MEC Regulatory & Toxicology Consulting, LLC
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Publication of Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals

2/3/2022

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I am excited to announce that our book, Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals, is out and available! Additional information can be located on the Taylor & Francis Group website and Amazon.
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Classic and evolving approaches to evaluating cross reactivity of mAb and mAb-like molecules - a survey of industry 2008-2019.

2/22/2021

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As co-author of the article Classic and evolving approaches to evaluating cross-reaching of mAb ad mAb-like molecules - a survey of industry 2008-2019, I would like to share a personalized URL that provides free access to the article through March 26th: www.sciencedirect.com/science/article/pii/S027323002100012X?dgcid=coauthor. I hope you enjoy the article!
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Inaugural Dean's Advisory Council Chosen for Diverse Expertise

7/27/2020

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Toxicologic Pathology for Non-Pathologists Now Available

12/14/2019

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I'm happy to announce that my new book titled Toxicologic Pathology for Non-Pathologists is now available via Amazon!  Order here. 

About the book: This extensive volume began as a short course primarily geared toward toxicologists who want to expand their understanding of toxicologic pathology in order to be better study directors while also proving to be of great interest to other drug development scientists and regulatory reviewers. The overall goal is to help non-pathologists understand, contextualize, and communicate the pathology data and interpretations from the study pathologist in a practical and usable format. Within the book, readers will find an overview of general pathology concepts that include fundamental vocabulary and the basics of pathophysiological processes, along with numerous chapters devoted to pathology in specific organ systems as well as topics such as biomarkers, correlation of clinical pathology endpoints (chemistry and hematology) with microscopic changes, and well-known pathology findings for classes of toxic substances. 

Authoritative, practical, and comprehensive, Toxicologic Pathology for Non-Pathologists aims to help non-pathologists understand, converse in, and apply a basic understanding of pathology in their day-to-day careers.

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Mary Ellen Awarded the Mildred Christian Women's Leadership in Toxicology Award

12/14/2019

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It was an honor to be selected as the recipient of the Mildred Christian Women's Leadership in Toxicology Award at the 2019 ACT Annual Meeting! 
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IUTOX ICTXV 2019, July 15 - 18

7/14/2019

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Looking forward to catching up with friends and colleagues at the IUTOX 2019 conference in Hawaii this week.  The Society of Toxicology (SOT) will be co-hosting this year and we are looking forward to an informative and educational conference. 
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No longer an option:  Pediatric considerations in drug development

7/18/2018

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Both Europe and US regulators have strengthened pediatric regulations with the goal of increasing the availability of new drugs for children. When the disease in children is similar or related to an adult disease the pathway is much clearer. There are still challenges in developing new drugs for diseases that occur only in children. Efforts continue to help guide the development of pediatric medicines.  

​https://www.outsourcing-pharma.com/Article/2018/07/17/No-longer-an-option-Pediatric-considerations-in-drug-development
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March for Science draws smaller crowds than last year, but attendees are still passionate.

4/29/2018

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Attended the 2018 March for Science in DC and am quoted in this CNN article. Small Victories also gave a shout out! 
​www.cnn.com/2018/04/14/us/march-for-science-2018/index.html
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38th Annual ACT Meeting in Palm Springs, November 5-8

5/24/2017

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The 38th Annual ACT meeting will be at the Palm Springs Convention Center, November 5 - 8, 2017.  Click here for more details.  Looking forward to catching up with friends and colleagues at this meeting!
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Int'l Workshop/SD Toxicology Course in Shanghai, China

5/24/2017

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I was fortunate to have the opportunity to teach at the 2016 Int’l Workshop/SD Course on Toxicology & Safety Evaluation in Shanghai, China.  The workshop was a great success with more than 300 scientists from the pharmaceutical industry and academia in attendance. Below are some pictures from the event. 
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