Dan Yuan, PhD

I am a global talent recruiter with many years of professional career of increasing responsibilities in the pharmaceutical industry; With thorough understanding of various functional roles in drug discovery/development, I am able to match your professional background/experiences to the most suitable career opportunities so as to maximize your value. Feel free to contact me at any time convenient to you. I endeavor to be an effective recruiter, a down-to-earth advisor and a tireless cheerleader for your future career advancement.

Fully responsible for the functional unit of translational medicine, including in vitro/in vivo pharmacology, bioanalysis, drug metabolism, pharmacokinetic/pharmacodynamic data analysis, modeling and simulation, toxicology, characterization of biotherapeutics, analytical support of biologics discovery and development, etc.. Building teams of experts in preclinical development (IND-enabling studies), provide high quality services and built strong business relationship. Actively participate in the operation and management of the integrated platform of drug discovery and development services and the development of both domestic and international business, as well as the operational management of the entire platform.

Oversaw and guided all aspects of discovery and preclinical development of drug candidates at PSB which are interferons/INFs, Interleukins/ILs, and fibroblast growth factors/FGFs in several disease areas such as antivirals, cartilage repair, etc. Focused on developing/ validating bioanalytical methods to support nonclinical and clinical PK/PD studies of protein therapeutics (INFs, ILs, FGFs, etc.) and especially to support the upcoming Phase I clinical trial of PSP001 in the US/Australia. Also developing/improving bioassays of protein therapeutics to support Nab testing, drug screening, manufacturing, QC/lot release, stability evaluation, preclinical development, etc. Functioned as the Alliance/Project Manager for the collaboration between PSB and a US drug development consulting group. Co-lead/managed the IND submission to conduct a Phase I trial of PSB’s first clinical candidate, PSP001, for norovirus infection in immunocompromised patients. Prepared briefing documents and response to FDA’s feedback for the pre-IND meeting with FDA. Identified, recruited and/or interacted with consultants in pharmacokinetics, toxicology, medical writing, and clinical pharmacology. Evaluated and selected clinical CROs and bioanalytical CRO’s to support Phase I trials in the US. Scouted and identified appropriate CROs for the quantitation and ADA testing of internal drug candidates; manage CRO deliverables and performance. Reviewed and approved data and reports generated at CROs and internally for IND-enabling pharmacology, pharmacokinetics and toxicology. Directed the preparation and review of the IND dossier, pre-IND meeting request/briefing packages, etc. Manage all communications with the external service providers and review budget proposals.

Lead the Stability Group in Analytical Sciences (AS), provide strategic oversight and guide all the stability studies performed in AS. Provide dynamic forecast of upcoming stability projects to the management team for management of resources and workload. Serve as the subject matter expert for all stability matters, participate and lead any stability investigations. Collaborate with other functions to meet projects timeline and deliverables.Draft and review relevant CMC sections for regulatory submissions including INDs and BLAs. Establish a group of scientists to perform data integrity check on AS technical reports and US IND submissions. Develop talent, inspire innovation and operational excellence and foster a continuous learning environment.

Responsible for all aspects of a specific partnership or IND/CTA-enabling program conducting at WuXi AppTec and for defining the project’s objectives and overseeing quality control throughout its life cycle to its NDA/BLA approval. Prepared and reviewed relevant sections of CFDA/FDA IND submissions for monoclonal antibodies (PD-1/PD-L1, CTLA-4, etc.). Communicate directly with partners and work across internal functional units to plan, execute, and complete testing programs within scope and required quality according to program requirements and timeline; Define and manage project resource needs, monitor team performance and facilitate adjustments when necessary. Actively participate in due diligence of new partnerships/collaborations, e.g., evaluated development candidates; Conducted expert consultation to assess clinical trial feasibility; work with partners/collaborators to evaluate the merits and the competitive landscape from the scientific and business perspective. Served as the Project Manager for a China co-development program of a Class 1.1 new small molecule drug with a major international pharma. Communicated with the co-development partner on all project issues, especially development timeline and budget; co-ordinate and monitor the conduct of preclinical studies and the manufacturing of clinical trial materials; coordinated the pre-IND regulatory inspections; organized quarterly program meetings; prepare/review quarterly budget and financial statements; resolve conflicts/issues; and work across internal functions (DMPK, CMC, Quality, etc.) to ensure data quality and regulatory compliance.

Managed all aspects of the newly created Large Molecule Service (LMS) focusing on analytical development, characterization and stability evaluation of large molecule DS/DP that are proteins/peptides, nucleic acids and synthetic polymers. Responsible for staff hiring and business development/quotation preparation, daily operation, GMP compliance, budget, and expense tracking. Grew the group from zero headcount to 10 in 9 months and with corresponding business growth. Built from scratch analytical capabilities for the characterization and quantitation of large molecule DS/DP in chromatography, capillary electrophoresis, and mass spectrometry. Oversaw analytical R&D method development, validation, stability study, and technology transfer for large molecule API and drug products. Conduct GMP release and stability evaluation from early phase to registration; provided IPC support of internal manufacturing activities. Interacted closely with Formulation Development, Process R&D, Manufacturing units for API and drug products, and/or Quality Assurance for integrated CMC development and manufacturing projects within WuXi and lead/conducted TC with internal and external business partners. Drove the enhancement of operation efficiency and productivity while improving the current quality systems and ensuring full compliance to all applicable regulatory standards. Rebuilt and lead the GMP SOP & Inspection Committee as the Chairperson and streamlined the process of SOP creation, review, revision, approval and implementation and addressed a number of related compliance issues such as OOS/OOT/OOA investigations.