Chun-Pyn Shen (沈君平) Dds Phd Email and Phone Number

>Reporting to CEO, provide high level strategic and operational regulatory direction.>Integrating functional expertise with business knowledge to solve problems and make good decisions for the overall business.>Building partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.https://en.impacttherapeutics.com/

>Responsible for global project development, including regulatory Affairs and clinical development.https://dynamicure.com/about-us/https://medicine.yale.edu/profile/lieping_chen/

>Ensure the success of US and global regulatory approval and market entry of pipeline products (oncology, infectious diseases, ophthalmology, immunologic disease, and orphan drugs).>Set global regulatory strategy to enable business development>Build and lead US and global regulatory affairs function. Lead all FDA interactions. https://hengenix.com/https://www.henlius.com/en/index.htmlhttps://www.fosunpharma.com/en/

>Provide scientific, clinical, regulatory intelligence and policy insights for immuno-oncology, oncology, neurology, and rheumatology projects (Avelumab and other pipeline products)>Lead competitive scientific, clinical, and regulatory intelligence to inform product strategies>Coordinate and deliver cross-functional communication/education to convey complex scientific, clinical, regulatory, and policy issues, impact to the business. >Build and leverage stakeholder relationships. Support executive management in trade association leadership roles with scientific, clinical, and regulatory positioninghttp://www.emdserono.com/en/index.htmlhttp://www.merckgroup.com/en/index.html

Leading Competitive/Regulatory Intelligence function, reporting to CSO (Questcor) >Evaluating the scientific, patent, regulatory, and market landscape of Acthar (19 indications on the label, including Neurology, Rheumatology, Nephrology, Pulmonology, Ophthalmology, and Dermatology area) and pipeline products >Assessing potential pathways for competitive generic and/or biosimilar products >Authoring regular research notes and Whitepapers on scientific, clinical, regulatory, patent, CMC, and policy related issues >Managing research projects and CRO to enable the mission of Life Cycle management of Acthar and new indication initiativeshttp://www.mallinckrodt.com/questcor/

Enabling several immuno-oncology phase I/IIa cell and gene therapy clinical trials, reporting to Executive Vice President (USA)>Authored clinical study protocol, ICF, investigator’s brochure, contributing IND applications>Interacted with KOL, presenting at SIV, interacting with investigators and other personals at research sites>lead the effort to redesign and contributed significantly on the content information of the company website>Managed translation research projects with academic KOL and CRO partnershttp://www.adaptimmune.com/

As lead principal consultant serving 2 of the top 5 global bio-pharmaceutical companies>Conducted primary and secondary (database/literature) intelligence gathering and analysis, conference coverage, stakeholder interviews, managing interaction with KOLs, investigators, and clients for scientific, clinical, regulatory, policy, and marketing issues>Organized and conducted symposiums and workshops (including competitive profiling, SWOT, situation analysis, scenario planning) to help clients understand the competitive landscape and generate counter strategies>Expended and maintained client base through business development and project management activities (project scope, communication, integration, time, cost, and quality management)http://www.cambridgesl.com

Project manager, scientific liaison, and laboratory head managing research projects in CNS, obesity, diabetes, CVD disease areas for 11 years.>Accelerated the identification of 8 pre-clinical development candidates, and participating in the clinical development programs. >Lead multi-disciplinary drug development team and developing research operation procedures and contributing in 6 IND applications>Developed and maintained research collaborations and relationships between Merck and contracted research organizations, KOLs, and scientific leaders>Drug Discovery/Development, Target Identification/Validation, Assay Development, High Through-Put Screening, Lead Identification/Optimization, Pre-clinical Evaluation, Pharmacology, Compound Profiling, >Research Project Management, Biomarker Discovery, Translational Research>Mentored and coached scientific staff http://www.merck.com/

Conducting independent research as a Damon Runyon Cancer Foundation Fellow Asymmetric Cell Division, Neurobiology, Genetics, Cell Biology, Molecular Biology, and Drosophila, http://www.damonrunyon.org/http://physio.ucsf.edu/Jan/http://www.ucsf.edu/

Trained as an Intern (Clinical Dentistry) and a Resident in Hospital and Emergency Dentistry.http://www.ntuh.gov.tw/en/http://www.ntu.edu.tw/