Cindy Xia
VP, Translational Sciences @ City Therapeutics
About
Bringing over two decades of experience in drug discovery and development, I am a strategic and innovative leader committed to advancing the field through collaboration and innovation. My expertise includes defining and implementing DMPK, ADMET, bioanalytics, and translational research efforts at various stages of drug discovery and development for diverse platforms and modalities, such as mRNA, siRNA, biologics, small molecules, and cell and gene therapies. I have a strong track record of building and leading high-performing, cross-functional teams, fostering a collaborative environment. My proven ability to design target product profiles and develop non-clinical development strategies has advanced compounds from discovery to clinical trials. I effectively lead, communicate, and leverage multidisciplinary expertise to achieve goals professionally and timely. My proficiency in regulatory guidelines enables me to provide scientifically sound justifications for actions. I have led DMPK/non-clinical activities for over 40 INDs/CTAs and 5 NDAs/MAAs, including Velcade, Ninlaro, Alunbrig, Exkivity, and Livtencity. I am enthusiastic about contributing to the scientific field by organizing conferences and workshops and have authored over 50 research papers and reviews.
United States
Cambridge
Pharmaceuticals
Strategic and Compassionate Leader; Cross-functional Team Leadership; Non-clinical Development; Translational ADMET Research, Teamwork, Strategic Leadership, Patent Prosecution, Relationship Building, Emerging Trends, Communication, In Vitro, ADME, Drug Discovery, Drug Development, Pharmaceutical Industry, Biotechnology, Clinical Development, Life Sciences, GLP, Pharmacology, Assay Development, DMPK, Drug Metabolism
Experience
VP, Translational Sciences
City Therapeutics
Cambridge, Massachusetts, United States
- Leading cross-functional teams of PK/Clinical Pharmacology, Nonclinical Safety Evaluation, and Bioanalysis/Biotransformation to support drug discovery and development. - Driving translational strategies, IND-enabling studies, and regulatory submissions to bridge preclinical research and clinical development.
Consultant for Non-Clinical Development
iHope Hill LLC
Cambridge, Massachusetts, United States
VP, Translational Sciences at ReNAgade Therapeutics
ReNAgade Therapeutics
Cambridge, Massachusetts, United States
- Was part of the leadership team in building a start-up biotech company. - Provided strategies for research plans and target product profiles. - Provided strategies and co-Led the the team to identify LNPs that deliver RNA(s) to immune cells or hematopoietic stem cells. - Led efforts to identify siRNA or LNP conjugates for delivery to muscle, CNS or kidney.
Head of Global DMPK Oncology and Rare Disease
Takeda
Cambridge, Massachusetts, United States
- Was part of the global leadership in developing global DMPK study strategies, reviewing global therapeutic discovery and development projects, and mentoring scientists globally. - Helped to establish the drug candidate criteria, IND filing and development strategies and TPP. - Developed the immunogenicity risk assessment strategy for globally relevant projects. - Provided DMPK support for discovery and development pipelines in oncology, rare diseases and AAV-based gene therapies. - Co-led the team to develop the biomarker playbook for all therapeutics (including oncology, rare diseases, GI and neuroscience).
Sr. Director of PK and Translational Research Group at TBOS DMPK
Takeda
Cambridge, MA
- Managed all DMPK activities in support of oncology discovery and development projects. - Supported regulatory required non-clinical ADME, clinical DDI and metabolite identification studies for IND/CTN and NDA/MAA submissions, and post marketing commitments/requirements. - Was part of the global leadership in developing global DMPK study strategies, reviewing global therapeutic discovery and development projects, and mentoring scientists globally.
Director of PK and Biopharmaceutics
Takeda
Cambridge, MA
Directly managed PK, modeling & simulation (M&S), and DMPK translational research groups including assessments of immunogenicity risk and biopharmaceutical properties’ impact on drug development
Associate Director of Discovery PK and In Vitro ADME
Takeda
Cambridge, MA
- Responsible for providing in vitro biotransformation study support to both discovery and development projects. - Set up innovative tools to solve ADMET-related questions and supported investigative toxicology works
Sr. Sci I-Associate Director
Millennium: Takeda Oncology Company
Cambridge, Massachusetts, United States
Group Leader in Research and Development.
Scientist-Sr. Scientist I
MILLENNIUM PHARMACEUTICALS, INC.
Cambridge, MA
Set-up in vitro ADMET studies and assess DDI liabilities.
Education
Peking University
School of Pharmacy
University of Southern California
Pharmaceutical Sciences
Cindy Xia's Contact Information
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