Mark Maggard Email and Phone Number

- Oversee study execution per ICH GCP, local regulations & Takeda SOPs, on schedule & on budget.- Oversee CROs and vendors for compliance with ICH-GCP and Takeda’s business objectives.- Accountable for planning and operational strategy and execution for assigned clinical trials- Provide subject matter and operational expertise for synopsis, protocol and study documents- Challenge study team to ensure operational feasibility, inclusive of patient and site burden- Validate budget and ensure impacts are adequately addressed- Participate in country and site feasibility/selection process- Challenge study team to ensure timelines meet the needs of the clinical development plan- Ensure new team members and vendors are appropriately onboarded- Lead the development of the Operational Strategy in preparation for Operational Strategy Review- Provide oversight/support/guidance to Strategic partners/CROs- Responsible for study budget planning/management and accountable for external spend- Communicates study status, cost and issues to Clinical Operations Program Lead(s); - Serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs- Oversee CRO/vendor selection, budget/contract negotiation, and supervision of performance - Review and approve of key monitoring documents/plans, decisions and actions- Review and endorse relevant study plans, as applicable- Review protocol deviations to support the identification of trends across sites and/or the study- Document monitoring issues, risks, decisions and implementation of appropriate mitigations - In partnership with DM, review and pressure test all database timelines and plans- Ensure studies are “inspection ready” at all times- Represent the COM role in functional initiatives or working groups- Help with onboarding and mentoring of new or junior COMs

Clinical Operations- Lead operational strategy and execution of multiple Phase 1-3 clinical trials from concept to CSR- Drive alignment, collaboration and accountability for cross-functional teams- Develop timelines and execute study to agreed timelines- Develop and approve study plans and documents- Provide operational expertise for protocol, regulatory submissions/responses and CSR - Track enrollment compared to study projections, develop mitigations and contingencies - Manage project resourcing needs and establish personnel contingency plans- Accountable for status reports to Governance, Leadership and Project Team - Manage risk per ICH E6 (R2)- Present at IMs, KOMs, Governance and Bid Defense Meetings- Ensure TMF is inspection ready- Provide training and mentorship to CTMs, CPS and cross-functional project teamsCRO & Vendor Management- Oversee selection- Interview and approve PMs, CMs and CRAs- Negotiate and approve budgets, SOWs, CNFs and COs- Primary point of contact and escalation- Ensure adherence to agreed budget and timelines per SOWs- Review and approve invoicesStudy Budgets- Estimate preliminary trial costs - Request and maintain governance approval throughout life of trial- Manage budgets and timelines for clinical trials- Accountable for external spend and alignment with FinanceSite Management- Identify potential sites, investigators and project enrollment rates- Oversee study feasibility and site selection activities- Approve investigators for trial- Develop good working relationships with KOLs- Ensure adherence to GCPs, SOPs and study protocols- Provide guidance, training oversight to CRA, CTM and CPS teams- Oversee SQV, SIV, IMV and COV activities, review CRA trip reports- Train sites and CRAs on protocols and trial processes Data Management- Approve CRF, CCGs, eCOA/RTSM Specs, eDiaries, DEPs and DMPs- Approve UAT and systems go-live- Oversee data cleaning, transfers, IAs and DB locks

Manage clinical trials from study concept to CSR, including:-Designing trials in collaboration with regulatory, scientific, and commercial stake holders-Authoring/approval of protocols, RFPs and study plans-Driving collaboration and accountability between key internal and external stake holders-Developing and managing timelines for reporting to Sr. Management-Evaluating and approving selection of CROs, vendors and investigators -Overseeing, tracking and reporting on CRO and vendor performance-Financial forecasting, oversight and reconciliationContribute to authoring of Regulatory submissions: NDAs/sNDAs, MAAs, Type II Variations, Modification Requests, Requests for Scientific Advice and arguments to support extrapolationOversee the execution of Phase 3 studies according to CFR, GCP guidelines and local regulations Develop Risk Management Process in accordance with ICH E6 (R2), including development of Risk Register/Risk Assessment Categorization Tool (RACT) and appropriate mitigations/contingenciesCollaborate with Regulatory and Commercial teams during study design and CSR developmentManage/present at Investigator Meetings, Operational Governance and Bid Defense MeetingsTrain CROs, vendors and cross-functional team members on protocols, IMP and trial processes Develop and approve eCRFs, CCGs, SAP, TLF Shells, RTSM/eCOA Specs, and vendor/project plansCoordinate data cleaning and review for interim and final database locksEnsure Regulatory, Clin Sciences, Medical Affairs, Commercial, QA, Stats, DM, PVD, CTS and Pharmacology are fully informed and contribute as required to the trial programCollaborate with Pharmacology to develop new bioanalytical methods to support trial needsDevelop and manage financial budgets and timelines for clinical trialsReview and approve vendor and CRO invoicesNegotiate and approve CRO and vendor budgets, Change Notification Forms and Change Orders

Manage clinical trials from study concept to CSR, including:-Designing trials in collaboration with regulatory, scientific, and commercial stake holders-Authoring/approval of protocols, RFPs and study plans-Driving collaboration and accountability between key internal and external stake holders-Developing and managing timelines for reporting to Sr. Management-Evaluating and approving selection of CROs, vendors and investigators -Overseeing, tracking and reporting on CRO and vendor performance-Financial forecasting, oversight and reconciliationContribute to authoring of Regulatory submissions: NDAs/sNDAs, MAAs, Type II Variations, Modification Requests, Requests for Scientific Advice and arguments to support extrapolationOversee the execution of Phase 3 studies according to CFR, GCP guidelines and local regulations Develop Risk Management Process in accordance with ICH E6 (R2), including development of Risk Register/Risk Assessment Categorization Tool (RACT) and appropriate mitigations/contingenciesCollaborate with Regulatory and Commercial teams during study design and CSR developmentManage/present at Investigator Meetings, Operational Governance and Bid Defense MeetingsTrain CROs, vendors and cross-functional team members on protocols, IMP and trial processes Develop and approve eCRFs, CCGs, SAP, TLF Shells, RTSM/eCOA Specs, and vendor/project plansCoordinate data cleaning and review for interim and final database locksEnsure Regulatory, Clin Sciences, Medical Affairs, Commercial, QA, Stats, DM, PVD, CTS and Pharmacology are fully informed and contribute as required to the trial programCollaborate with Pharmacology to develop new bioanalytical methods to support trial needsDevelop and manage financial budgets and timelines for clinical trialsReview and approve vendor and CRO invoicesNegotiate and approve CRO and vendor budgets, Change Notification Forms and Change Orders

Cross-functional Subject Matter Expert & BIMO Lead for FDA inspection readiness, including: -Site inspection readiness-Site Monitoring-IMP Develop IMP training materials for Commercial and Medical Affairs organizationsSupport rescheduling of IMP from Schedule 1 to Schedule 5Train investigators and study teams on transition of research patients from IMP to commercial drug, following commercial launchCoordinate collaboration between Clinical and Commercial organizations during transition of research patients from IMP to commercial drug, including support of insurance reimbursementReview CRA trip reports to ensure adequate content, CRA performance and adherence to Clinical Monitoring Plan and regulatory requirementsManage multiple database locks, including data cleaning and review of data listingsVerify that essential regulatory documents are complete and correct for drug release Review and approve trial documentation, including study plans, informed consents, etc. Create, customize, review, and configure, site-specific or study-related documents as delegated Prepare and submit IRB/IEC applications and coordinate responses to IRB/IEC questionsPrepare, negotiate and support execution of CTAs and budgets, including amendmentsApprove invoices and coordinate budget forecasting with Finance Ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, GW SOPs, other GW training requirements, and study specific procedures and training

-Considered an expert in all aspects of clinical monitoring-Member of the clinical trial cross-functional team-Train/mentor & provide support to CRAs/CPMs, Investigators, site personnel & ensure compliance with GW SOPs, Protocol, FDA, ICH GCP, DEA, MHRA & EMA requirements-Collaborate with Head of Clinical Monitoring & Core Project Team to identify, prevent & resolve training issues with CRAs/sites-Conduct CRA Oversight Visits, evaluating CRA performance, compliance, ICH GCP knowledge in practice & develop/implement CAPA, as needed-Support multiple project teams as needed in the areas of Investigator recruitment/evaluation, IMP accountability, data monitoring/collection & overall site monitoring/management activities-Assist Head of Clinical Monitoring & CRA Management Team with field operations initiatives & participate in the development/presentation of CRA/CPM training & on-boarding-Contribute to CRA team through participation in special assignments, technical training, process assessments & development of monitoring templates/tools-Prepare/review study documentation (e.g. - Protocol, CRF, ICF/IAF, Monitoring Guidelines, SDV documentation & Pharmacy Manuals)-Assist CRAs/CPMs/sites with resolution of difficult/challenging project issues-Support audit/inspection preparation & CAPA development/implementation-Organize training sessions, as required (e.g. for CRA/CPM Meetings & IMs)-Contribute to writing/review of SOPs & QC of clinical documents -Perform all duties required by Senior CRA

-Perform site management activities, including all required activities for ISEVs, SIVs, RMVs & COVs -Perform RMVs including SDV of CRFs, query resolution, essential document maintenance & proper receipt, storage, dispensing, accountability & return of IMP & clinical study materials-Ensure the integrity of clinical data & adherence to applicable regulatory guidelines & ensure the rights, safety & wellbeing of clinical trial subjects are maintained-Establish & maintain regular contact with Investigators, vendors & trial sites to ensure compliance with applicable regulations & the protocol-Assist in study feasibility analysis & planning, country assessment, site identification & subject recruitment & retention-Coordinate start-up activities, including site selection, document collection, review of essential documents, local translations of essential documentation & local & central IRB/IEC submissions-Conduct initial financial negotiation with sites & coordination of study payments-Provide training of clinical trial study staff at SIV on all study procedures & provides updated training throughout the duration of the study-Review AE & SAE reports & ensures sites are reporting events appropriately & in a timely manner-Ensure site compliance with trial protocol, ICH GCP & applicable local regulations prior to, during & following site visits. Works with site personnel & study team to prevent, identify, address & resolve issues using appropriate CAPAs-Assists with planning & coordination of IMs, including attendance & participation-ACRP - Certified Clinical Research Associate (CCRA)

-Responsible for monitoring all types of clinical trials; assures Investigator integrity and compliance with all study procedures-Assures compliance with local regulations, CFR/ICH and GCP guidelines, and Company and Sponsor SOPs-Performs management of study site activities to ensure the integrity of clinical data and adherence to all SOPs and Project Specific Operating Procedures-Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and TMF Plan-Assures timely reporting of AEs/SAEs and protocol violations-Ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials-Assures timely completion and submission of CRFs and DCFs according to the CMP and/or DMP-Participates in TMF and on-site audits as requested and responds to findings without oversight-Provides clinical and technical support for CRA I, II, and III and administrative staff, including completion of training and sign-off visits-May assume the role of a Lead CRA (LCRA)

•Manage and coordinate all clinical aspects of multiple Phase II, III and IV Trials•Primary point of contact for Sites, CRAs ,Sponsors, Vendors and Internal Project Team Members•Manage and oversee CRA, CTA, CM, DM, BioStats, IxRS, PRO and Vendor Activities•Coordinate, conduct, supervise, co-monitor and review/approve reports for SQVs, SIVs, IMVs and COVs•Coordinate and present at Bid-Defense Meetings, KOMs, IMs and CRA/Team Training Sessions •Review and revise Proposals, Study Plans, ICFs, Protocols and Study Materials/Manuals•Review, revise and approve CMPs, BRDs, TLFs, CRFs, CCGs, DMPs, DMRs and Edit Checks•Review and approve IDP Checklists for IP Release•Develop and maintain Study Projections and Study Status Reports•Query management, creation and resolution (Paper and EDC)•Train, mentor and supervise CRAs, CTAs and CMs

• Manage and monitor all clinical aspects of multiple Phase I and II Trials• Manage and oversee CRA, CRO, SMO, PRO and Vendor Activities• Coordinate and conduct SQVs, SIVs, IMVs and COVs• Coordinate and present at Kick-Off Meetings, Investigator Meetings and CRA Training Sessions • Develop, review and revise ICFs, IBs, Protocols and AE/SAE Narratives • Review and revise Tables/Listings/Figures, CSRs, CRFs, CCGs, BRDs and Edit Checks• Conduct Critical Field Review and First/Second Pass Data Entry• Develop and maintain study enrollment projections and study status spreadsheets• Query creation and resolution (Paper and EDC)• Interview, train and mentor new employees and clinical project team members

• Conduct co-monitoring visits • Organize and present at Investigator Meetings, Bid Proposals, Kick-Off Meetings and CRA Trainings• IRB submissions and management (Central and Local IRBs)• Essential document collection and review prior to the release of IP• Site selection and protocol feasibility• Audit preparation and resolution of audit findings• Co-author of multiple Clinical Monitoring Plans• Manage Trial Master File and Investigator Site Files • Create and maintain study enrollment projections, study status spreadsheets, enrollment logs and protocol deviation/violation logs • Manage investigator payments• Prepare essential documents, study materials and training materials for investigators, clients and the clinical project team• Interview, train and mentor new employees and clinical project team members

• Pharmacy management, training, supervision and long-term planning• Legal/audit compliance and resolution of audit findings• Certified Pharmacy Technician (CPhT)• Inventory management ($500k+) and Book keeping ($1 million/month)• Recruit, hire, staff, train, schedule and provide constructive feedback/discipline for 25-30 employees

• Development and maintenance of study protocols• Participant recruitment, screening and monitoring (150+ participants)• Development and administration of informed consent • Multi-phase/multi-session assessment and treatment (up to 5 hours/participant)• Data entry and analysis• Training, coaching and supervision of 5-8 assistants• Submissions to University IRB