KIMBERLY SUE CLARKE
* ******** ****, *********, **. 01748
C: 508-***-**** **********@*****.***
PROFESSIONAL PROFILE
Performance-driven expert focused on building relationships with internal and external partners, establishing and exceeding short and long term goals, with exceptional abilities as global clinical projects coordinator to execute and motive team during pre-clinical, medical affairs, clinical, and regulatory programs. Recognized and researcher of scientific, biomedical, biotechnology & clinical information, who communicates findings, knowledge & data with cross-functional teams, including R&D, and global thought leaders. 20+ years of proven leadership in clinical and therapeutic oncology/hematology treatment with patient focused care while maximizing efficiencies. Injects vision & passion for medical & biotech advancements to champion new health ventures and medical modalities for treating all phases of cancer, rare disease, unmet needs, Leverages engaging personality, superior managerial skills, written and verbal communication intelligence, and strategic leadership to influence.
SELECTED ACCOMPLISHMENTS
• GLOBAL CLINICAL PROJECTS DIRECTOR responsible for overseeing the planning, coordination, and execution of all phases of clinical trials within assigned therapeutic area(s)
• CLINICAL OPS EXPERT focused on clinical development team: project and product management
• SIGNIFICANT clinical and therapeutic experience in Oncology/Hematology; CAR T-Cell Therapy; NEX T; Targeted Therapies
(Biomarkers), Immuno-Oncology (Checkpoint Inhibitors), RNA Interference, (RNAI) THERAPY; ANTISENSE TECHNOLOGY; STEM CELL TRANSPLANT; BONE MARROW TRANSPLANT, DRUG DEVELOPMENT, DRUG/DEVICE DEVELOPMENT, GAS/DEVICE DEVELOPMENT PROCESSES
• CO-FOUNDER OF biotech company specializing in drug/gas and device innovative solutions to address unmet medical needs in oncology; immunology; neuroscience; infectious diseases; transplant
• PARTNERED with Sir Peter Medawar Prize scientist supporting HO-1 as a protective gene
• COLLABORATED with world renowned scientist who pioneered first bone marrow transplant
• SELECTED on a continual basis to network all internal & external global partners focused on addressing the unmet needs and complex medical challenges of patients with important, but less well-understood diseases PROFESSIONAL EXPERIENCE
CELGENE GCO-GLOBAL CLINICAL DEVELOPMENT OPERATIONS, GCRDO-GLOBAL CLINICAL RESEARCH & DEVELOPMENT ORGANIZATION SUMMIT, NEW JERSEY
MARCH 2019 – PRESENT
GLOBAL SENIOR PROGRAM MANAGER OF EARLY PHASE CAR T-CELL THERAPY (NEX T PROGRAM) PHASE 1, FIRST IN HUMAN
Principal Responsibilities/Project Strategies:
• CAR T cell therapy utilizes autologous T cells from a patient that have been modified with a chimeric antigen receptor (CAR). 1
• CARs are composed of an antigen-recognition domain, which is most often a single-chain variable fragment derived from a monoclonal antibody or an antigen-binding fragment, fused to signaling domains designed to redirect T cell function.
• CARs can allow the modified patient T cells to recognize tumor-cell antigens and initiate an immunologic response.
• Tumor cells are either targeted directly by CAR-modified T cells or through recruitment of other components of the immune system.
Rationale for Clinical Development:
• Preclinical studies have demonstrated the activity of the CAR T cell approach. Various CAR T cell therapies are currently being investigated for the treatment of hematologic malignancies and solid tumors.
• Celgene is developing CAR T cell therapies, including a collaboration with Juno Therapeutics in next generation of CAR T-Cell Therapy (NEX T)
Principal Responsibilities/Project Strategies:
Operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs. May include leading one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams. Financial Planning and Management:
•Development/management/reconciliation of overall study budget(s)
•Development/management of vendor scope of work (SOW) per contract, quality, and budget
•Review/approval of vendor invoices and management of accruals and SOW changes. Project Management:
•Oversight of study execution
•Oversight of clinical monitoring quality and adherence to established processes and plans
•Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] •Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
•Maintenance/updating of data as appropriate in project management tools including CTMS
•Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans Study Planning and Conduct:
•Facilitation of country and site feasibility/selection processes
•Operational input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
•Oversight of investigational product [IP]supply forecasting/management and study-level IP reconciliation [in collaboration with IMSC]
•Development of the subject recruitment/retention strategy and related initiatives Page2
•Participation in clinical service provider (vendor) selection, specification development, and management/oversight
•Oversight of TMF set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance
•Development/coordination of study training for study team, investigational sites, and vendors
•Oversight of required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC approvals/notifications
•Participation in Serious Adverse Event (SAE)reconciliation process
• Drive activities for efficient data cleaning and database closure.
• Lead close out activities for sites and vendors.
• Oversee CSR process to ensure timelines are being adhered to and functions are aligned. o Coordinate provision of operational appendices to CSR
• If required, address audit actions.
Relationship Management
•Development/maintenance of collaborative relationships with: internal partners/stakeholders including Clinical Research, Project Management, CR&D Operations, and Affiliates external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers. Able to act as a regional trial manager supporting a lead if required AKCEA THERAPEUTICS
CAMBRIDGE, MASSACHUSETTS (CONSULTANT)
SEPTEMBER 2017 – FEBRUARY 2019
CLINICAL PROJECT MANAGEMENT/GLOBAL CLINICAL OPERATIONS Principal Responsibilities/Project Strategies:
• Collaborate with Clinical Development in the strategic planning, management, and execution of Phase I through Phase IV trials. Define the medical strategy governing Investigator Initiated Research and oversee the proposals review and grants process
• Contribute to the building of a strong alliance; ensure the program(s) fulfill their partnership responsibilities and effectively communicate with the joint committees
• Align and execute field activities in support of Medical Affairs Strategic plan
• Identify and communicate research gaps, opportunities, and relevant field intelligence to inform medical strategy
• Accelerate recruitment efforts and enhance subject retention at targeted clinical trial sites
• Leverage expertise to enhance and broaden knowledge among field medical team colleagues Identify and forge professional peer-to-peer relationships with International, Regional, and Local key opinion leaders
• Attend medical/scientific meetings to represent Medical Affairs with KOLs and other HCPs, strengthen individual expertise as well as capture, integrate, and summarize information of strategic interest
• Appropriately facilitate submission of Medical Education grants and Investigator-Initiated Research
• Support cross-functional colleagues (e.g. commercial, clinical operations, clinical development), in appropriate activities
• Actively participate in relevant team meetings, organizational activities, and HQ-driven medical affairs and clinical research activities (e.g. advisory boards, publication planning, investigator meetings)
• Utilizing unique skills, assume lead responsibility for project work identified by Medical Affairs leadership and/or organizational priorities
• Communicate and coordinate project timelines for all required project functional service areas, client and third-party vendors, as required.
• Accountable for developing and maintaining project metrics, timelines, and deliverables.
• Hold team accountable for deliverables and timelines; in still appropriate sense of Urgency
• Foster a positive environment; mentor and develop a cross-functional team, create excitement and affiliation, sustain morale when tough times arise
• Local, regional and international travel
MERRIMACK PHARMACEUTICALS
CAMBRIDGE, MASSACHUSETTS (CONSULTANT)
APRIL 2017 – SEPTEMBER 2017
CLINICAL PROJECT MANAGEMENT/GLOBAL CLINICAL OPERATIONS Principal Responsibilities/Project Strategies:
• In a matrix environment, manage, lead and motivate the assigned cross-functional project team, facilitating the team’s ability to fulfill their responsibilities in accordance with project contracts, contract amendments and company policies, procedures and SOPs
• Develop and maintain a close relationship with the clinical study management teams to ensure company satisfaction, operational and service excellence.
• Ensure successful design, implementation, tracking and maintenance of project plans for assigned projects
• Working with the company functional areas, determine appropriate revenue forecasting and revenue recognition based on project plan, budget, and contract deliverables
• Proactively track budget and scope changes, obtaining necessary client approvals for change in scope of work. Initiate and follow up on change order/contract amendment activities
• Review, approve and follow-up on project invoices Page3
• Working with company functional department leads, determine and manage project resource needs and utilization according to project contract and contract amendments
• Collaborate with and provide scientific and clinical support and training for internal departments, including Marketing, Sales, Clinical Operations, Research, Corporate Development, Managed Care, and for external audiences, such as patient advocacy groups, physicians, other health care providers, and formulary and clinical guidelines decision makers
• Provide day-to-day clinical and medical guidance while working closely on joint projects with the medical affairs team and other departments within the organization (clinical development, commercial, etc.). Projects include medical affairs studies, scientific congress/conference strategy and planning, advisory boards, development of educational goals for medical education, publications, field force training, review of medical information standard response letters, health economics and epidemiology analyses, and marketing/policy related projects
• Identify, develop, and maintain relationships with thought leaders in the fields of hematology, oncology, and blood and marrow transplant. Collaborate with thought leaders to develop clinical therapeutic concepts that warrant additional study, identify messages for scientific communications based on preclinical or clinical data, and gain feedback on strategies to support the scientific and medical affairs plan for marketed products
• Communicate and coordinate project timelines for all required project functional service areas, client and third-party vendors, as required
• Accountable for developing and maintaining project metrics, timelines, and deliverables.
• Hold team accountable for deliverables and timelines; instill appropriate sense of urgency
• Function as primary liaison between client, third party vendors and company project team for project issues, including initiation, planning, execution and close-out of assigned studies
• Proactively communicate to appropriate company management, client and third-party vendors as warranted about project progress, potential issues and appropriate recommendations for issues resolution, i.e. Global Project Management Processes
(GPMP),
• From a global perspective, in concert with operational teams, identify and maximize opportunities to secure repeat business, remove or mitigate risks, blockages, and issues in existing projects with Strategic Alliances. Create action plans, in concert with operational teams, from a Strategic Alliance perspective, to minimize inefficiencies when recovery from a client is not possible
• Provide scientific input into manuscripts for publication and presentation at scientific meetings
• Participate in appropriate cross-functional and cross-company Clinical and Commercial teams to inform brand strategies and tactics and represent Medical Affairs
• Collaborate with Clinical Development in the strategic planning, management, and execution of Phase I through Phase IV trials. Define the medical strategy governing Investigator Initiated Research and oversee the proposals review and grants process
• Provide clinical and scientific support in responding to inquiries from healthcare professionals and managed care organizations
• Develop the overall program vision including scientific, clinical, and pre-commercial strategies and plans through BLA and commercialization
• Lead the strategic planning, decision-making, and risk assessment processes to deliver quality outcomes
• Ensures rigorous scientific debate and robust data quality through effectively gathering team, subject matter, and cross functional feedback
• Possess a basic understanding of all functions represented on the team in order to ask probing questions and assess risk
• Ensure cross-functional alignment within the project team and with corporate/Management Team strategy, proactively communicate throughout all phases of program strategy and execution
• Manage all aspects of program timelines and deliverables, anticipate risks and proactively communicate potential impacts and mitigation plans to the Management Team
• Represent the program to executive stakeholders including the Board of Directors
• Contribute to the building of a strong alliance; ensure the program(s) fulfill their partnership responsibilities and effectively communicate with the joint committee
CHILTERN INTERNATIONAL/KITE PHARMA
BOSTON, MASSACHUSETTS/ SANTA MONICA, CALIFORNIA
FEB. 2016 – APRIL 2017
SENIOR PROJECT DIRECTOR/PROJECT MANAGEMENT/CHILTERN ONCOLOGY “KITE PHARMA”, ( ZUMA 1 – ZUMA 4) CAR T – CELL THERAPY SANTA MONICA, CALIFORNIA
PRINCIPAL RESPONSIBILITIES/PROJECT STRATEGIES:
• Proven clinical development strategist with experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept and first-in-human studies
• Lead project teams to strategically design and implement hematology/oncology clinical studies
• Write protocols, investigator brochures, clinical study reports and review clinical trial documents
• Conduct investigator meetings and lead site initiation visits with clinical trial investigators
• Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
• Translate findings from research and nonclinical studies into clinical development opportunities
• Interact with clinical investigators and thought leaders
• Provide clinical leadership and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial)
• Provide strategic support and work closely with Medical Science Liaisons (MSLs), participation and insight in MSL activities, such as KOL interactions
• Provide medical support as needed on company and non-company sponsored studies, non-interventional studies and investigator sponsored studies
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• Provide medical monitoring to multiple oncology clinical trials
• Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
• Work with internal pre-clinical scientists, translational scientists, business and commercial organizations in a cross functional manner
• Work in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs
• Knowledge of carrying out hematology/oncology clinical trials, including knowledge of hematology/oncology treatment options
• Strategic leadership and tactical skills, excellent initiative and judgment, and demonstrated ability to positively represent the goals
• Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators
• Demonstrated ability to work well in teams in a cross functional manner
• Ability to communicate and work independently with scientific/technical personnel
• Ability to think critically, and demonstrated troubleshooting and problem solving skills
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities
• Ensure successful design, implementation, tracking and maintenance of project plans for assigned projects
• Working with the company functional areas, determine appropriate revenue forecasting and revenue recognition based on project plan, budget, and contract deliverables
• Proactively track budget and scope changes, obtaining necessary client approvals for change in scope of work. Initiate and follow up on change order/contract amendment activities
• Working with company functional department leads, determine and manage project resource needs and utilization according to project contract and contract amendments
• Communicate and coordinate project timelines for all required project functional service areas, client and third party vendors, as required
• Accountable for developing and maintaining project metrics, timelines, and deliverables
• Ensure project documentation is complete, current, stored appropriately and audit ready
• Function as primary liaison between client, third party vendors and company project team for project issues, including initiation, planning, execution and close-out of assigned studies
• Proactively communicate to appropriate company management, client and third party vendors as warranted about project progress, potential issues and appropriate recommendations for issues resolution, i.e. Global Project Management Processes
(GPMP)
• Organize regular face-to-face and remote liaisons with Strategic Alliances and Clinical Study teams to review and discuss risks, status of and opportunities for awarded projects, to ensure delivery, profitability, quality, and client satisfaction
• Ensure project teams within Strategic Alliances have relevant strategies in place to maintain bid profitability through thorough review of financial projections, estimates of cost to complete, and timely execution of contract modifications for awarded projects by reviewing lessons learned
• Function as the first point of escalation (internal and external) for issues and conflicts with Strategic Alliances. Liaise with key stakeholders to ensure prompt resolution, identify lessons learned, and leverage learnings to mitigate future issue recurrence CROMSOURCE North American HQ, CAMBRIDGE, MA
CROMSOURCE EU HQ, HEAD OFFICE, VERONA, ITALY
Sept. 2014 – FEB. 2016
DIRECTOR OF GLOBAL CLINICAL CLINIC OPERATIONS & RESEARCH, CAMBRIDGE, MA, VERONA, ITALY PRINCIPAL RESPONSIBILITIES/PROJECT STRATEGIES:
• Global Project Director (GPD) who drives the development programs and acts as project manager who leads the Global Development Team and Early Development Team
• Hands on role in the development of the Cambridge, Massachusetts office (Cromsource’s first US location)
• Responsible for management and delivery of the integrated operational plan, encompassing the strategy for the development of drugs and devices, and ensuring alignment across strategic, operational and tactical plans
• Leader of the Operational Sub-Committee of the Global Development Team or equivalent forum on Early Development Team and manages the operational plan and deliverables of the project so that they are achieved on or ahead of schedule, on budget, and support the target product profile, business deliverables, and/or key decisions required
• Drives development of global project level goals that contribute to the overall goals of R&D
• Leads the development of an Integrated Development Plan, encompassing the overall R&D strategy for the medicine and ensuring alignment between the overall product vision, strategy, and goals. (Oncology/Hematology, Phase I – IV, Acute AML, Phase III)
• Partners with team functional leads/delegates to ‘pressure-test’ assumptions and integrate planning across development into the overall project plan, (e.g. Medical Sciences, Regulatory, Clinical Operations, Biostatistics, Technical Operations, Commercial, Global Medical Affairs (GMA), Toxicology, Research functions, etc.) Page5
• Able to define the interdependent deliverables and ensures that quality, risk, cost, time are managed within the overall approved plan to drive delivery of project milestones and objectives on time and on budget
• Leads and negotiates project-level budgets and resource plans on behalf of the team. Proactively manages the project budget and resource demand including investment buy-ups/buy-downs in partnership with the Team Leader, Finance, and Functional lines
• Drives execution of the project in a manner that achieves delivery performance goals/objectives and the agreed plan without compromising project deliverables or relationships
• Leads the identification of operational and project/program issues for discussion with appropriate Team Leadership. Drives resolution across the team through options assessment, effectively documenting decisions and the rationale
• Develops options and solutions to complex project risk problems, providing guidance to leadership including trade-off and implications assessment (value, risk, cost, time) to the overall drug development approach, approval strategy, and launch
• Defines and aligns project messages and major communications (internal and external) with the Team Leader and team. Responsible for ensuring effective, accurate and timely communication of project information in order to facilitate development of action options and team recommendations to governance
• Strong track record in executing effective project management in cross-functional drug development teams or clinical, regulatory, medical functions, pharmaceutical sciences/technical operations in the biopharmaceutical industry
• Ensures quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices, collaborates with members of Clinical Trial Team(s) to develop clinical trial protocol summary, protocols, Informed Consent Form/Patient Information and other trial documents (e.g. CRF, Monitoring Guidelines, data cleaning plans, statistical analysis plans, vendor contracts)
Participates in clinical summary document generation (e.g. INDs, NDAs) and other submission activities for study specific issues, results or analysis and description of individual cases COASTAL POINTE THERAPEUTICS INC.
BOSTON, MASSACHUSETTS/ VIENNA, AUSTRIA/NAPLES, ITALY AUG. 2011 – SEP. 2014
VP, CO-FOUNDER, DIRECTOR OF GLOBAL CLINICAL
OPERATIONS & RESEARCH
PRINCIPAL RESPONSIBILITIES/PROJECT STRATEGIES:
• Innovator, significantly impacting the standard of care from a humanitarian and economic perspective, addressing unmet needs
• Developer, of the use of new drugs and therapies to treat acute inflammatory diseases, focused on organ transplantation; greatly increasing organ quality and availability while significantly improving recovery & reducing patient hospital stay
• Interacts with regulatory to assist and review in global trial submission documents. Assist in the preparation and review of documents/ correspondence for regulatory agencies (e.g., FDA Reports, response to inquiries, data submissions). Participate in the preparation of NDAs, etc.
• Development and execution of pre-clinical and clinical trial (Phase I-III) Oncology, Transplantation, Post-Operative Ileus, Sepsis, Cerebral Malaria, (Africa)
• Transplantation: Phase III – IV
• Treatment: Inhaled Carbon Monoxide (iCO) Oncology/Hematology, Solid Tumors
• Drug Delivery Device System: The therapeutic use of iCO is based on validated cyto-protective and anti- inflammatory properties discovered by CPT
The iCO technology received FDA approval in 2008 for Fast Track Status and Orphan Drug Designation for the treatment of delayed graft function (DGF) in kidney transplantation. Clinical studies are in Phase IIa;
• Supported Study Leads (Clinical Operation Leads & Clinical Project Managers)
• Clinical Operations Expert, Primary Focus: Protocol Review, ICF Review, Vendor Management, Country & Site Specific Essential Documents, US & International Regulatory Status;
• Responsible for managing the full scope of study conduct, including protocol development, interim analysis reports and FDA filings according to all applicable regulations and Standard Operating Procedures
• Hands on role managing projects through the full software development lifecycle and carefully monitoring and controlling through each of the Phases from initiation to closure
• Responsible for preparing documents for study use including clinical protocols, SOP's, literature searches and reviews, case report forms and informed consent documents.
• Train and mentor team of CRAs to ensure that clinical study sites strictly adhere to specific protocols and that sites follow all SOPs and ICH GCP guidelines
• Perform independent monitoring as well as co-monitoring with CRAs
• Ensures project objectives are met within the constraints of project scope, time, cost and required quality.
• Works closely with Product Development and functional teams to define project scope and all required deliverables, activities, activity sequence, Work Break-down Structure (WBS) and work estimates to create a framework for the project schedule.
• End to end project planning including Schedule Development, Resource Planning, Cost Estimating, Budgeting utilizing all internal project management tools.
• Coordinating and communication with project resources including SAP, internal team, stakeholders and vendors on all aspects of project progression/status
• Measures progress and monitoring performance (overall, scope, schedule, costs, quality)
• Proactively manage project stakeholder satisfaction to position and secure customer reference and success story. Coaching
& Mentoring
• Risk Management including issue escalation and resolution
• Post Project Implementation review to document lessons CONTEGO/KURATEK
MANCHESTER, MA & BOSTON, MA
FEB. 2007 – AUG. 2011
SENIOR ASSOCIATE DIRECTOR/CLINICAL TRIAL MANAGER (US AND EUROPE)
• Team Leader of overall operational planning and development of a private Biotech Company conducting human & animal trials with business advisory board based in U.S. with large scientific advisory board throughout Europe; Page6
• Team Lead responsible for product research, writing of protocols, development and execution of clinical trials (Phase I-III): trial management, data management, monitoring and CRO management; intimately involved with budgeting, selecting & inspecting clinical trial sites, monitoring, review of progress reports, educational grants, research grants, patents, NIH, and FDA; Management of studies from initial writing of protocol to database lock and NDA filing
• Coordinate the distribution of IND safety reports to clinical sites and IRBs
• Large Animal, Phase I and II Studies: Pig transplant studies best mimic the human condition. Pre-Clinical - Phase I Large Animal, Phase I and II Studies: Ischemic Reperfusion Injury (IRI)
• Proof of Concept - Phase I: Sepsis
• Pre-Clinical - Phase I-II: Oncology/Hematology, Solid Tumors
• Stem Cell: (Leukemia), Hemoglobin SS, Hemoglobin SC, (Sickle Cell)
• Primary Liaison, contact person, and meeting coordinator to major Pharmaceutical Companies, Nutraceutical Companies, consultants, medical personnel, legal representatives, and patent attorneys Clinical Trial Management Systems:
• CASTOR EDC, IWRS, IRT, MS Office, Bracket, Oracle, Medidata Rave, Share Point, Web Remind, Phlexglobal, Navision, MS Project, FERMI, Trial Share, Insight, Spotfire, Medrio, ClinCapture, Smartsheet, MasterControl Clinical Suite, Intrinsic CTMS, Catalyst eClinical, RAVE X
MINNEAPOLIS RADIATION ONCOLOGY, MINNEAPOLIS, MN
FEB. 1991 – JAN. 2007
SENIOR RADIATION THERAPIST/ DIRECTOR OF CLINICAL OPERATIONS
• Senior Radiation Therapist, with an extensive knowledge of: 1.) Varian TrueBeam STx with high-definition MLC (HDMLC) and flattening-filter free (FFF) beam modes with dose rates up to 24 Gy/min
2.) 4 multi-energy Varian Clinac linear accelerators equipped with RapidArcTM, Millennium MLCs, portal imaging, and kV- OBI CBCT systems for image-guided radiotherapy