San Francisco Bay Area Chapter and PBSS Workshop In Person: Regulatory Global Submission: Strategies

Workshop Objectives

• Understand the evolving regulatory landscape and its impact on drug development
• Develop effective IND/NDA submission strategies, including CMC-specific considerations
• Explore opportunities within the PMDA submission process
• Learn how public-private partnerships can enhance regulatory science and drug development
• Master CTIS best practices to optimize clinical studies in EU

Agenda

Dr. Yoshiko Stowell is VP of Regulatory Affairs at Kenai Therapeutics. She has over 20 years of experience in drug development. Additional roles include Head of RA at Neuron23, VP of RA and QA at AmyriAD Therapeutics and Sr. Director of RA at Eidos Therapeutics, BridgeBio Pharma. She is the Chair of the Regulatory Affairs Professional Society (RAPS) San Francisco Bay Area Chapter. She received her PhD in Pharmaceutical Science from University of the Pacific, MS in Chemical Engineering from University of Oklahoma, and BS in Chemistry from Tokyo University of Science.

Jay Fajiculay, PharmD, is a Senior Regulatory Health Project Manager with FDA’s Office of New Drugs, supporting the Division of Gastroenterology. Dr. Fajiculay first joined FDA in 2016, serving as the Designated Federal Officer for the Gastrointestinal Drugs Advisory Committee and Advisory Committee for Pharmaceutical Sciences and Clinical Pharmacology, before transitioning to the Office of New Drugs in 2020. Dr. Fajiculay completed his Doctor of Pharmacy degree at Midwestern University’s Chicago College of Pharmacy in 2014, followed by a two-year Regulatory Pharmaceutical Fellowship in Drug Information co-sponsored by Purdue University, Eli Lilly and Company, and the FDA in 2016.

Dr. Kristina Luong, PharmD, BCPS, is a Senior Regulatory Health Project Manager with FDA’s Office of New Drugs. Dr. Luong first joined FDA as the Program Manager for the Division of Clinical Outcome Assessment, where she provided oversight of advice on clinical outcome assessments in drug development and policy. She prior to transitioned to her current role in 2022, supporting the Division of Gastroenterology. Dr.  Luong earned a Bachelor of Science in Biochemistry from Virginia Tech in 2012 and a Doctor of Pharmacy from Virginia Commonwealth University School of Pharmacyin 2016. Following pharmacy school, she completed a PGY1 Pharmacy Practice Residency prior to joining FDA in 2018.

Huong directs the Regulatory Science Program at Critical Path Institute, leading strategic discussions with FDA and EMA and working in cross-functional and multi-disciplinary collaborations to develop regulatory strategies for the endorsements of novel drug development tools such as biomarkers, clinical endpoints, patient-reported outcome measures, clinical trial simulation tools and other quantitative solutions to address unmet medical needs through scientific collaborations in the pre-competitive space. Huong has 20+ years of regulatory experience including as an FDA regulatory reviewer and contributed to leading new initiatives across diverse disease areas, including rare diseases, neurodegenerative disorders, metabolic diseases, and pediatric conditions.

Terra Johnston is a seasoned professional in clinical research with over 30 years of experience. She holds an MBA from the University of Phoenix and a BS in Biology from the University of Puget Sound. Currently, she serves as the Director of Regulatory Operations at Novotech, having joined the company in 2016. Terra’s extensive career spans roles at UCB Pharma, Amgen, and Quintiles, where she worked on trials across multiple therapeutic areas, including oncology, neurology, and gastroenterology. Her expertise in regulatory affairs, project management, and leadership has made her an invaluable asset in the industry.

Xiling has over 24 years of experience in the pharmaceutical industry and currently serves as Vice President, Global Head of Regulatory CMC at BeiGene, where she oversees global CMC-related submissions for more than 50 small molecule and biologics products. Before joining BeiGene in 2019, Xiling spent 15 years at Roche Genentech and 5 years at Boehringer Ingelheim, holding roles such as Analytical Scientist, Regulatory CMC Lead, Quality Product Lead, and CMC Project Lead. She actively engages in regulatory intelligence, collaborating with agencies like the FDA and China CDE, and holds a Master of Science degree in Analytical Chemistry.

William (Willie) Salminen, PhD, DABT, RAC has 25 years of drug development experience. He leads the Nonclinical and Clinical Pharmacology groups within Premier, which provides nonclinical and clinical pharmacology strategies, study requirements and designs, pharmacokinetic modeling, input on regulatory submissions, and addressing nonclinical and clinical issues (e.g., Clinical Holds). William’s key experience includes but is not limited to regulatory strategy and advice, nonclinical safety and toxicology strategy and advice, US FDA pre-IND meetings, IND applications and maintenance and NDA and BLA submissions. He has significant experience with 505(b)(2) NDAs and the unique regulatory, nonclinical, and clinical strategies involved with developing drugs under the 505(b)(2) pathway.

Yoshimasa Shimoto has provided strategic consulting and navigation to companies seeking to enter the Japanese pharmaceutical market. Prior to joining CMIC, he served as the Executive Vice President at Daiichi Sankyo RD Novare, overseeing the execution of clinical studies. At Daiichi Sankyo, he also had served as Vice President of Global Project Management and Asia Development, responsible for portfolio/project management of R&D and clinical study implementation in the Asian region, respectively. Dr. Shimoto received a PhD from the University of Tokyo and completed a research fellowship at the University of Michigan.

Date/Time/RAC Check

10/10/2024 from 8:45 AM-5:30 PM PST RAC 5

Platinum Chapter Sponsors 

MDSS 

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