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Workshop
[In-Person] 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:
Merck Research lab, Boston
Major Sponsor:
Vendor show vendors registered to date:
(8)Alturas Analytics; Curia; Curia Global; Ellegaard BioResearch; Hypha Discovery Limited; Meadowhawk Biolabs; Q Squared; Veloxity Labs
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) |
2024-06-25, [Webcast from Boston-PBSS] Preclinical development and IND filing for small molecules: Nuts, Bolts and Best Practices
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Ads (in random order)
Submit a Text Ad ($250 for 2 months)
Alturas Analytics, Inc.
Expert Regulated & Non-Regulated LC-MS, GC-MS bioanalytical & PK/TK analysis of small & large molecules in any matrix. Discovery through phase IV.
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Lena Biosciences
Predictive toxicology. Mitochondrial toxicity in a drug metabolism-competent model with active transporters. Intrinsic & idiosyncratic DILI.
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Hypha Discovery
Synthesis, purification & NMR characterization of phase I and II drug metabolites & API impurities at mg-g scale with COAs.
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Lena Biosciences
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Submit a Text Ad
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