2017 Projects Kenneth Wu
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Similar a 2017 Projects Kenneth Wu
Similar a 2017 Projects Kenneth Wu(20)
2017 Projects Kenneth Wu
- 1. Kenneth Wu, LLC Page 1 of 6 Contracting and Consulting Projects Client Role Indication Deliverables Results Biopharma Company Clinical Consultant Anti-infective TMF Vendor Proposals and Recommendation • Qualified three Trial Master File (TMF) vendors in six weeks. • Defined scope of services, time to implement and costs per study and multi-study discounts Biopharma Company Clinical Consultant Anti-infective Preparation for BIMO audit • Prepared clinical TMF for BIMO audit. • Preparing scripts for subject matter experts: FAQ by BIMO inspector Combination device/drug Start-up Clinical Consultant Ophthalmic Update Sponsor Clinical SOPs Updated 13 Clinical SOPs: ICH GCP and FDA GCP compliant in three weeks Software Start-up Subject Matter Expert Clinical Operations • Software Design Concepts/prototype • Training materials • Blogs about functionality • Prototype Clinical Operations Dashboards Embedded into 2.x Update • Developed Training Materials for Developers and End Users • Blogged about software function and features Global Consulting Company Subject Matter Expert Clinical Operations Trial Designs for Biotech Discussed trial designs, such as cross over and adaptive trial designs, to streamline early development of new biologics. Biopharma Company Lead Reviewer on Trial Master File (TMF) Asset Due Diligence on Acquisition Report on Completeness and Content of TMF Produced a report with assessment of TMF in one week, three weeks ahead of schedule. • Led team of five reviewers to assess TMF for potential acquisition of drug Global Consulting Company Subject Matter Expert Clinical Operations Recommendations on CRO service opportunities Provided expert opinion on clinical best practices to service organization Global Consulting Network Subject Matter Expert Process Management Consultation to Global Service Companies Provided detailed insights to service companies on sponsor expectations
- 2. Kenneth Wu, LLC Page 2 of 6 Contracting and Consulting Projects Client Role Indication Deliverables Results Dermatology Site Clinical Consultant Dermatology Project Management System Organized Electronic Clinical Central Files • Organized historical and current clinical files • Prepared for sponsor audit Dermatology Site Clinical Consultant Dermatology Update Site SOPs Delivered sample SOPs to client • Piloted new SOP and staff training Dermatology Site Clinical Consultant Dermatology Prepared for Sponsor Audit Organized files for anticipated sponsor audit of processes and files Conference Organizer Conference Moderator Executive Roundtable Moderate topical discussions • Delivered meeting agenda and minutes following conference • Led discussion on expert topics File Database Start up Expert Consultant Smart Form Applications Recommendations of Potential Sponsor Clients Helped start up target potential sponsor company clients Global CRO Start up CRO Representative CRO Expert Introduced specialty CRO to sponsor Matched sponsor requirements to start up CRO with access to patients Global Medical Device Company Consultant Resource Forecasting Analyses and Recommendation on Forecasting Resources Recommended best practices in managing and forecasting clinical resources • Recommended software to benchmark forecasting Software Company Subject Matter Expert Contracts and Budgets White papers on clinical contracts and budgets Two publications on clinical contracts, budgets and forecasting Global CRO Start up Consultant Clinical SOPs Clinical SOPs compliant with ICH GCP Completed new set of clinical SOPs • Completed 20 SOPs in 6 weeks • Prepared for vendor qualification inspection Global Medical Device Company Consultant Resource Forecasting Analyses and Recommendation on Forecasting Resources Recommended best practices in managing and forecasting clinical resources • Recommended software to benchmark forecasting
- 3. Kenneth Wu, LLC Page 3 of 6 Contracting and Consulting Projects Client Role Indication Deliverables Results Training Services Instructor Contracts and Budget Two day training on contracts and budgets management Delivered onsite training to clinical department • Instructed students on basics of contracts • Developed case studies with client company historical records Global Biotechnology Sponsor Clinical Program Manager Oncology Clinical Program Management Led early stage phase I/II oncology trials • Saved $200k and three months on phase II trial • Initiated global phase II oncology trials Medical Device Company Interim clinical operations director Ultrasound Imaging Updated Clinical SOPs Revised SOPs to comply with ICH GCP Streamlined and updated SOPs to be compliant Global Consulting Network Subject Matter Expert CRO Management Consultation to Global Service Companies Provided detailed insights to service companies on sponsor expectations Global Consulting Network Subject Matter Expert Contract and Budget Consultation on best practices Suggested different approaches to contracts and budget management to sponsor company Early Stage Medical Device Company Interim clinical operations director Ultrasound Imaging Selected Clinical Trial Database System Hired Vendor to Provide Electronic/Remote Clinical Trial Database • Prepared RFP for services • Selected best vendor on cost and time Early Stage Medical Device Company Interim clinical operations director Ultrasound Imaging Mentored Clinical Research Associate (CRA) Trained newly hired CRA • Trained on protocol and Case Report Forms • Organized clinical central files Medical Device Start up Regulatory/ Clinical Consultant Ophthalmology: Age Related Macular Degeneration (AMD) Reviewed and commented on Investigational Device Exemption (IDE) Submission Provided comments on IDE • Gave perspective on operational feasibility • Commented on risk areas
- 4. Kenneth Wu, LLC Page 4 of 6 Contracting and Consulting Projects Client Role Indication Deliverables Results Medical Device Start up Clinical Consultant Ophthalmology: (AMD) Updated Clinical SOPs Revised SOPs to comply with ICH GCP Streamlined and updated SOPs to be compliant Biotechnology Start up Interim clinical operations director Generics: Neurologics Anti-infectives Led clinical strategy to be implemented in India Collaborated with clinical study team in India • Implemented clinical protocols designed in US • Contracted with Indian CROs • Analyzed data collected from Indian CROs Biotechnology Start up Interim clinical operations director Generics Updated Clinical SOPs Revised SOPs to comply with ICH GCP • Streamlined and updated SOPs to be compliant Biotechnology Company Interim clinical operations director Oncology Immunology Recruited director for continuous improvement Created job description for new director • Recruited and filled new position for Vice President of Clinical Operations Biotechnology Company Interim clinical operations director Oncology Immunology Updated Clinical Operations Standard Operating Procedures (SOP) Provided detailed process maps on all updated SOPs • Streamlined SOPs with maps • Used process maps for training Biotechnology Company Interim clinical operations director Oncology Immunology Led Vendor Management Group to Improve Processes Streamlined vendor management processes • Collaborated with legal to reduce cycle times on contracts • Introduced software to determine best budget terms for Clinical Research Organization (CRO) services • Forecasted time and resources for new programs with specialty software. Biotechnology Company Interim clinical operations director Oncology Immunology Enhanced Clinical Trial Management Systems (CTMS) Functionalities Rolled out two system enhancements • Improved end user interface • Added features and functionalities Linked clinical trial timelines to CTMS
- 5. Kenneth Wu, LLC Page 5 of 6 Contracting and Consulting Projects Client Role Indication Deliverables Results Biotechnology Company Clinical Consultant Oncology Immunology Advised Study Team on How to Accelerate Trial Recommended several options to accelerate trial • Increased enrollment at existing high enrolling sites instead of activating new US sites • Resolved barriers to enrolling patients Biotechnology Company Interim clinical operations director Oncology Immunology Initiated Phase II Oncology Trial to Enroll Patients Mentored clinical research associate (CRA) • Proctored CRA on site initiation and site activation • Selected CRO services; from request for proposal (RFP) to awarding contract
- 6. Kenneth Wu, LLC Page 6 of 6 Contracting and Consulting Projects Regulatory Submission Experiences NDA/PMA Role Results NDA (small molecule) Product Subject Matter Expert TMF Expert • Re-organized Trial Master File (TMF) for BIMO Inspection in 4 months • Prepared responses for BIMO inspector for company representative • Collected and organize documents for BIMO inspection • Prepared sites for BIMO inspection • Created and managed digital TMF for clinical module submission • Led selection of vendors to electronic TMF PMA (Class III Device) Study Team Advisor • Coached CRAs on preparing TMF for sponsor inspection • Managed progress of inspection readiness project NDA (small molecule) War Room Leader War Room Trainer • Led BIMO audit war room • Trained and developed war room participants: runner, copiers, subject matter experts, war room managers, schedulers PMA (Class III Device) PMA project leader PMA author/editor/publisher • Led pivotal trial database lock: team of 12 contractors/consultants • Led site inspection readiness • Locked database 24 hours after last patient visit • Authored efficacy section of clinical module • Edited final clinical module • Published and shipped clinical module to FDA