ShiaoPing Lu Email & Phone Number | I have over twenty five years of industry experiences in drug developments and been contributor to four successful regulatory submissions as listed below, Bevyxxa (VTE), NDA Approved 2017, Portola Pharmaceuticals Qutenza(PHN Pain), NDA and EMEA Approved in 2009, Neurogesx Ranexa (Angina), NDA Approved in 2006, CV Therapeutics Vistide (CMV Retinitis), NDA Approved 1996, Gilead Sciences A recent NDA/EMEA on Bevyxxa was filed in September, 2016. Bevyxxa won FDA approval in 2017 through 6-month priority review. Represented at regulatory meetings as statistical expert and addressed reviewers' questions; My role to those NDAs involved overall resources planning of NDA, meetings with FDA/or addressed EMEA reviewers’ questions, unblinding/analyses of the pivotal Phase III trials, development of ISE/ISS analyses plan, implemented/oversaw the analyses and writing of those sections in the NDA package. Post submission responsibilities included addressing reviewers’ questions through providing additional analyses or synthesizing from the existing submitted information on drug safety or efficacy data. In addition to the late stage developments, I have also contributed to a few INDs submissions which lead to Phase II trials. They were for indications in the Solid tumors, Alzheimer’s Disease, Crohn’s disease, and Osteoarthritis. My contribution involved writing clinical protocol, safety assessments and preclinical PK/PD sections. Aside from the functional roles, I have been a key team member in the Strategic Developments Committee that met on a regular basis to discuss new trials design, existing trials results/challenges and make recommendation to appropriate strategy moving forward. I was also a key member in the Business Development meetings at Oxigene, Avidia (acquired by Amgen in 2006) and Rinat Neuroscience (acquired by Pfizer in 2006). My role involved the preparation for due diligence questions, study results presentation and development strategy.

ShiaoPing Lu

I have over twenty five years of industry experiences in drug developments and been contributor to f...
Los Altos, California, United States

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ShiaoPing Lu’s Email shiaoping.lu@alector.com

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ShiaoPing Lu’s Location Los Altos, California, United States

ShiaoPing Lu’s Current Industry Nevro Sirnaomics Annji Etc City Of Los Altos

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Work Experience

Nevro Sirnaomics Annji Etc

Consultant for Biostatistics and Clinical Development

2021-07-01 00:00:00 - Present

City Of Los Altos

Environmental Commissioner

2021-04-01 00:00:00 - Present

Adaptimmune

Director of Biostatistics

2020-06-01 00:00:00 - 2021-09-01 00:00:00

Alector

Head of Biostatistics

2018-10-01 00:00:00 - 2020-03-01 00:00:00

Portola Pharmaceuticals

Director of Biostatistics

2016-08-01 00:00:00 - 2018-10-01 00:00:00

Durect

Executive Director of Biostatistics

2015-01-01 00:00:00 - 2016-08-01 00:00:00

Oxigene

Sr. Director of Biostatistics

2009-03-01 00:00:00 - 2011-12-01 00:00:00

Neurogesx

Director of Biometrics

2007-03-01 00:00:00 - 2009-03-01 00:00:00

Amgen Mountain View

Associate Director of Biostatisitcs and Clinical Operations

2006-01-01 00:00:00 - 2007-04-01 00:00:00

Rinat Neurosciences

Associate Director of Biostatistics

2004-01-01 00:00:00 - 2006-01-01 00:00:00

Cv Therapeutics

stat consultant

2000-01-01 00:00:00 - 2004-01-01 00:00:00

Wells Fargo

Statistical Consultant

1997-01-01 00:00:00 - 1999-01-01 00:00:00

Gilead Sciences

Manager of Biostatistics

1995-01-01 00:00:00 - 1996-01-01 00:00:00

Syntex Research

Biostatistician

1990-01-01 00:00:00 - 1992-01-01 00:00:00

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FAQ About ShiaoPing Lu

ShiaoPing Lu is located at
Los Altos, California, United States

ShiaoPing Lu is a I have over twenty five years of industry experiences in drug developments and been contributor to four successful regulatory submissions as listed below, Bevyxxa (VTE), NDA Approved 2017, Portola Pharmaceuticals Qutenza(PHN Pain), NDA and EMEA Approved in 2009, Neurogesx Ranexa (Angina), NDA Approved in 2006, CV Therapeutics Vistide (CMV Retinitis), NDA Approved 1996, Gilead Sciences A recent NDA/EMEA on Bevyxxa was filed in September, 2016. Bevyxxa won FDA approval in 2017 through 6-month priority review. Represented at regulatory meetings as statistical expert and addressed reviewers' questions; My role to those NDAs involved overall resources planning of NDA, meetings with FDA/or addressed EMEA reviewers’ questions, unblinding/analyses of the pivotal Phase III trials, development of ISE/ISS analyses plan, implemented/oversaw the analyses and writing of those sections in the NDA package. Post submission responsibilities included addressing reviewers’ questions through providing additional analyses or synthesizing from the existing submitted information on drug safety or efficacy data. In addition to the late stage developments, I have also contributed to a few INDs submissions which lead to Phase II trials. They were for indications in the Solid tumors, Alzheimer’s Disease, Crohn’s disease, and Osteoarthritis. My contribution involved writing clinical protocol, safety assessments and preclinical PK/PD sections. Aside from the functional roles, I have been a key team member in the Strategic Developments Committee that met on a regular basis to discuss new trials design, existing trials results/challenges and make recommendation to appropriate strategy moving forward. I was also a key member in the Business Development meetings at Oxigene, Avidia (acquired by Amgen in 2006) and Rinat Neuroscience (acquired by Pfizer in 2006). My role involved the preparation for due diligence questions, study results presentation and development strategy.

ShiaoPing Lu currently works in the Nevro Sirnaomics Annji Etc | City Of Los Altos |

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ShiaoPing Lu has prior
experience in the following industries:
Adaptimmune | Alector | Portola Pharmaceuticals | Durect | Oxigene | Neurogesx | Amgen Mountain View | Rinat Neurosciences | Cv Therapeutics | Wells Fargo | Gilead Sciences | Syntex Research

ShiaoPing Lu has the following professional experience:
Nevro Sirnaomics Annji Etc | City Of Los Altos | Adaptimmune | Alector | Portola Pharmaceuticals | Durect | Oxigene | Neurogesx | Amgen Mountain View | Rinat Neurosciences | Cv Therapeutics | Wells Fargo | Gilead Sciences | Syntex Research