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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
Meet the ACCP/ISoP Special Interest Group
Location: Grand Ballroom A-C
7:00 AM – 7:45 AM
ET
STEP & ESP Gathering
7:00 AM – 7:45 AM
ET
STEP & ESP Gathering
Location: Grand Ballroom D
7:00 AM – 8:00 AM
ET
Continental Breakfast
7:00 AM – 8:00 AM
ET
Continental Breakfast
Location: Grand Ballroom E-H
7:00 AM – 5:00 PM
ET
ACCP Registration Open
7:00 AM – 5:00 PM
ET
ACCP Registration Open
Location: Grand Ballroom Foyer
7:00 AM – 7:00 PM
ET
Exhibit Hall Open
7:00 AM – 7:00 PM
ET
Exhibit Hall Open
Location: Grand Ballroom E-H
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 Co
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 5: FDA Modernization Act 2.0: How Do We Fully Leverage this Unique Opportunity to Transform Drug Development?
Location: Grand Ballroom A-C
Co-Chair & Faculty:
Navin S. Goyal, PhD
– Janssen Research & Development, LLC, a Johnson & Johnson Co
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
1 - Introduction & Motivation
Co-Chair & Faculty:
Navin S. Goyal, PhD
– Janssen Research & Development, LLC, a Johnson & Johnson Co
8:00 AM – 9:30 AM
ET
2 - Evolving Drug Development Landscape: Challenges as We Move Away From the Traditional Paradigm
Co-Chair & Faculty:
Gwendolyn Pais, PhD
– Midwestern Univ Chicago Coll of Pharmacy
8:00 AM – 9:30 AM
ET
3 - Opportunity to Innovate & Push Frontiers: Regulatory Science
Faculty:
Wendy Wu, PhD
– US Food & Drug Administration
8:00 AM – 9:30 AM
ET
4 - Performance Assessment & Economic Analysis of a Human Liver-Chip for Predictive Toxicology
Faculty:
Daniel Levner, MS, PhD
– Emulate Inc
8:00 AM – 9:30 AM
ET
5 - Microfluidics & Organ-on-a-chip: Exploiting Potential to the Fullest
Faculty:
Rodrigo Cristofoletti, PhD (he/him/his)
– Univ of Florida Coll of Pharmacy
8:00 AM – 9:30 AM
ET
6 - Discussion, Questions & Answers, Learner Feedback & Evaluations
Translational Medicine/Physiologically-based Pharmacokinetics/Systems Pharmacology/In Vitro/In Vivo Extrapolation
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, 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
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
8:00 AM – 9:30 AM
ET
1 - Clinical Trial Diversity: What Comes to Your Mind?
Co-Chair & Faculty:
Shuangwu (Cheryl) Li, PhD
– Takeda Pharmaceutical Co Ltd
8:00 AM – 9:30 AM
ET
2 - Clinical Pharmacology Considerations for Diversity During Drug Development & Regulatory Assessment
Co-Chair & Faculty:
Anuradha Ramamoorthy, PhD
– US Food & Drug Administration
8:00 AM – 9:30 AM
ET
3 - Clinical Pharmacology Strategies to Advance Clinical Trial Diversity: Industry Perspectives
Faculty:
Gianluca Nucci, PhD (he/him/his)
– Pfizer Inc
8:00 AM – 9:30 AM
ET
4 - Case Examples on Enhancing Clinical Trial Diversity from Academic & Clinical Development Perspectives
Faculty:
R. Donald Harvey, PharmD (he/him/his)
– Emory Univ School of Medicine
8:00 AM – 9:30 AM
ET
5 - Discussion, Questions & Answers, Learner Feedback & Evaluations
Clinical Trials/General Drug Development Strategy & Practice
9:30 AM – 10:00 AM
ET
Coffee & Networking Break
9:30 AM – 10:00 AM
ET
Coffee & Networking Break
Location: Grand Ballroom E-H
9:30 AM – 10:00 AM
ET
Industry Theater: ACCP Inclusivity, Diversity & Equity (IDE) Committee Activities
9:30 AM – 10:00 AM
ET
Industry Theater: ACCP Inclusivity, Diversity & Equity (IDE) Committee Activities
Location: Industry Theater (Grand Ballroom E-H)
10:00 AM – 10:30 AM
ET
Meet the EICs
10:00 AM – 10:30 AM
ET
Meet the Editors-in-Chief
Location: Grand Ballroom A-D
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
10:30 AM – 11:30 AM
ET
Invited Keynote: How Precise Is Current Pharmacotherapy for Pediatric & Adolescent Obesity?
Location: Grand Ballroom A-D
Faculty:
Jack Yanovski, MD, PhD
– National Inst of Health
CE: 1
10:30 AM – 11:30 AM
ET
Invited Keynote
Faculty:
Jack Yanovski, MD, PhD
– National Inst of Health
10:30 AM – 11:30 AM
ET
How Precise Is Current Pharmacotherapy for Pediatric & Adolescent Obesity?
Faculty:
Jack Yanovski, MD, PhD
– National Inst of Health
11:30 AM – 1:30 PM
ET
Lunch Buffet
11:30 AM – 1:30 PM
ET
Lunch Buffet
Location: Grand Ballroom E-H
11:45 AM – 1:15 PM
ET
Lunch & Awards
11:45 AM – 1:15 PM
ET
Lunch & Awards
Location: Grand Ballroom A-D
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:
John Van Den Anker, MD, PhD, FCP, FAAP
– Children's National Hosp
Faculty:
Janelle M. Burnham, MD
– Otsuka Pharmaceuticals
Specific Populations
CE: 1.5
1:30 PM – 3:00 PM
ET
Symposium 7: Operational Considerations for Early-phase Pharmacokinetic/Pharmacodynamic/Safety Studies in Pediatric Patients
Location: Grand Ballroom A-C
Co-Chair & Faculty:
Dionna J. Green, MD
Co-Chair & Faculty:
Susan McCune, MD (she/her/hers)
– PPD, Part of Thermo Fisher Scientific
Faculty:
John Van Den Anker, MD, PhD, FCP, FAAP
– Children's National Hosp
Faculty:
Janelle M. Burnham, MD
– Otsuka Pharmaceuticals
Specific Populations
CE: 1.5
1:30 PM – 3:00 PM
ET
1 - Introduction of Session & History of Pediatric Clinical Pharmacology Units
Co-Chair & Faculty:
Susan McCune, MD (she/her/hers)
– PPD, Part of Thermo Fisher Scientific
1:30 PM – 3:00 PM
ET
2 - Considerations for Early-phase Pharmacokinetic/Pharmacodynamic/Safety Clinical Trials in Pediatrics
Co-Chair & Faculty:
Dionna J. Green, MD
1:30 PM – 3:00 PM
ET
3 - Current Status of Early-phase Pharmacokinetic/Pharmacodynamic/Safety Clinical Trials in Pediatrics
Faculty:
John Van Den Anker, MD, PhD, FCP, FAAP
– Children's National Hosp
1:30 PM – 3:00 PM
ET
4 - Operational Considerations in Early-phase Pharmacokinetic/Pharmacodynamic/Safety Clinical Trials in Pediatrics
Faculty:
Janelle M. Burnham, MD
– Otsuka Pharmaceuticals
1:30 PM – 3:00 PM
ET
5 - Discussion, Questions & Answers, Learner Feedback & Evaluations
Special Populations in Clinical Trials & Clinical Practice (geriatrics, organ impairment, transgender, other)
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:
Lanyan (Lucy) Fang, PhD
– US Food & Drug Administration
Clinical Trial Designs
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
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
1:30 PM – 3:00 PM
ET
1 - Introduction & Overview: Current Regulatory Horizon of Narrow Therapeutic Index Drugs & ICH Guideline Development for Bioequivalence Assessment
Co-Chair & Faculty:
Lei Zhang, PhD
– US Food & Drug Administration
1:30 PM – 3:00 PM
ET
2 - US FDA Narrow Therapeutic Index Drug Classification: Current Process & Research
Faculty:
Lanyan (Lucy) Fang, PhD
– US Food & Drug Administration
1:30 PM – 3:00 PM
ET
3 - Industry's Perspectives on Classification Criteria & Bioequivalence Standards for Narrow Therapeutic Index Drugs & the Need for Global Harmonization
Co-Chair & Faculty:
Yu Chung Tsang, PhD (he/him/his)
– YCT Scientific Inc
1:30 PM – 3:00 PM
ET
4 - A Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union
Faculty:
Paulo Paixao, PhD
– Univ of Lisbon
1:30 PM – 3:00 PM
ET
5 - Data-driven & Science-based Recommendation on Harmonization of Bioequivalence Standards for Narrow Therapeutic Index Drugs
Faculty:
Wenlei Jiang, PhD
– US Food & Drug Administration
1:30 PM – 3:00 PM
ET
6 - Discussion, Questions & Answers, Learner Feedback & Evaluations
Biosimilars/Generics
3:00 PM – 3:30 PM
ET
Coffee & Networking Break
3:00 PM – 3:30 PM
ET
Coffee & Networking Break
Location: Grand Ballroom E-H
3:00 PM – 3:30 PM
ET
STEP & ESP Podium Presentations
3:00 PM – 3:30 PM
ET
STEP & ESP Podium Presentations
Location: Industry Theater (Grand Ballroom E-H)
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 Co
Co-Chair & Faculty:
Martina Sahre, PhD
– US Food & Drug Administration
Faculty:
William B. Smith, MD
– Alliance for Multispecialty Research Knoxville
Faculty:
Xinyuan Zhang, PhD
– Daiichi Sankyo Inc
Specific Populations
CE: 1.5
3:30 PM – 5:00 PM
ET
Symposium 9: Rethinking Hepatic Impairment Studies: A Patient-centric Approach
Location: Grand Ballroom A-C
Co-Chair & Faculty:
Navin S. Goyal, PhD
– Janssen Research & Development, LLC, a Johnson & Johnson Co
Co-Chair & Faculty:
Martina Sahre, PhD
– US Food & Drug Administration
Faculty:
William B. Smith, MD
– Alliance for Multispecialty Research Knoxville
Faculty:
Xinyuan Zhang, PhD
– Daiichi Sankyo Inc
Specific Populations
CE: 1.5
3:30 PM – 5:00 PM
ET
1 - Hepatic Impairment Studies: Whom Do They Truly Benefit?
Co-Chair & Faculty:
Navin S. Goyal, PhD
– Janssen Research & Development, LLC, a Johnson & Johnson Co
3:30 PM – 5:00 PM
ET
2 - Informing Appropriate Dosing in Target Populations
Co-Chair & Faculty:
Martina Sahre, PhD
– US Food & Drug Administration
3:30 PM – 5:00 PM
ET
3 - Clinical Research in Subjects With Hepatic Impairment
Faculty:
William B. Smith, MD
– Alliance for Multispecialty Research Knoxville
3:30 PM – 5:00 PM
ET
4 - Role of Model-based Approaches in Hepatic Impairment Studies
Faculty:
Xinyuan Zhang, PhD
– Daiichi Sankyo Inc
3:30 PM – 5:00 PM
ET
5 - Discussion, Questions & Answers, Learner Feedback & Evaluations
Special Populations in Clinical Trials & Clinical Practice (geriatrics, organ impairment, transgender, other)
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)
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
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
3:30 PM – 5:00 PM
ET
1 - Global Health & Decentralized Clinical Trials
Co-Chair & Faculty:
Myong-Jin Kim, PharmD (she/her/hers)
3:30 PM – 5:00 PM
ET
2 - Decentralized Clinical Trials: Bringing Trial-related Activities to the Patient
Faculty:
Leonard V. Sacks, MD (he/him/his)
– US Food & Drug Administration
3:30 PM – 5:00 PM
ET
3 - Investigator's Perspective on Decentralized Clinical Trials
Co-Chair & Faculty:
Kyung-Sang Yu, MD, PhD
– Seoul National Univ College of Medicine & Hosp
3:30 PM – 5:00 PM
ET
4 - Management of Medication & Laboratory Specimens in Decentralized Clinical Trials: Mobile Application & Contactless Regional Shipping
Faculty:
Seol Ju Moon, MD, PhD (she/her/hers)
– Jeonbuk National Univ Hosp
3:30 PM – 5:00 PM
ET
5 - Discussion, Questions & Answers, Learner Feedback & Evaluations
5:00 PM – 5:30 PM
ET
STEP & ESP Poster Walk
5:00 PM – 5:30 PM
ET
STEP & ESP Poster Walk
Location: Grand Ballroom E-H
5:00 PM – 7:00 PM
ET
Evening Reception, Exhibits & Poster Session 2
5:00 PM – 7:00 PM
ET
Evening Reception, Exhibits & Poster Session 2
Location: Grand Ballroom E-H
6:00 PM – 6:30 PM
ET
Industry Theater Sponsor Presentation: Applications of Artificial Intelligence in Drug Development, presented by Patel Kwan Consultancy LLC
6:00 PM – 6:30 PM
ET
Industry Theater Sponsor Presentation: Applications of Artificial Intelligence in Drug Development, Presented by Patel Kwan Consultancy LLC
Location: Industry Theater (Grand Ballroom E-H)
7:00 PM – 9:00 PM
ET
JCP & CPDD Editorial Board Dinner (Invitation Only)
7:00 PM – 9:00 PM
ET
JCP & CPDD Editorial Board Dinner (Invitation Only)
Location: Brookside