MURIEL BOWSER
MAYOR
June 28, 2024
The Honorable Phil Mendelson
Chairman
Council of the District of Columbia
John A. Wilson Building
1350 Pennsylvania Avenue, NW, Suite 504
Washington, DC 20004
Dear Chairman Mendelson:
In accordance with section 2 of the Confirmation Act of 1978, effective March 3, 1979 (D.C. Law 2-
142; D.C. Official Code § 1-523.01), and pursuant to section 204 of the District Columbia Health
Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code § 3-
1202.04), I am pleased to nominate the following individual:
Ms. Brandi Saunders
5th Street, NW
Washington, DC 20011
(Ward 4)
for appointment as a registered nurse licensed and practicing in the District member of the Board of
Nursing, filling a vacant seat formerly held by Michelle Clausen, for the remainder of an unexpired
term to end July 21, 2026.
Enclosed, you will find biographical information detailing the experience of the above-mentioned
nominee, together with a proposed resolution to assist the Council during the confirmation process.
I would appreciate the Council's earliest consideration of this nomination for confirmation. Please
do not hesitate to contact me, or Steven Walker, Director, Mayor's Office of Talent and
Appointments, should the Council require additional information.
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at the request of the Mayor
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6 A PROPOSED RESOLUTION
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10 IN THE COUNCIL OF T HE DIST RICT OF COLUMBIA
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15 To confirm the appointment of Brandi Saunders to the Board of Nursing.
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17 RESOLVED, BY THE COUNCIL OF THE DISTRICT OF COLUMBIA, that this
18 resolution may be cited as the "Board of Nursing Brandi Saunders Confirmation
19 Resolution of 2024".
20 Sec. 2. The Council of the District of Columbia confirms the appointment of:
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22 Ms. Brandi Saunders
23 5th Street, NW
24 Washington, DC 20011
25 (Ward 4)
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27 as a registered nurse licensed and practicing in the District member of the Board of Nursing,
28 established by section 204 of the District Columbia Health Occupations Revision Act of 1985,
29 effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code§ 3-1202.04), filling a vacant seat
30 formerly held by Michelle Clausen, for the remainder of an unexpired term to end July 21 , 2026.
31 Sec. 3. The Council of the District of Columbia shall transmit a copy of this resolution,
32 upon its adoption, to the nominee and to the Office of the Mayor.
33 Sec. 4. This resolution shall take effect immediately.
 BRANDI SAUNDERS, RN, M.S.
EXECUTIVE SUMMARY
‘An enthusiastic, purpose-driven, resourceful leader with 20 years of experience across Regulatory Affairs, Healthcare Compliance
& Ethics, and Drug Safety & Pharmacovigilance built on a solid clinical foundation. Keen ability to discern and prioritize company,
client, and stakeholder needs within the context of sometimes varied information or organizational resources. Seamlessly forges
and sustains relationships at all levels of a broad network of multidisciplinary colleagues and industry experts. Nimble, solution:
oriented, value-centric, can-do attitude, team player. Agile mindset to adjust as needed to meet changingcircumstances, shit
needs and interests. Harmonizes, engages, and motivates cross functional teams and stakeholders to deliver compliant and
‘commercially viable solutions. Therapeutic Area experience in Immunology, Ophthalmology, Neurology (CNS), Dermatology,
Rheumatology, Gastroenterology, Oncology, Rare Disease, Regenerative and General Medicine.
AREAS OF EXPERTISE
+ Risk Mitigation + Polished interpersonal and + Regulatory Promotion Strategy
+ Collaborative Strategist Diplomacy Skills + Cultural Competence
+ Persuasive Communicator + Glient and Stakeholder Engagement = Regulatory Compliance
+ Competitor and Market Analysis + impeccable Judgment + Meticulous Attention to Detail
+ Business Process Improvement + Team Leadership + Product Claim Substantiation
PROFESSIONAL EXPERIENCE
Opus Regulatory | Cambridge, MA 06/2021-Present
Principal Consultant, US and Global Regulatory Affairs, Promotional Compliance and Strategy
lent therapeutic areas: Oncology (solid tumor), Rare Disease, Immunology, Covid-19 Vaccines, Regenerative Medicine
© Provides commercial regulatory strategy, leadership and operational oversight to enable clients to meet their commercial
‘needs in a compliant manner.
© Closely collaborate with chief compliance officers to develop, revise and train clients on SOPs relevant to both the
commercial and medical affairs organizations within the company.
© Closely collaborate with labeling leads and sit on Global labeling committees to ensure label text can support the
commercial business objectives and targets.
© Provides strategic regulatory guidance on corporate communications and appropriate pre-approval communications
Provides regulatory review of promotional materials, disease education content, new campaigns and launch strategies
for assigned products in various therapeutic areas.
Assists clients with assessment and development of existing advertising and promotion related processes and
procedures.
In-depth knowledge of regulatory requirements associated with US advertising and promotion.
Evaluates competing perspectives and provides pertinent commercial regulatory guidance.
Regulatory liaison to OPOP and APLB for US based clients.
Liaise with local marketing authorization holders in Australia, New Zealand, Singapore and Israel on promotional
‘materials to ensure commercial messages are aligned with local labels/prescribing information and approved
publications.
Facilitates cross-functional and team awareness and understanding of regulatory landscape issues.
© Provides regulatory advice, risk assessment and mitigation strategies to commercial teams, medical affairs, public affairs,
‘market access and other internal groups, on all promotional materials, strategies, concepts, and disease awareness for
various therapeutic areas.
‘© Apply clinical development knowledge in conjunction with health authority regulations and guidance documents to
support development of promotional product messages based on the target product profile and target product claims.
© Work directly with advertising agencies and 3rd party publishers for submissions to FDA OPOP, ex-US health authorities
and industry organizations.
'® Lead and/or assist in interactions with OPOP as well as build and maintain effective relationships with OPDP reviewers on
promotional matters.
 BRAND! SAUNDERS, RN MS
Page 2 of 3
AbbVie, Inc. | Chicago, IL 05/2014 - 06/2021
Director, Global Regulatory Affairs, Promotional Compliance and Strategy
Led the global (ex-US) regulatory promotional strategy for the HUMIRA Franchise, as well as multiple Immunology
pipeline compounds ensuring compliance with health authority regulations and company policies.
Provided critical support and strategic guidance to affiliates across all markets outside of the US on a multitude of topics
regarding pipeline and on-market products such as promotional labeling claim substantiation.
Collaborated extensively with critical internal functions including global/area/affiliate commercial, market access, legal,
compliance, medical/public/regulatory affairs on strategic imperatives, opportunities, and other focused activities.
Contributed to the planning of long-term Global Brand Team strategies, Immunology pipeline and marketed products as
well as Global Product Team tactics for the areas of WEC, EMEA, LATAM, and JAPAC.
Maintained in-depth knowledge of global codes of practice, regulations, and guidelines that impact the business at an
international level.
Coordinated and collaborated with affiliate regulatory and medical colleagues to conceptualize and implement brand
plans, commercial roadmaps, innovative campaigns, and congress plans, guaranteeing feedback obtained is disseminated
to global marketing leadership in a timely manner.
Trained, onboarded, and supervised contractors hired to support increasing workloads and demands ensuring minimal to
ro disruptions to the business.
Regulatory Advisory Employee Group (REAG) functional lead responsible for representing colleagues’ concerns and
insights to senior leaders along with spearheading solutions to improve transparency and morale.
Participated as an integral member of the Regulatory Advertising and Promotional leadership team, representing the
Immunology franchise's priorities, areas of focus and issues.
Coordinated and leads monthly agenda driven immunology functional team meetings.
Provided critical analysis and interpretation of the regulatory position of various ex-US health authorities that inform
future company messaging and communications with highly visible pharmaceutical content having political, financial, and
legal interests.
Coordinated and led collaboration with Latin American area colleagues in regulatory affairs, medical affairs, compliance,
and legal matters pertaining to commercial activities.
Served as member of the AbbVie Regulatory Affairs Diversity, Equity, Equality & Inclusion Council and the Diversity in
Clinical Trials and Recruitment team for AbbVie's aesthetic franchise.
Forest Laboratories Inc. | Jersey City, NJ 05/2012 - 05/2014
Associate Director, US Regulatory Affairs, Promotional Compliance and Strategy
Delivered strategic regulatory guidance on promotional and educational content for the Central Nervous System (CNS)
franchise, ensuring external communications complied with corporate policies and federal regulations.
‘Advised product development teams on advertising and promotional strategies; consulted brand teams/broader
regulatory teams on the creation of new product labeling and revisions across all marketed product labeling,
Formulated and executed product promotion best practices, business practices and Standard Operating Procedures
{SOPs}, guaranteeing consistency across company brands.
Facilitated and ledtraining to sales and marketing team, medical and fellow reviewers on industry trends, enforcement
reviews, Bad Ad program, proactive vs. reactive communications, and pre-approval communications.
Bausch & Lomb | Madison, NJ 05/2011 - 05/2012
Senior Manager, US Regulatory Affairs, Promotional Compliance and Strategy
‘Analyzed prescription and generic pharmaceutical advertising and promotional materials to ensure alignment with
corporate policies and regulatory requirements.
Positively represented the company to regulatory authorities on all pharmaceutical promotional and advertising matters.
Delivered strategic regulatory guidance in advance of market research testing of key messages, new campaigns, launch
readiness, and NDA (new drug application) submissions.
Cultivated long-term relationships with reviewers; monitored correspondence and advised the company on the business
impact. Prepared product launch packages for submission to FDA for advisory comments.
Led training on regulatory requirements to guide sales and marketing teams in designing compliant product promotional
materials.
 BRANDI SAUNDERS, RN MS
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+ Designed a comprehensive review process and analyzed existing promotional and disease education materials relative to
pending Merger &Acquisition (M&A) deals.
Amgen | Thousand Oaks, CA 02/2005 ~05/2011
‘Senior Manager, Healthcare Compliance and Business Ethics
+ Served as the compliance business partner to assigned business units and contributed to the development of abestin-
class compliance organization to support commercial therapeutic area business planning.
+ Identified compliance risks and co-developed plans to mitigate potential areas of compliance vulnerability.
+ Managed the compliance hotline and provided counseling on compliance questions, concerns, or issues to commercial and
sales team colleagues.
+ Reviewed, revised, and enhanced healthcare compliance policies, procedures, templates, forms, and other controlled
documents.
+ Supported client interactions with healthcare operations to improve operational efficiency.
+ Liaised with cross-functional departments including HR, compliance investigations, compliance monitoring, and
‘compliance audit to implement identified corrective actions.
+ Co-developed and led customized compliance training, materials and job aids to business units and external vendors;
incorporated training feedback to enhance policies and training. Trained field staff on corporate code of conduct.
+ Trained 500+ sales and marketing professionals on SOPs, contributing to the successful launch of new assets.
+ Led compliance discussions with commercial leadership to encourage engagement, while infusing compliance into
business activities focused on interactions with healthcare professionals.
+ Provided an expert-level compliance perspective in the review of marketing materials and activities during Material &
Approval Compliance meetings.
+ Trained fieldstaffon the corporate Code of Conduct and compliance policies.
+ Assisted with monitoring activities and provided training to new monitors.
Senior Manager, US Regulatory Affairs, Commercial Strategy and Compliance
‘Manager, Drug Safety and Pharmacovigilance
CLINICAL EXPERIENCE
University of SouthernCaliforniaMedical Center| Clinical Research Nurse 10/2004-12/2007
UniversityofCalifornia, San Francisco Medical Center | Clinical Research Nurse. 9/2002-7/2004
University of California, Los Angeles Medical Center | Post-Surgical Travel Nurse 2/2002-9/2002
National InstitutesofHealth (NIH) | Clinical Research Nurse 4/2000-1/2002
EDUCATION AND CREDENTIALS
‘Master of Science | Clinical Research Management | University of California, San Fran '8/2002-6/2004
BachelorofScience | Nursing | Hampton University | Hampton, VA 8/1995-6/1999
Certifications and Affiliations
+ Registered Nurse (RN) licensure | Certified Compliance and Ethics Professional (CCEP), Societyof Corporate Compliance
& Ethics (SCCE), 2010 | Drug Information Association (DIA) | Regulatory Affairs Professional Society (RAPS) | American
‘Nurses Association (ANA) | Health Care Compliance Association (HCA) |
 Executive Officeof the Mayor ~ Mayor’s OfficeofTalent and Appointments
John A. Wilson Building | 1350 Pennsylvania Avenue, Suite 600 | Washington, DC 20004
Brandi Saunders
Ms. Brandi Saundersis a seasoned Registered Nurse (RN) and brings a
wealth of experience and passion to the healthcare landscape, She
embodies purpose driven leadership making her an invaluable asset to
any healtheare team. Ms, Saunders journey began at the National
Institutes of Health, where she mastered medical-surgical care and
clinical research nursing before taking on opportunities as a travel
nurse. Her solid clinical foundation ensures patient-centered decision-
making.
After yearsofdirect patient care, Ms. Saunders transitioned to the
BioPharma industry. Her roles in Global Safety/Pharmacovigilance,
Healthcare Compliance, and Global Regulatory A fairs demonstrate her commitment to patient
safety and industry excellence. Ms. Saunders agile mindset allows her to adapt seamlessly to
changing circumstances. She easily forges strong relationships with multidisciplinary colleagues
and industry experts, ensuring collaborative success. Ms. Saunders’s therapeutic expertise spans
Immunology, Aesthetics, Ophthalmology, Neurology, Dermatology, Oncology, Rare diseases,
Rheumatology and more. Her solutions-oriented approach delivers compliant and commercially
viable outcomes. When not shaping healthcare, Ms. Saunders enjoys exploring the world through
travel and food.
A Ward 4 resident, Ms. Brandi Saunders earned her Bachelor ofScience in Nursing from Hampton
University and Master of Science of Clinical Research Management from the University of
California.
 GOVERNMENT OF THE DISTRICT OF COLUMBIA
Executive Office of Mayor Muriel Bowser
wk ok
WE ARE
WASHINGTON
all
Office of the General Counsel to the Mayor
To: ‘Tomas Talamante, Steve Walker
From: Betsy Cavendish
Date: June 4, 2024
Subject: Legal sufficiency review ofResolutions nominating Enrique (Rick) Garcia,
Patricia Howard-Chittams, Laverne Plater, Tiffany Simons, Anne Ford, and
Brandi Saunders as membersofthe Board ofNursing
This is to Certify that this oftice has reviewed the above-referenced resolutions and
found them to be legally unobjectionable. Ifyou have any questions in this regard, please do not
hesitate to call Erika Satterlee, Deputy General Counsel, Executive Office of the Mayor, at 202-
724-1303, or me at 202-724-7681.
Elizabeth A. (Betsy) Cavendish
‘The John A Wikon Building > 1350 Pennsylvania Avenue, NW» Sune
300”