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Lei Chuang (莊蕾潔), MSc, PMP, is an experienced Project Management Professional (PMP) with a successful career in project management, program management, portfolio management, risk management, and organizational process development/ implementation/ improvement in (bio)pharmaceutical industry.
She is a certified PMP with 20 years of project and program management experience for one small (Osiris), one large (GSK), and one hybrid (Morphotek/Eisai) (bio)pharmaceutical companies, she has successfully established integrative project management processes and practice to drive global cross-functional, cross-matrix drug development effort to ensure alignment between strategies and operations for small-molecule (GSK), biologics (Morphotek), and cell therapy (Osiris) drug development in compliance with ICH guidelines, FDA regulations, and worldwide regulatory systems.
Between 2007 and 2016, Lei was heading the Global Project Management Department in Morphotek, Inc., a biologic-focused subsidiary of Eisai Pharmaceuticals. With an expertise of integrative project management in a Global Drug Development Team environment (i.e., the International Project Team, a.k.a. IPT), she established a project-centered organization with an informal Project/Program Management Office (PMO) infrastructure to collaborate with Morphotek Executive Leadership Team and Therapy Area (TA) Leaders to oversee all preclinical/clinical project activities across all TAs as well as to review/prioritize company pipeline portfolio. During her 8+ years tenure in Morphotek, she established a GPM Department from ground up, hired/ supervised/ coached/ developed 3 PM staff and 2 PM Interns to manage 9-12 assets in Morphotek. She also managed two top-priority PhII/III IPTs and led the teams for the preparation of global simultaneous market application submissions. Under her leadership, she has fostered a very collaborative GPM Group and developed a group of empowered PM Staff to successfully manage and support their IPTs to deliver one PoC (Proof of Concept), 6 INDs, numerous CTAs, 3 Japan CTNs, and 2 Candidate Selections for biologic drug development.
In GSK, she provided project management leadership in small molecule drug development by serving as a Program Manager for 3 Program Teams in various discovery research stages from gene discovery, target localization/validation, lead optimization to candidate selection, as well as a Project Manager for 7 Global Project Teams from Candidate Selection, PreClinical, IND Submission, phase I, phase II and phase IV (Avandia) in Inflammatory, Respiratory, Cardiovascular, Metabolic and Oncology TAs.
In Osiris Therapeutics, she championed in project coordination and technical transfer for several key external R&D collaborations in discovery research, preclinical research and PhI/II clinical research stages with Novartis Pharma and several prestige clinical research institutes and hospitals such as Case Western Reserve University, Fred Hutchinson Cancer Research Center, Johns Hopkins University Oncology Center and Boston University Medical School Hospital.
Ms. Chuang holds a Master of Science Degree in Biochemistry and Cell Biology from the Joint Biomedical Sciences Program of East Virginia Medical School/Old Dominion University, Virginia, as well as a Project Management Certificate from Penn State University- Great Valley, Pennsylvania. She is a passionate PM advocate and educator who has served in PM Community Leadership Team of the Drug Information Association (DIA), as well as successfully delivered PM Tool Workshop in the 2015 DIA Annual Meeting. Has organized, built and led drug development and PM symposiums/workshop(s) to support young biotech company establishment and to advise the project transition from discovery research stage into preclinical/clinical development stages in Taiwan.
In this Symposium, she will continue from her 2014/2015 introductory lectures “A Project Manager’s View for Drug Development” and “Target Project Profile (TPP) - A critical asset development roadmap” to lead everybody enter the path of “Drug Development” with several critical drug development “Technical Know-hows” including project team management, development milestone management and drug development strategies/planning as well as regulatory activity planning, dossier preparation and submissions. By teaming up with Dr. Frank Lee, she will unwrap a Project Manager’s tool bag – a step-by-step check list for small molecule/biologic drug development and take us on a journey of FDA regulatory process and eCTD dossier preparation.
Contact Information: lei.chuangPM001@gmail.com
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Frank Wunfeng Lee 李文豐, Ph.D. |
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Frank Lee, PhD, is the Director of Upstream Development and Operations, Biopharmaceutical Development, Pharmaceutical Sciences and Technologies at Eisai Inc. He has previous experience at Regeneron and Johnson & Johnson in a variety of positions in R&D and Manufacturing. Dr. Lee has approximately 19 years of experience in the biopharmaceutical industry in the areas of Molecular Biology, Genetic Engineering, Cell Line Development, Culture Medium Development, Early and Late Phase Process Development, Technology Transfer, Process Scale-Up & -Down, Process Optimization, Process Validation and Characterization , Facility Design and Validation, Manufacturing Sciences and Technical Support, cGMP Manufacturing, and Raw Material and Supplier Qualification.
His experience covers product/process development, pre-clinical, clinical, and commercial biopharmaceutical drug substances. In addition, Dr. Lee has authored the CMC modules of a variety of international regulatory filings for Simponi® (golimumab) and Stelera®(ustekinumab), leading to successful pre-approval inspections and licensures of products in US, EU, Canada, and Japan, and post-licensure regulatory filings for Remicade® (infliximab). Dr. Lee holds a BS in Chemical Engineering from the National Cheng-Kung University in Taiwan, and a MS and a PhD from University of California, Irvine in Chemical and Biochemical Engineering.
This series of lectures on “Product Development – CMC Technical Operations” had covered the basic concepts of product and process development from discovery to early clinical development last year (in the Si2C SPARK symposium) and continuously to late clinical development and commercial launch this year (in the Si2C & TRPMA joint symposium) and advanced concepts of Quality by Design, Technology Transfer, and Product Scale-up and Optimization (covered in future years).
Contact Information: frankwunfenglee@gmail.com
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