Speakers: Yoshiko Stowell, Kenai Therapeutics; Vatzaki Efstratia, EMA; Jay Fajiculay, FDA; Kristina Luong, FDA; Huong Huynh, Critical Path Institute (C-Path); Bargavi Elangovan, Beigene; Xiling Song, Beigene; William Salminen, Premier Research; Yoshimasa Shimoto, CMIC Holdings; Brandon Rice, Weave
Organizers: Snow Ge (BridgeBio), Yoshiko Stowell (Kenai Therapeutics)
Date: 2024-10-10
Time: 8:45-17:15 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs/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: (1)BioIVT;(Major Sponsorship - afternoon session still open)
Vendor show vendors registered to date: (2)Elemental Machines; Meadowhawk Biolabs
Registration: http://www.PBSS.org
Registration deadline:2024-10-08  (it will close sooner if the seating cap is reached)

About the Topic

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.

Efstratia Vatzaki is a Senior specialist in the Regulatory Affairs of European Medicines Agency in Amsterdam, The Netherlands. Having been at the Agency for almost 20 years, she worked in different positions in Evaluation of medicines, Pharmacovigilance and Transparency. Efstratia was involved in academic research in several institutes in Europe (Pasteur Institute in Paris, France; CNRS in Orleans, France; and Bath University, UK), after receiving her PhD in Biochemistry and Immunology from University of Athens in Greece. Efstratia is a chemist by training.

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.

Bargavi Elangovan, BS, is Associate Director of Regulatory Information Management at Biogen. She has over 19 years of experience in Regulatory and R&D, focusing on streamlining business processes and implementation of IT solutions for leading pharmaceutical companies. At Biogen, she is responsible for the oversight of global regulatory systems, and previously, at Cognizant, she spearheaded the execution of multiple large-scale strategic engagements including RIM system implementation. Bargavi holds a Bachelor's degree in Electronics from Madras University and has obtained multiple professional certifications, including in Global Regulatory Strategy and Pharmaceuticals: EU and US Regulations from the Regulatory Affairs Professionals Society (RAPS).

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.

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.

Brandon Rice is a Chief Product Officer at Weave. He and his team are building AutoIND, an AI-powered software platform to streamline every aspect of IND preparation. He is deeply committed to building products that positively impact human lives, create meaningful value for customers, and are delightful to use. Brandon has spent the majority of his career in life science startups, spanning drug manufacturing (new CGT manufacturing platforms), discovery (CRISPR-based target discovery), and diagnostics (multi-omic early cancer detection). Prior to his years in venture-backed companies, he co-founded a genomics services company that's still building genomes today. He is obsessed with the discovery of pragmatic applications for emerging technologies.