Curriculum Vitae

Education

Doctorate of Philosophy in Technical Communication Ca. : Rhetoric of Science & Healthcare. Texas Tech University (TTU), Lubbock, TX, USA.

Master of Materials Science & Engineering. North Carolina State University (NSCU), Raleigh, NC, USA.

Post-Grad Chemistry Transfer Program. University of North Carolina at Wilmington (UNCW), Wilmington, NC, USA.

Bachelors of Fine Arts & Communications. East Carolina University (ECU), Greenville, NC, USA.

Professional Experience

Sigilon Therapeutics, Senior Director

Cambridge, MA USA (2019 – present)

• Provide inputs to Series B funding, regulatory strategy, and departmental oversight, with direct responsibility to top executives
• Oversee regulatory team, eCTD publishing team, and vendor services
• Provide strategic regulatory support for IND/BLA and multiple CTA/MAA programs
• Evaluate and contribute to nonclinical and CMC regulatory documents
• Coordinate FDA, EU CA, and global regulatory advice meetings
• Author primary IND documents, Orphan Drug Designations (ODD), and PRIME/Fast-track designations
• Advise on ISO 10993 and medical device compliance for combination products, cell scaffolding, and cell therapy components

IQVIA, Director –  Strategic Development and Market Access

Raleigh, NC USA (2018 – 2019)

• Lead cross-functional consulting team engaged in biopharma and biotech product development
• Design, plan and execute clinical trials from $2M-45M USD value
• Support VP of MedTech and VP of Sales in strategic initiatives with marketing, operations, inside and outside sales
• Develop strategic plans to support quarterly and annual sales goals

CTI Clinical Trial and Consulting Services, Associate Director Regulatory and Scientific Affairs

Cincinnati, OH USA (2017 – 2018)

• Participate on and lead assigned multidisciplinary consulting project teams in gene, cell, and rare disease therapy products
• Serve as scientific/regulatory resource for team members and clients
• Conduct scientific research and assimilate data into written deliverable products for clients
• Participate in advisory boards, training programs and review of scientific writing projects, including manuscripts, monographs, briefing documents, and market analysis
• Participate in Drug Development Projects, including strategic development plans, Pre-IND, IND, NDA/BLA and other regulatory documents or participate in/lead HECOR-related projects, such as systematic literature reviews, global value dossiers, and epidemiologic/observational studies
• Interact professionally with clients and thought leaders to understand their objectives and meet their needs
• Participate in business development capabilities presentations; client visits and programs
• Collaborate with Medical Directors, biostatistics and programming, clinical and other disciplines
• Provide input into development of or improvement in internal processes and operations
• Rely on experience and judgment to plan and accomplish goals. Perform a variety of complicated tasks. A high degree of creativity and flexibility is expected
• Prioritize and manage effectively time to meet the needs of multiple clients simultaneously

GE Healthcare, Senior Manager Clinical Affairs Operations / Senior Writing Lead

Milwaukee, WI USA (2013 – 2017)

• Led and directed medical writing, document quality control (QC), and documentation management/retention resources, including direct management of staff, vendors, and CROs
• Managed medical writing team, editing/QC staff, and study start-up statisticians
• Mentored and provided guidance/training to medical writing staff and other team members
• Led regular meetings with executive leadership, global medical writers, and clinical operations.
• Assigned, tracked, and communicated deliverables in close collaboration with regulatory and medical affairs teams to ensure high-quality and submission-ready clinical trial protocols/reports and submission documents
• Responsible for managing medical writing, QC, document management/retention, and statistics SOPs, CAPAs, and procedure lifecycles in the QMS system
• Wrote clinical trial documents (protocols, amendments, reports, consent, narratives) and submission documents for US FDA 510(k)/PMA, BLA, NDA/ANDA; CER; China CFDA registration, and other global filings
• Collaborated with cross-functional team of medical affairs, clinical operations, and regulatory affairs to produce agency responses, presentations, materials to support investigator meetings and advisory boards, and other materials
• Lead writer on high profile $20 million GE-National Football League (NFL) concussion trials
• Presented on protocol design and trial summaries to advisory boards and regulatory agencies
• Mentored junior medical writers and other team members on medical regulatory writing and applicable standards (e.g. ICH E6/ISO 14155, ISO 9001, and others)

MedSci Consulting, Bioon Group Ltd., Medical Writer – Regulatory

Shanghai, China (2010 – 2013)

• Wrote premarket clinical trial protocols, reports, and publications for device and pharmaceutical clients including Zeiss, GE, Merck Sharp & Dohme Ltd. (MSD), Sanofi-Aventis, Novo Nordisk Research Center, etc.
• Wrote submission-ready clinical study reports and supporting clinical modules.
• Reviewed translations/back-translations of documents for accuracy and compliance to standards, including ISO 14155/ICH E6 and China Order No. 5 (and now No. 25) compliance
• Developed slide decks, posters, and scientific presentations necessary to support regulatory filings and trials

EIS, Inc., Senior Technical Writer / Project Manager

Wilmington, NC, USA (2008 – 2010)

• Performed integral project management in consulting environment for enterprise healthcare IT systems
• Liaised with public health organizations and CROs including PPD and Quintiles
• Administered QMS ISO 9001, 21 CFR Part 11, PCI, HIPAA, US FTC, US FDA, and others

Queensboro Industrial, Inc., Creative Director – Premarket / Labeling

Wilmington, NC USA (2007 – 2008)

• Developed marketing materials, claims, and labeling for health/medical consulting clients

Dimension Design, Inc., Textiles Project Manager

Wilmington, NC USA (2007 – 2008)

Parrott Canvas, Inc. , Technical Writer – CAD Design

Greenville, NC USA (2004 – 2006)

Academic/Instructional Experience

Cont. Education Instructor and Curriculum Designer, Coastal Carolina Community College, 2011 – 2013

Teaching Assistant, University of North Carolina at Wilmington, 2010 – 2013

Courses Taught

Northeastern University, Boston, MA, 2020-21:

• RGA 6463 Regulatory Strategy Throughout the Lifecycle

University of NC at Wilmington (UNCW), Wilmington, NC, 2010-11:

• CHEM 101/102 Introductory Chemistry I (GTA)
• CHEM 201/202 Organic Chemistry I (GTA)

Coastal Carolina College, Jacksonville, NC, 2011-13:

• CE 141/142/143 Introductory Graphic Design for Business and Medical Professionals
• CE 111 Introduction to Document Design for Medical and Science Professionals

Publications

• Johnson, A.N. Ethnographic Social World and Actor-Network Analysis of the Gene Therapy Commercialization Landscape. Molecular Therapy [accepted]
• Johnson, A.N. A Look at FDA’s Gene and Cell Therapy Framework Launch in 2020, and its Impact on New Hemophilia Treatments in 2021 and Beyond. Dateline Federation: Emerging Therapies Special Issue, Journal of the Hemophilia Foundation of America (HFA) 22(1):7. https://www.hemophiliafed.org/dateline/HFA_Dateline_2021_Q1_Spring_Special/HFA_Dateline_2021_Q1_Spring_Special.pdf 
• Johnson, A.N. An Ethnographic Pilot Study of Decision-Making Among Non-Research Physicians. Molecular Therapy Vol 24 No 7 S1 April 2020: pp. 157.
• Johnson, A.N. Public Engagement in Novel Gene Therapies for Hemophilia and Blood Disorders: A Computational Analysis of Public Sentiments in Social Media. Molecular Therapy Vol 24 No 7 S1 April 2020: pp. 158.
• Johnson, A.N. Determinants of Patient Response to Clinical Trial Recruitment Advertisements in Gene Therapy: A Pilot Ethnographic Study and Trend-over-Time Simulation Model. Molecular Therapy Vol 27 No 4S1 April 2019: pp. 157.
• Johnson, A.N. Harmonization of Gene Therapy Regulation. Regulatory Focus. 2017.
• Qi W., Davis H. W., Chu Z., Vallabhapurapu, S. D., Hussain N., Franco R. S., Morris J. C., Johnson A. N., Olowokure, O. O. Combined effect of gemcitabine (GEM) and sapC-DOPS nanovesicles on pancreatic ductal adenocarcinoma (PDAC) in mice. 2018 ASCO Annual Meeting Proceedings, a Journal of Clinical Oncology supplement.
• Cruze C. A., Rixe O., Morris J. C., Puduvalli V. K., Villano J. L., Wise-Draper T. M., Johnson A. N., Wesolowski R., Thompson G. A.. Allometric scaling of preclinical pharmacokinetic and toxicokinetic parameters to predict clinical pharmacokinetics of BXQ-350 saposin C protein-phosphatidylserine nanovesicles. 2018 ASCO Annual Meeting Proceedings, a Journal of Clinical Oncology supplement.
• Cruze C. A., Rixe O., Morris J. C., Puduvalli V. K., Villano J. L., Wise-Draper T. M., Johnson A. N., Wesolowski R. Absence of indicators of hypercoagulability and antiphospholipid syndrome in bxq-350 first in human study. 2018 ASCO Annual Meeting Proceedings, a Journal of Clinical Oncology supplement.
• Rixe O., Morris J. C., Puduvalli V. K., Villano J. L., Wise-Draper T. M., Muller C., Johnson A. N., Wesolowski R., Qi X. First-in-human, first-in-class phase 1a study of BXQ-350 for solid tumors and gliomas. 2018 ASCO Annual Meeting Proceedings, a Journal of Clinical Oncology supplement.
• Johnson A. N. Virtual and Augmented Reality as Game-Changers in Anesthesiology: History, Applications, and Challenges for Clinical Virtuality. J Anest & Inten Care Med. 2018; 5(1) : 555652. https://juniperpublishers.com/jaicm/JAICM.MS.ID.555652.php
• Hassan A.E., Sanchez C., Johnson, A.N. (2017) Endovascular treatment outcomes using the Stroke Triage Education, Procedure Standardization, and Technology (STEPS-T) program. Interv Neuroradiol. https://www.ncbi.nlm.nih.gov/pubmed/29119876
• Johnson, A.N. (2017). Small Organizations, Big Regulatory Strategy. Regulatory Focus. Regulatory Affairs Professionals Society. http://www.raps.org/Regulatory-Focus/Features/2017/01/30/26742/Small-Organizations-Big-Regulatory-Strategy/
• Tanenbaum, L., Tsiouris, J.A., Johnson, A.N., Naidich, T.P., DeLano, M.C., Melham, E., Quarterman, P., Parameswaran, S.X., Shankaranarayanan, A., Goyen, M., Field, A. (2017). Synthetic MRI for Clinical Neuroimaging: Results of the MAGnetic resonance Image Compilation (MAGiC) Prospective, Randomized Multi-center, Multi-reader Trial. AJNR. http://www.ajnr.org/content/early/2017/04/27/ajnr.A5227
• Johnson, A.N., Peiffer, J.S., Halmann, N., Delaney, L., Owen, C.A., Hersh, J. (2017). Ultrasound-Guided Needle Technique Accuracy: Prospective comparison of passive magnetic tracking versus unassisted echogenic needle localization. Regional Anesthesia and Pain Medicine. 42(2):1-10. http://journals.lww.com/rapm/Abstract/onlinefirst/Ultrasound_Guided_Needle_Technique_Accuracy_.99371.aspx
• Johnson, A.N., Lauer, C., Cadogan, C. (2016). How Did You Get Here? Stories of Bench Research, Bollywood, and Stormy Epiphanies. AMWA Journal. 33(3): 118-119. http://www.amwa.org/files/Journal/2016v31n3_AroundTheCareerBlock.pdf 
• Johnson, A.N. (2016). Social Norms of “Good” Design: Interdisciplinary perspectives from a survey of engineers and clinicians in bioengineering, 2016 IEEE 38th Annual International Conference of the Engineering in Medicine and Biology Society (EMBC), Orlando, FL, USA, 4337-4340. http://ieeexplore.ieee.org/document/7591687/
• Johnson, A.N. (2016) Perception and Implementation of Collaborative Documentation Technologies Among Medical Physics Educators and Industry Professionals: A Current Practice Survey.
  Med. Phys. 43, 3355 (2016); http://dx.doi.org/10.1118/1.4955697
• Johnson, A.N. (2016) SU-F-J-227: Accuracy of Passive Magnetic Ultrasound Needle Guidance in High- Fidelity Conventional and Novel Simulated Block Approach Phantoms.
  Med. Phys. 43, 3461 (2016); http://dx.doi.org/10.1118/1.4956135

Chapters

• Johnson, A.N. “Regulating Cell & Gene Therapies, Genetically Modified Cells and Devices in Regenerative Medicine”. US Regulatory Affairs Fundamentals, 11^th Ed., Regulatory Affairs Professional Association (RAPS): Rockville, MD. 2019.
• Johnson, A.N. “Medical Device Clinical Testing and GCPs”. US Regulatory Affairs Fundamentals, 10^th Ed., Regulatory Affairs Professional Association (RAPS): Rockville, MD. 2017.

Refereed Presentations

• Johnson, A.N. Ethnographic Social World and Actor-Network Analysis of the Gene Therapy Commercialization Landscape. Poster Presentation at the American Society of Cell and Gene Therapy (ASGCT) 24th Annual Meeting, May 11 – May 14, 2021.
• Johnson, A.N. Optimizing Regulatory Strategy for Gene Therapies: Current Trends, Guidance and Industry Milestones. Gene Therapy for Rare Blood Disorders Conference March 9-11, 2021. Boston, MA USA.
• Johnson, A.N. Drug-Device Combination Treatments and Diagnostics. Roundtable Session at Proventa International Online Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs Summit on June 2, 2020.
• Johnson, A.N. Public Engagement in Novel Gene Therapies for Hemophilia and Blood Disorders: A Computational Analysis of Public Sentiments in Social Media. Poster Presentation at the American Society of Cell and Gene Therapy (ASGCT) 23rd Annual Meeting, May 12 – May 15, 2020.
• Johnson, A.N. Prescribing Gene Therapy: An Ethnographic Pilot Study of Decision-Making Among Non-Research Physicians. Poster Presentation at the American Society of Cell and Gene Therapy (ASGCT) 23rd Annual Meeting, May 12 – May 15, 2020.
• Johnson, A.N. Gaining Insights into a Successful Hemophilia Gene Therapy Trial. Gene Therapy for Rare Blood Disorders Conference March 3-5, 2020. Boston, MA USA.
• Johnson, A.N. [Workshop] Strategic Gene Therapy Product Platforms and Partnerships: From Codevelopment to Companion  Products. Gene Therapy for Rare Blood Disorders Conference March 3-5, 2020. Boston, MA USA.
• Johnson, A. N. Accelerating innovative device strategy: From modernizing the 510(k) to improving the de novo. Regulatory Affairs Professionals (RAPS) Convergence. 20198. Philadelphia, PA.
• Johnson, A.N. Determinants of Patient Response to Clinical Trial Recruitment Advertisements in Gene Therapy: A Pilot Ethnographic Study and Trend-over-Time Simulation Model. Conference of the American Society for Cell and Gene Therapy (ASGCT) 2019. Washington, DC.
• Johnson, A.N. Introducing Agile in Regulated Industries: Leading Agile in MedTech. TriAgile 2019. Raleigh, NC USA.
• Johnson, A.N. If You Can Write a Grant, You Can Write a Pitch Deck. Annual Conference of the American Medical Writers Association (AMWA 2018)
• Johnson, A.N. Leaping from Desk to Podium: Essential Presentation Skills for Medical Writers. Annual Conference of the American Medical Writers Association (AMWA 2018)
• Johnson, A. N. Human Gene Editing and Advanced Therapies: How will FDA, EMA, and Gene Therapy Mix? Regulatory Affairs Professionals (RAPS) Convergence. 2018. Vancover, BC.
• Johnson A. N. The Gap between Clinician-Led Cell Therapy Evidence and Marketed Products: a Quasi-Experimental Comparative Pilot Study of Young Venture Clinical Development. Poster Session. American Society of Cell and Gene Therapy Annual Conference 2018.
• Rixe O., Morris J. C., Puduvalli V. K., Villano J. L., Wise-Draper T. M., Muller C., Johnson A. N., Wesolowski R., Qi X. First-in-human, first-in-class phase 1a study of BXQ-350 for solid tumors and gliomas. Poster Discussion Panel Session. American Society of Clinical Oncology (ASCO) Annual Meeting 2018.
• Johnson, A.N. Explore the Global Medical Writing Movement and Emerging Career Growth Opportunities. CBI Insights. Medical Writing Summit. 2017. Philadelphia, PA.
• Martin, R. Johnson, A.N. From Additive to Algorithm [Medical Device Session]. Regulatory Affairs Professionals (RAPS) Convergence. 2017. Washington DC.
• Johnson, A.N. Mentoring and Growing Medical Writing Teams [Round Table Panel) (AMWA 2017)
• Wilson, E., Hebert, K.A., Turco, T.J., Johnson, A.N., Hersh, J.K. Direct and Indirect Costs Comparison of Cardiac Diagnostic Pathway in Coronary Artery Disease: CCTA as the Optimal Gateway to ICA [abstract]. Proceedings of the 2017 American College of Cardiology (ACC) Meeting. Washington, D.C.
• Johnson, A.N., Murphy, S. Usability and Interoperability of Medical Device Software. Regulatory Affairs Professionals (RAPS) Convergence. 2016. San Jose, CA.
• Johnson, A.N. Collaborative Writing Toolkit: Results of a Survey of American Medical and Technical Writers in Health Care [Poster]. Annual Conference of the American Medical Writers Association (AMWA 2016)
• Johnson, A.N. It’s Time for Medical Writers to Get Big and Dirty: Writing Opportunities in Data, Biometrics, and Technology. Annual Conference of the American Medical Writers Association (AMWA 2016)
• Johnson, A.N., Cadogan, C., Lauer, C. Writing under Fire: Skills and Opportunities for Writing in a Crisis. Annual Conference of the American Medical Writers Association (AMWA 2016)
• Johnson, A.N., Bippes B. Evidence and Power: Empowering research through mixed-methods in resource-limited, feasibility, and pilot studies. Annual Conference of the American Association for Bioethics and Humanities (ASBH 2016)
• Johnson, A.N., Bippes B. Picking the “Good” Drugs: Empirical evidence for the role of physician morality in prescribing new medications [Pharmacy Ethics Session]. Annual Conference of the American Association for Bioethics and Humanities (ASBH 2016)
• Johnson, A.N. Accuracy of Passive Magnetic Ultrasound Needle Guidance in High-Fidelity Conventional and Novel Simulated Block Approach Phantoms. Annual Conference of the American Association of Physicists in Medicine (AAPM 2016)
• Johnson, A.N. Social Norms of “Good” Design: Interdisciplinary perspectives from a survey of engineers and clinicians in bioengineering. Annual Conference of the IEEE Engineering in Medicine and Biology Society (IEEE/EMBS 2016)
• Johnson, A.N. Standards from the Start: A Practical Perspective on Strategic Use of CDISC Protocol Implementation Model 1.0. Clinical Data Interchange Standards Consortium (CDISC International Interchange 2015); http://www.cdisc.org/2015-International-Interchange
• Johnson, A.N. Traumatic Brain Injury Patient Narratives in Social Media. Annual Conference of the American Society of Bioethics and Humanities (ASBH 2015)
• Johnson, A.N. Social Media and Patient Communication: Writing and Research Strategies to Increase Online Impact [Poster and Oral Presentation]. Annual Conference of the American Medical Writers Association (AMWA 2015); www.amwa.org/Files/Events/AC2015/2015RegistrationBrochure.pdf
• Cadogan, C; Angela, A.N; Lauer, C. Transitioning Into Medical Writing for Diverse Professionals [Poster]. Annual Conference of the American Medical Writers Association (AMWA 2015); www.amwa.org/Files/Events/AC2015/2015RegistrationBrochure.pdf
• Johnson, A.N. How To: A Practical Introduction to the Language and Rhetoric of Medical Device Software [Poster and Oral Presentation]. Annual Conference of the American Medical Writers Association (AMWA 2014); www.amwa.org/files/events/ac2014/amwaregistrationbrochure2014.pdf
• Johnson, A.N; Cadogan, C; Wang, X. From R&D to Clinical Trials: Medical Writing Strategies for Global Teams [Poster and Oral Presentation]. Annual Conference of the American Medical Writers Association (AMWA 2014); www.amwa.org/files/events/ac2014/amwaregistrationbrochure2014.pdf
• Johnson, A.N. Hands-on Demonstration: Building and Growing Medical Writing Websites Using Open Source Content Management Systems (CMS) [Workshop]. Annual Conference of the American Medical Writers Association (AMWA 2013); www.amwa.org/files/events/ac2014/amwaregistrationbrochure2014.pdf

Editorial Experience

• Medicine. Wolters Kluwer Health. Academic Editor and Manuscript Reviewer. (2012-Present)
• Molecular Therapy. Reviewer (2017-present)
• Neurology. Reviewer. (2012-present)

Professional Service

• American Society of Cell and Gene Therapy (ASGCT). Government Relations Committee Member (2018-2022)
• American Society for Quality (ASQ). Contributing Member (2018-20)
• Association of Clinical Research Professionals (ACRP), Educational Board Member (2015-16)
• American Association of Physicists in Medicine (AAPM), Historical Board Member (2016-2017)
• ISO/IEEE 11073 Personal Health Data (PHD) Interoperability Standards, Working Group Member (2015-2016)
• GE-NFL Head Health Initiative, Medial Advisory Board Writer (2014-2016)
• Association for Clinical Research (ACRP), Co-Chair Educational Committee, Greater Chicago Area (2015-2016)
• Texas Tech University Humanities Center, Synoptics Wordscape Project (2015)
• American Medical Writers Association (AMWA), Online Resources/Web Development Committee (2014-2015)
• American Medical Writers Association (AMWA), Online Community/Web Development Committee (2013-2014)

Funding and Awards

• Lucien Levy Award – Best Original Research Article | 2017, American Journal of Neuroradiology (AJNR)
• Regulatory Affairs Convergence Faculty Speaker Honorarium (Grant Awarded) | 2016, Regulatory Affairs Professionals Society (RAPS), San Jose, CA
• GE Health Analytics Hackathon (Cardiac CAD in R) 1^st place (Grant Awarded) | 2016, Science and Technology Week, GE Healthcare, Waukesha, WI
• GE makerPOSSIBLE: Laser Cut Bridge Challenge (entry “The Art of Biomechanics”) – 1^st place in Artistry category (Grant Awarded) | 2016, Science and Technology Week, GE Healthcare, Waukesha, WI
• Employee Tuition Fellowship (Grant Awarded, 4 years) | 2013-18, GE Healthcare, Waukesha, WI
• Ralph W. Brauer Fellowship (awarded in Nuclear Magnetic Resonance Spectroscopy and Proteomics; 1 yr Grant Awarded) | 2010, University of North Carolina Wilmington, Wilmington, NC
• East Carolina Academic Merit Fellow (Scholarship Grant Awarded) | 2003, East Carolina University, Greenville, NC

Certifications

• Regulatory Affairs Certification (RAC-US) | Active 2015 – Present | Regulatory Affairs professionals Association (RAPS)
• Project Management Professional (PMP) | Active 2012 – Present | Project Management Institute (PMI)
• Design and Interpretation of Clinical Trials | Completed 2016 | Johns Hopkins University, Baltimore, MD
• Six Sigma Green Belt course | Completed 2016 | GE Crotonville, Healthcare Institute (HCI), Watertown, WI
• Operations Management | Completed 2016 | University of Illinois, Urbana-Champaign, IL
• Private Equity and Venture Capital Management | Completed 2015 | Università Bocconi, Italy
• High Speed Project Management Certificate | Completed 2013 | University of Wisconsin, Madison, WI
• Project Management Certificate | Completed 2008 | Cape Fear Community College, Wilmington, NC

Community Service

• Insight! Milwaukee (2016-18). Volunteer Health Career Coach, K9-12.
• Jubilant Kid’s Foundation of Kenya (2015-2016). Volunteer Fundraising Director (http://www.jubilantkidsfoundation.org/)
• GE-United Way Charity Drive, Milwaukee, WI (2013-2016). Volunteer Community Event Coordinator.
• Volunteer Armed Services Vocational Aptitude Battery (ASVAB) Tutor for Mathematics/Physics through Community Services, Wilmington, NC (2011-2012)
• Tilestone Clinic, Wilmington, NC – Patient Advocate (2009-2011). Volunteered in preparing applications for chronic medication assistance to pharmaceutical companies on behalf of low-income patients

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