Lacey Wallace Email and Phone Number

-Leader of a panel of volunteer PKists from across the international biotech industry for CDISC SDTM Pharmacokinetics Controlled Terminology. We specialize in standards development for pharmacokinetics modeling through monthly meetings to collaborate and produce the updates of the SDTM/ ADaM implementation guides and standard CT for pharmacokinetics. -The SDTM domains were rolled out in 2009 since then we have expanded the CT library to include new qualifiers, SEND units, and helped to kick off ADNCA, ADPPK and now we have begun contributing to ADPP Draft. -This team reaches across the PK Standards beyond SDTM and NCA and it is really an honor to continue to support this volunteer work. I also have a role in the SDTM core teams, PGx Team, and the ADaM Team.

-Served as the lead on project teams as a PKist and SDTM SME to instill efficiency, quality, and integrity of SDTM data standards and reporting project activities. Collaborated with external and internal teams providing input into study SDTM and ADaM database standards development, collection and cleaning tool development, and improvement of documentation process.-Represented Avance on CDISC collaboration efforts including leading the Pharmacokinetics Controlled Terminology Team, and collaborated on the PGx Team, ADNCA Team, and the ADPPK Team.-Performed/reviewed PK NCA analyses. Prepared/reviewed listings, tables and figures for clinical study reports. Advised on PK study design, protocol drafting, statistical analysis plans (SAP) development and randomization schedule planning. Drafted and reviewed PK results sections of clinical study reports. Also authored standalone PK Reports.-Liaised with cross-functional teams on PK dataflow including Data Management, project management, and bioanalytical laboratory teams on PK timelines, data transfers, PK Case Report Form reviews, and Data Management Plans.-Provide business development feedback on PK forecasting for budget planning. Participate kickoff meetings and client meetings.

-Served as the statistical programming lead on project teams as SDTM Oncology SME to instill efficiency, quality, and integrity of SDTM data standards and reporting project activities. -Collaborated with external and internal teams providing input into study SDTM and ADaM database standards development, collection and cleaning tool development, and improvement of documentation process. -Developed and evaluated data displays and analysis datasets in accordance with approved Statistical Analysis Plans and shell displays. Actively managed programming activities within parameters of project budgets.-Represented Gilead on CDISC collaboration efforts including leading the Pharmacokinetics Controlled Terminology Team, and collaborated on the PGx Team, ADNCA Team, and the ADPPK Team.

-Leader of change management through developing new concepts & strategies for standards mapping (often mapping via Medidata or InForm), by engaging and enabling cross-team implementations, further progressing innovations in SDTM mapping across the data flow.-Designed, deployed, & maintained cross-functional solutions, process maps, SOPs, & Work Instructions that improve quality data flow.-Built efficiency in business processes by supporting technologies that drive statistical computing environments, metadata repositories, output delivery depots, & standard macro libraries. Lead multi-disciplinary experts on projects to influence, elicit, analyze, and document functional requirements. Adhered to global and local regulations, GCP, ICH guidelines, SOPs, and functional QA standards. -Represented CSG on CDISC collaboration efforts including leading the Pharmacokinetics Controlled Terminology Team, and collaborated on the SDTM Team, QRS Team, PGx Team, ADNCA Team, and the ADPPK Team.

-Leader in the development of CDISC standards through collaboration with study team members and vendors. Partnered with IT and CQA to implement Pinnacle 21e (P21e) V5.0.0 by authoring a new, faster and compliance driven review process. -Supported leadership of various CDISC teams in the development of standards while working on initiatives as a CDISC representative. Implemented governance for CDISC standards at AGT, track their evolution, lead the creation and maintenance of process documentation.-Monitored regulatory authority and standards organization sites for updates and ensured AGT Leaders were informed of updates. Assured the SDTM deliverables support minimum submission requirements.-Represented AGT in the industry as a leader in the use of Standards and Automation. Provided guidance for new data collection tools and/or implementation of new standards. Partnered with clinical trial team members and biometric vendors as an authority in the use of CDISC Standards through communication, training, and mentorship. Provided input for P21e issues, SDTM aCRF mapping specifications, define.xml, and reviewer guides updates. Managed invoices for contractors as a Leader of the DM Biometrics AGT team during Audentes/ AGT leadership integrations. Co-lead of the Learning and Development Task Force as part of the diversity and inclusion efforts of AGT.

As a volunteer for several nonprofit organizations including Kent Arts Association as a online marketing consultant, I often assist artists like BA Wygant Studio with setting up a plan for social media and web content. Please feel free to reach out to me on LinkedIn to set up a weekend appointment for consultation. I'm also happy to present tips and tricks I've learned over the years at events in the local community.

-Drafted beginning to end global SDTM therapeutic area standards, from collection to analysis, with management of impacts across versions. Delivered trainings, presentations, and provided CDISC expertise and guidance to cross-functional partners as part of internal consultations and public reviews. Organized SDTM metadata library to ensure reuse and advance SDTM consistency across products. -Ensured changes were implemented quickly and consistently through governance process improvement of SDTM standards initiatives. Identified resource/timeline issues upstream of plan disruptions. Followed industry evolution of CDISC SDTM standards and Guides.

-Created timelines for SDTM domain data reviews with a focus on trial milestones.-Reviewed and generated P21 compliance reports, define, SDTM Trial Design Datasets, SDTM annotated eCRFs/ePRO/EHR, and Clinical Study Data Reviewer's Guide. Promoted upstream data use of CDASH, SDTM, and ADaM Standards and Controlled Terminology(CT ) via CDISC Library as early as possible in the planning phases with vendor UAT data, and ePRO devices. Interfaced with cross functional teams, ensuring transition through the data flow to SDTM datasets were functional and efficient.-Represented IQVIA as part of multiple SDTM CT Teams, lead the PK CT Team and participate on multiple ADaM Teams for CDISC. -Developed SDTM training resources for data managers and programmers. Provided CDISC, SDTM, and ADaM expertise and knowledge in an advisory capacity across projects. Tracked progress across training activities and logistics.

-Influenced, defined, and instantiated core and therapeutic area standards for broader reusability and drove toward consistency; via understanding, influencing, and incorporating industry standards (CDASH, SDTM, ADaM, ODM).-Represented Lilly and Global Data Delivery as part of multiple SDTM CT Teams, while continuing to lead the PK CT Team and the PK Cross Functional Team with CDISC.-Defined, implemented and managed the processes and technologies to support the clinical data flow from data collection through analysis/integrated databases/submission deliverables. Supported the portfolio by enabling delivery of observed and analysis data along with delivery of PK data, integrated databases and submission deliverables. -Provided solutions and consultation to support the Clinical Data Flow utilizing process, technology, standards, vendor management, data and regulatory expertise/knowledge, e.g. eSource, CFR 21 Part 11, guidance documents. Developed standards to be used and followed at each stage of the clinical trial data flow. Developed metadata used to control and automate the clinical trial data flow process.-Maintained libraries of clinical trial data standards, making them accessible to all Lilly personnel and partners. Ensured the capacity of data transfer between Lilly and external partners by defining relationships between internal and external standards.

-Developed and maintained a sufficient pre-qualified number of investigators to meet trial specific timelines and requirements.-Served as a liaison with sites while collecting trial specific investigator/site requirements to pre‐qualify potential investigators.-Developed and analyzed data via investigator systems, screens and metrics for tracking site information. Via aggregated data proactively identified potential site operational issues, obstacles, and barriers for data collection systems.

-Trial data manager (TDM) responsible for the database set-up in Oracle*Clinical and design of the eCRF for the collection of clinical trial data, including programming of data plausibility checks. Ensure the accuracy and consistency of the clinical trial database, coordinated and conducted trial team review of data via Medical Quality Review Meetings.-Presented the content and completion expectations of the eCRF at investigator meetings. Collaborated with international clinical sites and research associates in resolution of data issues and requests. Reviewed project standards and protocols.-Directed international pharmacokinetic data flow harmonization and innovation efforts with IT through implementation and development of a file validation PKChecker tool internationally. Lead CDISC–SDTM PK CT team of industry leaders specializing in standards development for PK modeling via weekly meetings to collaborate and produce the international implementation guide and standards for PK. The SDTM domains were rolled out in 2009.-TDM for virology trials expedited database design through collaboration with the clinical team prioritizing site and investigator access, tracking data entry metrics and identifying data flow abnormalities. Successfully managed multiple interim locks & the pilot trial for a new corporate database structure (SDTM+). Directed & implemented a new process & standards including a database structure later scaled to all clinical trials. Developed “by patient lock” process.

-Conducted protocol reviews, planning/scheduling of analysis and clinical trial report generation for pharmacokinetics (PK) sections on 47 clinical trials across 7 therapeutic areas (Respiratory, Virology, Oncology, CNS, Metabolic, Immunology, and Inflammation). -Collaborated and trained Data Management colleagues internationally on the data transmission structure and content. -Analysis leader collaborating with international harmonization teams from protocol to report, implemented transitions in workflow & tools.-Prioritized & organized the QC of all PK & pharmacodynamics (PD) analysis for CTR sections for Trial Clinical Pharmacokineticist.-Achievements and Awards: Special recognition from CDISC for contributions to PK terminology teams. 2 REACH awards from International Medical Management for the ADaM Pilots. 4 Medical Golden Achievements awards.

Developed instrumentation and reagents testing of new products. Performed stability testing. Drafted reports, presented analysis & QA testing outcomes. Managed harmonization efforts, ISO audits, reprogramming pilots, & beta testing reagents.

I studied toxic algae effects on juvenile clam growth and mortality using flowcytometry.

In the summer of 1999 I worked at North Carolina State’s Pfiesteria biohazard level lll lab. I also maintained an aquaculture facility with both shellfish, algae, and tilapia.