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Sunday, Sep 8th
3:30 PM – 5:00 PM ET
Symposium 4: Advances in Improving Pediatric Therapeutic Response
Location: Grand Ballroom A-D
Co-Chair & Faculty: Catherijne A.J. Knibbe, PharmD, PhD, FCP – St Antonius Hosp/Leiden Univ
Co-Chair & Faculty: Steve Leeder, PharmD, PhD (he/him/his) – Children's Mercy Kansas City
Faculty: Arjun Athreya, MS, PhD – Mayo Clinic
Faculty: Hao Zhu, PhD (he/him/his) – US Food & Drug Administration
Clinical Trial Designs
CE: 1.5
Monday, Sep 9th
8:00 AM – 9:30 AM ET
Symposium 6: Increasing Diversity in Clinical Trials: What Will It Take for Us to Close the Gap?
Location: Grand Ballroom D
Co-Chair & Faculty: Shuangwu (Cheryl) Li, PhD – Takeda Pharmaceutical Co Ltd
Co-Chair & Faculty: Anuradha Ramamoorthy, PhD – 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
Monday, Sep 9th
1:30 PM – 3:00 PM ET
Symposium 8: Harmonization of the Bioequivalence Assessments for Narrow Therapeutic Index Drugs: Delivering the Promise to Patients
Location: Grand Ballroom D
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: Lanyan (Lucy) Fang, PhD – US Food & Drug Administration
Clinical Trial Designs
CE: 1.5
Monday, Sep 9th
3:30 PM – 5:00 PM ET
Symposium 10: Hot Topics: Decentralized Clinical Trials & Clinical Pharmacology, A Joint ACCP & KSCPT Symposium
Location: Grand Ballroom D
Co-Chair & Faculty: Myong-Jin Kim, PharmD (she/her/hers)
Co-Chair & Faculty: Kyung-Sang Yu, MD, PhD – Seoul National Univ College of Medicine & Hosp
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
Tuesday, Sep 10th
8:00 AM – 9:30 AM ET
Symposium 11: Hot Topics: Current Bioethical Challenges in Clinical Research & Drug Development: A Joint ACCP & NYU Grossman School of Medicine Symposium
Location: Grand Ballroom D
Co-Chair & Faculty: Alison Bateman-House, PhD (she/her/hers) – New York Univ Grossman School of Medicine
Co-Chair & Faculty: Kenneth T. Moore, PhD (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
Tuesday, Sep 10th
8:00 AM – 9:30 AM ET
3 - Ethics of Artificial Intelligence & Machine Learning in Medical Research
Faculty: Kellie Owens, PhD (she/her/hers) – New York Univ Grossman School of Medicine
Clinical Trial Designs
Tuesday, Sep 10th
1:30 PM – 3:00 PM ET
Symposium 15: Project Optimus: A Paradigm Shift in Quantitative Clinical Pharmacology or Business as Usual? Part 1
Location: Grand Ballroom A-C
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 Univ of Tennessee Health Science Ctr
Faculty: Weirong Wang, PhD – Janssen Research & Development
Clinical Trial Designs
CE: 1.5
Tuesday, Sep 10th
3:30 PM – 5:00 PM ET
Symposium 15: Project Optimus: A Paradigm Shift in Quantitative Clinical Pharmacology or Business as Usual? Part 2
Location: Grand Ballroom A-C
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 Univ of Tennessee Health Science Ctr
Faculty: Weirong Wang, PhD – Janssen Research & Development
Clinical Trial Designs
CE: 1.5