research Associate / Postdoctoral Researcher: Conducted research with Dr. Gunther Dennart at the Department of Microbiology and Immunology at USC. Served as postdoctoral researcher with Dr. Donald Diamond at City of Hope Medical Center and with Dr. Louis Weiner at Fox Chase Cancer Center.

RESEARCH NOTE: In addition to scientific research positions, also served as a Graduate Research Assistant in the Division of Medical Microbiology at the University of British Columbia and as Research Assistant in the field of marine microbiology at Simon Fraser University. Research activities included:

Development of murine models for tumor and viral disease states

Use and modification as needed of cellular immunology techniques, including flow cytometry, effector cell assays, tissue culture of mammalian cells and antibody purification techniques

Utilization and modification of leukocyte isolation and separation techniques

Use of molecular biology techniques, including adenovirus vectors, PCR, and southern blots preparation

Findings published in peer-reviewed scientific journals (see below). Details are available upon request.

EDUCATION & PROFESSIONAL TRAINING

PhD in Cancer Immunology

Medical College of Pennsylvania (now Drexel University), Philadelphia, Pennsylvania

Master of Science in Medical Microbiology

University of Manitoba, Canada

Master of Science in Regulatory Science

University of Southern California

Bachelor of Science in Biology

University of Winnipeg, Canada

PROFESSIONAL AFFILIATIONS

Member: American Biological Safety Society 2006-2017

Editorial Reviewer: Journal of Applied Biosafety - As an editorial reviewer, I review proposed articles in biosafety for scientific validity and appropriate subject matter for the journal. 2006-2017

Member Walter Reed National Medical Hospital Institutional Biosafety Committee, November 2011

Additional Training

Defense Acquisition University: Acquisition 101, July 2012

RESEARCH PUBLICATIONS

Amoroso, A.R., Alpaugh, R.K., Barth, M.W., McCall, A.M., and L,M. Weiner. 1999. “Production and characterization of mice transgenic for the A and B isoforms of human FcγRIII.” Cancer Immunol. Immunother. – 48: 443-455.

Weiner, L.M., Alpaugh, R.K., Amoroso, A.R., Adams, G., Ring, D.B., and M.W. Barth.1996. “Human neutrophil interactions of a bispecific monoclonal antibody targeting tumor and Human Fc (RIII.” Cancer Immunol. Immunother. – 42:141-150.

Barth, M.W., Hendrzak, J.A., Melnicoff, M.J., and P.S. Morahan. 1995. “Review of the macrophage disappearance reaction.” J. Leuk. Biol. – 57:361-367.

Barth, M. W., and P. S. Morahan. 1994. “Role of macrophages in the host response to Lewis lung peritoneal carcinomatosis.” Cancer Immunol. Immunother. – 38:233-242.

Barth, M.W., J. Oger and J.K. Chantler. 1990. “Interaction of rubella virus with human immune cells. I. Permissiveness of lymphocyte subpopulations.” Viral Immunol. – 3:119-125.

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