ClinPharmPod

Clinical Pharmacology & Therapeutics recently published its third themed issue of 2022 – Transporters. Join Deputy Editor-in-Chief Dr. Kathy Giacomini as she relays what papers caught her eye, her thoughts around the growing importance of transporters in Clinical Pharmacology, and how the editorial team developed that eye-catching cover. If you're interested in submitting your research for any upcoming themed issues in ASCPT's Journal Family, you can find Calls for Papers and more information here.

Critical Path Institute's Dr. Diane Stephenson joins host Alaina Webster to discuss the importance of data sharing to improve patient care, particularly in Neuroscience. Diane and her co-authors recently published a Review, “Can Innovative Trial Designs in Orphan Diseases Drive Advancement of Treatments for Common Neurological Diseases?”, in the April Neuroscience-themed issue of Clinical Pharmacology & Therapeutics, and she ties this work into successful data sharing models and their impact on patient outcomes. Critical Path Institute has accumulated more than 300 clinical data studies across 15+ disease areas, and its repository of data currently includes information on the following neuroscience diseases: Alzheimer's disease, Huntington's disease, ataxias, Duchenne muscular dystrophy, Parkinson's disease, and multiple sclerosis.

Clinical Pharmacology & Therapeutics (CPT) has launched two Calls for Papers. The January 2023 issue of the journal will focus on Biosimilars, and the March 2023 issue will showcase research that highlights Diversity, Equity, and Inclusion in clinical pharmacology and translational science. CPT Editor-in-Chief Piet van der Graaf and Associate Editor Karthik Venkatakrishnan join host Alaina Webster to discuss types of submission they'd most like to see submitted for these themes.

Clinical Pharmacology & Therapeutics recently published its second themed issue of 2022 – Therapeutics in Neuroscience. Join Editor-in-Chief Dr. Piet van der Graaf and Associate/Guest Editors Drs. Spiros Vamvakas, Paulien Ravenstijn, and Iris Minichmayr as they delve into reasons for the theme, what papers caught their eyes, and what action items they hope to leave with readers. If you're interested in submitting your research for any upcoming themed issues in ASCPT's Journal Family, you can find Calls for Papers and more information here.

Clinical Pharmacology & Therapeutics (CPT) has launched a Call for Papers for its September 2022 themed issue on Transporters. Join host Alaina Webster as she welcomes CPT's Deputy Managing Editor Dr. Kathy Giacomini and Editor-in-Training Dr. Max Smith to discuss types of submissions they'd most like to see as well as why submitting to a themed issue could be a great visibility booster for your paper!

Host Alaina Webster sits down with Dr. Jonathan French to discuss the best organizational practices for a review – both from an associated editor's standpoint and from an author's. Jonthan, an Associate Editor for CPT: Pharmacometrics & Systems Pharmacology, delves into why he appreciates reviews that are broken up into three sections as well as why ASCPT's journals ask for comments to the editor as well as the reviewer. You can access PSP's Reviewer Instructions and contact the editorial office to volunteer as a reviewer here.

In the fourth episode in the peer review series, Dr. Stefanie Hennig joins host Alaina Webster to walk you through what editors do with a review once it's received. Stefanie, an Associate Editor for CPT: Pharmacometrics & Systems Pharmacology details her first steps upon receiving a review, how much a reviewer's opinion influences her decision on a manuscript, and how she decides is reviewers are needed for a revised manuscript. You can access PSP's Reviewer Instructions and contact the editorial office to volunteer as a reviewer here.

ClinPharmPod's peer review series continues as host Alaina Webster is chats with Dr. Richard Peck about what to avoid when completing a review. They cover what's too little and what's too much in a review, the appropriate tone to strike when providing feedback, and the tricky topic that is unconscious bias. You can access CPT's Reviewer Instructions and contact the editorial office to volunteer as a reviewer here.

Dr. Erica Woodahl is back as moderator to discuss “Applying an equity lens to pharmacogenetic research and translation to underrepresented populations” with Clinical and Translational Science authors Drs. Tiana Luczak and Jacob Brown. They break down the challenges to conducting pharmacogenetic studies in underrepresented populations, what steps researchers can take to overcome these obstacles, and why equitable studies for underrepresented groups is vital to the future of clinical pharmacology and translational science. You can access Tiana and Jacob's fully Open Access paper here.

In the second installment of ClinPharmPod's six-part peer review series, host Alaina Webster is joined by returning guest Dr. Deanna Kroetz, Professor at the University of California, San Francisco in the Department of Bioengineering Therapeutic Sciences and Deputy Editor-in-Chief of Clinical and Translational Science (CTS). They break down the top three things Deanna looks for when undertaking a peer review as well as the importance of peer review to sound science. You can access CTS's Reviewer Instructions here.

Kicking off a six-part series on peer review, ClinPharmPod host Alaina Webster chats with Dr. Sarah Holstein, Associate Professor at the University of Nebraska Medical Center and Associate Editor for Clinical Pharmacology & Therapeutics (CPT) about the importance of peer review in scientific research and what might constitute a conflict of interest for potential reviewers. You can access CPT's Reviewer Instructions here.

For this episode of ClinPharmPod, host Alaina Webster sits down with Dr. Don Willis, Assistant Professor at the University of Arkansas for Medical Sciences, and moderator Dr. Erica Woodahl, Professor at the University of Montana and Associate Editor for Clinical and Translational Science (CTS). They discuss Don and his colleagues' recent publication in CTS, “COVID-19 vaccine hesitancy: Race/ethnicity, trust, and fear,” digging into how location, race, past racism, and current systemic racism factor into the willingness to receive a COVID-19 vaccination.

On the latest episode of PSPod, host Alaina Webster is joined by France Mentré, MD, PhD, Editor-in-Chief of CPT: Pharmacometrics & Systems Pharmacology, Deanna L. Kroetz, PhD, Deputy Editor-in-Chief of Clinical and Translational Science, and Shirley K. Seo, PhD, Associate Editor of Clinical Pharmacology & Therapeutics, to discuss their experiences of how COVID-19 has affected submissions and peer review for the ASCPT Family of Journals. Brian Coughlin, Publisher at Wiley, serves as moderator for the discussion.

On the latest episode of ClinPharmPod, host Alaina Webster is joined by France Mentré, MD, PhD, Editor-in-Chief of CPT: Pharmacometrics & Systems Pharmacology, Deanna L. Kroetz, PhD, Deputy Editor-in-Chief of Clinical and Translational Science, and Shirley K. Seo, PhD, Associate Editor of Clinical Pharmacology & Therapeutics, to discuss their experiences of how COVID-19 has affected submissions and peer review for the ASCPT Family of Journals. Brian Coughlin, Publisher at Wiley, serves as moderator for the discussion.

On this episode of PSPod, Dr. Rajanikanth Madabushi from the US Food and Drug Administration continues our recent discussion on model-informed drug development (MIDD) and its role in the successful implementation of PDUFA VI. This discussion is based on his co-authored Perspective article (with Drs. Yaning Wang and Issam Zineh) “A Holistic and Integrative Approach for Advancing Model‐Informed Drug Development” which published in the January 2019 issue of PSP. The article is available here.

On this episode of PSPod, Drs. Lokesh Jain, Larissa Wenning, and Nitin Mehrotra from Merck discuss the important role model-informed drug development (MIDD) will play in the successful implementation of PDUFA VI. This discussion is based on their Perspective article “PDUFA VI: It’s Time to Unleash the Full Potential of Model-Informed Drug Development” which published in the January 2019 issue of PSP. The article is available here.

On this episode of PSPod, Drs. Piet van der Graaf and Suruchi Bakshi from Certara QSP and Leiden University, and Dr. Chao Chen from Clinical Pharmacology Modelling & Simulation at  GlaxoSmithKline, discuss quantitative systems pharmacology (QSP) modeling in relation to the study of Parkinson’s disease. This discussion is based on a Review article that published in the February 2019 issue of PSP, which is available here.

On today’s episode, Dr. Paul Watkins, the Howard Q. Ferguson Distinguished Professor at Eshelman School of Pharmacy, University of North Carolina at Chapel Hill and the Director of the University of North Carolina Institute for Drug Safety Sciences, discusses quantitative systems toxicology (QST) and quantitative systems pharmacology (QSP) modeling, recent examples of their application, and how they might better inform decision-making in the pharma industry. Dr. Watkins recently wrote a Commentary in PSP related to this topic and it is available here.

On this special joint episode of ClinPharmPod, the official podcast for Clinical Pharmacology and Therapeutics, and PSPod, the official podcast of CPT: Pharmacometrics and Systems Pharmacology Karthik Venkatakrishnan from Takeda Pharmaceuticals and Associate Editor for Clinical Pharmacology and Therapeutics, Lang Li, from the Ohio State University and Associate Editor for CPT: Pharmacometrics and Systems Pharmacology, and Valentina Shakhnovich from Children’s Mercy Hospital in Kansas City and Associate Editor for Clinical and Translational Science discuss reverse translation, the theme of a joint issue of articles recently published in the ASCPT journal family. They discuss the concept of reverse translation as a means to maximize the value of the ever-growing reservoir of real-world data in order to more effectively drive future research using retrospective analysis. Please visit the full joint virtual issue by clicking here.

In this episode Dennis Velasco speaks with Stuart MacLeod from the University of British Columbia about efforts to equip pediatric clinical pharmacologists and clinical pharmacists with the necessary skills in relevant research and educational methods to address a shortfall in the human resource pool, particularly in low- and lower-middle-income countries where a majority of children under 14 years of age reside. You can read more in the June 2017 issue of CPT focused on Drugs for Chirldren. Listen and subscribe for free on iTunes and Google Play

On today’s episode, Mike Smith from Pfizer, Justin Wilkins from Occams, and Amy Cheung from AstraZeneca discuss “Thoughtflow”, a set of standards compiled by the DDMoRe consortium to help facilitate the capture, storage, and reporting of knowledge in the context of MID3, as well as to support reproducibility.

This episode features Dr. Iñaki F. Trocóniz discussing how pharmacometric techniques can be used to counteract immuno-response suppression by tumor cells. Read his commentary from the January 2017 issue here. Also, please find additional CPT:PSP articles related to this topic in the Immuno-oncology Virtual Issue, which is available here. Listen and subscribe for free on iTunes

In this episode Dennis Velasco speaks with Marilyn Huestis from the University of Maryland School of Medicine about novel psychoactive substances (e.g., modafinil, psilocybin, lysergic acid diethylamide, and 3,4-methylenedioxymethamphetamine) and how they simultaneously offer new pharmacotherapies and pose serious health problems. You can read more in the February issue of CPT focused on Designer Drugs. Listen and subscribe for free on iTunes and Google Play

This episode features Marlene Haffner, MD, MPH of Haffner Associates, LLC discussing orphan drug regulation in the United States and beyond. Read her article which published in the October 2016 issue here. Listen and subscribe for free on iTunes and Google Play

This episode features Dr. Satyaprakash Nayak discussing application of advanced pharmacometrics and quantitative systems pharmacology in hematology. Read his article from the July 2016 issue here. Also, please find additional CPT:PSP articles related to hematology in the Hematology Virtual Issue, which is available here. Listen and subscribe for free on iTunes and Google Play

This episode features Bernard Vrijens of WestRock Healthcare discussing quantifying the influence of adherence and dose individualization. Read his Commentary which published in the April 2016 issue here. Listen and subscribe for free on iTunes and Google Play

In this episode, Drs. Scott Marshall from Pfizer, Sandra Visser from Merck, and Amy Cheung from AstraZeneca discuss “Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation”: their White Paper published in the March 2016 issue of PSP. You can get free access the White Paper by clicking here. Listen and subscribe for free on iTunes and Google Play

This episode features Daniel Hertz of the University of Michigan College of Pharmacy discussing pharmacogenetics and its potential role in screening and treating patients. Read his commentary from the February 2016 issue on Precision Medicine here. Listen and subscribe for free on iTunes and Google Play

In this episode, Peter Bonate from Astellas, discusses effective communication in systems pharmacology and pharmacometric models. You can read a review of Dr. Bonate’s book Be a Model Communicator and Sell Your Models to Anyone, reviewed by Ellen Leinfuss in the May 2015 issue, by clicking here. Listen and subscribe for free on iTunes and Google Play

This episode features Sandra Visser and Anne Chain from Merck & Co/MSD, discussing existing practice and modeling approaches and some thoughts with regard to future directions for modeling to assess and predict cardiovascular liabilities of new drugs. You can read Dr. Visser’s Review “Implementation of Quantitative and Systems Pharmacology in Large Pharma” by clicking here. Listen and subscribe for free on iTunes and Google Play

This episode features Aaron S. Kesselheim of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital discussing the 21st Century Cures Act. Read his commentary in CPT here. Listen and subscribe for free on iTunes and Google Play

This episode features Lutz Harnisch from Clinical Pharmacology Pharmacometrics at Pfizer, discussing the Drug Disease Model Resources (DDMoRe) consortium. His Perspective article that introduces the activities of the DDMoRe consortium can also be found here. Listen and subscribe for free on iTunes and Google Play

This episode features Michelle Roth-Cline, ‎Pediatric Ethicist in the Office of Pediatric Therapeutics at the FDA, discussing her Commentary “Microdosing Studies in Children: A US Regulatory Perspective” which published in the September 2016 issue of CPT. Read the commentary here. Listen and subscribe for free on iTunes and Google Play

This episode features Mark A. Ware of McGill University discussing perspectives, challenges, and opportunities related to medical education on cannabis and cannabinoids. Read the article here. Listen and subscribe for free on iTunes and Google Play

In this episode, we interview Dr. Shiew-Mei Huang, Deputy Director, Office of Clinical Pharmacology, Center for Drug Evaluation and Research at the Food and Drug Administration about a drug interaction database–a tool for evaluating the impact of renal or hepatic impairment in a pharmacologic inhibition on the systemic exposure of drugs. Read the article here. An Editorial describing the new Database article type can also be found here. Listen and subscribe for free on iTunes and Google Play

In this episode, we interview Dr. Steven E. Kern, Deputy Director of Quantitative Sciences at the Bill and Melinda Gates Foundation, about infectious diseases in context of the possibilities for pharmacometrics and systems pharmacology to contribute to improve treatments in the area. You can view PSP’s Infectious Diseases virtual issue online to view the most recently published articles related to this field by clicking here. Listen and subscribe for free on iTunes and Google Play