Pharmacist

Brittany Alicia Duke, PharmD RPh

Lanham, MD 202-***-**** *************@*****.*** Citizenship: U.S.A

Summary of Qualifications

Doctor of Pharmacy Degree, Registered Pharmacist with an active Maryland license.

Experience with regulatory submissions including CTAs, INDs, NDAs, BLAs, Annual Reports, DSUR, PADER, for products in compliance with global filing plans and HA regulatory requirements (PMR/PMC)

Clinical experience in infectious disease, immunology, rheumatology, gastroenterology, dermatology, CNS, endocrinology, cardiology, and oncology.

Agency contractor experience within the offices of OND, OC, and OSE

Experience leading and managing a collaborative clinical cross functional/multidisciplinary team responsible for the independent review of drug labels of medications used by Medicare Part D beneficiaries at the FDA as an ORISE Post-Doctoral Fellow for over two years.

Scientific literature research on drug-device combination product training that focused on Asthma Action Plans and Pharmacist Provided Education at the CDER Office of Surveillance and Epidemiology (OSE).

Proficiency in Word, PowerPoint, Excel, SharePoint, Adobe Acrobat, EndNote, SPSS, JMP, R Studio, SAS, and STATA statistical software.

Intermediate experience with MedDRA, FAERS, DMC, LORENZ docuBridge, DXC, PXL, Liquent, CARA/PRISM, Veeva Vault Verity, & eSub

Participation in synergistic activities across FDA, federal landscape, and external stakeholders

Experience using Real World Data (RWD) and Evidence based medicine (EBM) as a Clinical Research Associate, Pharmacist, and ORISE Post-Doctoral Fellow to integrate the best research evidence with clinical expertise and patient values with an understanding of biostatistics and pharmacoepidemiology.

Professional Experience

Pharmacist 07/01/24-Present

FDA

10903 New Hampshire Ave

Silver Spring, MD 209903

Full-time Permanent

Provides Pharmacist expertise in the Office of Generic Drugs (OGD), Office of Generic Drug Policy (OGDP) Division of Legal and Regulatory Support (DLRS) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA)

Provides technical direction to various aspects of the assessment of ANDAs and other generic drug submissions.

Performs regulatory duties that support the public health mission to help ensure high quality, affordable generic drugs are available to the American public.

Ensures the availability of therapeutically equivalent generic drug products to the American public through coordination with senior-level scientists and subject matter experts, such as regulatory counsels and clinicians, to conduct regulatory science research, evaluate generic drug applications, and/or investigate and research potential post-approval safety or product use issues.

Serves as a scientific and technical expert providing assessment and evaluation for the generic drug process and program activities within OGD. Carries out activities to determine the acceptability of Abbreviated New Drug Applications (ANDAs) such as data evaluation as part of the review process for applications, submitted under section 505 (j) of the Federal Food, Drug and Cosmetic (FD&C) Act.

Compiles data to prepare periodic and special reports relative to the work of the division for issuance to generic drug applicants and presentations or manuscripts for public venues or guidance.

Replies to correspondence from regulated industry and stakeholders to provide counsel as needed. Issues raised in these correspondences are often both regulatory and technical in scope. Leverages available methods, technology, and information to produce a quality work product. Prepares written deliverables in collaboration with team embers that convey relevant product development information to the generic drug industry.

Provides input, recommendations, and innovative strategies when collaborating with experts within the Office to modify and develop systems, policies, and procedures to address the needs of the program segments.

DLRS: Assesses patent and exclusivity matters for brand and generic drugs and determine timing of generic drug approval. Manages programs for adjudicating eligibility for priority review of applications, coordinating OGD’s response to drug shortages, and compiling and reporting on certain information related to generic drugs, including statutorily required reports to Congress.

Associate Director, Regulatory Affairs (Global Biosimilar) 06/27/22-05/31/24

Fresenius Kabi USA LLC

Fresenius Kabi Washington, DC Office

801 Pennsylvania NW

Washington DC, 20004

Full-time Permanent

Provides global regulatory leadership regarding biosimilar development and management of submission related documents, regulatory data for Biosimilars

Leads preparation, rehearsal and manages meeting with Health Authorities under the supervision of line manager

Develops, and manage the submission strategy of Biosimilar dossier that best serve the biosimilars business needs, whilst ensuring the work is done in compliance with Fresenius Kabi regulatory procedures and systems. Ensure the regulatory strategy is endorsed by the Development Team and the Project Development Committee

In alignment with the Development team, establishes necessary regulatory storyline for regulatory interactions (briefing book consultations and submission dossier)

In close collaboration with Regulatory Operations, contributes to and supports strategies to implement technologies supporting all current and future authorities’ requirements and ensures consistency of standards in systems and processes across Biosimilar functions

Provides global guidance and support to Market Units in their interactions with local health authorities (life cycle management) including mapping of regulatory constraints and contribution to wave 2 launch prioritization under supervision of a more experienced regulatory team member

Contributes to the Global Launch Readiness team by providing detailed understanding of the regulatory process and by guiding the team on the best regulatory approach (e.g., Ad Promo and Labeling, packaging, artworks)

Leads/participates in Regulatory Sub-teams

Serves as the North America Regional Lead (i.e., FDA and Health Canada)

Manages regulatory submission process through to approval

Provides recommendations on submission readiness

Keeps up to date with the current regulatory environment

Serves as an interface between other regulatory groups and company functions as appropriate

Drives third party collaborators, including set-up of the interaction

Senior Manager Clinical Regulatory Affairs 03/31/22-06/24/22

Pardes Biosciences Inc.

2173 Salk Ave., Suite 250, PMB #052

Carlsbad, CA 92008

Full-time Permanent

Served as the global and US/regional regulatory lead for the lead program PBI-0451, a novel direct-acting, oral antiviral drug candidate being developed for the treatment and prevention of SARS-CoV-2 infection and associated diseases (i.e., COVID-19).

Responsible for the development of product regulatory strategies, execution of regulatory plans, regulatory project management and collaboration cross-functionally and with regulatory operations professionals.

Responsible for preparing regulatory documents in line with applicable internal and external requirements and standards to achieve and maintain clinical trial authorizations, emergency use authorization and marketing application approvals.

Developed regulatory risks and predictions of interactions with regulatory agencies.

Provided regulatory guidance on US regulatory mechanisms to optimize product development (i.e., orphan drug, fast track, early access, pediatric plan).

Global Regulatory Manager 05/24/21-03/11/22

Bristol Myers Squibb

3401 Princeton Pike Lawrence Township, NJ 08648

Full-time Contract

Responsible for the day-to-day Global Regulatory Affairs base business operations and new product development projects for the Nivolumab Lung Cancer Portfolio and Immunology, Neuroscience, and Fibrosis assets in Phase 1, 2, or 3 studies which include contributing to regulatory strategies and content plans.

Supports Global Regulatory Lead (GRL) and US Regulatory Lead (USRL) in the preparation of HA interactions (GRST meeting preparation, execution, follow-up, and minutes) and the execution of their identified responsibilities, and interfaces with Regional Liaisons, i.e., EU, US FDA, and International, for Oncology and IN&F Therapy Areas by supporting the implementation of the GRST model for all assets.

Maintains tracking data for health authority RRT meetings, PMRs/PMCs, and other key regulatory milestones and liaise cross-functionally to generate periodic internal milestone reports

Provides operational support on strategic regulatory documents to help drive timely deliverables

Drives operational excellence in Global Regulatory Strategy & Policy through projects aimed to support collaboration and improve efficiency including the Oncology FDA Learnings Newsletter Spotlights

Contributes to the timely response of HAQs by organizing and facilitating rapid response team meetings, driving response development, and coordinating submission of final response to HAs including HAQ verification in Verity.

Maintains global submission plans (GSP) events in Verity and executing them on time

Provides support for all close out activities for terminated studies.

Supports the successful delivery and achievement of global regulatory eCTD submissions (modules 1, 2, 3, 4 & 5), approval, lifecycle management and compliance-related deliverables across portfolio including IND Annual Reports/DSURs (SDSP & GIP), and Core/Senior Review of ODD, PIP, iPSP, BB, CSR, and ICF.

Founder & Owner/Health Content Strategist 05/15/20-07/01/24

Rx Care Consulting LLC

10330 Vista Meadow Way Lanham, MD 20706

Provides Pharmacist expertise as a Medical Reviewer for Healthline Media/RVO

Helps to get rid of health misinformation by creating engaging content for companies that is marketable to their consumers.

Works with pharmacy consulting companies especially pharmacogenomics (PGx) companies and independent pharmacy consultants working for long-term care facilities and nursing homes.

Provides the following health content strategy marketing services: blog posts, articles, white papers, and medical reviews.

Drug Safety Specialist/Operations Specialist III 03/15/21-04/13/21

IQVIA

4820 Emperor Blvd, Durham, NC 27703

Part-time Contract

Created Adverse Event and Product Quality Complaint reports requiring concise data entry covering everything from patient symptoms, admission and results including medical terminology, writing narratives, and generating case queries for the Moderna COVID-19 Vaccine.

Clarified, investigated, and captured adverse event and product quality information.

Received, triaged, reviewed, and processed data from various sources on time, within budget and meet quality standards.

Performed data entry for tracking and safety database, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations, and ensuring reports are sent to the customer within assigned deadlines.

Assessed Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement.

Processed Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.

Assisted operations team with tasks, provide for back-up to the operations team, assist in generation of status reports, providing project metrics, drafting project instructions/guidelines and assist in implementation of new processes.

Contributed under guidance of senior staff to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information, or other service lines as appropriate.

Liaised with different functional team members, e.g., project management, clinical, data management; health care professionals e.g., investigators, medical monitors, site coordinators and designees to address project related issues.

Attended project team meetings and provides feedback to operations managers on any challenges/issues or successes.

Subject Matter Expert III- Medical Writer/Analyst IV 06/01/20-05/21/21

Brillient Corporation

1893 Metro Center Dr #210, Reston, VA 20190

Full-time Contract

U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Surveillance and Epidemiology (OSE) Division of Medication Error Prevention and Analysis (DMEPA) Rapid Response Team (RRT)

Responsible for the development of regulatory documents, guidances, regulations, policies, and procedure that affect the drug approval or post market product safety surveillance and evaluation process. This includes written documents pertaining to premarket safety, post-market safety, real-world data, REMS, risk management and risk assessment.

Responsible for the data analysis of FAERS US Study and Trial Reports with Med Error Codes and FAERS US Med Errors with Protocol in narrative in IND Cases from 2017 to December 2020.

Responsible for the Literature Search of articles and the proposal development on how Specific Gravity is Used in The IV Workflow in US Hospitals for Sterile Compounding.

Successfully reconciled the MedDRA Preferred Terms (PTs) in the Standardized MedDRA Query (SMQ) with the terms in the DMEPA Medication Error Surveillance Report (MESR) using an Excel file that gets updated twice a year.

Successfully completed the title and abstract screening of about 150 articles for a gap literature search for a paper on when patients do not receive training on the use of drug-device combination products using Rayyan QCRI by reanalyzing articles that focused on Asthma Action Plans and Pharmacist Provided Education and provided comments on the draft of the paper that is soon to be sent for publication once cleared.

Responsible for the Copy Editing of a Lybalvi (olanzapine- samidorphan) Epidemiology and Drug Utilization Review Document for the Office of Pharmacovigilance and Epidemiology (OPE)

Successfully completed the Rapid Response Team SharePoint Online Migration of 2,500+ files.

Responsible for conducting data analysis using Excel to review FAERS cases to determine whether the narrative describes possible confusion with once weekly versus twice weekly dosing of Estradiol.

Responsible for meeting with RRT Reviewers and compiling High Priority Screening Reports (HPSRs) Change Requests for Improvements to the Weekly Email and the Excel files provided by Mercado.

Attended and participated in the Post Market Training conducted by RRT which included Drug Safety Analytics Dashboards – Training and FAERS Case Studies - PM Training.

Successfully automated the DMEPA Knowledge Assessment for Post Market Training using Microsoft Forms on SharePoint Online.

Worked with RRT on implementing framework for DMEPA University and DMEPA Postmarket Training Program Process Improvement to Develop Training Module Content.

Edited the Agency Information Management System (AIMS) Record and Lifecycle Safety Tracker (LiST) Documents to be used as reference guides for Medication Error Signals.

Explained how to set up a DMEPA All-Hands Survey on SharePoint Online using Microsoft Forms.

Worked on modifications and restructuring edits to the RRT and USP Healthcare Quality and Safety EC SharePoint Online Sites.

Conducted a Medication Error Pharmacovigilance Literature Review search on the economic burden of medication errors in the United States using EMBASE and PubMed articles from the last 10 years.

Conducted a Literature Review on the REMS Program using PubMed articles from the last 2 years.

Pharmacist II- Medical Writer- Project Manager 08/12/19-05/29/20

Chenega Professional and Technical Services

609 Independence Parkway, Suite 210 Chesapeake, VA 23320

Full-time Contract

U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) Office of Drug Security, Integrity, and Response (ODSIR) Division of Global Drug Distribution and Policy Import Export Compliance Branch (IECB)

Performed post-market drug surveillance data analysis of Opioid abuse and misuse data, to support the development of Predictive Risk Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) rules.

Worked on two main projects to improve surveillance of import products to provide risk-based strategy of how we sample the drug products coming into the U.S. and expedite the regulatory process of how we handle import drug products that have been identified as possible violative products.

Developed the first project on a work instruction (WI), which is a field examination guidance for ORA imports staff. We first implemented a General Capabilities WI for Finished Dosage Forms for Oral Tablets and Capsules.

Prioritized the development of a specific WI for high-risk and high-volume drug products, by performing data analysis based on one-year imports data (10/1/2018 – 10/1/2019) and PREDICT Inherent Risk Score data. The sampling process can be more targeted and can minimize ad-hoc and for-cause sampling. A WI can also increase speed of accomplishing samples and allow increased surveillance of higher risk products. The drug products that are identified as high risk and high volume from this model will be further evaluated based on Product Assessment Criteria, Public Health and Regulatory Impact Criteria, and Feasibility Criteria that are being developed as a Work Instruction Work Group.

Achieved the Pearls of Excellence Award for Better Sampling at the Border for assembling a workgroup to develop field examination guidances for ORA Imports staff, improve sampling targeting, and implement process efficiencies at the ODSIR All Hands Meeting on February 25, 2020.

Developed the second project to improve the Joint Assessment Calls – Analytical Labs (JACAL) process. JACAL is required to discuss the technical aspects of the analytical testing when LC2/LC3 laboratory findings are encountered for medical product testing and regulatory actions for the violative products.

Streamlined the JACAL process to enhance surveillance of products with adverse laboratory findings by expediting regulatory actions including detention and import alerts, identify challenges and areas for improvement from JACAL stakeholders, propose a corrective action plan, and may suggest incorporating the changes to the JACAL SOP.

ORISE Post-Doctoral Fellow- Medical Writer- Project Manager 08/10/17-10/12/18

10903 New Hampshire Avenue, Silver Spring, MD 20993

Full-time Fellowship Contract

U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Surveillance and Epidemiology Division of Pharmacovigilance I

Managed a special project at the CDER Office of Surveillance and Epidemiology Division of Pharmacovigilance to develop regulatory AE/SAE drug safety reporting about Anti-Psychotic Drug-Induced Severe Cutaneous Adverse Reactions (SCAR).

Found case reports and researched medical literature and clinical medication information to provide responses to inquiries that are supportive of a causal relationship between antipsychotics or lithium carbonate and severe cutaneous adverse reactions (specifically Stevens-Johnson Syndrome [SJS]/Toxic epidermal necrolysis [TEN], drug reaction with eosinophilia and systemic symptoms [DRESS], and acute generalized exanthematous pustulosis [AGEP]).

Used medical information data resources for my case study literature search which included: EMBASE, PubMed and Web of Science.

Worked alongside safety evaluators to analyze FDA Adverse Event Reporting (FAERS) data for SCAR caused by Antipsychotics and use MedDRA coding version 22.0 search terms to determine the right SCAR term which included: SJS, DRESS, TEN, and AGEP.

The project case reports suggested at least a possible link between antipsychotics or lithium carbonate and the development of SCAR. Some drugs for example Zyprexa and Geodon, have SCAR in their labeling, so we wanted to see if further labeling changes need to be made for all antipsychotics.

Successfully documented my research in a Pharmacovigilance Review Report. My contributions to this report included: background information on SCAR, tables, regulatory history, product labeling, literature search and appendix.

ORISE Post-Doctoral Fellow- Medical Writer- Project Manager 07/03/17-08/09/19

10903 New Hampshire Avenue, Silver Spring, MD 20993

Full-time Fellowship Contract

U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Immunology & Inflammation (OII), Immediate Office (IO)

Worked on two research projects with Dr. Victor Crentsil, Deputy Director of OII, as my mentor. The first project was entitled “An Investigation of the Association Between Systemic Biologics for Plaque Psoriasis and Treatment-Emergent Suicidality Using a Bayesian Approach.” The second project was entitled “Geriatric Drug Labeling: An Analysis of the Past and Present to Gain Insights for the Future.”

Analyzed clinical trials and monitored the clinical trial result submissions from the biologic product sponsors in Global Submit Review for consistency with prespecified inclusion/exclusion criteria.

Collated the information sent from the manufacturers of the biologics so that I can gain a more detailed knowledge of the clinical trial analysis underlying the development programs.

Obtained data from clinical trials of approved systemic biologics indicated for psoriasis and/or psoriatic arthritis from the drug manufacturers (sponsors) with the primary endpoint or outcome of interest being Suicidal Ideation and Behavior (SIB).

Used the detailed knowledge to develop the optimal inclusion/exclusion criteria for data and the statistical analysis plan (SAP) for the meta-analyses. The project served as a case study to assess the safety signal of rare drug events in a regulatory environment through a meta-analysis of individual patient-level randomized controlled trial data using a Bayesian approach.

Assessed the availability of geriatric information in labeling for drug products approved for diseases prevalent in geriatric populations like Parkinson's and Alzheimer's Disease, the impact of the establishment of FDA’s geriatric labeling requirement and influence of lack of information on the absence of geriatric pharmacokinetic data in labeling for drug products approved for diseases prevalent in geriatric populations.

Responsible for Regulatory Affairs aspects of implementation of labeling changes including package inserts, medication guides, container labels, important safety information, and brief summaries.

Reviewed labels of 200 medications used by Medicare Part D beneficiaries and extracted data from the Orange Book, and the PDR or Drugs@FDA to create a database that facilitated the assessment of the availability of geriatric information in drug labeling.

Conducted a literature search for data indicative of clinically significant age-related quantitative changes in drug pharmacokinetic parameters (e.g., clearance, AUC, Cmax, half-life, etc.).

Co-authored an article with my mentor to be sent for publication entitled “The Pharmacological Implications of Geriatric Frailty and Considerations for Optimizing Drug Safety”. My contributions to the article focused on considerations for safe medication use in the frail geriatric patient, frailly as predictor of response to medicines, mediation review in frail geriatric patients and minimizing the use of high-risk medications.

Rotated in the OND Division of Dermatology and Dental Products with the Regulatory Project Management (RPM) staff to advance my knowledge of project management at the FDA.

Reviewed Pre-INDs/INDs, NDAs, BLAs and drafted Proposed Timelines, Study May Proceed Letters, Acknowledgement Letters, and Advice Letters. My duties primarily focused on Word formatting, PDF publishing and eCTD backbone compilation of regulatory submissions.

Analyzed Real World Data from the 2016 National Hospital and Ambulatory Medical Care Survey (NHAMCS) Data in STATA using the International Classification of Disease, Tenth Revision, Clinical Modification [ICD-10-CM] Coding that focused on Serious Adverse Drug Events in the Emergency Department Setting.

Remote Pharmacogenomics Certification Pharmacist 08/30/16-06/30/17

RxIGHT

10715 Double R Blvd, Suite 102 Reno, NV 89521, USA

Part-time Contract

Performed Personalized Medication Reviews (PMRs) with patients

Trained other Pharmacists to perform PMRs for RxIGHT PMR Certification Training program.

ORISE Health Care Quality Fellow- Medical Writer- Project Manager 02/16/16-08/30/16

1101 Wootton Parkway, Rockville, MD 20852

Full-time Fellowship Contract

US Department of Health and Human Services (HHS) Division of Health Care Quality Office of Disease Prevention and Health Promotion (ODPHP) Office of the Assistant Secretary for Health (OASH)

Worked closely with the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan)

Stayed actively involved in relevant medical literature and activities in health care quality research.

Created PowerPoint presentations on the role Pharmacist play in prevention of ADEs and the Pharmacist perspective on Anticoagulants.

Organized PMR Journal Club meetings every other month

Planned and organized meeting agendas and summaries for ADE Drug Class Leads for Anticoagulants and Diabetes Agents

Learned about the ADE Action Plan and organized reviews.

Learned about the Healthcare Associate Infections (HAI) Action Plan

Attended Federal Steering Committee meetings at HHS Headquarters in the Humphrey Building and wrote meeting summaries.

Wrote blog posts on how Pharmacists play a major role in patient safety (i.e., medication reconciliation, medication adherence, teach back method, and preventing medication errors)

Planned a Diabetes project in collaboration with the Prevention Science Division on how dietary guidelines play a role in prevention and control of Diabetes and related ADEs.

Submitted an abstract on ADEs to the American College of Clinical Pharmacy ACCP) Conference

Submitted a grant proposal for a federally funded project on Shared Decision Making for Individualizing Glycemic Targets for Diabetic patients

Clinical Staff Pharmacist 12/08/14-02/08/16

Holy Cross Hospital

1500 Forest Glen Rd, Silver Spring, MD 20910

Part-time

Supervised the IV room workflow using DoseEdge and verified inpatient Physician orders for example pharmacy to dose Warfarin, Zosyn, and Vancomycin. Checked INR values and made recommendations to hold Warfarin or change the dose.

Provided clinical knowledge to other healthcare providers and performed patient education visits, known as med teachings, in the following areas: Medicine/Surgery, Critical Care, Oncology and NICU/Mother/Pediatrics.

Provided information to other healthcare practitioners and patients about proper usage of medications and side effects and assess medication use patterns and outcomes for patients.

Gained Infectious disease experience by utilizing the Antimicrobial Stewardship program where I put 7 day stop dates on antibiotics depending on indication. On January 13, 2015, decentralized pharmacists printed the antimicrobial report every morning at the beginning of the shift and reviewed all antimicrobial medication orders for the respective patient care units. Pharmacists modified all adult intravenous antibiotic orders without a stop date or if the stop date defaults to 30 days to include a 7-day duration. Exceptions to this policy included indications for endocarditis, osteomyelitis, C. difficile infections and neutropenic fever as these conditions may warrant a longer duration of therapy. Pharmacists also evaluate the culture results, vitals and lab values and streamline the therapy after contacting the prescriber. Drug Bug Mismatch alerts report from quality compass software were also another solution to antimicrobial streamlining. Clinical pharmacists and pharmacy residents checked the dashboard every morning for Drug Bug Mismatch alert and resolved with the prescribing team.

Analyzed investigative new drugs undergoing clinical trials and monitored the clinical trial results submissions for dosing purposes, entering chemotherapy orders, supervising pharmacy technicians during the IV chemotherapy workflow process using DoseEdge software and rotating through the oncology floor and outpatient infusion center. Reviewed Pharmacy Establishment Plans (PEPs) to implement and utilize USP Guidance Chapters 795, 797, and 800.

Reduced preventable adverse health care-associated conditions to improve patient satisfaction, lower costs and improve quality.

Clinical Research Associate 09/10/14-12/05/14

Renaissance RX

1441 Canal St., Ste. 318, New Orleans, Louisiana 70112

Full-time

Performed clinical trial data analysis as part of an all Pharmacist CRA team.

Worked as a Pharmacist Consultant on the Diagnosing Adverse Reactions Trial (DART) protocol which was a clinical trial registry in a Clinical Study Report (CSR).

Provided consultation, advice, and guidance on regulatory and compliance issues in the pharmacy field by performing administrative, consultative, or staff advisory work for various doctor's offices. This clinical trial was funded by Medicare to determine if DNA testing can help prevent adverse reactions potentially caused by medications.

The primary objective of the Registry was to assess whether the use of pharmacogenomic data

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