PDA West Coast Chapter (PDA WCC)

🌟 Meet Eric Fulmer, one of our fantastic speakers for our upcoming Quality Seminar in San Francisco on Friday, November 7th from 6-10:30 pm! Eric is the Senior Vice President of Global Quality at Cellares. He oversees the teams that perform Quality Control, Quality Assurance, Validation, Design Assurance, and Regulatory Affairs activities for Cellares in-house technology development and operations, and of the Integrated Development and Manufacturing Organization (IDMO) services in the Cellares Smart Factories. Prior to Cellares, Eric established the phase-appropriate Quality Management System and the Quality, Regulatory, and EH&S teams at Bionova Scientific, a start-up CDMO with expertise in cell line development and complex biologics process design. He led the Drug Substance Quality team for Clinical and Commercial Plants at Samsung BioLogics in South Korea, providing inspection management and operational decision making for 186,000L of multi-client and multi-product capacity. Before moving to South Korea, Eric held roles in Quality and Manufacturing at Amgen, as well as product development and manufacturing at Profile Diagnostics. 📍 California Academy of Sciences 🎟️ Early bird discounted tickets are ON SALE NOW AND END NEXT WEEK! Secure your seat → https://lnkd.in/gZdQxbQt #pdawcc #cellgenetherapy #gala #networking #biotech #pharma #lifesciences

Last week, our team had the privilege of hosting the PDA WCC Interactive Seminar at the South San Francisco Conference Center. The event brought together quality and regulatory professionals to explore strategies for achieving inspection readiness that go beyond compliance. Throughout the day, attendees engaged with expert-led sessions covering: 🔹 Regulatory requirements and inspection expectations 🔹 Manufacturer-sponsor collaboration for PAI success 🔹 Inspection readiness infrastructure and support 🔹 Real-world case studies and group discussions Interactive discussions, knowledge checks, and Q&A sessions fostered meaningful dialogue and practical takeaways for strengthening inspection readiness programs. We are grateful to our speakers, volunteers, and attendees for making the seminar a highly productive and insightful experience. It’s inspiring to see the commitment across our community to advance quality, compliance, and operational excellence in life sciences. Speakers: James "Jim" Stumpff, Jennifer Cheung, Diana Aberion Organizers: Ming Lei, Nikoo Arasteh Officers: Yashu Sarna, Autumn Lee, Deirdre Killebrew (PhD, PMP), Alaina Touchton #PDAWCC #PharmaQuality #InspectionReadiness #ComplianceExcellence #LifeSciences #GMP #QualityCulture #PharmaManufacturing

Join PDA West Coast Chapter (PDA WCC) and Emery Pharma' free joint SIPS and Learn Session! 📅 Thursday, October 30 | 5:00–8:30 PM PT 📍 Emery Pharma, 1000 Atlantic Ave, Suite 110, Alameda, CA Gain valuable perspectives from industry leaders as they discuss key CMC considerations for parenteral and novel drug modalities. The panel will highlight common pitfalls, innovative strategies, and best practices to streamline development from lab to clinic. Moderator: Aryo Nikopour Speakers: Milan Tomic, Ramin (Ron) Najafi, Ph.D., Laurent Claisse, and Fariba Chalajour 🎃In the spirit of Halloween, costumes are welcome- and the best costume wins a prize! 🔗 Click the link below to register now! https://lnkd.in/gGidk3Tj #biotech #biopharma #networking

🌟 Meet Vinita Kumar, one of our fantastic panelists for our upcoming Quality Ball in San Francisco on Friday, November 7th from 6-10:30 pm! Vinita P. Kumar is currently at Mirum Pharmaceuticals as the Senior Vice President and Head of Global Quality. She is responsible for overseeing GxP quality operations across Mirum’s clinical, laboratory, document control, training, and IT systems. She led the development of quality strategy to enable Global launch of Mirum products. She was also instrumental in developing and executing global inspection readiness strategies, which includes the oversight of quality management system implementation and ongoing maintenance. Vinita has more than three decades of experience, distinguished by her ability to cultivate high-performing quality teams and seamlessly transition programs from early development through commercialization. Prior to her role at Mirum, she held significant quality leadership positions at Corcept Therapeutics (2018-2021), Versartis (2016-2018), and Relypsa (2007-2016). Her extensive background also includes work at various Bay Area biotech companies, notably NAME5/Roche, where she contributed to areas such as pre-formulation, analytical development, manufacturing, and quality control. Vinita earned a Master of Science in physical organic chemistry from Southern Illinois University, and holds both a Master of Science in organic chemistry and an undergraduate degree from Patna University. 📍 California Academy of Sciences 🎟️ Early bird discounted tickets are ON SALE NOW AND END THIS WEEK! Secure your seat → https://lnkd.in/gZdQxbQt #pdawcc #cellgenetherapy #gala #networking #biotech #pharma #lifesciences

🌟 Meet Gary Koe, one of our fantastic panelists for our upcoming Quality Ball in San Francisco on Friday, November 7th from 6-10:30 pm! Gary Koe serves as Chief Technical Officer at Electra Therapeutics, bringing more than 30 years of expertise in biopharmaceutical development, large-scale biologics manufacturing, and quality operations. Throughout his career, he has played a pivotal role in advancing complex biologics programs through the various phases of clinical development. Before joining Electra Therapeutics, Gary was Head of Technical Operations at Aravive, Inc., where he led the large-scale manufacturing of a novel affinity Fc-sAXL fusion protein. His prior experience includes leadership roles of increasing responsibility at prominent biopharmaceutical companies such as Genentech, Valentis, Revance, and Versartis. Gary has overseen the scale-up, technology transfer, manufacturing, and quality control testing for numerous clinical-stage biologics and has managed operations across more than ten manufacturing facilities, including both in-house and contract development and manufacturing organizations (CDMOs). Gary holds a PhD in Chemical Engineering from the University of California, Los Angeles, and a BS in Chemical Engineering from the University of California, Davis. 📍 California Academy of Sciences 🎟️ Early bird discounted tickets are ON SALE NOW AND END THIS WEEK! Secure your seat → https://lnkd.in/gZdQxbQt #pdawcc #cellgenetherapy #gala #networking #biotech #pharma #lifesciences

🌟 Meet Parsa (Al) Famili, one of our fantastic panelists for our upcoming Quality Ball in San Francisco on Friday, November 7th from 6-10:30 pm! Parsa Famili, is the President and CEO of Novatek International. He was honored as the business personality of Year 2019 for expanding Novatek worldwide. Novatek International has won several awards for Innovations, Export and Corporate Citizenship since its inception in 1996. Novatek’s products and solutions are in use in hundreds of corporations around the globe. Mr. Famili started his career as a professor of Chemistry at Vanier College and held senior management positions in the quality departments of several pharmaceutical companies in Montreal prior to joining Novatek. He is a worldwide speaker and author of several scientific papers and chapters. Mr. Famili has created and volunteers at Hope for Dementia Charity to give back to the society. Hope for Dementia is a registered Charity dedicated to supporting prevention, early diagnosis and treatment of dementia and other cognitive disorders. Mr. Famili received the King Charles III coronation medal for his charity work in 2025. 📍 California Academy of Sciences 🎟️ Early bird discounted tickets are ON SALE NOW AND END THIS WEEK! Secure your seat → https://lnkd.in/gZdQxbQt #pdawcc #cellgenetherapy #gala #networking #biotech #pharma #lifesciences

🌟 Meet Matt Cushing, our fantastic moderator for our upcoming Quality Seminar in San Francisco on Friday, November 7th from 6-10:30 pm! Matt Cushing is the Vice President of Quality and Science at Nelson Laboratories, where he oversees global initiatives and regulatory interactions for teams across multiple sites to uphold the company’s standards in quality, service, and science. With over 20 years of leadership experience in highly regulated environments—including GMP, GLP, ISO, FDA, and more—Matt brings a deep commitment to quality systems and people-centric leadership. His career at Nelson Labs spans roles from Quality Auditor to Senior Director and now Vice President, during which he has successfully managed global quality integration, high-risk scientific issues, and regulatory responses. Matt is known for building high-performing teams and mentoring future leaders, including facilitating leadership development programs, and participating in and driving mentorship initiatives across Sotera Health. A recipient of numerous academic and professional honors—including the President’s Award from the University of Utah and the 2025 Nelson Labs Inspired Mentorship Award—Matt continues to model values-driven leadership with a focus on service, collaboration, and continuous improvement. 📍 California Academy of Sciences 🎟️ Early bird discounted tickets are ON SALE NOW AND END NEXT WEEK! Secure your seat → https://lnkd.in/gZdQxbQt #pdawcc #cellgenetherapy #gala #networking #biotech #pharma #lifesciences

Join us for the PDA West Coast Chapter (PDA WCC)'s 2025 Quality Ball located at the California Academy of Sciences, a renowned research institute and natural history museum located in San Francisco's Golden Gate Park. The event will be focusing on the critical intersection of quality, compliance, and innovation in today’s rapidly evolving industries. This thought-provoking gathering will explore how these three areas can work in harmony to overcome challenges, drive success, and improve outcomes in today's industry. As new technologies emerge, innovation plays a crucial role in advancing quality improvements and enabling more efficient, effective ways of working. But how do we balance the drive for cutting-edge solutions with the rigorous demands of quality and compliance? This event will dive deep into the synergies—and tensions—between these three forces, while also addressing the challenges that regulations can place on technological advancement. Moderator: Matt Cushing Speakers: Parsa (Al) Famili, Gary Koe, Vinita Kumar, and Eric Fulmer 🔗 Click the Eventbrite link below to register now- early bird ticket sales end NEXT WEEK! Tickets are limited. https://lnkd.in/g5zZmMjd #pdawcc #biotech #biopharma #networking

✨ #FlashbackFriday ✨ Our PDA West Coast Chapter (PDA WCC) Board Members-at-Large Stephanie Lee, Ming Lei and Hanh-Uyen Nguyen were proud to attend the PDA - Parenteral Drug Association Regulatory Conference, a cornerstone event bringing regulators and industry leaders together to advance effective quality systems across the product lifecycle. We’re grateful to represent the West Coast Chapter at such an impactful event! #PDA #RegulatoryConference #QualitySystems #PharmaLeadership

🍻 Thank you to everyone who joined us for our annual Oktoberfest & Vendor Night! What do you get when you bring together over 300 biotech professionals, 23 incredible companies, smoked BBQ, an ice cream truck, a selection of local craft beer and exiting giveaways? An unforgettable evening of networking, learning, and celebration! Hosted at Devil’s Canyon Brewing Co. in San Carlos on September 18th, this year’s Oktoberfest was one of PDA WCC’s most anticipated events. The night featured casual conversations, vendor showcase, and our first research poster session where local university students showcased their work.  Whether you reconnected with familiar faces or forged new relationships, we hope you left with fresh perspectives, practical solutions, and new friendships. Events like this are possible thanks to the generosity of our vendors and the dedication of our volunteers. Thanks to all of our Sponsors for the event: Bayer Beckman Coulter Life Sciences Benchmark Products bioMérieux Bionova Scientific Boehringer Ingelheim Element Materials Technology Emery Pharma Entegris Eurofins Genentech Gilead Sciences Global Compliance Partners Körber Pharma Mango Inc MilliporeSigma Nelson Labs Novatek International Optimal Biotech Group Prudential Cleanroom Services Thermo Fisher Scientific Veltek Associates, Inc. ValSource Inc. Special thanks to our organizing leads: Jamie Alcira Lopez, Yashu Sarna, Namrata Sher, Rick (Ruikang) Tao, and Kaushik Thakkar. We can’t wait to see you at future PDA WCC events! 👉 Register for our Beyond Compliance: Inspection Readiness for Pharma Manufacturers & Sponsors Seminar here: https://lnkd.in/gSixqQn7 👉 Register for our Quality Ball here: https://lnkd.in/gQXZsMWP #PDAWCC #Networking #LifeSciences #Oktoberfest