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Full Schedule

Full Schedule

  • Friday, September 6, 2024
  • 6:00 PM – 10:00 PM ET
    ACCP Executive Committee Meeting & Dinner (Invitation Only)
  • Saturday, September 7, 2024
  • 7:00 AM – 7:00 PM ET
    ACCP Registration Open
  • 8:00 AM – 3:00 PM ET
    ACCP Board of Regents Meeting (Invitation Only)
  • 8:00 AM – 5:00 PM ET
    2024 ACCP Trends in Drug Development Seminar

    Co-Chair & Faculty: Stefanie Drescher, PhD – Pfizer Inc

    Co-Chair & Faculty: Jomy George, PharmD – National Inst of Health

    Faculty: Vivaswath Ayyar, PhD – Janssen Research & Development LLC

    Faculty: Haden Bunn, MS, PharmD – Pumas AI

    Faculty: Dorothy Chang, MD – US Food & Drug Administration

    Faculty: Zachary Dezman, MD – US Food & Drug Administration

    Faculty: David J. Greenblatt, MD – Tufts Univ School of Medicine

    Faculty: Bhargava Kandala, MS, PhD – Merck & Co Inc

    Faculty: Zhihua Li, PhD – US Food & Drug Administration

    Faculty: Nitin Mehrotra, PhD – AInylam Pharmaceuticals Inc

    Faculty: Elana Rosenthal, MD (she/her/hers) – Univ of Maryland School of Medicine

    Faculty: Amit Roy, PhD – Pumas AI

    Faculty: Maxwell Sherman, PhD – Serinus Biosciences

    Faculty: Patricia Slattum, PharmD, PhD – Virginia Commonwealth Univ

    Faculty: Weifeng Tang, PhD – AstraZeneca plc

    CE: 6.0

  • 8:00 AM – 5:00 PM ET
    PMWS: Physiologically-based Pharmacokinetic Analyses: Practical Applications in Clinical Drug Development

    Co-Chair & Faculty: Kacey Anderson, PhD – Terns Pharmaceuticals Inc

    Co-Chair & Faculty: Sumit Basu, PhD – Novartis

    Faculty: Robert Bies, PhD – Univ of Buffalo School of Pharmacy & Pharmaceutical Sciences

    Faculty: Hannah M. Jones, PhD – Certara UK Ltd

    Faculty: Jongbong Lee, PhD – Novartis

    Faculty: Yuching Yang, PhD – US Food & Drug Administration

    CE: 6.0

  • 7:00 PM – 10:00 PM ET
    PharmaFete
  • Sunday, September 8, 2024
  • 6:30 AM – 5:00 PM ET
    ACCP Registration Open
  • 7:00 AM – 7:45 AM ET
    Continental Breakfast
  • 7:00 AM – 7:45 AM ET
    New Member & First-time Attendee Welcome
  • 7:00 AM – 7:45 AM ET
    Student, Trainee & Early-stage Professional (STEP & ESP) Welcome
  • 7:00 AM – 7:00 PM ET
    Exhibit Hall Open
  • 7:45 AM – 8:00 AM ET
    Welcome & Opening Remarks by ACCP President
  • 8:00 AM – 9:30 AM ET
    Plenary Session: Fast Track to Health: How Artificial Intelligence Can Supercharge Drug Development

    Moderator: Cody J. Peer, PhD – Amgen Inc

    Faculty: Jogarao VS Gobburu, PhD, MBA – Univ of Maryland School of Pharmacy, Ctr for Translational Medicine

    Faculty: Qi Liu, M.Stat, FCP, PhD – US Food & Drug Administration

    CE: 1.5

  • 9:30 AM – 10:00 AM ET
    Coffee & Networking Break
  • 10:00 AM – 11:30 AM ET
    Symposium 1: Clinical Pharmacology of Cannabinoids: Drug Development & Public Health Implications

    Co-Chair & Faculty: Jeremiah D. Momper, PharmD, PhD – Univ of California San Diego

    Co-Chair & Faculty: Jashvant Unadkat, PhD – Univ of Washington

    Faculty: Mary F. Paine, PhD (she/her/hers) – Washington State Univ

    Faculty: Gina Pastino, PhD, DABT (she/her/hers) – Cerevel Therapeutics

    Translational Clinical Pharmacology

    CE: 1.5

  • 10:00 AM – 11:30 AM ET
    Symposium 2: Facilitating Drug Discovery & Development Using Artificial Intelligence/Machine Learning, An ACCP & ASPET Joint Symposium

    Co-Chair & Faculty: Robert Bies, PhD – Univ of Buffalo School of Pharmacy & Pharmaceutical Sciences

    Co-Chair & Faculty: Ross Corriden, PhD – RAPT Therapeutics Inc

    Faculty: Lisa Jo Benincosa, PhD – Allucent Clinical Research Organization

    Faculty: Peter Bloomingdale, PhD – Generate Biomedicines

    Faculty: Weifeng Tang, PhD – AstraZeneca plc

    Translational Clinical Pharmacology

    CE: 1.5

  • 11:30 AM – 1:30 PM ET
    Lunch Buffet
  • 11:45 AM – 1:15 PM ET
    Lunch & Awards
  • 1:30 PM – 3:00 PM ET
    STEP & ESP Panel Discussion & Career Guidance
  • 1:30 PM – 3:00 PM ET
    Symposium 3: Assessing the Impact of Obesity During Drug Development: What Can We Do Better?

    Co-Chair & Faculty: Kenneth T. Moore, MA, MS (he/him/his) – Janssen Scientific Affairs LLC, a Johnson & Johnson Co

    Co-Chair & Faculty: Suneet Shukla, PhD (he/him/his) – Boehringer Ingelheim

    Faculty: Gilbert J. Burckart, PharmD – US Food & Drug Administration

    Faculty: Walter K. Kraft, MD (he/him/his) – Thomas Jefferson Univ

    Faculty: Karen Rowland Yeo, PhD – Certara UK Ltd

    Specific Populations

    CE: 1.5

  • 3:00 PM – 3:30 PM ET
    Coffee & Networking Break
  • 3:00 PM – 5:00 PM ET
    STEP & ESP Networking Reception
  • 3:30 PM – 5:00 PM ET
    Symposium 4: Advances in Improving Pediatric Therapeutic Response

    Co-Chair & Faculty: Catherijne A.J. Knibbe, PharmD PhD FCP – St Antonius Hospital/Leiden University

    Co-Chair & Faculty: Steve Leeder, PharmD, PhD (he/him/his) – Children's Mercy Kansas City

    Faculty: Athreya Arjun, MS, PhD – Mayo Clinic

    Faculty: Hao Zhu, PhD (he/him/his) – U.S. Food and Drug Administration

    Clinical Trial Designs

    CE: 1.5

  • 5:00 PM – 7:00 PM ET
    Opening Reception, Exhibits & Poster Session 1
  • Monday, September 9, 2024
  • 7:00 AM – 7:45 AM ET
    Meet the ACCP/ISoP Special Interest Group
  • 7:00 AM – 7:45 AM ET
    STEP & ESP Gathering
  • 7:00 AM – 8:00 AM ET
    Continental Breakfast
  • 7:00 AM – 5:00 PM ET
    ACCP Registration Open
  • 7:00 AM – 7:00 PM ET
    Exhibit Hall Open
  • 8:00 AM – 9:30 AM ET
    Symposium 5: FDA Modernization Act 2.0: How do we Fully Leverage this Unique Opportunity to Transform Drug Development?

    Co-Chair & Faculty: Navin S. Goyal, PhD – Janssen Research & Development, LLC, a Johnson & Johnson Company

    Co-Chair & Faculty: Gwendolyn Pais, PhD – Midwestern Univ Chicago Coll of Pharmacy

    Faculty: Rodrigo Cristofoletti, PhD (he/him/his) – Univ of Florida Coll of Pharmacy

    Faculty: Daniel Levner, MS, PhD – Emulate Inc

    Faculty: Wendy Wu, PhD – US Food & Drug Administration

    Translational Clinical Pharmacology

    CE: 1.5

  • 8:00 AM – 9:30 AM ET
    Symposium 6: Increasing Diversity in Clinical Trials: What Will it Take for Us to Close the Gap?

    Co-Chair & Faculty: Shuangwu (Cheryl) Li, PhD – Takeda Pharmaceutical Co Ltd

    Co-Chair & Faculty: Anuradha Ramamoorthy, Ph.D – US Food & Drug Administration

    Faculty: R. Donald Harvey, PharmD (he/him/his) – Emory Univ School of Medicine

    Faculty: Gianluca Nucci, PhD (he/him/his) – Pfizer Inc

    Clinical Trial Designs

    CE: 1.5

  • 9:30 AM – 10:00 AM ET
    Coffee & Networking Break
  • 9:30 AM – 10:00 AM ET
    Industry Theater Presentation: ACCP Inclusivity, Diversity & Equity (IDE) Committee Activities
  • 10:00 AM – 10:30 AM ET
    Meet the EICs
  • 10:30 AM – 11:30 AM ET
    Invited Keynote: How Precise Is Current Pharmacotherapy for Pediatric & Adolescent Obesity?

    Faculty: Jack Yanovski, MD, PhD – National Inst of Health

    CE: 1

  • 11:30 AM – 1:30 PM ET
    Lunch Buffet
  • 11:45 AM – 1:15 PM ET
    Lunch & Awards
  • 1:30 PM – 3:00 PM ET
    Symposium 7: Operational Considerations for Early-phase Pharmacokinetic/Pharmacodynamic/Safety Studies in Pediatric Patients

    Co-Chair & Faculty: Dionna J. Green, MD

    Co-Chair & Faculty: Susan McCune, MD (she/her/hers) – PPD/Part of Thermo Fisher Scientific

    Faculty: Randi Gower, MHA – PPD/Part of Thermo Fisher Scientific

    Faculty: John Van Den Anker, MD, PhD (he/him/his) – National Inst of Health

    Specific Populations

    CE: 1.5

  • 1:30 PM – 3:00 PM ET
    Symposium 8: Harmonization of the Bioequivalence Assessments for Narrow Therapeutic Index Drugs: Delivering the Promise to Patients

    Co-Chair & Faculty: Yu Chung Tsang, PhD (he/him/his) – YCT Scientific Inc

    Co-Chair & Faculty: Lei Zhang, PhD – US Food & Drug Administration

    Faculty: Wenlei Jiang, PhD – US Food & Drug Administration

    Faculty: Paulo Paixao, PhD – Univ of Lisbon

    Faculty: Liang Zhao, PhD – US Food & Drug Administration

    Clinical Trial Designs

    CE: 1.5

  • 3:00 PM – 3:30 PM ET
    Coffee & Networking Break
  • 3:30 PM – 5:00 PM ET
    Symposium 9: Rethinking Hepatic Impairment Studies: A Patient Centric Approach

    Co-Chair & Faculty: Navin S. Goyal, PhD – Janssen Research & Development, LLC, a Johnson & Johnson Company

    Co-Chair & Faculty: Martina Sahre, PhD – US Food & Drug Administration

    Faculty: William B. Smith, MD – New Orleans Ctr for Clinical Research, an AMR Co

    Faculty: Xinyuan Zhang, PhD – Daiichi Sankyo Inc

    Specific Populations

    CE: 1.5

  • 3:30 PM – 5:00 PM ET
    Symposium 10: Hot Topics: Decentralized Clinical Trials & Clinical Pharmacology, a Joint ACCP-KSCPT Symposium

    Co-Chair & Faculty: Myong-Jin Kim, PharmD (she/her/hers) – US Food & Drug Administration

    Co-Chair & Faculty: Kyung-Sang Yu, MD, PhD – Seoul National University College of Medicine and Hospital

    Faculty: Seol Ju Moon, MD, PhD (she/her/hers) – Jeonbuk National Univ Hosp

    Faculty: Leonard V. Sacks, MD (he/him/his) – US Food & Drug Administration

    Clinical Trial Designs

    CE: 1.5

  • 5:00 PM – 7:00 PM ET
    Evening Reception, Exhibits & Poster Session 2
  • 7:00 PM – 9:00 PM ET
    JCP & CPDD Editorial Board Dinner (Invitation Only)
  • Tuesday, September 10, 2024
  • 7:00 AM – 7:45 AM ET
    STEP & ESP Gathering
  • 7:00 AM – 8:00 AM ET
    Continental Breakfast
  • 7:00 AM – 3:30 PM ET
    ACCP Registration Open
  • 8:00 AM – 9:30 AM ET
    Symposium 11: Hot Topics: Current Bioethical Challenges in Clinical Research & Drug Development: Joint ACCP-NYU Grossman School of Medicine Symposium

    Co-Chair & Faculty: Alison Bateman-House, PhD (she/her/hers) – New York Univ Grossman School of Medicine

    Co-Chair & Faculty: Kenneth T. Moore, MA, MS (he/him/his) – Janssen Scientific Affairs LLC, a Johnson & Johnson Co

    Faculty: Kellie Owens, PhD (she/her/hers) – New York Univ Grossman School of Medicine

    Clinical Trial Designs

    CE: 1.5

  • 8:00 AM – 9:30 AM ET
    Symposium 12: Towards Optimal Dosing in Malnutrition: Innovations for Improved Health Outcomes

    Co-Chair & Faculty: Vikram Gota, MD – Advance Ctr for Treatment Research & Education in Cancer, Tata Memorial Ctr

    Co-Chair & Faculty: Meenakshi Srinivasan, PharmD (she/her/hers) – GSK plc

    Faculty: Rada Savic, Ph.D. (she/her/hers) – UCSF

    Faculty: Erik Sjögren, PhD – Pharmetheus ab

    Specific Populations

    CE: 1.5

  • 9:30 AM – 10:00 AM ET
    Coffee & Networking Break
  • 10:00 AM – 11:30 AM ET
    Symposium 13: Advancements in Understanding Drug-induced Hypersensitivity Reactions

    Chair & Faculty: Santiago Alvarez-Arago, MD (he/him/his) – Johns Hopkins Univ School of Medicine

    Faculty: Melanie C. Dispenza, MD – Johns Hopkins Univ School of Medicine

    Faculty: Elizabeth Phillips, MD – Vanderbilt Univ Medical Ctr

    Translational Clinical Pharmacology

    CE: 1.5

  • 10:00 AM – 11:30 AM ET
    Symposium 14: At the Precipice of Induction-based Drug-Drug Interactions: An Opportunity to Define the Path Forward

    Co-Chair & Faculty: Diane Ramsden, BSc (she/her/hers) – Korrobio Inc

    Co-Chair & Faculty: Xinning Yang, Ph.D. (he/him/his) – US Food & Drug Administration

    Faculty: Tamara D. Cabalu, PhD – Merck & Co Inc

    Translational Clinical Pharmacology

    CE: 1.5

  • 11:30 AM – 1:30 PM ET
    Lunch Buffet
  • 11:45 AM – 1:15 PM ET
    Lunch & Annual Business Meeting (Open to All)
  • 1:30 PM – 3:00 PM ET
    Symposium 15: Project Optimus: A Paradigm Shift in Quantitative Clinical Pharmacology or Business as Usual? Part 1

    Co-Chair & Faculty: Nan Zheng, PhD – US Food & Drug Administration

    Co-Chair & Faculty: Honghui Zhou, PhD – Jazz Pharmaceuticals Inc

    Faculty: Brian Booth, PhD – US Food & Drug Administration

    Faculty: Chunze Li, PhD – Genentech Inc

    Faculty: Bernd Meibohm, PhD, FCP, FAAPS – The University if Tennessee Health Science Center

    Faculty: Weirong Wang, n/a – Janssen Research & Development

    Clinical Trial Designs

    CE: 1.5

  • 1:30 PM – 3:00 PM ET
    Symposium 16: New Perspectives on Drug Evaluation in Older Adults

    Co-Chair & Faculty: Federica Ferrari, MD, MSc, PhD – Univ of Pavia - IRCCS Mondino Fdtn

    Co-Chair & Faculty: Manjunath Amit Pai, PharmD – University of Michigan

    Faculty: Luigi Ferrucci, MD, PhD – National Inst of Health

    Faculty: Rajanikanth Madabushi, PhD – US Food & Drug Administration

    Specific Populations

    CE: 1.5

  • 3:00 PM – 3:30 PM ET
    Coffee & Networking Break
  • 3:30 PM – 5:00 PM ET
    Symposium 15: Project Optimus: A Paradigm Shift in Quantitative Clinical Pharmacology or Business as Usual? Part 2

    Co-Chair & Faculty: Nan Zheng, PhD – US Food & Drug Administration

    Co-Chair & Faculty: Honghui Zhou, PhD – Jazz Pharmaceuticals Inc

    Faculty: Brian Booth, PhD – US Food & Drug Administration

    Faculty: Chunze Li, PhD – Genentech Inc

    Faculty: Bernd Meibohm, PhD, FCP, FAAPS – The University if Tennessee Health Science Center

    Faculty: Weirong Wang, n/a – Janssen Research & Development

    Clinical Trial Designs

    CE: 1.5

  • 3:30 PM – 5:00 PM ET
    Symposium 17: Hot Topics: Advancements in Antisense Oligonucleotide Development: Challenges, Strategies & Novel Approaches

    Co-Chair & Faculty: Reena Kartha, MS, PhD (she/her/hers) – Ctr for Orphan Drug Research/Coll of Pharmacy/Univ of Minnesota

    Co-Chair & Faculty: Natalie Schmitz, PharmD, PhD – Biogen

    Faculty: Michael Monine, PhD – Biogen

    Faculty: Emily Noonan Place, PhD, MPH – Aclairo Pharmaceutical Development Group Inc

    Translational Clinical Pharmacology

    CE: 1.5

  • Wednesday, September 11, 2024
  • 8:00 AM – 5:00 PM ET
    Clinical Pharmacology Review Course, Hosted By ACCP & ABCP

    Chair & Faculty: Craig W. Hendrix, MD, DABCP – Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology

    Co-Chair & Faculty: Donald E. Mager, PharmD, PhD – Univ at Buffalo, SUNY School of Pharmacy & Pharmaceutical Sciences

    Faculty: Santiago Alvarez-Arago, MD (he/him/his) – Johns Hopkins Univ School of Medicine

    Faculty: David J. Greenblatt, MD – Tufts Univ School of Medicine

    Faculty: Walter K. Kraft, MD (he/him/his) – Thomas Jefferson Univ

    Faculty: Meena Madhur, MD, PhD – Indiana Univ

    Faculty: Anne N. Nafziger, MD, PhD, MHS (she/her/hers) – IMA Clinical Research

    Faculty: Wayne T. Nicholson, MD, PharmD – Mayo Clinic Coll of Medicine & Science

    Faculty: Lauren Price, PharmD (she/her/hers) – US Food & Drug Administration

    Faculty: Catherine MT Sherwin, PhD – Differentia Biotech Ltd

    CE: 6.0