Download - 2017 Projects Kenneth Wu
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
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
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
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
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
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