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  • ACCP 2018 Virtual Journal Club August - Evaluation of Flexible Tacrolimus Drug Concentration Monitoring Approach in Patients Receiving Extended‐Release Once‐Daily Tacrolimus Tablets

    Contains 5 Component(s), Medical Credits Offered Includes a Live Event on 08/08/2018 at 2:00 PM (EDT)

    Presented by: Timothy Horwedel, MHA, PharmD, BCPS and Patricia West-Thielke, PharmD. This webinar will assist learners to evaluate and apply a flexible tacrolimus concentration monitoring approach in the management of kidney transplant patients receiving extended-release once-daily tacrolimus tablets that allows for an extended therapeutic monitoring window based upon utilization of formulas and tools for interpreting drug levels within the expanded window.

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    Attendees Obtain Free CE Credits from ACCP Virtual Journal webinars!

    Evaluation of Flexible Tacrolimus Drug Concentration Monitoring Approach in Patients Receiving Extended‐Release Once‐Daily Tacrolimus Tablets

    ACCP 2018 Virtual Journal Club Webinars

    Live Session: Wednesday, August 8, 2018 from 2:00pm to 3:00pm ET

    On Demand: August 8, 2018 to August 8, 2021

    Why is this webinar important to you? 

    Learners that complete this course will be able to evaluate and apply a flexible tacrolimus concentration monitoring approach in the management of kidney transplant patients receiving extended‐release once‐daily tacrolimus tablets that allows for an extended therapeutic monitoring window based upon utilization of formulas and tools for interpreting drug levels within the expanded window.


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    ACPE Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

    UAN: 0238-0000-18-035-L/H01-P– ACPE 1 Contact Hours

    Activity Type:  Knowledge-based   Format: Live & Home-study   Target Audience: ‘P’

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    ACCME Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

    ACCME Designation Statement

    The Accreditation Council for Continuing Medical Education designates this live and enduring CE activity for 1 AMA PRA Category 1TM credit. Physicians should only claim credit commensurate with the extent of their participation in the activity.


    Target Audience

    Interprofessional team of Physicians, Pharmacists, PhDs, Nurse Practitioners and Physician Assistants.

    Learning Objectives

    After completing this activity, the learner will be able to:

    • Compare the different pharmacokinetic profiles of immediate release and extended-release once-daily tacrolimus formulations;
    • Describe the correlations between tacrolimus concentrations around trough levels and the overall exposure (plasma drug concentration curve/AUC) over a dosing interval;
    • Interpret non-standard tacrolimus concentration monitoring results and apply these approaches to dosage monitoring/adjustments plans in patients.

    Requirements to Receive Credit

    In order to receive CE credit, the learner must register for the educational activity, study the provided journal article, attend the Live webinar or view the on-demand webinar, complete the online learning self-assessment (post-test), complete the online course evaluation and print the certificate.

    Disclosures: 

    • Author/Faculty:   Timothy Horwedel, MHA, PharmD, BCPS, Transplant Clinical Specialist, Barnes-Jewish Hosp, Dept of Pharmacy, reports a relevant financial relationship (honoraria, grant support) with Veloxis Pharmaceuticals. An independent content review has been completed which finds the article and presentation to be evidence-based, unbiased and non-promotional in nature.
    • Author/Faculty:   Patricia West-Thielke, PharmD, Director of Clinical Transplant Research, Univ of Illinois, Dept of Surgery, reports relevant financial relationships (honoraria, grant support) with Veloxis Pharmaceuticals and Astellas Pharma US. An independent content review has been completed which finds the article and presentation to be evidence-based, unbiased and non-promotional in nature.
    • Moderator/CE Planner:  Parag Kumar, PharmD, Associate Director Clinical Pharmacology, Otsuka America Pharmaceuticals, has nothing to disclose related to this topic.
    • CE Content Reviewer:   Sandeep Kushal, MBBS, MD, Professor and Head, Dayanand Medical College and Hosp, Dept of Pharmacology, has nothing to disclose.

    Schedule & Fees

    The ACCP webinar programs occur several times per year. Registration for the webinars are required but are free of charge to all learners.

    Acknowledgement of Financial Support

    No financial support was received for this educational activity.

    Home Study Initial Release and Expiration Dates

    Date of Issuance: August 8, 2018

    Expiration Date: August 8, 2021

    Online Location: https://accp1.org/Members/Cont...


    ACCP is a Member-focused/Member-driven clinical pharmacology society with

    Member Benefits that enhance your professional growth. Join today!


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    Timothy Horwedel, MHA, PharmD, BCPS

    Clinical Pharmacy Specialist, Barnes-Jewish Hosp

    Timothy Horwedel, MHA, PharmD, BCPS, received his PharmD from Northeastern Univ in 2008, then completed a PGY1 residency at Henry Ford Hosp, followed by a PGY2 in Solid Organ Transplantation at Barnes-Jewish Hosp. Following training, he served first as a clinical specialist in liver, kidney, and pancreas transplant from 2010 – 2012 at Univ of Michigan. Since 2012, he has been a clinical specialist in liver, kidney, and pancreas transplant at Barnes-Jewish Hosp, as well as serving as transplant supervisor and PGY1 residency program director. He holds an appointment of Adjunct Experiential Assistant Professor with the St. Louis Coll of Pharmacy as well as an appointment as an Adjunct Instructor with Washington Univ School of Medicine.

    Patricia West-Thielke, PharmD

    Director of Clinical Transplant Research, Univ of Illinois, Dept of Surgery

    Dr. Patricia West-Thielke, PharmD, is the Director of Clinical Transplant Research and Research Assistant Professor of Surgery at the Univ of Illinois Hosp and Health Sciences System. She has  been the principal investigator for over 30 kidney transplant clinical trials and manages a clinical trials unit. She is actively involved with the transplant program educating patients in both the pre- and post-transplant phases. Her areas of research include adherence, pharmacokinetics and sensitization .  

    Parag Kumar, PharmD (Moderator)

    Associate Director, Otsuka Pharmaceutical America, Dept of Clinical Pharmacology

    Dr. Parag Kumar, PharmD, graduated with a Doctorate in Pharmacy Summa Cum Laude from the Univ of Georgia Coll of Pharmacy, and then completed a two-year Clinical Research and Drug Development Fellowship at the Univ of North Carolina Chapel Hill and United Therapeutics Corporation (Durham, NC).  Dr. Kumar is currently an Associate Director, Clinical Pharmacology at Otsuka American Pharmaceutical, Inc. (Rockville, MD).  Previously he served as the Director of the Clinical Pharmacokinetics Research Unit (CPRU) of the National Institutes of Health (NIH), Clinical Center Pharmacy Department. In his role as director of the CPRU, Dr. Kumar has been a principal investigator or lead investigator on several clinical studies at the NIH evaluating the potential for drug interactions between HIV medications and other medications that may be used in this population. In addition to HIV, Dr. Kumar has collaborated as an associate investigator in several clinical research investigations including studies of drug metabolism/transport, drug-drug interactions, drug-gene interactions, and dose-escalation/dose-safety/tolerability in various rare/orphan disease states at the NIH. 

  • ACCP 2018 Journal CE: The Journal of Clinical Pharmacology Monthly CE Offerings

    Contains 27 Component(s), Medical Credits Offered

    ACCP's The Journal of Clinical Pharmacology (JCP) monthly Journal CE Offerings. Each month, an article selected by the Editor-in-Chief is available for CE credit.

    Welcome to ACCP's The Journal of Clinical Pharmacology (JCP) monthly CE Offerings.
    Each month, an article selected by the Editor-in-Chief is available for CE credit.

    Instructions and Pricing

    JCP Journal CE articles are priced in packages of Jan - Dec for each year. Packages are available at no cost to ACCP Members and $75/calendar year to Non-members. Once you register, you have access to all of the articles for the calendar year. If you have an ACCP profile, make sure you have signed in to the ACCP website and then register by clicking the green register button at the top right.

    Requirements for Completion

    Once you have registered, you can access the articles under the Article tab above. The post-event test and evaluation are accessed in your dashboard to the right. CE Certificates are available after the learner scores 75% or better on the activity post-event test. You must print your CE Certificate in order to receive CE credit.  CPE data is uploaded into the CPE Monitor at the beginning of the following month.

    Registration Assistance

    If you have any difficulty registering or do not have an ACCP profile, one must be created before you can register for Journal CE articles. If you do not know if you have a profile, please contact KLevy@ACCP1.org for further information to avoid creating duplicate profiles. Please address all other questions to ce@ACCP1.org  

    Accreditation Statements

    The American College of Clinical Pharmacology (ACCP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

    The American College of Clinical Pharmacology (ACCP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.


    Disclosure Information


    Please see this activities individual, monthly announcements under the "Articles" tab for all other disclosure information related to this educational activity.  




     

  • ACCP 2018 Webinar: How to be a Great Journal Peer Reviewer

    Contains 4 Component(s), Medical Credits Offered

    Presented by: Joseph S. Bertino Jr., PharmD, FCP, FCCP, Editor-in-Chief, The Journal of Clinical Pharmacology and David J. Greenblatt MD, FCP, Editor-in-Chief Clinical Pharmacology in Drug Development. This webinar provides professional training on performing scientific journal manuscript peer reviews.

    ACCP 2018 Webinar - How to be a GREAT Journal Peer Reviewer

    Live webinar with the Editor-in-Chiefs: June 13, 2018   2:00 – 3:00 PM ET  

    On-demand webinar recording:  June 13, 2018 to June 13, 2021

    Why is this article important to your practice? 

    At the completion of this webinar participants will have a strong understanding and the skills to properly review a scientific manuscript, a professional competency applicable to journal peer reviewing across professions. Topics to be covered include: why one should serve as peer reviewer; the purpose of manuscript reviews; aspects of a great review; when to decline a review; confidentiality; a technical guide for reviews for each section of the manuscript; and writing the review.  

    Target Audience: 

    Researchers, Physicians, Pharmacists, and other professionals requiring training in the professional competencies of peer reviewing. 

    Learning Objectives: 

    After completing this activity, the learner will be able to:

    1. Describe why the peer review process is important;
    2. Explain how to review various sections of a scientific manuscript;
    3. Identify elements of writing a review that will be of benefit to the authors and to the Editor of the Journal.

    To receive full credit, learners must attend the complete live webinar or view the complete on-demand webinar; pass a post-course assessment with 75% or greater and complete an evaluation.


    Joseph S. Bertino Jr., PharmD, FCP, FCCP

    Editor-in-Chief The Journal of Clinical Pharmacology

    Joseph S. Bertino Jr., Pharm.D., FCP, FCCP, is currently a Principal at Bertino Consulting, located in Schenectady, NY.  He is an Associate Professor of Pharmacology at the College of Physicians and Surgeons, Columbia University, New York, NY and an adjunct Associate Professor at the University at Buffalo School of Pharmacy.  He is also an Honorary Professor, Hanoi University of Pharmacy and a Distinguished Professor of the Hai Phong University of Medicine and Pharmacy.

    Dr. Bertino received his B.S.Pharmacy and Pharm.D. degrees from the University at Buffalo in Buffalo, NY, USA.  He has published over 100 original research papers, review articles and book chapters and a textbook of pharmacogenomics. His publications have included work in the area of antimicrobial pharmacokinetics, pharmacodynamics and toxicity, drug-drug interactions, general clinical pharmacology, vaccine pharmacology and the application of pharmacogenetics and pharmacogenomics to the drug development process.

    He serves on the Editorial Board of The European Journal of Clinical Pharmacology and Antimicrobial Agents and Chemotherapy.  Dr. Bertino has served on the Food and Drug Administration’s Antiinfective and Antiviral Advisory Committees.  He also serves as the Editor-in-Chief of the Journal of Clinical Pharmacology.

     

    David J. Greenblatt MD, FCP

    Editor-in-Chief Clinical Pharmacology in Drug Development

    Dr. Greenblatt has been on the Faculty of Tufts University School of Medicine and the Staff of Tufts Medical Center since 1979.  He holds the Louis Lasagna, M. D., Endowed Professorship at Tufts University School of Medicine, in the Department of Immunology (formerly the Department of Pharmacology and Experimental Therapeutics), and is a senior faculty member in the Graduate Program in Pharmacology & Experimental Therapeutics at the Sackler School of Graduate Biomedical Sciences at Tufts University. He also holds appointments as Professor of Psychiatry, Medicine, and Anesthesia, Tufts University School of Medicine.  He has previously served as Chair of the Department of Pharmacology and Experimental Therapeutics at Tufts University School of Medicine, Program Director and Associate Program Director of the institution’s Clinical/Translational Research Center (formerly the General Clinical Research Center), and Chair of the Institutional Review Board. He is Editor-in-Chief of Clinical Pharmacology in Drug Development, operated by the American College of Clinical Pharmacology.  He also is Co-Editor-in-Chief, with Dr. Richard I. Shader, of the Journal of Clinical Psychopharmacology,

     

    A native of Newton, Massachusetts, Dr. Greenblatt is a Magna Cum Laude graduate of Amherst College (1966), where he was senior class president and co-captain of the varsity football team. After college he attended Harvard Medical School, graduating in 1970.  Thereafter he trained in internal medicine at the Montefiore Hospital, New York City (1970-1971), and on the Harvard Medical Service at Boston City Hospital (1971-1972).  Following a Fellowship in Clinical Pharmacology at Massachusetts General Hospital under the mentorship of Dr. Jan Koch-Weser (1972-1974), he stayed on to head the Clinical Pharmacology Unit at Mass. General from 1975 to 1979, at which time he moved to Tufts.

    Joan Korth-Bradley, PharmD, PhD, FCP (Moderator)

    Senior Director, Clinical Pharmacology, Pfizer Inc.

    Joan Korth-Bradley is Senior Director, Clinical Pharmacology at Pfizer Inc where she has worked since 1991.  She received her B.Sc.Phm. from the University of Toronto, her Pharm.D. from the University of Minnesota and her Ph.D. from the University of Texas at Austin.  She also completed a residency in hospital pharmacy at the Ottawa General Hospital and a post-PharmD fellowship in pediatric clinical pharmacy at the University of Texas at Austin/Brackenridge Hospital, Austin.  She serves on the editorial board of the Clinical Pharmacology and Therapeutics, Clinical and  Translational Science, and the Journal of Clinical Pharmacology.  Joan also serves as a peer reviewer for several other clinical therapeutics and pharmacology journals. In addition, she has served as a leader in the American Association of Pharmaceutical Scientists (CPTR Section), American College of Clinical Pharmacy (PK PRN, Industrial Pharmacy PRN), the American College of Clinical Pharmacology (Regent), and the American Society of Clinical Pharmacology and Therapeutics (TPM Network). Her work includes participating as a member of multi-disciplinary development teams working in rare diseases, including hemophilia and growth hormone deficiency.  Previously, she supported anti-infectives and anti-inflammatories as well as life-cycle management activities and market support for a variety of products. Her current research interests are the application of modeling and simulation of pharmacokinetic and pharmacodynamic data in drug development of hemophilia replacement products as well as for drugs in children and other special populations.

  • ACCP 2018 Virtual Journal Club February - Pharmacokinetic Study of Intravenous Acetaminophen Administered to Critically Ill Multiple-Trauma Patients at the Usual Dosage and a New Proposal for Administration

    Contains 4 Component(s), Medical Credits Offered

    Presented by: Manuel Gerónimo-Pardo, MD, PhD, Department of Anesthesiology, Complejo Hospitalario Universitario of Albacete, Spain. This article addresses a new dose form and therapeutic application of acetaminophen in multi-trauma patients.

    ACCP Virtual Journal Club - 2018 Feb - Pharmacokinetic Study of Intravenous Acetaminophen Administered to Critically Ill Multiple-Trauma Patients at the Usual Dosage and a New Proposal for Administration

    Live webinar with the author: February 21, 2018   2:00 – 3:00 PM EST  

    On-demand webinar recording:  February 28, 2018 to February 28, 2021

    Why is this article important to your practice? 

    This article addresses a new dose form and therapeutic application of acetaminophen in multi-trauma patients. 

    Target Audience: Physicians, Pharmacists, and other clinicians involved in treating multi-trauma patients. 

    Goal and Objectives - After completing this activity, the learner will be able to:

    • Describe three potential clinical benefits of acetaminophen in the critically ill patient.
    • List the primary hepatic metabolic routes and the reported renal clearance of acetaminophen.
    • Describe the serum concentrations of acetaminophen needed to provide an antipyretic effect and analgesia.
    • Compare the total daily dose of acetaminophen needed to maintain a serum concentration of 10 ug/ml using multiple dosing and a continuous infusion.  

    To receive full credit, learners must pre-read the article located in the "handouts" tab.

    See Continuing Education Information in the "handouts" tab for more details.


    Manuel Gerónimo-Pardo

    MD, PhD

    Manuel Gerónimo-Pardo, MD, PhD, became a specialist in Clinical Pharmacology at the “Hospital Clínico San Cecilio” of Granada, Spain, in 1998. He worked as a Clinical Pharmacologist first at that hospital and then at the “Complejo Hospitalario Universitario” of Albacete, Spain, for 4 years. While working as a pharmacologist his main field of interest was individualizing the dosage of antibiotics to each patients requirements, based in both pharmacokinetic and pharmacodynamic principles. In 2002 he started a new residence, this time in Anesthesiology, and since 2010 he has been working as an anesthesiologist at the Department of Anesthesiology for the “Complejo Hospitalario Universitario” of Albacete. There he worked some years as an intensive-care physician at the Reanimation Unit, where he could regain his activity adapting drug dosages to patients individual requirements based mainly on renal function. His main activity now, is in the operating theater, but his current field of interest is the development of a new indication for sevoflurane: administration of topical sevoflurane on chronic wounds with analgesic, antimicrobial and pro-healing purposes.

    Brian Decker (Moderator)

    MD, PharmD

    Brian Decker joined the nephrology faculty at the Indiana University School of Medicine in 2007 after completing his nephrology fellowship. Subsequently, Dr. Decker completed a Master’s of Science in clinical research in 2009 and a clinical pharmacology fellowship in 2012 at the Indiana University School of Medicine.  Dr. Decker’s primary clinical and research interests are nephrology, hypertension, clinical pharmacology and the clinical implementation of personalized medicine.  Dr. Decker is also the nephrology fellowship program director and the Clinical Research Center Phase One principal investigator.  In this latter capacity, he oversees the phase one drug studies that are conducted in the Indiana Clinical and Translational Sciences Institute Clinical Research Center.  In his role as an educator, Dr. Decker provides seminars and conferences to clinicians at the intersection of internal medicine, nephrology and personalized medicine.

  • ACCP Virtual Journal Club - Pharmacokinetics and Pharmacodynamics of Tolvaptan in Autosomal Dominant Polycystic Kidney Disease: Phase 2 Trials for Dose Selection in the Pivotal Phase 3 Trial

    Contains 4 Component(s), Medical Credits Offered

    Presented by: Susan E. Shoaf, PhD, Otsuka Pharmaceutical Development & Commercialization, Inc.

    ACCP Virtual Journal Club - Pharmacokinetics and Pharmacodynamics of Tolvaptan in Autosomal Dominant Polycystic Kidney Disease: Phase 2 Trials for Dose Selection in the Pivotal Phase 3 Trial

    Date: December 13, 2017   2:00 – 3:00 PM ET  

    Why is this article important to your practice? In the pivotal TEMPO 3:4 trial, the arginine vasopressin V2-receptor antagonist tolvaptan reduced the rate of kidney growth in patients with autosomal dominant polycystic kidney disease (ADPKD). Tolvaptan was initiated as daily morning/afternoon doses of 45/15 mg, and uptitrated weekly to 60/30 mg and 90/30 mg according to patient-reported tolerability. Since publication of the TEMPO 3:4 trial, there has been interest in better understanding how this dosing regimen was developed so that the rationale for uptitration to the 90/30-mg dose regimen or to the highest tolerated dose are made in ADPKD patients on tolvaptan.

    The article describes 3 phase 2 trials in adult autosomal dominant polycystic kidney disease subjects that were the basis for the titrated split-dose regimen: a single ascending-dose trial (tolvaptan 15 to 120 mg; n = 11), a multiple split-dose trial (tolvaptan 15/15 mg, 30/0 mg, 30/15 mg, and 30/30 mg; n = 37), and an 8-week open-label safety and efficacy trial in 46 of the 48 subjects who participated in the prior 2 trials (tolvaptan 30/15 mg, 45/15 mg, 60/30 mg, and 90/30 mg). 

    Target Audience: Physicians, Pharmacists, and other clinicians involved in treating ADPKD patients or other renal impairment conditions as well as pharmacologists involved in dose-response and exposure-response safety and efficacy analysis. 

    Goal and Objectives - After completing this activity, the learner will be able to:

    • Understand biomarkers related to vasopressin V2-receptor antagonist efficacy and safety
    • Fully comprehend and explain the PK-PD rationale behind dosing titrations with tolvaptan in ADPKD patients
  • ACCP Virtual Journal Club - Continuous Lidocaine Infusion as Adjunctive Analgesia in Intensive Care Unit Patients

    Contains 4 Component(s), Medical Credits Offered Recorded On: 10/25/2017

    Presented by Yoonsun Mo, PharmD, BCPS, BCCCP, Associate Professor of Pharmacy Practice, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University

    ACCP Virtual Journal Club - Continuous Lidocaine Infusion as Adjunctive Analgesia in Intensive Care Unit Patients

    Wednesday, October 25, 2017; 2:00 – 3:00 PM ET 

    Presented by Yoonsun Mo, PharmD, BCPS, BCCCP, Associate Professor of Pharmacy Practice, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University

    Why is this article important to your practice?
    This article evaluates the role of continuous intravenous lidocaine infusion (IVLI) as an adjunct agent in the management of pain in intensive care unit patients. This article is particularly important for ICU patients who are refractory to opioids or those in whom opioid-induced respiratory depression is a concern as IVLI may lead to a reduction in opioid requirements. This study suggests that IVLI could be a safe and effective adjunctive treatment option for selected ICU patients.

    Target Audience
    Physicians, ICU Nurses, Clinical Pharmacologists and Clinical Pharmacists

    Goal and Objectives
    After completing this activity, the learner will be able to: 

    1. Discuss the indications of IVLI in the management of pain
    2. Analyze the various adverse effects associated with IVLI Describe the limitations of the use of IVLI as an adjunct therapy for pain management in ICU patients


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    Dr. Mo received her PharmD from Creighton University in 2002 and completed a PGY-1 Pharmacy Practice Residency at Barnes-Jewish Hospital in St. Louis, Missouri and a PGY-2 residency in Critical Care at University of Washington Medical Center in Seattle, Washington. After completing residency trainings, she pursued her career as a clinical pharmacy specialist in Surgery/Trauma Intensive Care Unit (ICU) at Cedars-Sinai Medical Center. In the fall of 2016, Dr. Mo joined Long Island University (LIU) Pharmacy as an Associated Professor of Pharmacy Practice. Prior to joining LIU Pharmacy, she taught as an Assistant Professor in the Department of Pharmacy Practice at the Western New England University College of Pharmacy in Springfield, Massachusetts. She also served as an ICU pharmacy specialist at Mercy Medical Center. She is board certified in pharmacotherapy as well as critical care. Her research interests lie in the area of critical care medicine, including pain/sedation/delirium practices, anticoagulation/coagulation management, sepsis, and nosocomial infections. Dr. Mo is currently practicing in the medical ICU and precepting pharmacy students at Brookdale University Hospital and Medical Center in Brooklyn, New York.

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    ACPE Accreditation Statement

    http://accp1.inreachce.com/content/owners/accp1/images/ACPE-black.pngThe American College of Clinical Pharmacology is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. 

    ACPE 1 Contact Hours UAN Number: Live:  0238-0000-17-042-LO1-P On Demand: 0238-0000-17-043-H01-P

    Knowledge Based Activity


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    ACCME Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

    Designation Statement

    The American College of Clinical Pharmacology designates this journal CE activity for 1 AMA PRA Category 1TM credit.  Physicians should only claim credit commensurate with the extent of the participation in the activity.

    In order to receive CE credit, the learner must score 75% or better on the online post-test and must complete an online evaluation.

     

    Date of Issuance:  10/25/17

    Expiration Date:  10/25/20

    In order to receive CE credit, the learner must score 75% or better on the online post-test; complete an online evaluation and print a certificate.


    Disclosures 

    Presenter: Yoonsun Mo, PharmD, BCPS, BCCCP, Associate Professor of Pharmacy Practice, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University has nothing to disclose.

    Moderator: Theodoros Xanthos MD, Pg Dip (Ed), MSc, MRes (EdD), PhD, FHEA, FAcadMEd, FCP, FERC, ERT, FESC, Professor of Medicine European University Cyprus; Professor of Resuscitation, School of Specialties, University of Cagliari, Italy; Professor of Pharmaceutical Sciences (Adjunct) Midwestern University of Chicago who reviewed the activity has no disclosures related to its content.

  • ​ACCP Virtual Journal Club - Prediction of Clearance in Neonates and Infants (≤ 3 Months of Age) for Drugs That Are Glucuronidated: A Comparative Study Between Allometric Scaling and Physiologically Based Pharmacokinetic Modeling

    Contains 4 Component(s), Medical Credits Offered

    Presented by Iftekhar Mahmood PhD, Division of Clinical Evaluation and Pharmacology/Toxicology Branch, Office of Tissues & Advance Therapies, Center for Biologic Evaluation and Research, US Food & Drug Administration

    ACCP Virtual Journal Club - Prediction of Clearance in Neonates and Infants (≤ 3 Months of Age) for Drugs That Are Glucuronidated: A Comparative Study Between Allometric Scaling and Physiologically Based Pharmacokinetic Modeling

    Wednesday, August 30, 2017; 2:00 - 3:00 PM ET

    Presented by Iftekhar Mahmood PhD, Division of Clinical Evaluation and Pharmacology/Toxicology Branch, Office of Tissues & Advance Therapies, Center for Biologic Evaluation and Research, US Food & Drug Administation

    Why is this article important to your practice?
    The capacity of drug metabolism in neonates and infants occurs at a much slower rate than adults and is mainly affected by ontogeny of many drug metabolizing enzymes. This article evaluates several allometric and PBPK approaches to predict clearance in neonates (≤3 Months of Age) of nine drugs that undergo glucuronidation. It highlights key physiological factors and allometric exponents that should be considered for acceptable clearance prediction (i.e., ≤ 50% error) for better development of neonatal drugs.

    Target Audience
    Clinical Pharmacologists, Pharmacometricians, DMPK scientists, graduate and postgraduate trainees and pediatricians from academia, industry and regulatory agencies who are interested in neonatal drug development.

    Goal and Objectives
    After completing this activity, the learner will be able to:

    1. Evaluate several allometric and PBPK approaches to predict clearance in neonates (≤3 Months of Age) of nine drugs that undergo glucuronidation
    2. Acknowledge that allometric exponents are not universal and that there is a need to adjust the allometric exponents and incorporate glucuronidation processes for better clearance prediction in different age-groups.
    3. Identify the pros and cons of allometric approaches and how they compare to PBPK approaches to estimate first-in-neonatal dose during drug development.

    image(Author and Presenter) Iftekhar Mahmood, PhD, is a clinical Pharmacologist at the Center for Biologic Evaluation and Research (CBER), FDA.  He holds a Bachelor of Pharmacy degree and a PhD in Pharmaceutical Sciences with specialization in pharmacokinetics.  Dr. Mahmood joined the FDA in December 1993 and for more than eight years served as a clinical pharmacologist dealing with neuro-pharmacology products. In the last ten years, Dr. Mahmood has been a clinical pharmacologist for therapeutic proteins and blood products.  Over the years, Dr. Mahmood has published several papers on the application of allometry to interspecies scaling as well as to pediatric drug development.  Dr. Mahmood has published more than 100 scientific papers in peer-reviewed scientific journals. He is the author of the books Interspecies Pharmacokinetic Scaling, Pediatric Pharmacology and Pharmacokinetics and Pharmacokinetic allometric scaling in pediatric drug development and the editor of the books Clinical Pharmacology of Therapeutic Proteins and Immunogenicity of Therapeutic Proteins.  Dr. Mahmood is the recipient of several CDER Intramural Research Grants as well as the recipient of several CDER and CBER awards.


    image(Moderator) Hazem E. Hassan, PhD is an Assistant Professor of Clinical Pharmacology and Pharmacometrics and Director of the Pharmacokinetics and Biopharmaceutics Laboratory (PBL) at the school of Pharmacy, University of Maryland Baltimore (UMB). His research program is supported by grants from FDA, NIH and NIPTE and focuses on investigating the underlying factors that impact drug development and drug therapy optimization in adults and pre-term neonates via employing in vitro, in vivo and in silico quantitative pharmacology (QP) approaches. Dr. Hassan received several national and international awards including the AAPS award in Pharmacokinetics, Pharmacodynamics, and Drug Metabolism/Clinical Sciences (PPDM/CS), Dr. Ralph Shangraw award, Dr. Arthur Shwartz award, the Egyptian Government General Mission award and was recently selected as the ASCPT Dedicated Member. Dr. Hassan is actively serving on different capacities on several scientific leadership committees including ACCP, ASCPT, AAPS and AACP (i.e., Educational, QP, DDDI and Pharmaceutics, respectively) committees. Dr. Hassan received his doctorate degree (Drug Metabolism and Pharmacokinetics), post-doctoral training (Clinical Pharmacology) and master’s degree (Pharmacometrics) from UMB. He is a registered pharmacist by NABP and a certified controlled dangerous substances researcher by the State of Maryland and the US Department of Justice.  


    Presenter: Iftekhar Mahmood PhD, Div of Hematology Clinical Review, Office of Blood Review & Research, Center for Biologic Evaluation & Research, US Food & Drug Administration, has nothing to disclose.

    Moderator:Hazem Hassan, PhD, MS, RPh, RCDS, Assistant Professor & Director, University of Maryland School of Pharmacy, has nothing to disclose. 

    Reviewer:  Theodoros Xanthos MD, Pg Dip (Ed), MSc, MRes (EdD), PhD, FHEA, FAcadMEd, FCP, FERC, ERT, FESC, Professor of Medicine European University Cyprus; Professor of Resuscitation, School of Specialties, University of Cagliari, Italy; Professor of Pharmaceutical Sciences (Adjunct) Midwestern University of Chicago who reviewed the activity has no disclosures related to its content.

    imageACPE Accreditation Statement

    http://accp1.inreachce.com/content/owners/accp1/images/ACPE-black.pngThe American College of Clinical Pharmacology is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. 

    ACPE 1 Contact Hours
    UAN Number:
    Live:  0238-0000-17-037-L01-P
    On Demand: 0238-0000-17-038-H01-P

    Knowledge Based Activity


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    ACCME Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

    Designation Statement

    The American College of Clinical Pharmacology designates this journal CE activity for 1 AMA PRA Category 1TM credit.  Physicians should only claim credit commensurate with the extent of the participation in the activity.

    Date of Issuance:  8/30/17
    Expiration Date:  8/30/20

    In order to receive CE credit, the learner must score 75% or better on the online post-test and must complete an online evaluation.

     


  • THERAPEUTIC DILEMMAS: How to Get Targeted Agents to the Patients Who Need Them

    Contains 4 Component(s), Medical Credits Offered Recorded On: 07/11/2017

    Presented by Joanna Yi, MD, Assistant Professor of Pediatric Hematology/Oncology, Baylor College of Medicine/ Texas Children’s Cancer and Hematology Centers

    THERAPEUTIC DILEMMAS: How to Get Targeted Agents to the Patients Who Need Them.  

    Tuesday, July 11th 2017; 2:00 – 3:00 pm ET

    Presented by Joanna Yi, MD, Assistant Professor of Pediatric Hematology/Oncology, Baylor College of Medicine/ Texas Children’s Cancer and Hematology Centers 

    Why is this topic important to your practice?
    Since the discovery of molecularly targeted agents such as Imatinib, there has been an ever-increasing drive to identify other targeted therapeutics to treat patients with more efficacy and less toxicity.  With the advent of genomic sequencing and more recently other "omics" technologies however, the information known about a patient's tumor has outstripped the physician's ability to prescribe medications precisely targeting all the known "drivers" of that disease. Precision medicine efforts to better match patients with targeted agents and innovative trial designs are underway and will be reviewed. Additionally, other methods to expedite and maximize the translation of targeted agents to patients will be addressed.  This will be illustrated with specific examples, including those from pediatric oncology.

    Target Audience
    This webinar is intended for pharmacologists, pharmacists, clinicians or graduate/postgraduate trainees wishing to better understand current developments in oncology to match patients with the appropriate molecularly targeted therapeutic agents and innovative trial designs with an emphasis on pediatric malignancies. This webinar is also suitable for pharmacology/biomedical graduate or medical students who are interested in oncology, clinical pharmacology or integrative medicine. Additionally, individuals who are likely to be involved in the facilitating patient care such as physician assistants, nursing and pharmacy professionals may also benefit from this webinar.

    Goal and Objectives After completing this activity, the learner will be able to:

    1. Identify obstacles blocking the translation of therapeutics in the lab to clinical trials
    2. List several strategies to accelerate the translation of therapeutics to clinical trials
    3. List reasons why pediatric drug discovery uniquely slower than desired
    4. Identify strategies which may aid in mitigating the development of resistance to targeted therapy

    Joanna Yi, MD, is an assistant professor of Pediatric Hematology/Oncology at Baylor College of Medicine/ Texas Children’s Cancer and Hematology Centers.  She completed her pediatric hematology/oncology fellowship at Dana-Farber/Boston Children’s Cancer and Hematology Centers, where she trained in the laboratory of James Bradner in epigenetics and chemical biology, focusing on the development of DOT1L inhibitors and BET bromodomain inhibitors.  She is a member of the Center for Drug Discovery at BCM, where she seeks to develop and translate targeted small molecules for challenging pediatric cancers. She serves as an intermediary between Texas Children’s Cancer Center labs to champion targets of interest through the drug screening platforms available at the Center for Drug Discovery, including the DNA-Encoded Technology platform.  Her lab has a specific interest chromatin-modifying small molecules, identifying and assessing top synergistic combinations for development pre-clinically and eventually clinically, and concurrently developing the necessary pharmacodynamics biomarkers for translation of these agents.   She is a member of the Developmental Therapeutics, Leukemia, and Neuroblastoma teams at Texas Children’s, and she will be chairing a first-in-children trial of a BET bromodomain inhibitor through the Children’s Oncology Group.

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    ACPE Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. 

    ACPE 1 Contact Hours UAN Number: Live:  0238-0000-17-035-L05-P On-demand: 0238-0000-17-036-H05-P

    Knowledge Based Activity


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    ACCME Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

    Designation Statement

    The American College of Clinical Pharmacology designates this journal CE activity for 1 AMA PRA Category 1TM credit.  Physicians should only claim credit commensurate with the extent of the participation in the activity.

    In order to receive CE credit, the learner must score 75% or better on the online post-test and must complete an online evaluation.

     

    Date of Issuance:  July 11, 2017
    Expiration Date:  July 11, 2020

  • ACCP Virtual Journal Club: The Bial 10-2474 Phase 1 Study—A Drug Development Perspective and Recommendations for Future First-in-Human Trials

    Contains 4 Component(s), Medical Credits Offered Recorded On: 06/28/2017

    Presented by Joseph E. Rower, PhD, Assistant Professor, University of Utah

    ACCP Virtual Journal Club: The Bial 10-2474 Phase 1 Study—A Drug Development Perspective and Recommendations for Future First-in-Human Trials

    Wednesday, June 28, 2017; 2:00 - 3:00 PM ET

    Presented by Joseph E. Rower, PhD, Assistant Professor, University of Utah

    Why is this article important to your practice?
    First in human studies are a critical step in new drug development. Historically, these studies have been safe for subjects, however, a recent study resulted in multiple drug-related serious adverse events, including the death of one subject. Specifically, in a phase 1 study of the fatty acid amide hydrolase BIA 10-2474, the multiple ascending dose phase of the study resulted in significant CNS illness within the first week of the study. Further investigation revealed that the CNS toxicity was likely related to BIA 10-2474 binding to an off-target cerebral receptor. The article discusses the critical need to understand both the on- and off-target effects of a study drug prior to human administration. The tragic death of a study subject is an important reminder to fully evaluate a drug’s safety profile and off-target effects prior to initiating a study, a reminder which is pertinent for every phase of in-vivo drug study.

    Target Audience
    This webinar is intended for pharmacologists, pharmacists, clinicians or graduate/postgraduate trainees wishing to better understand the risks and safety concerns of conducting first in human studies, using BIA 10-2474 as an example case. Understanding practical aspects and consequences related to first in human drug studies will be discussed. This webinar is also suitable for pharmacology/biomedical graduate or medical students who are interested in clinical pharmacology and/or drug development. Additionally, individuals who are likely to be involved in the facilitating drug studies such as physician assistants, nursing and pharmacy professionals may also benefit from this webinar.

    Goal and Objectives
    After completing this activity, the learner will be able to:

    1. Identify the risks of conducting first in human studies.
    2. Identify and evaluate data which inform the safety of first in human studies.
    3. Describe recommendations for conducting safe first in human studies.
    4. Apply lessons from this subject’s death to studies ranging from first in human to post-marketing.

    ACCP Virtual Journal Clubs are typically presented by one of the authors of the article being presented. However, for this Virtual Journal Club a guest presenter has been invited to interpret the material and lead the discussion

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    Joseph E. Rower, PhD joined the Division of Clinical Pharmacology at the University of Utah School of Medicine as a Post-Doctoral Fellow in 2015, and has since advanced to the rank of Assistant Professor within the division. Dr. Rower’s current research focuses on optimizing pediatric clinical dosing, with a focus on anti-infective and immunosuppressant drugs.

    He earned his PhD in 2013 at the University of Colorado Anschutz Medical Campus under the tutelage of Dr. Peter Anderson, where he studied the intracellular pharmacology of HIV reverse transcriptase inhibitors. A portion of his graduate work led to the labelling of the antiretrovirals tenofovir and emtricitabine for use as pre-exposure prophylaxis (PrEP) against HIV in men who have sex with men. He has received Young Investigator Awards from the Conference on Retroviruses and Opportunistic Infections, as well as the International Workshop on the Clinical Pharmacology of HIV Therapy. Dr. Rower received his BS in Chemistry and Mathematics from California Lutheran University.

    ACCP Virtual Journal Clubs are typically presented by one of the authors of the article being presented. However, for this Virtual Journal Club a guest presenter has been invited to interpret the material and lead the discussion

    ACPE Accreditation Statement

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    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. 

    UAN Number:
    Live:  0238-0000-17-032-L01-P
    On Demand: 0238-0000-17-033-H01-P

    ACPE 1 Contact Hours
    Knowledge Based Activity

    ACCME Accreditation Statement

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    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

    Designation Statement

    The American College of Clinical Pharmacology designates this journal CE activity for 1 AMA PRA Category 1TM credit.  Physicians should only claim credit commensurate with the extent of the participation in the activity.

    In order to receive CE credit, the learner must score 75% or better on the online post-test and must complete an online evaluation.

    Date of Issuance:  6/28/17 Expiration Date:  6/26/20

    In order to receive CE credit, the learner must score 75% or better on the online post-test; complete an online evaluation and print a certificate.

    Presenters:  Joseph Rower, PhD, has nothing to disclose. 

    Moderator:Jonathan Constance, PhD has nothing to disclose

    Reviewer:

  • High Resolution Personalized Precision Therapeutics

    Contains 4 Component(s), Medical Credits Offered Recorded On: 06/14/2017

    Presented by Roland Valdes Jr.​, PhD, Univ of Louisville and Keri Donaldson​, MD, PhD, Penn State Coll of Medicine and Milton S. Hershey Medical Ctr

    High Resolution Personalized Precision Therapeutics

    Wednesday, June 14, 2017; 2:00 – 3:00 PM ET 

    Presented by Roland Valdes Jr., PhD, Univ of Louisville and Keri Donaldson, MD, PhD, Penn State Coll of Medicine and Milton S. Hershey Medical Ctr

    Why is this article important to your practice?
    A growing use of medications has led to both polypharmacy and addiction. Novel technologies and pharmacogenetic tools are available to increase the precision and personalization of drug selection. We will review and demonstrate the need for novel predictive algorithms to optimize therapeutic approaches based on pharmacogenetic and related molecular diagnostic testing.   

    Target Audience
    Clinical pharmacologist providing both research and clinical practice. Practitioners of pharmacology services.

    Goal and Objectives
    After completing this activity, the learner will be able to:

    1. Define the need and availability for personalizing drug therapy using pharmacogenetics and targeted informatics tools
    2. Apply novel algorithms based on PGx-testing to increase precision of drug selection and reduce polypharmacy 
    3. Demonstrate and compare options for providing targeted selection of drugs to reduce or avoid drug addiction

    Roland Valdes Jr., PhD is a Tenured Professor of Pathology and Laboratory Medicine and of Biochemistry and Molecular Biology at the University of Louisville’s School of Medicine. He has held the appointment as Distinguished University Scholar and as Senior Vice-Chairman for the Department of Pathology. He presently serves as Chief of Clinical Chemistry and Toxicology for the University Hospital and as Director of the Clinical Chemistry Postdoctoral Fellowship Program.  Dr. Valdes received his Ph.D. in Molecular Biophysics from the University of Virginia where he also completed postdoctoral training in Biochemistry and in Clinical Chemistry and Toxicology. Prior to his move to Louisville in 1989, Dr. Valdes was on the faculty at Washington University School of Medicine in St. Louis. He is a Diplomat of the American Board of Clinical Chemistry and a Fellow of the National Academy of Clinical Biochemistry.  Dr. Valdes is nationally and internationally recognized as a leader in advancing the profession of clinical chemistry and personalized medicine through his contributions in promoting clinical chemistry as a discipline via the scholarships of clinical service, research, and teaching.  Dr. Valdes has served on numerous federal/national committees such as CLIA and NIH Study Sections, and has served as President of several key professional organizations including the Clinical Ligand Assay Society (CLAS), the National Academy of Clinical Biochemistry (NACB), the Commission for Accreditation in Clinical Chemistry (ComACC), and, most recently, the Association of Clinical Scientists (ACS).  Dr. Valdes has also served on the Board of Directors of the American Association for Clinical Chemistry (AACC) and as a Director on the American Board of Clinical Chemistry (ABCC).  He has received several distinguished scientist and recognition awards from professional organizations such as the AACC, NACB, CLAS, and ACS and has authored more than 260 publications. Dr. Valdes holds several patents and is a pioneer in establishing the application of personalized and precision medicine via laboratory diagnostics by founding the first CLIA-accredited laboratory (PGXL Laboratories) focused on providing pharmacogenetic services. He continues working on developing novel laboratory services to enable the practice of precision/personalized medicine using advanced techniques in clinical chemistry.


    Keri Donaldson, MD, PhD is Medical Director and CEO of Prescient Medicine,  His work is fueled by an extensive background in the fields of pathology, genomics, and diagnostics. An active ad hoc reviewer and consultant, Dr. Donaldson has earned a reputation as an innovative member of the medical community and garnered key positions within respected institutions and national committees. Throughout his time with Penn State College of Medicine, he’s served as Assistant Professor of Pathology (also at Hershey Medical Center), Assistant Professor of Public Health Sciences (a joint appointment also at Hershey Medical Center), Assistant Professor of Medicine, and Assistant Professor of Biochemistry. He was certified as a diplomate of both the American Board of Pathology and the National Board of Medical Examiners, and is a frequent guest speaker at regional and national symposia. Dr. Donaldson holds a BS from Pennsylvania State University, an MD from Temple University School of Medicine, and a master of science in clinical epidemiology (MSCE) from the University of Pennsylvania School of Medicine.


    Knowledge Based Activity

    ACPE Accreditation Statement

    http://accp1.inreachce.com/content/owners/accp1/images/ACPE-black.pngThe American College of Clinical Pharmacology is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. 

    UAN Number:
    Live:  0238-0000-17-029-L01-P
    On Demand: 0238-0000-17-030-H01-P

    ACPE 1 Contact Hours


    ACCME Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

    Designation Statement

    The American College of Clinical Pharmacology designates this journal CE activity for 1 AMA PRA Category 1TM credit.  Physicians should only claim credit commensurate with the extent of the participation in the activity.

    In order to receive CE credit, the learner must score 75% or better on the online post-test and must complete an online evaluation.

    Date of Issuance:  6/14/17
    Expiration Date:  6/14/20

    In order to receive CE credit, the learner must score 75% or better on the online post-test; complete an online evaluation and print a certificate.

    Roland Valdes Jr., PhD, Professor, Univ of Louisville School of Medicine discloses that he receives consulting fees from PGXL Laboratories for being member of the Board of Directors and Univ of Louisville receives Grants from PGXL Laboratories.