Cong Wei Email & Phone Number | Specialties: ❑ Strong knowledge of bioanalysis, pharmacokinetics, drug metabolism, pharmacology, biochemistry and cell and molecular biology. ❑ Group leader and DMPK project leader with over 14 years of pharmaceutical industry experience in quantification and characterization of small molecules and large molecules [antibody-drug conjugates (ADC), antibodies (mAbs), proteins, peptides, oligonucleotides and gene therapy] supporting PK, PD, TK and biomarker projects (preclinical and clinical) for oncology, neuroscience, immunology, ophthalmology and rare disease therapeutic areas. ❑ Fully responsible for preparing and reviewing regulatory filing dossiers for IND and NDA packages as DMPK representative leader for multiple programs, including sections of DMPK and e-CTD 2.7.1, for filing to FDA, EMA, Japan PMDA, China NMPA, and other health councils. ❑ Independently and collaboratively perform the PK/PD modeling, and prepare solid PK/PD data package for drug candidate Research-to-Development transition (R2D transition). ❑ Lead the outsourcing effort for both clinical and nonclinical Bioanalysis, PK, ADA and ADME studies. ❑ Hands-on experience and good knowledge of regulated bioanalysis/GLP compliance requirements and worldwide regulatory requirements for bioanalysis, reviewing regulated bioanalytical study reports. ❑ IQ TALG member of several discussion groups, including Biotransformation group, ADME/Drug Distribution group, and Biologics group etc. ❑ Tracked record of scientific excellence, evidenced by 50+ peer-reviewed publications including research articles, review articles, white paper and book chapters. ❑ Mentor and help junior scientists to develop their careers, and oversee performance and deliverable. Capability building, resource planning and yearly budgeting.

Cong Wei

Specialties: ❑ Strong knowledge of bioanalysis, pharmacokinetics, drug metabolism, pharmacology, bio...
Greater Boston, Greater Boston, United States

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Cong Wei’s Email cwei@biogen.com

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Cong Wei’s Location Greater Boston, Greater Boston, United States

Cong Wei’s Current Industry Biogen

Cong Wei’s Prior Industry Vertex Pharmaceuticals | Pfizer | Bristol Myers Squibb | University Of Pennsylvania School Of Medicine | Hoffmann La Roche

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Work Experience

Biogen

Associate Director and DMPK Project Lead

2019-01-01 00:00:00 - Present

Vertex Pharmaceuticals

Principal Scientist / Group Leader

2016-01-01 00:00:00 - 2019-01-01 00:00:00

Pfizer

Senior Scientist

2014-01-01 00:00:00 - 2016-01-01 00:00:00

Bristol Myers Squibb

Research Investigator I & II

2010-01-01 00:00:00 - 2014-01-01 00:00:00

University Of Pennsylvania School Of Medicine

Graduate Student (Ph.D.) in Pharmacology

2005-09-01 00:00:00 - 2010-05-01 00:00:00

Hoffmann La Roche

Senior Scientific Intern in DMPK

2009-05-01 00:00:00 - 2009-11-01 00:00:00

Skills

No Skills Available

Languages

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FAQ About Cong Wei

Cong Wei is located at
Greater Boston, Greater Boston, United States

Cong Wei is a Specialties: ❑ Strong knowledge of bioanalysis, pharmacokinetics, drug metabolism, pharmacology, biochemistry and cell and molecular biology. ❑ Group leader and DMPK project leader with over 14 years of pharmaceutical industry experience in quantification and characterization of small molecules and large molecules [antibody-drug conjugates (ADC), antibodies (mAbs), proteins, peptides, oligonucleotides and gene therapy] supporting PK, PD, TK and biomarker projects (preclinical and clinical) for oncology, neuroscience, immunology, ophthalmology and rare disease therapeutic areas. ❑ Fully responsible for preparing and reviewing regulatory filing dossiers for IND and NDA packages as DMPK representative leader for multiple programs, including sections of DMPK and e-CTD 2.7.1, for filing to FDA, EMA, Japan PMDA, China NMPA, and other health councils. ❑ Independently and collaboratively perform the PK/PD modeling, and prepare solid PK/PD data package for drug candidate Research-to-Development transition (R2D transition). ❑ Lead the outsourcing effort for both clinical and nonclinical Bioanalysis, PK, ADA and ADME studies. ❑ Hands-on experience and good knowledge of regulated bioanalysis/GLP compliance requirements and worldwide regulatory requirements for bioanalysis, reviewing regulated bioanalytical study reports. ❑ IQ TALG member of several discussion groups, including Biotransformation group, ADME/Drug Distribution group, and Biologics group etc. ❑ Tracked record of scientific excellence, evidenced by 50+ peer-reviewed publications including research articles, review articles, white paper and book chapters. ❑ Mentor and help junior scientists to develop their careers, and oversee performance and deliverable. Capability building, resource planning and yearly budgeting.

Cong Wei currently works in the Biogen |

No Languages Available

Cong Wei has prior
experience in the following industries:
Vertex Pharmaceuticals | Pfizer | Bristol Myers Squibb | University Of Pennsylvania School Of Medicine | Hoffmann La Roche

Cong Wei has the following professional experience:
Biogen | Vertex Pharmaceuticals | Pfizer | Bristol Myers Squibb | University Of Pennsylvania School Of Medicine | Hoffmann La Roche