American College of Clinical Pharmacology

American College of Clinical Pharmacology

American College of Clinical Pharmacology (ACCP) is a non-profit membership association with a 40+ year history of providing exceptional interdisciplinary,

Founded in 1969 by a group of eminent physicians, the College today consists of a full spectrum of healthcare professionals who remain dedicated to advancing clinical pharmacology with the goal of providing exceptional patient care. As an organization whose primary role is education, the College does not concentrate on any one aspect of the discipline. Rather, the College seeks to address the educational needs of its diverse membership and all healthcare professionals, covering a range of topics that span the entire area of the interaction between drugs and humans. These areas include, but are not limited to, pharmaceutical chemistry, biochemistry, drug metabolism, pharmacokinetics, pharmacodynamics, pharmacometrics, pharmacogenomics, clinical pharmacology practice in the outpatient and inpatient settings, human toxicology, drug interactions, and clinical drug trials. The diversity of the College is expressed not only in the composition of its membership, but also in its leadership. Maintaining a balance of elected Regents and Officers from all pertinent professional backgrounds ensures that the College remains attuned to the needs of all professionals engaged in the practice of or with a strong interest in clinical pharmacology, from the research laboratory (academic and industrial) to the classroom, and from the clinical trial to improved patient care.

American College of Clinical Pharmacology (ACCP) is a non-profit membership association with a 40+ year history of providing exceptional interdisciplinary, accredited Continuing Education programs, publications, networking and other career-enhancing opportunities to a wide spectrum of health care professionals using clinical pharmacology in disciplines from research to patient care.

Mission: Vision & Mission To improve health by optimizing therapeutics. Provide innovative leadership and interdisciplinary education that will enable the generation, integration and translation of scientific knowledge to optimize research, development and utilization of medication for the benefit of all.

Operating as usual

The Journal of Clinical Pharmacology - COVID-19 Research Virtual Issue

The #COVID19 Research Virtual Issue is a repository for all material published on COVID-19 in The Journal of Clinical Pharmacology. The virtual issue will be updated as COVID-19 related papers are published. The COVID-19 Research Virtual Issue can be found here: https://bit.ly/3cTC1xB

COVID-19 Articles

*TMPRSS2: Potential Biomarker for COVID‐19 Outcomes*
Jonathan D. Strope BS, Cindy H. Chau PharmD, PhD, William D. Figg PharmD
First Published: 21 May 2020

*Intuitive Global Insight Into COVID‐19 Clinical Research Activities—The “COVID‐19 Map of Hope”*
Markus Ries MD, PhD, MHSc, FCP, Konstantin Mechler MD, Donna L. Smith MS, MT(ASCP)SBB, Benjamin Herfort, Johannes Visintini, Amon Veiga Santana, Alexander Zipf PhD, Sven Lautenbach PhD
First Published: 21 May 2020

*Severe Acute Lung Injury Related to COVID‐19 Infection: A Review and the Possible Role for Escin*
Luca Gallelli MD, PhD, Leiming Zhang MD, PhD, Tian Wang MD, PhD, Fenghua Fu MD, PhD
First Published: 22 May 2020

*Can Colchicine as an Old Anti‐Inflammatory Agent Be Effective in COVID‐19?*
Somayyeh Nasiripour PharmD, Farhad Zamani MD, Maryam Farasatinasab PharmD
First Published: 23 May 2020

*Hydroxychloroquine and Azithromycin to Treat Patients With COVID‐19: Both Friends and Foes?*
Bruno Mégarbane MD, PhD, Jean‐Michel Scherrmann PharmD, PhD
First Published: 20 May 2020

*Evaluation of Potential Therapeutic Options for COVID‐19*
Daren Austin BSc, PhD, Malek Okour BDS, PhD
First Published: 29 May 2020

*A Comprehensive Updated Review on SARS‐CoV‐2 and COVID‐19*
Yunzhao R. Ren MD, PhD, Amit Golding MD, PhD, Alfred Sorbello DO, MPH, Ping Ji PhD, Jianmeng Chen MD, PhD, Bhawana Saluja PhD, Kimberly Witzmann MD, Vikram Arya PhD, FCP, Kellie S. Reynolds PharmD, Su‐Young Choi PharmD, PhD, Nikolay P. Nikolov MD, Chandrahas Sahajwalla PhD, FCP
First Published: 29 May 2020

*Colchicine and COVID‐19*
Pablo Corral MD, Gonzalo Corral MD, Rafael Diaz MD
First Published: 08 June 2020

*Why Your Patients’ Believing Hydroxychloroquine and Chloroquine Are 90% Effective for COVID‐19 Is 100% Dangerous*
C. Michael White PharmD, FCP, FCCP, Adrian V. Hernandez MD, PhD
First Published: 12 June 2020

*Critical Need for Implementation of Clinical Pharmacology Principles in Developing Drugs for the Treatment or Prevention of COVID‐19*
Gina Pastino PhD, DABT
First Published: 14 June 2020

*A Comprehensive Review of Tocilizumab in COVID‐19 Acute Respiratory Distress Syndrome*
Sajad Khiali PharmD, Elnaz Khani PharmD, Taher Entezari‐Maleki PharmD, PhD
First Published: 18 June 2020
#pharmacology #research

Save the date for the #2021ACCP Annual Meeting, "Spearheading Innovations in Clinical Pharmacology", Sept 12 - 14, 2021 at the Renaissance Phoenix Downtown Hotel!

Registration includes Pre-meeting Workshops, a Plenary Session, Symposia, Exhibits, Poster Sessions, STEP events and networking during catered Evening Receptions & Poster Sessions, Lunch & Awards events and session breaks.

CE credits are provided to attendees at no cost. We look forward to seeing you in Phoenix! https://bit.ly/2VGpXaX

At 2:00 PM ET today the ACCP Early-stage Professional Webinar: Lessons Learned: Perspectives from Government, Academia & Industry will begin.

This webinar provides career development tools to Students, Trainees & Early-stage Professionals entering or at the beginning of their careers in the field clinical pharmacology. It's not too late to register. We hope to see you soon!

Register now...https://bit.ly/2RypgyC
#pharmacology #CME #CPE #careerdevelopment

The Journal of Clinical Pharmacology - October 2020, Vol 60, Issue 10 is now available!

COVID RELATED ARTICLES

*Continuing Education: Review*
Immunomodulatory Therapeutic Proteins in COVID‐19: Current Clinical Development and Clinical Pharmacology Considerations
Ping Ji PhD, Jianmeng Chen MD, PhD, Amit Golding MD, PhD, Nikolay P. Nikolov MD, Bhawana Saluja PhD, Yunzhao R. Ren MD, PhD, Chandrahas G. Sahajwalla PhD, FCP
Pages: 1275-1293 | First Published: 10 August 2020

NON COVID ARTICLES

*Drug Interactions*
Proposal of a Safe and Effective Study Design for CYP3A‐Mediated Drug‐Drug Interactions
Brit Silja Rohr, Gerd Mikus MD, MSc
Pages: 1294-1303 | First Published: 21 May 2020

A Phase 2, Double‐Blind, Placebo‐Controlled Trial to Investigate Potential Drug‐Drug Interactions Between Cannabidiol and Clobazam
Kevan E. VanLandingham MD, PhD, Julie Crockett PhD, Lesley Taylor PhD, Gilmour Morrison HND
Pages: 1304-1313 | First Published: 11 July 2020

Pharmacokinetic Drug Interactions of an Orally Available TRH Analog (Rovatirelin) With a CYP3A4/5 and P‐Glycoprotein Inhibitor (Itraconazole)
Kaoru Kobayashi MS, Yoshikazu Abe PhD, Asuka Kawai BS, Takao Furihata PhD, Takuro Endo PhD, Hiroo Takeda PhD
Pages: 1314-1323 | First Published: 27 May 2020

*Exposure‐Response*
Talazoparib Exposure‐Efficacy Analysis in Patients With Advanced Breast Cancer and Germline BRCA1/2 Mutations in the EMBRACA Trial
Yanke Yu PhD, Mohamed Elmeliegy PhD, Jennifer K. Litton MD, Iulia Cristina Tudor PhD, Akos Czibere MD, PhD, Jenny Zheng PhD, Diane D. Wang PhD
Pages: 1324-1333 | First Published: 28 May 2020

Exposure‐Safety Analyses of Talazoparib in Patients With Advanced Breast Cancer and Germline BRCA1/2 Mutations in the EMBRACA and ABRAZO Trials
Mohamed Elmeliegy PhD, Yanke Yu PhD, Jennifer K. Litton MD, Akos Czibere MD, PhD, Gary G. Wilson PhD, Iulia Cristina Tudor PhD, Jenny Zheng PhD, Diane D. Wang PhD
Pages: 1334-1343 | First Published: 28 May 2020

*Pharmacokinetics*
Predictors of Systemic Exposure to Topical Crisaborole: A Nonlinear Regression Analysis
Vivek Purohit PhD, Steve Riley PhD, Huaming Tan PhD, William C. Ports DVM
Pages: 1344-1354 | First Published: 20 May 2020

*Therapeutics*
Effects of Atypical Antipsychotics on Neuroactive Vitamins in Patients With Schizophrenia
Tengfei Yuan PhD, Shaoting Wang PhD, Juan Le MD, Yan Li PhD
Pages: 1355-1361 | First Published: 19 May 2020

*Editor's Choice: Therapeutics*
Rivaroxaban as an Alternative Agent for Heparin‐Induced Thrombocytopenia
Maryam Farasatinasab PharmD, Behnaz Zarei PharmD, Mehdi Moghtadaei MD, Somayyeh Nasiripour PharmD, Nafiseh Ansarinejad MD, Masoumeh Zarei MD
Pages: 1362-1366 | First Published: 10 June 2020

*Pharmacovigilance*
Suspected Adverse Drug Reactions From Corticosteroids: Analysis of Reported Notifications to the Portuguese Pharmacovigilance System
Cristel Gonçalves MD, Cristina Monteiro PharmD, MSc, Jorge Luiz Santos MD, PhD
Pages: 1367-1375 | First Published: 02 June 2020

*Women's Health*
Impact of Anxiety or Depression Symptoms on Propofol Requirements for Sedation in Females: A Prospective Cohort Study
Rui‐yun Li MD, Ming Lin MD, Hong‐ye Jiang MD, Shi‐hong Wen MD, PhD, Jian‐tong Shen MD, Wen‐qi Huang MD, PhD, Xu‐yu Zhang MD, PhD
Pages: 1376-1384 | First Published: 23 May 2020

*Pediatric Pharmacology*
Exposure‐Response Analysis of Vamorolone (VBP15) in Boys With Duchenne Muscular Dystrophy
Xiaonan Li PhD, Laurie S. Conklin MD, John van den Anker MD, PhD, Eric P. Hoffman PhD, Paula R. Clemens MD, William J. Jusko PhD
Pages: 1385-1396 | First Published: 20 May 2020

*Special Populations*
Pharmacokinetics and Safety of Ranirestat in Patients With Hepatic Impairment
Minoru Itou MD, PhD, Tomoe Fujita MD, PhD, Kazuaki Inoue MD, PhD, Naoki Uchida MD, PhD, Takeshi Takagaki MSc, Daisuke Ishii MSc, Hiroyoshi Kakuyama PhD
Pages: 1397-1403 | First Published: 21 May 2020

http://bit.ly/2Ijxci7 #ACCPJCP

A Note of Gratitude and Appreciation from Vikram Arya, PhD, FCP, President of the American College of Clinical Pharmacology®

It has been my honor and pleasure to serve as the President of the American College of Clinical Pharmacology during the 2018 – 2020 term. As I think back, I would like to acknowledge the recent accomplishments of the society.

In 2019, ACCP celebrated 50 years of serving the global clinical pharmacology community. The year-long celebration included a historical retrospective series on the society’s accomplishments and the production of a memorial lapel pin. The celebration culminated in a Gala at the 2019 ACCP Annual Meeting.

Consistent with its Vision & Mission, ACCP continues to provide exceptional continuing education programs, including Live and On Demand webinars such as the ACCP Virtual Journal Club, plus Journal CE for The Journal of Clinical Pharmacology. The 2019 ACCP Annual Meeting was a huge success, providing an outstanding educational program and celebrating the 50-year anniversary. Continue reading...https://conta.cc/3jsncEO

Only one week until the Oct ACCP Early-stage Professional Webinar: Lessons Learned: Perspectives from Government, Academia & Industry

Date: Wednesday, October 7, 2020
Time: 2:00 - 3:00 PM ET
Register today...https://bit.ly/2RypgyC
#pharmacology #CME #CPE #careerdevelopment

ACCP/ISoP Clinical Pharmacometrics Special Interest Group Post-ACCP 2020 Award Presentation and Networking Event

Friday, October 2nd @ 2:00 PM ET

The Clinical Pharmacometrics Special Interest Group cordially invites you to a special post-ACCP 2020 session dedicated to advancing model-based precision medicine. Join us as our Student Abstract Award winner, Dr. Mu'taz Jaber, presents his work in applying pharmacometric concepts for hydrocortisone dose individualization and engage in a virtual forum to connect with fellow scientists interested in improving patient care through quantitative pharmacology. Participants will further learn about the SIG’s present and future initiatives, including how they can get involved.

Register today: https://bit.ly/2RZ4DMb

[09/25/20]   The winner of the ACCP365 Mobile App Game Zone is Christine Brandquist, PharmD, MS! Dr. Brandquist placed first due to her extensive participation in the Game Zone. Thank you Dr. Brandquist for scanning the session QR Codes and submitting Session Evaluation and CE Credits! A $50 gift card is coming your way!

We would also like to announce the winners of the Evaluation drawings...Barbara Ameer, PharmD, MBA, BCPS and Michael J. Fossler, Jr, PharmD, PhD. They will also each receive a $50 gift card. Thank you, Drs. Ameer and Fossler, for your diligent completion of the Evaluations that will provide ACCP and its Faculty Speakers with valued feedback.

Congratulations everyone! ACCP appreciates your support and participation in during the #2020ACCP Virtual Annual Meeting.

The cooler temps of fall are bringing more job leads! Check out what's new on the #ACCPJOBCTR! http://bit.ly/2J0TTKj
#pharmacology #jobsearch

The #2020ACCP Annual Meeting is in the books! Thank you again to all who made this virtual event possible. It was a learning curve for all of us but in the end was a great success and allowed ACCP to support its Objective and Mission.

Yesterday, ACCP Staff celebrated at the conclusion of the event with a little bubbly and sweets. Cheers to all and we hope to see you for the #2021ACCP Annual Meeting in Phoenix, AZ, September 12 - 14, 2021!

Don't forget to register for the Oct ACCP Early-stage Professional Webinar: Lessons Learned: Perspectives from Government, Academia & Industry

Date: Wednesday, October 7, 2020
Time: 2:00 - 3:00 PM ET
Register: https://bit.ly/2RypgyC

Learning Objectives
After completing this activity, the learner will be able to:
1) Identify behaviors associated with facilitating successful career advancement;
2) Learn from specific examples of professional conduct that can be applied to their own career
circumstances enabling them to better navigate or overcome barriers to career advancement;
3) Demonstrate domain specific (i.e., academics, industry, and/or regulatory) knowledge regarding
career advancement in the field of clinical pharmacology;
4) Gain practical insights into avoiding and addressing potential career missteps.

Faculty:
Manjunath (Amit) P. Pai, PharmD, Associate Professor, Coll of Pharmacy, Univ of Michicgan
Dionna Green, MD, FCP, Deputy Director, Office of Pediatric Therapeutics, US Food & Drug Administration
John D. Davis PhD, FCP, MRPharmS, Executive Director & Head, Clinical Pharmacology, Regeneron
#pharmacology #CME #CPE #careerdevelopment

fda.gov

New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic

FDA Announces ICH E14/S7B Webinar: New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment

The Food and Drug Administration (FDA) will host a free, two-day public webinar on October 15-16, 2020 titled “New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment.” Multiple regulatory and industry members from around the world that are members of the International Council for Harmonisation (ICH) E14/S7B Implementation Working Group will present on the Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential.

The ICH E14/S7B Implementation Working Group developed new Questions & Answers (Q&As) to ICH E14 and S7B, which were released by ICH as a Draft Guideline for public consultation on August 27, 2020.

The webinar will cover the background, motivation for, and overview of the new Q&As for ICH E14/S7B, followed by presentations on each of the main Q&A topics. The new Q&As describe how nonclinical assays can be used as a part of an integrated risk assessment prior to first-in-human studies as they are used today, and in later stages of clinical development as a part of a combined nonclinical-clinical integrated risk assessment. If implemented, they can lead to a reduction in the number of “Thorough QT” clinical studies and improved decision-making at the time of a marketing application.

Example cases will be presented that highlight the potential impact of applying the principles in the new Q&As on drug development and regulatory evaluation. Questions can be submitted via the Q&A pod during the webinar and will be discussed at the end of each of the two sessions by members of the E14/S7B working group.

This webinar is intended for the following audience:

• Nonclinical and clinical scientists involved in the performance, assessment, or evaluation of studies under ICH E14 and S7B from regulators, pharmaceutical industry, contract research organizations and instrument providers, as well as pharmaceutical/regulatory consultants with expertise in this area
• Researchers or clinicians with an interest in assessment of proarrhythmia
• Drug development professionals and stakeholders with an interest in understanding the potential impact of the draft Q&As

Dates/Times of the Webinar:
• Tuesday, October 15, 2020 – 8:00-10:30 am US EDT (UTC/GMT -4 hours)
• Wednesday, October 16, 2020 – 8:00-10:30 am US EDT (UTC/GMT -4 hours)

Additional details about this webinar, including registration, agenda, and supplementary resources such as the original E14/S7B Guidelines (May 2005), Work Plan (April 2020), and Concept Paper (2018), are available at https://bit.ly/3kU4KFt.

fda.gov New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment

It's hard to believe the last day of the #2020ACCP Annual Meeting is here. Day 3 begins with presentations from our remaining Recognition Award Winners followed by Symposia 15 - 21.

Thank you to all of the Attendees, Faculty Speakers, Poster Presenters, Sponsors, Abstract Judges, 2020 Annual Meeting Program Committee and Co-chairs and the ACCP Officers and Board of Regents for making this 2020 Virtual ACCP Annual Meeting possible! This could not have happened without your support! Another congratulations to our deserving ACCP Recognition Award Winners and Student & Trainee Abstract Award Winners on a job well done!

We hope you enjoy your day and please mark your calendars for the 2021 ACCP Annual Meeting at the Renaissance Phoenix Downtown Hotel in Phoenix, AZ September 12 - 14, 2021!
#pharmacology #annualmeeting #CE

Congratulations to the New Member Abstract Award & Wayne A. Colburn Memorial Award Winners | #2020ACCP Annual Meeting

New Member Abstract Award Winner - Lana Tran, PharmD
The New Member Abstract Award is given for the best poster presented by a New Member. The New Member Abstract Award winner receives a trophy and an honorarium of $500.

Wayne A. Colburn Memorial Award Winner - Karthik Lingineni, MS
The Wayne A. Colburn Memorial Award is given to the best poster presented by one of the eight Student & Trainee Abstract Award winners. The Wayne A. Colburn Memorial Award winner receives a trophy and an honorarium of $500.
#pharmacology

Day 2 of the #2020ACCP Annual Meeting!

Today begins with presentations from our Recognition Award Winners followed by the Keynote Address from Steven D. Gore, MD, 20 years of ‘Epigenetic’ Cancer Therapy - Who are We Fooling?

Altasciences presents "Navigating Early Phase CNS-Activity Drug Development" at their Round Table Talk at 9:30 AM ET.

It's another full day of exceptional Symposium. Enjoy Day 2 and please share your experience in the comments below!
#pharmacology #drugdevelopment

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21750 Red Rum Dr, Ste 137
Ashburn, VA
20147

General information

ACCP is a member-driven/member-focused organization that provides accredited continuing education to healthcare professionals. ACCP also publishes The Journal of Clinical Pharmacology and will soon publish the eJournal Clinical Pharmacology in Drug Development.

Opening Hours

Monday 08:00 - 17:00
Tuesday 08:00 - 17:00
Wednesday 08:00 - 17:00
Thursday 08:00 - 17:00
Friday 08:00 - 17:00
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