Pharmaceutical & BioScience Society, PBSS

Webcast

[Webcast from Boston-PBSS] Preclinical development and IND filing for small molecules: Nuts, Bolts and Best Practices

Speakers: Shaji Theodore, FDA; Griff Humphreys, Aranmore Pharma Consulting; Patricia White-Cipriano, consultant; Aarti Sawant, AstraZeneca; Dustin Smith, Merck; Nathalie Rioux, Certara; Jonathan Jackson, Pfizer; Marie Lemper, UCB; Drew Barlow, Syner-G BioPharma Group
Organizers: Rob Foti, Merck; Anshul Gupta, Editas Medicine
Date: 2024-06-25
Time: 8:45-17:00 Eastern Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs: $45; Out-of-Pocket: $45; Major Sponsorship: $3000; Vendor Show: $695, Happy Hour Sponsorship: $975; Lunch Sponsorship: $1250; On-site Registration: $500
Location: Webcast from PBSS Boston.
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2024-06-24 (it will close sooner if the seating cap is reached)

About the Topic

Time EST	Topic	Speaker
8:00 – 8:40 am	Registration and Coffee	-
8:40 – 8:50 am	Welcome	Chandra Prakash, PhD, Senior Research Fellow, Agios Pharmaceuticals
8:50 – 9:00 am	Workshop Objectives and Introduction	Rob Foti, PhD, Senior Director, Merck; Anshul Gupta, VP, Editas Medicine
9:00 – 9:40 am	FDA Guidance on Preclinical IND Package	Shaji Theodore, PhD, DABT, Senior Pharmacologist, FDA
9:40 –10:20 am	Overview of Sections 2.6.2, 2.6.4 and 2.6.5	Griff Humphreys, PhD, Principal, Aranmore Pharma Consulting
10:20 – 10:30 am	Sponsor Presentation	Frontage Laboratories, Inc.
10:30 – 10:50 am	Break and Vendor show	-
10:50 – 11:25 am	Overview of Section 2.6.6	Patricia White-Cipriano, PhD, Independent Consultant, Nonclinical/Scientific/Regulatory Drug Development
11:25 am – 12:00 pm	Overview of Clinical section, CDP	Aarti Sawant, PhD, Director, Clinical Pharmacology, AstraZeneca
12:00 – 1:00 pm	Lunch	Sponsor (Alturas Analytics)
1:00 – 1:35 pm	In Vitro & In Vivo ADME Characterization	Dustin Smith, PhD, Principal Scientist, Merck
1:35 – 2:10 pm	Evaluation and Translation of Preclinial DDI	Nathalie Rioux, PhD, VP, Early Drug Development, Certara
2:10 – 2:20 pm	Sponsor Presentation	TBD
2:20 – 2:40 pm	Break and Vendor Show	-
2:40 – 3:15 pm	Preclinical DILI Assessment	Jonathan Jackson, PhD, DABT, Senior Principal Scientist, Discovery & Investigative Toxicology, Pfizer
3:15 – 3:50 pm	IQ Consortium - Starting Dose Selection	Marie Lemper, PhD, Head of US Toxicology, UCB
3:50 – 4:25 pm	Chemistry, Manufacturing, and Controls (CMC)	Drew Barlow, MPH, SVP, Head of Regulatory Partnerships, Syner-G BioPharma Group
4:25 – 4:55 pm	Panel Discussion	Rob Foti, PhD, Senior Director, Merck; Anshul Gupta, VP, Editas Medicine
4:55 – 5:55 pm	Happy Hour	Sponsor (Veloxity Labs)

Other Events of PBSS-Boston:

2024-06-25, [In-Person] Preclinical development and IND filing for small molecules: Nuts, Bolts and Best Practices