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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, Vaxcyte; 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: (21)Adare Pharma Solutions; Altasciences; Ardena; AustinPx; BioDuro-Sundia; Biomere; Cambrex; Catalent; CP Lab Safety; Curia; DGCI; digiM solution; Emery Pharma; FreeThink Technologies, Inc.; Frontage Laboratories, Inc.; Meadowhawk Biolabs; Phlow Corp; Primera Analytical Solutions Corp; Quotient Sciences; ReechPharma; 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 - 10:00 am Regulatory agency perspectives Paresma Patel, PhD, Division Director, Office of Product Quality Assessment III, FDA
10:00 - 10:50 am CTD Module 3 and best practices for IND/NDA preparation Leane Scoz, MS, Senior Director, Regulatory Affairs, CMC, BeiGene
10:50 -11:00 am Major Sponsor Presentation TBD
11:00 -11:20 am Break and Vendor Show -
11:20 am -12:10 pm Drug substance process development and manufacturing controls Shinji Fujimori, PhD, Executive Director, Erasca, Inc
12:10 - 1:10 pm Lunch Sponsor (DGCI)
1:10 - 2:00 pm Strategies for drug product development and manufacturing controls – solid oral dosage forms Diana Sperger, PhD, Director, Formulation and Process Development, Gilead Sciences.
2:00 - 2:50 pm Strategies for Drug product development – injectable Gerard Jensen, Oliyai Consulting
2:50 - 3:00 pm Major Sponsor Presentation TBD
3:00 - 3:20 pm Break and Vendor Show -
3:20 - 4:20 pm Analytical development for drug substance and drug product Ziqi Gui, PhD, Senior Director, Analytical Development and Quality Control, Vaxcyte
4:20 - 5:00 pm Understand and control Nitrosamine risks Mike Brandl, PhD, Scientific Fellow, Sumitomo Pharma
5:00 - 5:30 pm Panel Discussion All Speakers
5:30 - 6:30 pm Happy Hour and Networking Sponsor (Adare Pharma Solutions)

Dr. Paresma (Pinky) Patel, serves as Division Director in CDER’s Office of Pharmaceutical Quality, Office of Product Quality Assessment III. In her role, she leads teams that evaluate chemistry, manufacturing, and controls (CMC) information to ensure drug substance quality from clinical development to marketing application submission. Prior to her current position, she was a Branch Chief working with oncology and anti-viral clinical divisions. Prior to FDA she was a medicinal chemist at the National Institutes of Health. Dr. Patel earned her PhD in organic chemistry from The Scripps Research Institute and completed a postdoctoral fellowship at the California Institute of Technology.

Leane Scoz is a Senior Director, Regulatory CMC, at BeiGene. Leane is a chemist by training and has over 19 years of industry experience in Regulatory, Quality Control and Manufacturing supporting both development and commercial products across multiple therapeutic areas. At BeiGene, Leane leads the US small molecule Regulatory CMC team focusing on developing and executing global regulatory CMC strategy for right-first time small molecule CMC related submissions, including the global expansion of Bruton tyrosine kinase inhibitor, Brukinsa, to over 70 countries. Leane is also dedicated to process optimization and is passionate about developing and mentoring fellow team members.

Dr. Shinji Fujimori is Executive Director of Process Development and Manufacturing at Erasca, Inc.  He received his B.A. in Chemistry from Lake Forest College and PhD in Synthetic Organic Chemistry from University of Illinois Urbana-Champaign.  Before starting his industry career, he was a postdoctoral researcher at Eidgenössische Technische Hochschule Zürich in Switzerland.  He has over 17 years of experience in process research and development at both large and small pharmaceutical companies including Merck, Gilead, Medivation, Pfizer, Myovant Sciences and Global Blood Therapeutics.  He has more than a dozen publications. 

Dr. Diana Sperger is a Director in Formulation and Process Development at Gilead. She is responsible for lead optimization of pre-clinical drug candidates, preformulation, formulation development, process scale-up, technology transfer, and validation of clinical drug candidates.  Diana has been involved in the development of Odefsey®, Vemlidy®, Harvoni®, and Jyseleca®. She is also an inventor on U.S. and international patents related to drug product formulation, and process. Diana received her BA degree in Chemistry from the College of the Holy Cross followed by a PhD degree in Pharmaceutical Chemistry from the University of Kansas.

Dr. Gerard M. Jensen is with the Oliyai Consulting.  He served as Vice President and General Manager of the Gilead San Dimas and La Verne parenteral manufacturing sites.  He studied at UCLA and USC, obtaining a PhD in Physical Chemistry, and after a postdoc at Scripps worked at NeXstar Pharmaceuticals, and later Gilead, leading formulation, process, and analytical development, and scale-up, manufacturing and testing of complex parenteral therapeutics.  Commercial products produced at these sites include the liposome products AmBisome® and DaunoXome®, Macugen®, an oligonucleotide aptamer ophthalmic injection, Cayston®, an inhaled antibiotic, Veklury® for COVID-19, and developmental/clinical products including long acting antivirals and ADCs.

Dr. Ziqi Gui, a Senior Director of Analytical Development and Quality Control at Vaxcyte, San Carlos, CA, holds PhD in analytical chemistry.  Ziqi has over 28 years of experience in analytical development and quality control in support of CMC projects from early clinical development to commercial launch.  His core responsibilities throughout his pharmaceutical/biotech career are method development, method validation/verification/transfer, analytical method troubleshooting, ICH stability program, authoring and reviewing regulatory submissions, such as IND/IMPD/NDA/MAA, leading specification committee for drug substances and drug products, and providing analytical control strategy in pharmaceutical development.

Dr. Michael Brandl is a Distinguished Fellow in the CMC group at Sumitomo Pharma America. He studied organic chemistry at the University of Toronto with Ronald Kluger and post-doctoral studies with Ronald Breslow at Columbia University before joining Syntex Research/Roche as a pharmaceutical scientist.  After leaving Roche in 2010 he joined Gilead Sciences as an analytical scientist and joined Myovant in 2018. He has more than 25 publications and patents in organic and pharmaceutical chemistry.


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