Meet-the-Colleague: Clinical Pharmacometrician

Tues, April 9, 12h15 – 13h45

This session will be a Q&A session led by Yusuke Tanigawara (Keio University) and Nick Holford (University of Auckland).

The purpose of this session is to provide a discussion opportunity for health care providers who use pharmacometric method on research and clinical practice. Questions around the following topics and any other relevant questions will be covered. Participants are expected to share experience and tips to answer the questions.

  • Which types of clinical questions are most suitable to apply pharmacometric method?
  • How to communicate/convince physicians and pharmacists who do not know pharmacometrics?
  • What are the next target therapeutic fields for pharmacometrics?
  • What are the most difficult hurdles to perform pharmacometric research as academic setting?
  • How to implement modeling and simulations into routine clinical practice. What are the barriers?

Those who have comments on this session, please contact Yusuke at Tanigawara@a7.keio.jp

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Dr. Yusuke Tanigawara is Professor of Clinical Pharmacokinetics and Pharmacodynamics, Keio University School of Medicine, Tokyo, Japan. His research interests include pharmacokinetics, pharmacodynamics and optimal dosing algorithms for personalized medicine. Oncology and infectious diseases are his major fields for research. He applied pharmacometric approach to a number of new drug development as well as rational use of drugs for patient care such as clinical implementation of TDM. He also investigated multi-omics biomarkers including pharmacogenomics, proteomics and metabolomics as a novel indicator to predict responder/non-responder variation to drug therapy.

Dr Holford is Professor of Clinical Pharmacology at the University of Auckland. His research interests include population PKPD analyses of clinical trials of drugs, PKPD in neonates and children and rational approaches to dose individualization. He has developed the use of disease progress models for understanding clinical pharmacology with an emphasis on the effects of drugs in Parkinson’s Disease and predicting clinical outcome events through the use of biomarker driven hazard functions. A web-based dosing tool (www.nextdose.org) has been created to implement dose individualization using the target concentration strategy. http://holford.fmhs.auckland.ac.nz/

Meet the Advisor

Wed, April 8, 12h15 – 13h45

This session will be a Q&A session led by Holly Kimko (AstraZeneca) and Nick Holford (University of Auckland).

The purpose of this session is for individuals to present a pharmacometric problem to the advisors (Kimko and Holford) and others who wish to attend the session. After each problem presentation, a group discussion will be facilitated by the advisors to identify possible solutions.

Those who have pharmacometric analysis-related topics to ask should contact the advisors by emailing to Holly.Kimko@AstraZeneca.com with the following information by March 27, 2020.

  1. Full name, affiliation, and role
  2. Description of the topic (as much as you can share)

Are you willing to present the topic for 10 minutes during the session? Or, do you want an advisor to summarize the topic and provide comments?

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Dr Holford is Professor of Clinical Pharmacology at the University of Auckland. His research interests include population PKPD analyses of clinical trials of drugs, PKPD in neonates and children and rational approaches to dose individualization. He has developed the use of disease progress models for understanding clinical pharmacology with an emphasis on the effects of drugs in Parkinson’s Disease and predicting clinical outcome events through the use of biomarker driven hazard functions. A web-based dosing tool (www.nextdose.org) has been created to implement dose individualization using the target concentration strategy. http://holford.fmhs.auckland.ac.nz/

Dr. Holly Kimko works at AstraZeneca in Clinical Pharmacology & Safety Science since 2019. Previously she was at Johnson & Johnson and Georgetown University Medical School. She has championed the use of modeling and simulations using population analysis & quantitative systems pharmacology approaches and edited three books. She implements modeling & simulation tools in drug development by designing cost-effective clinical studies and solving compound-specific regulatory challenges in all aspects of drug development and post-approval life cycle management. She has a PhD in Pharmaceutical Sciences from the University at Buffalo with a thesis on Physiological Indirect Response Modeling.

Meet the African Pharmacometrician

Thurs, April 9, 12h15 – 13h45

This will be a Q&A session led by Emmanuel (Mannie) Chigutsa (Eli Lilly and Company), Chiara Zecchin (GlaxoSmithKline), Maxwell Chirehwa (University of Cape Town).

The purpose of this session is to provide a networking opportunity for African pharmacometricians. After introductions, discussions will include the ways to become a pharmacometrician and what is possible with knowledge of pharmacometrics in an African setting. Questions around the following topics will be covered (and any others of interest) considering the current status and potential of pharmacometrics in Africa:

  • Possible paths to becoming an impactful pharmacometrician within the African setting
  • Applications of modeling and simulations in academia and public health (African-specific examples of cases where drug doses were optimized through pharmacometrics)
  • Discussion and evaluation of whether participant’s projects could benefit from pharmacometric approaches as opposed to traditional statistical methods
  • Pharmacometrics networks (African and global)

Those who have comments on this session, please contact Mannie at chigutsa_emmanuel@lilly.com

Dr Chiara Zecchin works as a Quantitative Clinical Pharmacologist at GlaxoSmithKline, where she supports the clinical development of monoclonal antibodies and small molecules for immune-inflammation mediated diseases, with a focus on the application of model-informed drug development and statistical principles for decision-making, design, analysis, and interpretation of clinical studies. Prior to GlaxoSmithKline, Chiara worked as Post-doctoral research fellow at Eli Lilly and participated in Drug Disease Model Resources (DDMoRe) consortium activities. Her research focused on models for prediction of survival of oncology patients, based on early treatment driven biomarkers and patient characteristics. Chiara completed her PhD and her Master degree in Bioegnineering at the University of Padova.

Dr Emmanuel Chigutsa is a Pharmacometrics Team Leader at Eli Lilly and Company. Emmanuel applies modeling and simulation-based methods in all phases of clinical drug development across various therapeutic areas including autoimmune, diabetes, oncology and pain. Emmanuel received his PhD degree in Clinical Pharmacology from the University of Cape Town in 2013, a Masters in Pharmacogenetics from the University of Zimbabwe (UZ) and a Bachelor of Pharmacy degree from UZ 2005.

Dr Maxwell Chirehwa is a pharmacometric research officer at the University of Cape Town (UCT), South Africa. He completed his PhD in pharmacometrics at UCT in 2018. Maxwell currently applies pharmacometric modelling to the optimisation of drugs and drug combinations for the treatment of tuberculosis and HIV. He is also involved in building capabilities in pharmacometric modelling and biostatistics in Africa.

Meet the Mentor

Thurs, April 9, 12h15 – 13h45

This session with mentors Stefanie Hennig (Certara) and Stacey Tannenbaum (Astellas) will include general career consultation topics which are relevant to supporting professional growth for students and early career scientists in Pharmacometrics, including: communication and soft skill development, leadership advancement, publication guidance, and modeling strategy.

The format of this session will be some introductory remarks from each of the mentors and then some Q&A/panel discussions with the participants. Please come prepared with your questions!

Dr. Stefanie Hennig, MSc, PhD is a PK/PD consultant at Certara since July 2019. Before joining Certara, she held a tenured academic position at the University of Queensland (2011-2019) and was a senior fellow of the Humboldt Foundation with the Freie Universitaet in Germany. She supervised and mentored > 20 higher research students and taught thousands of undergraduate students on PK/PD. Stefanie is very active within the Pharmacometrics community worldwide, as the secretary of PAGANZ, a member of the executive committee of WCoP and the Chair of the local organising committee for WCoP2016. Her main research interests are around optimising dosing in children and dose individualization using Bayesian forecasting.

Stacey Tannenbaum, Ph.D., FISoP, Senior Director, leads the Pharmacometrics group at Astellas Pharma, and Chairs the WCoP Executive Committee. She co-founded the International Society of Pharmacometrics, serving as its first President, and sits on a number of ISoP committees and interest groups. She also co-founded the American Conference on Pharmacometrics (ACoP) and was conference chair for the first three events. She received the ISoP Fellowship in 2014 and Leadership Award in 2018. Stacey served as a board member of the American Association of Pharmaceutical Scientists, chaired the M&S Focus Group, and was the co-chair for the AAPS Forum for Connecting Predictive Modelers.