2017 projects kenneth wu

Kenneth Wu, LLC 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


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


Clinical Operations

Recommendations on CRO service opportunities

Provided expert opinion on clinical best practices to service organization

Global Consulting Network


Process Management

Consultation to Global Service Companies

Provided detailed insights to service companies on sponsor expectations



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


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



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



CRO Management

Consultation to Global Service Companies

Provided detailed insights to service companies on sponsor expectations



Contract and Budget

Consultation on best practices

Suggested different approaches to contracts and budget management to sponsor company

Early Stage Medical Device Company


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


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


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


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


Generics Updated Clinical SOPs

Revised SOPs to comply with ICH GCP • Streamlined and updated SOPs to be compliant

Biotechnology Company


Oncology Immunology

Recruited director for continuous improvement

Created job description for new director • Recruited and filled new position for Vice

President of Clinical Operations



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



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.



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




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



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


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

2017 projects kenneth wu

Documents