Ning Shan
Chief Scientific Officer @ Aclipse Therapeutics
About
I am an experienced pharmaceutical scientist with a PhD in Chemistry and has a robust working knowledge in small molecule drug development. I have a deep understanding of pharmaceutical science, current industry best practices, and regulatory requirements. My expertise focuses on preclinical and clinical-stage CMC development, with a span of cross-function pharmaceutical development, preformulation, formulation, drug delivery, regulatory affairs, IP protection, and business development. I have been involved in strategic planning of pharmaceutical development and intellectual property protection. I have been managing a number of small molecule projects from preclinical stage to Phase 1/2/3. I was a key CMC member to support FDA NDA approval of Syndros® for commercialization. I am a renowned subject matter expert in organic solid-state chemistry, with a special focus on pharmaceutical solid forms and formulations. I invented the innovative “solvent-drop grinding” technology for solid form screening. As a prominent scientist, I have been continuously involved in academic activities, serving as an adjunct professor and supervising and teaching at several universities (NUS, USF, UPacific). I have authored 35 peer-reviewed journal publications with over 5000 citations (h-index: 27) and hold more than 50 issued and pending patents.
United States
Chandler
Pharmaceuticals
Chemistry, Manufacturing, and Controls (CMC), Preformulation, Formulation, GMP, Drug Delivery, Drug Discovery, CRO Management, Project Management, Cross-functional Team Leadership, Translational Research, Crystal form, Computational Chemistry, Programming, Python (Programming Language), Java, Chemical Analysis, Pharmaceuticals, Preclinical development, GLP, Chemistry
Experience
Chief Scientific Officer
Aclipse Therapeutics
King of Prussia, PA
• Lead CMC product development (preformulation and formulation) to support preclinical and clinical development • Manage CMC regulatory filings (pre-IND/IND/CTN/orphan designation) and communications with US FDA and other regulatory authorities • Support cross-function project management (DMPK, toxicology, regulatory, clinical) to support drug development • Support business and drug development activities; strong technical R&D experience along with business development and licensing/collaboration experience to support internal development
Senior Manager, Formulation
Insys Therapeutics, Inc.
Chandler, AZ
• CMC development from preclinical stage to NDA (oral, buccal, sublingual, intranasal) • Development and life cycle management of small molecule and combination drug products • Key CMC team member to support the FDA NDA approval of Syndros® • Managed CROs for GMP manufacturing to support IND filing and clinical studies • Support external preclinical DMPK studies for formulation development • Authored and reviewed scientific reports, regulatory filings and patent applications • Key technical person for R&D project evaluation and in-licensing opportunities • Supervised a group of 8 PhD/MSc/BSc level formulation and analytical scientists
Director, Pharmaceutical Development / Sr Scientist
Thar Pharmaceuticals Inc (Grünenthal Pharma GmbH)
Tampa/St. Petersburg, Florida Area
• Small molecule preformulation and formulation development (indications: oncology, pain, CNS, antibiotics) from preclinical to Phase 1/2/3 • Managed external cGMP manufacturing and analytical development • Developed Thar’s propitiatory ENHANCE™ technology for solubility and permeability enhancement of small molecule drugs • Prepared and reviewed CMC scientific reports, patent application and documents for regulatory filings. Support overall corporate IP protection activities and fund raising • Supported preclinical in vivo studies (PKPD, tox). • Scientific lead to support project selection, potential scientific goal setting, and budgets and produce development planning • Mentored and supervised PhD/BSc-level research scientists
Sr Scientist
Thar Pharmaceuticals Inc (Grünenthal Pharma GmbH)
Tampa/St. Petersburg, Florida Area
Postdoctoral Research Fellow
Institute of Chemical and Engineering Sciences
Visiting Scientist
Massachusetts Institute of Technology
Cambridge, Massachusetts
• Computer modeling with multiple languages to set up and simulate systems involving amino acids, peptides and proteins • Data analysis and presentation of findings to the research team • Development of software tools to automate data analysis processes
Education
University of Cambridge
Physical Chemistry
Wuhan University
Chemistry
Ning Shan's Contact Information
Phone
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