Lu Hao Email & Phone Number

Shanghai, China

- Function as the matrix leader of the China Opdivo® Lung Development Team (DT) and Reblozyl® DT. Provide strategic leadership to the cross-functional DT including R&D, medical and commercial to ensure robust enterprise level strategy alignment and simultaneous development with US.-Serve as GPT extended member of the two programs and accountable for China program strategy, governance interactions, trial execution, (s)NDA/(s)BLA filing and approval in China.

Shanghai, China

• Function as the Amgen alliance clinical lead, provide sponsor oversight, strategic leadership and enabling operational delivery of clinical trials within various collaborator companies in China. • Proactively assess needs to support China development strategy of portfolio programs. Serve as internal consultant on general China regulatory requirements, competitive landscape and development considerations to ensure utilization of consistent approaches and experience sharing among clinical development programs under strategic collaborations. • Act as point of contact in the context of clinical trial execution, work closely with strategy collaborators and Full-Service-Providers, to drive continuous improvement of the collaboration operating model, govern resource allocation and budgeting, and track clinical trial deliverables.

Shanghai, China

• In addition to leading assigned clinical trial, provide line management oversight to 4 direct reports which comprise of CPAs/aCTLs/CTLs. Assess associate capability, workload and responsibility assignments. Provide on-going coaching and support to associates in performance management and career development. • Involved in alignment discussions with global Early Program Teams (EPTs) and China Global Drug Development (GDD) in brining early stage assets focusing on China prevalent indications. Based on the know-how of China regulatory environment, medical practice and treatment landscape, propose and support the execution of China strategy for such key projects, including site identification, conduct joint medical-operational feasibility and on-going dialogues with KOLs.

Shanghai City, China

Lead a number of high profile global Phase I trials across Novartis early oncology pipeline, including the First-in-Human trial of a First-in-Class compound; novel combination involves IO-IO, IO-small molecule in both solid tumor and hematology malignancies. Key responsibility includes: • Lead the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures. • Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): as author for complex clinical protocols, amendments and related documents; clinical sections of regulatory documents like Investigators’ Brochures, safety updates, IND/NDA submission documents, responses to Health Authorities questions.• In collaboration with the CPL lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations. Prepare and run dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, imaging and biomarker data, to provide consolidated information for dose escalation meetings.• Develop effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related advisory boards. Lead investigators meetings. Lead protocol training meetings and support Country Organizations (COs) in the conduct of regional meetings. Accountable for all internal clinical meetings related to the clinical trial(s).

Shanghai

Taking on increasing responsibilities in global trial management over the years, focusing on HCC and NSCLC. Started to function as independent Study Lead since 2015 and achieved multiple Proof-of-Concept (PoCs) which contributed to the concept of on-going NDA-enabling registration trials.

Shanghai

Shanghai City, China

• Discovered a novel mechanism, by which an epigenetic regulator function as a switch in TGF-β signaling induced EMT. Provided insights into the role and mechanism of epigenetic modulation during tumor progression and metastasis. Facilitated target validation of histone methyltransferases (HMTs) in cancer and drug discovery effort targeting HMTs.• Identified/isolated the cancer stem cell like population with resistance to a panel of oncogenic signaling pathway inhibitors. Characterized the epigenetic properties of the drug resistant cells by microarray study, as well as compound/si RNA screening. Provided MOA for combination therapy using epigenetic inhibitors with current cancer regimens. • Supported target validation and cellular screening effort for multiple drug discovery projects.