Lan Fong

Venture Partner

2020 - Current

Member of the Investment Committee, focusing on Health Technology, Medical Device, and Medical Technology.

Final Selection Committee Member, Angel Investor

2020

Founder & Principal Consultant

2015

• Lead global clinical development teams through all phases of clinical trials • Provide operational expertise and leadership to global clinical operations teams • Ensure effective and efficient delivery of all operational aspects of clinical trials • Develop and manage study timelines, resources, budget, risk and quality plans • Develop Protocols, Investigator's Brochures, Informed Consent Forms, and Clinical Study Reports • Manage CROs and all study vendors to ensure delivery against Scope of Work and MSAs • Ensure study adherence to ICH/GCP Regulations, local regulations, and SOPs • Provide operations input on program feasibility, vendor selection, and risk management plan • Conduct site selection visits, site audits, and CRO audits • Conduct CRO selection and all other key study vendor selections • Screen, interview, and assist in selection of key members of the Clinical Operations team • Provide input on SOPs and clinical development plans • Provide program management support, study management, and alliance/partnership support • Global clinical trial experience including North and South America, Europe, AsiaPac, and China

Clinical Development Operations

2011 - 2015

• Manage CRO and Central Lab activities for global Phase 3 study, including negotiation of scope of work, budgets, performance management, and issue resolution • Lead Clinical Study Team and collaborate with cross functional subteams (Regulatory, Contracts, Global Clinical Supply/CMC, DM, IVD/Diagnostics) to enable site activation and patient enrollment • Manage site selection and problem solve barriers to country/site activation and patient enrollment • Plan, prepare, and present at Investigator Meetings and CRO F2F meetings • Lead internal and external development of clinical study documents including, but not limited to study protocols, study specific plans, study processes, study tools, monitoring visit report templates, ICF templates, pharmacy manuals, study manuals, newsletters, and site communications • Review monitoring visit reports, country and site specific ICFs, regulatory packets, and various study tools • Manage finalization of clinical study reports • Collaborate with Global Clinical Supply to forecast and maintain sufficient clinical supplies • Collaborate with regulatory affairs on Clinical Trial Application filings and regulatory agency responses • Collaborate with legal and finance to negotiate study contracts and budgets • Collaborate with data management on the development of CRFs/eCRFs and facilitate timely flow of clinical data • Ensure vendor or internal oversight of EC/IRB/IEC submissions and approvals • Recommend and implement innovative process ideas to impact clinical trials management • Ensure clinical operations activities align with other cross functional activities contributing to the overall conduct of the clinical trial • Provide study-specific direction and mentoring to CTAs and contract CTMs • Develop and review Clinical Operations SOPs and best practices • Lead the Achaogen Culture Team to establish and continuously assess the company culture, core values, and make Achaogen a great place to work

Clinical Trial Manager

2008 - 2011

Drug Development Project Manager

2005 - 2008

• Managed project activities, including team, investigator, and sponsor meetings • Managed the project plan, scope of work, budget, timeline, and schedule of activities • Managed budget and resource assumptions, forecasting, and tracking for monthly reconciliation • Served as sponsor relations manager on project teams • Prepared and reviewed status reports, agendas, meeting minutes, project activity tracking reports, communication plans, risk management plans, and Gantt Charts • Conducted monitoring visits at clinical sites including Site Initiation, Interim Monitoring, and Close-out visits • Trained and mentored Project Coordinators on processes and SOPs • Coordinated regulatory submissions to the FDA, NIH Recombinant DNA Advisory Committee, and Health Canada • Worked with the FDA Project Manager to submit meeting request letters, meeting packages, and meeting minutes • Prepared for and participated in FDA and Health Canada meetings • Created and maintained regulatory submissions log, regulatory correspondence, and regulatory history trackers • Coordinated the compilation and QC of IND, NDA, and Orphan Drug Applications for sponsor companies • Experience in supporting a complete Chemistry, Manufacturing, and Controls (CMC) program from Phase I-III • Assisted in compiling a regulatory strategy and clinical development plan to sponsors in the Pre-IND Phase

English Teacher

2004 - 2005

• Taught beginner, developmental, and proficiency level classes • Developed course plans and implemented plan throughout school semesters

Research Associate

2001 - 2004

• Waggoner Center for Alcohol Addiction Research • Researched the molecular mechanisms of glycine receptors and the effects of receptor mutations • Acquired skills in voltage clamp electrophysiology and site directed mutagenesis

Undergraduate Research Assistant

2000 - 2000

• Researched effects of protein nitration on signal transduction pathways • Acquired skills in western immunoblotting and SDS-PAGE