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Workshop

[In-Person] CMC Strategies and Activities for IND and NDA Filing for Small Molecules: Nuts, Bolts and Best Practices


Speakers: Leane Scoz, BeiGene; Shinji Fujimori, Erasca Inc; Diana Sperger, Gilead; Gerard Jensen, Oliyai Consulting; Ziqi Gui, Stealth startup; Mike Brandl, Sumitomo Pharma; Paresma Patel, FDA
Organizers: Minli Xie, Erasca; Jim Zhang, Olema Oncology
Date: 2024-06-13
Time: 8:45-17:00 Pacific 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: Crowne Plaza, Foster City, CA (San Francisco Bay Area)
Major Sponsor:
Vendor show vendors registered to date: (9)Adare Pharma Solutions; Ardena; Biomere; Cambrex; digiM solution; Emery Pharma; Meadowhawk Biolabs; Quotient Sciences; Veranova
Registration: http://www.PBSS.org
Registration deadline:2024-06-12  (it will close sooner if the seating cap is reached)

About the Topic

This PBSS workshop will cover the CTD Module 3 content, development, manufacturing and testing of drug substance and drug products of small molecule therapeutics through different phases of clinical development as well as regulatory expectations and key activities required to establish the commercial process and appropriate control strategy. The topics would include approaches such as phase-appropriate CMC strategies and Quality-by-Design elements in design and develop process and products.  This workshop will cover best practices and example case studies from leaders in the field.


About the Speakers

Time (PST) Topic Presenter
8:45 - 9:00 am PBSS Welcome and Introduction Shichang Miao, PhD, President, PBSS; Minli Xie, PhD, SVP, Erasca Inc.
9:00 - 9:50 am CTD Module 3 and best practices for IND/NDA preparation Leane Scoz, MS, Senior Director, Regulatory Affairs, CMC, BeiGene
9:50 - 10:40 am Drug substance process development and manufacturing controls Shinji Fujimori, PhD, Executive Director, Erasca, Inc
10:40 -10:50 am Major Sponsor Presentation TBD
10:50 -11:10 am Break and Vendor Show -
11:10 am -12:00 pm Strategies for drug product development and manufacturing controls – oral solid dosage forms Diana Sperger, PhD, Director, Formulation and Process Development, Gilead Sciences.
12:00 - 1:00 pm Lunch Sponsor (Biomere)
1:00 - 1:50 pm Strategies for Drug product development – injectable Gerard Jensen, Oliyai Consulting
1:50 - 2:50 pm Analytical development for drug substance and drug product Ziqi Gui, PhD, Senior Director, Analytical Development and Quality Control, Vaxcyte
2:50 - 3:00 pm Major Sponsor Presentation TBD
3:00 - 3:20 pm Break and Vendor Show -
3:20 - 4:00 pm Understand and control Nitrosamine risks Mike Brandl, PhD, Scientific Fellow, Sumitomo Pharma
4:00 - 5:00 pm Regulatory agency perspectives Paresma Patel, PhD, Division Director, Office of Product Quality Assessment III, FDA
5:00 - 5:30 pm Panel Discussion All Speakers
5:30 - 6:30 pm Happy Hour and Networking Sponsor (Adare Pharma Solutions)


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┬ęPharmaceutical & BioScience Society, International; Last Modified: 4/23/2024; Admin Logon
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