Lan GE MD PhD

VP，APAC Regional Medical Officer @ PPD

About

20+ years clinical practice, drug development, and medical affairs experience in Neuroscience, Psychiatry, Neuro-oncology, Uro-oncology, and Women Health areas. 9+ years managerial experience in MNC & Biotech. Neurologist by training. Proven success in the clinical development at Phase I-III, Phase IV, and real-world studies, and product registration. Strategic planning of China clinical development programs as part of global projects. Map the landscape of CNS development in China. Orchestrate and manage clinical aspects of regulatory strategies and close interaction with NMPA, and FDA for Pre-IND meeting, Pre-NDA meeting, onsite CFDI inspection. Oversee end-to-end trial planning & execution. 2 successful NDA approvals in China, 4 new products launched in China and Asia Pacific. Drive China medical strategy, RWE strategy, and life-cycle management in line with commercial and Mkt access throughout pre-launch and post-launch stage. Extensive experience of collaboration among clinical research, regulatory, medical, commercial, Market Access and BD, developing portfolio strategy, product positioning and LCM with broad medical knowledge and business acumen. Established people leadership in building up clinical science and medical affairs functions, including CRPs, ClinOps, MA/MSL team, medical education, and MI function.

Country

China

City

Chaoyang District

Industry

Pharmaceuticals

Skill

Lifesciences, Medical Affairs, Regulatory Affairs, CRO, R&D, Clinical Development, Pharmacology, Neurology, Oncology, Medical Education, Alzheimer's disease, Clinical Trials, Western Blotting, GCP, Clinical Research, Medicine, Pharmaceutical Industry, Cell Culture, Life Sciences

Experience

VP，APAC Regional Medical Officer

PPD

2021-7 - Present · 5 yrs 3 mos

中国北京市

Executive Medical Director, Global Clinical Development

Denovo Biopharma (索元生物）

2019-10 - 2021-7 · 1 yr 10 mos

Beijing, China

1. Lead Biomarker-driven drug development. Early and late phase global clinical development in China/US. 2. Strategic planning and regulatory strategy. Lead Biomarker-guided POC, PhII-PhIII clinical programs in Neurology, Psychiatry and Neuro-oncology (Alzheimer's disease, TRD，Schizophrenia, TRS，GBM). 3. Engage with BD, Investors with medical and scientific expertise. Explore innovative digital therapy for CNS disease.

Sr. Medical Director, Clinical Science Organization

Ferring Pharmaceuticals

2019-3 - 2019-10 · 8 mos

Shanghai City, China

1. Lead Medical team (25+), Accountable for China medical strategy, activity excellence across multiple TAs, including Fertility&Obstetrics, GI, Urology, and Uro-oncology. 2. China portfolio strategy and develop clinical program strategy of Fertility & Obstetrics in global programs. 3. launch prostate cancer product, develop PAP strategy to support Mkt access and pricing strategy

Sr. Medical Director, China Drug Development

Lundbeck

2018-1 - 2019-3 · 1 yr 3 mos

Beijing City, China

1. Established leadership in clinical development & medical affairs (MA/MSL/MI/medical education)with 25+ members. 2. strategic planning. advancing and integrating China clinical programs with global program, global early pipelines in Neuroscience area. 3. Drive business growth. Two successful commercial launches in China. Drive scientific & medical strategy and tactic plan at pre-launch & post-launch stage. Develop RWE strategy and lead HEOR study to support MKT access (NRDL) and pricing strategy

Director, Head of China Clinical Development & MA

Lundbeck

2012-1 - 2017-12 · 6 yrs

Beijing City, China

Lead Ph1/ Ph3 clinical development programs and RWE in CNS area at country level (Alzheimer's disease, Parkinson, mental disorder, Stroke etc). strategic planning and execution of China clinical programs. Build-up a high-performance medical function in China, ie. clinical development team, Study manager, Medical affairs & MSL team, MI and Medical Education.

Clincal Research Scientist Lead, Asia Pacific Clinical Development Center

Lundbeck

2008-1 - 2011-12 · 4 yrs

Beijing City, China

1. Act as clinical physician lead in Global Study Management team, responsible for protocol development, and performing day-to-day medical monitoring in global PhIII trials (AD, Depression, Parkinson). 2. Drive Asia Pacific medical affairs activities in China, Australia, and across southeastern Asian countries/regions (Hong Kong, Korea, Singapore, Malaysia, Thailand, Philippines and Indonesia), including post-launch studies, IITs.

Medical Expert, Neuroscience

Johnson & Johnson

2006-7 - 2007-12 · 1 yr 6 mos

Beijing City, China

Responsible for late-phase clinical trial design (PhIIIb, PhIV) in the areas of neurology and psychiatry (ADHD, epilepsy, depression), as well as medical activity of in-market products.