Ariel Brown, PhD

• Clinical development writing lead for all efficacy-related documents in the zuranolone NDA • Study medical lead for Phase 1 through Phase 4 clinical studies of multiple GABA compounds; responsible for trial design, PI/site recruitment and engagement, medical data oversight, developing medical-related trial materials, training stakeholders, and data review, interpretation, and reporting • Medical reviewer for all non-promotional external communications related to early-stage assets, as member of medical-legal-regulatory review committee • Co-founder of Sage's Diversity, Equity, and Inclusion Action Team fostering inclusive culture in service of corporate core values and increasing employee engagement; co-lead of SageLavender, Sage’s LGBT+ employee resource group

• Medical writing lead for successful NDA submission for ZULRESSO®, tasked with writing or managing the writing of program CSRs as well as Module 2 summary documents • Supporting functional build for medical writing department, recruiting and onboarding in house writers and vendors, creating document management and review system, training materials, tools, processes, and best practices in use by all department writers • Managed direct report medical writers and external vendors to complete project writing work • Triage lead for FDA advisory committee, tasked with creating and managing all slides related to efficacy data in the clinical program; responded live to committee questions with appropriate slides • Recognized leader in cultural build, founding employee book club with 100+ members, bringing in outside speakers to increase engagement, member of multiple focus groups run by HR • Completed 6-month management course for employees with great promise in management • Individual contributor to clinical team, authoring clinical protocols/amendments, IBs, and CSRs

The Emotional PPE Project is a 501 (c)(3) nonprofit charitable organization started in April 2020 in response to the need for professional emotional support in healthcare workers impacted by the COVID-19 pandemic. Our mission is to reduce barriers to accessing mental health treatment in healthcare workers through research, advocacy, and the promotion of our online directory of volunteer therapists providing no cost, no insurance, confidential sessions. Since our inception 1 year ago, we have connected approximately 1,000 US healthcare workers with professional emotional support in their time of greatest need. Our work has been recognized nationwide, and featured on The Today Show, NPR’s All Things Considered, and in JAMA.

• Core member of clinical filing team, tasked with planning and preparing for speed filing of simultaneous NDA and MAA submissions for orphan drug (ONPATTRO®) • Individual contributor authoring clinical study protocols and amendments, IBs, and CSRs • Contributed to process improvement, including building safety narrative capabilities • Contributed to infrastructure by recruiting internal medical writers and medical writing vendors • Member of EMA policy 0070 task force, educating cross-functional groups on data transparency • Co-founder of Alnylam’s Diversity and Inclusion initiative “Constellation”, fostering open culture in service of corporate core values and increasing employee engagement

• Core member of clinical filing team, tasked with planning and preparing filing of NDA submissions for oncology drug (COPIKTRA®) • Medical writing lead for lymphoma indication within duvelisib clinical program, managing and/or writing all clinical regulatory documents, including protocols/amendments, IBs, and CSRs • Responsible for managing direct report contract medical writer • Co-authored and managed the process and content of clinical and translational medicine abstracts, designing posters, leading publication planning meetings and contributing to publications strategy • Core member of cross-functional clinical study teams, representing medical writing • Contributed to process improvement, authoring SOPs, developing SharePoint collaborative review

• Medical writing lead for ALKS 5461 development program, writing and/or managing writing of all clinical regulatory documents related to compound • Core member of clinical team tasked with completing Phase 2 and executing a Phase 3 clinical program, including designing and operationalizing 16 trials supporting regulatory submission • Developed and maintained timelines for all clinical regulatory documents in ALKS 5461 program, contributed to resource allocation and project budgeting • Participated in site initiation visits, investigator meetings and advisory boards • Representative on cross-functional task forces including knowledge management system task force, protocol template task force, TFL standardization task force

Responsible for supporting the development of all regulatory documents related to clinical trials for products indicated in drug and alcohol addiction, depression, and schizophrenia. Writing projects include, but are not limited to clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, and clinical sections of regulatory submissions such as NDAs or INDs.

• Led scientific development of psychiatric neuroimaging research protocols • Managed cross-functional/inter-institutional teams to conduct psychiatric neuroimaging research in individuals diagnosed with ADHD and/or bipolar disorder • Secured research funding by presenting project proposals and results to private donor boards • Collected, coordinated, maintained and analyzed neuroimaging and neurocognitive datasets • Developed expert up-to-date knowledge of the psychiatric neuroimaging research landscape • Developed publication strategy and authored peer-reviewed publications and posters • Responsible for hiring and managing direct report research assistants • Led scientific development on several grant applications to public and private organizations

Visiting postdoctoral position as part of inter-institutional psychiatric neuroimaging project.