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Sunday, November 10, 2024
7:00 AM – 8:00 AM
MST
Registration - Workshop Attendees and Preconference Attendees
7:00 AM – 8:00 AM
MST
Registration - Workshop Attendees and Preconference Attendees
Location: Arizona Grand Ballroom Foyer
8:00 AM – 8:15 AM
MST
Welcome, Introduction & Problem Statement
8:00 AM – 8:15 AM
MST
ACoP Preconference - Exploring New Frontiers: Quantitative Pharmacology for Emerging Therapeutic Modalities - Welcome, Introduction & Problem Statement
Location: Sonoran Sky Ballroom 4
Co-Chair:
Joy C. Hsu, PhD
– Genentech
Co-Chair:
Mark Lovern, PhD (he/him/his)
– InSilicoTrials
Preconference
8:00 AM – 5:00 PM
MST
Biologics (ADC) whole-body PBPK/QSP in PK-Sim and MoBi
8:00 AM – 5:00 PM
MST
Biologics (ADC) whole-body PBPK/QSP in PK-Sim and MoBi, ESQlabs GmbH
Location: Kaibab
Speaker:
Wilhelmus E.A. De Witte, PhD
– ESQlabs
Speaker:
Alexander Kulesza, PhD (he/him/his)
– Systems Pharmacology Lead
Workshop
8:00 AM – 5:00 PM
MST
Efficient reproducible Bayesian population PK modeling with NONMEM and Stan/Torsten, Metrum Research Group
8:00 AM – 5:00 PM
MST
METRUM002 - Efficient reproducible Bayesian population PK modeling with NONMEM and Stan/Torsten, Metrum Research Group
Location: Mesquite
Speaker:
Bill Gillespie
Speaker:
Tim Waterhouse, PhD (he/him/his)
– Metrum Research Group
Speaker:
Curtis Johnston, PharmD
– Metrum Research Group
Speaker:
Seth Green
Workshop
8:00 AM – 5:00 PM
MST
Modeling Delays in Pharmacokinetics and Pharmacodynamics using Phoenix, ISoP MCS SIG
8:00 AM – 5:00 PM
MST
Modeling Delays in Pharmacokinetics and Pharmacodynamics using Phoenix, ISoP MCS SIG
Location: Palm 2A/B
Speaker:
Wojciech Krzyzanski, n/a
– University at Buffalo
Speaker:
Shuhua Hu, PhD
– Certara
Workshop
8:00 AM – 5:00 PM
MST
Scientific Modeling Augmented by Machine-Learning with DeepPumas, PumasAI
8:00 AM – 5:00 PM
MST
PUMAS002 - Scientific Modeling Augmented by Machine-Learning with DeepPumas, PumasAI
Location: Lantana
Speaker:
Niklas Korsbo, Ph.D. (he/him/his)
– DeepPumas, Pumas-AI Inc.
Speaker:
Mohamed Tarek, PhD
– Pumas-AI Inc., USA
Speaker:
Vijay Ivaturi, PhD
– PUMAS Inc
Speaker:
Andreas Noack, PhD
– PumasAI
Workshop
8:00 AM – 5:00 PM
MST
Simcyp Designer PBPK-QSP Focused Workshop, Certara
8:00 AM – 5:00 PM
MST
Simcyp Designer PBPK-QSP Focused Workshop, Certara
Location: Noble
Speaker:
Abdallah Derbalah
Speaker:
Felix Stader, PhD (he/him/his)
– Certara
Workshop
8:15 AM – 9:00 AM
MST
A brief history of model-informed discovery and development of advanced therapies
8:15 AM – 9:00 AM
MST
A brief history of model-informed discovery and development of advanced therapies
Location: Sonoran Sky Ballroom 4
Speaker:
Piet van der Graaf, PharmD, PhD
– Certara
Preconference
9:00 AM – 10:15 AM
MST
Cell & Gene Therapies
Moderator:
Mark Lovern, PhD (he/him/his)
– InSilicoTrials
Speaker:
Jared Weddell, PhD
– Astellas
Speaker:
Hardik Mody, PhD (he/him/his)
– Genentech
Speaker:
Ahmed Abdelhady Abozeid, PhD (he/him/his)
– Intellia
Preconference
9:00 AM – 10:15 AM
MST
Cell & Gene Therapies
Location: Sonoran Sky Ballroom 4
Moderator:
Mark Lovern, PhD (he/him/his)
– InSilicoTrials
Speaker:
Jared Weddell, PhD
– Astellas
Speaker:
Hardik Mody, PhD (he/him/his)
– Genentech
Speaker:
Ahmed Abdelhady Abozeid, PhD (he/him/his)
– Intellia
Preconference
9:00 AM – 9:25 AM
MST
Hitting the target (dose) in one shot: MIDD for cell and gene therapies
Location: Sonoran Sky Ballroom 4
Speaker:
Jared Weddell, PhD
– Astellas
Preconference
9:25 AM – 9:50 AM
MST
Quantitative Pharmacology Considerations in the Development of Cell Therapies - Opportunities & Challenges
Location: Sonoran Sky Ballroom 4
Speaker:
Hardik Mody, PhD (he/him/his)
– Genentech
Preconference
9:50 AM – 10:15 AM
MST
Quantitative Pharmacology Approach to Inform the Bench-to-Bed Translation of CRSPR-Based in-vivo Gene Editing Therapy across Multiple Development Phases
Location: Sonoran Sky Ballroom 4
Speaker:
Ahmed Abdelhady Abozeid, PhD (he/him/his)
– Intellia
Preconference
10:15 AM – 10:30 AM
MST
Coffee Break
10:15 AM – 10:30 AM
MST
Coffee Break
Location: Sonoran Patio
10:30 AM – 11:45 AM
MST
siRNA Therapies
Moderator:
Nitin Mehrotra, Phd
– Alnylam Pharmaceuticals
Speaker:
Jeff Kearns, PhD (he/him/his)
– Novartis
Speaker:
Vivaswath S. Ayyar, PhD
– J&J Innovative Medicine
Speaker:
Nitin Mehrotra, Phd
– Alnylam Pharmaceuticals
Preconference
10:30 AM – 11:45 AM
MST
siRNA Therapies
Location: Sonoran Sky Ballroom 4
Moderator:
Nitin Mehrotra, Phd
– Alnylam Pharmaceuticals
Speaker:
Jeff Kearns, PhD (he/him/his)
– Novartis
Speaker:
Vivaswath S. Ayyar, PhD
– J&J Innovative Medicine
Speaker:
Nitin Mehrotra, Phd
– Alnylam Pharmaceuticals
Preconference
10:30 AM – 10:55 AM
MST
First, Best, or Next in class? Applying forward and reverse translation approaches to accelerate siRNA projects from discovery to FIH.
Location: Sonoran Sky Ballroom 4
Speaker:
Jeff Kearns, PhD (he/him/his)
– Novartis
Preconference
10:55 AM – 11:20 AM
MST
Quantitative Pharmacology Principles and Model-Informed Development Approaches for RNAi Therapeutics
Location: Sonoran Sky Ballroom 4
Speaker:
Vivaswath S. Ayyar, PhD
– J&J Innovative Medicine
Preconference
11:20 AM – 11:45 AM
MST
Innovating the landscape: Is MIDD of siRNA unique?
Location: Sonoran Sky Ballroom 4
Speaker:
Nitin Mehrotra, Phd
– Alnylam Pharmaceuticals
Preconference
11:45 AM – 12:45 PM
MST
Preconference Attendees Lunch/Posters
11:45 AM – 12:45 PM
MST
Preconference Attendees Lunch/Posters
Location: Sonoran Sky Ballroom 1-3
12:00 PM – 1:00 PM
MST
Workshop Attendees Lunch
12:00 PM – 1:00 PM
MST
Workshop Attendees Lunch
Location: Sunset Patio and Grand Veranda
12:00 PM – 7:30 PM
MST
ACoP 2024 Conference Registration
12:00 PM – 7:30 PM
MST
ACoP 2024 Conference Registration
Location: Sonoran Sky Lobby
12:45 PM – 1:45 PM
MST
The Regulatory Landscape of Quantitative Pharmacology for New Therapeutic Modalities at the FDA
Moderator:
Joy C. Hsu, PhD
– Genentech
Speaker:
Sojeong Yi, PhD
– FDA
Panelist:
Hao Zhu, PhD
– ISoP
Preconference
12:45 PM – 1:45 PM
MST
The Regulatory Landscape of Quantitative Pharmacology for New Therapeutic Modalities at the FDA
Location: Sonoran Sky Ballroom 4
Moderator:
Joy C. Hsu, PhD
– Genentech
Speaker:
Sojeong Yi, PhD
– FDA
Panelist:
Hao Zhu, PhD
– ISoP
Preconference
1:45 PM – 3:00 PM
MST
Emerging New Therapeutic Modalities
Moderator:
Joy C. Hsu, PhD
– Genentech
Speaker:
Samira Khalili (she/her/hers)
– Ionis
Speaker:
Donghua Yin, PhD
– Pfizer
Speaker:
Eric Masson, PharmD
– Arvinas
Preconference
1:45 PM – 3:00 PM
MST
Emerging New Therapeutic Modalities
Location: Sonoran Sky Ballroom 4
Moderator:
Joy C. Hsu, PhD
– Genentech
Speaker:
Samira Khalili (she/her/hers)
– Ionis
Speaker:
Donghua Yin, PhD
– Pfizer
Speaker:
Eric Masson, PharmD
– Arvinas
Preconference
1:45 PM – 2:10 PM
MST
Applications of A Platform PBPK Model of Antisense Oligonucleotides Towards Candidate Selection, Tox Study Design and Human Dose Projection
Location: Sonoran Sky Ballroom 4
Speaker:
Samira Khalili (she/her/hers)
– Ionis
Preconference
2:10 PM – 2:35 PM
MST
Model-Informed Drug Development Applications to Oncology Bispecifics and Antibody-Drug Conjugates
Location: Sonoran Sky Ballroom 4
Speaker:
Donghua Yin, PhD
– Pfizer
Preconference
2:35 PM – 3:00 PM
MST
Unique Model Informed Drug Development Opportunities with PROTAC Protein Degrader
Location: Sonoran Sky Ballroom 4
Speaker:
Eric Masson, PharmD
– Arvinas
Preconference
3:00 PM – 3:15 PM
MST
Coffee Break-Preconference Attendees
3:00 PM – 3:15 PM
MST
Coffee Break-Preconference Attendees
Location: Sonoran Patio
3:15 PM – 4:30 PM
MST
Interactive Session: Development Challenges for New Therapeutic Modalities
3:15 PM – 4:30 PM
MST
Interactive Session: Development Challenges for New Therapeutic Modalities
Location: Sonoran Sky Ballroom 4
Facilitator:
Peter Bonate, PhD
– Executive Director at Astellas/ Editor-in-Chief, JPKPD
Preconference
4:30 PM – 4:45 PM
MST
Preconference Concluding Remarks
4:30 PM – 4:45 PM
MST
Preconference Concluding Remarks
Location: Sonoran Sky Ballroom 4
Speaker:
Joy C. Hsu, PhD
– Genentech
Speaker:
Mark Lovern, PhD (he/him/his)
– InSilicoTrials
Preconference
4:45 PM – 5:15 PM
MST
ISoP Awards & Fellow Reception (invitation only)
4:45 PM – 5:15 PM
MST
ISoP Awards & Fellow Reception (invitation only)
Location: Palms 3 Patio
5:30 PM – 7:30 PM
MST
ACoP 2024 Opening Session
Speaker:
Wei Gao, PhD
– Moderna
Speaker:
Nahor Haddish-Berhane
5:30 PM – 7:30 PM
MST
ACoP 2024 Opening Session
Location: Canyon Ballroom
Speaker:
Wei Gao, PhD
– Moderna
Speaker:
Nahor Haddish-Berhane
5:30 PM – 5:45 PM
MST
Welcome to ACoP 2024
Location: Canyon Ballroom
Speaker:
Wei Gao, PhD
– Moderna
5:45 PM – 6:15 PM
MST
Presentation of ISoP Awards & Induction of Fellows
Location: Canyon Ballroom
Speaker:
Nahor Haddish-Berhane
6:15 PM – 7:30 PM
MST
Lewis B. Sheiner Award Lecture
Location: Canyon Ballroom
Speaker:
Donald E. Mager, PharmD, PhD (he/him/his)
– University at Buffalo, SUNY
7:30 PM – 10:00 PM
MST
Welcome Reception
7:30 PM – 10:00 PM
MST
Welcome Reception
Location: Arizona Grand Ballroom/Palm Court/Paseo West
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