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Chris Penland PhD

Director, Clinical Pharmacology/Pharmacometrics at AstraZeneca

Watertown, MA

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About

Proven leader with experience in drug development, data sciences, clinical PK/PD/pharmacometrics, physiological systems modeling, and translational safety pharmacology. Passionate about data driven decision support and evidence creation. Highly effective communicator with cross-cultural awareness and emotional intelligence honed in global multi-disciplinary and highly-matrixed environments. Advanced capabilities in data science, pharmacometrics (pk/pd, translational, clinical, and RWE) and longitudinal drug-disease modeling. Data sciences, workflow development, R, Python, Monolix, NONMEM, PsN/Xpose, Matlab; Experience programming and administrating high performance cluster and cloud environments.

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Pharmaceutical Consulting
Data science
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Clinical Research Software
Statistical Analysis Software
clinical pharmacology
Work experience
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Sep 2014 - Present

AstraZeneca

Director, Clinical Pharmacology ADME, and AI (CPAA)

Lead, Late Phase Renal & Metabolic Therapies • Responsible for pharmacometric/data science strategy for type 2 diabetes medications (BYDUREON/exenatide, FARXIGA/dapagliflozin, ONGLYZA/saxagliptin) including QSP, MBMA, PK/PD, and disease progression modeling - critical to optimizing and expanding their appropriate use in patients with cardivascular and CKD risk factors. • Experienced as clinical pharmacometrics lead on worldwide regulatory filings: USA, EU, Canada, Australia, China, Russia, Mexico. • Led multiple clinical pharmacology contributions to successful NDA (eCTD 2.7.2), sNDA, End-of-Phase-2 and labeling negotiations • Led the development of a mechanistic (QSP) model of potassium absorption and homeostasis used in regulatory interactions and planned trial design for novel hyperkalemic therapy (LOKELMA/sodium zirconium cyclosilicate) • Mentored junior pharmacometricians, post-doctoral scientists and interns on pharmacometrics analysis methods, program strategy, and communications. Recognized internal expert for strategic MIDD thinking, clear writing and presentation skills • Strong publication and conference presentation record Infrastructure / Training / Outreach • Co-designed & implemented QCP Knowledge Management system on high performance computing platform • Member of pharmacometrics industrialization team; senior expert on high-performance computing platforms • 2019 Chair, International Society of Pharmacometrics, New England chapter. Prior service on steering committee and scientific event chair (2015-2017, Chair-elect 2018)

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Mar 2014 - Sep 2014

Novartis

Associate Director & Group Head, Advanced Quantitative Sciences

PM Lead, Antithrombotic (PRT128/elinogrel) • Provided integrated quantitative understanding of dose, PK/PD, and outcomes. • Responsible for all pharmacometrics in support of dose selection and safety risk management. • Co-led phase 3 dose selection workshops, KOL roundtables with leading clinicians. • Presented at multiple successful face-to-face US and European regulatory meetings. • Supported phase 3 trial design: provided dose justification, PK/PD design and sampling • Originated and designed inpatient infusion regimen for ACS patients. PM Lead, Metabolic (LCQ908/pradigastat, DGATi) • Responsible for strategy and execution of phase 2-3 pharmacometrics • Supported orphan indication FCS program, Pediatric Investigational Plan (EMA accepted) • Supported decision to halt multifactorial chylomicronemia indication PM contributor • Supported multiple due diligence evaluations in CV/metabolics. Provided alignment of dose, exposure, efficacy & safety to support team decisions • Vildagliptin, DPP4i: Developed popPK for parent & 2 metabolites in CKD3b-5 subjects • Multiple sclerosis: Developed popPD model of lymphocyte counts and MRI-tagged lesions to support individualized dosing • Oncology: Conducted popPK analyses. Optimized dose regimens for efficacy vs. thrombocytopenia Core team member, Trials of the Future • Provided expert due diligence support for >10 technologies per year • Supported ambulatory, non-cuff, BP sensor search and evaluation • Co-led pharmacometrics for advanced biosensor justification in planned heart failure trial Safety Pharmacology • Led translational PK/PD analysis of clinical ECG PR interval • Co-wrote guidance for cardiac sodium channel blockade. • Novartis lead for model-based Hepatotoxicity / DILI assessment • Comentored post-doc to assess human iPSC myocytes for cardiac safety • Co-developed a PK/QSP framework to jointly assess cardiac safety of active parent and metabolites

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Mar 2012 - Feb 2014

Novartis

Senior Expert Pharmacometrician

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Nov 2008 - Mar 2012

Novartis

Expert Pharmacometrician

Sep 2003 - Jan 2008

EpiX Pharmaceuticals (formerly Predix Pharmaceuticals until 2006)

Principal Scientist

Model-based Drug Development • Developed biophysical models of cardiac electrophysiology to characterize novel therapeutic target • Performed computer modeling to guide optimization of lead drug compounds in several programs. - Developed predictive structure-activity models of metabolic stability and hERG ion channel binding - Led site directed mutagenesis collaboration to minimize hERG liability of drug candidates - Created novel statistical metric used to support Go/No-Go decisions for new drug candidates Cardiovascular disease • Directed Kv1.5/Kv4.3 ion channel drug discovery program for atrial fibrillation - Created target product profile and directed in vitro and in vivo proof-of-concept experiments - Led external project to develop high-throughput screening assay for potassium ion channels - Designed and analyzed preclinical in vitro and in vivo ADME and PK/PD studies - Co-inventor on patent applications for Kv1.5/Kv4.3 potassium ion channel blockers • Directed testing for cardiovascular safety pharmacology (in vitro/in vivo) and QT prolongation risk Other disease areas • Led CXCR2 chemokine drug program for the treatment of Chronic Obstructive Pulmonary Disease - Directed in vitro and in vivo pharmacology, toxicology, and preclinical proof-of-concept animal studies - Oversaw external in vitro assay development to support primary screening and lead optimization (radioligand binding, calcium flux, GTPgS, receptor internalization, chemotaxis, others) • Managed drug discovery programs for S1P phospholipid and chemokine receptors - Oversaw key external in vitro assay development to enable S1P phospholipid program advancement

Sep 2000 - Sep 2003

Physiome Sciences

Senior Modeling Scientist

Scientific lead for team that commercialized a biomodeling sytem for predicting TdP/QTc prolongation risk, also for consulting projects with pharma clients on drug-induced TdP/QTc risk • Developed method to infer risk of drug candidates by statistical comparison with reference library data (clustering, "fingerprinting" now generally "machine learning") • Developed simulation-based reverse engineering method to evaluate cardiac safety of new drug candidates (Bottino et al., Prog Biophys Mol Bio 2006) • Managed development of company’s proprietary biophysical models of cardiac electrophysiology • Managed multi-year sponsored research and consulting agreement with a leading cardiovascular research institute to provide proprietary data for product development

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