Li Yan Email and Phone Number
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A strategic and collaborative leader with 17 years of experience in clinical pharmacology and pharmacometrics for biotherapeutics and small molecules from discovery to Phase 4. Goal-oriented with a problem-solving attitude to guide teamwork for troubleshooting and delivering multi-staged projects. Demonstrated ability to adhere to milestones and timelines. Extensive hands-on experience in translational TK/PK/PD and exposure-response modeling and simulation to support optimal drug candidate and dosage selection from preclinical through Phase 3 registrational trials. Track record of successful INDs, EOP2, BLAs, and MAAs. Achieved success in global filing, defense, and approval of 2 BLAs (UPLIZNA®, FASENRA®, and FASENRA® Self-Administration).Committed to professional development, I earned my PhD in a Joint Bioengineering Program from UCSF-UC Berkeley. Furthermore, my areas of expertise include: • Model-informed drug development (MIDD)• PK/PD and exposure-response analyses• Optimal study design and dosage selection• Global regulatory filing, defense and approval• Oncology, autoimmune, inflammatory, and rare diseases • Highly proficient in NONMEM, WinNonlin, R, etc.• Effective management of internal/external resources• Strong publication record: 50+ peer-reviewed publications & presentations
Candid Therapeutics
View- Website:
- candidrx.com
- Employees:
- 35
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Vp, Clinical PharmacologyCandid TherapeuticsCalifornia, United States
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Senior Director, Head Of Clinical PharmacologySpyre Therapeutics May 2024 - PresentSan Francisco, Ca, Us -
Adjunct ProfessorUniversity Of The Pacific - Thomas J. Long School Of Pharmacy Jan 2024 - PresentStockton, California, Us -
Senior Director, Head Of Clinical Pharmacology And DmpkNgm Biopharmaceuticals Mar 2022 - Mar 2024South San Francisco, Ca, UsBuilt and led a high-performing Clinical Pharmacology & DMPK team. Oversaw and managed clinical pharmacology and DMPK-related activities from discovery to EOP2 for all NGM therapeutic areas. Provided extensive clinical pharmacology and DMPK leadership for the development and execution of the company-wide strategy. -
Senior Director, Clinical Pharmacology And DmpkHorizon Oct 2021 - Mar 2022Dublin, Ireland, IeAssumed expanded responsibilities following the acquisition. Grew the function by recruting & retaining top-performing talent. Collaborated with cross-functional teams to develop and execute Horizon's overall development strategy. Proactively evaluated risk/benefit and guided development decisions, including study design and optimal dose selections. -
Director, Clinical Pharmacology And DmpkHorizon Mar 2021 - Sep 2021Dublin, Ireland, IeIn March 2021, Viela Bio was acquired by Horizon Therapeutics. Assumed responsibility for the post-acquisition initiatives by leading pharmacology activities across all Viela Bio legacy programs.
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Director, Head Of Clinical PharmacologyViela Bio Jul 2018 - Mar 2021Gaithersburg, Maryland, UsOversaw all clinical pharmacology activities for Viela Bio's portfolio, including study design, protocol development, study execution, data interpretation and reporting, and preparation of regulatory documents, interactions, and submissions. Thrived in an entrepreneurial organization by working with a highly hands-on and productive approach in a fast-paced, highly challenging, and collaborative environment. Led the clinical pharmacology effort for the BLA filing, defense, and approval of UPLIZNA (Inebilizumab) -
Senior Clinical PharmacokineticistAstrazeneca Aug 2012 - Jun 2018Cambridge, Cambridgeshire, GbDMPK, clinical pharmacology, and pharmacometric lead for biotherapeutic products at various stages of research and clinical development. Oversaw all aspects of nonclinical and clinical pharmacology for multiple projects. Successfully led the clinical pharmacology effort for the EOP2, BLA filing, defense, and global approval of FASENRA (Benralizumab), and FDA approval of FASENRA self-administration -
Associate ScientistCertara 2010 - 2012Radnor, Pennsylvania, UsPharmacometrician responsible for population PK, PD, exposure-response modeling and simulation, and dosing regimen selection and optimization for small molecules and biologics across diverse therapeutic areas, including oncology, Alzheimer’s disease, cardiovascular diseases, erectile dysfunction and antiviral & biodefense. -
Postdoctoral FellowBioengineering And Therapeutic Sciences, Ucsf 2007 - 2010San Francisco, California, Us• Collaborated with UCSF physicians, conducted pharmacometrics modeling and simulation, and developed a piperaquine dosing strategy in Ugandan infants with malaria• Optimized enoxaparin dosing for factor Xa inhibition in gastric bypass patients.
Li Yan Skills
Li Yan Education Details
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University Of California, San FranciscoBioengineering -
University Of California, BerkeleyBioengineering
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University Of Colorado BoulderCellular & Developmental Biology
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Jilin UniversityMolecular Biology
Frequently Asked Questions about Li Yan
What company does Li Yan work for?
Li Yan works for Candid Therapeutics
What is Li Yan's role at the current company?
Li Yan's current role is VP, Clinical Pharmacology.
What is Li Yan's email address?
Li Yan's email address is ly****@****bio.com
What schools did Li Yan attend?
Li Yan attended University Of California, San Francisco, University Of California, Berkeley, University Of Colorado Boulder, Jilin University.
What are some of Li Yan's interests?
Li Yan has interest in Hiking, Skiing.
What skills is Li Yan known for?
Li Yan has skills like Clinical Study Design, Pharmacodynamics, Oncology, Pharmacokinetics, Clinical Pharmacology, Regulatory Submissions, Winnonlin, Clinical Research, Protein Chemistry, Life Sciences, Clinical Development, Pharmacometrics.
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