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

    Contains 9 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 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


    image

    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.

    image

    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


    image

    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

    image

    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

    image

    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

    image

    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.

  • ACCP Virtual Journal Club - Utility of Model-Based Approaches for Informing Dosing Recommendations in Specific Populations: Report From the Public AAPS Workshop

    Contains 4 Component(s), Medical Credits Offered

    Presented by Islam R. Younis, PhD and Amin Rostami-Hodjegan, PharmD, PhD

    ACCP Virtual Journal Club - Utility of Model-Based Approaches for Informing Dosing Recommendations in Specific Populations: Report From the Public AAPS Workshop

    Wednesday, May 31, 2017:  2:00 - 3:00 pm ET

    Presented by Islam R. Younis, PhD and Amin Rostami-Hodjegan, PharmD, PhD

    Why is this article important to your practice? 
    There is a need to increase drug dosing recommendations available for all specific patient populations at the time of drug approval.  This is not fully met by the current model of capturing dosing data in clinical studies. This article reports the discussions and outcomes from a workshop at the annual 2015 AAPS meeting where strategies for determining how predicted dosing recommendations and models could be qualified and continuously improved for drug labeling.

    Target Audience
    Clinical and Quantitative Pharmacologists, Pharmacokineticists, Pharmacometricians, Regulatory Scientists and other stakeholders in academia, the pharmaceutical industry and government in related areas of special populations drug development.

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

    1. Discuss the current state, challenges, opportunities, and future direction of utilizing model-based approaches to inform dosing recommendations in specific populations
    2. Identify specific populations in which there is a high need and availability of data for model-informed dosing recommendations 
    3. Outline available database platforms to utilize in data gathering for developing population specific dosing models



    Amin Rostami-Hodjegan, PharmD, PhD is a Professor of Systems Pharmacology at the Centre for Applied Pharmacokinetic Research (CAPKR) in the Manchester Pharmacy School at the University of Manchester. He has an active program of training PhD students involving proteomics, physiologically-based pharmacokinetics and pharmacodynamics and precision dosing within CAPKR. Amin was a Professor of Systems Pharmacology at the University of Sheffield prior to joining the University of Manchester and numerous graduates from his team are currently active in pharmaceutical industry or academic research. Professor Rostami has authored/co-authored over 200 peer-reviewed full articles and serves on the Editorial Boards of several journals. He has been an invited speaker at over 170 national and international meetings and has led a number of hands on workshops in the area of in vitro-in vivo extrapolation as applied to ADME in Drug Development.

    Amin is also the Senior Vice President of Research & Development and Chief Scientific Officer at Certara, a company with a scientific team which includes almost 100 PhDs or MDs. His mission is to ensure that the latest scientific advances in the field of biosimulation are incorporated into all of the drug development efforts by various pharmaceutical companies.


    Islam R. Younis, PhD, holds a BS. in Pharmacy from An-Najah National University, Palestine and earned his MS. and PhD degrees in Pharmaceutical Sciences from West Virginia University.  Islam has completed additional training leading to graduate certificates in Public Health, Drug Development and Regulatory Sciences, and Pharmacoepidemiology from Georgetown University, University of California at San Francisco, and University of Pennsylvania, respectively. He joined FDA in 2008 and worked as a clinical pharmacology reviewer on the CardioRenal and Psychiatry teams. In 2012, Islam was selected as the team leader for the Antiviral Team 2. In 2016, Islam was selected to also lead the Clinical Pharmacology team responsible for review of application submitted under the animal rule and as an associate member in the Office of Clinical Pharmacology OCP Guidance and Policy Team. Islam has been active in regulatory science and mentorship of Pharm D students and fellows.  Islam has published 17 peer reviewed papers, 19 conference abstracts, and two book chapters and presented in many national meetings. He is also leading multiple regulatory research projects focusing on leveraging prior knowledge toward optimizing clinical trials and improving drug development efficiency in schizophrenia and specific populations (mainly hepatic and renal impairment). Islam served as a member on several FDA guidance working groups.


    UAN Number:
    Live:  0238-0000-17-026-L01-P
    On Demand: 0238-0000-17-027-H01-P

    ACPE 1 Contact Hours

    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. 

    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:  5/31/17
    Expiration Date:  5/31/20

    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 

    Presenters: 
    Islam R. Younis, PhD has nothing to disclose.
    Amin Rostami-Hodjegan, PharmD, PhD is a member of the Centre for Applied Pharmacokinetic Research (CAPKR) group at the University of Manchester. CAPKR is a consortium operating in collaboration with, and supported by the pharmaceutical industry. CAPKR's industrial consortium members represent the following pharmaceutical companies: Lilly and Pfizer. Amin is seconded to Certara / Simcyp for part of his time. The following Pharmaceutical companies are part of the Simcyp Consortium and they are relied on to fund research in Simcyp: Abbvie, Actelion, Amgen, Astellas Pharma inc., AstraZeneca, Biogen ldec, Bristol Myers Squibb, Celgene Corporation, Daiichi-Sankyo, Dainippon-Sumitomo, Eisai, Eli Lilly, F. Hoffmann-La Roche Ltd, Gilead, GlaxoSmithKline, Grunenthal, H Lundbeck A/S, Incyte Corporation, Johnson & Johnson Pharmaceutical Research & Development, Merck & Co., Merck KGaA, Mitsubishi Tanabe Pharma Corporation, Nektar Therapeutics, Novartis Pharma, Ono Pharmaceutical Co, Otsuka Pharmaceutical Group, Pfizer, Sanofi aventis, Servier, Shionogi & Co., Shire Pharmaceuticals, Taisho Pharmaceutical, Takeda, UCB Pharma, Vertex Pharmaceuticals.

    Amin visited Takeda in February 2017 and served on a discussion panel. They paid for his travel and accommodation.

    Amin visited AbbVie in February 2017 where he gave a presentation. They paid for his internal US flights and accommodation and he received an honorarium.

    Certara – Shares via Certara’s Holding Company, contribution to university salary

    Moderator:
    Parag Kumar, PharmD owns stock in Ionis Pharmaceuticals (not received as a result of any relationship).

  • ​THERAPEUTIC DILEMMAS: At The Intersection of Environmental Air Pollutant Exposure, Genetic Variation and Asthma Control

    Contains 4 Component(s), Medical Credits Offered Recorded On: 05/24/2017

    ​Presented by Christopher Reilly, PhD, Associate Professor, Pharmacology and Toxicology, College of Pharmacy, University of Utah

    THERAPEUTIC DILEMMAS: At The Intersection of Environmental Air Pollutant Exposure, Genetic Variation and Asthma Control

    Wednesday, May 24, 2017; 2:00 - 3:00 PM ET

    Presented by Christopher Reilly, PhD, Associate Professor, Pharmacology and Toxicology, College of Pharmacy, University of Utah

    Why is this important to your practice?
    Air pollution is a global problem with serious health consequences. The effects of poor air quality on the efficacy of asthma control medications is of great concern for patients with respiratory disorders, their families, and healthcare providers. Exposures environmental or dietary xenobiotics are well recognized to impact drug disposition and response, such as through the induction or interactions with drug metabolizing enzymes or drug transporters. Additionally, drug responsiveness can also be modulated through receptor expression/activity within the cells lining airways. Genetic predisposition among some individuals may cause sensitization to air pollutants and interfere with the expected metabolic clearance of drugs, therefore requiring adaptation of asthma control regimens to treat more effectively an individual’s disease characteristics. This webinar will discuss new findings that connect pulmonary irritant sensing and xenobiotic clearance pathways with variations in asthma control as well as the resulting implications for treatment of asthma.

    Target Audience
    This webinar is intended for pharmacologists, pharmacists, clinicians or graduate/postgraduate trainees wishing to better understand the implications of environmental contaminants on the activity and efficacy of asthma control medication. This webinar is also suitable for pharmacology/biomedical graduate or medical students who are interested in respiratory disorders, clinical pharmacology, or integrative medicine. Additionally, individuals who are likely to be involved in 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. Describe the mechanisms by which particulate matter, such as coal fly ash, can stimulate pro-inflammatory signaling cascades within the respiratory tract
    2. Discuss the potential consequences of exposure to particulate matter for those who suffer from asthma as it relates to respiratory tract physiology and medical interventions
    3. Among individuals with and without asthma, describe how genetic variation in TRP channels may predispose or influence susceptibility to inhaled particulate matter
    4. Discuss the ramifications of the findings for asthma control intervention for individuals living in different environments (i.e., different levels of exposure to particulate matter due to proximity to emissions)



    Christopher Reilly, PhD is an Associate Professor of Pharmacology and Toxicology and Associate Director of the Center for Human Toxicology at the University of Utah.  He received his PhD in Toxicology (1999) from Utah State University under Dr. Steven D. Aust. Dr. Reilly’s work focused on peroxidase- and oxygen radical-mediated toxicities and enzymatic mechanisms for iron loading and storage in ferritin. Dr. Reilly was a post-doctoral fellow from 1999-2001 at the University of Utah with Dr. Garold S. Yost and the Center for Human Toxicology where he studied mass spectrometry and catalytic mechanisms for the metabolism and bioactivation of xenobiotics by Cytochrome P450 enzymes, pulmonary-selective drug metabolism, and the pulmonary toxicity of pepper sprays. Through this work Dr. Reilly became interested in Transient Receptor Potential cation channels as mediators of xenobiotic toxicities in the lung. His work on the TRP ion channels has evolved and is now focused on interactions between TRP channels and airway inflammation and injury. His group’s work on CYP enzymes and TRP channels has fortuitously intersected leading to new insights on how genetic variations in CYPs and TRPs as well as exposure to environmental pollutants may affect asthma symptom control using traditional therapeutics.

    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 Number:
      Live:  0238-0000-17-024-L01-P
      On Demand: 0238-0000-17-025-H01-P
    • ACPE 1 Contact Hours
    • Knowledge Based Activity


    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:  May 24, 2017
    Expiration Date:  May 25, 2020

    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.

    Moderators:
    Catherine Sherwin, PhD, MS, FCP and Jonathan Constance, PhD, are with the University of Utah School of Medicine.  As Moderators of the webinar. They developed the continuing education portion of this activity (target audience, goals and objectives and questions with solutions).  They have nothing to disclose.

    Presenter:
    Christopher Reilly, PhD is an Associate Professor of Pharmacology and Toxicology and Associate Director of the Center for Human Toxicology at the University of Utah and has nothing to disclose.

  • ACCP Virtual Journal Club - Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development

    Contains 4 Component(s), Medical Credits Offered Recorded On: 03/14/2017

    Presented by Gilbert J. Burckart, PharmD, Associate Director of Pediatrics, Office of Clinical Pharmacology, Ctr for Drug Evaluation & Research, US Food & Drug Administration and Kevin Krudys, PhD, Pharmacometrics Team Leader, Office of Clinical Pharmacology, US Food & Drug Administration

    ACCP Virtual Journal Club - Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development

    Recorded March 14, 2017

    Presented by Gilbert J. Burckart, PharmD, Associate Director of Pediatrics, Office of Clinical Pharmacology, Ctr for Drug Evaluation & Research, US Food & Drug Administration and Kevin Krudys, PhD, Pharmacometrics Team Leader, Office of Clinical Pharmacology, US Food & Drug Administration

    Why is this article important to your practice?
    Conducting pediatric clinical trials is an ethically and logistically difficult task in drug development.  Extrapolation of efficacy from adults was proposed by the US FDA to maximize the use of adult or other data when designing pediatric drug development programs.  When the pediatric disease, expected response and exposure-response relationship is similar to that in adults, then full extrapolation of efficacy is performed by selecting the dosing regimen where the doses achieve pediatric exposures that are similar to adult exposures.  The current article reviews the FDA’s experience with pediatric extrapolation and exposure matching based on pediatric trials submitted between 1998-2012.  The paper explores different methods used for exposure matching, and challenges involved in the analysis of exposure matching between adults and pediatric patients.  This article also provides a summary of approaches to exposure matching that have been used in FDA Guidances.

    Target Audience:  

    Clinical pharmacologists, drug development scientists, pediatric pharmacists, pediatricians.

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

    1. Discuss various approaches to exposure matching for extrapolating efficacy to pediatric patients from adult data
    2. Describe the regulatory history of exposure matching and applicability to pediatric extrapolation 
    3. List the pros and cons of establishing predefined acceptance boundaries for exposure matching in pediatric partial and full extrapolation of adult efficacy

    ACPE 1 Contact Hours

    UAN Number:
    Live:  0238-0000-17-020-L01-P
    On Demand: 0238-0000-17-021-H01-P

    Knowledge Based Activity

    imageACPE 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. 

    imageACCME 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:  3/14/17

    Expiration Date:  3/13/20

    Gilbert J. Burckart, PharmDis presently Associate Director for Pediatrics, Office of Clinical Pharmacology, US Food & Drug Administration (FDA).  Dr. Burckart received his BS in Pharmacy from the University of Pittsburgh in 1972, his PharmD from the University of Kentucky in 1975, and did his pediatric residency at the UK Medical Center in Lexington and Norton Children’s Hospital in Louisville.  He served on the faculties of the State University of New York at Buffalo at Buffalo Children’s Hospital, and the University of Tennessee at LeBonheur Children’s Hospital.  He joined the University of Pittsburgh and the Pittsburgh Children’s Hospital in 1982 where his research focused on drug therapy in organ transplant patients.  He has been Principal Investigator on NIH grants in both liver and lung transplantation.  At Pitt, he was a Professor of Pharmacy, Pediatrics and Surgery, and served as Director of Research for the Division of Cardiothoracic Surgery.

    In 2003, he moved to the University of Southern California in Los Angeles, where he was Chairman of the Department of Pharmacy, Director of the Clinical Pharmacogenomics Laboratory, Professor of Pharmacy and Professor of Pediatrics.  Dr. Burckart was an investigator at the Children’s Hospital of Los Angeles.

    Dr. Burckart has previously served as the President of the American College of Clinical Pharmacy, and as President of the American College of Clinical Pharmacology. He is a member of the Pediatric Pharmacy Advocacy Group, and received their Sumner J. Yaffe Lifetime Achievement Award in Pediatric Pharmacology and Therapeutics in 2014.

    Dr. Burckart moved to the FDA in 2008.  His duties include the direction of the Pediatric Clinical Pharmacology program within the Office of Clinical Pharmacology, and participation in the FDA’s Pediatric Review Committee.  His present research program includes analyses of pediatric drug development studies from 1997 to present.




    Kevin Krudys, PhD is currently a Team Leader in the Division of Pharmacometrics in the Office of Clinical Pharmacology at the FDA. He previously served as the Scientific Lead of the QT Interdisciplinary Review Team and is currently a member of the Pediatric Review Committee. Prior to joining the FDA he was a fellow in the Clinical Pharmacology Modelling and Simulation group at GlaxoSmithKline. He earned his PhD in bioengineering from the University of Washington.


    Disclosures 

    Presenters:  Gilbert J. Burckart, PharmD and Kevin Krudys, PhD have nothing to disclose. 

    Moderator: Chaturvedula, Ayyappa, MA, BSP, RPh, has nothing to disclose

    Reviewer: Michael Jann, PharmD, Professor & Chair, Dept of Pediatrics, Univ of North Texas System Coll of Pharmacy, who developed the continuing education portion of this activity (target audience, goals and objectives and questions with solutions), discloses that he receives a Honoria from Janssen Pharmaceutical for a Speaker’s Bureau.