Meet the 2018 September Land O’ Lakes Speakers

I’m excited to be talking about the challenges of CYP reaction phenotyping at the September 2018 Land O’Lakes Conference on Wednesday, September 19th. Accurately predicting the CYP isoform contributions to metabolic elimination of new drug candidates is a vital component of the DDI victim risk assessment. What has generally been considered a mature portfolio of tools and reagents for predicting phenotypic profiles is facing new challenges imposed by candidates with low overall metabolic clearance, multiple contributing enzymatic clearance mechanisms, and atypical kinetic profiles, among many other reasons. Additionally the influence of PBPK modeling in DDI risk prediction imparts additional pressures for defining the contributing enzymes. I am looking forward to discussing the hurdles we’ve encountered and solutions we’ve found in this area over the past several years.

Angela Doran, PhD
Principal Scientist
Medicine Design, ADME Sciences
Pfizer Global Research and Development
Pfizer Inc. 

Hi I am Cheng Chang, a clinical pharmacologist from Pfizer. I will be talking about “Model-based translation analysis and its application in the development of an irreversible KAT II inhibitor” at the “2018 Land O Lakes Conference on 9/18”.  I am really excited because “this presentation demonstrates how modeling and simulation was applied to accelerate the development of new drugs”. I look forward to seeing you there.

Cheng Chang, PhD
Associate Director 
Pfizer Clinical Pharmacology
Pfizer Inc. 

I am a Clinical Pharmacologist and Policy Lead in the Office of Clinical Pharmacology (OCP) at the Food and Drug Administration (FDA). I am looking forward to discussing the evaluation of clinical drug–drug interactions at the September 2018 Land O Lakes Conference on September 18^th. I am excited to be presenting on this topic following the release of the FDA draft guidance last October. I look forward to the discussion and seeing you there.

Elimika Pfuma Fletcher, PhD
Clinical Pharmacology Policy Lead
US Food and Drug Administration 

I am currently a Senior Director at Madrigal Pharmaceuticals where I am largely responsible for the oversight of our preclinical projects to support the development of our lead drug MGL-3196 to treat NASH and other dyslipidemia diseases. Before my tenure at Madrigal I spent 12 years in a Tox/Path facility, followed 20 years in the department of drug metabolism and pharmacokinetics for a few large companies and a CRO, where I specialized in designing and conducting various radiolabeled ADME studies to support the discovery and development of small and large molecules to treat a variety of diseases. During that time, I have continually learned about estimating radiation dosimetry, which enables the use of radiolabeled test compounds to be used for examining mass balance and metabolite identification in human subjects. The concern here being that we don’t expose human test subjects to dangerous levels of radiation during the clinical radiolabeled drug disposition study. When I started learning about radiation dosimetry the topic and techniques were quite confusing, but after studying it over time I began to understand the history and techniques used to comply with the regulatory requirements needed to determine radiation dosimetry to support drug research. I am looking forward to sharing what I have learned about estimating human radiation dosimetry and how it is applied to drug research at the Land O’Lakes Drug Metabolism, Pharmacokinetics and Applied Drug Development Conference, on September 17-20, 2018. I hope to see you there!

Eric Solon, PhD
Senior Director
Preclinical Development
Madrigal Pharmaceuticals, Inc.

I have been working in Drug Discovery (Metabolism and Pharmacokinetics) for the past 27 years here and at Parke-Davis Pharmaceutical Research. I will be talking about the latest in vitro DDI Guidance by the FDA covering inhibition, induction and reaction phenotyping at the 21st Annual Drug Metabolism and Applied Pharmacokinetics Conference, New Opportunities for DMPK: The 21st Century Cures Act on September 18. I am really excited to be presenting this topic because it will describe some of the new changes for predicting drug-drug interactions. I look forward to seeing you there.

Michael Sinz, PhD
Director DMPK
Bristol-Myers Squibb