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About Us

Senior scientific leaders providing directly engaged, integrated support across DMPK, translational science, clinical pharmacology, modeling and simulation, and development strategy.

Jin Xiao

Jin (Jim) Xiao, Ph.D.

Principal Consultant & Co-Founder

Clinical pharmacology, DMPK, and model-informed drug development executive with more than 20 years of experience supporting programs from discovery and candidate selection through IND, End-of-Phase 2, NDA/BLA/MAA submissions, and lifecycle management. Dr. Xiao has held senior leadership roles across oncology and broader therapeutic areas, including former Vice President and department head roles at BridgeBio Oncology, Nikang Therapeutics, Akeso Biopharma, and Clovis Oncology, with earlier scientific leadership experience at Amgen and Genentech.

His work integrates clinical pharmacology, translational science, nonclinical DMPK, biomarker strategy, and quantitative analyses—including R-based exploratory and statistical analyses, PK/PD modeling, population PK, and exposure-response analyses—to address critical questions across clinical development and support cohesive strategies aligned with clinical, regulatory, and business objectives.

Dr. Xiao works directly with clients as a senior strategic and operational partner, helping lean biotech companies anticipate development risks, make informed decisions quickly, and execute efficiently with practical, hands-on scientific leadership.

25+ INDs • 6+ EoP2 programs • 7+ NDA/BLA/MAA submissions
40+ peer-reviewed publications
Expertise in exploratory modeling and simulation
Jiyun Chen

Jiyun (Sunny) Chen, Ph.D.

Principal Consultant & Co-Founder

Translational sciences, clinical pharmacology, and DMPK leader with more than 20 years of experience supporting discovery, translational, and clinical development programs across oncology, inflammation, neurosciences, metabolic diseases, and biologics development. Dr. Chen has held scientific and translational leadership roles across biotech and pharmaceutical organizations and has co-founded three biotechnology companies.

Her experience spans translational medicine strategy, biomarker integration, PK/PD and exposure-response strategy, IND-enabling development, clinical pharmacology planning, and cross-functional program leadership. She has also provided strategic translational and development consulting support to emerging biotech companies, helping organizations navigate complex early-stage development decisions with limited internal resources.

Dr. Chen brings a complementary perspective that connects translational science, clinical pharmacology, DMPK, and broader portfolio strategy. Together, Drs. Xiao and Chen provide unusually broad, integrated expertise while remaining directly engaged and accessible throughout the collaboration.

3 biotech co-founder roles
Translational strategy
Discovery to clinical development

Selected Publications in the Fields of Consulting Service

Selected peer-reviewed work demonstrating experience across clinical pharmacology, PK/PD modeling, exposure-response, DMPK, assays, toxicology, and translational development.

Clinical Pharmacology & Clinical Development

  1. Xiao JJ et al, Pharmacokinetics and clinical evaluation of 125I radiolabeled humanized CC49 monoclonal antibody (HuCC49DCH2) in recurrent and metastatic colorectal cancer patients. Cancer Biother Radiopharm. 2005
  2. Emu B et al, Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin: results of a phase I randomized, placebo-controlled trial, Arthritis Res Ther. 2012
  3. Kristeleit R et al, A Phase I-II Study of the oral poly(ADP-ribose) polymerase inhibitor rucaparib in patients with germline BRCA1/2-mutated ovarian carcinoma or other solid tumors, Clinical Cancer Research. 2017
  4. Subramanian R et al. Pharmacokinetics, biotransformation, and excretion of [14C]etelcalcetide (AMG 416) following a single microtracer intravenous dose in patients with chronic kidney disease receiving hemodialysis. Clin Pharmacokinet. 2017
  5. Shapiro GI et al. Pharmacokinetic study of rucaparib in patients with advanced solid tumors, pharmacokinetic study of rucaparib in patients with advanced solid tumors. Clin Pharmacol Drug Dev. 2019
  6. Xiao JJ et al. Evaluation of drug-drug interactions of rucaparib and CYP1A2, CYP2C9, CYP2C19, CYP3A4, and P-gp substrates in patients with an advanced Solid tumor. Clin Transl Sci. 2019
  7. Liao M et al. Evaluation of absorption, distribution, metabolism, and excretion of [14C]-rucaparib, a poly(ADP-ribose) polymerase inhibitor, in patients with advanced solid tumors. Invest New Drugs. 2020
  8. Liao M et al, A phase 1, open-label, drug-drug interaction study of rucaparib with rosuvastatin or oral contraceptives in patients with advanced solid tumors, Cancer chemother Pharmacol. 2021
  9. Kristeleit R et al, PARP inhibition with rucaparib alone followed by combination with atezolizumab: Phase Ib COUPLET clinical study in advanced gynaecological and triple-negative breast cancers. Br J Cancer, 2024

PK/PD Modeling and ER analysis

  1. Fang LY et al, Population pharmacokinetics of humanized monoclonal antibody huCC49∆CH2 and murine antibody CC49 in Colorectal cancer patients. J Clin Pharmacol. 2007
  2. Xiao JJ et al, Pharmacokinetics of anti-hepcidin monoclonal antibody Ab12B9m and hepcidin in cynomolgus monkeys, The AAPS Journal. 2010
  3. Wang YM et al, Pharmacodynamics-mediated drug disposition (PDMDD) and precursor pool lifespan model for single dose of romiplostim in healthy subjects. The AAPS Journal. 2010
  4. Xiao JJ. FcRn-mediated IgG Pharmacokinetic Models. J Biomed Biotechnol. 2012
  5. Shen J et al. A pharmacokinetic/pharmacodynamic model for AMG 416, a novel calcimimetic peptide, following a single intravenous dose in healthy subjects. J Clin Pharmacol. 2014
  6. Pan WJ et al, Modeling the pharmacokinetic-pharmacodynamic relationship of the monoclonal anti-macaque-IL-15 antibody Hu714MuXHu in cynomolgus monkeys, Pharmacol. Res. Perspect. 2015
  7. Vu T et al, Population pharmacokinetic-pharmacodynamic modeling of omecamtiv mecarbil, A cardiac myosin activator, in healthy volunteers and patients with stable heart failure, J. Clin. Pharmacol. 2015
  8. Chen P et al, Population pharmacokinetics analysis of AMG 416, an allosteric activator of the calcium-sensing receptor, in subjects with secondary hyperparathyroidism receiving hemodialysis, J Clin Pharmacol. 2015
  9. Krzyzanski W et al, Pharmacodynamic model of hepcidin regulation of iron homeostasis in cynomolgus monkeys, AAPS Journal. 2016
  10. Wang Y et al, Short-term efficacy reliably predicts long-term clinical benefit in rheumatoid arthritis Clinical trials as demonstrated by model-based meta-analysis, J Clin Pharmacol. 2016
  11. Konecny GE et al. Population exposure-efficacy and exposure-safety analyses for rucaparib in patients with recurrent ovarian carcinoma from Study 10 and ARIEL2. Gynecol Oncol. 2021
  12. Green M et al, Population pharmacokinetics (PK) of rucaparib (CO-338) in patients with advanced ovarian cancer (AOC) or other solid tumors, Cancer Chemother. Pharmacol. 2022
  13. Liao M et al, Population pharmacokinetics modeling of lucitanib in patients with advanced cancer, European Journal of Drug Metabolism and Pharmacokinetics. 2022
  14. Byrd JC et al. A phase 1 and pharmacodynamic study of depsipeptide in CLL and AML. Blood. 2005

DMPK / Assays / Toxicology / Biology

  1. Xiao JJ et al, Identification of thiols and glutathione conjugates of depsipeptide FK228 (FR901228), a novel histone protein deacetylase inhibitor, in the blood. Rapid Commun. Mass Spectrom. 2003
  2. Berg SL et al. Plasma and cerebrospinal fluid pharmacokinetics of depsipeptide (FR901228) in nonhuman primates. Cancer Pharmacol. Pharmacol. 2004
  3. Roychowdhury S et al. Selective efficacy of depsipeptide in a xenograft model of Epstein-Barr virus-positive lymphoproliferative disorder. J. Natl. Cancer Inst. 2004
  4. Liu Z et al. An API LC/MS/MS quantitation method for ansamitocin P-3 and its preclinical pharmacokinetics. J. Pharm. Biomed. Anal. 2004
  5. Xiao JJ et al, Chemoresistance to depsipeptide FK228 Is mediated by reversible MDR1 induction in human cancer cell lines. JPET. 2005
  6. Xiao JJ et al, Efflux of depsipeptide FK228 (FR901228, NSC-630176) is mediated by both P-glycoprotein and MRP1. JPET. 2005
  7. Huang Y et al. Correlating gene expression with chemical scaffolds of cytotoxic agents. Pharmacogenetics J. 2005
  8. Liu Z et al. Characterization of decomposition products and PK of decitabine. Rapid Commun. Mass Spectrom. 2006
  9. Fang L et al. Discovery of a daunorubicin analogue that overcomes P-gp-mediated resistance. J. Med. Chem. 2006
  10. Shah MH et al. Cardiotoxicity of histone deacetylase inhibitor depsipeptide. Clin. Cancer Res. 2006
  11. Wilson SF et al, Development and validation of a method for the determination of a therapeutic peptide with affinity for the human B1 receptor in human plasma using HPLC-MS/MS, J. Chromatogr. 2010
  12. Wang H et al, Assessment of placental transfer and the effect on embryo-fetal development of a humanized monoclonal antibody targeting lymphotoxin- alpha in non-human primates, Reproductive Toxicology. 2016
  13. Zboralski D et al, Preclinical evaluation of FAP-2286 for fibroblast activation protein targeted radionuclide imaging and therapy, European Journal of Nuclear Medicine and Molecular Imaging. 2022

Reviews

  1. Xiao JJ et al, A Survey of renal impairment pharmacokinetic studies for new oncology drug approvals in the USA from 2010 to early 2015: A focus on development strategies and future directions, Anticancer Drugs. 2017
  2. Liao M et al, Evaluation of in vitro absorption, distribution, metabolism and excretion and assessment of drug-drug interaction of rucaparib, an orally potent poly-adenosine diphosphate ribose polymerase inhibitor, Xenobiotica. 2020
  3. Grechko N et al, Pharmacokinetics and safety of rucaparib in patients with advanced solid tumors and hepatic impairment, Cancer Chemother Pharmacol 2021
  4. Liao M et al, Clinical pharmacokinetics and pharmacodynamics of rucaparib, Clinical Pharmacokinetics. 2022