Joanna

About Joanna

I have over 20 years of experience in Clinical Pharmacology and Pharmacometrics and have worked with multiple modalities (e.g, small molecules, peptides, monoclonal antibodies, antibody-drug conjugates, and gene therapies). My broad experience also extends to several therapeutic areas, including oncology, autoimmune diseases, metabolic diseases, cardiovascular diseases, antivirals, pulmonary diseases, and hematology. I am the founder/president of Q-Q PK Consulting, LLC and affiliated with Nuventra (part of Allucent; as a VP) and other consulting companies. During the last 6 years of being a consultant, my contribution to conducting PK analyses, modeling and simulation, writing NDA sections (2.7.1, 2.7.2 and 2.5.3), and advising on strategy has led to 3 NDA and 2 sNDA approvals. In addition, I have supported 8 IND submissions, 11 clinical programs and 4 pediatric programs. Prior to consulting, I had a successful career at several well-established pharmaceutical and biotech companies, including Abbott (now AbbVie), Merck, Amgen and Seattle Genetics. My job responsibilities spanned from being the Clinical Pharmacology Lead to being the modeler for multiple programs ranging from preclinical (human dose prediction), Phase 1 through Phase 4. I worked on 4 approved drugs, 2 IND submissions, 14 clinical programs and 1 pediatric program. As the Clinical Pharmacology Lead for Humira, I contributed to 4 successful sBLA approvals and my innovative population PK/PD analysis resulted in a novel dosing regimen that was approved for labeling. I am able to produce key drug development reports under tight timelines. I have also attended regulatory meetings with the FDA, EMEA and MPA. I am proficient in several types of software, such as NONMEM, R, Berkeley Madonna, Phoenix, and WinNonlin, which enables me to do hands-on analyses, in addition to providing clinical development strategies.

Experience

1. Vice President, Clinical Pharmacology and Pharmacometrics

   Allucent

   Feb 2022 — Present

Education

• University of Minnesota

  Ph.D., Pharmaceutical Science

  1997 — 2002

• University of Minnesota

  Doctor of Philosophy - PhD, Pharmaceutics (specialized in pharmacokinetics)

  1997 — 2002

• Shanghai Medical College of Fudan University

  Bachelor’s Degree, Pharmacy

  1992 — 1996