About
Expertise in:
Early & late stage clinical drug development…
Articles by John
Activity
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This week I had the amazing opportunity to work backstage at the Justin Cassin AW25 show during this year’s #LondonFashionWeek! From backstage…
This week I had the amazing opportunity to work backstage at the Justin Cassin AW25 show during this year’s #LondonFashionWeek! From backstage…
Liked by John Davis
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This week I had the opportunity to attend two British Fashion Council talks for London Fashion Week. The first was a conversation with Stylist…
This week I had the opportunity to attend two British Fashion Council talks for London Fashion Week. The first was a conversation with Stylist…
Liked by John Davis
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Always a pleasure to attend #PKUK. To meet up with friends and colleagues old and new and discuss clinical pharmacology. A big thank you to the…
Always a pleasure to attend #PKUK. To meet up with friends and colleagues old and new and discuss clinical pharmacology. A big thank you to the…
Liked by John Davis
Experience
Education
Publications
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Exploratory Population PK Analysis of Dupilumab, a Fully Human Monoclonal Antibody Against IL‐4Rα, in Atopic Dermatitis Patients and Normal Volunteers
CPT: Pharmacometrics and Systems Pharmacology
WHAT QUESTION DID THIS STUDY ADDRESS?
☑ The study focused on the determination of a population PK model of dupilumab to support clinical development.
WHAT THIS STUDY ADDS TO OUR KNOWLEDGE
☑ The model determines the PK parameters of dupilumab with weight as a covariate. The model demonstrated that there were no differences in production rate of IL-4Rα between normal volunteers and AD patients. The model successfully accounted for singularities caused by a pronounced target-mediated…
WHAT QUESTION DID THIS STUDY ADDRESS?
☑ The study focused on the determination of a population PK model of dupilumab to support clinical development.
WHAT THIS STUDY ADDS TO OUR KNOWLEDGE
☑ The model determines the PK parameters of dupilumab with weight as a covariate. The model demonstrated that there were no differences in production rate of IL-4Rα between normal volunteers and AD patients. The model successfully accounted for singularities caused by a pronounced target-mediated clearance.Other authorsSee publication -
Monoclonal Antibodies: From Structure to Therapeutic Application
in Pharmaceutical Biotechnology Fundamentals and Applications (4th Edition) Crommelin, Daan J. A.; Sindelar, Robert D.; Meibohm, Bernd (Eds.)
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Population pharmacokinetic analysis from phase I and phase II studies of the humanized monovalent antibody, onartuzumab (MetMAb), in patients with advanced solid tumors
J Clin Pharmacol
Onartuzumab is a unique, humanized, monovalent (one-armed) monoclonal antibody (mAb) against the MET receptor. The intravenous (IV) pharmacokinetics (PK) of onartuzumab were investigated in a phase I study and a phase II study in recurrent non-small cell lung cancer (NSCLC) patients. The potential for drug–drug interaction (DDI) was assessed during co-administration of IV onartuzumab with oral erlotinib, by measuring the PK of both drugs.
Other authorsSee publication -
Discriminating changes in QT/QTc interval due to moxifloxacin or vardenafil using dynamic beat-to-beat electrocardiogram analyses
Clinical Pharmacology & Therapeutics
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Translational pharmacokinetic–pharmacodynamic modelling; application to cardiovascular safety data for PF-00821385, a novel HIV agent
Br J Clin Pharmacol 69(4) pp336–345
Patents
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Anti-PCSK9 antibodies, formulations, dosing, and methods of use
Issued US US20130344085 A1
The invention relates to anti-PCSK9 antibodies, antibody formulations, dosing regimens, and methods of using the same. Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a member of the mammalian subtilisin family of proprotein convertases. PCSK9 plays a critical role in cholesterol metabolism by controlling the levels of low density lipoprotein (LDL) particles that circulate in the bloodstream. Elevated levels of PCSK9 have been shown to reduce LDL-receptor levels in the liver, resulting…
The invention relates to anti-PCSK9 antibodies, antibody formulations, dosing regimens, and methods of using the same. Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a member of the mammalian subtilisin family of proprotein convertases. PCSK9 plays a critical role in cholesterol metabolism by controlling the levels of low density lipoprotein (LDL) particles that circulate in the bloodstream. Elevated levels of PCSK9 have been shown to reduce LDL-receptor levels in the liver, resulting in high levels of LDL-cholesterol in the plasma and increased susceptibility to coronary artery disease. (Peterson et al. , / Lipid Res. 49(7): 1595-9 (2008)). Therefore, it would be highly advantageous to produce a therapeutic-based antagonist of PCSK9 that inhibits or antagonizes the activity of PCSK9 and the corresponding role PCSK9 plays in various therapeutic conditions. The invention is in part based on a variety of antibodies to PCSK9. PCSK9 presents as an important and advantageous therapeutic target, and the invention provides antibodies as therapeutic and diagnostic agents for use in targeting pathological conditions associated with expression and/or activity of PCSK9.
Honors & Awards
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Fellow
American College of Clinical Pharmacology
Languages
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English
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Organizations
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ASCPT
Vice-chair, Biologics community
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#PKUK was an interesting and varied meeting this year. Also a great opportunity to meet up with friends and colleagues. Chao Chen Scott Marshall…
#PKUK was an interesting and varied meeting this year. Also a great opportunity to meet up with friends and colleagues. Chao Chen Scott Marshall…
Liked by John Davis
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I’m happy to share that I’m starting a new position as Independent Consultant at R&B Pharmacometrics! I'm excited to start this new job based in…
I’m happy to share that I’m starting a new position as Independent Consultant at R&B Pharmacometrics! I'm excited to start this new job based in…
Liked by John Davis
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