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  • 2018 ACCP Virtual Journal Club November | Precision Oncology Medicine: The Clinical Relevance of Patient‐specific Biomarkers Used to Optimize Cancer Treatment - ON DEMAND

    Contains 5 Component(s), Includes Credits

    Presented by: William D. Figg, PharmD, Senior Investigator, Natl Cancer Inst of the Natl Inst of Health, Molecular and Clinical Pharmacology Program. Learners that complete this course will be able to provide a comprehensive overview of clinically-relevant biomarkers and molecular profiling platforms in precision oncology medicine to optimize cancer treatment outcomes.

    Precision Oncology Medicine: The Clinical Relevance of Patient-specific Biomarkers Used to Optimize Cancer Treatment - LIVE

    ACCP Virtual Journal Club Webinars

    Live Session: Wednesday, November 28, 2018 from 2:00-3:00pm ET

    On Demand: Starting November 28, 2018


    Why is this webinar important to you? 

    Learners that complete this course will be able to provide a comprehensive overview of clinically-relevant biomarkers and molecular profiling platforms in precision oncology medicine to optimize cancer treatment outcomes.

    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:

    1) Describe the difference between prognostic and predictive oncology biomarkers;

    2) Discuss prognostic biomarkers including drug-target pairs and their companion diagnostic tests;

    3) Explain how drug sensitivity/resistance, metabolism and toxicity relate to predictive biomarkers;

    4) List current efforts to improve the advancing field of precision oncology medicine.

    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 within 30-days of attending the webinar.


    See CE Info in handouts tab for more information on CME and CPE credits.


  • 2017 ACCP Virtual Journal Club October | Continuous Lidocaine Infusion as Adjunctive Analgesia in Intensive Care Unit Patients

    Contains 4 Component(s), Includes Credits 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


    image

    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.

    image

    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


    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:  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.

  • 2017 ​ACCP Virtual Journal Club August | 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), Includes Credits

    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.

     


  • 2017 ACCP Virtual Journal Club June | The Bial 10-2474 Phase 1 Study—A Drug Development Perspective and Recommendations for Future First-in-Human Trials

    Contains 4 Component(s), Includes Credits 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:  6/28/20

    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:

  • 2017 ACCP Virtual Journal Club May | Utility of Model-Based Approaches for Informing Dosing Recommendations in Specific Populations: Report From the Public AAPS Workshop

    Contains 4 Component(s), Includes Credits

    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).

  • 2017 ACCP Virtual Journal Club March | Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development

    Contains 4 Component(s), Includes Credits 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:  3/14/20

    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.

  • 2017 ACCP Virtual Journal Club March | How Informative Are Drug-Drug Interactions of Gene-Drug Interactions?

    Contains 4 Component(s), Includes Credits Recorded On: 03/01/2017

    Presented by Stephan Schmidt, PhD, FCP, Assistant Professor & Associate Director, Univ of Florida

    ACCP Virtual Journal Club:  How Informative Are Drug-Drug Interactions of Gene-Drug Interactions?

    Recorded March 1, 2017

    Presented by Stephan Schmidt, PhD, FCP, Assistant Professor & Associate Director, Univ of Florida

    Why is this article important to your practice?
    Understanding the mechanism of potential gene-drug interactions is necessary to support the pharmacogenomics subsection of drug labels. Available Drug-drug interaction data could serve as a surrogate to determining the potential for gene-drug interactions which may then be useful in predicting other potential drug-drug interactions. This has the potential to reduce the regulatory burden involved in the drug development process without compromising optimal pharmacotherapy

    Target Audience

    Quantitative clinical pharmacologists in industry, academia and regulatory agencies

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

    1. Identify criteria for selection of victim and perpetrator drugs for both drug drug and drug gene interaction studies
    2. Understand the impact of convergence of drug drug and drug gene clinical interaction study results 
    3. Appreciate the role of descriptive and PBPK analysis models in both testing and validation of study data



    Stephan Schmidt, PhD, FCP, is an Assistant Professor & Associate Director of the Center for Pharmacometrics and Systems Pharmacology in Lake Nona (Orlando). His research focuses on the application of Pharmacometrics and Systems Pharmacology tools to address clinically relevant research questions in the area of antimicrobial chemotherapy, pediatrics, diabetes, cardiovascular safety and post-menopausal osteoporosis. Dr. Schmidt published more than 40 peer-reviewed articles in highly respected journals in the clinical pharmacology arenas well as 4 book chapters on the application of quantitative analysis techniques in various therapeutic areas. He is the editor of a book entitled, “Applied Pharmacometrics”, published in 2014 as part of an AAPS series on advancing Pharmaceutical Sciences.

     

    Dr. Schmidt received the Paul Ehrlich Society for Chemotherapy Thesis Award in 2010, the University of Florida Clinical Translational Science Institute Junior Faculty Pilot Program Award in 2012, the University of Florida Excellence Award for Assistant Professors in 2013, the Tanabe Young Investigator Award from the American College of Clinical Pharmacology (ACCP) in 2016 and was named International Educator of the Year of the College of Pharmacy at the University of Florida in 2014. He serves as the Chair of the Special Interest Group on PK/PD and Systems Pharmacology of the International Pharmaceutical Federation (FIP) and Vice Chair of the Systems Pharmacology Community for the American Society for Clinical Pharmacology and Therapeutics (ASCPT). Dr. Schmidt is a Section Editor for the European Journal of Pharmaceutical Sciences and Editorial Board Member for the Journal of Clinical Pharmacology and ASCPT’s Pharmacometrics and Systems Pharmacology journal.

    Disclosures 

    Presenters:  Stephan Schmidt, PhD discloses that he receives a honorarium from Pharma as a Consultant

    Moderators: Otito Frances Iwuchukwu has nothing to disclose. 

    Reviewer: Arun Ram, MBBS, MD

    ACPE 1 Contact Hours

    UAN Numbers:
    Live:  0238-0000-17-005-L03-P  
    On-demand:  0238-0000-17-006-H03-P

    Knowledge Based Activity

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    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. 

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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:  3/2/17

    Expiration Date:  3/2/20