Workshop
Dose Projection for First-in-Human Studies for Small Molecules, Protein Therapeutics, and Gene Therapy (Fundamentals, Methodology, Challenges, and Regulatory Considerations)
Speakers:
Punit Marathe (BMS, NJ), Kefeng Sun (Shire, MA) , Haiqing Wang (BMS, NJ), Dhaval Shah (SUNY Buffalo, NY), Jing-Tao Wu (Alnylam, MA), John Murphy (Pfizer, MA)
Organizers:
Pratap Singh (Alexion), Haojing Rong (Shire)
Date:
2018-04-27
Time:
8:30-16:30 Eastern Time
Registration fee:
(USD): Regular: $175; For Academic / Unemployed: $125
Location:
Boston Marriott Cambridge, 50 Broadway, Cambridge, MA 02142
Major Sponsor:
Vendor show vendors registered to date:
(10)BioreclamationIVT; Eurofins Bioanalytical Services; Intertek; Medpace; MicroConstants; QPS; Qualyst Transporter Solutions, LLC; RES Group; Simulations Plus; Worldwide Clinical Trials
Registration: http://www.PBSS.org
Registration deadline:2018-04-25
(it will close sooner if the seating cap is reached)
About the Topic
“All things are poison and nothing is without poison, only the dose permits something not to be poisonous” by Paracelsus of 16th century remains to be true in the 21st century. Successful drug development hinges on getting the dose right. Even though the right dose can’t be confirmed until Phase 3 clinical trial readout, human dose projection starts early in research, and is the centerpiece of the “Learn & Confirm” drug development paradigm. In this one-day workshop we bring a panel of speakers to share their experience in the art and science of human dose projection, on a variety of therapeutic modalities, including small molecules, proteins, mAbs, RNA therapies, and gene therapies Talks will focus on human efficacious dose projection, setting safe starting dose in first in human (FIH) trials, safety margin assessment, and regulatory considerations.
Workshop Agenda
08:15 – 08:45 Breakfast and Registration
08:45 – 09:00 Welcome and workshop introduction (Pratap Singh, Alexion and Haojing Rong, Shire)
09:00 – 10:00 Punit Marathe (BMS, NJ) - Human PK and dose projections for small molecules- A discovery and lead optimization perspective
10:00 – 10:45 Kefeng Sun (Shire, MA) - Mechanistic PK/PD modeling and simulation for projections of human dose and response of glucagon-like peptide-2 receptor (GLP2R) agonists
10:45 – 11:05 Break & Vendor Show
11:05 – 11:20 Major Sponsor Presentation – Applied BioMath
11:20 – 12:05 Haiqing Wang (BMS, NJ) - Integration of Nonclinical PK/PD Data for First-in-Human Starting Dose Selection of Agonistic Cancer Immune Therapeutics.
12:05 – 13:15 Lunch, Network, and Vendor Show
13:15 – 13:30 Major Sponsor Presentation – Covance
13:30 – 14:15 Dhaval Shah (SUNY Buffalo, NY) - PK-PD M&S Driven FIH Dose Projection for ADCs
14:15 – 14:30 Break & Vendor Show
14:30 – 15:15 Jing-Tao Wu (Alnylam, MA) – Human dose projection for siRNA-GalNAc conjugates
15:15 – 16:00 John Murphy (Pfizer, MA) – Learnings from gene therapy trials in hemophilia B patients
16:00 – 16:30 Round table discussion, Raffle, and Closing Remarks
2024-06-25, [In-Person] Preclinical development and IND filing for small molecules: Nuts, Bolts and Best Practices
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2024-06-25, [Webcast from Boston-PBSS] Preclinical development and IND filing for small molecules: Nuts, Bolts and Best Practices
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