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

• CHEM 101 Introductory Chemistry I (GTA)
  
• CHEM 102 Introductory Chemistry II (GTA)
  
• CHEM 201 Organic Chemistry I  (GTA)
  
• CHEM 202 Organic Chemistry II (GTA)
• CE141 Introductory Photoshop – Introduces students to basic functions of photo editing and image manipulation in Adobe Photoshop.
• CE142 Intermediate Photoshop – Students will complete practical projects using basic functions, including photo editing and image manipulation. Students will be introduces to paths, vectors, levels, and working with color in Photoshop to take their skills to the next level. Previous completion of CE140 or equivalent Adobe Photoshop experience is required.
• CE143 Photoshop for Business & Entrepreneurs – Students will learn to use Photoshop for business applications, including developing professional identity through logos, business cards, and other visual media. We will also address practical applications such as how and where to affordably print or publish your materials. No previous Adobe Photoshop experience is required.
• CE161 Introduction to Web Design – Introduces students to basic HTML, CSS, forms and templates for web design. Students will build a website as part of the course. No previous wed design experience is required.
• CE162 Intermediate Web Design – Students will complete practical projects using HTML, CSS, and web design packages, including WordPress and its plugins. Students will create a functional website with advanced forms and features. Previous completion of CE161 or equivalent web design  experience is required.
• CE163 Web Design for Business & Entrepreneurs – Students work hands-on to learn basic web design and maintenance tools to create their own highly functional websites for small business using the WordPress Platform. We will also address practical applications such as how and where to affordably print or publish your materials.
• CE111 Introduction to MS Word for Business & Entrepreneurs – Students will learn to create documents by applying text, styles, and tables using Microsoft Word for business and finance use.

Publications

• 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 Regulatory Affairs Professional Association (RAPS): Rockville, MD. 2019.
• Johnson, A.N. “Medical Device Clinical Testing and GCPs”. US Regulatory Affairs Fundamentals, 10^th Regulatory Affairs Professional Association (RAPS): Rockville, MD. 2017.

Refereed Presentations

• Johnson, A.N. Drug-Device Combination Treatments and Diagnostics. Rountable 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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